chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye irritation, Herpes zoster, Rash
Clinical narrative: my face had a severe rash; my right eye was swollen; Shingles; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: FF2590), dose 3 via an unspecified route of administration, administered in arm left on 27Oct2021 12:15 (age at the vaccination was 59-year-old) as dose 3 (booster), single for covid-19 immunisation. Facility type Vaccine was Pharmacy or Drug Store. The patient medical history was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ramipril, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), ezetimibe, rosuvastatin, atenolol taken for an unspecified indication, start and stop date were not reported was received within two weeks of vaccination. Historical vaccine included, the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0169), dose 2 via an unspecified route of administration, administered in arm left on 20Apr2021 15:00 (age at the vaccination was 58-year-old) as dose 2, single and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: ER8733), dose 1 via an unspecified route of administration, administered in arm left on 26Mar2021 14:00 (age at the vaccination was 58-year-old) as dose 1, single for covid-19 immunisation. The patient was perfectly healthy on the day of the booster shot. On 28Oct2021 06:00 (next morning), after his booster shot, my face had a severe rash, and my right eye was swollen. The patient went to urgent care and was diagnosed as had shingles. Since the vaccination, the patient had not tested for COVID-19. The patient received treatment with anti-viral medication (unspecified) for the events. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Herpes zoster, Rash
Clinical narrative: my face had a severe rash; my right eye was swollen; Shingles; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: FF2590), dose 3 via an unspecified route of administration, administered in arm left on 27Oct2021 12:15 (age at the vaccination was 59-year-old) as dose 3 (booster), single for covid-19 immunisation. Facility type Vaccine was Pharmacy or Drug Store. The patient medical history was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ramipril, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), ezetimibe, rosuvastatin, atenolol taken for an unspecified indication, start and stop date were not reported was received within two weeks of vaccination. Historical vaccine included, the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0169), dose 2 via an unspecified route of administration, administered in arm left on 20Apr2021 15:00 (age at the vaccination was 58-year-old) as dose 2, single and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: ER8733), dose 1 via an unspecified route of administration, administered in arm left on 26Mar2021 14:00 (age at the vaccination was 58-year-old) as dose 1, single for covid-19 immunisation. The patient was perfectly healthy on the day of the booster shot. On 28Oct2021 06:00 (next morning), after his booster shot, my face had a severe rash, and my right eye was swollen. The patient went to urgent care and was diagnosed as had shingles. Since the vaccination, the patient had not tested for COVID-19. The patient received treatment with anti-viral medication (unspecified) for the events. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Nervousness, Paraesthesia
Clinical narrative: stomach pains; hot flashes; low appetite; headache; blood pressure spike to 160; feet tingling; legs felt heavy and weak; legs felt heavy and weak; arms and light-headed weak all over/felt faint and heavy; heart rate increased; feet and hands felt numb; Booster; felt weak; feverish/Fever; chills; leg cramps; This is a spontaneous report from a contactable Consumer (patient). A 38-year-old female patient received third dose of BNT162B2 on 01Nov2021 09:15 (at age of 38 years old, lot number: FF8839) at single dose on left arm for COVID-19 immunization. Medical history included Hidradenitis suppurativa and Silent Acid Reflux. Concomitant medications included influenza vaccine (FLU VACCINE VII) on 12Oct2021 and spironolactone Historical vaccine included BNT162B2 first dose on 01Apr2021 (at age of 38 years old, Batch/Lot No: ER 8733) for COVID-19 immunization, second dose on 22Apr2021 09:00 AM (at age of 38 years old, Batch/Lot No: EW 0158) for COVID-19 immunization. Patient was not pregnant. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. After 15 min observation, started to walk out of clinic, feet tingling, shortly afterwards legs felt heavy and weak. Following was arms and light-headed weak all over, heart rate increased, felt faint and heavy, blood pressure spike to 160 and always around 110-120, feet and hands felt numb. Never had a reaction to vaccines before. Taken in ambulance to local hospital due to blood pressure spikes. decreased over two hours back to baseline. Once home from hospital, felt weak and feverish. Fever and chills and leg cramps over course of night. Next day, stomach pains and occasional hot flashes, low appetite. Headache. AE results in: Emergency room/department or urgent care]. The outcome of the events was recovering. No treatment for events. No covid prior vaccination. No covid tested post vaccination. No Known allergies. The seriousness was reported as no.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Asthenia, Blood pressure measurement, Chills, Decreased appetite
