chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid, has mild cough,  after first vaccine; Tested positive for Covid, has mild cough,  after first vaccine; Metallic taste in mouth, after first vaccine; burning between her toes and fingers; like a hot and cold feeling, also to her legs, arms, mouth, randomly to eyes and cheek; itching in different areas; numbness in different areas; This is a spontaneous report from a Pfizer sponsored regulatory authority from a contactable consumer (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration in the arm left on 15Sep2021, at the age of 41-years-old, at single dose for COVID-19 immunization. Medical history included ongoing diabetes from Oct2019, ongoing depression from Aug2017 and ongoing anxiety from Aug2017. Concomitant medications included desvenlafaxine succinate monohydrate (PRISTIQ, 150 mg) oral from unspecified date in 2017 and ongoing at 150 mg, 1x/day for depression and anxiety; bupropion hydrochloride (WELLBUTRIN, 150 mg) oral from Aug2017 and ongoing at 150 mg, 1x/day for depression and anxiety; and metformin (strength: 500 mg) oral from Nov2019 and ongoing at 500 mg, 2x/day for diabetes. On 15Sep2021, about an hour after the vaccine, the patient had metallic taste in mouth. On unspecified date in Sep2021 (around 18Sep2021 or 19Sep2021), the patient had burning between toes and fingers, like a hot and cold feeling, also to her legs, arms, mouth, randomly to eyes and cheek, associated with itching and numbness in different areas, after first vaccine. On 23Sep2021, the patient tested positive for COVID, has mild cough. Patient wanted to know anything she can do for her symptoms other than taking diphenhydramine hydrochloride (BENADRYL). Therapeutic measure was taken in response to the events which included taking Benadryl. Patient underwent laboratory test which included COVID-19 virus test on 23Sep2021: positive. Outcome of the events (metallic taste in mouth; and burning between toes and fingers, like a hot and cold feeling, also to her legs, arms, mouth, randomly to eyes and cheek, associated with itching and numbness in different areas) was not recovered; while event tested positive for COVID was recovering.  The lot number for [BNT162B2] was not provided and will be requested during follow-up.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium, Systemic: Joint Pain-Medium, Additional Details: pt had muscle aches,chills,fever,sore throat, sinus pressure in face up to 2 days after vax took ibuprofn and sudafed.  pt continues to experience "not feeling herself", neck/back pain, muscle soreness and moderate fatigue
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Feeling abnormal
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium, Systemic: Joint Pain-Medium, Additional Details: pt had muscle aches,chills,fever,sore throat, sinus pressure in face up to 2 days after vax took ibuprofn and sudafed.  pt continues to experience "not feeling herself", neck/back pain, muscle soreness and moderate fatigue
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Myalgia, Oropharyngeal pain, Pain, Paranasal sinus discomfort
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium, Systemic: Joint Pain-Medium, Additional Details: pt had muscle aches,chills,fever,sore throat, sinus pressure in face up to 2 days after vax took ibuprofn and sudafed.  pt continues to experience "not feeling herself", neck/back pain, muscle soreness and moderate fatigue
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium, Systemic: Joint Pain-Medium, Additional Details: pt had muscle aches,chills,fever,sore throat, sinus pressure in face up to 2 days after vax took ibuprofn and sudafed.  pt continues to experience "not feeling herself", neck/back pain, muscle soreness and moderate fatigue
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chills, Decreased appetite, Disturbance in attention, Electrocardiogram
Clinical narrative: This is a spontaneous report from a contactable consumer (patient himself). A 44-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; solution for injection; batch/lot number: FF2588), at the vaccination age of 44, via an unspecified route of administration, left arm, on Aug 28, 2021, at 09:00, single dose, for COVID-19 immunisation. The patient's medical history: None. Concomitant medications not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient has not been diagnosed with COVID-19. 5 days after the shot, he had a headache (Sep 2, 2021). On Sep 6, 2021, he had fatigue, cold chills, nausea and brain fog. On an unspecified date, he was in bed for a little over 16 hours. He had a COVID-19 test on Sep 8, 2021 and on Sep 11, 2021. He was hit again with fatigue, cold chills, nausea and brain fog on Sep 10, 2021. He felt bad again, and went to the hospital. The reporter considered the events as non-serious. The patient has been diagnosed with COVID-19 since the vaccination. The patient underwent lab tests and procedures, which included diagnostics: Negative on Sep 8, 2021, nasal swab and COVID-19: tested for COVID-19: Yes on Aug 28, 2021. COVID-19: clear on Sep 11, 2021. The outcome of fatigue, cold chills, nausea and brain fog not recovered and other event: unknown. Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Impaired work ability, Mobility decreased
Clinical narrative: This is a spontaneous report from a contactable consumer (patient himself). A 44-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; solution for injection; batch/lot number: FF2588), at the vaccination age of 44, via an unspecified route of administration, left arm, on Aug 28, 2021, at 09:00, single dose, for COVID-19 immunisation. The patient's medical history: None. Concomitant medications not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient has not been diagnosed with COVID-19. 5 days after the shot, he had a headache (Sep 2, 2021). On Sep 6, 2021, he had fatigue, cold chills, nausea and brain fog. On an unspecified date, he was in bed for a little over 16 hours. He had a COVID-19 test on Sep 8, 2021 and on Sep 11, 2021. He was hit again with fatigue, cold chills, nausea and brain fog on Sep 10, 2021. He felt bad again, and went to the hospital. The reporter considered the events as non-serious. The patient has been diagnosed with COVID-19 since the vaccination. The patient underwent lab tests and procedures, which included diagnostics: Negative on Sep 8, 2021, nasal swab and COVID-19: tested for COVID-19: Yes on Aug 28, 2021. COVID-19: clear on Sep 11, 2021. The outcome of fatigue, cold chills, nausea and brain fog not recovered and other event: unknown. Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, SARS-CoV-2 test negative
Clinical narrative: This is a spontaneous report from a contactable consumer (patient himself). A 44-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; solution for injection; batch/lot number: FF2588), at the vaccination age of 44, via an unspecified route of administration, left arm, on Aug 28, 2021, at 09:00, single dose, for COVID-19 immunisation. The patient's medical history: None. Concomitant medications not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient has not been diagnosed with COVID-19. 5 days after the shot, he had a headache (Sep 2, 2021). On Sep 6, 2021, he had fatigue, cold chills, nausea and brain fog. On an unspecified date, he was in bed for a little over 16 hours. He had a COVID-19 test on Sep 8, 2021 and on Sep 11, 2021. He was hit again with fatigue, cold chills, nausea and brain fog on Sep 10, 2021. He felt bad again, and went to the hospital. The reporter considered the events as non-serious. The patient has been diagnosed with COVID-19 since the vaccination. The patient underwent lab tests and procedures, which included diagnostics: Negative on Sep 8, 2021, nasal swab and COVID-19: tested for COVID-19: Yes on Aug 28, 2021. COVID-19: clear on Sep 11, 2021. The outcome of fatigue, cold chills, nausea and brain fog not recovered and other event: unknown. Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bedridden, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer (patient himself). A 44-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; solution for injection; batch/lot number: FF2588), at the vaccination age of 44, via an unspecified route of administration, left arm, on Aug 28, 2021, at 09:00, single dose, for COVID-19 immunisation. The patient's medical history: None. Concomitant medications not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient has not been diagnosed with COVID-19. 5 days after the shot, he had a headache (Sep 2, 2021). On Sep 6, 2021, he had fatigue, cold chills, nausea and brain fog. On an unspecified date, he was in bed for a little over 16 hours. He had a COVID-19 test on Sep 8, 2021 and on Sep 11, 2021. He was hit again with fatigue, cold chills, nausea and brain fog on Sep 10, 2021. He felt bad again, and went to the hospital. The reporter considered the events as non-serious. The patient has been diagnosed with COVID-19 since the vaccination. The patient underwent lab tests and procedures, which included diagnostics: Negative on Sep 8, 2021, nasal swab and COVID-19: tested for COVID-19: Yes on Aug 28, 2021. COVID-19: clear on Sep 11, 2021. The outcome of fatigue, cold chills, nausea and brain fog not recovered and other event: unknown. Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient himself). A 44-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; solution for injection; batch/lot number: FF2588), at the vaccination age of 44, via an unspecified route of administration, left arm, on Aug 28, 2021, at 09:00, single dose, for COVID-19 immunisation. The patient's medical history: None. Concomitant medications not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient has not been diagnosed with COVID-19. 5 days after the shot, he had a headache (Sep 2, 2021). On Sep 6, 2021, he had fatigue, cold chills, nausea and brain fog. On an unspecified date, he was in bed for a little over 16 hours. He had a COVID-19 test on Sep 8, 2021 and on Sep 11, 2021. He was hit again with fatigue, cold chills, nausea and brain fog on Sep 10, 2021. He felt bad again, and went to the hospital. The reporter considered the events as non-serious. The patient has been diagnosed with COVID-19 since the vaccination. The patient underwent lab tests and procedures, which included diagnostics: Negative on Sep 8, 2021, nasal swab and COVID-19: tested for COVID-19: Yes on Aug 28, 2021. COVID-19: clear on Sep 11, 2021. The outcome of fatigue, cold chills, nausea and brain fog not recovered and other event: unknown. Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Candida infection
Clinical narrative: Experienced thrush after COVID 19 booster shot; This is a spontaneous report from contactable consumer. A 55-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history included kidney transplant last year and was on immunosuppressants. The patient concomitant medications were not reported. On unspecified date, the patient experienced thrush after COVID 19 booster shot. The outcome of the event was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: die; dizzy; low blood pressure.; weakness; fall down the stairs; hit his head; hit his head; poor appetize; He got his third vaccine; He got his third vaccine; This is a spontaneous report from a contactable consumer. A 53-year-old male patient received the third dose of BNT162B2 via an unspecified route of administration on the left arm on 02Sep2021 (Lot Number: FC3182) at the age of 53-year-old as single dose for COVID-19 immunization. Medical history included diabetic and hypertension. The patient didn't received other vaccine in four weeks. Known allergies included not fresh seafood. Covid prior vaccination was none. Covid tested (Nasal swab) post vaccination on 01Sep2021 and result was negative. The patient received other medications in two weeks. The patient previously received the first dose an the second dose of BNT162B2, the first dose on 13Mar2021 (Lot Number: EN6208) at the age of 53-year-old, the second dose on an unspecified date, (Lot Number: ER8737), both via an unspecified route of administration on the left arm as single dose for COVID-19 immunization. The patient experienced edema started to get worse, started to have side effects like dizzy all the time, weakness and low blood pressure. One day morning, his dizziness caused him to fall down the stairs and hit his head. He told (Doctor) through the (Facility name). During those days, he had poor appetize. He said everything taste funny. On 14Sep2021, he had three hours of dialysis in the morning and removed his dialysis port in the afternoon on the same day. But PA only noted "wound care" on his visit record. The day after, he said he felt great, vivid and had good appetize. He even cooked steak and black cod for the dinner. He even had his first shower after 3 months and was very happy on 15Sep2021. They can't image he will die in the next morning. Treatment was not received. The patient died on 16Sep2021. Autopsy was unknown. The outcome of unknown cause of death was fatal. The outcome of other events was not recovered.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: die
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Death, Dialysis, Discomfort, Dizziness, Feeling abnormal
Clinical narrative: die; dizzy; low blood pressure.; weakness; fall down the stairs; hit his head; hit his head; poor appetize; He got his third vaccine; He got his third vaccine; This is a spontaneous report from a contactable consumer. A 53-year-old male patient received the third dose of BNT162B2 via an unspecified route of administration on the left arm on 02Sep2021 (Lot Number: FC3182) at the age of 53-year-old as single dose for COVID-19 immunization. Medical history included diabetic and hypertension. The patient didn't received other vaccine in four weeks. Known allergies included not fresh seafood. Covid prior vaccination was none. Covid tested (Nasal swab) post vaccination on 01Sep2021 and result was negative. The patient received other medications in two weeks. The patient previously received the first dose an the second dose of BNT162B2, the first dose on 13Mar2021 (Lot Number: EN6208) at the age of 53-year-old, the second dose on an unspecified date, (Lot Number: ER8737), both via an unspecified route of administration on the left arm as single dose for COVID-19 immunization. The patient experienced edema started to get worse, started to have side effects like dizzy all the time, weakness and low blood pressure. One day morning, his dizziness caused him to fall down the stairs and hit his head. He told (Doctor) through the (Facility name). During those days, he had poor appetize. He said everything taste funny. On 14Sep2021, he had three hours of dialysis in the morning and removed his dialysis port in the afternoon on the same day. But PA only noted "wound care" on his visit record. The day after, he said he felt great, vivid and had good appetize. He even cooked steak and black cod for the dinner. He even had his first shower after 3 months and was very happy on 15Sep2021. They can't image he will die in the next morning. Treatment was not received. The patient died on 16Sep2021. Autopsy was unknown. The outcome of unknown cause of death was fatal. The outcome of other events was not recovered.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: die
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Hypotension, Oedema peripheral, SARS-CoV-2 test negative, Syncope
Clinical narrative: die; dizzy; low blood pressure.; weakness; fall down the stairs; hit his head; hit his head; poor appetize; He got his third vaccine; He got his third vaccine; This is a spontaneous report from a contactable consumer. A 53-year-old male patient received the third dose of BNT162B2 via an unspecified route of administration on the left arm on 02Sep2021 (Lot Number: FC3182) at the age of 53-year-old as single dose for COVID-19 immunization. Medical history included diabetic and hypertension. The patient didn't received other vaccine in four weeks. Known allergies included not fresh seafood. Covid prior vaccination was none. Covid tested (Nasal swab) post vaccination on 01Sep2021 and result was negative. The patient received other medications in two weeks. The patient previously received the first dose an the second dose of BNT162B2, the first dose on 13Mar2021 (Lot Number: EN6208) at the age of 53-year-old, the second dose on an unspecified date, (Lot Number: ER8737), both via an unspecified route of administration on the left arm as single dose for COVID-19 immunization. The patient experienced edema started to get worse, started to have side effects like dizzy all the time, weakness and low blood pressure. One day morning, his dizziness caused him to fall down the stairs and hit his head. He told (Doctor) through the (Facility name). During those days, he had poor appetize. He said everything taste funny. On 14Sep2021, he had three hours of dialysis in the morning and removed his dialysis port in the afternoon on the same day. But PA only noted "wound care" on his visit record. The day after, he said he felt great, vivid and had good appetize. He even cooked steak and black cod for the dinner. He even had his first shower after 3 months and was very happy on 15Sep2021. They can't image he will die in the next morning. Treatment was not received. The patient died on 16Sep2021. Autopsy was unknown. The outcome of unknown cause of death was fatal. The outcome of other events was not recovered.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: die
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Death, Decreased appetite, Dizziness, Fall
Clinical narrative: die; dizzy; low blood pressure.; weakness; fall down the stairs; hit his head; hit his head; poor appetize; He got his third vaccine; He got his third vaccine; This is a spontaneous report from a contactable consumer. A 53-year-old male patient received the third dose of BNT162B2 via an unspecified route of administration on the left arm on 02Sep2021 (Lot Number: FC3182) at the age of 53-year-old as single dose for COVID-19 immunization. Medical history included diabetic and hypertension. The patient didn't received other vaccine in four weeks. Known allergies included not fresh seafood. Covid prior vaccination was none. Covid tested (Nasal swab) post vaccination on 01Sep2021 and result was negative. The patient received other medications in two weeks. The patient previously received the first dose an the second dose of BNT162B2, the first dose on 13Mar2021 (Lot Number: EN6208) at the age of 53-year-old, the second dose on an unspecified date, (Lot Number: ER8737), both via an unspecified route of administration on the left arm as single dose for COVID-19 immunization. The patient experienced edema started to get worse, started to have side effects like dizzy all the time, weakness and low blood pressure. One day morning, his dizziness caused him to fall down the stairs and hit his head. He told (Doctor) through the (Facility name). During those days, he had poor appetize. He said everything taste funny. On 14Sep2021, he had three hours of dialysis in the morning and removed his dialysis port in the afternoon on the same day. But PA only noted "wound care" on his visit record. The day after, he said he felt great, vivid and had good appetize. He even cooked steak and black cod for the dinner. He even had his first shower after 3 months and was very happy on 15Sep2021. They can't image he will die in the next morning. Treatment was not received. The patient died on 16Sep2021. Autopsy was unknown. The outcome of unknown cause of death was fatal. The outcome of other events was not recovered.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: die
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Head injury, Headache, Hypotension, Immunisation, Off label use
Clinical narrative: die; dizzy; low blood pressure.; weakness; fall down the stairs; hit his head; hit his head; poor appetize; He got his third vaccine; He got his third vaccine; This is a spontaneous report from a contactable consumer. A 53-year-old male patient received the third dose of BNT162B2 via an unspecified route of administration on the left arm on 02Sep2021 (Lot Number: FC3182) at the age of 53-year-old as single dose for COVID-19 immunization. Medical history included diabetic and hypertension. The patient didn't received other vaccine in four weeks. Known allergies included not fresh seafood. Covid prior vaccination was none. Covid tested (Nasal swab) post vaccination on 01Sep2021 and result was negative. The patient received other medications in two weeks. The patient previously received the first dose an the second dose of BNT162B2, the first dose on 13Mar2021 (Lot Number: EN6208) at the age of 53-year-old, the second dose on an unspecified date, (Lot Number: ER8737), both via an unspecified route of administration on the left arm as single dose for COVID-19 immunization. The patient experienced edema started to get worse, started to have side effects like dizzy all the time, weakness and low blood pressure. One day morning, his dizziness caused him to fall down the stairs and hit his head. He told (Doctor) through the (Facility name). During those days, he had poor appetize. He said everything taste funny. On 14Sep2021, he had three hours of dialysis in the morning and removed his dialysis port in the afternoon on the same day. But PA only noted "wound care" on his visit record. The day after, he said he felt great, vivid and had good appetize. He even cooked steak and black cod for the dinner. He even had his first shower after 3 months and was very happy on 15Sep2021. They can't image he will die in the next morning. Treatment was not received. The patient died on 16Sep2021. Autopsy was unknown. The outcome of unknown cause of death was fatal. The outcome of other events was not recovered.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: die
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: SOB and hospitalization
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, SARS-CoV-2 test
Clinical narrative: SOB and hospitalization
Age: 57.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received on 29-09-2021 and contains non significant information
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Chills, Nausea, Vomiting
Clinical narrative: continuous vomiting, temp of 103.7,  extremely lethargic, needed an ambulance to hospital, sepsis
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood culture, Body temperature increased, Computerised tomogram, Electrocardiogram, Laboratory test
Clinical narrative: continuous vomiting, temp of 103.7,  extremely lethargic, needed an ambulance to hospital, sepsis
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Magnetic resonance imaging, Sepsis, Urine analysis, Vomiting
Clinical narrative: continuous vomiting, temp of 103.7,  extremely lethargic, needed an ambulance to hospital, sepsis
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: continuous vomiting, temp of 103.7,  extremely lethargic, needed an ambulance to hospital, sepsis
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 21-SEP-2021) dose was not reported, administered on 29-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211006668 and 20211006371.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Blood test normal, Computerised tomogram normal, Confusional state, Electrocardiogram normal
Clinical narrative: Received 1st dose of vaccine on 9/27/21. Patient reported fever and symptoms of "not feeling well" on 9/29/21. On 9/30/21, patient was evaluated by a healthcare professional.  Patient had tachycardia (107), elevated BP (148/88), and was visibly "shaken & confused." Patient stated her 20 minute commute took 40 minutes since she had pull over due to feeling of confusion. At visit, patient was still confused and was escorted to the emergency department for further evaluation.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electroencephalogram normal, Heart rate increased, Hyperhidrosis, Impaired driving ability, Pyrexia
Clinical narrative: Received 1st dose of vaccine on 9/27/21. Patient reported fever and symptoms of "not feeling well" on 9/29/21. On 9/30/21, patient was evaluated by a healthcare professional.  Patient had tachycardia (107), elevated BP (148/88), and was visibly "shaken & confused." Patient stated her 20 minute commute took 40 minutes since she had pull over due to feeling of confusion. At visit, patient was still confused and was escorted to the emergency department for further evaluation.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Received 1st dose of vaccine on 9/27/21. Patient reported fever and symptoms of "not feeling well" on 9/29/21. On 9/30/21, patient was evaluated by a healthcare professional.  Patient had tachycardia (107), elevated BP (148/88), and was visibly "shaken & confused." Patient stated her 20 minute commute took 40 minutes since she had pull over due to feeling of confusion. At visit, patient was still confused and was escorted to the emergency department for further evaluation.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Confusional state, Malaise, Pyrexia, Tachycardia
Clinical narrative: Received 1st dose of vaccine on 9/27/21. Patient reported fever and symptoms of "not feeling well" on 9/29/21. On 9/30/21, patient was evaluated by a healthcare professional.  Patient had tachycardia (107), elevated BP (148/88), and was visibly "shaken & confused." Patient stated her 20 minute commute took 40 minutes since she had pull over due to feeling of confusion. At visit, patient was still confused and was escorted to the emergency department for further evaluation.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Amnesia, Blood pressure increased, Chest X-ray normal, Computerised tomogram head, Confusional state
Clinical narrative: Received 1st dose of vaccine on 9/27/21. Patient reported fever and symptoms of "not feeling well" on 9/29/21. On 9/30/21, patient was evaluated by a healthcare professional.  Patient had tachycardia (107), elevated BP (148/88), and was visibly "shaken & confused." Patient stated her 20 minute commute took 40 minutes since she had pull over due to feeling of confusion. At visit, patient was still confused and was escorted to the emergency department for further evaluation.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Electroencephalogram, Heart rate increased, Seizure like phenomena, Tremor
Clinical narrative: Received 1st dose of vaccine on 9/27/21. Patient reported fever and symptoms of "not feeling well" on 9/29/21. On 9/30/21, patient was evaluated by a healthcare professional.  Patient had tachycardia (107), elevated BP (148/88), and was visibly "shaken & confused." Patient stated her 20 minute commute took 40 minutes since she had pull over due to feeling of confusion. At visit, patient was still confused and was escorted to the emergency department for further evaluation.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Troponin
Clinical narrative: Received 1st dose of vaccine on 9/27/21. Patient reported fever and symptoms of "not feeling well" on 9/29/21. On 9/30/21, patient was evaluated by a healthcare professional.  Patient had tachycardia (107), elevated BP (148/88), and was visibly "shaken & confused." Patient stated her 20 minute commute took 40 minutes since she had pull over due to feeling of confusion. At visit, patient was still confused and was escorted to the emergency department for further evaluation.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphoedema
Clinical narrative: lymph node swelling under right armpit
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymph node swelling under right armpit
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The school district is requiring that she get a second shot of MMRII.; The school district is requiring that she get a second shot of MMRII.; The patient did not report any adverse events after receiving the vaccination / No additional AE reported.; the prescribing information is not clear; This spontaneous report was received from a pharmacist and refers to a 34-year-old non-pregnant female patient who was a teacher in a public school. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date in June 2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) injectable dosage form, one dose in the left arm, lot # T013728, expiration date: 21-APR-2022 (strength, dose number and route of administration were not reported) for vaccination against Measles, Mumps, and Rubella.  On an unspecified date, the school district was requiring that she got a second shot of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The reporter stated that it was not clear in the prescribing information (product label confusion), but it appeared that she only needed to receive one vaccination (circumstance or information capable of leading to medication error, inappropriate schedule of product administration). The pharmacist inquired whether the patient needed to receive a second vaccination. The patient did not report any adverse events after receiving the vaccination (no adverse event).  The outcome was unknown.
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: No AE; Use of a pediatric dose in an adult; The caller said the patient was supposed to received Engerix B and not VAQTA; The patient received two doses of VAQTA.; This spontaneous report has been received from a consumer and refers to a 48-years-old male patient. The patient's concurrent conditions, medical history, concomitant therapies, drug allergies and reactions were not reported.   On an unknown date, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated(VAQTA) (Lot #, expiration date, Strength, route of administration and anatomical location of vaccine) 1 mL, for prophylaxis. On 27-SEP-2021, the patient received a pediatric dose of hepatitis a vaccine, inactivated(VAQTA) (Lot #, expiration date, Strength, route of administration and anatomical location of vaccine) 0.5 mL; the patient supposed to received to Hepatitis b vaccine rhbsag (YEAST) (ENGERIX B). The patient did not present any adverse event.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event reported; Expired Pneumovax23 was administared; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported.      On 29-SEP-2021, the patient was vaccinated with 0.5 milliliter of an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T010293, expiration date 30-AUG-2021 (route was not reported) for prophylaxis (expired product administered). No additional adverse event and no product quality complaint were reported.
Age: 9.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Menstruation irregular
Clinical narrative: The patient would not get a period for 2-4 months; This spontaneous report was received from a medical assistant via company representative and refers to her 12 -year-old daughter. The patient's concurrent conditions and drug reactions or allergies were not reported. The patient's mother had ovarian issues.   On unknow dates in 2015, the patient received two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, lot #, expiration date and route were not reported) for HPV vaccination. Concomitant therapies included medroxyprogesterone acetate(PROVERA).     The patient did not have any immediate adverse events.  At the age of 12 years in 2018, the patient started period. The first few periods were normal (the patient received her period monthly), but after that, the patient would not get period for 2-4 months (amenorrhoea). When the patient's period were more, than 3-4 months apart she took medroxyprogesterone acetate(PROVERA), pills 10 mg  as needed.  The medical assistant stated: "I don't think this is because of GARD ASIL".  At the time of the report, the outcome of amenorrhoea was not reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event, Wrong product administered
Clinical narrative: Caller did not report the patient has experienced any side effects from the administration.; the patient was accidently administered PROQUAD and VARIVAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 30-SEP-2021, the patient was accidently administered measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) 0.5 mL, lot # T034826, expiration date 11-APR-2022 (route of administration and anatomical location were not provided) and varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 mL, lot # T032318, expiration date 22-SEP-2022 (route of administration and anatomical location were not provided) for prophylaxis (accidental overdose). The nurse did not report the patient has experienced any side effects from the administration (no adverse event).
Sex: M
Vaccine: MMR
Symptoms: Viral titre decreased
Clinical narrative: titer for MMR II and the titer result came back "low"; This spontaneous report was received from a patient's mother and refers to a 29-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown dates (reported as "at recommended age"), the patient received two doses of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) administered intramuscularly (dose, anatomical location, lot # and expiration date were not reported) as immunization for prevention of measles, mumps and rubella. On an unknown date, the patient's healthcare professional (HPC) took a titer for measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) and the titer result came back "low" (viral titre decreased). The patient's HCP recommended a third dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II). The outcome of the event was unknown.  Causality assessment was not provided.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug ineffective
Clinical narrative: original live shingles vaccine that was ineffective; This spontaneous report was received from a 74 years old female via Pfizer, referring to the patient herself. The patient's medical history, concurrent conditions and historical drugs were not reported. The patient's concomitant medication included etanercept (ENBREL).  On an unknown date (reported as a few years ago), the patient was vaccinated with zoster vaccine live (manufacturer unknown) (strength, dose, frequency, route, lot# and expiration date were not reported) for prophylaxis.  On an unknown date, the patient considered the original vaccine zoster vaccine live (manufacturer unknown) was ineffective. The outcome of the event was unknown. The causal relationship between the event and zoster vaccine live (manufacturer unknown) was related.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Erythema, Pain, Pain in extremity
Clinical narrative: Redness at injection site along with other symptoms; Severe arm pain; Soreness/ aches; Redness; Itching; Joint pain; Fever; Chills; This case was reported by a consumer and described the occurrence of injection site erythema in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2021, the patient received the 1st dose of Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced pain in arm, pain, erythema, pruritus, joint pain, fever and chills. On 28th September 2021, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema, pain in arm, pain, erythema, pruritus, joint pain, fever and chills were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, pain in arm, pain, erythema, pruritus, joint pain, fever and chills to be related to Shingrix.  Additional details were provided as follows:  The reporter was the patient.  The patient received the first dose of Shingrix (lot and expiry date unknown) and was experiencing sever arm pain, soreness, redness, itching and joint pain, aches, fever, and chills all weekend.  On Tuesday, 5 days after the vaccination, the patient started experiencing redness at injection site along with the other symptoms.  All the symptoms were reported by the patient to the doctor's office who administered the vaccine and doctor said that the symptoms were normal up to a week and asked to monitor and report if symptoms lasted longer than a week.  The reporter consented to follow-up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: Redness at injection site along with other symptoms; Severe arm pain; Soreness/ aches; Redness; Itching; Joint pain; Fever; Chills; This case was reported by a consumer and described the occurrence of injection site erythema in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2021, the patient received the 1st dose of Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced pain in arm, pain, erythema, pruritus, joint pain, fever and chills. On 28th September 2021, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema, pain in arm, pain, erythema, pruritus, joint pain, fever and chills were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, pain in arm, pain, erythema, pruritus, joint pain, fever and chills to be related to Shingrix.  Additional details were provided as follows:  The reporter was the patient.  The patient received the first dose of Shingrix (lot and expiry date unknown) and was experiencing sever arm pain, soreness, redness, itching and joint pain, aches, fever, and chills all weekend.  On Tuesday, 5 days after the vaccination, the patient started experiencing redness at injection site along with the other symptoms.  All the symptoms were reported by the patient to the doctor's office who administered the vaccine and doctor said that the symptoms were normal up to a week and asked to monitor and report if symptoms lasted longer than a week.  The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction
Clinical narrative: Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 52-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself /himself. The age at vaccination was not reported. The patient got his/her shingles vaccine and got a huge outbreak of shingles immediately after, that went right up to the side of his/her face and in his/her mouth and then cleared up. The follow up would not possible as contact information was not available. For 2nd shingles outbreak refer case US2021AMR205369, reported by same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205369:same report
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Muscle discomfort
Clinical narrative: muscles discomfort in arm; This case was reported by a consumer via interactive digital media and described the occurrence of muscle discomfort in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, several weeks after receiving Shingles vaccine, the patient experienced muscle discomfort. On an unknown date, the outcome of the muscle discomfort was recovered/resolved.   It was unknown if the reporter considered the muscle discomfort to be related to Shingles vaccine.  Additional information was provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received the Shingles shot a few weeks ago. The patient had no pain, just minor muscles discomfort in arm for 1 day. The patient would get the second shot in February (year unspecified). The patient further stated that get the shot and Shingles could be prevented. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: left arm is hurting; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional information was provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received the shot in left arm and it was hurting after the shot at the time of reporting.