chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: M
Vaccine: COVID19, FLUC4, COVID19, FLUC3
Symptoms: Eye pain, Ocular hyperaemia
Clinical narrative: Right eye and surrounding area became red and painful; Right eye and surrounding area became red and painful; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 9 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Nov2021 17:00 (Lot number: fl0007) at the age of 9 years as dose 1, single for covid-19 immunization in Pharmacy or Drug Store; influenza vaccine inact sag 3v (FLUCELVAX), administered in arm right, administration date 29Nov2021 (Lot number: 309617) as dose 1, single. The patient's relevant medical history was not reported. There were no concomitant medications. No other vaccine in four weeks. The following information was reported: OCULAR HYPERAEMIA (medically significant), EYE PAIN (medically significant) all with onset 29Nov2021 18:15, outcome "unknown" and all described as "Right eye and surrounding area became red and painful". The event "right eye and surrounding area became red and painful" and "right eye and surrounding area became red and painful" was evaluated at the physician office visit and emergency room visit. It was unknown if therapeutic measures were taken as a result of ocular hyperaemia, eye pain. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Transient ischaemic attack
Clinical narrative: Had a TIA; This is a spontaneous report received from contactable Consumer. The reporter is the patient. A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 12:00 (Lot number: 320308D) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 2, Left arm,lot number EW0169), administration date: 20Apr2021, when the patient was 63 years old, for COVID-19 immunization; Bnt162b2 (dose 1, Left arm, lot number ER8733), administration date: 30Mar2021, when the patient was 63 years old, for COVID-19 immunization. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (medically significant) with onset 21Nov2021 10:15, outcome "recovered" (Nov2021), described as "Had a TIA". The event "had a tia" was evaluated at the physician office visit. Therapeutic measures were taken as a result of transient ischaemic attack.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: Had a TIA; This is a spontaneous report received from contactable Consumer. The reporter is the patient. A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 12:00 (Lot number: 320308D) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 2, Left arm,lot number EW0169), administration date: 20Apr2021, when the patient was 63 years old, for COVID-19 immunization; Bnt162b2 (dose 1, Left arm, lot number ER8733), administration date: 30Mar2021, when the patient was 63 years old, for COVID-19 immunization. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (medically significant) with onset 21Nov2021 10:15, outcome "recovered" (Nov2021), described as "Had a TIA". The event "had a tia" was evaluated at the physician office visit. Therapeutic measures were taken as a result of transient ischaemic attack.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Blood thyroid stimulating hormone normal, Fatigue, Hepatic function abnormal, Hypothyroidism
Clinical narrative: HYPOTHYROIDISM; This spontaneous report received from a patient concerned a 42 year old male. The patient's weight was 210 pounds, and height was not reported. The patient's past medical history included: the patient had covid exposure twice, once on 08-FEB-2020 when came back from out of town and was sick between 09-FEB-2020 to 13-FEB-2020 with extreme headache, body and muscle aches. He also had a second exposure on 18-NOV-2020 which he tested negative but all his family tested positive for covid. He also mentioned that he has had vocal injuries and has been getting Botox injections once on 03-DEC-2020 which he had extreme fatigue and affected his thyroid level and secondly on 28-APR-2021 on his neck couple of days before getting his vaccination and concurrent conditions included: penicillin allergy and cannot remember the reaction because he was a child at the time, alcoholic (rarely a little bit of wine), and non-smoker, and other pre-existing medical conditions included: The patient did not have any drug abuse or illicit drug usage. On 18-NOV-2020, Laboratory data included: patient tested (NR: not provided) negative for COVID-19 virus test.  The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total administered to left arm on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-MAY-2021, the patient experienced hair started falling out and received Rogaine and was extremely tired. On 29-JUN-2021, patient had a blood work and it showed a TSH (thyroid stimulating hormone) of 4.2 and had gained 25lb weight and he was diagnosed with hypothyroidism. The patient also visited physician office. The patient felt better on the medication but had weight gain since stopped taking it and is now at 210Ib. The patient mentioned that the patient was athletic and never had such issues and these happened after his vaccination. On 16-AUG-2021, treatment medications included: levothyroxine sodium (treatment stopped because he had digestive issues). Laboratory data (dates unspecified) included: Liver function tests (NR: not provided) Elevated. Additional treatment medications (dates unspecified) included: minoxidil for hair loss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hypothyroidism. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211222596-COVID-19 VACCINE AD26.COV2.S-Hypothyroidism. 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).
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sexual dysfunction, Thyroid disorder, Weight increased
Clinical narrative: HYPOTHYROIDISM; This spontaneous report received from a patient concerned a 42 year old male. The patient's weight was 210 pounds, and height was not reported. The patient's past medical history included: the patient had covid exposure twice, once on 08-FEB-2020 when came back from out of town and was sick between 09-FEB-2020 to 13-FEB-2020 with extreme headache, body and muscle aches. He also had a second exposure on 18-NOV-2020 which he tested negative but all his family tested positive for covid. He also mentioned that he has had vocal injuries and has been getting Botox injections once on 03-DEC-2020 which he had extreme fatigue and affected his thyroid level and secondly on 28-APR-2021 on his neck couple of days before getting his vaccination and concurrent conditions included: penicillin allergy and cannot remember the reaction because he was a child at the time, alcoholic (rarely a little bit of wine), and non-smoker, and other pre-existing medical conditions included: The patient did not have any drug abuse or illicit drug usage. On 18-NOV-2020, Laboratory data included: patient tested (NR: not provided) negative for COVID-19 virus test.  The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total administered to left arm on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-MAY-2021, the patient experienced hair started falling out and received Rogaine and was extremely tired. On 29-JUN-2021, patient had a blood work and it showed a TSH (thyroid stimulating hormone) of 4.2 and had gained 25lb weight and he was diagnosed with hypothyroidism. The patient also visited physician office. The patient felt better on the medication but had weight gain since stopped taking it and is now at 210Ib. The patient mentioned that the patient was athletic and never had such issues and these happened after his vaccination. On 16-AUG-2021, treatment medications included: levothyroxine sodium (treatment stopped because he had digestive issues). Laboratory data (dates unspecified) included: Liver function tests (NR: not provided) Elevated. Additional treatment medications (dates unspecified) included: minoxidil for hair loss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hypothyroidism. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211222596-COVID-19 VACCINE AD26.COV2.S-Hypothyroidism. 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).
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Hypothyroidism, Liver function test, SARS-CoV-2 test negative, Weight
Clinical narrative: HYPOTHYROIDISM; This spontaneous report received from a patient concerned a 42 year old male. The patient's weight was 210 pounds, and height was not reported. The patient's past medical history included: the patient had covid exposure twice, once on 08-FEB-2020 when came back from out of town and was sick between 09-FEB-2020 to 13-FEB-2020 with extreme headache, body and muscle aches. He also had a second exposure on 18-NOV-2020 which he tested negative but all his family tested positive for covid. He also mentioned that he has had vocal injuries and has been getting Botox injections once on 03-DEC-2020 which he had extreme fatigue and affected his thyroid level and secondly on 28-APR-2021 on his neck couple of days before getting his vaccination and concurrent conditions included: penicillin allergy and cannot remember the reaction because he was a child at the time, alcoholic (rarely a little bit of wine), and non-smoker, and other pre-existing medical conditions included: The patient did not have any drug abuse or illicit drug usage. On 18-NOV-2020, Laboratory data included: patient tested (NR: not provided) negative for COVID-19 virus test.  The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total administered to left arm on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-MAY-2021, the patient experienced hair started falling out and received Rogaine and was extremely tired. On 29-JUN-2021, patient had a blood work and it showed a TSH (thyroid stimulating hormone) of 4.2 and had gained 25lb weight and he was diagnosed with hypothyroidism. The patient also visited physician office. The patient felt better on the medication but had weight gain since stopped taking it and is now at 210Ib. The patient mentioned that the patient was athletic and never had such issues and these happened after his vaccination. On 16-AUG-2021, treatment medications included: levothyroxine sodium (treatment stopped because he had digestive issues). Laboratory data (dates unspecified) included: Liver function tests (NR: not provided) Elevated. Additional treatment medications (dates unspecified) included: minoxidil for hair loss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hypothyroidism. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211222596-COVID-19 VACCINE AD26.COV2.S-Hypothyroidism. 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).
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood prolactin increased, Headache, Migraine
Clinical narrative: ELEVATED PROLACTIN; HEADACHES THAT INTENSIFIED; BLURRY VISION; BODYACHES; CHILLS; FEVER; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 20-MAR-2021) dose was not reported, administered on 16-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-OCT-2021, the patient experienced body aches. On 16-OCT-2021, the patient experienced chills. On 16-OCT-2021, the patient experienced fever. On 07-NOV-2021, the patient experienced blurry vision. On 08-DEC-2021, Laboratory data included: Prolactin (NR: not provided) Elevated. On an unspecified date, the patient experienced elevated prolactin, and headaches that intensified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and fever on 18-OCT-2021, had not recovered from headaches that intensified, and the outcome of blurry vision and elevated prolactin was not reported. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood prolactin, Blood prolactin increased, Chills, Headache, Pain
Clinical narrative: ELEVATED PROLACTIN; HEADACHES THAT INTENSIFIED; BLURRY VISION; BODYACHES; CHILLS; FEVER; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 20-MAR-2021) dose was not reported, administered on 16-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-OCT-2021, the patient experienced body aches. On 16-OCT-2021, the patient experienced chills. On 16-OCT-2021, the patient experienced fever. On 07-NOV-2021, the patient experienced blurry vision. On 08-DEC-2021, Laboratory data included: Prolactin (NR: not provided) Elevated. On an unspecified date, the patient experienced elevated prolactin, and headaches that intensified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and fever on 18-OCT-2021, had not recovered from headaches that intensified, and the outcome of blurry vision and elevated prolactin was not reported. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vision blurred
Clinical narrative: ELEVATED PROLACTIN; HEADACHES THAT INTENSIFIED; BLURRY VISION; BODYACHES; CHILLS; FEVER; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 20-MAR-2021) dose was not reported, administered on 16-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-OCT-2021, the patient experienced body aches. On 16-OCT-2021, the patient experienced chills. On 16-OCT-2021, the patient experienced fever. On 07-NOV-2021, the patient experienced blurry vision. On 08-DEC-2021, Laboratory data included: Prolactin (NR: not provided) Elevated. On an unspecified date, the patient experienced elevated prolactin, and headaches that intensified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and fever on 18-OCT-2021, had not recovered from headaches that intensified, and the outcome of blurry vision and elevated prolactin was not reported. This report was non-serious.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Crying, Headache, Pyrexia
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Severe, Additional Details: Patient called and reported chest pain after getting vaccine. Received vaccine 12/10, symptom started the next day, said pain scale of 8/10. but symptoms resolved when call on 12/13.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Severe, Additional Details: Patient called and reported chest pain after getting vaccine. Received vaccine 12/10, symptom started the next day, said pain scale of 8/10. but symptoms resolved when call on 12/13.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Computerised tomogram head, Condition aggravated, Dyspnoea, Fall
Clinical narrative: Guillain Barre Syndrome
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Headache, Immunoglobulin therapy, Lumbar puncture, Magnetic resonance imaging head
Clinical narrative: Guillain Barre Syndrome
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Muscular weakness, Pain in extremity, Palpitations, Paraesthesia
Clinical narrative: Guillain Barre Syndrome
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Subacute inflammatory demyelinating polyneuropathy, Venogram
Clinical narrative: Guillain Barre Syndrome
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: Guillain Barre Syndrome
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anion gap, Blood fibrinogen increased, Blood lactate dehydrogenase increased, C-reactive protein increased, COVID-19
Clinical narrative: hospitalized due to COVID
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Carbon dioxide increased, Chest X-ray normal, Dyspnoea, Exposure to SARS-CoV-2, Fibrin D dimer increased
Clinical narrative: hospitalized due to COVID
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Malaise, N-terminal prohormone brain natriuretic peptide, Oedema peripheral, SARS-CoV-2 test positive
Clinical narrative: hospitalized due to COVID
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized due to COVID
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Extrasystoles, Fatigue, Nausea
Clinical narrative: Diagnosed with premature heart beat in upper atrium after 2nd shot; Felt Nauseous after 2nd dose; Dizziness after 2nd dose; Exhausted after 2nd dose; Diarrhea on & off after 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of EXTRASYSTOLES (Diagnosed with premature heart beat in upper atrium after 2nd shot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced NAUSEA (Felt Nauseous after 2nd dose), DIZZINESS (Dizziness after 2nd dose), FATIGUE (Exhausted after 2nd dose) and DIARRHOEA (Diarrhea on & off after 2nd dose). In October 2021, the patient experienced EXTRASYSTOLES (Diagnosed with premature heart beat in upper atrium after 2nd shot) (seriousness criterion medically significant). On 20-Mar-2021, NAUSEA (Felt Nauseous after 2nd dose), DIZZINESS (Dizziness after 2nd dose), FATIGUE (Exhausted after 2nd dose) and DIARRHOEA (Diarrhea on & off after 2nd dose) had resolved. At the time of the report, EXTRASYSTOLES (Diagnosed with premature heart beat in upper atrium after 2nd shot) outcome was unknown.            