Clinical narrative: stomach pains; hot flashes; low appetite; headache; blood pressure spike to 160; feet tingling; legs felt heavy and weak; legs felt heavy and weak; arms and light-headed weak all over/felt faint and heavy; heart rate increased; feet and hands felt numb; Booster; felt weak; feverish/Fever; chills; leg cramps; This is a spontaneous report from a contactable Consumer (patient). A 38-year-old female patient received third dose of BNT162B2 on 01Nov2021 09:15 (at age of 38 years old, lot number: FF8839) at single dose on left arm for COVID-19 immunization. Medical history included Hidradenitis suppurativa and Silent Acid Reflux. Concomitant medications included influenza vaccine (FLU VACCINE VII) on 12Oct2021 and spironolactone Historical vaccine included BNT162B2 first dose on 01Apr2021 (at age of 38 years old, Batch/Lot No: ER 8733) for COVID-19 immunization, second dose on 22Apr2021 09:00 AM (at age of 38 years old, Batch/Lot No: EW 0158) for COVID-19 immunization. Patient was not pregnant. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. After 15 min observation, started to walk out of clinic, feet tingling, shortly afterwards legs felt heavy and weak. Following was arms and light-headed weak all over, heart rate increased, felt faint and heavy, blood pressure spike to 160 and always around 110-120, feet and hands felt numb. Never had a reaction to vaccines before. Taken in ambulance to local hospital due to blood pressure spikes. decreased over two hours back to baseline. Once home from hospital, felt weak and feverish. Fever and chills and leg cramps over course of night. Next day, stomach pains and occasional hot flashes, low appetite. Headache. AE results in: Emergency room/department or urgent care]. The outcome of the events was recovering. No treatment for events. No covid prior vaccination. No covid tested post vaccination. No Known allergies. The seriousness was reported as no.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Heart rate, Heart rate increased, Hot flush
Clinical narrative: stomach pains; hot flashes; low appetite; headache; blood pressure spike to 160; feet tingling; legs felt heavy and weak; legs felt heavy and weak; arms and light-headed weak all over/felt faint and heavy; heart rate increased; feet and hands felt numb; Booster; felt weak; feverish/Fever; chills; leg cramps; This is a spontaneous report from a contactable Consumer (patient). A 38-year-old female patient received third dose of BNT162B2 on 01Nov2021 09:15 (at age of 38 years old, lot number: FF8839) at single dose on left arm for COVID-19 immunization. Medical history included Hidradenitis suppurativa and Silent Acid Reflux. Concomitant medications included influenza vaccine (FLU VACCINE VII) on 12Oct2021 and spironolactone Historical vaccine included BNT162B2 first dose on 01Apr2021 (at age of 38 years old, Batch/Lot No: ER 8733) for COVID-19 immunization, second dose on 22Apr2021 09:00 AM (at age of 38 years old, Batch/Lot No: EW 0158) for COVID-19 immunization. Patient was not pregnant. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. After 15 min observation, started to walk out of clinic, feet tingling, shortly afterwards legs felt heavy and weak. Following was arms and light-headed weak all over, heart rate increased, felt faint and heavy, blood pressure spike to 160 and always around 110-120, feet and hands felt numb. Never had a reaction to vaccines before. Taken in ambulance to local hospital due to blood pressure spikes. decreased over two hours back to baseline. Once home from hospital, felt weak and feverish. Fever and chills and leg cramps over course of night. Next day, stomach pains and occasional hot flashes, low appetite. Headache. AE results in: Emergency room/department or urgent care]. The outcome of the events was recovering. No treatment for events. No covid prior vaccination. No covid tested post vaccination. No Known allergies. The seriousness was reported as no.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Hypoaesthesia, Immunisation, Limb discomfort, Muscle spasms
Clinical narrative: stomach pains; hot flashes; low appetite; headache; blood pressure spike to 160; feet tingling; legs felt heavy and weak; legs felt heavy and weak; arms and light-headed weak all over/felt faint and heavy; heart rate increased; feet and hands felt numb; Booster; felt weak; feverish/Fever; chills; leg cramps; This is a spontaneous report from a contactable Consumer (patient). A 38-year-old female patient received third dose of BNT162B2 on 01Nov2021 09:15 (at age of 38 years old, lot number: FF8839) at single dose on left arm for COVID-19 immunization. Medical history included Hidradenitis suppurativa and Silent Acid Reflux. Concomitant medications included influenza vaccine (FLU VACCINE VII) on 12Oct2021 and spironolactone Historical vaccine included BNT162B2 first dose on 01Apr2021 (at age of 38 years old, Batch/Lot No: ER 8733) for COVID-19 immunization, second dose on 22Apr2021 09:00 AM (at age of 38 years old, Batch/Lot No: EW 0158) for COVID-19 immunization. Patient was not pregnant. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. After 15 min observation, started to walk out of clinic, feet tingling, shortly afterwards legs felt heavy and weak. Following was arms and light-headed weak all over, heart rate increased, felt faint and heavy, blood pressure spike to 160 and always around 110-120, feet and hands felt numb. Never had a reaction to vaccines before. Taken in ambulance to local hospital due to blood pressure spikes. decreased over two hours back to baseline. Once home from hospital, felt weak and feverish. Fever and chills and leg cramps over course of night. Next day, stomach pains and occasional hot flashes, low appetite. Headache. AE results in: Emergency room/department or urgent care]. The outcome of the events was recovering. No treatment for events. No covid prior vaccination. No covid tested post vaccination. No Known allergies. The seriousness was reported as no.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Paraesthesia, Pyrexia
Clinical narrative: stomach pains; hot flashes; low appetite; headache; blood pressure spike to 160; feet tingling; legs felt heavy and weak; legs felt heavy and weak; arms and light-headed weak all over/felt faint and heavy; heart rate increased; feet and hands felt numb; Booster; felt weak; feverish/Fever; chills; leg cramps; This is a spontaneous report from a contactable Consumer (patient). A 38-year-old female patient received third dose of BNT162B2 on 01Nov2021 09:15 (at age of 38 years old, lot number: FF8839) at single dose on left arm for COVID-19 immunization. Medical history included Hidradenitis suppurativa and Silent Acid Reflux. Concomitant medications included influenza vaccine (FLU VACCINE VII) on 12Oct2021 and spironolactone Historical vaccine included BNT162B2 first dose on 01Apr2021 (at age of 38 years old, Batch/Lot No: ER 8733) for COVID-19 immunization, second dose on 22Apr2021 09:00 AM (at age of 38 years old, Batch/Lot No: EW 0158) for COVID-19 immunization. Patient was not pregnant. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. After 15 min observation, started to walk out of clinic, feet tingling, shortly afterwards legs felt heavy and weak. Following was arms and light-headed weak all over, heart rate increased, felt faint and heavy, blood pressure spike to 160 and always around 110-120, feet and hands felt numb. Never had a reaction to vaccines before. Taken in ambulance to local hospital due to blood pressure spikes. decreased over two hours back to baseline. Once home from hospital, felt weak and feverish. Fever and chills and leg cramps over course of night. Next day, stomach pains and occasional hot flashes, low appetite. Headache. AE results in: Emergency room/department or urgent care]. The outcome of the events was recovering. No treatment for events. No covid prior vaccination. No covid tested post vaccination. No Known allergies. The seriousness was reported as no.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Balance disorder, Candida infection, Condition aggravated, Decreased appetite
Clinical narrative: Thrush, photosensitivity, diarrhea, fatigue, migraine, body aches, vertigo, gastroenteritis,
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, Fatigue, Magnetic resonance imaging, Migraine, Myalgia
Clinical narrative: Thrush, photosensitivity, diarrhea, fatigue, migraine, body aches, vertigo, gastroenteritis,
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Ophthalmological examination normal, Pain, Photophobia, Vertigo
Clinical narrative: Thrush, photosensitivity, diarrhea, fatigue, migraine, body aches, vertigo, gastroenteritis,
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting, Weight decreased
Clinical narrative: Thrush, photosensitivity, diarrhea, fatigue, migraine, body aches, vertigo, gastroenteritis,
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Candida infection, Diarrhoea, Fatigue, Full blood count, Gastroenteritis
Clinical narrative: Thrush, photosensitivity, diarrhea, fatigue, migraine, body aches, vertigo, gastroenteritis,
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Metabolic function test, Migraine, Pain, Photosensitivity reaction
Clinical narrative: Thrush, photosensitivity, diarrhea, fatigue, migraine, body aches, vertigo, gastroenteritis,
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: Thrush, photosensitivity, diarrhea, fatigue, migraine, body aches, vertigo, gastroenteritis,
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: 15 YEAR OLD MALE PATIENT GOT THE VACCINE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 15 year old male. 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: 213D21A, expiry: 11-APR-2022) dose was not reported, administered on 11-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-NOV-2021, the patient experienced 15 year old male patient got the vaccine. On 11-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 15 year old male patient got the vaccine and off label use was not reported. This report was non-serious.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: 15 YEAR OLD MALE PATIENT GOT THE VACCINE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 15 year old male. 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: 213D21A, expiry: 11-APR-2022) dose was not reported, administered on 11-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-NOV-2021, the patient experienced 15 year old male patient got the vaccine. On 11-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 15 year old male patient got the vaccine and off label use was not reported. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Feeling hot, Hypersensitivity, Nausea
Clinical narrative: Allergic Reaction: Patient reported feeling flushed to lower portion of body, then increased to head, experienced nausea, vomiting, tingling, itching to upper extremities and shortness of breast. Patient was alert, oriented x3 and able to speak in full sentences.  Patient is under rx of epinephrine (PRN), methylprednisone and benadryl after hospitalization. Patients states feeling itching spontaneously 4 days after the event.  Patient states being released from the hospital at 1500 on the day of adverse event.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Flushing, Hypersensitivity, Nausea, Paraesthesia
Clinical narrative: Allergic Reaction: Patient reported feeling flushed to lower portion of body, then increased to head, experienced nausea, vomiting, tingling, itching to upper extremities and shortness of breast. Patient was alert, oriented x3 and able to speak in full sentences.  Patient is under rx of epinephrine (PRN), methylprednisone and benadryl after hospitalization. Patients states feeling itching spontaneously 4 days after the event.  Patient states being released from the hospital at 1500 on the day of adverse event.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Vomiting
Clinical narrative: Allergic Reaction: Patient reported feeling flushed to lower portion of body, then increased to head, experienced nausea, vomiting, tingling, itching to upper extremities and shortness of breast. Patient was alert, oriented x3 and able to speak in full sentences.  Patient is under rx of epinephrine (PRN), methylprednisone and benadryl after hospitalization. Patients states feeling itching spontaneously 4 days after the event.  Patient states being released from the hospital at 1500 on the day of adverse event.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Headache, Hypoacusis, Joint range of motion decreased, Pain in extremity
Clinical narrative: SWOLLEN INJECTION SITE; MUFFLED HEARING; TINGLING BELOW THE INJECTION SITE TO THE WRIST OF LEFT ARM; TINNITUS TO THE  RIGHT EAR THAT BECOMING UNBEARABLE; DIARRHEA; BARELY ABLE TO RAISE LEFT ARM; INJECTION SITE PAIN; HEADACHE; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient was prescribed a steroid pack. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: 11-APR-2022) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-NOV-2021, the patient experienced injection site pain. On 08-NOV-2021, the patient experienced headache. On 09-NOV-2021, the patient experienced barely able to raise left arm. On 09-NOV-2021, the patient experienced tinnitus to the right ear that becoming unbearable. On 09-NOV-2021, the patient experienced diarrhea. On 10-NOV-2021, the patient experienced tingling below the injection site to the wrist of left arm. On 11-NOV-2021, the patient experienced muffled hearing. On 12-NOV-2021, the patient experienced swollen injection site. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain, barely able to raise left arm, headache, tingling below the injection site to the wrist of left arm, tinnitus to the right ear that becoming unbearable, muffled hearing, diarrhea, and swollen injection site. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Peripheral swelling, Tinnitus
Clinical narrative: SWOLLEN INJECTION SITE; MUFFLED HEARING; TINGLING BELOW THE INJECTION SITE TO THE WRIST OF LEFT ARM; TINNITUS TO THE  RIGHT EAR THAT BECOMING UNBEARABLE; DIARRHEA; BARELY ABLE TO RAISE LEFT ARM; INJECTION SITE PAIN; HEADACHE; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient was prescribed a steroid pack. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: 11-APR-2022) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-NOV-2021, the patient experienced injection site pain. On 08-NOV-2021, the patient experienced headache. On 09-NOV-2021, the patient experienced barely able to raise left arm. On 09-NOV-2021, the patient experienced tinnitus to the right ear that becoming unbearable. On 09-NOV-2021, the patient experienced diarrhea. On 10-NOV-2021, the patient experienced tingling below the injection site to the wrist of left arm. On 11-NOV-2021, the patient experienced muffled hearing. On 12-NOV-2021, the patient experienced swollen injection site. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain, barely able to raise left arm, headache, tingling below the injection site to the wrist of left arm, tinnitus to the right ear that becoming unbearable, muffled hearing, diarrhea, and swollen injection site. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Headache, Hypoacusis, Injection site pain, Injection site swelling
Clinical narrative: SWOLLEN INJECTION SITE; MUFFLED HEARING; TINGLING BELOW THE INJECTION SITE TO THE WRIST OF LEFT ARM; TINNITUS TO THE  RIGHT EAR THAT BECOMING UNBEARABLE; DIARRHEA; BARELY ABLE TO RAISE LEFT ARM; INJECTION SITE PAIN; HEADACHE; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient was prescribed a steroid pack. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: 11-APR-2022) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-NOV-2021, the patient experienced injection site pain. On 08-NOV-2021, the patient experienced headache. On 09-NOV-2021, the patient experienced barely able to raise left arm. On 09-NOV-2021, the patient experienced tinnitus to the right ear that becoming unbearable. On 09-NOV-2021, the patient experienced diarrhea. On 10-NOV-2021, the patient experienced tingling below the injection site to the wrist of left arm. On 11-NOV-2021, the patient experienced muffled hearing. On 12-NOV-2021, the patient experienced swollen injection site. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain, barely able to raise left arm, headache, tingling below the injection site to the wrist of left arm, tinnitus to the right ear that becoming unbearable, muffled hearing, diarrhea, and swollen injection site. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle rigidity, Paraesthesia, Tinnitus
Clinical narrative: SWOLLEN INJECTION SITE; MUFFLED HEARING; TINGLING BELOW THE INJECTION SITE TO THE WRIST OF LEFT ARM; TINNITUS TO THE  RIGHT EAR THAT BECOMING UNBEARABLE; DIARRHEA; BARELY ABLE TO RAISE LEFT ARM; INJECTION SITE PAIN; HEADACHE; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient was prescribed a steroid pack. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: 11-APR-2022) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-NOV-2021, the patient experienced injection site pain. On 08-NOV-2021, the patient experienced headache. On 09-NOV-2021, the patient experienced barely able to raise left arm. On 09-NOV-2021, the patient experienced tinnitus to the right ear that becoming unbearable. On 09-NOV-2021, the patient experienced diarrhea. On 10-NOV-2021, the patient experienced tingling below the injection site to the wrist of left arm. On 11-NOV-2021, the patient experienced muffled hearing. On 12-NOV-2021, the patient experienced swollen injection site. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain, barely able to raise left arm, headache, tingling below the injection site to the wrist of left arm, tinnitus to the right ear that becoming unbearable, muffled hearing, diarrhea, and swollen injection site. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Paraesthesia, Rash macular
Clinical narrative: passed out after vaccination
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Electrocardiogram, Loss of consciousness, Urine analysis
Clinical narrative: passed out after vaccination
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: Sterile water was used as diluent instead of NS
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: Sterile water was used as diluent instead of NS
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: Sterile water was used as diluent instead of NS
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Diarrhoea, Echocardiogram abnormal, Hypotension, Intensive care
Clinical narrative: Patient presented with classic signs and symptoms of MIS-C.  High fevers for days (admitted on 11/11/21), emesis, abdominal pain, rash, and bilateral conjunctivitis.  Had very elevated inflammatory (CRP = 14.8 mg/dL) and cardiac (pro NT BNP = 21,900, troponin = 0.374) markers.  He also had hyponatremia (Na - 128) and lymphopenia (ALC = 760).   His SARS-CoV-2 anti-N IgG antibody was positive.  He had known documented previous infection about 5-6 weeks prior and his sister also had known COVID-19.   His initial ECHO showed mild decreased LV dysfunction.  He rapidly developed hypotension and was transferred to our PICU and started on pressors (norepi and epi).  He was treated with IVIG and infliximab and eventually improved.    It is our impression that this was related to his previous SARS infection and not due to his vaccine.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Left ventricular dysfunction, Multisystem inflammatory syndrome in children, N-terminal prohormone brain natriuretic peptide increased, Pyrexia, Rash
Clinical narrative: Patient presented with classic signs and symptoms of MIS-C.  High fevers for days (admitted on 11/11/21), emesis, abdominal pain, rash, and bilateral conjunctivitis.  Had very elevated inflammatory (CRP = 14.8 mg/dL) and cardiac (pro NT BNP = 21,900, troponin = 0.374) markers.  He also had hyponatremia (Na - 128) and lymphopenia (ALC = 760).   His SARS-CoV-2 anti-N IgG antibody was positive.  He had known documented previous infection about 5-6 weeks prior and his sister also had known COVID-19.   His initial ECHO showed mild decreased LV dysfunction.  He rapidly developed hypotension and was transferred to our PICU and started on pressors (norepi and epi).  He was treated with IVIG and infliximab and eventually improved.    It is our impression that this was related to his previous SARS infection and not due to his vaccine.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Septic shock, Shock, Vomiting
Clinical narrative: Patient presented with classic signs and symptoms of MIS-C.  High fevers for days (admitted on 11/11/21), emesis, abdominal pain, rash, and bilateral conjunctivitis.  Had very elevated inflammatory (CRP = 14.8 mg/dL) and cardiac (pro NT BNP = 21,900, troponin = 0.374) markers.  He also had hyponatremia (Na - 128) and lymphopenia (ALC = 760).   His SARS-CoV-2 anti-N IgG antibody was positive.  He had known documented previous infection about 5-6 weeks prior and his sister also had known COVID-19.   His initial ECHO showed mild decreased LV dysfunction.  He rapidly developed hypotension and was transferred to our PICU and started on pressors (norepi and epi).  He was treated with IVIG and infliximab and eventually improved.    It is our impression that this was related to his previous SARS infection and not due to his vaccine.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Blood sodium decreased, C-reactive protein increased, Conjunctivitis, Echocardiogram abnormal
Clinical narrative: Patient presented with classic signs and symptoms of MIS-C.  High fevers for days (admitted on 11/11/21), emesis, abdominal pain, rash, and bilateral conjunctivitis.  Had very elevated inflammatory (CRP = 14.8 mg/dL) and cardiac (pro NT BNP = 21,900, troponin = 0.374) markers.  He also had hyponatremia (Na - 128) and lymphopenia (ALC = 760).   His SARS-CoV-2 anti-N IgG antibody was positive.  He had known documented previous infection about 5-6 weeks prior and his sister also had known COVID-19.   His initial ECHO showed mild decreased LV dysfunction.  He rapidly developed hypotension and was transferred to our PICU and started on pressors (norepi and epi).  He was treated with IVIG and infliximab and eventually improved.    It is our impression that this was related to his previous SARS infection and not due to his vaccine.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyponatraemia, Hypotension, Immunoglobulin therapy, Inflammatory marker increased, Intensive care
Clinical narrative: Patient presented with classic signs and symptoms of MIS-C.  High fevers for days (admitted on 11/11/21), emesis, abdominal pain, rash, and bilateral conjunctivitis.  Had very elevated inflammatory (CRP = 14.8 mg/dL) and cardiac (pro NT BNP = 21,900, troponin = 0.374) markers.  He also had hyponatremia (Na - 128) and lymphopenia (ALC = 760).   His SARS-CoV-2 anti-N IgG antibody was positive.  He had known documented previous infection about 5-6 weeks prior and his sister also had known COVID-19.   His initial ECHO showed mild decreased LV dysfunction.  He rapidly developed hypotension and was transferred to our PICU and started on pressors (norepi and epi).  He was treated with IVIG and infliximab and eventually improved.    It is our impression that this was related to his previous SARS infection and not due to his vaccine.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Left ventricular dysfunction, Lymphocyte count decreased, Lymphopenia, N-terminal prohormone brain natriuretic peptide increased, Pyrexia
Clinical narrative: Patient presented with classic signs and symptoms of MIS-C.  High fevers for days (admitted on 11/11/21), emesis, abdominal pain, rash, and bilateral conjunctivitis.  Had very elevated inflammatory (CRP = 14.8 mg/dL) and cardiac (pro NT BNP = 21,900, troponin = 0.374) markers.  He also had hyponatremia (Na - 128) and lymphopenia (ALC = 760).   His SARS-CoV-2 anti-N IgG antibody was positive.  He had known documented previous infection about 5-6 weeks prior and his sister also had known COVID-19.   His initial ECHO showed mild decreased LV dysfunction.  He rapidly developed hypotension and was transferred to our PICU and started on pressors (norepi and epi).  He was treated with IVIG and infliximab and eventually improved.    It is our impression that this was related to his previous SARS infection and not due to his vaccine.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, SARS-CoV-2 antibody test, Troponin increased, Vomiting
Clinical narrative: Patient presented with classic signs and symptoms of MIS-C.  High fevers for days (admitted on 11/11/21), emesis, abdominal pain, rash, and bilateral conjunctivitis.  Had very elevated inflammatory (CRP = 14.8 mg/dL) and cardiac (pro NT BNP = 21,900, troponin = 0.374) markers.  He also had hyponatremia (Na - 128) and lymphopenia (ALC = 760).   His SARS-CoV-2 anti-N IgG antibody was positive.  He had known documented previous infection about 5-6 weeks prior and his sister also had known COVID-19.   His initial ECHO showed mild decreased LV dysfunction.  He rapidly developed hypotension and was transferred to our PICU and started on pressors (norepi and epi).  He was treated with IVIG and infliximab and eventually improved.    It is our impression that this was related to his previous SARS infection and not due to his vaccine.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Eye pain, Headache, Hypersensitivity, Peripheral swelling
Clinical narrative: PATIENT REPORTED THAT SHE WOKE UP THE NEXT MORNING AFTER RECIEVING VACCINE AND EXPERIENCE SWELLING OF THROAT AND TONGUE SWELLING.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Swelling, Swelling face, Swollen tongue, Throat tightness
Clinical narrative: PATIENT REPORTED THAT SHE WOKE UP THE NEXT MORNING AFTER RECIEVING VACCINE AND EXPERIENCE SWELLING OF THROAT AND TONGUE SWELLING.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Swollen tongue
Clinical narrative: PATIENT REPORTED THAT SHE WOKE UP THE NEXT MORNING AFTER RECIEVING VACCINE AND EXPERIENCE SWELLING OF THROAT AND TONGUE SWELLING.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; 10/20/2021 one dose of an improperly stored V AQT A vaccine was administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 20-OCT-2021, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) lot # U013969 was confirmed to be valid, expiration date 06-FEB-2023 (exact dose, route of administration, anatomical location were not reported) for prophylaxis. The temperature excursion was 51 degrees Fahrenheit for 4 hours and 15 minutes. There were no previous excursions reported. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA006206: US-009507513-2110USA005970:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient received improperly stored V ARlV AX.; No additional AEs were reported; This spontaneous report was received from a Licensed Practical Nurse and refers to a currently 15-year-old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On and unknown date, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 ml, (route of administration, anatomical location were not reported), lot # U016065 was confirmed to be valid, expiration date 20-MAY-2023 for prophylaxis. The temperature excursion was 0.3 degree Celsius (C) for 2 hours and 34 minutes; no previous temperature excursions were reported. No adverse symptoms were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA006386: US-009507513-2110USA006418:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional adverse event; Medical Assistant calling to report adverse event for VARlVAX that was administered after improperly stored; This spontaneous report was received from a certified medical assistant regarding a patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies, and concomitant medications were not provided.  On 28-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 mL (route of administration was not reported) lot# T027303, expiration date 12-AUG-2022, given as prophylaxis (Product storage error).  The improperly stored dose underwent a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (average temperature: 8.5 °F) for 0 hours, 18 minutes and 0 seconds; and of 6°F to 14°F (average temperature: 11.9°F) for 1 hour, 0 minutes and 0 seconds. The cumulative timeframe was 1 hour and 18 minutes, with no previous temperature excursion. No further information given, and no additional adverse event was reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: VARIVAX vaccine was administered 3 days past it's expiration date; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies, and concomitant medications were not provided.  On 25-OCT-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 mL (route of administration was not reported) lot# S033540, expiration date 22-OCT-2022, given as prophylaxis (Expired product administered).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; VARlVAX that was administered after improperly stored; This spontaneous report was received from a certified medical assistant regarding a patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies, and concomitant medications were not provided.  On 04-OCT-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 mL (route of administration was not reported) lot# T027303, expiration date 12-AUG-2022, given as prophylaxis (Product storage error).  The improperly stored dose underwent a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (average temperature: 8.5 °F) for 0 hours, 18 minutes and 0 seconds; and of 6°F to 14°F (average temperature: 11.9°F) for 1 hour, 0 minutes and 0 seconds. The cumulative timeframe was 1 hour and 18 minutes, with no previous temperature excursion. No further information given, and no additional adverse event was reported (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: no adverse event; an improperly stored ROTATEQ that was administered; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not reported.  On 25-OCT-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), lot # 1707460, expiry date 14-MAR-2022, orally for prophylaxis. The dose was stored at 14 Celsius degrees (C) for 3 hours. There was no previous temperature excursions and the patient had no adverse events.
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: He was supposed to receive PREVNAR 13 but received PNEMOV AX 23 instead; Caller stated her son just had PNEUMOV AX 23 in October of 2020; This spontaneous report as received from a consumer (patient's mother) and refers to an adult male patient. His concurrent conditions included crohn's disease. No information regarding the patient's drug reactions or allergies and concomitant therapies was provided.  On an unknown date in October 2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 02-NOV-2021, the patient was was supposed to receive pneumococcal vaccine conj 13v (crm197)(PREVNAR 13) but he was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 0.5 milliliter (route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (wrong product administered and extra dose administered).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE reported.; dose of PROQUAD was inadvertently administered to an adult.The nurse reports that the consumer was at the office for a physical and was supposed to receive an MMR-II booster; dose of PROQUAD was inadvertently administered to an adult.; This spontaneous report was received from a registered nurse and refers to an adult patient of unspecified age and gender. The patient's pertinent medical history, concomitant medication, past drug reactions or allergies were not reported.  On 03-NOV-2021, the patient was inadvertently vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rHA (recombinant Human albumin) (PROQUAD) at a dose reported as 0.5 (units not provided) (dose number, vaccination scheme frequency, route and anatomical site of administration were not provided; lot number T036738 that was verified to be a valid lot number with an expiration date reported and established as 28-APR-2022) for prophylaxis (product administered to patient of inappropriate age). However, it was reported that the patient was supposed to receive a Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) booster (wrong product administered).   No additional adverse event was reported (no adverse event).
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This patient was administered an invalid dose of VARIVAX (due to non-supported TE); This spontaneous report was received from a physician via an agent regarding a female patient. The patient's concurrent condition, pertinent medical history, concomitant therapies, drug reactions and allergies were not provided.   On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (route of administration,  anatomical site, dose, lot number,  and expiration date were not provided) for prophylaxis. It was unknown the temperature excursion of the dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) administered.   On an unknown date, the physician was requesting information of dosing schedules for second doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD). Subsequently, he reported that this patient was administered an invalid dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (due to a non-supported temperature excursion (TE)) (Incorrect product storage) when she was one year old.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; vaccines were previously short dated for 1 month after excursion and then were administered after the short date.; This spontaneous report was received from a medical assistan referring to a male patient of unknown age. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided      On 29-OCT-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number T032321, expiration date 22--SEP-2022 (route of administration and dose not reported) for prophylaxis (product storage error). No adverse event waqs reported.  The vaccines underwent a temperature excursion of 55.9 degrees Farhrenheit for 30 minutes.; Sender's Comments:  US-009507513-2111USA002253: