chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest pain, Heart rate, Hypertension, Hypoaesthesia
Clinical narrative: Blood pressure it was 200/ 110 pulse was 112; pulse was 112; Pains in  my chest; Left arm is tingling and numb at times; Left arm is tingling and numb at times; This case was initially received on 12Jul2021 and it was previously submitted under the incorrect Sender's (Case) Safety Report Unique Identifier JE-PFIZER INC-2021881208. The information for this patient is now filed under US-PFIZER INC- 02101295783. All subsequent follow-u p information will be reported under this manufacture number. This is a spontaneous report from a contactable consumer (patient).  A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 01Jun2021 10:00 (at the age of 41-year-old) (Batch/Lot Number: Ew0178) as single dose for covid-19 immunisation. Medical history included hypertension, pain, post laminectomy syndrome, arthritis. Concomitant medications included oxycodone hydrochloride (OXYCONTIN) taken for an unspecified indication, start and stop date were not reported; oxycodone taken for an unspecified indication, start and stop date were not reported; diazepam (DIAZEM) taken for an unspecified indication, start and stop date were not reported; metoprolol taken for an unspecified indication, start and stop date were not reported; ondansetron (ZOFRAN) taken for an unspecified indication, start and stop date were not reported; certolizumab pegol (CIMZIA) taken for an unspecified indication, start and stop date were not reported; amlodipine taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11May2021 (lot number Ew0182. Vaccine location=Left arm) for COVID-19 immunization. The patient received the second shot at 10am. At 3 pm, had pains in her chest, took blood pressure it was 200/ 110 pulse was 112. called Dr they sent her to ER; she still have chest pains and have to see a heart doctor. She has never had any heart issues. She had 4 back surgical procedures done. Her left arm was tingling and numb at times. Events onset date was 01Jun2021; outcome was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Blood pressure it was 200/ 110 pulse was 112; pulse was 112; Pains in  my chest; Left arm is tingling and numb at times; Left arm is tingling and numb at times; This case was initially received on 12Jul2021 and it was previously submitted under the incorrect Sender's (Case) Safety Report Unique Identifier JE-PFIZER INC-2021881208. The information for this patient is now filed under US-PFIZER INC- 02101295783. All subsequent follow-u p information will be reported under this manufacture number. This is a spontaneous report from a contactable consumer (patient).  A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 01Jun2021 10:00 (at the age of 41-year-old) (Batch/Lot Number: Ew0178) as single dose for covid-19 immunisation. Medical history included hypertension, pain, post laminectomy syndrome, arthritis. Concomitant medications included oxycodone hydrochloride (OXYCONTIN) taken for an unspecified indication, start and stop date were not reported; oxycodone taken for an unspecified indication, start and stop date were not reported; diazepam (DIAZEM) taken for an unspecified indication, start and stop date were not reported; metoprolol taken for an unspecified indication, start and stop date were not reported; ondansetron (ZOFRAN) taken for an unspecified indication, start and stop date were not reported; certolizumab pegol (CIMZIA) taken for an unspecified indication, start and stop date were not reported; amlodipine taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11May2021 (lot number Ew0182. Vaccine location=Left arm) for COVID-19 immunization. The patient received the second shot at 10am. At 3 pm, had pains in her chest, took blood pressure it was 200/ 110 pulse was 112. called Dr they sent her to ER; she still have chest pains and have to see a heart doctor. She has never had any heart issues. She had 4 back surgical procedures done. Her left arm was tingling and numb at times. Events onset date was 01Jun2021; outcome was not recovered.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Large bullseye rash on upper left arm - other side of elbow; This is a spontaneous report from a contactable consumer or other non hcp. A 75-years-old female non pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration, administered in Arm Left on 13Feb2021 10:30 (at the age of: 75-years-old) as dose 2, single for covid-19 immunisation. Medical history included systemic lupus erythematosus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.The patient previously took tetracycline, neurontin and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccine with in 4 weeks prior to covid vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 12Mar2021 the patient experienced large bullseye rash on upper left arm - other side of elbow. The event resulted in physician office visit. Therapeutic measures were taken as a result of large bullseye rash on upper left arm other side of elbow with antibiotics. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovered with sequelae.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Raynaud's phenomenon
Clinical narrative: Raynaud's attack in finger about 5 minutes after injection; Raynaud's attack in finger about 5 minutes after injection; This is a spontaneous report from a contactable consumer, the patient. A 63-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), dose 1 via an unspecified route of administration, administered in arm left on 12Mar2021 12:15 as dose 1, single (at the age of 63-yaers-old) for covid-19 immunisation. Medical history included rheumatoid arthritis, raynaud's disease, autoimmune dysfunction and bee allergy. It was unknown if patient had covid prior to vaccination. Concomitant medications included levothyroxine sodium and cyclobenzaprine. The patient did not receive any other vaccine in four weeks. On 12Mar2021 at 12:15, the patient experienced raynaud's attack in finger about 5 minutes after injection. The patient did not visit the emergency room and physician office. Patient did not receive treatment for adverse event. The patient did not test for covid post vaccination. The outcome of the event was recovered in Mar2021.  No follow-up attempts were possible; information about lot/batch number could not been obtained
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Rash, Scab
Clinical narrative: Felt achy all over; splitting headache day after vaccine. Like I'd been hit by a bus; Exhausted on day 2; rash on both of my lower legs; healing scabbed over rash on both of my lower legs; This is a spontaneous report from a contactable consumer (patient). A 61-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6208, Expiration date not reported), via an unspecified route of administration, administered in left arm on 09Mar2021 11:45 (at the age of 61 years) as dose 2, single for covid-19 immunization. Medical history included known allergies to nickle, ampicillin and Thimerosal. Other medical history was reported as none. The patient's concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201), via an unspecified route of administration, administered in left arm on an unknown date in Feb2021 10:15 (at the age of 61 years) for covid-19 immunization. Patient did not take other vaccine in four weeks and other medications in two weeks of vaccination. Prior to vaccination patient did not have covid and not covid tested post vaccination. On an unknown date, the patient felt achy all over. On an unknown date in Mar2021, patient experienced splitting headache day after vaccine, like she had been hit by a bus, was exhausted on day 2, and on day 3 she noticed a healing scabbed over rash on both of her lower legs. Patient did not receive any treatment for events. The outcome of all the events was recovering.  No follow-up attempts were possible. No further information was expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Insomnia, Neck pain
Clinical narrative: Headache; Achy hips; Achy lower back shoulders; Achy neck; sore arm; fatigue; insomnia from pain; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: El9267) via an unspecified route of administration, administered in Arm Left on 11Mar2021 at 10:30 as dose 1, single for COVID-19 immunisation. Medical history included covid-19. Concomitant medication included citalopram (CITALOPRAM) taken for an unspecified indication. Patient known allergies reported as none. On 11Mar2021 at 14:00 the patient experienced headache, achy hips and lower back shoulders and neck, sore arm, fatigue, insomnia from pain. Patient was not received treatment for the events. Outcome of the events was not recovered.  No follow up attempts are Possible. No further information is expected
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Headache; Achy hips; Achy lower back shoulders; Achy neck; sore arm; fatigue; insomnia from pain; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: El9267) via an unspecified route of administration, administered in Arm Left on 11Mar2021 at 10:30 as dose 1, single for COVID-19 immunisation. Medical history included covid-19. Concomitant medication included citalopram (CITALOPRAM) taken for an unspecified indication. Patient known allergies reported as none. On 11Mar2021 at 14:00 the patient experienced headache, achy hips and lower back shoulders and neck, sore arm, fatigue, insomnia from pain. Patient was not received treatment for the events. Outcome of the events was not recovered.  No follow up attempts are Possible. No further information is expected
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Nausea, Pain
Clinical narrative: Tightness in chest; Nauseous; Headaches; Achiness; This is a spontaneous report from a non-contactable consumer or other non hcp. A 52-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 05Mar2021 11:45 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included gluten sensitivity from an unknown date and unknown if ongoing, Amoxicillin, Sulfa drugs (drug hypersensitivity) from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took amoxicillin and experienced drug hypersensitivity. On 05Mar2021 at 12:00 the patient experienced tightness in chest, nauseous, headaches and achiness. Patient was not pregnant at the time of vaccination. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive other medications in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. No other medical history was given. The outcome for the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Myalgia
Clinical narrative: joint/muscle pain; Severe weakness; chills; joint/muscle pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 77-year-old male patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Lot number: EN6207, Expiry date: unknown) via an unspecified route of administration, administered in arm left on 11Mar2021 at 11:00 (age at vaccination 77-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included diabetes, heart disease, parkinson's disease and allergies to latex from an unknown date and unknown if ongoing. The patient previously took morphine and cyclosporine and experienced drug hypersensitivity. Concomitant medications were not reported. The patient had known allergies. The patient was tested positive for COVID-19 prior to vaccination and had not been tested post vaccination. Patient did not receive any other vaccines within 4 weeks prior and patient was on other medications 2 weeks prior to the COVID vaccine. On 12Mar2021 at 12:00, the patient experienced severe weakness, chills, joint pain and muscle pain on an unspecified date. No treatment was received as a result of events. The outcome of the event muscle pain was unknown and all other events were recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Chills, Cough
Clinical narrative: chills; cough; Short of breath; sore throat; fatigue; loss of taste/smell & appetite; Loss of taste/smell & appetite; Loss of taste/smell & appetite; muscle & joint aches; muscle & joint aches; swollen lymph nodes; hoarseness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 71-year-old non- pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6200) via an unspecified route of administration, administered in Arm Left on 05Mar2021 14:00 as DOSE 2, SINGLE (at the age of 71-years-old) for covid-19 immunisation. The patient's medical history included diabetes, hypothyroidism, fibromyalgia, neuropathy, and known allergies: penicillin all from an unknown date and unknown if ongoing. There were no concomitant medications. The patient was not tested to COVID prior and post vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3246) via an unspecified route of administration, administered in Arm Left on 10Feb2021 02:00 PM as DOSE 1 SIINGLE for covid-19 immunisation. The patient was not tested to COVID prior and post vaccination. The patient experienced chills, cough, short of breath, sore throat, fatigue, loss of taste/smell & appetite, muscle & joint aches, swollen lymph nodes, hoarseness all on 12Mar2021 10:30. Patient had not taken any other vaccines in four weeks. Patient had not received any treatment for the events. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dysphonia, Dyspnoea, Fatigue, Lymphadenopathy
Clinical narrative: chills; cough; Short of breath; sore throat; fatigue; loss of taste/smell & appetite; Loss of taste/smell & appetite; Loss of taste/smell & appetite; muscle & joint aches; muscle & joint aches; swollen lymph nodes; hoarseness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 71-year-old non- pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6200) via an unspecified route of administration, administered in Arm Left on 05Mar2021 14:00 as DOSE 2, SINGLE (at the age of 71-years-old) for covid-19 immunisation. The patient's medical history included diabetes, hypothyroidism, fibromyalgia, neuropathy, and known allergies: penicillin all from an unknown date and unknown if ongoing. There were no concomitant medications. The patient was not tested to COVID prior and post vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3246) via an unspecified route of administration, administered in Arm Left on 10Feb2021 02:00 PM as DOSE 1 SIINGLE for covid-19 immunisation. The patient was not tested to COVID prior and post vaccination. The patient experienced chills, cough, short of breath, sore throat, fatigue, loss of taste/smell & appetite, muscle & joint aches, swollen lymph nodes, hoarseness all on 12Mar2021 10:30. Patient had not taken any other vaccines in four weeks. Patient had not received any treatment for the events. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain
Clinical narrative: chills; cough; Short of breath; sore throat; fatigue; loss of taste/smell & appetite; Loss of taste/smell & appetite; Loss of taste/smell & appetite; muscle & joint aches; muscle & joint aches; swollen lymph nodes; hoarseness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 71-year-old non- pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6200) via an unspecified route of administration, administered in Arm Left on 05Mar2021 14:00 as DOSE 2, SINGLE (at the age of 71-years-old) for covid-19 immunisation. The patient's medical history included diabetes, hypothyroidism, fibromyalgia, neuropathy, and known allergies: penicillin all from an unknown date and unknown if ongoing. There were no concomitant medications. The patient was not tested to COVID prior and post vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3246) via an unspecified route of administration, administered in Arm Left on 10Feb2021 02:00 PM as DOSE 1 SIINGLE for covid-19 immunisation. The patient was not tested to COVID prior and post vaccination. The patient experienced chills, cough, short of breath, sore throat, fatigue, loss of taste/smell & appetite, muscle & joint aches, swollen lymph nodes, hoarseness all on 12Mar2021 10:30. Patient had not taken any other vaccines in four weeks. Patient had not received any treatment for the events. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Hyperhidrosis
Clinical narrative: severe body aches; 100.2 fever; chills; sweating; fatigue; generalized weakness; This is a spontaneous report from a contactable other hcp (patient). A 23-years-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in arm left on 04Mar2021 at 08:45 AM (age at vaccination was 23 years) as DOSE 2, SINGLE for covid-19 immunisation at public health clinic/veterans administration facility. The patient was not pregnant at the time of the vaccination. Medical history was reported as none. No known allergies was reported. No other vaccines were received within four weeks of vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken within two weeks for an unspecified indication, start and stop date were not reported. Historical vaccine included bnt162b2 (Batch/Lot Number: EN6201), via an unspecified route of administration, administered in arm left on 11Feb2021 at 10:00 AM (age at vaccination was 23 years) as DOSE 1, SINGLE for covid-19 immunisation. On 04Mar2021 at 05:00 PM, the patient experienced severe body aches, 100.2 fever, chills & sweating, fatigue, generalized weakness. The patient underwent lab tests and procedures which included body temperature: 100.2 on 04Mar2021. Therapeutic measures were taken as a result of events. Treatment included 400 mg ibuprofen. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: severe body aches; 100.2 fever; chills; sweating; fatigue; generalized weakness; This is a spontaneous report from a contactable other hcp (patient). A 23-years-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in arm left on 04Mar2021 at 08:45 AM (age at vaccination was 23 years) as DOSE 2, SINGLE for covid-19 immunisation at public health clinic/veterans administration facility. The patient was not pregnant at the time of the vaccination. Medical history was reported as none. No known allergies was reported. No other vaccines were received within four weeks of vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken within two weeks for an unspecified indication, start and stop date were not reported. Historical vaccine included bnt162b2 (Batch/Lot Number: EN6201), via an unspecified route of administration, administered in arm left on 11Feb2021 at 10:00 AM (age at vaccination was 23 years) as DOSE 1, SINGLE for covid-19 immunisation. On 04Mar2021 at 05:00 PM, the patient experienced severe body aches, 100.2 fever, chills & sweating, fatigue, generalized weakness. The patient underwent lab tests and procedures which included body temperature: 100.2 on 04Mar2021. Therapeutic measures were taken as a result of events. Treatment included 400 mg ibuprofen. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 antibody test
Clinical narrative: loss of taste; loss of smell; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EN6206),  via an unspecified route of administration, administered in left arm on 10Mar2021 07:00 (at the age of 35-years-old) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not receive any other vaccines within 4 weeks to the COVID vaccine and other medications within two weeks to the COVID vaccine was NA. The patient did not have COVID prior vaccination, and the patient had tested for Covid-19, post vaccination. The patient experienced loss of taste and loss of smell on 12Mar2021 09:00. The patient underwent lab tests and procedures which included (Nasal Swab) sars-cov-2 antibody test: negative on 12Mar2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the adverse events. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood glucose decreased, Fatigue, Feeling abnormal, Headache
Clinical narrative: Headache; joint pain; nausea; fatigued; fever; felt strange; low blood sugar( weak); This is a spontaneous report from a contactable consumer (patient) reported for herself. A 52-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: unknown), via an unknown route of administration in right arm on 12Mar2021 at 15:15 (at the age of 52-years-old) as dose 2, single for COVID-19 immunization at workplace clinic. The patient's medical history included type 2 diabetes. She had allergy from bee stings and sulfa. Concomitant medication included metformin and Osteo Bioflex taken for an unknown indication from an unknown date (these medications in two weeks). No other vaccine in four weeks. The patient received succinylcholine and sulfamethoxazole as past drug and developed allergy. The patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: unknown), via an unknown route of administration in left arm on 18Feb2021 at 15:15 (at the age of 52-years-old) as historical vaccine as dose 1, single for COVID-19 immunization. On 12Mar2021 at 15:15, the patient experienced headache, joint pain, nausea, fatigued, fever for 2 days. On third day still had a headache but no fever. About 20 minutes after the injection the patient felt strange, like a feeling like low blood sugar (weak). She was ok enough to drive home. She slept for about 15 hours. No COVID prior vaccination. No COVID tested post vaccination. No treatment for event. The outcome of the event fever was recovered, while the outcome of remaining events was recovering.  No follow-up attempts are possible. Information about lot or batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Headache; joint pain; nausea; fatigued; fever; felt strange; low blood sugar( weak); This is a spontaneous report from a contactable consumer (patient) reported for herself. A 52-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: unknown), via an unknown route of administration in right arm on 12Mar2021 at 15:15 (at the age of 52-years-old) as dose 2, single for COVID-19 immunization at workplace clinic. The patient's medical history included type 2 diabetes. She had allergy from bee stings and sulfa. Concomitant medication included metformin and Osteo Bioflex taken for an unknown indication from an unknown date (these medications in two weeks). No other vaccine in four weeks. The patient received succinylcholine and sulfamethoxazole as past drug and developed allergy. The patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: unknown), via an unknown route of administration in left arm on 18Feb2021 at 15:15 (at the age of 52-years-old) as historical vaccine as dose 1, single for COVID-19 immunization. On 12Mar2021 at 15:15, the patient experienced headache, joint pain, nausea, fatigued, fever for 2 days. On third day still had a headache but no fever. About 20 minutes after the injection the patient felt strange, like a feeling like low blood sugar (weak). She was ok enough to drive home. She slept for about 15 hours. No COVID prior vaccination. No COVID tested post vaccination. No treatment for event. The outcome of the event fever was recovered, while the outcome of remaining events was recovering.  No follow-up attempts are possible. Information about lot or batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Hypersensitivity, Presyncope
Clinical narrative: Dizziness; weakness; felt like I was going to pass out/I felt a little crummy for about the first 24 hours/I felt like my blood sugar was low/vasovagal response; an allergic reaction; This is a spontaneous report from a non-contactable other health care professional (Patient). A (Age: 44; Unit: Unknown) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on 23Feb2021 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 23Feb2021, patient experienced dizziness, weakness, a vasovagal response, my blood sugar was low, i felt a little crummy for about the first 24 hours/i felt like i was going to pass out, but didn't, an allergic reaction. Caller read that dizziness and weakness was an allergic reaction. She experienced dizziness and weakness a minute after the vaccine. Caller stated that the patient had received many vaccines, practiced blood draws and never had a vasovagal response from a needle or shot. The patient felt like my blood sugar was low, felt a little crummy for about the first 24 hours and thought that was normal. The patient concerned because they talked about these symptoms as an allergic reaction. It was not severe, it lasted a long time, felt like was going to pass out, but did not and was very dizzy and weak. Caller wanted to know if this was an allergic reaction or not.The outcome of all events was unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be requested. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Fatigue, Lymph node pain, Migraine
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 45-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EN6198, expiration date: unknown), at the age of 45, via an unspecified route of administration, left arm, on Mar 8, 2021, at 16:45, single dose, for COVID-19 immunisation. Medical history included COVID-19 from Mar 2020 to Mar 2020. There were no concomitant medications. She has not tested for COVID-19 post vaccination. She did not receive any other vaccine in 4 weeks. She was not on medications in the last two weeks. She had COVID-19 in Mar 2020. She didn't know if this was why she was still experiencing side effects from her first vaccine. The patient experienced migraine and fatigue on Wednesday, Mar 10, 2021, at 6:00 pm, she had really bad nausea; stomach cramping on Friday Mar 12, 2021 for most of the day; really sore lymph nodes under her arms and on her neck on Monday, Mar 15, 2021; and her joints  ached on an unspecified date in Mar 2021. The outcome of the events: recovering. No follow-up attempts possible. No further information expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 45-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EN6198, expiration date: unknown), at the age of 45, via an unspecified route of administration, left arm, on Mar 8, 2021, at 16:45, single dose, for COVID-19 immunisation. Medical history included COVID-19 from Mar 2020 to Mar 2020. There were no concomitant medications. She has not tested for COVID-19 post vaccination. She did not receive any other vaccine in 4 weeks. She was not on medications in the last two weeks. She had COVID-19 in Mar 2020. She didn't know if this was why she was still experiencing side effects from her first vaccine. The patient experienced migraine and fatigue on Wednesday, Mar 10, 2021, at 6:00 pm, she had really bad nausea; stomach cramping on Friday Mar 12, 2021 for most of the day; really sore lymph nodes under her arms and on her neck on Monday, Mar 15, 2021; and her joints  ached on an unspecified date in Mar 2021. The outcome of the events: recovering. No follow-up attempts possible. No further information expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Pyrexia
Clinical narrative: Chills; high fevers 103.5; achy joints; headache; This is a spontaneous report from a contactable consumer (patient). A 54-years-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN6206 and Expiration date was not reported) via an unspecified route of administration, administered in left arm on 14Mar2021 at 08:00 hours as dose 2, single (at the age of 54-years) for COVID-19 immunisation. Medical history included Acquired Immunodeficiency Syndrome (AIDS), Non-cirrhotic hyper portal tension, low platelets and known allergies: penicillin (all from an unknown date and unknown if ongoing). Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN6198 and Expiration date was not reported) via an unspecified route of administration, administered in left arm on 21Feb2021 at 08:15 hours as dose 1, single (at the age of 54-years) for COVID-19 immunisation. Concomitant medication(s) included cobicistat, darunavir ethanolate (Prezcobix) taken for an unspecified indication from an unspecified start date to 14Mar2021; nadolol (Nadol), valacyclovir, levothyroxine and PRA (all taken for an unspecified indication, start and stop date were not reported). Patient had no other vaccine in four weeks. On 14Mar2021 11:00, patient experienced chills, high fevers 103.5, achy joints, headache, the patient has not been tested. On an unspecified date the patient underwent lab tests and procedures which included body temperature result was high fevers 103.5.  Therapeutic measures were taken as a result of all events. The outcome of the events was not resolved.   No Follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Foetal hypokinesia, Oropharyngeal pain
Clinical narrative: Currently pregnant. Baby movement has decreased some since injection. Sore throat followed 1 day after injection
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Ear pain, Hyperhidrosis, Lymph node pain
Clinical narrative: I was fine until almost twelve hours after my shot. Then I woke up sweating with a fever and chills to the point I was shaking uncontrollably.  I was so dizzy I couldn?t open my eyes. I vomited four times.  This episode lasted approximately three hours.  I took some ibuprofen for my fever.   I had a sore arm for about seven days after. Since the vaccine I have experienced constant tenderness on lymph nodes in my underarms.  Every three weeks or so I get dizzy spells that last for a few hours.  I have had consistent pain in my right ear and neck tenderness since the second dose. Nothing seems to help any of these symptoms.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Pyrexia, Tremor, Vomiting
Clinical narrative: I was fine until almost twelve hours after my shot. Then I woke up sweating with a fever and chills to the point I was shaking uncontrollably.  I was so dizzy I couldn?t open my eyes. I vomited four times.  This episode lasted approximately three hours.  I took some ibuprofen for my fever.   I had a sore arm for about seven days after. Since the vaccine I have experienced constant tenderness on lymph nodes in my underarms.  Every three weeks or so I get dizzy spells that last for a few hours.  I have had consistent pain in my right ear and neck tenderness since the second dose. Nothing seems to help any of these symptoms.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: My period was longer and heavier than it usually is, now it?s just brown blood coming out consistently but not as heavy as before
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Heart rate decreased, Lip swelling, Mouth swelling
Clinical narrative: Swelling of the lips, mouth, tongue, itching of left side of face, itching of arms and chest, drop of heart rate to the 40's per ER MD, rash all over arms and chest, face
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swollen tongue
Clinical narrative: Swelling of the lips, mouth, tongue, itching of left side of face, itching of arms and chest, drop of heart rate to the 40's per ER MD, rash all over arms and chest, face
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: achy deltoids for a day or so; This is a spontaneous report from contactable consumer. This consumer reported similar events for 2 patients. This report is for 2nd of 2 patients.  A female patient (reporter's wife) of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot Number: EL8982) via an unspecified route of administration on 18Jan2021 as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot Number: EM9809) via an unspecified route of administration on 08Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced achy deltoids for a day or so, otherwise no adverse reactions after receiving both doses of the Pfizer COVID-19 vaccine on 18Jan and 08Feb2021 (Batches EL8982 and EM9809, respectively). The events were non-serious. The clinical outcome of the events were not reported.  No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021283957 Same reporter/drug/event, different patient
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia, Somnolence
Clinical narrative: Headache; Was real sleepy, I slept for all the night and then next day I slept, although I was awake with a headache about midday; Had a fever of a 101.7; This is a spontaneous report from two contactable consumers. Both consumers (Husband and wife) reported for female patient (Wife) that:  A 67-year-old female patient received bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Batch/Lot number was not reported) dose 1 single via an unspecified route of administration on 11Mar2021 (at the age of 67-year-old) as single dose for COVID-19 immunisation. Medical history included diabetes mellitus and hypertension from an unknown date and unknown if ongoing. Patient reported that she does not take diabetes medication. Concomitant medications included lisinopril (LISINOPRIL) taken for high blood pressure, start and stop date were not reported. On 11Mar2021, the patient had headache. On an unspecified date in Mar2021, the patient had a fever of 101.7 and was really sleepy, slept for all the night and then next day she slept, although she was awake with a headache about midday. That was all the side effects the patient had. The patient underwent lab tests and procedures which included body temperature: 101.7. The patient took Ibuprofen for headache. The clinical outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to synthetic fabric, Lip swelling, Petroleum distillate poisoning
Clinical narrative: swollen lower inside lip; I have a petrolium reaction; I am allergic to plastic in my mouth; This is a spontaneous report from a contactable consumer (patient) reported herself. A 69-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EN6203), via an unknown route of administration in left arm on an unknown date in Mar2021 at 12:00 as dose 1, single for COVID-19 immunization. Facility type vaccine was reported as other. The patient's medical history included high BP, diabetes, high cholesterol, heart bypass surgery and 2 cancers. She had known allergies of plastics adhesives. Concomitant medication was not reported. No other vaccine in four weeks. Yes, other medications in two weeks. The patient received Augmentin (amoxicillin; clavulanate potassium) as past drug and develop augmentin allergy. On 11Mar2021, the patient experienced swollen lower inside lip, I have a petroleum reaction I am allergic to plastics in my mouth, causes this same issue. Yes, COVID prior vaccination. No COVID tested post vaccination. No treatment received. The outcome of the events was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: Throat swelling; This is a spontaneous report from a contactable consumer (Patient). A 61-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EN6206, expiration date: unknown) via an unspecified route of administration in arm left on 15Mar2021 10:00 as dose 1, single for COVID-19 immunization. Medical history included high blood pressure. Patient was not pregnant at time of vaccination. No other vaccine in four weeks, no COVID prior vaccination and not tested COVID post vaccination. The patient received concomitant therapy (unspecified) in two weeks. The patient previously took Naprosyn/Naproxen and Sesame and experienced allergies. On 15Mar2021 10:15, the patient experienced throat swelling. Patient received treatment with Benadryl orally for the event throat swelling. On an unspecified date in 2021, the event throat swelling was resolved.  No follow-up attempts were possible. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Hypoaesthesia, Lip swelling, Pain in extremity
Clinical narrative: My arm hurt after first shot; dry mouth; swollen and numb lips; swollen and numb lips. Even my cheeks felt numb; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 67-years-old female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: unknown), via an unknown route of administration on 16Jan2021 as dose 1, single and on 06Feb2021 as dose 2, single for COVID-19 immunization. The patient's medical history included psoriasis on scalp and eyes. Concomitant medication included estradiol (ESTRACE) vaginally was taken for an unknown indication from an unknown date. The patient received Itraconazole as past drug and experienced contact dermatitis diagnosis. In Sep2020, the patient suffered a scratch from a rose bush and was prescribed itraconazole x 9 days for contact dermatitis diagnosis. On an unknown date in 2021, the patient experienced her arm hurt after first shot.  Also, after first shot, she started experiencing very dry mouth and swollen and numb lips.  Even her cheeks felt numb.  There was no saliva in her mouth so bought some Biotene and a spray for mouth and gel for tongue. She had no other symptoms, no dry eyes, no joint pain. Sjogren's test came back negative.  Tomorrow would be 2 months from the first shot and the dry mouth and swollen and numb lips were still a concern and ongoing.  When she touches lips and cheeks, it feels like the numbness feeling after going to the dentist when you are waiting for the Novacaine to wear off. The last couple of days, the dry mouth was a little better due to gargling and sucking on candy so there was a little saliva, but lips were so dry they were stuck like a bandaid to teeth and have to pull them away from her teeth. She was not on any other medications besides Estrace cream, applied vaginally a couple of times/week. She was very active; walk and bike. In Sep2020, I suffered a scratch from a rose bush and was prescribed itraconazole x 9 days for contact dermatitis diagnosis. Perhaps it was related to her taking itraconazole since she read that product has many side effects. She had an appointment with an internist tomorrow, 16Mar2021, for further evaluation. The outcome of event My arm hurt after first shot' was unknown. The outcome of the event dry mouth was recovering, while the outcome of remaining events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Decreased appetite, Diarrhoea
Clinical narrative: rash-throat & chest; prickly sensation; slight wheeze cough; slight wheeze cough; Flu; fever; chills; diarrhea; weakness; dizzy; no appetite; tender beneath ears; tiredness; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6203, Expiry date: not reported), via an unspecified route of administration, administered in left arm on 11Mar2021 14:00 as dose number unknown, single for covid-19 immunisation at  Clinic. Medical history included asthma, allergies, high blood pressure, high cholesterol, overweight, migraines. Concomitant medications included hydrochlorothiazide, meloxicam, loratadine (lorat), metoprolol taken for an unspecified indication, start and stop date were not reported. The patient previously took valtrex, cortisone, prednisone, codeine, feldene, prilosec, femhrt, nasacort, statins, breo and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has been tested for COVID-19. On 11Mar2021 14:15, the patient experienced rash-throat & chest, prickly sensation, slight wheeze cough, flu, chills, diarrhea, weakness, dizzy, no appetite, tender beneath ears, fever, tiredness. All symptoms continued for 3 days. Afterwards, continued cough, low fever & tiredness. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab, rapid test): negative on 15Mar2021. The outcome for rash-throat & chest, prickly sensation, slight wheeze cough, flu, chills, diarrhea, weakness, dizzy, no appetite, tender beneath ears was recovering; for slight wheeze cough, fever, tiredness was not recovered.  No follow-up attempts are possible; No further information is expected.