No concomitant medications reported. No treatment details provided.  She reports that she had a reaction with the second shot: 2 hours after second shot, she felt Nauseous, Dizziness, exhausted and had Diarrhea on & off.  In OCT2021, She visited the doctor and she was diagnosed with upper Atrium in the heart premature beat. She declined providing the doctor's name or what type of test was done. She states after vaccination, she never had chest pain, nor Shortness of breath. She never had heart fluttering either. She did not feel anything after vaccination that would give her a clue as to having atrium problems. She has never had a positive COVID test.   Reporter did not allow further contact; Sender's Comments: This case concerns a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) with no relevant medical history who experienced the serious unexpected event of extra systoles approximately 7 months after the second dose of the vaccine. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 8 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (8 year old) in an 8-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (8 year old). On 07-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (8 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter. No Concomitant medicines were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2021: Non-Significant follow up appended: reporter added
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced RASH (Rash). The patient was treated with CORTISONE (topical) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Rash) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication reported.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Vaccination complication
Clinical narrative: Symtoms of vaccine when pregnant; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Symtoms of vaccine when pregnant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced VACCINATION COMPLICATION (Symtoms of vaccine when pregnant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, VACCINATION COMPLICATION (Symtoms of vaccine when pregnant) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitants and treatment drugs were provided. AE submitted.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: Bled quite a bit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bled quite a bit) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unk, Unk and Unk) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL A) for Pain.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (Bled quite a bit). At the time of the report, VACCINATION SITE HAEMORRHAGE (Bled quite a bit) outcome was unknown.            A couple of days ago, patient received Moderna booster dose. While it was being injected, patient bled quite a bit. Patient said it was probably due to sleeve being tight and pulled up. Also said that 4-5 hours before booster took Tylenol. Consent for Safety to follow up: Not provided.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: low-grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low-grade fever) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 011M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included VITAMINS NOS, ASPIRIN [ACETYLSALICYLIC ACID] and TAMSULOSIN for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (low-grade fever). On 06-Mar-2021, PYREXIA (low-grade fever) had resolved.            Patient stated that concomitant medication vitamins are used for eyes  Treatment medication were not reported.  Patient stated he became weak from the COVID-19 infection and is still weak today. He was prescribed an inhaler while he had COVID-19.   This case was linked to MOD-2021-408571 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: 28 patient received expired vaccine; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer vaccine (First dose was taken on 24-Mar-2021) on 24-Mar-2021 and Pfizer vaccine (second dose on 14-Apr-2021) on 14-Apr-2021. Past adverse reactions to the above products included No Adverse event with Pfizer vaccine; and No adverse event with Pfizer vaccine.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter No treatment medication was provided by the reporter
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, Headache, Immunisation, Induration, Inflammation
Clinical narrative: Booster; headache; muscle pains; axillary inflammation/Axillary induration; Local induration/ Axillary Induration; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  An adult male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 02Nov2021 (Lot number: 3203080) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "HBP", start date: 2006 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose: , Time: 09:00, Anatomical location: Lt arm, Route of administration: Intramuscular, Lot number: EK5730), administration date: 17Dec2020, when the patient was 56 years old, for Covid-19 immunization; Bnt162b2 (Second dose: , Time: 12:00, Anatomical location: Lt arm, Route of administration: Intramuscular, Lot number: EK4176), administration date: 04Jan2021, when the patient was 56 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Nov2021, outcome "unknown", described as "Booster"; HEADACHE (non-serious) with onset Nov2021, outcome "unknown", described as "headache"; MYALGIA (non-serious) with onset Nov2021, outcome "unknown", described as "muscle pains"; INFLAMMATION (non-serious) with onset Nov2021, outcome "unknown", described as "axillary inflammation/Axillary induration"; INDURATION (non-serious) with onset Nov2021, outcome "unknown", described as "Local induration/ Axillary Induration". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient (Age:56; Unit: Unknown) was given the Pfizer Covid vaccine booster or COMIRNATY after which he developed headache, muscle pains and axillary inflammation. Event took place after use of product. Follow-up on 23Nov2021 was a follow up-spontaneous report from a contactable Physician. This Physician(patient) reported in response to HCP letter via follow-up letter which included that the patient provided information regarding the reported adverse event(s) with the use of the product and the patient considered the Pfizer product had a causal effect to the adverse event. The patient took booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). There were no prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Weight
Clinical narrative: Booster; headache; muscle pains; axillary inflammation/Axillary induration; Local induration/ Axillary Induration; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  An adult male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 02Nov2021 (Lot number: 3203080) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "HBP", start date: 2006 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose: , Time: 09:00, Anatomical location: Lt arm, Route of administration: Intramuscular, Lot number: EK5730), administration date: 17Dec2020, when the patient was 56 years old, for Covid-19 immunization; Bnt162b2 (Second dose: , Time: 12:00, Anatomical location: Lt arm, Route of administration: Intramuscular, Lot number: EK4176), administration date: 04Jan2021, when the patient was 56 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Nov2021, outcome "unknown", described as "Booster"; HEADACHE (non-serious) with onset Nov2021, outcome "unknown", described as "headache"; MYALGIA (non-serious) with onset Nov2021, outcome "unknown", described as "muscle pains"; INFLAMMATION (non-serious) with onset Nov2021, outcome "unknown", described as "axillary inflammation/Axillary induration"; INDURATION (non-serious) with onset Nov2021, outcome "unknown", described as "Local induration/ Axillary Induration". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient (Age:56; Unit: Unknown) was given the Pfizer Covid vaccine booster or COMIRNATY after which he developed headache, muscle pains and axillary inflammation. Event took place after use of product. Follow-up on 23Nov2021 was a follow up-spontaneous report from a contactable Physician. This Physician(patient) reported in response to HCP letter via follow-up letter which included that the patient provided information regarding the reported adverse event(s) with the use of the product and the patient considered the Pfizer product had a causal effect to the adverse event. The patient took booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). There were no prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Immunisation, Pregnancy test
Clinical narrative: I don't have my menstrual period since the last dose of the vaccine October 2021.; Dose received: 3; This is a spontaneous report received from a contactable reporter (nurse). The reporter is the patient. A 29-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 01Oct2021 (Lot number: 30155BA)at the age of 29 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: E11284), administration date: 28Dec2020, when the patient was 28 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN), administration date: 15Jan2021, when the patient was 28 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 01Oct2021, outcome "unknown", described as "Dose received: 3"; AMENORRHOEA (non-serious) with onset 07Oct2021, outcome "not recovered", described as "I don't have my menstrual period since the last dose of the vaccine October 2021". The event "I don't have my menstrual period since the last dose of the vaccine October 2021." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of amenorrhoea.  Additional Information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. It was reported that pregnancy test was all negative.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-DEC-2021, the patient was vaccinated with expired dose of Measles, Mumps, and Rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) 0.5 milliliter, lot # reported as S013713 (lot # not valid for Measles, Mumps, and Rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) however is valid for Measles, Mumps, Rubella and Varicella (oka-merck) virus vaccine live (PROQUAD)(albumin status rHA)), expiration date was reported as 04-DEC-2021 (route of administration and anatomical location were not reported) for prophylaxis. No additional adverse event was reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional information provided/no additional AE reported; a patient was administered ROTATEQ and PEDVAXHIB after a temperature excursion; This spontaneous report has been received from a health business professional referring to a patient of unknown age and unknown gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 02-DEC-2021, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 mL orally (lot # T033510, expiration date 28-DEC-2021; strength was not reported) and Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) 0.5 mL (lot# T037650, expiration date 21-JUL-2023; strength and route were not reported) for prophylaxis after a temperature excursion. The vaccines were improperly storage at 47.29 F for 3 hours 22 minutes (product storage error). There was not previous temperature excursion. No additional information or adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA003366: US-009507513-2112USA003448: US-009507513-2112USA003663: US-009507513-2112USA003663:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a pharmacist referred to a patient of unknown age and gender. The patient's current condition, pertinent medical history and concomitant therapy were not reported. On 09-DEC-2021 the patient was accidently vaccinated with expired dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II), lot # S037499 and expiry date 20-NOV-2021, 1 dose, (Frequency and route of administration not provided) for prophylaxis (expired product administered).
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported; PEDVAX HIB was administered to a patient after a temperature excursion; This spontaneous report was received from a health care professional referring to a specific patient of unknown age or gender.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 17-NOV-2021, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T026066, expiry date on 01-APR-2023; at 0.5 milliliter for prophylaxis (route not reported) after a temperature excursion: temperature at 9.13C, time frame of 30 minutes and no previous temperature excursion occurred. No additional adverse event reported. No product quality complaint involved.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Blood glucose decreased, Blood pressure measurement, Hypotension, Rheumatoid arthritis
Clinical narrative: had a huge flare up and were taken into the Emergency room.; low blood pressure; low blood sugar; This is a solicited report received from a contactable reporter(s) (Consumer or other non HCP) from Agency for a sponsored program. Other Case identifier(s): US-AMGEN INC-21-0329654-SR-01, US-AMGEN-USASL2021191240).  This serious solicited report (USASL2021191240) was reported to Agency on 30/NOV/2021 by a consumer from a commercial program and involves a 47 year old female patient who had a huge flare up and were taken into the emergency room [PT: rheumatoid arthritis], low blood pressure [PT: hypotension], low blood sugar [PT: blood glucose decreased] while receiving Enbrel, 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, Flu Vaccine Vii (influenza vaccine). The patient began Enbrel, Single Dose Prefilled Autoinjector on an unknown date. On an unknown date two weeks ago, the patient had both COVID booster and flu vaccine on the same day. She mentioned that after she received both vaccinations, she had a huge flare up and was taken into the Emergency room. The patient had low blood sugar and low blood pressure. It was also mentioned that she had quite a bit of steroids. She stated she was not admitted. The outcome of the events rheumatoid arthritis, hypotension, blood glucose decreased were reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the events rheumatoid arthritis, hypotension and blood glucose decreased. The causal relationship between the events rheumatoid arthritis, hypotension, blood glucose decreased and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up. No follow-up attempts are possible. No further information is expected.  Amgen comment:This individual case report does not change the safety profile of the product.  Etanercept (ENBREL) is under agreement with Agency.  Agency's Causality Assessment: The events Rheumatoid arthritis flare up, Blood sugar decreased were unrelated to etanercept. The event Low blood pressure was related to etanercept.  The reporter's assessment of the causal relationship of the events with the suspect products 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.; Sender's Comments: Based on the available information, the events rheumatoid arthritis flare up, blood sugar decreased and lowblood pressure were unrelated to the  BNT162B2 (COVID-19 VACCINE-Manufacturer Unknown). The events Rheumatoid arthritis flare up, Blood sugar decreased were unrelated to etanercept. The event Low blood pressure was related to etanercept. This case will be re-assessed should additional information becomes available.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 05/13/10, 2nd dose 05/27/11; This case was reported by a other health professional and described the occurrence of drug dose administration interval too long in a 11-year-old male patient who received Hepatitis A vaccine for prophylaxis.   Previously administered products included Hepatitis A (received first dose on 13th May 2010).   On 27th May 2011, the patient received Hepatitis A vaccine. On 27th May 2011, unknown after receiving Hepatitis A vaccine, 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 also received 2nd dose of Hepatitis A, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up. This case was linked with US2021165573, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021165573:same reporter
Sex: M
Vaccine: UNK
Symptoms: Syncope
Clinical narrative: collapsed on floor; This case was reported by a nurse via market research programs and described the occurrence of fainting in a male patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   Previously administered products included took old shingles vaccine (received old shingles vaccine on an unknown date).   On an unknown date, the patient received the 1st dose of Hz/su + AS01B. On an unknown date, less than a day after receiving Hz/su + AS01B, the patient experienced fainting (serious criteria GSK medically significant). On an unknown date, the outcome of the fainting was unknown.   The reporter considered the fainting to be possibly related to Hz/su + AS01B.  Additional details were reported as follows: The age at vaccination was not reported. After received Shingrix the patient collapsed on floor that night and the reporter had to call ambulance to assess.  The patient did not received 2nd dose, no money back, but the reporter did more than VAERS. The reporter had not given permission for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Im Vaccinated and I got shingles/ suspected vaccination failure; shingles; 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.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 10 months 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: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she in April the patient went to get his/her Shingles shot.  The patient stated he/she in the past got shingles in February 2021. The patient stated 10 months after he/she thought all would be ok. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.