VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1442259
Sex: U
Age:
State: NV

Vax Date: 06/22/2021
Onset Date: 06/22/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: no other AEs reported; PROQU AD was accidentally administered intramuscularly on 22Jun2021.; This spontaneous report was received from a nurse who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided. On 22-JUN-2021, the patient was accidentally vaccinated with dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) 1 injection, via intramuscular route (lot number T016989 was confirmed to be valid; expiration date was not reported but upon internal validation process, it was established as 11-NOV-2021; strength, dose, route of administration and anatomical location were not provided) for prophylaxis. No adverse events were reported.

Other Meds:

Current Illness:

ID: 1442260
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: she had a high fever for a week. going up to 105 degrees; This spontaneous report was received via Pfizer from a currently 63 years old female patient reporting on herself. The patient's pertinent medical history included fever of 105F when she was a baby after receiving the Smallpox vaccine. Concurrent conditions included hypersensitivity and concomitant medication was not provided. On an unspecified date, when the patient was 9 years old, she was was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) dose, route of administration, anatomical location, lot number and expiration date were not provided for prophylaxis. On an unspecified date, the patient experienced a high fever for a week, going up to 105 degrees. The reporter stated that her physicians said that her body reacted "fairly strenuously to the introduction of foreign substances". The outcome of pyrexia was unknown, the reporter did not assess the causal relationship between the fever and the vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown).

Other Meds:

Current Illness: Hypersensitivity reaction

ID: 1442261
Sex: U
Age:
State: NJ

Vax Date: 03/22/2021
Onset Date: 03/22/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported. On 22-MAR-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error). It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided. This is one of the multiple reports reported by the same reporter.; Sender's Comments: US-009507513-2106USA007360: US-009507513-2106USA007361: US-009507513-2106USA007362:

Other Meds:

Current Illness:

ID: 1442262
Sex: U
Age:
State: NJ

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported. On 26-MAR-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error). It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided. This is one of the multiple reports reported by the same reporter. ; Sender's Comments: US-009507513-2106USA007355:

Other Meds:

Current Illness:

ID: 1442263
Sex: U
Age:
State: NJ

Vax Date: 06/21/2021
Onset Date: 06/21/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported. On 21-JUN-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error). It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided. This is one of the multiple reports reported by the same reporter.; Sender's Comments: US-009507513-2106USA007355:

Other Meds:

Current Illness:

ID: 1442264
Sex: U
Age:
State: NJ

Vax Date: 03/29/2021
Onset Date: 03/29/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported. On 29-MAR-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error). It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided. This is one of the multiple reports reported by the same reporter.; Sender's Comments: US-009507513-2106USA007355:

Other Meds:

Current Illness:

ID: 1442265
Sex: U
Age:
State: NJ

Vax Date: 03/31/2021
Onset Date: 03/31/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported. On 31-MAR-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error). It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided. This is one of the multiple reports reported by the same reporter.; Sender's Comments: US-009507513-2106USA007355:

Other Meds:

Current Illness:

ID: 1442266
Sex: U
Age:
State: IN

Vax Date:
Onset Date:
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: inadequate titer response; This literature marketed report was received from the authors of a published literature article, titled as stated below, and refers to a child patient of unknown age and gender (mean age of group of the patients in the article was 12 years old +/- 2.9). The patient's concurrent conditions included sickle cell disease (SCD) and immunodeficiency. The patient's medical history included chronic transfusion therapy. The patient was vaccinated with 7-valent pneumococcal conjugate vaccine (reported as PCV7) or 13-valent pneumococcal conjugate vaccine (reported as PCV13), or both. On an unknown date, the patients was vaccinated with 2 doses of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as PPSV23), for prophylaxis (dose, route of administration, lot # and expiration date were not provided). The vaccinations were given at 2 and 5 years of age, or in 3 to 5 years interval if vaccination was initiated at a later age. Five (+/- 1) years after completion of a 2-dose pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) vaccination series (also reported as 5.42 +/- 1.19 years) , the patient had inadequate titers (also reported as inadequate response) which was defined as immunoglobin (Ig) G levels less than 1.3 mcg/mL. The patient did not have any serious pneumococcal infections. The outcome of the event was not provided. The data analysis did not demonstrate associations between disease characteristics with an inadequate immune response. It was considered that the event was related to the suspect vaccine, as the authors stated that the patient had inadequate titers despite vaccination. A copy of the published article is attached as further documentation of the patient's experience. This is one of two reports derived from the same literature article (cross-referenced with US-009507513-2106USA002866).; Sender's Comments: US-009507513-2106USA002866:

Other Meds:

Current Illness: Immunodeficiency; Sickle cell disease

ID: 1442267
Sex: U
Age:
State: CA

Vax Date: 06/25/2021
Onset Date: 06/25/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: no other AEs reported; Caller is a medical assistant reporting that a 35 year old patient received a dose ofPROQUAD today, 25Jun2021. Per caller, the patient was supposed to receive MMR II and V ARlV AX separately.; Caller is a medical assistant reporting that a 35 year old patient received a dose ofPROQUAD today, 25Jun2021. Per caller, the patient was supposed to receive MMR II and V ARlV AX separately.; This spontaneous report was received from a medical assistant and refers to a 35-year-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 25-JUN-2021, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human albumin) (PROQUAD) lot # T027112 was confirmed to be valid, expiration date 07-FEB-2022, 1 injection for prophylaxis (exact dose, route and site of administration were not reported) (inappropriate age at vaccine administration ). The patient was supposed to receive Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) separately (wrong vaccine administered). No additional adverse event was reported.

Other Meds:

Current Illness:

ID: 1442268
Sex: U
Age:
State: NJ

Vax Date: 06/15/2021
Onset Date: 06/15/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: NO additional AE's; M-M-R II that underwent a temperature excursion and was administered.; This spontaneous report was received from an office manager and refers a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 15-JUN-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # S020162 was confirmed to be valid, expiration date 30-JUN-2021, for prophylaxis (dose, route and site of administration were not reported). The administered dose was exposed to the temperature of 57 degrees Fahrenheit (F) for 1 hour and 53 minutes, 56.3 F for 48 minutes, 47.8 F for 11 minutes and 47.8 F for 5 minutes. The previous temperature excursion was reported as temperature out of range on 03-JUN-2020 for 1 hour and 53 minutes and reached 57 F, 04-JUN-2020 for 48 minutes and reached 56.3 F, 10-SEP-2020 for 11 minutes and reached 47.8 F. The call was because of a digital data logger. No additional adverse event was reported.

Other Meds:

Current Illness:

ID: 1442269
Sex: U
Age:
State: NJ

Vax Date: 06/24/2021
Onset Date: 06/24/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: No additional AE's.; temperature excursion that occurred on ROTATEQ; This spontaneous report was received from a physician referring to patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 24-JUN-2021, the patient was vaccinated with oral rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, frequency, were not provided) for prophylaxis. Lot No. T028130 has been verified to be a valid lot number for [rotavirus vaccine, live, oral, pentavalent], expiration date reported as 28-JAN-2022, and upon internal validation established as the same. The physician reported that the vaccine dose was administered on 24-JUN-2021 to the patient and the vaccine was improperly stored (incorrect product storage). The vaccine presented a temperature excursion with digital data logger, at a temperature of 36 Fahrenheit (F) to 46F (47.8F) for 0 hours 5 minutes and 0 seconds and a second temperature excursion with a temperature of 36F to 46F (47.8F) for 0 hours 5 minutes and 0 seconds. No previous temperature excursion had occurred. And no adverse events were reported.

Other Meds:

Current Illness:

ID: 1442270
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: unspecified number of patients have potentially been given a smaller than recommended dose; prescribing information is confusing and contradictory; no additional information; This spontaneous report as received from a nurse, referring to multiple unspecified patients of unknown age and unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided. On an unknown date, the patients was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (0.5 ml, strength, route and lot# were not provided), measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (0.5 ml, strength, route and lot# were not provided) and varicella virus vaccine live (oka/merck)(VARIVAX) (0.5 ml, strength, route and lot# were not provided) for prophylaxis (an unspecified number of patients have potentially been given a smaller than recommended dose) (underdose). The prescribing information was confusing and contradictory (product label confusion). In section 2.2 of the prescribing information it states to withdraw the entire amount of the reconstituted vaccine, inject the total volume and discard the vial. She states that most of the time the reconstituted amount is greater than 0.5 ml. She has always administered 0.5 ml which the prescribing information also states as the appropriate dose (section 2.1). She was concerned because "for 10 years" that she has worked in pediatrics she had given and taught other nurses and MA's to give 0.5 ML dose of the vaccine. She is worried that the children have not been adequately vaccinated based on this information in the prescribing information (Section 2.2). No additional information. This is a non-valid case due to no patients' identifiers.

Other Meds:

Current Illness:

ID: 1442271
Sex: U
Age:
State: IN

Vax Date: 06/28/2021
Onset Date: 06/28/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: No additional adverse events reported; an expired dose of ROTATEQ was administered today; This spontaneous report was received from a medical assistance regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not provided. On 28-JUN-2021 (reported as "today"), the patient was vaccinated with 1 expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot number 1660992 has been verified to be valid, expiration date reported and validated as 30-APR-2021; vaccination scheme frequency was not reported) via oral route for prophylaxis (expired product administered). It was also reported that Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was properly stored up through the time of administration.

Other Meds:

Current Illness:

ID: 1442272
Sex: F
Age:
State: HI

Vax Date: 05/09/2021
Onset Date:
Rec V Date: 07/02/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: Facial paralysis; This case was received via FDA VAERS (Reference number: 1389251) on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of FACIAL PARALYSIS (Facial paralysis) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (diflucan) and Allergy (poppy seeds). On 09-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FACIAL PARALYSIS (Facial paralysis) (seriousness criteria hospitalization and medically significant). At the time of the report, FACIAL PARALYSIS (Facial paralysis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication information was not provided. Treatment medication information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Allergy (poppy seeds); Drug allergy (diflucan)

ID: 1442273
Sex: U
Age:
State:

Vax Date: 10/01/2020
Onset Date: 04/19/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: first shot last Oct 2020; experienced the allergic reactions; This case was reported by a consumer and described the occurrence of allergic reaction in a unspecified number patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 19th April 2021, between 5 and 7 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the allergic reaction and incomplete course of vaccination were unknown. It was unknown if the reporter considered the allergic reaction to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported for 1st dose. The patient received 1st dose and experienced allergic reaction. Till the time of reporting, patient didn't received second dose of Shingrix, which led to incomplete course of vaccination. This case was linked with US2021AMR137024, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR137024:Same reporter

Other Meds:

Current Illness:

ID: 1442274
Sex: F
Age: 24
State: NY

Vax Date: 10/06/2020
Onset Date: 10/07/2020
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: Mild anaphylaxis; This case was reported by a nurse via sales rep and described the occurrence of anaphylaxis in a 25-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number 7923K, expiry date unknown) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 6th October 2020, the patient received Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 7th October 2020, 1 days after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the patient experienced . On an unknown date, the outcome of the anaphylaxis and were unknown. The reporter considered the anaphylaxis to be related to Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The patient had received Fluarix and experienced mild anaphylaxis on the next day after vaccination. The patient went to Emergency Room and was out of work for the day. Reporter and Emergency Room's doctor believed that the event was related to the vaccine. The reporter consented to follow-up.

Other Meds:

Current Illness:

ID: 1442275
Sex: M
Age:
State: MD

Vax Date: 06/21/2021
Onset Date: 06/21/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: Rotarix dose via IM instead of oral; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate route of vaccination in a 5-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 7S55T, expiry date 7th September 2021) for prophylaxis. Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator (batch number 7S55T, expiry date 7th September 2021) for prophylaxis. On 21st June 2021, the patient received the 1st dose of Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 21st June 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows: On 21st June 2021, the patient received a Rotarix dose via IM instead of oral, wrong route of administration occurred which led to inappropriate route of vaccination. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1442276
Sex: M
Age: 0
State: PA

Vax Date: 06/29/2021
Onset Date: 06/29/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: patient received a dose of expired Pediarix.; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 7-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number YS4Z5, expiry date 21st June 2021) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 29th June 2021, the patient received Pediarix (intramuscular) .5 ml and Pediarix Pre-Filled Syringe Device. On 29th June 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows : This case was reported by a nurse. The nurse reported that the patient received a dose of Pediarix, which was expired on 21st June 2021. The Health care professional reported the dose was 0.5 ml. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1442277
Sex: M
Age:
State:

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 07/02/2021
Hospital: Y

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: BILATERAL LOWER EXTREMITY PAIN; MULTIPLE ACUTE BILATERAL PULMONARY EMBOLI; PLATELET COUNT DECREASED; DEEP VEIN THROMBOSIS; VACCINE INDUCED THROMBOTIC THROMBOCYTOPENIA; ULTRASOUND DOPPLER ABNORMAL; FULL BLOOD COUNT; METABOLIC FUNCTION TESTS; MUSCLE SPAMS; SWELLING; MILD HEADACHE; This spontaneous report was received from a health care professional via a Regulatory Authority and from literature: Vaccine-induced thrombotic thrombocytopenia following Ad26.COV2.S vaccine in a man presenting as acute venous thromboembolism. 2021 Jun 03;1-4., and concerned a 48 year old white male (not Hispanic or Latino). The patient's height, and weight were not reported. The patient's concurrent conditions included exercise induced asthma, and no tobacco use (both current and historically), and other pre-existing medical conditions included the patient had no known allergies. The patient was not obese, denied recent procedures, prolonged immobility, family history of bleeding or clotting disease, etc. The patient was up to date on cancer screenings based on age/family history. He was reported as being an unusually physically active and fit 48 year-old male who has enjoyed good health and exercised regularly. In 2019, his platelet count was 177 10*9/L. The patient reported flying out of town and back on 30-MAR-2021 and 04-APR-2021 respectively with the longest continuous flight lasting around 4 hours. The patient at age 48, received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included finasteride, and salbutamol. On an unspecified date in APR-2021, the patient experienced mild headache. On 18-APR-2021, 11 days after receiving the vaccine, the patient experienced deep vein thrombosis, vaccine induced thrombotic thrombocytopenia; new pain in his big toe, bilateral leg cramping (muscle spasm), bilateral lower extremity pain, and swelling. The patient attributed soreness in the large muscle groups of his thighs to Peloton riding and exercise. The patient travelled again via airplane to an unspecified location 22-APR-2021 and 25-APR-2021 (both1 hr long flights). The patient administered Advil for the leg pain when he returned on an unspecified date. On an unspecified date he felt a leg vessel that "didn't seem right." On 26-APR-2021 the patient went to emergency department for evaluation presenting with leg pain and chest discomfort. He had normal vital signs and oxygen saturation. Additional laboratory results: Platelet count (NR 140-440 K/uL) 74; fibrinogen (NR 150-430 mg/dL) of 254; D-dimer (NR 0-499 ng/mL FEU) 15,109 ng/mL FEU; activated partial thromboplastin time (aPTT) (NR 25.1-36.5 s) 31.8. Venous duplex ultrasound of the lower extremities revealed non-occlusive DVT in the bilateral popliteal veins extending to the gastrocnemius veins, an occlusive DVT of the left posterior tibial vein, as well as occlusive superficial venous thrombosis in the bilateral saphenous veins. The patient was discharged from the emergency room on rivaroxaban 15 mg twice daily with two-day follow-up with his primary care physician. He had no known exposure to heparin before the onset of symptoms and no exposure during his emergency room visit. On 28-APR-2021 (also reported as the next day), the patient complained of a new onset of chest pain (pleuritic) and presented again to the emergency room. Chest CT showed presence of acute pulmonary embolism, with emboli present in segmental and more proximal arteries. He had already taken his rivaroxaban for the night (1800). The patient was hospitalized for further evaluation and work up. A peripheral smear showed thrombocytopenia without schistocytes. The hematology service was consulted, and a presumptive diagnosis of VITT (vaccine induced thrombotic thrombocytopenia) was made. His anti-PF4 enzyme-linked immunosorbent assay (ELISA) (LIFECODES PF4 IgG), performed on a sample collected prior to initiating IVIG therapy, demonstrated a strongly positive result of 3.323 optical density (OD) units (reference interval < 0.399), consistent with a diagnosis of VITT. The patient was immediately treated with 1 g/kg of intravenous immunoglobulins (IVIG) for 2 days, 1 mg/kg of prednisone, and switched from rivaroxaban to an intravenous argatroban infusion drip, during which he achieved therapeutic aPTT levels between 44 - 50 sec. The patient was also treated with apixaban. Other studies included: Magnetic resonance venography (MRV) and angiography (MRA) of the brain, performed due to symptoms of mild headaches, were unremarkable. Platelet factor 4 (NR: not provided) strong positive at 2.9 OD; Prothrombin mutation G20210A not detected, Red blood cell count (NR: 3.98 - 5.98) 5.07 M/ microliter, Red blood cell sedimentation rate (NR: not provided) Normal, SARS-CoV-2 test was negative, Serotonin release assay was positive, and WBC (NR: 3.2 - 10.6) 5.8 K/microliter. Anticardiolipin antibodies (NR: not provided) 5 GPL, Beta-2 glycoprotein 1 antibodies (NR: 0 - 20) 0 SGU, 5 SMU, Blood homocysteine (NR: not provided) 13.4 nml (normal), C-reactive protein (NR: not provided) 2.6, Cardiolipin immunoglobulin G (NR: 0 - 12) 6 MPL, Cell marker increased was positive, EKG (NR: not provided) Normal, Hematocrit (NR: 36.9 - 52.1) 42.2 %, Hemoglobin (NR: 2.5 - 18.0) 15.0 g/dL, Lupus anticoagulant (NR: not provided) not detected, MCHC (NR: 33.4 - 35.3) 35.5 g/dL, MCV (NR: 80.6 - 97.6) 83.2 fL. On an unspecified date the serotonin release assay was no longer positive. Within a week post-discharge, the patient developed recurrent thrombocytopenia, with a platelet count that down trended to 107 10*9/L His thrombocytopenia appeared to somewhat correlate with prednisone dose adjustments, suggesting an autoimmune-driven process, although it did not respond to repeat IVIG administration. Due to the normalized D-Dimer levels and negative SRA, it was assumed that there was no further ongoing platelet activation. The authors stated the patient had no prior risk factors for thrombosis other than the 2 recent 4-hour flights. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bilateral lower extremity pain, was recovering from deep vein thrombosis, vaccine induced thrombotic thrombocytopenia, platelet count decreased, swelling, full blood count, metabolic function tests, muscle spasms, ultrasound doppler abnormal, and multiple acute bilateral pulmonary emboli, and the outcome of mild headache was not reported. This report was serious (Hospitalization Caused / Prolonged). This case is a duplicate of 20210642952. Additional information was received from literature article on 19-JUN-2021. The following information was updated and incorporated into the case narrative: literature reference information, additional reporters, laboratory data, updated events. It has been determined that Manufacture Report Number 20210514958 is a duplicate of deleted case 20210642952. All relevant information from Manufacture Report Number 20210642952 will be reported in this case 20210514958.; Sender's Comments: V2: Follow up consisted of a literature citation, presenting this case as a case report. This does not change the previous assessment. This case obtained via VAERS (ID 1264060) concerns a 48-year-old White male who developed symptoms of bilateral lower extremity deep vein thromboses (DVT) and thrombocytopenia 11 days after receiving Janssen Covid-19 vaccine. Concurrent conditions included exercise induced asthma. Patient was not obese, did not smoke, denied recent procedures, family history of bleeding/clotting disease & was physically active. He was up to date on cancer screenings based on age/family history. He had taken two 1-hour long flights 15 days and 18 days post-vaccination. Concomitant medications included finasteride & salbutamol. After 1 week of bilateral leg cramping & swelling which began 11 days post-vaccination, he presented to emergency department (ED) where complete blood count showed platelets 74 k/uL, peripheral smear with gi

Other Meds: FINASTERIDE; ALBUTEROL [SALBUTAMOL]

Current Illness: Exercise induced asthma; Non-smoker

ID: 1442278
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: SWELLING OCCURRING FROM TIME TO TIME IN LEFT FOOT/SWELLING OF LEFT FOOT AND RIGHT HAND/FINGER; BRUISE; TENDERNESS; BURNING SENSATION; VEINS ARE MORE PUFFED UP DISTENDED AND SWOLLEN; DISCOLORATION OF FOOT AND HAND/ FINGER; LESION/BLISTER ON FOOT; ITCHING ON LEFT FOOT; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight was 200 pounds, and height was 65 inches. The patient's concurrent conditions included deep vein thrombosis, hypothyroidism, hypertension, penicillin allergy, nickel allergy, wasp sting, peanut allergy, alcohol user, and non smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: 20-MAY-2021) dose was not reported, administered on 11-MAR-2021 15:11 for prophylactic vaccination. Concomitant medications included epinephrine for anaphylaxis, cannabidiol for burning sensation on back of hand/are of foot or hand, acetylsalicylic acid for prevention of deep vein thrombosis, amlodipine for treatment of hypertension, and levothyroxine sodium for treatment of hypothyroidism. On APR-2021, the subject experienced lesion/blister on foot. On APR-2021, the subject experienced itching on left foot. On 17-APR-2021, the subject experienced discoloration of foot and hand/ finger. On an unspecified date, the subject experienced swelling occurring from time to time in left foot/swelling of left foot and right hand/finger, bruise, tenderness, burning sensation, and veins are more puffed up distended and swollen. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, and X-ray (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lesion/blister on foot, had not recovered from itching on left foot, discoloration of foot and hand/ finger, swelling occurring from time to time in left foot/swelling of left foot and right hand/finger, and bruise, and the outcome of tenderness, burning sensation and veins are more puffed up distended and swollen was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

Other Meds: AMLODIPINE; SYNTHROID; EPIPEN; ACETYLSALICYLIC ACID; CANNABIDIOL

Current Illness: Alcohol use (The patient consumes alcohol very, very rarely - e.g. 1 glass of wine once yearly.); Deep vein thrombosis (Patient was hospitalized for 5 days and was prescribed low dose ASA once daily long-term.); Hypertension; Hypothyroidism; Nickel sensitivity (Irritation of skin); Non-smoker; Peanut allergy (Vomiting, heavy , severe GI reaction.); Penicillin allergy (oral swelling); Wasp sting (anaphylaxis - carries epi-pen now initial reaction in summer 2020 sent Patient to hospital.)

ID: 1442279
Sex: F
Age:
State: IN

Vax Date:
Onset Date: 06/21/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: WEIRD DREAMS; COGNITIVE CHANGES; FEELING LIKE FREEZING; CHILLS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-JUN-2021, the subject experienced feeling like freezing. On 21-JUN-2021, the subject experienced weird dreams. On 21-JUN-2021, the subject experienced cognitive changes. On 21-JUN-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, weird dreams, cognitive changes, and feeling like freezing. This report was non-serious.

Other Meds:

Current Illness:

ID: 1442280
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 06/19/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: KNOT AT INJECTION SITE (2 INCHES IN DIAMETER); INJECTION SITE WARMTH; ACHINESS IN THE LEFT ARM; STIFFNESS IN LEFT ARM; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and pneumonia, and concurrent conditions included haskimoto thyroiditis, fibromyalgia, asthma, and allergies. The patient experienced ibuprofen allergy when treated with ibuprofen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the subject experienced stiffness in left arm. On 19-JUN-2021, the subject experienced achiness in the left arm. On 21-JUN-2021, the subject experienced knot at injection site (2 inches in diameter). On 21-JUN-2021, the subject experienced injection site warmth. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive, Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stiffness in left arm, and achiness in the left arm on 21-JUN-2021, and was recovering from knot at injection site (2 inches in diameter), and injection site warmth. This report was non-serious.; Sender's Comments: V0-Medical Assessment comment is not required as per standard procedures, as the case was assessed as non-serious.

Other Meds:

Current Illness: Allergy multiple; Asthma; Fibromyalgia; Hashimoto's thyroiditis (Prescribed antibiotics.)

ID: 1442281
Sex: F
Age:
State: WA

Vax Date:
Onset Date: 03/14/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: A STRONG HEADACHE; DID NOT EAT MUCH; UNEXPECTED THERAPEUTIC BENEFIT/ ROSACEA SYMPTOMS IMPROVED/DISAPPEARED; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included bruising on thumb, and concurrent conditions included rosacea, iodine allergy, dust allergy, pollen allergy, pustules mostly present on her face and nose, and ocular rosacea. The patient was previously treated with acetylsalicylic acid for bruising on thumb; and experienced drug allergy when treated with dextropropoxyphene hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. Concomitant medications included doxycycline for ocular rosacea, rosacea, and pustules mostly present on her face and nose, and clindamycin. On 14-MAR-2021, the subject experienced unexpected therapeutic benefit/ rosacea symptoms improved/disappeared. On 15-MAR-2021, the subject experienced a strong headache. On 15-MAR-2021, the subject experienced did not eat much. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a strong headache on 16-MAR-2021, and the outcome of unexpected therapeutic benefit/ rosacea symptoms improved/disappeared and did not eat much was not reported. This report was non-serious.

Other Meds: DOXYCYCLINE; CLINDAMYCINE [CLINDAMYCIN]

Current Illness: Dust allergy; Iodine allergy; Ocular rosacea (since her 30s, and has been on oral antibiotics, doxycycline); Pollen allergy; Pustule (since her 30s, and has been on oral antibiotics, doxycycline); Rosacea (for over 40 years (since her 30s, and has been on oral antibiotics, doxycycline))

ID: 1442282
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: FLU LIKE SYMPTOMS AFTER BEING VACCINATED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: paliperidone palmitate ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On an unspecified date, the subject experienced flu like symptoms after being vaccinated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with paliperidone palmitate was not reported. The outcome of flu like symptoms after being vaccinated was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1442283
Sex: F
Age:
State: AL

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: FLARE LOWER BACK/ SCALP/EARS AND ON FACE; A LOT OF PAIN; MAKING DAILY ACTIVITIES DIFFICULT; This solicited report received from a patient via PPSIMM001960: Pharmacy concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included morphine allergy. The patient was treated with guselkumab (solution for injection, subcutaneous, batch number was not reported) 100 mg, 1 time every 8 weeks, from 25-SEP-2020 for psoriatic arthritis. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, Expiry : unknown) dose was not reported, 1 total, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included naproxen for drug used for unknown indication, hydrochlorothiazide/triamterene, losartan potassium, metformin, and metoprolol. On MAY-2021, the patient experienced flare of Psoriatic arthritis in the lower back/ scalp/ears and on face. The patient was also experiencing a lot of pain, making daily activities difficult. The action taken with covid-19 vaccine ad26.cov2.s, and guselkumab was not applicable. The patient had not recovered from flare lower back/ scalp/ears and on face, a lot of pain, and making daily activities difficult. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and flare lower back/ scalp/ears and on face, a lot of pain, and making daily activities difficult was not related; and between guselkumab, and flare lower back/ scalp/ears and on face was related, and between guselkumab, and a lot of pain, and making daily activities difficult was not related. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210652721-covid-19 vaccine ad26.cov2. s- flare lower back/ scalp/ears and on face. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE. V0: 20210652721- Guselkumab- flare lower back/ scalp/ears and on face was related. This event(s) is labeled per regulatory authority and is therefore considered potentially related.

Other Meds: LOSARTAN POTASSIUM; METFORMIN; METOPROLOL; NAPROXEN; TRIAMTERENE/HCTZ

Current Illness: Drug allergy

ID: 1442284
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 05/12/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: LACTOSE INTOLERANCE; FEVER; SORE THROAT; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced sore throat. On 12-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. On 23-JUN-2021, the subject experienced lactose intolerance. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lactose intolerance, and the outcome of fever and sore throat was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1442285
Sex: M
Age:
State: IA

Vax Date:
Onset Date: 06/23/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: 2ML OF VACCINE ADMINISTERED TO A PATIENT; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) 2 ml, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-JUN-2021, the subject experienced 2ml of vaccine administered to a subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 2ml of vaccine administered to a patient was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1442286
Sex: M
Age:
State: CT

Vax Date:
Onset Date: 06/24/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: SICK FOR 1 DAY AFTER EVERY COUPLE OF WEEKS; SAD REACTION; SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a 45 year old male patient. The patient's weight was 170 pounds, and height was 68 inches. The patient's concurrent conditions included cancer and non smoker and other pre-existing medical conditions included no known allergies. The patient suffers from cancer and had gone through chemotherapy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: 1805018 expiry: unknown) dose was not reported, with frequency 1 total dose administered on APR-2021 (exact date asked but unknown) for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced sad reaction to the vaccine which lasted for 5 days (no hospitalization) and after every couple of weeks, patient felt sick for 1 day. On 20-JUN-2021, the patient started feeling fatigue and loss of appetite. On 23-JUN-2021, the patient tested for Covid-19, and the results came back positive on 24-JUN-2021. On 24-JUN-2021, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection. However, consumer could not provide details on the type of Covid-19 testing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick, and sad reaction, and the outcome of suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000184005. The suspected product quality complaint has been confirmed to be not voided, the reported allegation could not be confirmed. a manufacturing related root cause could not be identified. based on the PQC evaluation/investigation performed. Additional information received from product quality department on 28-JUN-2021. The following information was updated and incorporated into case narrative: PQC result updated.; Sender's Comments: V0: 20210654471-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, SPECIAL SITUATIONS.

Other Meds:

Current Illness: Cancer; Non-smoker

ID: 1442287
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 06/23/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: VACCINE ADMINISTERED TO A 14 YEAR OLD PATIENT; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 14 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-JUN-2021, the subject experienced vaccine administered to a 14 year old subject. On 23-JUN-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to a 14 year old patient and off label use was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1442288
Sex: M
Age:
State: UT

Vax Date:
Onset Date: 06/12/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: EXPIRED VACCINE USED; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no illness at the time of vaccination, past history of similar event, patient had no adverse event after any previous vaccination, patient had no history of allergy to vaccine, drug, or food, patient had no family history of any disease (relevant to vaccination) or allergy. it was not confirmed by test, if event is covid-19 infection. patient have no allergies and history of history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, expiry: 11-JUN-2021) .5 ml, administered on 12-JUN-2021 09:15 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced expired vaccine used. On 12-JUN-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine used and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210629340.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1442289
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 04/09/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: URINARY TRACT INFECTION SYMPTOMS (URGENCY TO URINATE AND BURNING)/ ELEVATED WBC AND NITRATES; UPSET STOMACH; INCREASED FREQUENCY OF BOWEL MOVEMENTS/NUMBER 2 MORE OFTEN; STIFF NECK; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 235 pounds, and height was 64 inches. The patient's past medical history included hysterectomy, gall bladder removal, lost voice, urinary tract infections, factor v leiden, and biceps tenodesis, and concurrent conditions included high blood pressure, seasonal allergies, and environmental allergies ( cannot use cleaners wheeze and headache with bleach, perfume).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included salbutamol for allergies, amlodipine for high blood pressure, lisinopril for high blood pressure, and epinephrine for stings. On 09-APR-2021, the subject experienced stiff neck. On JUN-2021, the subject experienced upset stomach. On JUN-2021, the subject experienced increased frequency of bowel movements/number 2 more often. On 16-JUN-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Enlarged liver, but her bladder was emptying properly, and Urine analysis (NR: not provided) Not reported. On an unspecified date, the subject experienced urinary tract infection symptoms (urgency to urinate and burning) / elevated wbc and nitrates. Laboratory data (dates unspecified) included: Urinalysis (NR: not provided) positive for increased WBC, nitrates and negative for infection, positive urinary tract infections. Treatment medications (dates unspecified) included: ibuprofen, nitrofurantoin, azithromycin, phenazopyridine, and phenazopyridine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from urinary tract infection symptoms (urgency to urinate and burning)/ elevated wbc and nitrates, and increased frequency of bowel movements/number 2 more often, and had not recovered from stiff neck, and upset stomach. This report was non-serious.

Other Meds: LISINOPRIL; AMLODIPINE; EPIPEN; ALBUTEROL

Current Illness: Blood pressure high (HBP treated with diet and exercise lisinopril 10 mg once daily, amlodipine 5 mg once daily); Environmental allergy (Environmental allergies: cannot use cleaners wheeze and headache with bleach, perfume); Seasonal allergy (Seasonal allergies mold, trees, weeds, pollen)

ID: 1442290
Sex: F
Age:
State: WI

Vax Date:
Onset Date: 03/17/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: BLOODY STOOL; INFLAMED BURSA OF LEFT HIP, RADIATING TOWARDS SPINE; ARTHRALGIA; MYALGIA; SLIGHTLY LOW KIDNEY FUNCTION; FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism. The patient had no known allergies. The patient was previously treated with cortisone in shoulder joint. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, 1 total, administered on 16-MAR-2021 on right arm for prophylactic vaccination. Concomitant medications included ascorbic acid, calcium, chondroitin sulfate/glucosamine hydrochloride, colecalciferol, levothyroxine sodium, and magnesium. In the morning of 17-MAR-2021, the patient felt some fatigue, stayed in bed until noon and fatigue disappeared in the afternoon. On 07-APR-2021, the patient started experiencing pain and soreness in hamstring, behind knees and in hips. The pain and soreness gradually progressed upwards towards spine. The symptoms were worse in the morning and evening, with the period between noon and 8 PM saw some improvement. Since pain and soreness started, the patient had been taking painkillers like candy, Tylenol (paracetamol), Advil (ibuprofen) and Aleve (naproxen sodium) and had no effect on symptoms. On 21-APR-2021, the patient had some bloody stool and saw primary care physician that week. The blood tests, bone density and thyroid function were done. Only finding of note was slightly low kidney function and diagnosis of myalgia and arthralgia. The patient was told to discontinue painkiller use. On 12-JUN-2021, the patient saw orthopedist, was diagnosed with inflamed bursa on the left hip, radiating towards spine and was prescribed a 5 days tapering course of prednisone. The symptoms disappeared starting on the second day of prednisone. The symptoms reappeared with same severity 2 days after stopping prednisone (19-JUN-2021). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bloody stool on 21-APR-2021, and fatigue on 17-MAR-2021, had not recovered from inflamed bursa of left hip, radiating towards spine, myalgia, and arthralgia, and the outcome of slightly low kidney function was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210660357-covid-19 vaccine ad26.cov2.s- bloody stool, slightly low kidney function. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds: SYNTHROID; OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]; CALCIUM; VITAMIN D3; VITAMIN C [ASCORBIC ACID]; MAGNESIUM

Current Illness: Hypothyroidism

ID: 1442291
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 06/01/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: POSSIBLE BLOOD CLOT ISSUE; ELEVATED HEART RATE (OVER 100 AT REST); KIDNEY PAIN; NO APPETITE; FLU LIKE SYMPTOMS; SWOLLEN GLANDS IN NECK; SERIOUS BRAIN FOG; DIARRHEA; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to contrast dye. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: unknown) dose was not reported, 1 total, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021 after getting vaccination, the patient experienced elevated heart rate of over 100 at rest for four days. On an unspecified date in JUN-2021 after vaccination, the patient also experienced shortness of breath, headache, kidney pain, diarrhea, no appetite, flu-like symptoms, swollen glands in neck, aches and pains and had severe fatigue. On 14-JUN-2021, after four days of vaccination, the patient heart rate decreased to a healthier range but shortness of breath, headache, swollen glands, extreme fatigue and diarrhea continued. The patient also had serious brain fog. On 21-JUN-2021, after 11 days of vaccination, the patient had a severe shortness of breath and the patient's PCP (primary care physician) directed patient to visit an emergency room in a hospital. The patient took blood test and showed an elevated d-dimer indicating possible blood clot issue. The patient could not perform lung CT (computed tomography) or angiography due to a severe allergy to contrast dye. The patient also had an MRI (magnetic resonance imaging) of brain and ultra sound of the legs and the results were normal. The patient was on day 16 post vaccination at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated heart rate (over 100 at rest) on 14-JUN-2021, had not recovered from flu like symptoms, swollen glands in neck, possible blood clot issue, serious brain fog, and diarrhea, and the outcome of shortness of breath, kidney pain and no appetite was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210660381-Covid 19 Vaccine ad26.cov2.s-Possible blood Clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness: Contrast media reaction

ID: 1442292
Sex: M
Age:
State: DE

Vax Date:
Onset Date: 06/24/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: USING WHEELCHAIR; FEEL LIKE COMPLETELY FULL BLADDER; URINATES 5 OR 6 TIMES IN THE LAST HOUR; SLUGGISH; MULTIPLE SCLEROSIS; PROBLEMS STANDING UP; This spontaneous report received from a consumer concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker, and no alcohol user, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage. patient had no any side effect from a previous vaccine in the past. he had cold as a cucumber and temperature is in normal range. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980 expiry: 04-AUG-2021) dose was not reported, administered on 24-JUN-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced multiple sclerosis, experienced problems standing up and sluggish. On 26-JUN-2021, the subject experienced feel like completely full bladder, urinates 5 or 6 times in the last hour, using wheelchair. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Normal. Treatment medications (dates unspecified) included: fampridine, and teriflunomide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sluggish, had not recovered from problems standing up, feel like completely full bladder, and urinates 5 or 6 times in the last hour, and the outcome of using wheelchair and multiple sclerosis was unknown. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210660422-COVID-19 VACCINE AD26.COV2.S-Multiple sclerosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s)

Other Meds:

Current Illness: Abstains from alcohol; Smoker (Patient smoke less than half a pack a day.)

ID: 1442293
Sex: M
Age:
State: AR

Vax Date:
Onset Date: 06/17/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: SWOLLEN LEFT LEG; LEG PAIN; This spontaneous report received from a patient concerned a 71 year old male. The patient's weight was 285 pounds, and height was 178 centimeters. The patient's concurrent conditions included high blood pressure, non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known allergies and no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) dose was not reported, administered on 12-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-JUN-2021, the subject experienced swollen left leg. On 17-JUN-2021, the subject experienced leg pain. Laboratory data included: Pain scale (NR: not provided) 8/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen left leg, and leg pain. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Blood pressure high (HIGH BLOOD PRESSURE-90/100); Non-smoker

ID: 1442294
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/11/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: Maternal exposure during pregnancy; This spontaneous pregnancy report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced maternal exposure during pregnancy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of maternal exposure during pregnancy was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1442295
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 03/20/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: CAR ACCIDENT; WHIPLASH INJURY; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; HEADACHE; This spontaneous report received from a patient concerned a 76-year-old female. The patient's height, and weight were not reported. The patient's past medical history included measles, and chicken pox. On 20-MAR-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the patient experienced headache on the day of vaccination. Treatment medications included: paracetamol. The reporter stated she was involved in car accident after 1-2 month of vaccination. The patient mentioned she received stem cell injections to treat whip lash injury following accident. On an unspecified date the patient reported that she had Covid-19 antibody test drawn by her primary care physician which came negative. On 24-JUN-2021, the patient had another lab test COVID IGG test, and the results came negative on 25-Jun-2021(confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 21-MAR-2021, and the outcome of confirmed immunological vaccine failure, car accident and whiplash injury was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210660662- covid-19 vaccine ad26.cov2.s - Confirmed Immunological failure. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug.

Other Meds:

Current Illness:

ID: 1442296
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: REACTION TO THE SHOT; This spontaneous report received from a consumer concerned multiple patients. The patient's height, and weight were not reported. The patient's concurrent conditions included birth control. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced reaction to the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of reaction to the shot was not reported. This report was non-serious.

Other Meds:

Current Illness: Birth control

ID: 1442297
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 06/25/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: ABDOMINAL PAIN, CRAMPS LIKE KIDNEY PAIN OR LIKE CRAMPING THAT COMES PREMENSTRUAL; PAIN OVER THE OVARY; BACK PAIN THAT IT IS ON THE RIGHT SIDE IS THE MOST; NAUSEA; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced abdominal pain, cramps like kidney pain or like cramping that comes premenstrual. On 25-JUN-2021, the subject experienced pain over the ovary. On 25-JUN-2021, the subject experienced back pain that it is on the right side is the most. On 25-JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from back pain that it is on the right side is the most, and the outcome of abdominal pain, cramps like kidney pain or like cramping that comes premenstrual, nausea and pain over the ovary was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1442298
Sex: F
Age:
State: OR

Vax Date:
Onset Date: 05/27/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; EXPIRED VACCINE WAS GIVEN; This spontaneous report received from a health care professional concerned a 43 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19 sars-cov2-igg, igm and iga (Immunoglobulin G Immunoglobulin M, Immunoglobulin A) The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 and expiry: 25/MAY/2021) dose was not reported, 1 total dose administered on 27-MAY-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. Vaccine stored in appropriate temperature condition and 30 minutes to an hour as an estimation removed from storage On 27-MAY-2021, the patient administered the expired vaccine was given and had a negative antibody test (unspecified date), Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine was given and suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000184136 The suspected product quality complaint has been confirmed to be void:y based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210660757 -COVID-19 VACCINE AD26.COV2.S-Suspected Immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1442299
Sex: M
Age:
State:

Vax Date:
Onset Date: 06/01/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned an male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, dose was not reported, on an unspecified date in MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date in JUN-2021, the patient was diagnosed with Covid-19 and was sick for few days. Patient experienced suspected clinical vaccination failure. He was on rest at time of reporting. He was well with no medical condition. It was not known how he was diagnosed with Covid and which test was used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000184096 The suspected product quality complaint has been confirmed to be non voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0-20210660759-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1442300
Sex: F
Age:
State: CT

Vax Date:
Onset Date: 03/14/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: SHORTNESS OF BREATH, LABORED BREATHING COULD NOT LIE IN SUPINE POSITION; TIGHTNESS IN CHEST; SWELLING IN LEFT ARM, PALM, RIGHT HAND, SOLE OF FOOT RIGHT AND LEFT; REDNESS IN LEFT PALM, RIGHT HAND, LEFT AND RIGHT SOLE; ITCHY IN LEFT PALM, ARM,RIGHT HAND, SOLE OF FOOT RIGHT AND LEFT; TIP OF TONGUE REDNESS; WEIRD FEELING ON TONGUE-TINGLING; LEFT ARM PAIN/ACHY COULD NOT MAKE A FIST; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 119 pounds, and height was 64 inches. The patient's past medical history included autogenic dental bone graft, and concurrent conditions included hypothyroidism, non-smoker, penicillin allergy, and abstains from alcohol, and other pre-existing medical conditions included the patient not had any drug abuse / illicit drug use. The patient experienced drug allergy when treated with clindamycin, and minocycline hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine sodium. On 14-MAR-2021, the subject experienced shortness of breath, labored breathing could not lie in supine position. On 14-MAR-2021, the subject experienced tightness in chest. On 14-MAR-2021, the subject experienced swelling in left arm, palm, right hand, sole of foot right and left. On 14-MAR-2021, the subject experienced redness in left palm, right hand, left and right sole. On 14-MAR-2021, the subject experienced itchy in left palm, arm, right hand, sole of foot right and left. On 14-MAR-2021, the subject experienced tip of tongue redness. On 14-MAR-2021, the subject experienced weird feeling on tongue-tingling. On 14-MAR-2021, the subject experienced left arm pain/achy could not make a fist. On JUN-2021, Laboratory data included: Chest X-ray (NR: not provided) Normal, and Ultrasound Doppler (NR: not provided) Negative blood clots. On 08-JUN-2021, Laboratory data included: PCR (NR: not provided) Negative. On 16-JUN-2021, Laboratory data included: PCR (NR: not provided) Negative. On 17-JUN-2021, Laboratory data included: Antibody test (NR: not provided) low by 4%. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling in left arm, palm, right hand, sole of foot right and left, redness in left palm, right hand, left and right sole, itchy in left palm, arm,right hand, sole of foot right and left, tip of tongue redness, weird feeling on tongue-tingling, and left arm pain/achy could not make a fist on 15-JUN-2021, and had not recovered from shortness of breath, labored breathing could not lie in supine position, and tightness in chest. This report was non-serious.

Other Meds: SYNTHROID

Current Illness: Abstains from alcohol; Hypothyroidism; Non-smoker; Penicillin allergy

ID: 1442301
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 06/25/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: BODY ACHES; DULL HEADACHE; FEVER; HEAD CONGESTION WORSENED; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 147 pounds, and height was 67 inches. The patient's past medical history included hyperthyroidism, and concurrent conditions included allergic to chocolate and caffeine, head congestion, migraines, and allergic to some antibiotics. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced body aches. On 25-JUN-2021, the subject experienced dull headache. On 25-JUN-2021, the subject experienced fever. On 25-JUN-2021, the subject experienced head congestion worsened. Laboratory data included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, dull headache, fever, and head congestion worsened. This report was non-serious.

Other Meds:

Current Illness: Allergic reaction to antibiotics (Some antibiotics cause sensitivity but patient did not list which ones.); Food allergy (patient stated some antibiotics causes sensitivity but did not list which ones); Head cold; Migraine headache (patient sometimes gets migraines after eating certain foods, and had a little bit of a headache after eating one of those foods last week.)

ID: 1442302
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: REACTIONS; SLEEPY; SLEPT A LOT; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced reactions, sleepy, and slept a lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sleepy, reactions and slept a lot was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1442303
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 06/25/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: EXTREMELY LARGE BRUISE 5 INCH LONG ON FOREARM; BUMP NODULE PEA SIZE; CRAMPING IN LEGS; SORE ARM; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure, and diabetes.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 09-JUL-2021) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. Concomitant medications included amlodipine for blood pressure, benazepril for blood pressure, and metformin for diabetes. On 25-JUN-2021, the subject experienced extremely large bruise 5 inch long on forearm. On 25-JUN-2021, the subject experienced bump nodule pea size. On 25-JUN-2021, the subject experienced cramping in legs. On 25-JUN-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extremely large bruise 5 inch long on forearm, bump nodule pea size, sore arm, and cramping in legs. This report was non-serious.

Other Meds: BENAZEPRIL; AMLODIPINE; METFORMIN

Current Illness: Blood pressure; Diabetes

ID: 1442304
Sex: F
Age:
State: CO

Vax Date:
Onset Date: 06/21/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: 3 BRUISES IN THE AREA LINED UP VERTICALLY ON RIGHT KNEE AND FEELS HARD TO TOUCH; A LITTLE SWOLLEN RIGHT KNEE; PAIN IN RIGHT LEG SPECIFICALLY BELOW THE KNEE; GENERAL BODY WEAKNESS; A LITTLE TIRED; CHILLS; GENERAL BODY DISCOMFORT; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included motor problems specifically to legs ( weakness in bilateral legs due to being born premature), non smoker, and non alcoholic, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281 and expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUN-2021, the subject experienced general body discomfort. On 21-JUN-2021, the subject experienced chills. On 21-JUN-2021, the subject experienced general body weakness. On 21-JUN-2021, the subject experienced a little tired. Treatment medications included: acetylsalicylic acid. On 22-JUN-2021, treatment medications included: ibuprofen. On 25-JUN-2021, the subject experienced 3 bruises in the area lined up vertically on right knee and feels hard to touch. On 25-JUN-2021, the subject experienced a little swollen right knee. On 25-JUN-2021, the subject experienced pain in right leg specifically below the knee. Laboratory data included: Pain scale (NR: not provided) 7-8 on a scale of 1-10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general body discomfort, chills, general body weakness, and a little tired on 22-JUN-2021, and had not recovered from pain in right leg specifically below the knee, a little swollen right knee, and 3 bruises in the area lined up vertically on right knee and feels hard to touch. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Motor dysfunction; Non-smoker

ID: 1442305
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: HIGH BLOOD PRESSURE; FAST HEART BEAT; TWITCHING ON LEFT LEG; DIZZINESS; CHILLS; HEADACHES; NAUSEA; DULL ACHE ON LEFT LEG; BIT OF SLOW CLOTTING; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, non alcohol use, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced bit of slow clotting. On MAR-2021, the subject experienced dull ache on left leg. Laboratory data included: Blood test (NR: not provided) Normal Platelet, CT brain scan (NR: not provided) did not show abnormal clotting but a bit of slow clotting, and Investigation (NR: not provided) Negative for blood clots. On 16-MAR-2021, the subject experienced dizziness. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced headaches. On 16-MAR-2021, the subject experienced nausea. On 25-MAR-2021, the subject experienced twitching on left leg. On 30-MAR-2021, the subject experienced high blood pressure. On 30-MAR-2021, the subject experienced fast heart beat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, headaches, and nausea on 06-APR-2021, had not recovered from twitching on left leg, and dull ache on left leg, and the outcome of high blood pressure, fast heart beat and bit of slow clotting was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as the case assessed as non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker; Penicillin allergy (Rashes)

ID: 1442306
Sex: M
Age:
State: OK

Vax Date:
Onset Date: 05/12/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: ELEVATED HEART RATE; DISCOMFORT SLEEPING ON THE LEFT SIDE; 4 EPISODES OF CAPILLARY BURSTING, 2 IN EACH EYE; CHRONIC DIARRHEA 2-3 TIMES DAY; RIGHT HAND/FINGERS JOINTS ACHY; SEVERE HEADACHE; INJECTION SITE SWELLING; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 172 pounds, and height was 71 inches. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 12-MAY-2021, the subject experienced right hand/fingers joints achy. On 12-MAY-2021, the subject experienced severe headache. On 12-MAY-2021, the subject experienced injection site swelling. On 15-MAY-2021, the subject experienced chronic diarrhea 2-3 times day. On 19-MAY-2021, the subject experienced 4 episodes of capillary bursting, 2 in each eye. On an unspecified date, the subject experienced elevated heart rate, and discomfort sleeping on the left side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right hand/fingers joints achy, and injection site swelling on 15-MAY-2021, 4 episodes of capillary bursting, 2 in each eye on 29-MAY-2021, and severe headache on 12-JUN-2021, had not recovered from chronic diarrhea 2-3 times day, and the outcome of elevated heart rate and discomfort sleeping on the left side was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1442307
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 06/24/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: SWEATING; DIZZINESS; DRY MOUTH; BONES HURT; GOOD FOR NOTHING; BRAIN IS FLOATING AROUND; FREEZING; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNWON) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. Concomitant medications included buprenorphine hydrochloride/naloxone hydrochloride. On 24-JUN-2021, the subject experienced headache. On 25-JUN-2021, the subject experienced sweating. On 25-JUN-2021, the subject experienced dizziness. On 25-JUN-2021, the subject experienced dry mouth. On 25-JUN-2021, the subject experienced bones hurt. On 25-JUN-2021, the subject experienced good for nothing. On 25-JUN-2021, the subject experienced brain is floating around. On 25-JUN-2021, the subject experienced freezing. On 25-JUN-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided). Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from freezing, headache, sweating, dizziness, dry mouth, bones hurt, good for nothing, brain is floating around, and fever. This report was non-serious.

Other Meds: SUBOXONE

Current Illness:

ID: 1442308
Sex: F
Age:
State: IL

Vax Date:
Onset Date: 06/01/2021
Rec V Date: 07/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: BRONCHITIS; This spontaneous report received from a health care professional concerned a 71 year old female. The patient's weight was 86 kilograms, and height was 148 centimeters. The patient's concurrent conditions included no tobacco use, and abstains from alcohol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced bronchitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bronchitis was not reported. This report was non-serious. This case, involving the same patient is linked to 20210405798.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-tobacco user

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm