chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Antigen / reconstituted with sodium chloride / was administered to patient; Antigen / reconstituted with sodium chloride / was administered to patient; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amza417a, expiry date 30th September 2021) for prophylaxis.   On 29th June 2021, the patient received the 1st dose of Menveo. On 29th June 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details provided as follows: The patient was administered Menveo in which the powder component of menveo was reconstituted with sodium chloride solution and not the provided diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021142845:Same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Rash papular, Vaccination failure
Clinical narrative: got Shingrix first shot and second shot / believes he might have developed shingles/suspected vaccination failure; believes he might have developed shingles; bumps on his lower leg, inner thigh and stomach on same side; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and papular rash. On an unknown date, the outcome of the vaccination failure, shingles and papular rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and papular rash to be related to Shingrix and Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. For tolerance of 1st dose of Shingrix, refer case US2021AMR146065. The patient got bumps on his lower leg, inner thigh and stomach on same side. The patient believed he might have developed shingles. This case was considered as suspected vaccination failure as details regarding  time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The patient declined to provide demographics or any additional information. The reporter did not consent to follow up. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR146065:Same reporter
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose of Shingrix on 09/272019 / Second dose of Shingrix on 06/28/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number 393C7, expiry date 25th October 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 27th September 2019, Batch number- 227FL and expiration date- 26th September 2020).   On 28th June 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 28th June 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 patient received the 2nd dose of Shingrix in right arm, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose of Shingrix in december 2019 / wanted to know if she can vaccinate the patient with the second dose today 1st of July 2021; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2019, batch number- BY244, expiry date- 28 July 2022).   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. The pharmacist wanted to know if she could vaccinate the patient with the second dose today 1st of July 2021.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with cases US2021088008, US2020066996, US2019151165, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021088008:same reporter US-GLAXOSMITHKLINE-US2020066996:same reporter US-GLAXOSMITHKLINE-US2019151165:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose / on  7/24/19 and had not yet received the second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 24th July 2019).   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. No further events were reported. The reporter consented to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the second dose / after the maximum recommended time of 6 months / first dose was administered / during Nov 23rd 2019; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 7f94c, expiry date 11th November 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 23rd November 2019).   On 2nd July 2021, the patient received the 2nd dose of Shingrix. On 2nd July 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 patient received the 2nd dose of Shingrix after the maximum recommended time of 6 months, which led to lengthening of vaccination schedule. The reporter consented to follow up. The case is linked with the case- US2021143504, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021143504:Same reporter
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: GOT 2 PFIZER SHOTS AFTER GETTING THE JANSSEN VACCINE; OFF LABEL USE WITHOUT AE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included bnt 162 for prophylactic vaccination. On an unspecified date, the subject experienced got 2 pfizer shots after getting the janssen vaccine, and off label use without ae. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use without ae and got 2 pfizer shots after getting the janssen vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: MULTIPLE SIDE EFFECTS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 multiple side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of multiple side effects was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE  ADMINISTERED AFTER TEMPERATURE  EXCURSION OCCURRED; OUT OF SPECIFICATION PRODUCT USE; 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: 206A21A  expiry: 07-AUG-2021) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAY-2021, the subject experienced vaccine administered after temperature excursion occurred. On 25-MAY-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after temperature excursion occurred and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210701990.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Exposure during pregnancy
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; SOME SIDE EFFECTS FOR 48 HOURS; This spontaneous pregnancy report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. It was not reported whether the patient had been pregnant before. 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 06-APR-2021, the subject experienced vaccine exposure during pregnancy. On 06-APR-2021, the subject experienced some side effects for 48 hours. The date of the subject's last menstrual period and expected delivery date were not reported. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from some side effects for 48 hours on 08-APR-2021, and the outcome of vaccine exposure during pregnancy was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: SLIGHT BODY ACHES; FEVER; 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. 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, start therapy date were not reported for prophyalctic 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 slight body aches, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) fever 100.9 TO 103.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight body aches, and fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Multiple sclerosis
Clinical narrative: MULTIPLE SCLEROSIS FLARE UP; This spontaneous report received from a patient concerned white, not hispanic or latino male of an unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: unknown) dose was not reported, 1 total, administered on 12-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 15-JUN-2021, the patient experienced multiple sclerosis flare up symptoms including difficulty walking and moving the right leg specifically, patient experienced numbness about 50 percent numbness in both legs and had visited physician's office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from multiple sclerosis flare up. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-20210608685-covid-19 vaccine ad26.cov2.s-Multiple sclerosis flare up. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Myalgia, Pyrexia, Rhinorrhoea
Clinical narrative: COLD SWEATS; MINOR SNIFFLES; FEVER; TIREDNESS; MUSCLES PAINS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 cold sweats, minor sniffles, fever, tiredness, and muscles pains. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold sweats, fever, tiredness, muscles pains and minor sniffles was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: ACHES; CHILLS; 101 FEVER; 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. 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, 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 aches, chills, and 101 fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 101 fever, chills and aches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Paraesthesia
Clinical narrative: NUMBNESS IN FEET AND HANDS; TINGLING IN NERVES; CHILLS; This spontaneous report received from a physician concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. Batch number was not reported and has been requested.  On an unspecified date, the subject experienced numbness in feet and hands, tingling in nerves, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, numbness in feet and hands and tingling in nerves was not reported. This report was non-serious. This case, from the same reporter is linked to 20210710727.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sore throat, and mild fever after 72 hours of getting the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore throat and mild fever after 72 hours of getting the shot was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER FOR A NIGHT; This spontaneous report received from a patient 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, 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 fever for a night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever for a night. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Dyspnoea, Pyrexia
Clinical narrative: COULD NOT BREATHE NORMALLY; BAD SIDE EFFECTS; FEVER; 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. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced could not breathe normally, bad side effects, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the could not breathe normally, fever and bad side effects was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: GAVE EXPIRED MED; USED A VIAL THAT HAD BEEN USED / OPENED AND RETURNED TO THE REFRIGERATOR OVERNIGHT; This spontaneous report received from a pharmacist concerned a 60 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: 18-AUG-2021) dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-JUL-2021, the subject experienced gave expired med. On 06-JUL-2021, the subject experienced used a vial that had been used / opened and returned to the refrigerator overnight. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the gave expired med and used a vial that had been used / opened and returned to the refrigerator overnight was not reported. This report was non-serious.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Feeling abnormal, Gait disturbance, Muscular weakness
Clinical narrative: Fell flat on my stomach, face first; After about 30  minutes I felt the surface descending  and my walk pace increased; Finally I fell forward on my face; Suddenly felt like I was walking down a hill, I was descending. The street was flat.; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Fell flat on my stomach, face first), GAIT DISTURBANCE (After about 30  minutes I felt the surface descending  and my walk pace increased) and FALL (Finally I fell forward on my face) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Prostate cancer since 01-Jul-1996 and Cane user. Concomitant products included LEUPRORELIN ACETATE (LUPRON) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced MUSCULAR WEAKNESS (Fell flat on my stomach, face first) (seriousness criterion hospitalization), GAIT DISTURBANCE (After about 30  minutes I felt the surface descending  and my walk pace increased) (seriousness criterion hospitalization), FALL (Finally I fell forward on my face) (seriousness criterion hospitalization) and FEELING ABNORMAL (Suddenly felt like I was walking down a hill, I was descending. The street was flat.). The patient was hospitalized from 07-Apr-2020 to 08-Apr-2020 due to FALL. The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 2 UNK. At the time of the report, MUSCULAR WEAKNESS (Fell flat on my stomach, face first), GAIT DISTURBANCE (After about 30  minutes I felt the surface descending  and my walk pace increased), FALL (Finally I fell forward on my face) and FEELING ABNORMAL (Suddenly felt like I was walking down a hill, I was descending. The street was flat.) outcome was unknown.            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.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received medical history, concomitant medications and events were added and reporter information was updated and 1st dose details were updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Death, Epistaxis
Clinical narrative: healthy woman dying within 48 h of vaccination; blood coming out of her nose; This spontaneous case was reported by a physician and describes the occurrence of DEATH (healthy woman dying within 48 h of vaccination) and EPISTAXIS (blood coming out of her nose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEATH (healthy woman dying within 48 h of vaccination) (seriousness criteria death, medically significant and life threatening) and EPISTAXIS (blood coming out of her nose) (seriousness criteria death and life threatening). The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  The subject stated that "there are many deaths related to the Covid vaccine and autopsies have been ordered."  The subject also stated that many deaths have occurred within 48 hours of the vaccination. He also reported that a healthy young woman was found deceased in her apartment within 48 hours of vaccination. The deceased was found with blood coming out of her nose.    No treatment information was provided by the reporter.  Very limited information regarding this events has been provided at this time.  Details regarding the exact brand of vaccine received, dosing dates, Medical history, concomitant medication, and date/cause of death are required for further evaluation. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Details regarding the exact brand of vaccine received, dosing dates, Medical history, concomitant medication, and date/cause of death are required for further evaluation. Further information has been requested.; Reported Cause(s) of Death: Many deaths related to the COVID vaccine
Sex: U
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) outcome was unknown. Not Provided          It was reported that the patient had started to have Rheumatoid Arthritis flare ups after beening in remission for 8 years. The patient reported RA flare ups after  each COVID-19 vaccine. I t was reported that the patient went to see Rheumatologist who stated 4 other of his RA patients reported RA flare ups after COVID-19 vaccine. Concomitant and treatment information was not reported.   This case was linked to MOD-2021-231450, MOD-2021-114609, MOD-2021-114592 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested. Causality is confounded with patient's medical history of rheumatoid arthritis as it is a complex disease with variable course, characterized by remissions and flares which can be triggered by various environmental factors in genetically susceptible individuals.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction, Panic attack
Clinical narrative: Erectile Dysfunction; Panicking; This spontaneous case was reported by a consumer and describes the occurrence of ERECTILE DYSFUNCTION (Erectile Dysfunction) in a 31-year-old male 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.     No Medical History information was reported.    On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-2021, the patient experienced ERECTILE DYSFUNCTION (Erectile Dysfunction) (seriousness criterion medically significant) and PANIC ATTACK (Panicking). At the time of the report, ERECTILE DYSFUNCTION (Erectile Dysfunction) and PANIC ATTACK (Panicking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was mentioned No treatment medication information was mentioned  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainting; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not provided) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Fainting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not reported.  No treatment information was provided by the reporter.; 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.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Tremor
Clinical narrative: still has shakes on and off; Had a seizure/basically started seizing and couldn't stop/by the time when she arrived at the hospital, she was still convulsing but could talk/duration of seizures to be 1 or 1.5 hours long/still has shakes on and off; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (Had a seizure/basically started seizing and couldn't stop/by the time when she arrived at the hospital, she was still convulsing but could talk/duration of seizures to be 1 or 1.5 hours long/still has shakes on and off) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SEIZURE (Had a seizure/basically started seizing and couldn't stop/by the time when she arrived at the hospital, she was still convulsing but could talk/duration of seizures to be 1 or 1.5 hours long/still has shakes on and off) (seriousness criterion medically significant). On an unknown date, the patient experienced TREMOR (still has shakes on and off). At the time of the report, SEIZURE (Had a seizure/basically started seizing and couldn't stop/by the time when she arrived at the hospital, she was still convulsing but could talk/duration of seizures to be 1 or 1.5 hours long/still has shakes on and off) was resolving and TREMOR (still has shakes on and off) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. Patient was treated with IV medication in emergency room that helped her stop the seizures. She was discharged from the emergency room once she stopped having tremors. She still had shakes on and off and saw her primary care provider who had referred her to a neurologist.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cellulitis, Limb mass, Oedema, Ultrasound scan
Clinical narrative: Diagnosed with Cellulitis of the Left upper extremities; describes the masses as abscess-like and diagnosed with subcutaneous edema; Mass growing on the injection arm (left side); mass growing on the injection arm (left side), then it spread to her left leg, and now the right arm is also having mass growth"; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CELLULITIS (Diagnosed with Cellulitis of the Left upper extremities) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced OEDEMA (describes the masses as abscess-like and diagnosed with subcutaneous edema). 11-Jun-2021, the patient experienced VACCINATION SITE MASS (Mass growing on the injection arm (left side)) and LIMB MASS (mass growing on the injection arm (left side), then it spread to her left leg, and now the right arm is also having mass growth"). On 19-Jun-2021, the patient experienced CELLULITIS (Diagnosed with Cellulitis of the Left upper extremities) (seriousness criterion medically significant). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) for Adverse event, at a dose of 1 dosage form. At the time of the report, CELLULITIS (Diagnosed with Cellulitis of the Left upper extremities), OEDEMA (describes the masses as abscess-like and diagnosed with subcutaneous edema), VACCINATION SITE MASS (Mass growing on the injection arm (left side)) and LIMB MASS (mass growing on the injection arm (left side), then it spread to her left leg, and now the right arm is also having mass growth") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jun-2021, Blood test: normal (normal) normal. On 19-Jun-2021, Ultrasound scan: abnormal (abnormal) findings: subcutaneous edema. On 19-Jun-2021, X-ray: normal (normal) normal.         Concomitant product use was not provided by the reporter.  The patient reported the masses as "abscess-like" and "hard-lumps." She was sent to the emergency room (ER) on 19-Jun-2021 and discharged the same day.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, X-ray
Clinical narrative: Diagnosed with Cellulitis of the Left upper extremities; describes the masses as abscess-like and diagnosed with subcutaneous edema; Mass growing on the injection arm (left side); mass growing on the injection arm (left side), then it spread to her left leg, and now the right arm is also having mass growth"; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CELLULITIS (Diagnosed with Cellulitis of the Left upper extremities) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced OEDEMA (describes the masses as abscess-like and diagnosed with subcutaneous edema). 11-Jun-2021, the patient experienced VACCINATION SITE MASS (Mass growing on the injection arm (left side)) and LIMB MASS (mass growing on the injection arm (left side), then it spread to her left leg, and now the right arm is also having mass growth"). On 19-Jun-2021, the patient experienced CELLULITIS (Diagnosed with Cellulitis of the Left upper extremities) (seriousness criterion medically significant). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) for Adverse event, at a dose of 1 dosage form. At the time of the report, CELLULITIS (Diagnosed with Cellulitis of the Left upper extremities), OEDEMA (describes the masses as abscess-like and diagnosed with subcutaneous edema), VACCINATION SITE MASS (Mass growing on the injection arm (left side)) and LIMB MASS (mass growing on the injection arm (left side), then it spread to her left leg, and now the right arm is also having mass growth") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jun-2021, Blood test: normal (normal) normal. On 19-Jun-2021, Ultrasound scan: abnormal (abnormal) findings: subcutaneous edema. On 19-Jun-2021, X-ray: normal (normal) normal.         Concomitant product use was not provided by the reporter.  The patient reported the masses as "abscess-like" and "hard-lumps." She was sent to the emergency room (ER) on 19-Jun-2021 and discharged the same day.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, COVID-19, Coombs test, Death, SARS-CoV-2 antibody test negative
Clinical narrative: passed away; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 01Jul2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient) and patient's wife. A 69-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6201), via an unspecified route on 10Feb2021 (at the age of 69-years) as dose 1, single and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6203), via an unspecified route on 03Mar2021 (at the age of 69-years) as dose 2, single for covid-19 immunisation. The patient medical history included Hodgkin's disease from 1978 (they took his spleen out, so he was a little immunocompromised and they took out his spleen and appendix after diagnosis) and unknown if ongoing. The patient concomitant medications were not reported. On unspecified date, the patient experienced had 3 antibody tests- one that was a 15minutes finger prick and two others that were all 2-3 weeks apart. Patient stated all 3 tests were negative for antibodies and his doctors don't know why. His doctors said maybe it did not detect antibodies to the vaccine. In 1978, he had Hodgkin's disease and they took his spleen out, so he was a little immunocompromised. However, the infectious disease doctor said since he got both doses he should still be protected. Reporter was concerned that he didn't had great immune system when three negative tests came back, he just want to make sure that everybody thinks he was not okay because he was going out over usual instructions because of them. His primary care physician (PCP) said he talked to another doctor and said if he had the vaccine it should be covered but the test came back negative. Reporter stated that the "last test he had was on 24May2021, it was COVID-19 antibody test, SARS test, COB test 2, AbIG Quantitative. This one was done on maybe 10th (unspecified date in 2021) it was rapid test for SARS, COB-2, IGg antibody. That was done on 07Apr201 and stated if Pfizer want, he can give that also, SARS, COVID, COB-2, IGgAb, AbIGm, they all came back negative". Patient's wife stated her husband passed away and at the time of the vaccination she and her daughter got adverse reactions she would like to fill the form for both her and her daughter. The patient died on unspecified date in 2021 with unknown cause of death and autopsy results was unknown. The outcome of the event was fatal. Follow up needed, further information has been requested.; Reported Cause(s) of Death: passed away
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Computerised tomogram, Echocardiogram, Electrocardiogram, Hypoaesthesia
Clinical narrative: Experiencing problems with memory, balance and feeling in right foot; Experiencing problems with feeling in right foot.; Experiencing problems with memory; On April 6 I suffered a stroke.  It was minor.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 69-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EP6955), via unspecified route of administration in arm left on 27Mar2021 (at the age of 68-years-old) as dose 2, single and first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6205), via unspecified route of administration in arm left on 06Mar2021 (at the age of 68-years-old) as dose 1, single both the doses for COVID-19 immunisation. The medical history of the patient included myacins and codeine allergy from an unknown date and unknown if ongoing. The concomitant medications of the patient included just vitamins. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient had been tested with covid-19 nasal swab and resulted negative on 06Apr2021. The patient reported on 06April I suffered a stroke. It was minor. Experiencing problems with memory at 16:30 and experiencing problems with memory, balance and feeling in right foot on an unspecified date. The patient visited Emergency room/department or urgent care. The patient was hospitalized for one day as a result of events. The patient underwent lab tests and procedures which included minor catscan (2); MRI; EKG; bubble test. Therapeutic measures were taken as a result of experiencing problems with memory and on april06 and suffered a stroke it was minor catscan (2); MRI; EKG; bubble test. The outcome of the events was reported as resolving.  Follow up attempts are possible. Further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Memory impairment, SARS-CoV-2 test, Transient ischaemic attack
Clinical narrative: Experiencing problems with memory, balance and feeling in right foot; Experiencing problems with feeling in right foot.; Experiencing problems with memory; On April 6 I suffered a stroke.  It was minor.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 69-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EP6955), via unspecified route of administration in arm left on 27Mar2021 (at the age of 68-years-old) as dose 2, single and first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6205), via unspecified route of administration in arm left on 06Mar2021 (at the age of 68-years-old) as dose 1, single both the doses for COVID-19 immunisation. The medical history of the patient included myacins and codeine allergy from an unknown date and unknown if ongoing. The concomitant medications of the patient included just vitamins. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient had been tested with covid-19 nasal swab and resulted negative on 06Apr2021. The patient reported on 06April I suffered a stroke. It was minor. Experiencing problems with memory at 16:30 and experiencing problems with memory, balance and feeling in right foot on an unspecified date. The patient visited Emergency room/department or urgent care. The patient was hospitalized for one day as a result of events. The patient underwent lab tests and procedures which included minor catscan (2); MRI; EKG; bubble test. Therapeutic measures were taken as a result of experiencing problems with memory and on april06 and suffered a stroke it was minor catscan (2); MRI; EKG; bubble test. The outcome of the events was reported as resolving.  Follow up attempts are possible. Further information is expected.