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

Incidents per State

State Total
72,296
AK1,638
AL5,339
AR3,412
AS44
AZ13,316
CA58,147
CO11,002
CT7,824
DC1,626
DE1,670
FL36,235
FM3
GA13,429
GU82
HI2,195
IA4,332
ID2,473
IL19,261
IN22,568
KS4,284
KY6,945
LA4,714
MA13,886
MD11,901
ME2,997
MH8
MI17,865
MN11,345
MO8,919
MP30
MS2,676
MT2,147
NC15,401
ND1,273
NE2,732
NH2,859
NJ17,232
NM3,702
NV4,071
NY32,763
OH18,072
OK5,940
OR7,954
PA22,457
PR2,104
QM2
RI1,911
SC6,055
SD1,133
TN8,691
TX34,122
UT4,023
VA13,944
VI49
VT1,661
WA13,811
WI10,395
WV2,220
WY805
XB5
XL1
XV2

ID: 1465643
Sex: F
Age:
State:

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 07/12/2021
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Symptoms: flare; her injection site reactions which use to be 6 inches and itchy are down to 3 inches and much less itch; injection site reactions/started out as size of a quarter/now 6 inches on stomach/last week did it on leg, it was less in size but still raised, red, angry but not as painful as stomach one/down to 3; injection site reactions/started out as size of a quarter/now 6 inches on stomach/last week did it on leg, it was less in size but still raised, red, angry but not as painful as stomach one/down to 3; injection site reactions/started out as size of a quarter/now 6 inches on stomach/last week did it on leg, it was less in size but still raised, red, angry but not as painful as stomach one/down to 3; increase in joint pain; increase in swelling in her hands and toes; liver enzyme increased; allergic reaction; dizzy; could not breathe/shortness of breath; hot flash; arrhythmia; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer, based on information received by Pfizer(manufacturer control number: US-AMGEN-USASL2021055143), license party for etanercept (ENBREL). This solicited report (USASL2021055143) was reported on 08Apr2021 by a consumer from a commercial program (PSP00086) and involves a 39 years old female patient who experienced injection site reactions/started out as size of a quarter/now 6 inches on stomach/last week did it on leg, it was less in size but still raised, red, angry but not as painful as stomach one (PT: injection site swelling, PT: injection site erythema, PT: injection site pain), increase in joint pain (PT: arthralgia), increase in swelling in her hands and toes (PT: peripheral swelling) while receiving Enbrel, Single Dose Prefilled Autoinjector. The patient's historical medical condition included shoulder surgery. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date in Jan2021. On an unknown date in Jan2021, the patient reported that she had been doing Enbrel since January and just this month after her surgery. On an unknown date 2021, it was reported that surgery went well, took 10 days off of Enbrel and could feel an increase in joint pain and swelling in her hands and toes. After ten days, in 2021, the patient back on Enbrel, so she knows the Enbrel was helping her RA. Additionally, the patient developed injection site reactions. She said they started out as the size of a quarter but are now up to 6 inches 2 weeks ago on her stomach. On an unknown date in 2021, last week, she did it on her leg and used topical Hydrocortisone cream which helped. Additionally, it was less in size but was still raised, red and angry but not as painful as her stomach one. Her doctor recommend Benadryl cream (diphenhydramine hydrochloride), icing and to take an oral Benadryl (diphenhydramine hydrochloride), 30 minutes before the injection to minimize the reaction. The outcome of the events injection site swelling, injection site erythema was reported as not recovered/not resolved. The outcome of the events injection site pain, arthralgia, peripheral swelling were reported as unknown. Action taken with Enbrel, Single Dose Prefilled Autoinjector was reported as unknown for the events injection site swelling, injection site erythema and injection site pain. The causal relationship between the events injection site swelling, injection site erythema, injection site pain, arthralgia, peripheral swelling and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent to contact. No follow up attempts are possible. No further information is expected. Causality Assessment for the events Peripheral swelling, Arthralgia, Injection site pain, Injection site erythema, Injection site swelling: Not related. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Follow-up (29Jun2021): This is a follow-up solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer based on information received by Pfizer (manufacturer control number: US-AMGEN-USASL2021055143), license party for etanercept (ENBREL). ADDITIONAL INFORMATION RECEIVED ON 29/JUN/2021: This case was upgraded to serious. In this follow-up, it was reported that the patient had flare [PT: rheumatoid arthritis], liver enzyme increased [PT: hepatic enzyme increased], injection site reactions which use to be six inches and itchy are down to three inches and much less itchy [PT: injection site pruritus], down to three inches and much less itchy [PT: injection site swelling, injection site erythema and injection site pain] while receiving Enbrel, Single Dose Prefilled Autoinjector. The patient's co-suspect medication included covid-19 vaccine. On an unknown date in early APR/2021, the patient gad the first dose of covid-19 vaccination. Subsequently, the patient had an allergic reaction. The patient felt dizzy, could not breathe, shortness of breath, hot flash and arrhythmia. On an unknown date in 2021, the patient was straightened out in the ER (Emergency room) and was placed on unspecified steroids and inhalers. The patient recovered all right. On an unknown date in 2021, the patient had flare. Subsequently, the patient was placed on methotrexate. On an unknown date in 2021, the patient was doing better and injection site reactions which used to be six inches and itchy are down to three inches. They are much less itchy. The patient stated that her energy was up and her pain if down. The patient contributes that to Enbrel. On an unknown date in 2021, the patient had some laboratory test with an increase in her liver enzymes. On an unknown date in 2021, the dose of methotrexate was increased with the flare-up. At the time of this report, the patient is still scheduled to ween off some steroids. The patient thought that her physician would decrease the dose in two days (01/JUL/2021) on her physician visit. The outcome of the event rheumatoid arthritis was reported as not recovered/not resolved. The outcome of the events injection site pruritus, injection site swelling, injection site erythema, injection site pain were reported as recovering/resolving. The outcome of the event hepatic enzyme increased was reported as unknown. Action taken with Enbrel with Single Dose Prefilled Autoinjector was reported as unknown for the events rheumatoid arthritis, injection site pruritus and hepatic enzyme increased. The causal relationship between the events rheumatoid arthritis, injection site pruritus, hepatic enzyme increased and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter did not and would never have access to lot number. The reporter declined consent for follow up. No follow up attempts are possible. No further information is expected. Comment: This individual report does not change the safety profile of the product. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Causality Assessment: The event injection site itching was assessed as related to etanercept. The events injection site swelling, injection site redness, injection site pain, joint pain, peripheral swelling, rheumatoid arthritis flare up and hepatic enzyme increased were assessed as unrelated to etanercept. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, the events hypersensitivity, dizziness, dyspnea, hot flush, and arrhythmia are assessed as related to BNT162B2 and are unrelated to Etanercept and Methotrexate. The even

Other Meds: Methotrexate Sodium; Enbrel

Current Illness: Rheumatoid arthritis

ID: 1465644
Sex: F
Age:
State:

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Onset Date:
Rec V Date: 07/12/2021
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Symptoms: having a flare up; feeling "weak" after her last Enbrel/having a stressful week and feeling completely drained; also recently a " bad cold; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASL2021087467), license party for etanercept (ENBREL). This serious solicited report (USASL2021087467) was reported to Amgen on 04/JUN/2021 by a consumer from a commercial program and involves a 66 year old female patient who experienced having a "flare up [PT: rheumatoid arthritis], feeling "weak" after her last enbrel [PT: asthenia], also recently a bad cold [PT: nasopharyngitis] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. The patient's co-suspect medication included covid-19 vaccine. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. The patient stated that she was weaning herself off of her Enbrel injections due to her inability to pay for them.Since on an unknown date in 2021, the patient was having a flare up after receiving her second covid-19 vaccine injection. The patient state that she was feeling weak after her last Enbrel injection prior to this report. Also, on an unknown date in 2021, the patient recently had a bad cold. No treatment information was received. The outcome of the event rheumatoid arthritis was reported as not recovered/not resolved. The outcome of the events asthenia, nasopharyngitis were reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the events asthenia, nasopharyngitis and rheumatoid arthritis. The causal relationship between the events asthenia, nasopharyngitis, rheumatoid arthritis and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined to provide lot number. The reporter declined consent for follow up. No follow-up attempts are possible. No further information is expected. Amgen comment: This individual report does not change the safety profile of the product. Company (Amgen)'s causality assessment of event 'rheumatoid arthritis flare up and cold' was not related; of event 'weakness' was related. The reporter's assessment of the causal relationship of event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Follow-up (24Jun2021): This is a follow-up solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASL2021087467), license party for etanercept (ENBREL). Additional information received on 24/JUN/2021: It was reported that the patient was having a stressful week and feeling completely drained [PT: asthenia] while receiving Enbrel, Single Dose Prefilled Autoinjector. On an unknown date, the patient was having a stressful week and feeling completely drained. No treatment information was received. The reporter did not and would never have access to lot number. The reporter declined consent for follow up. No follow-up attempts are possible. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: COVID-19 VACCINE was re-coded as Pfizer product.; Sender's Comments: Reported event RA flare and bad colds are assessed as intercurrent medical conditions and are not related to Enbrel. Asthenia is considered related to Enbrel based on temporal association. Events RA, asthenia, and nasopharyngitis are considered intercurrent conditions and unrelated to suspect BNT162B2.

Other Meds: Enbrel

Current Illness: Rheumatoid arthritis

ID: 1465645
Sex: U
Age:
State:

Vax Date:
Onset Date: 02/15/2019
Rec V Date: 07/12/2021
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Symptoms: PHYSICIAN REPORTING THAT WHEN GIVING FLUMIST IN THE PAST PATIENTS HAVE EXPERIENCED IENCED MYALGIA AND NASAL IRRITATION; PHYSICIAN REPORTING THAT WHEN GIVING FLUMIST IN THE PAST PATIENTS HAVE EXPERIENCED IENCED MYALGIA AND NASAL IRRITATION; A spontaneous report has been received from a consumer. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin. No medical history was reported. No concomitant products were reported. The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v), via nasal route, on an unknown date. No malfunction has been reported for FLUMIST QUADRIVALENT. On 15-FEB-2019, the patient experienced not applicable physician reporting that when giving flumist in the past patients have experienced ienced myalgia and nasal irritation (preferred term: Myalgia) and not applicable physician reporting that when giving flumist in the past patients have experienced ienced myalgia and nasal irritation (preferred term: Nasal discomfort). The outcome of the event(s) of physician reporting that when giving flumist in the past patients have experienced ienced myalgia and nasal irritation and physician reporting that when giving flumist in the past patients have experienced ienced myalgia and nasal irritation was unknown. The events were considered non-serious. Device Information: Combination Product Report: Yes Product As Reported: FLUMIST QUADRIVALENT Common Device Name: Nasal Spray Procode: CCQ Product Role: Suspect

Other Meds:

Current Illness:

ID: 1465646
Sex: M
Age:
State:

Vax Date: 04/12/2021
Onset Date: 04/14/2021
Rec V Date: 07/12/2021
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Symptoms: briefly Blacked out; Fell; Broke his right proximal humerus; Bruised his right knee; Split open his upper lip; Dental bridge was also broken in the fall; This is a spontaneous report from a non-contactable consumer, based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-061722), license party for apixaban (ELIQUIS). This spontaneous case was reported by a patient family member or friend and describes the occurrence of LOSS OF CONSCIOUSNESS (briefly Blacked out), FALL (Fell) and HUMERUS FRACTURE (Broke his right proximal humerus) in 79-year-old male patient who received apixaban (Eliquis) for an unknown indication. The occurrence of additional non-serious events is detailed below Product or product use issues identified: DEVICE BREAKAGE (Dental bridge was also broken in the fall) on 14-Apr-2021. On an unknown date, the patient started Eliquis (unknown route). On 14-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (seriousness criterion medically significant), FALL (seriousness criterion medically significant), HUMERUS FRACTURE (seriousness criterion medically significant), CONTUSION (Bruised his right knee) and LIP INJURY (Split open his upper lip). The patient was treated with Physical therapy for Humerus fracture. The action taken with Eliquis (Unknown) was unknown. At the time of the report, LOSS OF CONSCIOUSNESS, FALL, HUMERUS FRACTURE, CONTUSION and LIP INJURY outcome was unknown. Patient was taking Eliquis at the time he fell and broke his arm. He had been gardening and was wearing old, worn sneakers when they went to a hardware store for some supplies. At one point he slipped and fell forward to the floor. He broke his right proximal humerus, bruised his right knee, and split open his upper lip, and briefly 'blacked out'. A dental bridge was also broken in the fall. When the attending ER physician learned that he was taking Eliquis he was taken for brain scans to look for hemorrhages. His arm did not require surgery or casting. He wore a sling for several weeks and slept in a recliner until 19-Jun-2021. He's been undergoing physical therapy for almost four weeks and has regained almost 9000 mobility in that arm. There were no specific treatments received for the knee. He received his second Pfizer Covid vaccination on 12-Apr-2021 DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Scan brain: No bleeding was present. For Eliquis(Unknown), the reporter did not provide any causality assessments.; Sender's Comments: BMS Medical Evaluation Comment: This 79-year-old patient had multiple events after receiving apixaban therapy. Based on the nature of the reported event, loss of consciousness which could have led to fall leading to humerus fracture in this elderly patient, they are considered as not related to apixaban therapy.

Other Meds:

Current Illness:

ID: 1465647
Sex: U
Age: 20
State: TX

Vax Date: 05/26/2021
Onset Date: 05/26/2021
Rec V Date: 07/12/2021
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Symptoms: Expired Dose of Heplisav-B was Administered; Initial Report Received on 26-May-2021 A nursing supervisor reported that a 20 year-old female (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. Relevant medical history included scoliosis. The patient had no known allergies. No relevant concomitant medications were reported. On 26-May-2021, the patient received a dose of HEPLISAV-B (Lot # 933094, expiration date 17-Apr-2021, NDC # unknown, serial number 977676332283) in the right deltoid from a medical doctor's office. A tetanus, diphtheria and acellular pertussis (Tdap) vaccine was administered in the left deltoid during the same visit. The patient also received a purified protein derivative (PPD) skin test. At the time of reporting, no adverse symptoms were reported. No additional information was provided. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.

Other Meds: Tdap; Purified protein derivative of tuberculin (TB-PPD)

Current Illness:

ID: 1465648
Sex: U
Age:
State: NC

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Rec V Date: 07/12/2021
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Symptoms: first / vaccine November 2019 / unable to get the 2nd vaccine because of COVID; This case was reported by a other health professional via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in November 2019). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient was unable to get the 2nd dose of Shingrix because of Covid. The reporter asked if the patient should repeat that and get both vaccines or if just take the 2nd vaccine now.

Other Meds:

Current Illness:

ID: 1465649
Sex: U
Age:
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Rec V Date: 07/12/2021
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Symptoms: Initial shot a couple of years ago / due to various things including the pandemic / unable to get the second shot; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose two years ago, from the day of reporting). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. The patient had the initial shot a couple of years ago but, due to various things including the pandemic, he or she was unable to get the second shot. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The patient was quite sure it was Shingrix vaccine but did not know for sure. The reporter was asking if they should start over and get two shots or just get the second shot. The follow-up would not possible as no contact details were available. The case had been linked with the case- US2021AMR145801, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR145801:Same reporter. Master case for "We"

Other Meds:

Current Illness:

ID: 1465650
Sex: U
Age:
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Rec V Date: 07/12/2021
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Symptoms: Initial shot a couple of years ago / due to various things including the pandemic / unable to get the second shot; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st shot two years ago, from the day of reporting). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The patients had the initial shot a couple of years ago but, due to various things including the pandemic, they were unable to get the second shot. The reporter was asking if they should start over and get two shots or just get the second shot. The case is linked with the case- US2021AMR145748, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR145748:Same reporter.

Other Meds:

Current Illness:

ID: 1465651
Sex: U
Age:
State:

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Onset Date:
Rec V Date: 07/12/2021
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Symptoms: Because of the Covid epidemic, I just got my 2nd Shingrix shot. But the time between shots was 2 years.; This case was reported by a consumer via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received 2 years before the 2nd dose). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown. Additional details were provided as follows: The case was reported by the patient himself/herself. The age at vaccination was not reported The patient stated that he/she received the 2nd dose of Shingrix 2 years later due to Covid epidemic. The reporter stated the time between shots was 2 years and also stated that his/her doctor said that patient should get a 'third' shot because of the time elapsed between the first two. The reporter asked did he/she need another shot in 4-6 months and also asked was there any time that was preferred in the 2 to 6 month time-frame to get your second shingrix shot. It was stated that the patient was advised to talk to his/her healthcare provider about that guidance and patient's individual situation.

Other Meds:

Current Illness:

ID: 1465652
Sex: U
Age:
State:

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Onset Date:
Rec V Date: 07/12/2021
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Symptoms: Because of the Covid epidemic, I just got my 2nd./time between shots was 2 years.; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on unknown date 2 years ago). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown. Additional details were provided as follows: The patient had reported the case for himself/herself. The age at vaccination was not reported. Because of the Covid epidemic, the patient just got 2nd Shingrix shot but the time between shots was 2 years. The patient enquired if he/she need another shot in 4 to 6 months.

Other Meds:

Current Illness:

ID: 1465653
Sex: U
Age:
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Rec V Date: 07/12/2021
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Symptoms: My arm hurt for a week after each vaccination shot; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. Additional details provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient reported that after every Shingle shot, his/her arm hurts for a week. The patient stated that he/she could not imagine how painful shingles were. The follow-up would not possible as no contact details were available. For tolerance of 2nd dose, refer link case US2021AMR149445.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR149445:Same reporter.

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Current Illness:

ID: 1465654
Sex: U
Age:
State:

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Rec V Date: 07/12/2021
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Symptoms: Vaccinated and still got them / Suspected Vaccination failure; Vaccinated and still got them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The patient had reported the case for himself/herself. The age at vaccination was not reported. The patient was vaccinated with Shingles vaccine and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible, as no contact details were available.

Other Meds:

Current Illness:

ID: 1465656
Sex: F
Age: 34
State: PA

Vax Date: 10/07/2020
Onset Date:
Rec V Date: 07/12/2021
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Allergies:

Symptom List:

Symptoms: received the vaccine when she was 13 weeks and 6 days pregnant; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 34-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 9HT27, expiry date 30th June 2021) 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 7th October 2020, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Tetra 2020-2021 season at day 97 of the pregnancy. On an unknown date, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. 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: The reporter was the patient. She was a physician resident. The patient received the vaccine when she was 13 weeks and 6 days pregnant which led to vaccine exposure during pregnancy. The reporter consented to follow up. Follow-up information received on 05th July 2021: After completion of all the follow up attempts the case was considered as pregnancy lost to follow up.

Other Meds:

Current Illness:

ID: 1465658
Sex: U
Age:
State: NY

Vax Date: 04/21/2021
Onset Date: 04/21/2021
Rec V Date: 07/12/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: received a late second dose of Shingrix, first dose on 5Jul2018 and second on 21Apr2021; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 5th July 2018). On 21st April 2021, the patient received the 2nd dose of Shingrix. On 21st April 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1465660
Sex: F
Age: 57
State: IL

Vax Date: 07/01/2021
Onset Date: 07/01/2021
Rec V Date: 07/12/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Received her 2nd dose / on 01Jul2021 and the needle leaked; This case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date). On 1st July 2021, the patient received the 2nd dose of Shingrix. On 1st July 2021, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown. Additional details were provided as follows: The pharmacy student reported that a patient received her dose of Shingrix and the needle leaked, which led to incomplete dose administered. The reporter did not mention if the leakage touched the patient or the health care professional. The health care professional did not have the lot number or expiry date at the time of reporting. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1465662
Sex: F
Age: 75
State:

Vax Date: 12/09/2020
Onset Date:
Rec V Date: 07/12/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: First dose / on 12/09/2020 / still did not receive second dose; Had a sore arm / after first dose; Had trouble sleeping for about 8 days after first dose; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 9th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm, difficulty sleeping and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm and difficulty sleeping were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the pain in arm and difficulty sleeping to be related to Shingrix. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report for 2nd dose. The patient received Shingrix had sore arm and trouble sleeping for about 8 days. The patient still did not receive second dose, which led to incomplete course of vaccination. The reporter did not consent to follow up. The reporter was referred to the health care professional. Limited information obtained.

Other Meds:

Current Illness:

ID: 1465663
Sex: M
Age:
State: VT

Vax Date: 07/08/2021
Onset Date: 07/08/2021
Rec V Date: 07/12/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: administration of less than the recommended dose / due to a syringe malfunction the vaccine leaked during the administration / did not know how many milliliters the patient received; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 272F3, expiry date 1st October 2022) for prophylaxis. On 8th July 2021, the patient received Shingrix. On 8th July 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the administration of less than the recommended dose of the Shingrix vaccine. The HCP claimed that due to a syringe malfunction the vaccine leaked during the administration and the reporter did not know how many milliliters the patient received, which led to accidental underdose. The vaccine was administrated on the same day of the call. No further events were reported. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1465665
Sex: M
Age:
State: FL

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: do not remember whether they got the 1 and/or 2 doses of the vaccine/they got vaccinated was 3-4 years ago; do not remember whether they got the 1 and/or 2 doses of the vaccine/they got vaccinated was 3-4 years ago; This case was reported by a other health professional via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received doses 3 to 4 years ago of reporting date, did not remember dose number 1 or 2). On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced circumstance or information capable of leading to medication error and extra dose administered. On an unknown date, the outcome of the circumstance or information capable of leading to medication error and extra dose administered were unknown. Additional details were reported as follows: The case was reported by the patient's for himself. The age at vaccination was not applicable for this report. Health care professional (also patient) reported that he wanted to have, it might be a 3rd dose of Shingrix. The patient did not remember whether he got the 1st and/or 2 doses of the vaccine, which was the circumstance or information capable of leading to medication error and if had already received 2 doses, this dose would result in extra dose administered. The reporter asked when was he vaccinated and the patient told that they got vaccinated was 3 to 4 years ago. The reporter called to have more data regarding getting re-vaccinated. The reporter consented to follow up. The case had been linked with US2021149599 reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021149599:Same reporter

Other Meds:

Current Illness:

ID: 1465666
Sex: F
Age:
State: FL

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: do not remember whether they got the 1 and/or 2 doses / got vaccinated was 3-4 years ago.; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received 3 or 4 years ago from reporting date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were reported as follows: The case was reported by the patient's husband. The age at vaccination was not applicable for this report. The health care professional reported that the patient wanted to have it might be a 3rd dose of Shingrix as she did not remember whether she got the 1st and/or 2 doses of the vaccine which led to incomplete course of vaccination. The reporter called to have more data regarding getting re-vaccinated. The reporter consented to follow up. The case had been linked with US2021149594 reported by same reporter. Note: This case was conservatively kept valid with event incomplete course of vaccination as it was not clear if patient had received 2nd dose of Shingrix or not. ; Sender's Comments: US-GLAXOSMITHKLINE-US2021149594:Same reporter

Other Meds:

Current Illness:

ID: 1465667
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 03/26/2021
Rec V Date: 07/12/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
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Lab Data:

Allergies:

Symptom List:

Symptoms: POSITIVE SIDE EFFECT; HAIR GROWTH; NAIL GROWTH; This spontaneous report received from a patient concerned an 80 year old male. The patient's weight was 150 pounds, and height was 71 inches. The patient's past medical history included malignant melanoma removed, and food poisoning, and concurrent conditions included nail fungus, and other pre-existing medical conditions included took black walnut husk and it affected gut flora, so patient started taking a probiotic as well. The patient was previously treated with juglans nigra fruit for food poisoning, influenza vaccine for prophylactic vaccination; and experienced asthma, edema and high eosinophil count when treated with naproxen sodium, and severe allergy/anaphylactic when treated with diethyltoluamide. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1805031, and expiry:10-JUL-2021) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced hair growth. On 26-MAR-2021, the subject experienced nail growth. On an unspecified date, the subject experienced positive side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hair growth, nail growth and positive side effect was not reported. This report was non-serious.

Other Meds:

Current Illness: Fungal infection of nail

ID: 1465668
Sex: M
Age:
State: NC

Vax Date:
Onset Date: 06/01/2021
Rec V Date: 07/12/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
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Lab Data:

Allergies:

Symptom List:

Symptoms: SORE ALL OVER THE BODY; WEAKNESS IN BODY; HEADACHES; POSSIBLE BLOOD CLOT IN RIGHT LEG; SWELLING IN BOTH FEET; This spontaneous report received from a patient concerned a 57 year old. The patient's height, and weight were not reported. The patient's past medical history included accident affected right leg in 2010 and concurrent conditions included penicillin allergy (happened when patient was when very young) and severe back pain (from accident). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043AZ1A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 16-JUN-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. In JUN-2021 (week and a half after getting the vaccine), the patient had swelling in both feet but mostly in the right foot. The right foot swelled up during the day and then shrunk back down in the night. The skin looked pink and red and felt hot (warmth). The patient started noticing it when he started to experience pain in shins and then it got sore and then started to swell. The patient started noticing puffiness, soreness and warmth after. By 2 weeks it was very puffy and sore. The patient was able to walk and it was the right foot that was mainly bothering. The patient had not seen any health care professional during this time. The patient was concerned that he might had blood clot in right leg due to the fact that it was swollen, red and warm, as per the symptoms they read about. The patient had some headaches in the beginning, took aspirin, and it had improved. The patient also felt weak (weakness in body) and sore all over the body. These all had resolved except the right leg issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore all over the body, weakness in body, and headaches, and had not recovered from swelling in both feet, and possible blood clot in right leg. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210713160-covid-19 vaccine ad26.cov2.- Possible blood clot in right leg. 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: Back pain; Penicillin allergy

ID: 1465669
Sex: F
Age:
State: IL

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 07/12/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: RAPID HEARTBEAT; SORE ARM; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 20 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, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced rapid heartbeat. On JUL-2021, the subject experienced sore arm. On JUL-2021, the subject experienced headache. On JUL-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) not reported, and Heart rate (NR: not provided) rapid. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heartbeat, headache, and fever on JUL-2021, and had not recovered from sore arm. 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: 1465671
Sex: U
Age:
State: MD

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: VACCINE WAS NOT HANDLED RIGHT BEFORE ADMINISTRATION; 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) 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 vaccine was not handled right before administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was not handled right before administration was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1465672
Sex: U
Age:
State: CA

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 07/12/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
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Lab Data:

Allergies:

Symptom List:

Symptoms: VACCINE ADMINISTERED TO TWO PATIENTS WAS AT ROOM TEMPERATURE FOR FOUR HOURS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients. 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 expiry: 04-AUG-2021) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced vaccine administered to two subjects was at room temperature for four hours. On 01-JUL-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to two patients was at room temperature for four hours and incorrect product storage was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1465673
Sex: U
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: ARM PAIN; HUGE HEADACHE; MINI FEVER; This spontaneous report received from a patient . The patient's weight, height, and medical history were not 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 07-JUL-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 07-JUL-2021, the subject experienced arm pain. On 07-JUL-2021, the subject experienced huge headache. On 07-JUL-2021, the subject experienced mini fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm pain, huge headache, and mini fever. This report was non-serious.

Other Meds:

Current Illness:

ID: 1465674
Sex: U
Age:
State: MI

Vax Date:
Onset Date: 06/28/2021
Rec V Date: 07/12/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: TEMPERATURE RANGED FROM 24.8 DEGREES F FROM TO 35 DEGREES F; TEMPERATURE EXCURSION; This spontaneous report received from a health care professional 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: Unknown) dose was not reported, administered on 28-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-JUN-2021, the subject experienced temperature ranged from 24.8 degrees f from to 35 degrees f. On 28-JUN-2021, the subject experienced temperature excursion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature ranged from 24.8 degrees f from to 35 degrees f and temperature excursion was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1465675
Sex: F
Age:
State: KS

Vax Date:
Onset Date: 07/09/2021
Rec V Date: 07/12/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: POOR QUALITY VACCINE ADMINISTERED; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 76 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1820096, expiry: 06-SEP-2021) .5 ml, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced poor quality vaccine administered. On 09-JUL-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the poor quality vaccine administered and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210722914.

Other Meds:

Current Illness: Non-smoker

ID: 1465676
Sex: F
Age:
State: MO

Vax Date:
Onset Date: 07/09/2021
Rec V Date: 07/12/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: INAPPROPRIATE DOSE OF VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. the patient was not pregnant at the time of vaccination.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978, expiry: 28-JUL-2021) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced inappropriate dose of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inappropriate dose of vaccine administered was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1465677
Sex: U
Age:
State: AR

Vax Date:
Onset Date: 07/10/2021
Rec V Date: 07/12/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: CANNOT STOP SHAKING; COLD; BACK HURTS; MUSCLES HURTING/MUSCLES ACHE; HEADACHE; This spontaneous report received from a patient concerned a 26 year old of unspecified sex. The patient's weight was 275 kilograms, and height was 76 inches. 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 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUL-2021, the subject experienced cannot stop shaking. On 10-JUL-2021, the subject experienced cold. On 10-JUL-2021, the subject experienced back hurts. On 10-JUL-2021, the subject experienced muscles hurting/muscles ache. On 10-JUL-2021, the subject experienced headache. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cannot stop shaking, cold, back hurts, muscles hurting/muscles ache, and headache. This report was non-serious.

Other Meds:

Current Illness:

ID: 1465678
Sex: F
Age:
State: KS

Vax Date:
Onset Date: 07/09/2021
Rec V Date: 07/12/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: ADMINISTRATION OF EXPIRED VACCINE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known allergies and had no medical conditions.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1820096, expiry: 06-SEP-2021) .5 ml, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced administration of expired vaccine. On 09-JUL-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210722813.

Other Meds:

Current Illness: Non-smoker

ID: 1465679
Sex: F
Age:
State:

Vax Date:
Onset Date: 07/09/2021
Rec V Date: 07/12/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: SEVERE BODY ACHE; GIGGLES; HIGH ANXIETY; FEELING DRUNK; LOW GRADE FEVER; MILD AND DRY SORE THROAT; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to some topical polyethylene glycol (peg), and hand injury. 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 09-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included naproxen for hand injury. On 09-JUL-2021, the subject experienced mild and dry sore throat. On 09-JUL-2021, the subject experienced giggles. On 09-JUL-2021, the subject experienced high anxiety. On 09-JUL-2021, the subject experienced feeling drunk. On 09-JUL-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 98.8. On 10-JUL-2021, the subject experienced severe body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild and dry sore throat, severe body ache, low grade fever, feeling drunk, giggles, and high anxiety. This report was non-serious.

Other Meds: NAPROXEN 500 MG

Current Illness: Allergy to chemicals; Hand injury (Naproxen 500 mg (generic for Naproysn) for an injury to my hand prior to being vaccinated which I was instructed to stop taking 24 hours before and 6 hours after vaccination. I waited as long as I could and took the Naproxen 10 hours later.)

ID: 1465680
Sex: U
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: AGGRAVATING AN OLD ROTATOR CUFF INJURY; INSANE PAIN; SHOT WAS SLIGHTLY OFF AND WENT DIRECTLY INTO A TENDON; BIG RED BUMP; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included rotator cuff injury. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced aggravating an old rotator cuff injury, insane pain, shot was slightly off and went directly into a tendon, and big red bump. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the big red bump, insane pain, shot was slightly off and went directly into a tendon and aggravating an old rotator cuff injury was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1465681
Sex: F
Age:
State: LA

Vax Date:
Onset Date: 03/05/2021
Rec V Date: 07/12/2021
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Symptoms: DIZZINESS; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness. This report was non-serious.

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ID: 1465682
Sex: F
Age: 80
State: IA

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 07/12/2021
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Symptoms: really high blood pressure; could not get up; a reaction to the vaccine at the site of injection with a rash; Nauseous; Passed out; Light Headed/dizzy; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included LEVOTHYROXINE for Thyroid disorder NOS, PRAMIPEXOLE HCL for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced DIZZINESS (Light Headed/dizzy). On 28-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), HYPERTENSION (really high blood pressure), MOBILITY DECREASED (could not get up), VACCINATION SITE RASH (a reaction to the vaccine at the site of injection with a rash) and NAUSEA (Nauseous). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), DIZZINESS (Light Headed/dizzy), HYPERTENSION (really high blood pressure), MOBILITY DECREASED (could not get up), VACCINATION SITE RASH (a reaction to the vaccine at the site of injection with a rash) and NAUSEA (Nauseous) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: high (High) high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications was reported Treatment 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. This case was linked to MOD-2021-248557 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information received; 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: LEVOTHYROXINE; PRAMIPEXOLE HCL

Current Illness:

ID: 1465683
Sex: F
Age: 67
State: WA

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 07/12/2021
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Symptoms: New 5 and 7 mm ill-defined nodular densities are seen in the left upper\ increased calcification; Difficulty breathing; Feeling hot; Increased thoracic kyphosis noted; Anterior spondylosis is seen in the upper lumbar; likely infectious or inflammatory in etiology; patient has increased mucus production; very dry cough with just little tiny specs of mucus; felt slightly crappy; Fever; back muscle spasms; little sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PNEUMONIA (likely infectious or inflammatory in etiology), PULMONARY CALCIFICATION (New 5 and 7 mm ill-defined nodular densities are seen in the left upper\ increased calcification), DYSPNOEA (Difficulty breathing) and COUGH (very dry cough with just little tiny specs of mucus) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Chronic bronchitis (given gamma globulin shots, took up swimming and gradually the frequency for illness decreased (over a decade or so).), Pneumonia, Watering eyes, Runny nose and Hormone replacement therapy. Previously administered products included for an unreported indication: PNEUMOCOCCAL CONJUGATE VACCINE in October 2019. Concurrent medical conditions included Allergy to animal dander (Cat hair caused watery eyes, runny nose & stuffed head.) since 18-Dec-1972, Allergy to animal dander (dog hair caused watery eyes, runny nose & stuffed head.) since 18-Dec-1972, Allergy to animals (cattle caused watery eyes, runny nose & stuffed head.) since 18-Dec-1972 and Smoke inhalation (tobacco mix caused watery eyes, runny nose & stuffed head.) since 18-Dec-1972. Concomitant products included TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID)) from 05-Jan-2018 to an unknown date for Contact dermatitis, PREGNENOLONE from 09-Jan-2007 to an unknown date and PROGESTERONE from 09-Jan-2007 to an unknown date for HRT, KRILL OIL, UBIDECARENONE (COQ10 [UBIDECARENONE]) and CRANBERRY [VACCINIUM MACROCARPON] for Supplementation therapy, CYANOCOBALAMIN (VIT B12) and COLECALCIFEROL (VIT D3) for Vitamin supplementation. On 28-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced MUSCLE SPASMS (back muscle spasms) and PAIN IN EXTREMITY (little sore arm). On 29-Jan-2021, the patient experienced PYREXIA (Fever). On 31-Jan-2021, the patient experienced DEPRESSED MOOD (felt slightly crappy). On 01-Feb-2021, the patient experienced PRODUCTIVE COUGH (patient has increased mucus production) and COUGH (very dry cough with just little tiny specs of mucus) (seriousness criterion medically significant). On an unknown date, the patient experienced PNEUMONIA (likely infectious or inflammatory in etiology) (seriousness criterion medically significant), PULMONARY CALCIFICATION (New 5 and 7 mm ill-defined nodular densities are seen in the left upper\ increased calcification) (seriousness criterion medically significant), DYSPNOEA (Difficulty breathing) (seriousness criterion medically significant), FEELING HOT (Feeling hot), KYPHOSIS (Increased thoracic kyphosis noted) and SPINAL OSTEOARTHRITIS (Anterior spondylosis is seen in the upper lumbar). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at a dose of UNK dosage form; BENZONATATE (oral) ongoing since an unknown date for Cough, at a dose of 200 mg; AZITHROMYCIN (oral) ongoing since an unknown date for Mucus discharge, at a dose of 250 mg and FLUTICASONE PROPIONATE (FLOVENT HFA) (oral) ongoing from 25-Feb-2021 for Adverse event, at a dose of 200mcg/act aer glax. On 29-Jan-2021, PAIN IN EXTREMITY (little sore arm) and PYREXIA (Fever) had resolved. On 30-Jan-2021, MUSCLE SPASMS (back muscle spasms) had resolved. On 31-Jan-2021, DEPRESSED MOOD (felt slightly crappy) had resolved. On 28-Apr-2021, PNEUMONIA (likely infectious or inflammatory in etiology), PRODUCTIVE COUGH (patient has increased mucus production), PULMONARY CALCIFICATION (New 5 and 7 mm ill-defined nodular densities are seen in the left upper\ increased calcification), DYSPNOEA (Difficulty breathing), COUGH (very dry cough with just little tiny specs of mucus), FEELING HOT (Feeling hot), KYPHOSIS (Increased thoracic kyphosis noted) and SPINAL OSTEOARTHRITIS (Anterior spondylosis is seen in the upper lumbar) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, COVID-19: negative (Negative) negative. On 11-Feb-2021, Chest X-ray: inconclusive (Inconclusive) New 5 and 7 mm ill-defined nodular densities are seen in the left upper lobe compared with 2007. On 15-Feb-2021, Computerised tomogram thorax: inconclusive (Inconclusive) Chest x-ray findings correspond with mild left upper lobe ground-glass opacities, likely infectious or inflammatory in etiology. Lungs, Pleura and Airways: Mild left upper lobe stellate peribronchovascular and subpleural ground-glass opacities. No airway narrowing or obstruction. No pleural effusion or pneumothorax.. 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. Patient started taking flu shots in her 50s which did help. On Monday 08 Feb 2021, patient called her PCP, and had a zoom call. She prescribed a cough med and suggested I get a chest xray and Ct scan. The medication helped a bit with the cough (especially at night) but she still had mucus production. Patient had another call with PCP on 16Feb 2021, where she prescribed a five day course of antibiotic, but that didn't result in clearing up the mucus production either. Patient was but on an inhaler to help clear up the likely infection/mucus. Patient had little to no (new) symtoms as a result of the 2nd shot. Patient used the inhaler for about two months and gradually the mucus production and cough went away. Patient weaned myself off the inhaler over the course of the first 2-3 weeks in May and was perfectly fine until she went in to have the pneumonia vaccine (PPSV-23) on 13 Jun 2021. After the shot patient's mucus production started up again and patient started back on the inhaler but only once a day, which seems to keep my symptoms in check. Patient met PCP on 29 Feb 2021, to talk about this on-going lung issue. Patient was going to take a pulmonary Function Test some time this month (July). 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. This case was linked to MOD-2021-246799 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: No new information. On 05-Jul-2021: Follow-up case - Second dose, height, weight, ethnic group, race, previous allergies, concomitant medications, treatment medications, new labs added. Action taken event outcome and inarrative 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. Further information has been requested.

Other Meds: PREGNENOLONE; PROGESTERONE; TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID); VIT B12; VIT D3; KRILL OIL; COQ10 [UBIDECARENONE]; CRANBERRY [VACCINIUM MACROCARPON]

Current Illness: Allergy to animal dander (dog hair caused watery eyes, runny nose & stuffed head.); Allergy to animal dander (Cat hair caused watery eyes, runny nose & stuffed head.); Allergy to animals (cattle caused watery eyes, runny nose & stuffed head.); Smoke inhalation (tobacco mix caused watery eyes, runny nose & stuffed head.)

Date Died: 06/13/2021

ID: 1465684
Sex: F
Age: 71
State: LA

Vax Date: 04/08/2021
Onset Date: 04/08/2021
Rec V Date: 07/12/2021
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Symptoms: Elevated blood pressure since receiving first dose.; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Elevated blood pressure since receiving first dose.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. Concurrent medical conditions included Bone cancer. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (Elevated blood pressure since receiving first dose.) (seriousness criterion death). The patient died on 13-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Blood pressure measurement: high (High) Elevated blood pressure. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment information was not provided. Company Comment: Very limited information regarding the event has been provided at this time. Further information is not expected. Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up received on 07 Jul 2021 included relevant history detail (bone cancer), seriousness (death) and outcome of the event (fatal).; Sender's Comments: Very limited information regarding the event has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death

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Current Illness: Bone cancer

ID: 1465685
Sex: F
Age:
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Rec V Date: 07/12/2021
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Symptoms: Guillain barre; Vertigo; Cannot walk at all; weakness in my lower extremities; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain barre) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain barre) (seriousness criteria hospitalization prolonged and medically significant), VERTIGO (Vertigo), GAIT INABILITY (Cannot walk at all) and MUSCULAR WEAKNESS (weakness in my lower extremities). The patient was hospitalized for 45 days due to GUILLAIN-BARRE SYNDROME. At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain barre), VERTIGO (Vertigo), GAIT INABILITY (Cannot walk at all) and MUSCULAR WEAKNESS (weakness in my lower extremities) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.

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ID: 1465686
Sex: M
Age: 63
State: TN

Vax Date: 02/21/2021
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Rec V Date: 07/12/2021
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Symptoms: After 1st shot he was paralyzed from waist down; He felt like he lost a good chunk of his life, got screwed; This spontaneous case was reported by a consumer and describes the occurrence of PARAPLEGIA (After 1st shot he was paralyzed from waist down) and FEELING ABNORMAL (He felt like he lost a good chunk of his life, got screwed) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAPLEGIA (After 1st shot he was paralyzed from waist down) (seriousness criterion medically significant) and FEELING ABNORMAL (He felt like he lost a good chunk of his life, got screwed) (seriousness criterion medically significant). At the time of the report, PARAPLEGIA (After 1st shot he was paralyzed from waist down) and FEELING ABNORMAL (He felt like he lost a good chunk of his life, got screwed) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product was not provided by the reporter. It was noted that the patient lives in a assisted living facility. After the onset of events, the patient reported that he was put in a wheel chair but no longer needs the wheel chair. The patient was also advised by his doctor's not to receive the second shot. Further information regarding treatment was not reported. 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. Further information has been requested.; 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. Further information has been requested.

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ID: 1465687
Sex: F
Age: 42
State: FL

Vax Date: 06/21/2021
Onset Date: 06/28/2021
Rec V Date: 07/12/2021
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Symptoms: threw up a few times; I actually past out that morning; I woke up 5 AM and I was bleeding very heavy; My right side (side I fell on) of the head still hurts; severe headache/ My right side (side I fell on) of the head still hurts; feel nauseous; I got my period days early from my usual; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (I actually past out that morning) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Nausea and Pain. Concomitant products included ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, NAPROXEN SODIUM (ALEVE) for Pain. On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jun-2021, the patient experienced MENSTRUAL DISORDER (I got my period days early from my usual). On 29-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (I actually past out that morning) (seriousness criterion medically significant), HEAVY MENSTRUAL BLEEDING (I woke up 5 AM and I was bleeding very heavy), FALL (My right side (side I fell on) of the head still hurts), HEADACHE (severe headache/ My right side (side I fell on) of the head still hurts) and NAUSEA (feel nauseous). On an unknown date, the patient experienced VOMITING (threw up a few times). At the time of the report, LOSS OF CONSCIOUSNESS (I actually past out that morning) was resolving, HEAVY MENSTRUAL BLEEDING (I woke up 5 AM and I was bleeding very heavy), MENSTRUAL DISORDER (I got my period days early from my usual), FALL (My right side (side I fell on) of the head still hurts) and VOMITING (threw up a few times) outcome was unknown and HEADACHE (severe headache/ My right side (side I fell on) of the head still hurts) and NAUSEA (feel nauseous) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient never had any issues with the menstrual cycle and never had this much blood. Patient went to emergency department and ran a few imaging tests like CT scans and others which were turned out as normal. Treatment medication were not reported. 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.Very limited information regarding this event has been provided at this time.; 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.Very limited information regarding this event has been provided at this time

Other Meds: ZOFRAN [ONDANSETRON]; ALEVE

Current Illness: Nausea; Pain

ID: 1465688
Sex: F
Age: 82
State: NJ

Vax Date: 02/24/2021
Onset Date: 06/01/2021
Rec V Date: 07/12/2021
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Symptoms: Started feeling weakness at the back of her neck; red blotches; itchy; disorder sleep; Phone monitoring device and it stated it might be afib and something else (she cannot remember the term); Heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Phone monitoring device and it stated it might be afib and something else (she cannot remember the term)) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Lupus erythematosus, Polymyalgia rheumatica, Sjogren's syndrome, Raynaud's syndrome and Hypothyroidism. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced ARRHYTHMIA (Phone monitoring device and it stated it might be afib and something else (she cannot remember the term)) (seriousness criterion medically significant), PALPITATIONS (Heart palpitations), MUSCULAR WEAKNESS (Started feeling weakness at the back of her neck), RASH MACULAR (red blotches), PRURITUS (itchy) and SLEEP DISORDER (disorder sleep). At the time of the report, ARRHYTHMIA (Phone monitoring device and it stated it might be afib and something else (she cannot remember the term)), PALPITATIONS (Heart palpitations), MUSCULAR WEAKNESS (Started feeling weakness at the back of her neck), RASH MACULAR (red blotches), PRURITUS (itchy) and SLEEP DISORDER (disorder sleep) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment medication included an unspecified cream for an unknown indication. A week after the 1st dose (??-Mar-2021), patient reportedly had red blotches on her arms, face, back, thigh and chest areas. She consulted with two doctors and was prescribed with an unspecified cream which did not help. The red blotches are still present - they are itchy and she cannot sleep. She also says that she has to explain to everyone she meets that they are not contagious. She has an appointment with her rheumatologist on the last week of September. 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. This case was linked to MOD-2021-248016 (Patient Link).; 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.

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Current Illness: Hypothyroidism; Lupus erythematosus; Polymyalgia rheumatica; Raynaud's syndrome; Sjogren's syndrome

ID: 1465690
Sex: F
Age:
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Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 07/12/2021
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Symptoms: her face was red; her face was red, "rashy" and "blotchy."; She said her skin was so itchy; she found a big bump under her eye; face was itchy; big bump on her neck; This is a spontaneous report from a Non-contactable consumer. This female consumer reported for herself that. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was not reported) dose 1 via an unspecified route of administration on 09Feb2021 13:00 as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications were not reported. The patient said she received vaccine on Tuesday, 09Feb2021 at 1 PM. Then when she woke up last night, she said her face was itchy. She also said she found a big bump on her neck. On 11Feb2021 when she got up, her face was red, "rashy" and "blotchy." She said her skin was so itchy, and she found a big bump under her eye. The outcome of the events was unknown. No follow-up attempts are possible. Information regarding lot/batch cannot be obtained. No further information is expected.

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Current Illness:

ID: 1465691
Sex: M
Age:
State: OH

Vax Date: 02/11/2021
Onset Date: 02/12/2021
Rec V Date: 07/12/2021
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Symptoms: Redness on left arm where he got injection of second dose of Pfizer COVID-19 Vaccine; Itching on left arm where he got injection of second dose of Pfizer COVID-19 Vaccine; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 93-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN9581, Expiration date was unknown, NDC number: 59267-1000-1), via an unspecified route administration, administered in left arm on 11Feb2021 around 09:00 (at last thursday, as per report) as a single dose for covid-19 immunization. The patient had no medical history and did not administered any concomitant medications. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN9581), via an unspecified route administration, administered in left arm around 09:00 on 20Jan2021 as a single dose for covid-19 immunization. Patient was administered his second dose of Pfizer COVID-19 Vaccine on 11Feb2021. Everything went very well no problems. He woke up on 12Feb2021 with redness on left arm where he got injection of second dose of Pfizer COVID-19 Vaccine. He then had onset of itching on left arm where he got injection of second dose of Pfizer COVID-19 Vaccine. He had no idea why he developed these events. His son was a retired doctor, so patient went over to him retired doctor(son) said it was not shingles which was patient first idea. He and the retired doctor (son) decided it was caused by the Pfizer COVID-19 Vaccine. Patient received some anti-itch cream on the itching on left arm area and he was asked for information about these events and what was the expected duration of the events, enquired whether it was normal, how long will this last. Redness on left arm and Itching on left arm where he got injection of second dose of Pfizer COVID-19 Vaccine was worsened (increased) for a day or two and then became constant level now and controlled. The outcome of the events was not recovered. The relatedness of the events was confirmed related to Pfizer COVID-19 Vaccine by the reporter and from his son who is a retired doctor. Follow-up attempts completed. No further information expected.

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Current Illness:

ID: 1465692
Sex: F
Age:
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Vax Date: 02/07/2021
Onset Date: 02/01/2021
Rec V Date: 07/12/2021
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Symptoms: itching and hives on her neck; Chills; Ache; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EN5318), dose 2 via an unspecified route of administration on 07Feb2021 as single dose and received first dose of (bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EL3246) dose via unspecified route of administration on 17th January2021 as a single dose for covid-19 immunisation. Medical history included pain in extremity from an unknown date and unknown if ongoing, rash from Dec2020 to an unknown date. The patient's concomitant medications were not reported. The patient reported that she had second dose of COVID-19 vaccination on 07Feb2021 (not clarified). After the second shot, she had minor reaction. Chills and aches which was resolved after 24 hours. 3-4 days later she began itching and hives on her neck and that was continuing. She was taking half a tablet benadryl every 4 hours round the clock because it wakes her up in the middle night when it wears off. The minute it starts wearing off hive and severe itchiness returns. The patient reported that benadryl makes sleepy. So, she was looking for an alternative and an end to this, that she cannot take it around the clock. She did not take benadryl prior to receiving the second dose. So, she wants to know, when this will go away. The patient was not recovered from itching and hives and recovered from chills and ache on an unspecified date in FEB-2021. Follow-up attempts are completed. No further information is expected.

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Current Illness:

ID: 1465693
Sex: F
Age:
State: MI

Vax Date: 02/10/2021
Onset Date: 02/11/2021
Rec V Date: 07/12/2021
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Symptoms: Allergic reaction; my leg was like just itching; This is a spontaneous report from a contactable consumer (Patient). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration on 10Feb2021 (at the age of 74-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication included furosemide (FUROSEMIDE) taken for an unspecified indication, start and stop date were not reported. On 11Feb2021 patient experienced leg was like just itching and allergic reaction on an unspecified date. It was reported that her height is about 5 Feet and 6 inches. She think and weight should be about 300 Pounds not positive about the weight." The only thing it says here is Pfizer and that number that she gave you and there is a date which was 02/10 and that is the only thing seeing except my name and birth date." Well, she took Zyrtec. Anyway so she did take Zyrtec this morning but that itching, she had taken that yesterday. That itching was something that was not usual." She queried Can you tell me is this something that would normally happen, a rash of any kind. I guess that is what I am concerned with." When Informed about the role of Pfizer Drug Safety again, she stated, "So, you do not have advice whether I should I be concerned about this or somewhere I should go to check this out." Patient did not underwent any lab test. She just need someone to tell her that if this is something to check out or is it something that normally happens. That is what it is. The itching is uncomfortable. she was unwilling to complete the report. Hence, limited information was available over the call. The outcome of the event was unknown. Follow-up (21May2021): Follow-up attempts completed. No further information expected.

Other Meds: FUROSEMIDE

Current Illness:

ID: 1465694
Sex: F
Age:
State: IL

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 07/12/2021
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Symptoms: I had severe chest pain from Tuesday evening- Friday and still have minor residual pain when I take a deep breath; I had severe chest pain from Tuesday evening- Friday and still have minor residual pain when I take a deep breath; The pain was so bad I thought I was having a heart attack. It was primarily on the left side of my chest and felt like a stabbing pain. I went to the dr that following week.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 32-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: el1283), via an unspecified route of administration, administered in Arm Right on 02Feb2021 13:30 (at the time of vaccination 32-years-old), as a single dose for COVID-19 immunization. The patient's medical history included thyroid. The patient's concomitant medications were not reported. The patient had no known allergies from food sensitivities. Patient had no other vaccine in fourweeks and no other medications in twoweeks. Patient did not have covid prior vaccination and no covid tested post vaccination. On 02Feb2021, the patient experienced the pain was so bad i thought i was having a heart attack, it was primarily on the left side of my chest and felt like a stabbing pain, i went to the dr that following week (myocardial infarction) (medically significant); and i had severe chest pain from tuesday evening- friday and still have minor residual pain when i take a deep breath. The patient visited to Doctor or other healthcare professional office/clinic visit. The outcome of the event was unknown. Follow-up (14May2021): Follow-up attempts completed. No further information expected.

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Current Illness:

ID: 1465695
Sex: F
Age:
State: MI

Vax Date: 01/28/2021
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Rec V Date: 07/12/2021
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Symptoms: pernicious anemia; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection), (Lot number and expiry date was not reported) dose 1 via an unspecified route of administration on 28Jan2021 as a single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced pernicious anaemia. The patient's 2nd dose will be on 18Feb, she should be on B12 injections, but she missed it this month due to the vaccine, she had pernicious anaemia. She would like to know if she can take it with the covid vaccine. Outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

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Current Illness:

ID: 1465696
Sex: F
Age:
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Rec V Date: 07/12/2021
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Symptoms: needle pain sensation all over my body; joint pain; mild fatigue; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age (Age:48; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as a DOSE 1, SINGLE for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient reported, she has been administered both doses of Pfizer covid vaccine. She is experiencing covid like symptoms. She had a negative PCR test and waiting on results from another PCR test. After her first dose, the day after, she had needle pain sensation all over my body and joint pain and mild fatigue. That lasted only a day, she had gone out and got the PCR test, and that test was negative. Outcome of the event was recovered on unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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Current Illness:

ID: 1465697
Sex: M
Age:
State: CA

Vax Date: 02/08/2021
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Rec V Date: 07/12/2021
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Symptoms: body itchy; Fever; watery eyes; has been working with a person that found out that he is positive for Covid; This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on 08Feb2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that he had a vaccine yesterday and after that the patient experienced body itchy, fever and watery eyes on unspecified date. The patient Wanted to know if this is normal if the vaccine does this. The patient takes care of an elderly person and before he got the vaccine that the person had a Covid test which he got back and they told him that it was positive on an unspecified date. The patient reported he is a provides care to this elderly person that is 86 years old and Wanted to know if he can still work with him. The events outcome was Unknown. Information on the lot/batch number has been requested. Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.

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Current Illness:

ID: 1465698
Sex: F
Age:
State: MI

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 07/12/2021
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Symptoms: Lips, face and neck went tingly; Lips, face and neck went tingly; They became semi-numb (sort of feeling like when your feet fall asleep); This is a spontaneous report from a contactable consumer who is reported for herself that. A 31-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: 9265 Expiry date UNKNOWN) via an unspecified route of administration in the left arm on 08Feb2021 16:00 (age at vaccination was 31-year-old) as a SINGLE DOSE for COVID-19 immunisation and first dose was administered in left arm on 18Jan2021 16:30 (Lot number 3249 Expiry date UNKNOWN) as a SINGLE DOSE for COVID-19 immunisation. The patient had allergy to Codeine. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19 and post vaccination. The patient had not been tested for COVID-19. Concomitant medications included in two weeks was sertraline hydrochloride (ZOLOFT) The patient did not receive any other vaccines in four weeks. On 08Feb2021 17:15 patient's Lips, face and neck went tingly and became semi-numb (sort of feeling like when your feet fall asleep). No treatment received for the events. The outcome of the events was recovering. Follow-up (14May2021): Follow-up attempts completed. No further information expected

Other Meds: ZOLOFT

Current Illness:

ID: 1465699
Sex: F
Age:
State: FL

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 07/12/2021
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Symptoms: generalized itching; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for Injection; Lot Number: EN6200) via an unspecified route of administration in arm left on Wednesday, 17Feb2021 10:00 (at the age of 69-year-old), as dose 1, single for COVID-19 immunization. Medical history included kidney transplant from 2011 to 2011, takes a lot of medicines (routine immunosuppressant medications), diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities including diabetes and obesity. The patient's relevant family medical history was none. No other vaccinations within four weeks prior to the first administration date of the suspect vaccines. No vaccines administered on same date with the Pfizer vaccine considered as suspect. The patient's concomitant medication included unspecified routine immunosuppressant medications. On 17Feb2021, Wednesday after receiving the vaccination, the patient experienced generalized itching (starting in the afternoon), with no rash but got itching everywhere. she had no problems breathing and no swelling. She confirmed that she had a history of a kidney transplant and was taking routine immunosuppressant medications. Patient asked if generalized itching was a common side effect from the vaccine and asked if she should get her second dose. At transplant centre, nephrologist said it was okay to get the shot. At about 10: 00 AM, in the afternoon her skin has been itching everywhere. She has no problems breathing, no swelling. No lab and relevant test. The clinical outcome of the event was not resolved. The reporter assessed case non-serious. No follow-up attempts are possible. No further information is expected.

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Current Illness:

Total 2021 VAERS Injuries: 599,999

Page last modified: 03 October 2021 5:28pm