VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
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: 1536943
Sex: F
Age:
State:

Vax Date: 12/23/2020
Onset Date: 12/01/2020
Rec V Date: 08/09/2021
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: heat, cluster of little bity bumps on the backside of my back, lower part of the back; A spontaneous report was received from a consumer, concerning a female patient (age unspecified) who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced heat, cluster of little bity bumps on the backside of my back, lower part of the back. The patient's medical history was not provided. No relevant concomitant medications were reported. On 23-DEC-2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) unknown route, in an unknown arm for prophylaxis of COVID-19 infection. Reporter stated that she is calling concerning Moderna Covid-19 vaccine that she had received on 23-DEC-2020. Patient reported having "heat, clusters of little bity bumps on the lower part of the back" "looks a little rash, thought it was heat bumps at first, but not sure". Patient stated she did not have this before the vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. Outcome of the event, heat, cluster of little bity bumps on the backside of my back, lower part of the back, was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1536944
Sex: F
Age: 62
State: MA

Vax Date: 12/23/2020
Onset Date: 12/28/2020
Rec V Date: 08/09/2021
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: Positive Covid rapid test; A spontaneous report was received from a consumer concerning a 62-years-old female patient who received Moderna's COVID-19 vaccine and tested positive for COVID-19 rapid test. The patient's medical history was not provided. No relevant concomitant medications were reported. On 23 Dec 2020, prior to onset of the events, the patient received their dose of mRNA-1273 (Lot/batch number: unknown), for prophylaxis of COVID-19 infection. On 28 Dec 2020, the patient tested positive for COVID-19 rapid test. The patient does not have any symptoms. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event positive COVID-19 test was not reported.; Reporter's Comments: Based on the current available information, patient testing positive for COVID-19 is unlikely related to vaccine. Very limited information regarding this event has been provided at this time.

Other Meds:

Current Illness:

ID: 1536945
Sex: M
Age: 61
State: FL

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 08/09/2021
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: Fatigue; Nausea; Headache; A spontaneous report was received from consumer concerning a 61-year-old male patient who received Moderna's COVID-19 vaccine and developed headache, fatigue, and nausea. The patient's medical history, as provided by the reporter, included human immunodeficiency virus (HIV). Concomitant medications reported included metoprolol, acyclovir, baby aspirin, clopidogrel, tramadol, atorvastatin, raltegravir potassium, diazepam, and edesse. On 28 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 28 Dec 2020, the patient developed a slight headache after receiving the vaccine. On 30 Dec 2020, patient developed fatigue, nausea and still had an ongoing headache. Treatment for the events included acetaminophen. Action taken with the second dose of mRNA-1273 in response to the events was not reported. The outcome of the events headache, fatigue, and nausea was not reported.; Reporter's Comments: This spontaneous report concerns a 61-year-old male patient with medical history of HIV infection who experienced non-serious events of headache, fatigue and nausea. The event of headache occurred on the same day after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: 025J20A, expiration date-Unknown). The events of fatigue and nausea occurred the following day after the administration of mRNA-1273 vaccine. Treatment administered included Tylenol and outcome is unknown. The events of headache, fatigue and nausea are consistent with the safety profile for mRNA-1273 vaccine. Based on the information provided, including temporal association a causal association cannot be excluded.

Other Meds: METOPROLOL; ACYCLOVIR [ACICLOVIR]; BABY ASPIRIN; PLAVIX; TRAMADOL; ATORVASTATIN; ISENTRESS HD; DIAZEPAM; Edesse

Current Illness: HIV carrier

ID: 1536946
Sex: M
Age: 30
State: NY

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 08/09/2021
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: Fever up to 102.1?F; Chills; Could not fall asleep; Shoulder pain localized around injection site; A spontaneous report was received from a consumer concerning a 30 year old male patient who received Moderna's COVID-19 vaccine and experienced insomnia, injection site pain, fever, and chills. The patient's medical history was not provided. No relevant concomitant medications were reported. On 29-Dec-2020, the patient received their first of two planned doses of mRNA-1273 (Lot # 026L20A) intramuscularly for prophylaxis of COVID-19 infection. On 29-Dec-2020, the patient experienced shoulder pain localized around the injection site. At night, he woke up with a fever of up to 102.1?F, chills, and could not fall back asleep. Treatment medications included Tylenol. Action taken with mRNA-1273 in response to the events was not reported. The events fever and chills were recovering/resolving. The outcome of events, insomnia and injection site pain, were considered as not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1536947
Sex: F
Age: 30
State: TX

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
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: A spontaneous report was received from a consumer concerning a 30-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) experienced breastfeeding. The patient's medical history was not reported. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 (Lot# 037K20A) intramuscularly for prophylaxis of COVID-19 infection on 29 Dec 2020. On 30 Dec 2020, the patient was breastfeeding after taking the vaccine. She reported no symptoms and consented to follow-up with her primary care physician. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event was unknown.; Reporter's Comments: This is a case of product exposure for mRNA-1273 (Lot# 037K20A) during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs

Other Meds:

Current Illness:

ID: 1536948
Sex: F
Age: 44
State: NH

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 08/09/2021
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: half dollar size, erythematous, tender lump on the injection site; sand papery type of skin rash on the neck; Half dollar size, erythematous, tender lump on the injection site; Half dollar size, erythematous, tender lump on the injection site; Erythematous swelling at the injection site; A spontaneous report was received from a nurse concerning a 44-year- old, female patient who who received Moderna's COVID-19 vaccine and experienced erythematous swelling at the injection site (R. deltoid) and later, a half dollar size, erythematous tender lump on the injection site. This was associated with sand papery type of skin rash on the neck. The patient's medical history was not provided. Concomitant product use was not provided. The patient received their first of two planned doses of mRNA-1273 (LOT # 039K20A) on 23-Dec-2020 intramuscularly in the right deltoid for prophylaxis of COVID-19 infection. A healthcare provider (HCP) reported that the patient received the Moderna vaccine at their facility on 23-Dec-2020. Following vaccine administration, the patient initially developed erythematous swelling at the injection site which she did not treat and per HCP report, resolved without treatment the same day. However, on 30-Dec-2020, the patient was seen by the HCP and had developed a half dollar-sized, erythematous, tender lump at the injection site. Additionally, the patient had developed a sand-papery type of skin rash on her neck. The patient was prescribed prednisone for 10 days. Treatment for the event included Prednisone for 10 days. Action taken with mRNA-1273 in response to the events, erythematous swelling at the injection site (R. deltoid) and a half dollar size, erythematous tender lump on the injection site associated with a sand papery type of skin rash on the neck was not provided. The events, erythematous swelling at the injection site (R. deltoid), were considered resolved. The events, a half dollar size, erythematous tender lump on the injection site associated with a sand papery type of skin rash on the neck was not provided.; Reporter'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:

ID: 1536949
Sex: F
Age: 56
State: MI

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 08/09/2021
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: whole body hurts; Not sure if can smell; Not sure if can taste; Stomach is killing her, Has stomach pains; arm feels like a sledgehammer hit it where she was injected; Feels nausea; Headache; Body chills; Can't keep anything down she throws up everything; A spontaneous report was received from a healthcare professional concerning a 56 year old, female patient who experienced her whole body "hurts," arm feels like a sledgehammer where injected, can't keep anything down, she just throws up everything, feels nauseous, not sure if she can taste or smell, head is pounding, body chills, and stomach pains. The patient's medical history was in Mar-2020 the patient was positive for COVID-19. The patient's concomitant medications included omeprazole magnesium. On 28 Dec 2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch: unknown) in the left arm for prophylaxis of COVID-19 infection. On 28 Dec 2020, the patient experienced events, her whole body hurt, arm felt like a sledgehammer hit it where she was injected, couldn't keep anything down and she threw up everything, felt nauseous, and wasn't sure she could smell or taste, her head was pounding, body chills, and stomach pains. Treatment for the event included ibuprofen. Action taken with mRNA-1273 in response to the events was not provided. . The outcome of the events, whole body "hurts," arm feels like a sledgehammer where injected, can't keep anything down, she just throws up everything, feels nauseous, not sure if she can taste or smell, head is pounding, body chills, and stomach pains was unknown.; Reporter's Comments: This case concerns a 56-year-old female, with PMH of COVID-19, who had NS unexpected events of pain, anosmia, ageusia, abdominal pain upper and NS expected events of injection site pain, chills, nausea, vomiting, and headache. Event onset the same day as the first dose of mRNA-1273. Treatment with ibuprofen. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: PRILOSEC [OMEPRAZOLE MAGNESIUM]

Current Illness:

ID: 1536950
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/09/2021
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: feeling achey; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feeling achey. The patient's medical history was not provided. No concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot# unknown, Exp unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced feeling achey. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. Outcome for the event, feeling achey was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1536951
Sex: M
Age: 55
State: GA

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 08/09/2021
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: swollen lymph nodes the size of a lemon; Fever; Chills; Ackyness; Soreness; Nausea; Dizziness; Sweating; Felt clammy; A spontaneous report was received from a consumer concerning a 55-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple event(s) of swollen lymph nodes the size of a lemon on left arm, fever, nausea, dizziness, chills, sweating, soreness, ackyness and felt clammy. The patient's medical history included hypertension. The concomitant medications reported included chlorthalidone. On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# unknown) intramuscularly for prophylaxis of COVID-19 infection. On 28 Dec 2020, the patient experienced multiple events of swollen lymph nodes the size of a lemon on left arm, fever, nausea, dizziness, chills, sweating, soreness, ackyness and felt clammy. Treatment for the event(s) included Acetaminophen. Action taken with mRNA-1273 in response to the events was unknown. The outcome for the event(s), swollen lymph nodes the size of a lemon on left arm, fever, nausea, dizziness, chills, sweating, soreness, ackyness and felt clammy were considered unknown.; Reporter's Comments: This case concerns a 55-year-old male with PMH of COVID-19 who had NS unexpected pain, lymphadenopathy, dizziness, hyperhidrosis, cold sweat, and NS expected fever, chills, nausea, myalgia. Event onset occurred the same day as the first dose of mRNA-1273. Treatment included acetaminophen. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: CHLORTHALIDONE

Current Illness:

ID: 1536952
Sex: F
Age:
State: LA

Vax Date: 12/28/2020
Onset Date: 12/29/2020
Rec V Date: 08/09/2021
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: didn't feel well; dizziness; fast heartbeat; fever, temperature was 101.6; headache; body aches; joint pain; chills; her left arm was really sore at the injection site; A spontaneous report was received from a consumer concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced not feeling well/malaise, dizziness, fever temperature was 101.6/pyrexia, headache, body aches/pain, joint pains/arthralgia, chills, fast heartbeat/heart rate increased and left arm sore at injection site/injection site pain. The patient's medical history was not provided. No concomitant medications were reported. On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot#) intramuscularly for prophylaxis of COVID-19 infection. On 29 Dec 2020, the patient didn't feel well, had dizziness, had a fever of 101.6 degrees Fahrenheit, headache, body aches, joint pains, chills, fast heartbeat and her left arm was sore at injection site. Treatment information included Tylenol, Benadryl and Nyquil. The Action taken with mRNA-1273 in response to the events was unknown. The outcome for the events, didn't feel well, dizziness, headache, body aches, joint pains, chills, fast heartbeat and left arm sore at injection site was considered unknown. The outcome for the event, fever temperature was 101.6 considered recovered/resolved on 30 Dec 2020.; Reporter'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:

ID: 1536953
Sex: M
Age: 51
State: OH

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 08/09/2021
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: Body ache; Headache; Fatigue; This spontaneous case was reported by a paramedic (subsequently medically confirmed) and describes the occurrence of in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The patient's past medical history included COVID-19 (and was hospitalized for over 2 weeks.) in October 2020. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Follow up #1 received with no new information which does not change company causality assessment. Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Agency; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Follow up #1 received with no new information which does not change company causality assessment.

Other Meds:

Current Illness:

ID: 1536954
Sex: F
Age: 68
State: FL

Vax Date: 12/29/2020
Onset Date:
Rec V Date: 08/09/2021
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: Foot soreness; A spontaneous report was received from a consumer on 29 Dec 2020. This case concerns a 68 year old female patient. The patient is a participating in the mRNA-1273 Emergency Use Program and experienced foot soreness with the use of mRNA-1273. Relevant medical history included foot soreness. There were no concomitant medications provided. On 29 Dec 2020 the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the non-serious event foot soreness. It was noted the patient experienced the event of foot soreness prior to vaccination and she went to the urgent care seeking treatment on 30 Dec 2020. She was prescribed cephalexin for treatment. It was also noted the reporter did not believe the urgent care visit had anything to do with his wife getting the vaccine. There were no relevant laboratory tests provided. Action taken with mRNA-1273 in response to the event of foot soreness was not reported. The event of a little soreness was not recovered/not resolved at the time of this report.; Reporter's Comments: Based on the current available information the event is unrelated to vaccination (started prior to the first dose of the vaccine).

Other Meds:

Current Illness: Foot pain

ID: 1536955
Sex: F
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 08/09/2021
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: Muscle cramps; Achy all over; A spontaneous report was received from a nurse concerning a 47 year old female patient, who received Moderna's COVID-19 vaccine and experienced muscle spasms and aches. The patient's medical history, as provided by the reporter, included cancer in 2017 and Rocky Mountain Spotted Fever in 2019. Concomitant medications included Vitamin D3, Vitamin C, and occasionally Benadryl for sleep. On an unknown date, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the right arm for prophylaxis of Covid-19 infection. On an unknown date, the patient experienced muscle cramps, muscle spasms and aches. She was feeling better at the time of the report. Treatment medications included Advil and Tylenol. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, muscle cramps, muscle spasms and aches, was considered as resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: VITAMIN D3; VITAMIN C [ASCORBIC ACID]; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]

Current Illness:

ID: 1536956
Sex: F
Age: 66
State: SC

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 08/09/2021
Hospital:

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: Strong wave of intense nausea; Minor sore arm; A spontaneous report was received from a healthcare professional (reporting on self) concerning a 66-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced minor sore arm and strong wave of intense nausea. The patient's medical history was not provided. No concomitant medications were reported. On 28-DEC-2020, the patient received their first of two planned doses of mRNA-1273 (Lot# 039K20A) intramuscularly in left arm for prophylaxis of COVID-19 infection On 28-DEC-2020, the patient experienced minor sore arm. On 29-DEC-2020, the patient experienced strong wave of intense nausea. She did not vomit, but she had to take Zofran to help with nausea. It wiped her out for the evening. She felt fine this morning (30-DEC-2020) and went to work and again was hit by an intense nausea. Action taken with mRNA-1273 in response to events was not reported. The outcome for the event, minor sore arm was unknown and for strong wave of intense nausea was not recovered.; Reporter'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. Further information has been requested

Other Meds:

Current Illness:

ID: 1536957
Sex: F
Age: 34
State: VA

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 08/09/2021
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: Pregnant; This spontaneous retrospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination. The patient's past medical history included GERD (worsened with pregnancy, no change with vaccine, improved after delivery) and Food poisoning (food poisioning with dehydration, electrolyte changes) from 01-Dec-2020 to 02-Dec-2020. Previously administered products included for Product used for unknown indication: Tdap on 10-Dec-2020. Past adverse reactions to the above products included Product used for unknown indication with Tdap. Concurrent medical conditions included Penicillin allergy, Drug allergy and Sulfonamide allergy (sulfa allergy). Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) and CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for Acid reflux (esophageal), ONDANSETRON (ZOFRAN [ONDANSETRON]) and PROMETHAZINE (PHENERGAN [PROMETHAZINE]) for Nausea, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy. On 28-Dec-2020 at 6:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 24-May-2020 and the estimated date of delivery was 25-Feb-2021. On 28-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the thirty-fifth week of the pregnancy. The cesarean delivery occurred on 13-Feb-2021, which was reported as Full-term. For neonate 1, the birth weight was 3160 grams (6lbs 15oz) with an APGAR score of 8 and 8 at (1, 5 minutes). The outcome was reported as Term Birth w Complications. Non-reassuring fetal tracing due to nuchal cord. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Ultrasound scan: normal (normal) normal. On 26-Jun-2020, Pregnancy test: positive (Positive) positive. In December 2020, Glucose tolerance test: normal (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Estimated date of conception was 06 Jun 2021. Number of fetus is one. Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Pregnancy outcome form added; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 34-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; PEPCID [FAMOTIDINE]; TUMS [CALCIUM CARBONATE]; ZOFRAN [ONDANSETRON]; PHENERGAN [PROMETHAZINE]

Current Illness: Drug allergy; Penicillin allergy; Sulfonamide allergy (sulfa allergy)

ID: 1536958
Sex: F
Age: 27
State: NY

Vax Date: 12/24/2020
Onset Date: 12/24/2020
Rec V Date: 08/09/2021
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: A spontaneous report was received from a healthcare professional concerning a 27-year old, female patient who received Moderna's COVID-19 vaccine and experienced chills, sore arm, tingling in fingers, fatigue, fever, body aches, difficulty walking and legs feeling loose. The patient's medical history was not provided. No relevant concomitant medications were reported. On 24 Dec 2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch No: 039K20-24) in the left arm for prophylaxis of COVID-19 infection. On 24 Dec 2020, the patient started experiencing chills, sore arm, tingling in fingers, fatigue, fever, body aches. On 28 Dec 2020, 4 days after vaccination, the patient experienced difficulty walking and it was ongoing with legs feeling loose. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, chills, sore arm, tingling in fingers, fatigue, fever, body aches, difficulty walking, and legs feeling loose, was unknown.; Reporter'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:

