chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: TINY RED SPOTS ON BODY; 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 was not reported, administered on 30-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 30-JUN-2021, the subject experienced tiny red spots on body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tiny red spots on body was not reported. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness
Clinical narrative: HEADACHE; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight was 170 pounds, and height was 69 inches. The patient's past medical history included cyst, and headache, and concurrent conditions included hypertension, hyperlipidemia, alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies, no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 06-JUN-2021 for prophylactic vaccination. Concomitant medications included losartan, omeprazole, rosuvastatin calcium, and ubidecarenone.  On 07-JUN-2021, the subject experienced flu like symptoms. On 16-JUN-2021, the subject experienced headache. Treatment medications (dates unspecified) included: ibuprofen, paracetamol, and acetylsalicylic acid/caffeine/paracetamol/salicylamide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 08-JUN-2021, and had not recovered from headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; TEMPERATURE EXCURSION FOR FEW MINUTES AT 34.97 F; This spontaneous report received from a pharmacist 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: 29-JUN-2021) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-JUN-2021, the subject experienced incorrect product storage. On 16-JUN-2021, the subject experienced temperature excursion for few minutes at 34.97 f. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and temperature excursion for few minutes at 34.97 f was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT IN ARM; 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, frequency 1 total, 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 patient had blood clot in arm within 24 hours of vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in arm was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210700353 -covid-19 vaccine ad26.cov2.s - Blood clot in arm. This event is considered unassessable. The event 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
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE(PAST 6 HOURS); INCORRECT PRODUCT STORAGE; 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: 205A21A expiry: not reported) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced administration of expired vaccine (past 6 hours). On 24-JUN-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine(past 6 hours) and incorrect product storage was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate decreased, Pain in extremity, Therapeutic response unexpected
Clinical narrative: LOWER HEART RATE; LITTLE HEADACHE; SORE ARM; POTENTIALLY HELPED SYMPTOMS OF POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME/LESS ADRENALINE RUSH/ LESS NEUROPATHY; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included postural orthostatic tachycardia syndrome, neuropathy, hepatitis c, and adrenaline rush, and other pre-existing medical conditions included patient wore a heart monitor and normally heart rate was in 150 - 160s when play ball. patient can not take certain medications because liver enzymes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a71a, and expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUN-2021, the subject experienced potentially helped symptoms of postural orthostatic tachycardia syndrome/less adrenaline rush/ less neuropathy. Laboratory data included: Heart rate (NR: not provided) 10 beats lower per minute, 140s, 130s, Low 140s, 156. On 02-JUN-2021, the subject experienced sore arm. On 03-JUN-2021, the subject experienced little headache. On 05-JUN-2021, the subject experienced lower heart rate. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 150s. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little headache, sore arm, lower heart rate and potentially helped symptoms of postural orthostatic tachycardia syndrome/less adrenaline rush/ less neuropathy was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Limb mass, Nausea, Pain in extremity
Clinical narrative: PAINFUL LUMP ON ARM; SEVERE LEG PAIN; FATIGUE; NAUSEA; This spontaneous report received from a consumer concerned a 64 year old male. The patient's weight was 375 pounds, and height was 62 inches. The patient's concurrent conditions included chronic pain, no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-JUN-2021, the subject experienced painful lump on arm. On 23-JUN-2021, the subject experienced severe leg pain. On 23-JUN-2021, the subject experienced fatigue. On 23-JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, and painful lump on arm, and had not recovered from fatigue, and severe leg pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SYMPTOMS; This spontaneous report received from a consumer 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of symptoms was not reported. This report was non-serious. This case, from the same reporter is linked to 20210666990.
Sex: M
Vaccine: COVID19
Symptoms: Fall, Fracture, Haemorrhage intracranial, Product dose omission issue
Clinical narrative: fell down; brain bleed; fracture; More than 42 days since first dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (fell down), HAEMORRHAGE INTRACRANIAL (brain bleed) and FRACTURE (fracture) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (fell down) (seriousness criterion hospitalization), HAEMORRHAGE INTRACRANIAL (brain bleed) (seriousness criteria hospitalization and medically significant), FRACTURE (fracture) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (More than 42 days since first dose). At the time of the report, FALL (fell down), HAEMORRHAGE INTRACRANIAL (brain bleed) and FRACTURE (fracture) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (More than 42 days since first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment information were not provided..  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.   Reporter did not allow further contact; 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: Dyspnoea, Thrombosis
Clinical narrative: blood clots; Shortness of breath when walking upstairs; 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 THROMBOSIS (blood clots) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criterion medically significant) and DYSPNOEA (Shortness of breath when walking upstairs). At the time of the report, THROMBOSIS (blood clots) and DYSPNOEA (Shortness of breath when walking upstairs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.  Very limited information regarding this event has been provided at this time.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time.
Sex: M
Vaccine: COVID19
Symptoms: Neonatal aspiration, Respiratory disorder neonatal
Clinical narrative: swallowed some fluid while he was coming out; baby was in NICU for 3 days for respiratory issue; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISORDER NEONATAL (baby was in NICU for 3 days for respiratory issue) and NEONATAL ASPIRATION (swallowed some fluid while he was coming out) in a 6-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included Maternal exposure during pregnancy on 30-Dec-2020.    No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) 1 dosage form. On 15-Jan-2021, the patient experienced NEONATAL ASPIRATION (swallowed some fluid while he was coming out) (seriousness criterion hospitalization). On an unknown date, the patient experienced RESPIRATORY DISORDER NEONATAL (baby was in NICU for 3 days for respiratory issue) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to NEONATAL ASPIRATION and RESPIRATORY DISORDER NEONATAL. At the time of the report, RESPIRATORY DISORDER NEONATAL (baby was in NICU for 3 days for respiratory issue) and NEONATAL ASPIRATION (swallowed some fluid while he was coming out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) was unknown.       The mother was at 36 weeks of gestational age when she received the first Moderna COVID-19 vaccine (025L20A) on 30 Dec 2020. She was taking prenatal vitamins and had been on progesterone suppository to prevent shortening of cervix, but she stopped it at 32 weeks of gestation. Her estimated due date was 26 Jan 2021, but she gave birth to 1 baby. There were no complications, except the baby was in the neonatal intensive care unit for 3 days for respiratory issue because he swallowed some fluid while he was coming out.   Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-200573, MOD-2021-200726 (Parent-Child Link).   See case MOD-2021-200573,MOD-2021-200726 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: No new information; 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Ophthalmic herpes zoster
Clinical narrative: shingles in corner of eye; This spontaneous case was reported by a consumer and describes the occurrence of OPHTHALMIC HERPES ZOSTER (shingles in corner of eye) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OPHTHALMIC HERPES ZOSTER (shingles in corner of eye) (seriousness criterion medically significant). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Herpes zoster, at an unspecified dose and frequency and VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for Herpes zoster, at an unspecified dose and frequency. At the time of the report, OPHTHALMIC HERPES ZOSTER (shingles in corner of eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  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: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Pruritus, Rash, Vaccination site erythema
Clinical narrative: Missed second dose; Spread to ears and neck and felt hot and itchy/skin felt like sandpaper and could not sleep/itchiness; She noticed small red dots near injection site; rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over body) and PRURITUS (Spread to ears and neck and felt hot and itchy/skin felt like sandpaper and could not sleep/itchiness) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced RASH (rash all over body) (seriousness criterion life threatening), PRURITUS (Spread to ears and neck and felt hot and itchy/skin felt like sandpaper and could not sleep/itchiness) (seriousness criterion life threatening) and VACCINATION SITE ERYTHEMA (She noticed small red dots near injection site). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) at an unspecified dose and frequency; HYDROXYZINE at an unspecified dose and frequency and CIPROFIBRATE (CITRAC) at an unspecified dose and frequency. At the time of the report, RASH (rash all over body), PRURITUS (Spread to ears and neck and felt hot and itchy/skin felt like sandpaper and could not sleep/itchiness), VACCINATION SITE ERYTHEMA (She noticed small red dots near injection site) and PRODUCT DOSE OMISSION ISSUE (Missed second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. Other treatment included IM shot of an unspecified drug.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up received on 22-Jun-2021 included case upgraded from non-serious to serious. Start date  of events 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: M
Vaccine: COVID19
Symptoms: Deafness, Ear discomfort, Ear infection
Clinical narrative: 60% hearing loss/ deafness; Fluid build up in ears; Ear infection; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (60% hearing loss/ deafness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEUPRORELIN ACETATE (ELIGARD) for an unknown indication.    On 15-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced DEAFNESS (60% hearing loss/ deafness) (seriousness criterion medically significant), EAR DISCOMFORT (Fluid build up in ears) and EAR INFECTION (Ear infection). The patient was treated with PREDNISONE (oral) at a dose of 40 mg once a day. At the time of the report, DEAFNESS (60% hearing loss/ deafness), EAR DISCOMFORT (Fluid build up in ears) and EAR INFECTION (Ear infection) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had 60% hearing loss/deafness due to fluid buildup and infection in ears that developed shortly after second vaccine on 15-May-1021. Very limited information regarding these events has been provided at this time. Further information is required.   This case was linked to MOD-2021-225579, MOD-2021-225579 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information is required.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: 26 patients received the vaccine prepared without the final inverting after diluent added; 26 patients received the vaccine prepared without the final inverting after diluent added; This case is considered as invalid as there is no indication that the patient experienced an event under BNT162b2.  This is a spontaneous report from a contactable pharmacist. This Pharmacist reported similar events for 26 patients. This is 6th of 26 patients. A patient of unspecified age and gender started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller wanted information about needing to revaccinate patients with the COVID 19 vaccine in the instance where all preparation steps were followed except gently inverting the vial 10 times after adding the diluent. The caller stated that the vial color and appearance was off white with no particulate matter. Caller stated 26 patients received the vaccine prepared without the final inverting after diluent added.  Follow-up (08Feb2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Follow-up (09Feb2021): New significant information received from a contactable pharmacist, which include that the pharmacist never reported any adverse event and that the event in the report was all a confusion and everything was fine. HCP did not provide fax number or mailing address and does not wish to be contacted any further.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020521662 same reporter/drug/event, different patient
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Peripheral swelling
Clinical narrative: Finger tip swollen, red; Raspy throat; The initial case was missing the following minimum criteria: as there is no indication that the consumer experienced an event under BNT162B2. Upon receipt of follow-up information on (11Jun2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) reported similar events for three patients. This is the first of three reports. A 80-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via intramuscular route of administration, administered in arm on 12Feb2021 12:30 (at the age of 80-year-old) at a 2nd dose, single dose for COVID-19 immunization. The patient medical history included she has allergies, allergies to latex, sulfa; patient is a breast cancer survive, diagnosed on an unspecified date in 2008 (survivor 13 years), mastectomy from on an unspecified date in 2008. The patient concomitant medication included diphenhydramine hydrochloride (BENADRYL) via oral route from 22Jan2021 to 23Jan2021 and 02Feb2021 to 03Feb2021. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: EL1283, Expiration date: 30Apr2021), via intramuscular of administration, administered in arm left on 22Jan2021 10:00 AM (at the age of 80-year-old) at a 1st dose, single dose for COVID-19 immunization and experienced headache, her finger tips got red and she had swollen red hands, red puffed up, chills/terrible chills, throat raspy was with a dry mouth, muscles hurting. Duration of reaction was 21 days. Events were recovered on an unspecified date in 2021. Patient previously took flu shot prior vaccinations (within 4 weeks), Cipro and experienced allergies to cipro. The patient experienced finger tip swollen, red; 5 minutes after it raspy throat on 12Feb2021 10:00. Patient said she, her husband and her sister received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine last 22Jan2021 and was scheduled to receive the 2nd dose 2 weeks after the 1st dose. Patient got the first shot on 22Jan2021 and was sent an email that her second dose is scheduled for 05Feb2021. Patient had an allergic reaction to the vaccine she is nervous about getting the second shot. Outcome of the events was unknown.   Follow-up attempts completed. No further information needed.; Sender's Comments: Linked Report(s) :PFIZER INC-2021128085 same reporter/vaccine and different patients.;PFIZER INC-2021128086 same reporter/vaccine and different patients.;PFIZER INC-2021128086 same reporter/drug/AE and different patient
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site irritation
Clinical narrative: injection site irritation; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3249 and Expiration date: unknown), via an unknown route of administration, in left arm on 17Jan2021 at 09:30 (at the age of 40-years-old) as dose 1, single for covid-19 immunisation. Patient has none medical history. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. Patient has no allergies to medications, food or other products. Patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and not tested for covid-19 since the vaccination. On an unknown date in 2021, the patient experienced injection site irritation. It was unknown, if patient has received treatment for event. Outcome of event was recovered on an unknown date in 2021.   Follow-up attempts are completed. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: tiredness; headache; muscle pain; joint pain; nausea; feeling unwell; This is a spontaneous report from a contactable consumer or other non hcp (patient).   An 87-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number: EL9262 and Expiration date was not reported), via an unspecified route of administration, administered in Arm Right at the age of 87-year-old on 03Feb2021 at 13:45 as single dose for covid-19 immunization. Medical history included 10-year cancer survivor, 2016 mild heart attack, thyroid imbalance, dust mites, mold, mildew. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Feb2021 02:15 the patient experienced tiredness, headache, muscle pain, joint pain, nausea, feeling unwell. The patient did not receive treatment for the events. The outcome of events was recovered on an unspecified in Feb2021.  Follow-up attempts are completed. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: tiredness; headache; muscle pain; joint pain; nausea; feeling unwell; This is a spontaneous report from a contactable consumer or other non hcp (patient).   An 87-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number: EL9262 and Expiration date was not reported), via an unspecified route of administration, administered in Arm Right at the age of 87-year-old on 03Feb2021 at 13:45 as single dose for covid-19 immunization. Medical history included 10-year cancer survivor, 2016 mild heart attack, thyroid imbalance, dust mites, mold, mildew. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Feb2021 02:15 the patient experienced tiredness, headache, muscle pain, joint pain, nausea, feeling unwell. The patient did not receive treatment for the events. The outcome of events was recovered on an unspecified in Feb2021.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cough, Heart rate, Heart rate increased, Oxygen saturation
Clinical narrative: low oxygen; high heart rate; cough; This is a spontaneous report from a contactable (patient). A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9262, Expiration date: Unknown), via an unspecified route of administration on 25Jan2021 (at the age of 79-year-old) as dose 1, single for covid-19 immunisation in hospital. Medical history included diabetes mellitus from 2011 and ongoing (10 years ago), chronic obstructive pulmonary disease from 2016 to an unknown date (5 years ago), high blood pressure from 2011 and ongoing (10 years back) , prostate issues (10 years ago). Concomitant medication(s) included METFORMIN 500 mg, twice a day taken for diabetes mellitus; salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]) taken for an unspecified indication from an unspecified start date and ongoing; FINASTERIDE 5mg, once a day taken for an unspecified indication; TAMSULOSIN once a day taken for an unspecified indication; METOPROLOL 50mg, once a day taken for hypertension all from an unspecified start date and stop date, ATORVASTATIN once a day taken for an unspecified indication from 2016 to an unspecified stop date. On an unspecified date in 2021, the patient experienced low oxygen, high heart rate and cough. He went to emergency and he was treated there, and he was okay the next day. Patient reported that he experienced side effects after his first dose of the Pfizer covid 19 vaccine that he received on 25Jan2021. Patient reported that he had a high heart rate low oxygen and a cough the next day. Patient went to the ER for 4-5 hours. Patient stated that he tested negative for covid, but his MD told him he probably had covid. Patient wanted to know if he should get the second dose due to the side effects and due to him possibly having covid. Patient stated, he just wanted to report adverse effect he had from his first Pfizer shot and he was wondering if he should get the second one or if he can wait for 3 months. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date, heart rate: high: reported that he had a high heart rate low oxygen and a cough the next day, on an unspecified date, oxygen saturation: low on an unspecified date, sars-cov-2 test: negative on an unspecified date: Patient stated that he tested negative for covid, but his MD told him he probably had covid. Therapeutic measures were taken as a result of the events. Regarding treatment the patient stated that, he did not know. They gave him an IV in the hospital. That's all he did remember. It was not like he was dehydrated. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, SARS-CoV-2 test
Clinical narrative: low oxygen; high heart rate; cough; This is a spontaneous report from a contactable (patient). A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9262, Expiration date: Unknown), via an unspecified route of administration on 25Jan2021 (at the age of 79-year-old) as dose 1, single for covid-19 immunisation in hospital. Medical history included diabetes mellitus from 2011 and ongoing (10 years ago), chronic obstructive pulmonary disease from 2016 to an unknown date (5 years ago), high blood pressure from 2011 and ongoing (10 years back) , prostate issues (10 years ago). Concomitant medication(s) included METFORMIN 500 mg, twice a day taken for diabetes mellitus; salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]) taken for an unspecified indication from an unspecified start date and ongoing; FINASTERIDE 5mg, once a day taken for an unspecified indication; TAMSULOSIN once a day taken for an unspecified indication; METOPROLOL 50mg, once a day taken for hypertension all from an unspecified start date and stop date, ATORVASTATIN once a day taken for an unspecified indication from 2016 to an unspecified stop date. On an unspecified date in 2021, the patient experienced low oxygen, high heart rate and cough. He went to emergency and he was treated there, and he was okay the next day. Patient reported that he experienced side effects after his first dose of the Pfizer covid 19 vaccine that he received on 25Jan2021. Patient reported that he had a high heart rate low oxygen and a cough the next day. Patient went to the ER for 4-5 hours. Patient stated that he tested negative for covid, but his MD told him he probably had covid. Patient wanted to know if he should get the second dose due to the side effects and due to him possibly having covid. Patient stated, he just wanted to report adverse effect he had from his first Pfizer shot and he was wondering if he should get the second one or if he can wait for 3 months. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date, heart rate: high: reported that he had a high heart rate low oxygen and a cough the next day, on an unspecified date, oxygen saturation: low on an unspecified date, sars-cov-2 test: negative on an unspecified date: Patient stated that he tested negative for covid, but his MD told him he probably had covid. Therapeutic measures were taken as a result of the events. Regarding treatment the patient stated that, he did not know. They gave him an IV in the hospital. That's all he did remember. It was not like he was dehydrated. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling drunk, Movement disorder, Nausea, Oral candidiasis
Clinical narrative: nausea; hard to move around; Vomiting; right side is dysfunctional and weak,; feel drunk; diagnosed with thrush mouth or yeast; tongue diagnosed to thrush; This is a spontaneous report received from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EL9265, Expiration date unknown) dose 1, via an unspecified route of administration, administered in Arm Right on 28Jan2021 as single (at the age of 71-year-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tongue diagnosed to thrush and diagnosed with thrush mouth or yeast on 29Jan2021, right side is dysfunctional and weak and feel drunk on 12Feb2021, vomiting on 14Feb2021 and then nausea and hard to move around on an unspecified date. It was reported as, the patient received her first dose on 28Jan2021, the following day on 29Jan2021, she went to urgent care, had rash on her tongue, diagnosed with thrush mouth or yeast, states she treated that and it got better around 10Feb2021 or 12Feb2021. The patient states right side is dysfunctional and weak, feel drunk, nausea, and hard to move around hard to do things correctly and not make a mess, states it is hard for her to adjust. States this started on Friday 12Feb2021, States on 11Feb2021, she went to her stomach doctor and did not complain about that so she believes it started on 12Feb2021. States she also has vomited some the past two nights. States she is due for second dose tomorrow. Wants to know if these symptoms are related to the vaccine. States she is going to see a heart doctor tomorrow. Caller states she does have a bad back and neck that she will take medication for, does not know if this is related. Diagnosed with bad back and neck, sees pain management doctor for neck and shoulders. No further information provided. The patient underwent lab tests and procedures which included weight: 110-112 lbs on an unspecified date. Therapeutic measures were taken as a result of tongue diagnosed to thrush. The outcome of the events tongue diagnosed to thrush was recovering, for vomiting not recovered and while for outcome of other events were unknown.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Oral fungal infection, Vomiting, Weight
Clinical narrative: nausea; hard to move around; Vomiting; right side is dysfunctional and weak,; feel drunk; diagnosed with thrush mouth or yeast; tongue diagnosed to thrush; This is a spontaneous report received from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EL9265, Expiration date unknown) dose 1, via an unspecified route of administration, administered in Arm Right on 28Jan2021 as single (at the age of 71-year-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tongue diagnosed to thrush and diagnosed with thrush mouth or yeast on 29Jan2021, right side is dysfunctional and weak and feel drunk on 12Feb2021, vomiting on 14Feb2021 and then nausea and hard to move around on an unspecified date. It was reported as, the patient received her first dose on 28Jan2021, the following day on 29Jan2021, she went to urgent care, had rash on her tongue, diagnosed with thrush mouth or yeast, states she treated that and it got better around 10Feb2021 or 12Feb2021. The patient states right side is dysfunctional and weak, feel drunk, nausea, and hard to move around hard to do things correctly and not make a mess, states it is hard for her to adjust. States this started on Friday 12Feb2021, States on 11Feb2021, she went to her stomach doctor and did not complain about that so she believes it started on 12Feb2021. States she also has vomited some the past two nights. States she is due for second dose tomorrow. Wants to know if these symptoms are related to the vaccine. States she is going to see a heart doctor tomorrow. Caller states she does have a bad back and neck that she will take medication for, does not know if this is related. Diagnosed with bad back and neck, sees pain management doctor for neck and shoulders. No further information provided. The patient underwent lab tests and procedures which included weight: 110-112 lbs on an unspecified date. Therapeutic measures were taken as a result of tongue diagnosed to thrush. The outcome of the events tongue diagnosed to thrush was recovering, for vomiting not recovered and while for outcome of other events were unknown.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Dyspnoea, Endoscopy, Fatigue, Feeling cold
Clinical narrative: Shortness of breath; there was a time where she felt like her blood sugar had dropped, almost like she was having a hypoglycemic meltdown; became really sweaty and had to lay down; got really, really cold; Fatigue; pretty sick; This is a spontaneous report from a contactable consumer (Patient). A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9269) via an intramuscular route of administration and administered in right upper arm on 05Feb2021 at around 14:30 (at the age of 50-year-old) as a single dose for COVID-19 immunization at public high school. The patient medical history included ongoing asthma, (diagnosed at 12 years old). Earlier in this week (as per report on Tuesday), she did have an endoscopy and had to go under, results not provided, this was prior to receiving vaccine. Concomitant medication included new stomach medication (Pantoprazole) on an unspecified date in 2021 (she just started it). She does not know if that caused an interaction and they told her it was fine, but who knows. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and additional vaccines administered on the same day of vaccine. On 06Feb2021, the patient was pretty sick over the weekend. She did not have a fever, but she experienced shortness of breath. There also was a time where she felt like her blood sugar had dropped. She became really sweaty and had to lay down. She also got really, really cold, almost like she was having a hypoglycemic meltdown. She did not know if that was something to be expected. Her and husband were a little nervous about her experience. She was feeling fatigued. These symptoms began Saturday morning (as per report) and have improved. She is feeling much better now. The events did not result in emergency room or physician office. Patient wants to know if what she was experiencing was normal and didn't think it was bad enough. She just figured it was a side effect and she didn't think to get checked out further and made a comment that she hasn't talked to her doctor about this. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoglycaemia, Illness
Clinical narrative: Shortness of breath; there was a time where she felt like her blood sugar had dropped, almost like she was having a hypoglycemic meltdown; became really sweaty and had to lay down; got really, really cold; Fatigue; pretty sick; This is a spontaneous report from a contactable consumer (Patient). A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9269) via an intramuscular route of administration and administered in right upper arm on 05Feb2021 at around 14:30 (at the age of 50-year-old) as a single dose for COVID-19 immunization at public high school. The patient medical history included ongoing asthma, (diagnosed at 12 years old). Earlier in this week (as per report on Tuesday), she did have an endoscopy and had to go under, results not provided, this was prior to receiving vaccine. Concomitant medication included new stomach medication (Pantoprazole) on an unspecified date in 2021 (she just started it). She does not know if that caused an interaction and they told her it was fine, but who knows. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and additional vaccines administered on the same day of vaccine. On 06Feb2021, the patient was pretty sick over the weekend. She did not have a fever, but she experienced shortness of breath. There also was a time where she felt like her blood sugar had dropped. She became really sweaty and had to lay down. She also got really, really cold, almost like she was having a hypoglycemic meltdown. She did not know if that was something to be expected. Her and husband were a little nervous about her experience. She was feeling fatigued. These symptoms began Saturday morning (as per report) and have improved. She is feeling much better now. The events did not result in emergency room or physician office. Patient wants to know if what she was experiencing was normal and didn't think it was bad enough. She just figured it was a side effect and she didn't think to get checked out further and made a comment that she hasn't talked to her doctor about this. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Fatigue, Feeling jittery, Tremor
Clinical narrative: burning sensation through my body; shakes; jitteriness; lightheaded; exhaustion; injection site redness and soreness; injection site redness and soreness; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EL9264 and Expiration date: unknown), via an unspecified route of administration, in left arm on 07Feb2021 (at the age of 40-years-old) as dose 2, single for Covid-19 immunization. Facility where the most recent covid-19 vaccine was administered was hospital. The patient medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. Historical vaccination included dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EL3249 and Expiration date: unknown), via an unknown route of administration, in left arm on 17Jan2021 at 09:30 (at the age of 40-years-old) as dose 1, single for covid-19 immunisation and experienced injection site irritation. Patient had no allergies to medications, food or other products. The patient did not receive any other vaccine 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 not been tested for COVID-19. On 07Feb2021 (at 09:45), the patient experienced after 2nd dose burning sensation through her body followed by shakes and jitteriness and lightheaded. Then exhaustion. 2 days later still had injection site redness and soreness. The case was assessed as non-serious. It was reported that " Was treatment received for the adverse event: Unknown". Outcome of the events was resolved on an unspecified date in Feb2021.  Follow-up attempts are completed. No further information is expected.