chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hot flush, Nausea, Parosmia, Vaginal haemorrhage, Vertigo
Clinical narrative: Nausea; increased sensitivity to smell, (like pregnant); vertigo; blurry vision; hot flashes; (never had before) vaginal spotting; This is a spontaneous report from a contactable consumer. This 46-year-old non-pregnant female consumer (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0185) via an unspecified route of administration on 11Aug2021 at 10: 00 AM (at 45-year-old) in left arm as dose 1, single for COVID-19 immunization. The patient had history of Hashimotos Disease and POTS and had no allergies. It was mentioned that no other vaccine was received in four weeks. The patient received Synthroid Prozac in two weeks. It was reported that patient did not have COVID prior vaccination. On 12Aug2021 at 02:00 Pm the patient experienced nausea, increased sensitivity to smell, (like pregnant) vertigo blurry vision, hot flashes (never had before) vaginal spotting. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received vertigo medicine as treatment and had not recovered. On 26Aug2021 the patient had a nasal swab rapid test for which result was negative. Follow-up attempts were completed. No further information was expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred, Vomiting
Clinical narrative: Nausea; increased sensitivity to smell, (like pregnant); vertigo; blurry vision; hot flashes; (never had before) vaginal spotting; This is a spontaneous report from a contactable consumer. This 46-year-old non-pregnant female consumer (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0185) via an unspecified route of administration on 11Aug2021 at 10: 00 AM (at 45-year-old) in left arm as dose 1, single for COVID-19 immunization. The patient had history of Hashimotos Disease and POTS and had no allergies. It was mentioned that no other vaccine was received in four weeks. The patient received Synthroid Prozac in two weeks. It was reported that patient did not have COVID prior vaccination. On 12Aug2021 at 02:00 Pm the patient experienced nausea, increased sensitivity to smell, (like pregnant) vertigo blurry vision, hot flashes (never had before) vaginal spotting. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received vertigo medicine as treatment and had not recovered. On 26Aug2021 the patient had a nasal swab rapid test for which result was negative. Follow-up attempts were completed. No further information was expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hot flush, Nausea, Parosmia, SARS-CoV-2 test, Vaginal haemorrhage
Clinical narrative: Nausea; increased sensitivity to smell, (like pregnant); vertigo; blurry vision; hot flashes; (never had before) vaginal spotting; This is a spontaneous report from a contactable consumer. This 46-year-old non-pregnant female consumer (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0185) via an unspecified route of administration on 11Aug2021 at 10: 00 AM (at 45-year-old) in left arm as dose 1, single for COVID-19 immunization. The patient had history of Hashimotos Disease and POTS and had no allergies. It was mentioned that no other vaccine was received in four weeks. The patient received Synthroid Prozac in two weeks. It was reported that patient did not have COVID prior vaccination. On 12Aug2021 at 02:00 Pm the patient experienced nausea, increased sensitivity to smell, (like pregnant) vertigo blurry vision, hot flashes (never had before) vaginal spotting. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received vertigo medicine as treatment and had not recovered. On 26Aug2021 the patient had a nasal swab rapid test for which result was negative. Follow-up attempts were completed. No further information was expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo, Vision blurred
Clinical narrative: Nausea; increased sensitivity to smell, (like pregnant); vertigo; blurry vision; hot flashes; (never had before) vaginal spotting; This is a spontaneous report from a contactable consumer. This 46-year-old non-pregnant female consumer (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0185) via an unspecified route of administration on 11Aug2021 at 10: 00 AM (at 45-year-old) in left arm as dose 1, single for COVID-19 immunization. The patient had history of Hashimotos Disease and POTS and had no allergies. It was mentioned that no other vaccine was received in four weeks. The patient received Synthroid Prozac in two weeks. It was reported that patient did not have COVID prior vaccination. On 12Aug2021 at 02:00 Pm the patient experienced nausea, increased sensitivity to smell, (like pregnant) vertigo blurry vision, hot flashes (never had before) vaginal spotting. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received vertigo medicine as treatment and had not recovered. On 26Aug2021 the patient had a nasal swab rapid test for which result was negative. Follow-up attempts were completed. No further information was expected.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaesthesia oral, Chills, Confusional state, Dyspnoea, Fatigue
Clinical narrative: Loss of consciousness; sweating; chills; nausea; numb tongue; shortness of breath; confusion; odd taste sensations; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 18-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FC3181), via unspecified route of administration in arm left on 29Aug2021 at 04:00 PM (at the age of 18-years-old) as dose 1, single for COVID-19 immunisation. The patient had no known allergies. No other medical history and no other medications (in two weeks) were not reported. Facility type vaccine was Pharmacy or Drug store where the patient took vaccine, the patient took no other vaccine in four weeks. The patient did not take COVID prior vaccination and was not COVID tested post vaccination. On 29Aug2021 at 04:15 PM, the patient experienced Loss of consciousness, sweating, chills, nausea, numb tongue, shortness of breath, confusion, odd taste sensations. The patient took treatment with Vitals being checked by EMS for the events. The outcome of the events was not recovered.  Follow-up attempts were completed. No further information was expected.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Nausea, Oxygen saturation normal, Taste disorder
Clinical narrative: Loss of consciousness; sweating; chills; nausea; numb tongue; shortness of breath; confusion; odd taste sensations; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 18-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FC3181), via unspecified route of administration in arm left on 29Aug2021 at 04:00 PM (at the age of 18-years-old) as dose 1, single for COVID-19 immunisation. The patient had no known allergies. No other medical history and no other medications (in two weeks) were not reported. Facility type vaccine was Pharmacy or Drug store where the patient took vaccine, the patient took no other vaccine in four weeks. The patient did not take COVID prior vaccination and was not COVID tested post vaccination. On 29Aug2021 at 04:15 PM, the patient experienced Loss of consciousness, sweating, chills, nausea, numb tongue, shortness of breath, confusion, odd taste sensations. The patient took treatment with Vitals being checked by EMS for the events. The outcome of the events was not recovered.  Follow-up attempts were completed. No further information was expected.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Confusional state, Dyspnoea, Hyperhidrosis, Hypoaesthesia oral
Clinical narrative: Loss of consciousness; sweating; chills; nausea; numb tongue; shortness of breath; confusion; odd taste sensations; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 18-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FC3181), via unspecified route of administration in arm left on 29Aug2021 at 04:00 PM (at the age of 18-years-old) as dose 1, single for COVID-19 immunisation. The patient had no known allergies. No other medical history and no other medications (in two weeks) were not reported. Facility type vaccine was Pharmacy or Drug store where the patient took vaccine, the patient took no other vaccine in four weeks. The patient did not take COVID prior vaccination and was not COVID tested post vaccination. On 29Aug2021 at 04:15 PM, the patient experienced Loss of consciousness, sweating, chills, nausea, numb tongue, shortness of breath, confusion, odd taste sensations. The patient took treatment with Vitals being checked by EMS for the events. The outcome of the events was not recovered.  Follow-up attempts were completed. No further information was expected.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Nausea, Taste disorder
Clinical narrative: Loss of consciousness; sweating; chills; nausea; numb tongue; shortness of breath; confusion; odd taste sensations; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 18-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FC3181), via unspecified route of administration in arm left on 29Aug2021 at 04:00 PM (at the age of 18-years-old) as dose 1, single for COVID-19 immunisation. The patient had no known allergies. No other medical history and no other medications (in two weeks) were not reported. Facility type vaccine was Pharmacy or Drug store where the patient took vaccine, the patient took no other vaccine in four weeks. The patient did not take COVID prior vaccination and was not COVID tested post vaccination. On 29Aug2021 at 04:15 PM, the patient experienced Loss of consciousness, sweating, chills, nausea, numb tongue, shortness of breath, confusion, odd taste sensations. The patient took treatment with Vitals being checked by EMS for the events. The outcome of the events was not recovered.  Follow-up attempts were completed. No further information was expected.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Catheterisation cardiac abnormal, Chest pain, Coronary artery occlusion, Migraine
Clinical narrative: swelling in lower legs; pain in soft tissue behind knees; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168), via an unspecified route of administration, administered in right arm on 04May2021 (at the age of 56-years-old) as dose 2, single for covid-19 immunisation. The patient previously received first dose of bnt162b2 (lot EW0161), administered in left arm on an unspecified date for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. Medical history included traumatic brain injury (TBI), hypertension, asthmatic bronchitis and allergy. Concomitant medications included atenolol, hydrochlorothiazide, morphine sulfate (MS CONTIN) and caffeine/chlorzoxazone/paracetamol/ thiamine disulfide (SOMA), all taken for an unspecified indication, start and stop date were not reported. On 11Aug2021 the patient experienced pain in soft tissue behind knees, swelling in lower legs that increased with passing of time. The events resulted in hospitalization, life threatening illness (immediate risk of death from the event) and doctor or other healthcare professional office/clinic visit. The events were treated with emergent heart catherization and installation of ste (as reported). The patient was hospitalized for 3 days. The patient underwent lab tests and procedures which included nasal swab: negative on 11Aug2021.  The outcome of events was recovering.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction, Nausea, Peripheral swelling, Vomiting
Clinical narrative: swelling in lower legs; pain in soft tissue behind knees; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168), via an unspecified route of administration, administered in right arm on 04May2021 (at the age of 56-years-old) as dose 2, single for covid-19 immunisation. The patient previously received first dose of bnt162b2 (lot EW0161), administered in left arm on an unspecified date for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. Medical history included traumatic brain injury (TBI), hypertension, asthmatic bronchitis and allergy. Concomitant medications included atenolol, hydrochlorothiazide, morphine sulfate (MS CONTIN) and caffeine/chlorzoxazone/paracetamol/ thiamine disulfide (SOMA), all taken for an unspecified indication, start and stop date were not reported. On 11Aug2021 the patient experienced pain in soft tissue behind knees, swelling in lower legs that increased with passing of time. The events resulted in hospitalization, life threatening illness (immediate risk of death from the event) and doctor or other healthcare professional office/clinic visit. The events were treated with emergent heart catherization and installation of ste (as reported). The patient was hospitalized for 3 days. The patient underwent lab tests and procedures which included nasal swab: negative on 11Aug2021.  The outcome of events was recovering.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: swelling in lower legs; pain in soft tissue behind knees; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168), via an unspecified route of administration, administered in right arm on 04May2021 (at the age of 56-years-old) as dose 2, single for covid-19 immunisation. The patient previously received first dose of bnt162b2 (lot EW0161), administered in left arm on an unspecified date for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. Medical history included traumatic brain injury (TBI), hypertension, asthmatic bronchitis and allergy. Concomitant medications included atenolol, hydrochlorothiazide, morphine sulfate (MS CONTIN) and caffeine/chlorzoxazone/paracetamol/ thiamine disulfide (SOMA), all taken for an unspecified indication, start and stop date were not reported. On 11Aug2021 the patient experienced pain in soft tissue behind knees, swelling in lower legs that increased with passing of time. The events resulted in hospitalization, life threatening illness (immediate risk of death from the event) and doctor or other healthcare professional office/clinic visit. The events were treated with emergent heart catherization and installation of ste (as reported). The patient was hospitalized for 3 days. The patient underwent lab tests and procedures which included nasal swab: negative on 11Aug2021.  The outcome of events was recovering.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Dehydration, Heart rate increased, Monoclonal antibody unconjugated therapy
Clinical narrative: FRUSTRATED; NAUSEA; HALLUCINATION; VERY EXHAUSTED; FEELING BAD; FEVER; This spontaneous report received from a patient concerned a 56 year old female and unspecified ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient reported no prior contact/ exposure to anyone infected with COVID-19. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, 1 total administered to left arm on 18-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, Laboratory data included: Body temperature (NR: not provided) 100 Fahrenheit (F). On 21-AUG-2021, 3 days after receiving the COVID-19 vaccine, she started feeling bad. She began to have a fever that maybe reached 102 F. On AUG-2021, she took treatment medication: Day/Nyquil (dextromethorphan hydrobromide/paracetamol/pseudoephedrine hydrochloride) for fever which brought her fever down to around 100 F. On 26-AUG-2021, after about 5 days of feeling bad, she was very exhausted and visited urgent care. MD did Laboratory data included: Lab test (NR: not provided) not reported, and X-ray (NR: not provided) not reported and while she did not specify breakthrough COVID-19 infection, she was treated with antibody infusions. On 31-AUG-2021, (for the last 3 days when she was reporting) she stated that she was feeling a little better since her fever went down, but she was still generally feeling bad, like she was poisoned and has been experiencing nausea and hallucinations. She describes the hallucinations as feeling really weird like she was in another world. It has been 15 days since she received her vaccination and on 03-SEP-2021, she was frustrated that she was still feeling this bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, had not recovered from hallucination, feeling bad, frustrated, nausea, and the outcome of very exhausted was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210908135- Covid-19 vaccine ad26.cov2.s- Hallucination, feeling bad, frustrated. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210908135- Covid-19 vaccine ad26.cov2.s- Nausea, fever, very exhausted. This event(s) is labeled per Agency and is therefore considered potentially related.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, X-ray
Clinical narrative: FRUSTRATED; NAUSEA; HALLUCINATION; VERY EXHAUSTED; FEELING BAD; FEVER; This spontaneous report received from a patient concerned a 56 year old female and unspecified ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient reported no prior contact/ exposure to anyone infected with COVID-19. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, 1 total administered to left arm on 18-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, Laboratory data included: Body temperature (NR: not provided) 100 Fahrenheit (F). On 21-AUG-2021, 3 days after receiving the COVID-19 vaccine, she started feeling bad. She began to have a fever that maybe reached 102 F. On AUG-2021, she took treatment medication: Day/Nyquil (dextromethorphan hydrobromide/paracetamol/pseudoephedrine hydrochloride) for fever which brought her fever down to around 100 F. On 26-AUG-2021, after about 5 days of feeling bad, she was very exhausted and visited urgent care. MD did Laboratory data included: Lab test (NR: not provided) not reported, and X-ray (NR: not provided) not reported and while she did not specify breakthrough COVID-19 infection, she was treated with antibody infusions. On 31-AUG-2021, (for the last 3 days when she was reporting) she stated that she was feeling a little better since her fever went down, but she was still generally feeling bad, like she was poisoned and has been experiencing nausea and hallucinations. She describes the hallucinations as feeling really weird like she was in another world. It has been 15 days since she received her vaccination and on 03-SEP-2021, she was frustrated that she was still feeling this bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, had not recovered from hallucination, feeling bad, frustrated, nausea, and the outcome of very exhausted was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210908135- Covid-19 vaccine ad26.cov2.s- Hallucination, feeling bad, frustrated. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210908135- Covid-19 vaccine ad26.cov2.s- Nausea, fever, very exhausted. This event(s) is labeled per Agency and is therefore considered potentially related.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Fatigue, Feeling abnormal, Frustration tolerance decreased, Hallucination
Clinical narrative: FRUSTRATED; NAUSEA; HALLUCINATION; VERY EXHAUSTED; FEELING BAD; FEVER; This spontaneous report received from a patient concerned a 56 year old female and unspecified ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient reported no prior contact/ exposure to anyone infected with COVID-19. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, 1 total administered to left arm on 18-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, Laboratory data included: Body temperature (NR: not provided) 100 Fahrenheit (F). On 21-AUG-2021, 3 days after receiving the COVID-19 vaccine, she started feeling bad. She began to have a fever that maybe reached 102 F. On AUG-2021, she took treatment medication: Day/Nyquil (dextromethorphan hydrobromide/paracetamol/pseudoephedrine hydrochloride) for fever which brought her fever down to around 100 F. On 26-AUG-2021, after about 5 days of feeling bad, she was very exhausted and visited urgent care. MD did Laboratory data included: Lab test (NR: not provided) not reported, and X-ray (NR: not provided) not reported and while she did not specify breakthrough COVID-19 infection, she was treated with antibody infusions. On 31-AUG-2021, (for the last 3 days when she was reporting) she stated that she was feeling a little better since her fever went down, but she was still generally feeling bad, like she was poisoned and has been experiencing nausea and hallucinations. She describes the hallucinations as feeling really weird like she was in another world. It has been 15 days since she received her vaccination and on 03-SEP-2021, she was frustrated that she was still feeling this bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, had not recovered from hallucination, feeling bad, frustrated, nausea, and the outcome of very exhausted was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210908135- Covid-19 vaccine ad26.cov2.s- Hallucination, feeling bad, frustrated. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210908135- Covid-19 vaccine ad26.cov2.s- Nausea, fever, very exhausted. This event(s) is labeled per Agency and is therefore considered potentially related.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Nausea, Pyrexia, X-ray
Clinical narrative: FRUSTRATED; NAUSEA; HALLUCINATION; VERY EXHAUSTED; FEELING BAD; FEVER; This spontaneous report received from a patient concerned a 56 year old female and unspecified ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient reported no prior contact/ exposure to anyone infected with COVID-19. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, 1 total administered to left arm on 18-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, Laboratory data included: Body temperature (NR: not provided) 100 Fahrenheit (F). On 21-AUG-2021, 3 days after receiving the COVID-19 vaccine, she started feeling bad. She began to have a fever that maybe reached 102 F. On AUG-2021, she took treatment medication: Day/Nyquil (dextromethorphan hydrobromide/paracetamol/pseudoephedrine hydrochloride) for fever which brought her fever down to around 100 F. On 26-AUG-2021, after about 5 days of feeling bad, she was very exhausted and visited urgent care. MD did Laboratory data included: Lab test (NR: not provided) not reported, and X-ray (NR: not provided) not reported and while she did not specify breakthrough COVID-19 infection, she was treated with antibody infusions. On 31-AUG-2021, (for the last 3 days when she was reporting) she stated that she was feeling a little better since her fever went down, but she was still generally feeling bad, like she was poisoned and has been experiencing nausea and hallucinations. She describes the hallucinations as feeling really weird like she was in another world. It has been 15 days since she received her vaccination and on 03-SEP-2021, she was frustrated that she was still feeling this bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, had not recovered from hallucination, feeling bad, frustrated, nausea, and the outcome of very exhausted was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210908135- Covid-19 vaccine ad26.cov2.s- Hallucination, feeling bad, frustrated. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210908135- Covid-19 vaccine ad26.cov2.s- Nausea, fever, very exhausted. This event(s) is labeled per Agency and is therefore considered potentially related.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Right arm--sore arm, numbness, tingling, burning.....feels like her arm is asleep. She is unable to grip with her right hand. Slow reaction time with fingers. She was doing a twisting motion (twisting ground pepper)-two fingers locked up and her whole arm locked up for a few seconds-- this happened 09/6, 09/07  and 09/10. No issues with left arm. Right arm is weak.  she did test positive for COVID in January 2021.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Extremity contracture, Grip strength decreased, Hypoaesthesia, Muscular weakness
Clinical narrative: Right arm--sore arm, numbness, tingling, burning.....feels like her arm is asleep. She is unable to grip with her right hand. Slow reaction time with fingers. She was doing a twisting motion (twisting ground pepper)-two fingers locked up and her whole arm locked up for a few seconds-- this happened 09/6, 09/07  and 09/10. No issues with left arm. Right arm is weak.  she did test positive for COVID in January 2021.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Right arm--sore arm, numbness, tingling, burning.....feels like her arm is asleep. She is unable to grip with her right hand. Slow reaction time with fingers. She was doing a twisting motion (twisting ground pepper)-two fingers locked up and her whole arm locked up for a few seconds-- this happened 09/6, 09/07  and 09/10. No issues with left arm. Right arm is weak.  she did test positive for COVID in January 2021.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Catheterisation cardiac normal, Chest pain, Chills, Echocardiogram normal, Fatigue
Clinical narrative: Meicarditis; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 27Aug2021 17:45 (Batch/Lot number was not reported) as dose 2, single at the age of 24-year-old for COVID-19 immunisation. No other medical history. No known allergies. No concomitant medications. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. Historic vaccine was bnt162b2 received via an unspecified route of administration, administered in left arm on 06Aug2021 17:45 (Batch/Lot number was not reported) as dose 1, single at the age of 24-year-old for COVID-19 immunisation. The patient experienced meicarditis on 29Aug2021 21:00. The patient was hospitalized for meicarditis for 2 days. Therapeutic measures were taken as a result of meicarditis which included a bunch of drugs and tests. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of event was recovering.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Pain, Pyrexia, Troponin increased
Clinical narrative: Meicarditis; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 27Aug2021 17:45 (Batch/Lot number was not reported) as dose 2, single at the age of 24-year-old for COVID-19 immunisation. No other medical history. No known allergies. No concomitant medications. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. Historic vaccine was bnt162b2 received via an unspecified route of administration, administered in left arm on 06Aug2021 17:45 (Batch/Lot number was not reported) as dose 1, single at the age of 24-year-old for COVID-19 immunisation. The patient experienced meicarditis on 29Aug2021 21:00. The patient was hospitalized for meicarditis for 2 days. Therapeutic measures were taken as a result of meicarditis which included a bunch of drugs and tests. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of event was recovering.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: Meicarditis; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 27Aug2021 17:45 (Batch/Lot number was not reported) as dose 2, single at the age of 24-year-old for COVID-19 immunisation. No other medical history. No known allergies. No concomitant medications. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. Historic vaccine was bnt162b2 received via an unspecified route of administration, administered in left arm on 06Aug2021 17:45 (Batch/Lot number was not reported) as dose 1, single at the age of 24-year-old for COVID-19 immunisation. The patient experienced meicarditis on 29Aug2021 21:00. The patient was hospitalized for meicarditis for 2 days. Therapeutic measures were taken as a result of meicarditis which included a bunch of drugs and tests. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of event was recovering.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, Magnetic resonance imaging, Musculoskeletal stiffness, Pain
Clinical narrative: LOSS OF MOBILITY OF LEFT ARM AND SHOULDER; PAIN TO LEFT ARM AND SHOULDER; SORENESS AT THE INJECTION SITE, PROGRESSIVELY WORSE AND IT IS NOW PAIN; TIGHTNESS TO LEFT ARM AND SHOULDER; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the patient experienced tightness to left arm and shoulder. On 03-APR-2021, the patient experienced pain to left arm and shoulder. On 03-APR-2021, the patient experienced soreness at the injection site, progressively worse and it is now pain. On 03-MAY-2021, the patient experienced loss of mobility of left arm and shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness at the injection site, progressively worse and it is now pain, pain to left arm and shoulder, loss of mobility of left arm and shoulder, and tightness to left arm and shoulder. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder, Ultrasound scan, X-ray
Clinical narrative: LOSS OF MOBILITY OF LEFT ARM AND SHOULDER; PAIN TO LEFT ARM AND SHOULDER; SORENESS AT THE INJECTION SITE, PROGRESSIVELY WORSE AND IT IS NOW PAIN; TIGHTNESS TO LEFT ARM AND SHOULDER; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the patient experienced tightness to left arm and shoulder. On 03-APR-2021, the patient experienced pain to left arm and shoulder. On 03-APR-2021, the patient experienced soreness at the injection site, progressively worse and it is now pain. On 03-MAY-2021, the patient experienced loss of mobility of left arm and shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness at the injection site, progressively worse and it is now pain, pain to left arm and shoulder, loss of mobility of left arm and shoulder, and tightness to left arm and shoulder. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Mobility decreased, Muscle tightness, Pain in extremity
Clinical narrative: LOSS OF MOBILITY OF LEFT ARM AND SHOULDER; PAIN TO LEFT ARM AND SHOULDER; SORENESS AT THE INJECTION SITE, PROGRESSIVELY WORSE AND IT IS NOW PAIN; TIGHTNESS TO LEFT ARM AND SHOULDER; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the patient experienced tightness to left arm and shoulder. On 03-APR-2021, the patient experienced pain to left arm and shoulder. On 03-APR-2021, the patient experienced soreness at the injection site, progressively worse and it is now pain. On 03-MAY-2021, the patient experienced loss of mobility of left arm and shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness at the injection site, progressively worse and it is now pain, pain to left arm and shoulder, loss of mobility of left arm and shoulder, and tightness to left arm and shoulder. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Computerised tomogram, Contusion
Clinical narrative: PLEURISY; SORE ARM (ELBOW TO SHOULDER); HEADACHE; NAUSEA; SORE ARM AT INJECTION SITE; LIGHTHEADED; BLURRED VISION; ITCHY ARM AT INJECTION SITE; BRUISE ON RIGHT LEG; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: thyroid, and other pre-existing medical conditions included: Patient was not sick prior to vaccine and have not had any vaccinations for at least 20 years. Patient did not have a family or personal history of heart disease, clotting issues, or cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for thyroid.  On 03-SEP-2021, the patient experienced lightheaded. On 03-SEP-2021, the patient experienced blurred vision. On 03-SEP-2021, the patient experienced itchy arm at injection site. On 03-SEP-2021, the patient experienced bruise on right leg. On 03-SEP-2021, the patient experienced headache. On 03-SEP-2021, the patient experienced nausea. On 03-SEP-2021, the patient experienced sore arm at injection site. On 05-SEP-2021, the patient experienced pleurisy. On 05-SEP-2021, the patient experienced sore arm (elbow to shoulder). Laboratory data included: CAT scan (NR: not provided) No sign of blood clots, Chest X-ray (NR: not provided) No sign of blood clots, Electrocardiogram (NR: not provided) No sign of blood clots, Fibrin D dimer (NR: not provided) Elevated, and Laboratory test (NR: not provided) No sign of blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, nausea, bruise on right leg, lightheaded, blurred vision, itchy arm at injection site, sore arm at injection site, sore arm (elbow to shoulder) and pleurisy was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Cough, Dizziness, Dyspnoea, Fibrin D dimer increased, Headache
Clinical narrative: PLEURISY; SORE ARM (ELBOW TO SHOULDER); HEADACHE; NAUSEA; SORE ARM AT INJECTION SITE; LIGHTHEADED; BLURRED VISION; ITCHY ARM AT INJECTION SITE; BRUISE ON RIGHT LEG; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: thyroid, and other pre-existing medical conditions included: Patient was not sick prior to vaccine and have not had any vaccinations for at least 20 years. Patient did not have a family or personal history of heart disease, clotting issues, or cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for thyroid.  On 03-SEP-2021, the patient experienced lightheaded. On 03-SEP-2021, the patient experienced blurred vision. On 03-SEP-2021, the patient experienced itchy arm at injection site. On 03-SEP-2021, the patient experienced bruise on right leg. On 03-SEP-2021, the patient experienced headache. On 03-SEP-2021, the patient experienced nausea. On 03-SEP-2021, the patient experienced sore arm at injection site. On 05-SEP-2021, the patient experienced pleurisy. On 05-SEP-2021, the patient experienced sore arm (elbow to shoulder). Laboratory data included: CAT scan (NR: not provided) No sign of blood clots, Chest X-ray (NR: not provided) No sign of blood clots, Electrocardiogram (NR: not provided) No sign of blood clots, Fibrin D dimer (NR: not provided) Elevated, and Laboratory test (NR: not provided) No sign of blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, nausea, bruise on right leg, lightheaded, blurred vision, itchy arm at injection site, sore arm at injection site, sore arm (elbow to shoulder) and pleurisy was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain in extremity, Pruritus, Vision blurred
Clinical narrative: PLEURISY; SORE ARM (ELBOW TO SHOULDER); HEADACHE; NAUSEA; SORE ARM AT INJECTION SITE; LIGHTHEADED; BLURRED VISION; ITCHY ARM AT INJECTION SITE; BRUISE ON RIGHT LEG; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: thyroid, and other pre-existing medical conditions included: Patient was not sick prior to vaccine and have not had any vaccinations for at least 20 years. Patient did not have a family or personal history of heart disease, clotting issues, or cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for thyroid.  On 03-SEP-2021, the patient experienced lightheaded. On 03-SEP-2021, the patient experienced blurred vision. On 03-SEP-2021, the patient experienced itchy arm at injection site. On 03-SEP-2021, the patient experienced bruise on right leg. On 03-SEP-2021, the patient experienced headache. On 03-SEP-2021, the patient experienced nausea. On 03-SEP-2021, the patient experienced sore arm at injection site. On 05-SEP-2021, the patient experienced pleurisy. On 05-SEP-2021, the patient experienced sore arm (elbow to shoulder). Laboratory data included: CAT scan (NR: not provided) No sign of blood clots, Chest X-ray (NR: not provided) No sign of blood clots, Electrocardiogram (NR: not provided) No sign of blood clots, Fibrin D dimer (NR: not provided) Elevated, and Laboratory test (NR: not provided) No sign of blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, nausea, bruise on right leg, lightheaded, blurred vision, itchy arm at injection site, sore arm at injection site, sore arm (elbow to shoulder) and pleurisy was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Computerised tomogram, Contusion, Dizziness, Electrocardiogram
Clinical narrative: PLEURISY; SORE ARM (ELBOW TO SHOULDER); HEADACHE; NAUSEA; SORE ARM AT INJECTION SITE; LIGHTHEADED; BLURRED VISION; ITCHY ARM AT INJECTION SITE; BRUISE ON RIGHT LEG; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: thyroid, and other pre-existing medical conditions included: Patient was not sick prior to vaccine and have not had any vaccinations for at least 20 years. Patient did not have a family or personal history of heart disease, clotting issues, or cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for thyroid.  On 03-SEP-2021, the patient experienced lightheaded. On 03-SEP-2021, the patient experienced blurred vision. On 03-SEP-2021, the patient experienced itchy arm at injection site. On 03-SEP-2021, the patient experienced bruise on right leg. On 03-SEP-2021, the patient experienced headache. On 03-SEP-2021, the patient experienced nausea. On 03-SEP-2021, the patient experienced sore arm at injection site. On 05-SEP-2021, the patient experienced pleurisy. On 05-SEP-2021, the patient experienced sore arm (elbow to shoulder). Laboratory data included: CAT scan (NR: not provided) No sign of blood clots, Chest X-ray (NR: not provided) No sign of blood clots, Electrocardiogram (NR: not provided) No sign of blood clots, Fibrin D dimer (NR: not provided) Elevated, and Laboratory test (NR: not provided) No sign of blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, nausea, bruise on right leg, lightheaded, blurred vision, itchy arm at injection site, sore arm at injection site, sore arm (elbow to shoulder) and pleurisy was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.