ID: 1536959
Sex: F
Age:
State: IA

Vax Date: 12/28/2020
Onset Date: 12/29/2020
Rec V Date: 08/09/2021
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: Feeling bad; Severe body aches; Dry cough; Oxygen went to 90; Chest felt heavy; Short of breath; Headache; Fever; Chills; Fatigue; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of feeling bad, severe body aches, fatigue, dry cough, fever, chills, headache, oxygen went to 90, short of breath and chest felt heavy. The patient's medical history was not provided. Concomitant medications reported included blood thinner for unknown indication. On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# 025JA20) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 29 Dec 2020, the patient experienced feeling bad, severe body aches, fatigue, dry cough, fever, chills, headache, oxygen went to 90 percent, short of breath and chest felt heavy. The treatment information reported included Tylenol number 3 for headache. The Action taken with mRNA-1273 in response to the events was unknown. The outcome for the events, feeling bad, severe body aches, fatigue, dry cough, fever and chills, was considered as resolving. The outcome for the event, headache was considered as not resolved. The outcome for the events, oxygen went to 90 percent, short of breath and chest felt heavy was considered as unknown.; Reporter's Comments: This case concerns a female of unknown age who had NS unexpected chest discomfort, dyspnea, cough, oxygen saturation decreased, feeling abnormal and NS expected fatigue, fever, chills, headaches. Event onset occurred on Day 2 after the first dose of mRNA-1273. Treated with Tylenol #3. Most events resolving, but headache ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1536960
Sex: F
Age:
State: UT

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
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: Breast-feeding; Arm is Sore; A spontaneous report was received from a consumer concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine and developed a sore arm and breastfeeding. The patient's medical history included pregnancy (date of LMP: 12 Jun 2020, live full-term birth. delivery type: vaginal) and alcohol use 1-2 per week. Products known to have been used by the patient, within two weeks prior to the event, included Wellbutrin 150 (unit unknown) daily via oral route, multivitamin daily and fish oil daily. On 30 Dec 2020, prior to the onset of events, the patient's received their first of two planned doses of mRNA-1273 (Batch number: 027-K20A, Expiry date: 22 Jun 2021) intramuscularly in the right deltoid for prophylaxis of Covid-19 infection. On an unknown date, the patient reported sore arm and breastfeeding. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, sore arm and breastfeeding, was considered unknown.; Reporter's Comments: This is a case of product exposure during breastfeeding with expected event of vaccination site pain. Patient will continue to be contacted for further monitoring of AEs.

Other Meds: WELLBUTRIN; MULTIVITAMIN AND MINERAL; FISH OIL

Current Illness:

ID: 1536961
Sex: F
Age: 29
State: KS

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 08/09/2021
Hospital:

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: Pregnant; Sore arm; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and PAIN IN EXTREMITY (Sore arm) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. No Medical History information was reported. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 11-Jun-2020 and the estimated date of delivery was 22-Mar-2021. On 29-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and PAIN IN EXTREMITY (Sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twenty-eighth week of the pregnancy. On 29-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported No treatment medication was reported; Reporter's Comments: This is a case of product exposure during pregnancy with associated sore arm for this 29-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy

Other Meds:

Current Illness:

ID: 1536962
Sex: F
Age: 62
State: FL

Vax Date: 12/29/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
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: The entire right arm is hurting on movement and is sore; Mild Diarrhea; Pain on the injection site; Mild headache; A spontaneous report was received from a 62-year-old female patient who participated in the mRNA-1273 Emergency Use Program and experienced pain on the injection site, right arm pain and soreness, a mild headache, and diarrhea. The patient's medical history was not reported. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 intramuscularly in the right deltoid for prophylaxis of COVID-19 infection on 29 Dec 2020. On 30 Dec 2020, the patient experienced pain on the injection site, right arm pain and soreness, a mild headache, and diarrhea. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events was not reported.; Reporter's Comments: This case concerns a 62-year-old female who experienced NS unexpected events of pain in extremity and diarrhea and NS expected events of injection site pain and headache. Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment not reported. Event outcome known. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1536963
Sex: F
Age: 37
State: OR

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
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: Mild shortness of breath; Tachycardia; Severe itching to her face; Tingling to her face; Overall generalized anxiety; A report was received from a healthcare professional concerning a 37-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced mild shortness of breath, tachycardia, severe itching to her face, tingling to her face, and overall generalized anxiety. The patient's medical history was not provided. Concomitant medications included an intrauterine contraceptive device (IUD). On 30 Dec 2020, approximately 0 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right deltoid for prophylaxis of COVID-19 infection. On 30 Dec 2020, following vaccine administration, the patient experienced mild shortness of breath, tachycardia, severe itching to her face, tingling to her face, and overall generalized anxiety that lasted for about an hour. They took Zyrtec and reported the symptoms resolved within 20 minutes. Treatment for the event included Zyrtec. Action taken with mRNA-1273 in response to the events was unknown. The events, mild shortness of breath, tachycardia, severe itching to her face, tingling to her face, and overall generalized anxiety, were considered resolved on 30 Dec 2020. The reporter did not provide an assessment for the events, mild shortness of breath, tachycardia, severe itching to her face, tingling to her face, and overall generalized anxiety.; Reporter's Comments: This case concerns a 37-year-old, female patient who experienced non-serious adverse events of mild shortness of breath, tachycardia, severe itching to her face, tingling to her face, and overall generalized anxiety. Based on the current information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds: IUD NOS

Current Illness:

ID: 1536964
Sex: F
Age: 38
State: NJ

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 08/09/2021
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: Sore arm, can't even lift my arm, feels worse than tetanus shot/arm is painful; A spontaneous report was received from a 38 year old female patient (Nures) concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and developed pain in arm. The patient's medical history was not provided. No relevant concomitant medications were reported. On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20A) intramuscularly in left arm for prophylaxis of COVID-19. On 28 Dec 2020, a few hours after administration, the patient stated that her arm was "pretty painful", that she can't even lift her arm. She stated that there was no redness and it's not swollen. She mentioned that it "feels worse than tetanus, it is past soreness". She also mentions that the pain was not "excruciating". Treatment included ibuprofen, which she mentioned taking around the clock. Action taken with mRNA-1273 in response to the event was not reported. The outcome for the event was unknown.; Reporter's Comments: This case concerns a 38-Year-old female who experienced NS unexpected event of pain of extremity. Event onset occurred a few hours after the first dose of mRNA-1273. Treatment included ibuprofen. Event outcome known. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1536965
Sex: M
Age: 55
State: OK

Vax Date: 12/29/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
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 spontaneous report was received from a non-healthcare professional of a 55-year-old, male consumer who received Moderna's COVID-19 vaccine and experienced heartburn. The patient's past medical history, as provided by the reporter, included heartburn. On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 30 Dec 2020, the patient experienced heartburn after he ate something spicy. It is unknown if the prior history of heartburn was exacerbated regarding the vaccine. Treatment included omeprazole. Action taken with the second dose of mRNA-1273 in response to the event was unknown. The outcome of the event was unknown. The reporter's assessment of causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The patient's medical history of heart burn remains a confounder.

Other Meds:

Current Illness: Heartburn (The patient has a medical history of heart burn prior to taking the vaccine.)

ID: 1536966
Sex: M
Age: 57
State: MI

Vax Date: 12/22/2020
Onset Date: 12/23/2020
Rec V Date: 08/09/2021
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: Dizzy; cough; Rib pain; Urine output down; Pulse OX 94 (normal pO2 is 95); Bowels felt crampy; He was unable to get out of bed; Appetite down; Persistent fever up to 102 F.; Nausea; Headache; Extreme chills.; feeling sick.; Body aches and pains; He began feeling fatigued; A spontaneous report was received from a dietician concerning a 57 year-old, male patient experienced fatigue, extreme chills, body aches and pains, persistent fever, nausea, dizziness, cough, rib pain, headache, decreased urine output, decreased appetite, decreased pulse ox, and bowel cramps. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, approximately 24 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 23 Dec 2020, the patient began to feel fatigued. On 25 Dec 2020, he was feeling sick and by that night had extreme chills, and body aches and pains. On 26 Dec 2020, he had a persistent fever up to 102F, nausea, dizziness, cough, rib pain, headache, decreased urine output, decreased appetite, and bowel cramping. His pulse oxygen saturation was reported to be 94 percent. Patient was unable to confirm COVID-19 exposure. Treatment for the event included paracetamol, prochlorperazine, and dextromethorphan hydrobromide. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events was unknown/not reported; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1536967
Sex: F
Age: 38
State: MT

Vax Date: 12/28/2020
Onset Date: 12/01/2020
Rec V Date: 08/09/2021
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: Tired; Nausea; Headache; Body ache; A spontaneous report was received from a consumer who is 38-year-old female patient that received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced headache, feeling tired, body ache, and nausea. Patient was breastfeeding but this was reported as a separate case. The patient's medical history was not provided. No relevant concomitant medications were reported. On 28-Dec-2020, the patient received the first of two planned doses of mRNA-1273 (Lot number: 039K-202A) in the left deltoid for COVID-19 for infection prophylaxis. On 28-Dec-2020, the patient reported she had a bad headache, was tired, had body ache, and nausea. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, headache, tired, body ache, and nausea was unknown.; Reporter'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:

ID: 1536968
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/09/2021
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: Pregnant; This female patient was participating in mRNA-1273 Emergency Use Program and became pregnant. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date ,the patient received the first of the two planned doses of mRNA-1273 intramuscularly for the prophylaxis of COVID-19 infection. On 31 Dec 2020, the patient called to state that she would like to register for the pregnancy patient information for Moderna COVID-19 vaccine. The estimated date of conception was not provided. Action taken with mRNA-1273 was not provided.; Reporter's Comments: This report concerns a female subject of unknown age, who became pregnant (Vaccine exposure during pregnancy) on an unknown date after administration of the of mRNA-1273 vaccine. The patient's last menstrual period, expected date of conception and delivery are all unknown

Other Meds:

Current Illness:

ID: 1536969
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/09/2021
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: Sore arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna (mRNA-1273) and experienced a sore arm. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On an unknown date in 2020, the patient reported having a sore arm. No treatment information was provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event having a sore arm was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1536970
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 08/09/2021
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: Arm was sore in the area of injection; A spontaneous report was received from a consumer concerning a female patient of unspecified age and gender, who received Moderna's COVID-19 vaccine and experienced arm soreness in the area of injection. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced a sore arm in the area of injection. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event was unknown.; Reporter's Comments: This case concerns a female patient of unspecified age, who experienced a non-serious expected event of Injection site pain. The event occurred on unknown date after first dose of mRNA-1273, (lot unknown). Treatment was not reported. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1536971
Sex: F
Age: 53
State: NY

Vax Date: 12/30/2020
Onset Date: 12/31/2020
Rec V Date: 08/09/2021
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: 101 fever; A spontaneous report was received from a certified nurse assistant concerning a 53 year- old, female patient who received Moderna's COVID-19 vaccine and experienced 101 fever. There were no medical history and concomitant medications reported. On 30 Dec 2020, approximately twenty-four hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 31 Dec 2020, the patient woke up with a 101 fever. Treatment for this event included ibuprofen. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, 101 fever was unknown.; Reporter's Comments: This case concerns a 53 year-old female patient, who experienced a non-serious expected event of Pyrexia. The event of Pyrexia occurred approximately one day after first dose of mRNA-1273, lot # 025J20A. Treatment included ibuprofen. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1536972
Sex: F
Age: 43
State: PA

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 08/09/2021
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: missing period since first dose; Irregular menstrual period, got very little discharge on 22Feb2021; Tingling in left foot immediately after the injection/tingling more in right foot; Feels like ball is rolling around in the sole of foot; arm pain where she got the injection; This spontaneous case was reported by a dentist (subsequently medically confirmed) and describes the occurrence of AMENORRHOEA (missing period since first dose), MENSTRUATION IRREGULAR (Irregular menstrual period, got very little discharge on 22Feb2021), PARAESTHESIA (Tingling in left foot immediately after the injection/tingling more in right foot), LIMB DISCOMFORT (Feels like ball is rolling around in the sole of foot) and VACCINATION SITE PAIN (arm pain where she got the injection) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 028L20A) for COVID-19 vaccination. Concurrent medical conditions included Thyroid disorder (Patient is on thyroid medication). Concomitant products included LEVOTHYROXINE for Thyroid disorder. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Dec-2020, the patient experienced AMENORRHOEA (missing period since first dose), MENSTRUATION IRREGULAR (Irregular menstrual period, got very little discharge on 22Feb2021), PARAESTHESIA (Tingling in left foot immediately after the injection/tingling more in right foot), LIMB DISCOMFORT (Feels like ball is rolling around in the sole of foot) and VACCINATION SITE PAIN (arm pain where she got the injection). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. In December 2020, VACCINATION SITE PAIN (arm pain where she got the injection) had resolved. At the time of the report, AMENORRHOEA (missing period since first dose), MENSTRUATION IRREGULAR (Irregular menstrual period, got very little discharge on 22Feb2021) and PARAESTHESIA (Tingling in left foot immediately after the injection/tingling more in right foot) had not resolved and LIMB DISCOMFORT (Feels like ball is rolling around in the sole of foot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment included ibuprofen. Consumer stated she had her period in Dec-2020, did not have it in Jan-2021, had very little discharge on 22-Feb-2021, did not have it in Mar-2021, and had not had it in Apr-2021. She visited a gynecologist, and blood tests performed to check her hormone levels had normal results. Consumer visited a physician for the tingling sensation. Blood tests from this visit also had normal results. The patient also stated that she was emotionally distressed, it affects her a lot and it also changed her body. Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: The patient information, 1st and 2nd dose of vaccine information along with batch number, concomitant drug, additional events amenorrhea and menstruation irregular were updated. On 26-Apr-2021: No new information was provided.; Sender's Comments: Based on the current available information and temporal association beteen the use of the product and the start date of the events a causal relationship cannot be excluded.

Other Meds: LEVOTHYROXINE

Current Illness: Thyroid disorder (Patient is on thyroid medication)

ID: 1536973
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/09/2021
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: Ear pain; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's Covid-19 vaccine (mRNA-1273) and developed ear pain. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Lot # not provided) on (date of vaccine not provided) intramuscularly for prophylaxis of COVID-19 infection. The pharmacist called to report that she has received an email from HR at her work facility asking if ear pain is a common side effect of the Moderna vaccine due to a "couple people experiencing it". Treatment for the event was not provided. Action taken with mRNA-1273 in response to the events was not provided. The event, ear pain, was considered unresolved. The reporter did not provide an assessment of the event, ear pain.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.

Other Meds:

Current Illness:

ID: 1536974
Sex: F
Age: 61
State: MI

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 08/09/2021
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: Fever really bad; Chills; arm site is sore; Tired; A spontaneous report was received from a 61 year old female healthcare facility staff member who received Moderna (mRNA-1273) and developed fever, sore arm site, feeling tired, shivery.and chills The patient's medical history, included history of COVID-19 infection in May 2020. No relevant concomitant medications were reported. On 29 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Lot # 026L20A) in the left arm for prophylaxis of COVID-19 infection. Patient developed fever 101.8-102?F, , sore arm site, feeling tired, chills and shivery after receiving vaccine. Treatment for the event included alternating paracetamol and ibuprofen. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, fever, chills, sore arm site, feeling tired and shivery, were unknown. The reporter did not provide an assessment for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1536975
Sex: F
Age:
State: FL

Vax Date: 12/28/2020
Onset Date:
Rec V Date: 08/09/2021
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: Numbness in fingers; Fever; Chills; Severe headache; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, chills, severe headache and numbness of her fingers. The patient's medical history was not provided. Concomitant medications reported included blood thinner. On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: Unknown). On an unknown date, the patient experienced fever, chills, severe headache and numbness of her fingers. No treatment information was reported. The Action taken with mRNA-1273 in response to the events was unknown. The outcome of fever, chills, severe headache and numbness of her fingers were considered as unknown. The reporter did not provide an assessment for the events.; Reporter'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:

ID: 1536976
Sex: F
Age:
State: CA

Vax Date: 12/28/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
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: Ear pain; Sore Throat; This spontaneous case was reported by a pharmacist and describes the occurrence of EAR PAIN (Ear pain) and OROPHARYNGEAL PAIN (Sore Throat) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 28-Dec-2020 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced EAR PAIN (Ear pain) and OROPHARYNGEAL PAIN (Sore Throat). At the time of the report, EAR PAIN (Ear pain) and OROPHARYNGEAL PAIN (Sore Throat) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EAR PAIN (Ear pain) and OROPHARYNGEAL PAIN (Sore Throat) to be possibly related. No concomitant information provided. No treatment information provided. This case was linked to MOD-2020-001825 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-Mar-2021: The reporter information, patient identifiers, event details and vaccine information were updated.; 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:

ID: 1536977
Sex: F
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 08/09/2021
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: Sore throat; Ear pain; Discomfort in shoulder, neck and jaw; A spontaneous report was received from a healthcare professional who was a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sore throat [Oropharyngeal pain], ear pain [Ear pain] and some discomfort in her shoulder, neck and jaw [arthralgia]. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection. The patient reported that after receiving the vaccine, she experienced a sore throat, ear pain and some discomfort in her shoulder, neck and jaw. Treatment information was unknown. Action taken with mRNA-1273 in response to the events was not provided. The outcomes of the events were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1536978
Sex: F
Age:
State:

Vax Date:
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
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: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccination during pregnancy) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccination during pregnancy). On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Vaccination during pregnancy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medications was provided by the reporter. No Treatment medications was provided by the reporter.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this unknown age female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness:

ID: 1536979
Sex: F
Age:
State:

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
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: Pregnant and recieved vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and recieved vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and recieved vaccine). On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and recieved vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medications were provided. No treatment information provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this female of unknown age. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy .

Other Meds:

Current Illness:

ID: 1536980
Sex: U
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 08/09/2021
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: bursitis; A spontaneous report was received from a pharmacist, concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bursitis. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced bursitis. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, bursitis, was unknown.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.

Other Meds:

Current Illness:

ID: 1536981
Sex: F
Age: 30
State: MO

Vax Date: 12/01/2020
Onset Date:
Rec V Date: 08/09/2021
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: having a lot of chills; muscle aching; Joint aching; injection site is swollen; injection site hurts very badly; A spontaneous report was received from a 30-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced having a lot of chills, muscle aching, joint aching, injection site is swollen and injection site hurts very badly. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date in Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Batch number: 025L20A) in her right arm for prophylaxis of COVID-19 infection. On 30-Dec-2020, the patient reported that she was experiencing some side effects after taking the vaccine. She stated she was having a lot of chills, muscle and join aching, and that the injection site was swollen and hurts very badly. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcomes of the events, having a lot of chills, muscle aching, join aching, injection site is swollen, and injection site hurts very badly, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1536982
Sex: M
Age:
State:

Vax Date:
Onset Date: 12/31/2020
Rec V Date: 08/09/2021
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: A spontaneous report was received from a consumer concerning a male patient of unknown age, who experienced dizziness, nausea, diarrhea and weakness. The patient's medical history was not provided. Concomitant product use was not provided. The patient received their first of two planned doses of mRNA-1273 (Lot/Batch number unknown) for prophylaxis of COVID-19 infection. The patient left a voicemail inquiring what to take for the side effects he was experiencing. Per patient, he was experiencing dizziness, nausea/diarrhea, and reported being "real, real weak." Treatment information was not provided/unknown. Action taken with mRNA-1273 in response to the events is not applicable. The outcome of the events, dizziness, nausea, diarrhea, and weakness were not reported. The reporter did not provide causality for the events, dizziness, nausea, diarrhea, and weakness were unknown/not reported.; Reporter'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:

ID: 1536983
Sex: F
Age:
State:

Vax Date: 12/29/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
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: Felt pretty crummy; Fever; Chills; Body ache; A spontaneous report was received from a consumer, concerning herself, a female patient of unspecified age, who received Moderna's COVID-19 vaccine and experienced fever, chills, body ache and felt pretty crummy. The patient's medical history included COVID-19 since 11-Dec-2020. Concomitant product use was not provided by the reporter. On 29-Dec-2020, approximately one day prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection. On 30-Dec-2020 at 11:00AM, the patient developed fever, chills, body ache and felt pretty crummy until waking up the next day on 31-Dec-2020 and at this time patient was feeling much better. Action taken with mRNA-1273 in response to the events were not provided. The outcome of the events, fever, chills, body ache and felt pretty crummy were considered resolved on 31-Dec-2020.; Reporter's Comments: This case concerns a female patient, with a historical medication condition of Covid-19 infection (fully recovered), who experienced a non-serious unexpected event of malaise and pain, non-serious expected events of pyrexia and chills. The event occurred 1 day after first dose of mRNA-1273, lot # unknown. Treatment details was no provided. Very limited information regarding these events has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1536984
Sex: F
Age:
State:

Vax Date: 12/30/2020
Onset Date:
Rec V Date: 08/09/2021
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: A spontaneous report was received from a consumer concerning a female patient who received Modena's COVID-19 vaccine (mRNA-1273) and experienced generalized fatigue, muscle weakness, arm pain, neck pain, shoulder pain and headache. The patient's medical history was not reported. No relevant concomitant medications were reported. The patient received her first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 30-Dec-2020. On an unknown date, the patient experienced generalized fatigue, muscle weakness, arm pain, neck pain, shoulder pain, and headache. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcomes of the events, generalized fatigue, muscle weakness, arm pain, neck pain, shoulder pain and headache, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1536985
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/09/2021
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: A spontaneous report was received from a consumer who was a pregnant, female patient of unknown age who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced vaccine exposure during pregnancy. There was no medical history and no relevant concomitant medications reported On an unknown date in 2020, the patient received her first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly for prophylaxis of COVID-19 infection while. The patient's estimated date of conception was not reported. The patient's due date was not reported. She wished to participate in the pregnancy registry. Action taken with mRNA-1273 in response to the event was not reported. The outcome event, vaccine exposure during pregnancy, was considered recovered/resolved.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness:

ID: 1536986
Sex: F
Age:
State: VA

Vax Date: 12/01/2020
Onset Date:
Rec V Date: 08/09/2021
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: breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (breastfeeding) in a female patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) , while the mother received the product for COVID-19 vaccination. MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding. MEDICAL HISTORY (Patient): The patient's past medical history included No adverse event (No reported medical history.). In December 2020, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with EXPOSURE VIA BREAST MILK (breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (breastfeeding) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient's medical history and relevant concomitant medications weren't reported Treatment information was not provided Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Added reporter contact information.

Other Meds:

Current Illness:

ID: 1536987
Sex: F
Age:
State: FL

Vax Date: 12/24/2020
Onset Date: 12/01/2020
Rec V Date: 08/09/2021
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: Tested positive for COVID on PCR test; A spontaneous report was received from a pharmacist concerning a female patient in her mid 40s who received Moderna's COVID-19 Vaccine and then tested positive for COVID-19 on PCR test. The patient's medical history included lupus. No relevant concomitant medications were reported. On 24-Dec-2020, the patient received the first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On the 26th or 27th of December 2020, the patient was swabbed via PCR test for COVID-19 which was positive. Treatment for the event was not reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, tested positive for COVID on PCR test, was considered unknown.; Reporter's Comments: This case concerns a female of unknown age, with medical history of Lupus, who had a nonserious unexpected event of COVID-19 (SARS-CoV-2 test positive). Event onset 3-4 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Systemic lupus erythematosus

ID: 1536988
Sex: M
Age:
State: FL

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 08/09/2021
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: A report was received from a physician concerning a male patient who was participating in the mRNA-1273 Emergency Use Program and experienced fever, chills, bone crashing body aches (far worse than when he had COVID), shaking that would not let him hold a cup, and heavy sweating at night. The patient's medical history, as provided by the reporter, included COVID-19. No relevant concomitant medications were reported. On 29 Dec 2020, approximately 10 hours prior to the onset of the events, fever, chills, bone crashing body aches (far worse than when he had COVID), shaking that would not let him hold a cup, and 1 day prior to the onset of the event heavy sweating at night, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 30 Dec 2020, the patient was reportedly feeling fine the first 10 hours following vaccine administration, then began to experience fever, chills, bone crashing body aches that were worse than when he had COVID, and shaking that would not let him hold a cup, for another 10 hours. On 30 Dec 2020, the patient reported experiencing heavy night sweating that caused him to change his clothes and sheets 3 times. Action taken with mRNA-1273 in response to the events was not reported. The events, fever, chills, bone crashing body aches (far worse than when he had COVID), shaking that would not let him hold a cup, were considered resolved on 30 Dec 2020. The outcome of the event, heavy sweating at night, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events ten hours after vaccination, a causal relationship cannot be excluded. Further information has been requested

Other Meds:

Current Illness:

ID: 1536989
Sex: F
Age: 23
State:

Vax Date: 12/30/2020
Onset Date: 12/31/2020
Rec V Date: 08/09/2021
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: Fever; Felt sweaty; Really nauseous; Arm was sore; Arm was bruised; Arm swollen; A spontaneous report was received from a consumer concerning herself, a 23-year-old, female patient who received Moderna's COVID-19 (mRNA-1273) vaccine and who experienced feeling sweaty [Sweaty], a sore and bruised arm [Administration site bruise/Injection site pain], fever/ongoing fever [Pyrexia], feeling nauseous [Nausea] and her arm was swollen [Peripheral swelling]. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 30-Dec-2020, one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly for prophylaxis of COVID-19 infection. The morning after receiving the vaccine, at approximately 3 AM, the patient felt sweaty and really nauseous. Later that same day, she experienced a fever and her arm was sore, bruised and swollen. She is still able to lift her arm. Treatment for the event included acetaminophen. Action taken with mRNA-1273 in response to the events was not provided. The outcomes of the events, feeling sweaty [Sweaty], a sore and bruised arm [Administration site bruise/Injection site pain], fever/ongoing fever [Pyrexia], feeling nauseous [Nausea] and her arm was swollen [Peripheral swelling], were considered unknown.; Reporter'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:

ID: 1536990
Sex: F
Age: 33
State: NH

Vax Date: 12/23/2020
Onset Date: 12/29/2020
Rec V Date: 08/09/2021
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: lost sense of taste; A report was received from a consumer who is a 33-year old, female patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lost sense of taste. The patient's medical history was not provided. Concomitant medications reported included ascorbic acid and colecalciferol. On 23-Dec-2020, approximately 6 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (BATCH # 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 29-Dec-2020, the patient noticed they lost their sense of taste. The patient took a SARS-CoV-2 test, which resulted negative. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, lost sense of taste, was unknown. The reporter did not provide an assessment for the event lost sense of taste.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds: VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]

Current Illness:

ID: 1536991
Sex: F
Age: 23
State: OK

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 08/09/2021
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: Can't move left arm because of the pain; Trouble moving her left arm yesterday; Tingling in the left arm from left shoulder to left hand; Sharp pain in the left shoulder that radiated to left elbow; A spontaneous report was received from a consumer concerning a 23-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of tingling in the left arm from left shoulder to left hand, sharp pain in the left shoulder that radiated to left elbow, trouble moving her left arm, can't move left arm because of pain. The patient's medical history included connective tissue disorder. Concomitant medications included Montelukast, hydroxychloroquine, fexofenadine and vitamins. On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# 025J20-2A). On that same day, the patient experienced tingling in the left arm from left shoulder to left hand and sharp pain in the left shoulder that radiated to left elbow. The treatment information reported included aleve. On 30 Dec 2020, the patient experienced trouble moving her left arm. The treatment information reported included aleve. On 31 Dec 2020, the patient experienced can't move left arm because of pain. The treatment information reported included aleve. The action taken with mRNA-1273 in response to the events was unknown. The outcomes of the events, tingling in the left arm from left shoulder to left hand, sharp pain in the left shoulder that radiated to left elbow, trouble moving her left arm, can't move left arm because of pain, were considered unknown.; Reporter's Comments: This case concerns a 23-year-old female with nonserious events of unexpected injection site movement impairment, paraesthesia, pain in extremity, and expected arthralgia. Event onset the same day as the first dose of mRNA-1273. Treatment with Aleve. Event outcomes unknown. 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: MONTELUKAST; HYDROXYCHLOROQUINE; FEXOFENADINE; VITAMINS NOS

Current Illness: Connective tissue disorder

ID: 1536992
Sex: F
Age:
State:

Vax Date: 12/29/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
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: severe lower back pain; pain going into hips; pain going into knees; A spontaneous report was received from a consumer concerning a patient who received the mRNA-1273 and experienced severe lower back pain going into hips and knees. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 on 29-Dec-2020 intramuscularly for prophylaxis of COVID-19 infection. Patient reported that they received the Moderna vaccine on 29-Dec-2020 at 8 a.m. She said that by midnight that night, she began to experience severe lower back pain going into hips and knees. Patient reported that they had been taking paracetamol, naproxen and ibuprofen along with application of a heating pad; none of which provided any relief. Treatment for the event included paracetamol, naproxen, ibuprofen and application of a heating pad. Action taken with mRNA-1273 in response to the events, severe lower back pain going into hips and knees, was not provided. The outcome of the events, severe lower back pain going into hips and knees, was not reported. The reporter did not provide a causality assessment of the events, severe lower back pain going into hips and knees.; Reporter'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:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm