chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphonia, Dizziness, Immunisation, Laryngeal oedema
Clinical narrative: laryngeal edema; This was my 3rd dose booster dose; This was my 3rd dose booster dose; complete loss of voice, could only whisper; slightly lightheaded; This is a spontaneous report from a contactable physician (patient).    A 56-year-old female patient received third booster dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FF2587), via an unspecified route of administration in Arm Right on 27Sep2021 at 18:15 (at 56 years)as single dose for covid-19 immunisation . Concomitant medication included influenza vaccine (FLUBLOCK) on 23Sep2021 in left arm for immunization. Medical history included very mild seasonal allergies, no chronic cough. No covid tested post vaccination no known allergies.Patient had covid prior vaccination, on an unknown date. On 27Sep2021 at 19:15, laryngeal edema onset just over an hour after injection. Progressed over 30-60 minutes to complete loss of voice, could only whisper on 27Sep2021. No stridor or shortness of breath. It started to subside without any treatment after about 2 hours (as reported). Symptoms had begun to subside before treatment was given. No other symptoms. No rash, tachycardia, clamminess, nausea or vomiting. Slightly lightheaded at peak (on 27Sep2021) but then it subsided. Events resulted in Emergency room/department or urgent care and Decadron 12 mg and Benadryl 25 mg were given as treatment (as reported). Patient recovered from the events in Sep2021.; Sender's Comments: Based on the temporal relation, the association between the events of laryngeal oedema and aphonia and the suspect product of BNT162B2 cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: started my menstrual cycle later that evening around 8 PM and it has been extremely heavy and has not stopped; started my menstrual cycle later that evening around 8 PM and it has been extremely heavy and has not stopped; This is completely abnormal for me I typically have my period for 4 to 5 days; This is a spontaneous report from a contactable other hcp (patient). A 39-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: FE3592, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 01Sep2021 (at the age of 39 years old) as DOSE 2, SINGLE for covid-19 immunisation. Also, previously the patient has received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0186, Expiry date was not reported) via an unspecified route of administration administered in Arm Left 01Aug2021 03:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Insomnia from an unknown date and unknown if ongoing, no known allergies were reported. Concomitant medication(s) included quetiapine fumarate (SEROQUEL) taken for an unspecified indication, start and stop date were not reported. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. List of any other medications the patient received within 2 weeks of vaccination: Seroquel. The patient had not received any other vaccine within 4 weeks. The reporter reported that, received my second dose of the COVID-19 vaccine on 01Sep2021 and I started my menstrual cycle later that evening around 8 PM and it has been extremely heavy and has not stopped. It's going on a month of constant heavy bleeding. This is completely abnormal for me I typically have my period for 4 to 5 days. Patient received no treatment for the events. The outcome for the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Oligomenorrhoea
Clinical narrative: started my menstrual cycle later that evening around 8 PM and it has been extremely heavy and has not stopped; started my menstrual cycle later that evening around 8 PM and it has been extremely heavy and has not stopped; This is completely abnormal for me I typically have my period for 4 to 5 days; This is a spontaneous report from a contactable other hcp (patient). A 39-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: FE3592, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 01Sep2021 (at the age of 39 years old) as DOSE 2, SINGLE for covid-19 immunisation. Also, previously the patient has received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0186, Expiry date was not reported) via an unspecified route of administration administered in Arm Left 01Aug2021 03:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Insomnia from an unknown date and unknown if ongoing, no known allergies were reported. Concomitant medication(s) included quetiapine fumarate (SEROQUEL) taken for an unspecified indication, start and stop date were not reported. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. List of any other medications the patient received within 2 weeks of vaccination: Seroquel. The patient had not received any other vaccine within 4 weeks. The reporter reported that, received my second dose of the COVID-19 vaccine on 01Sep2021 and I started my menstrual cycle later that evening around 8 PM and it has been extremely heavy and has not stopped. It's going on a month of constant heavy bleeding. This is completely abnormal for me I typically have my period for 4 to 5 days. Patient received no treatment for the events. The outcome for the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Culture, Genital ulceration, Mononucleosis heterophile test negative, Pain, Sexually transmitted disease test
Clinical narrative: Lipschutz genital ulcersAcute Non sexually active teen no STD No virus No Covid nothing; This is a spontaneous report from a contactable other HCP (patient, as reported). A 13-year-old female patient (also reported as 16-year-old) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 23Sep2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient was not pregnant. The vaccine was administered at Pharmacy or Drug Store. The patient medical history was not reported. The patient did not have COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included methylphenidate hydrochloride (JORNAY PM) taken for an unspecified indication, start and stop date were not reported.  Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 26Aug2021 at the age of 13-year-old at single dose for COVID-19 immunisation. The patient has known allergy to cephalosporins. On 27Sep2021 the patient experienced 'Lipschutz genital ulcers acute, non sexually active teen, no Sexually transmitted disease (STD) no virus no covid nothing'. The event resulted in Doctor or other healthcare professional office/clinic visit and treatment of steroids, 5% lidocaine was administered. The patient underwent cultures, and blood work. The event had not resolved.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow-up.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Lipschutz genital ulcers acute" and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urinary retention
Clinical narrative: Lipschutz genital ulcersAcute Non sexually active teen no STD No virus No Covid nothing; This is a spontaneous report from a contactable other HCP (patient, as reported). A 13-year-old female patient (also reported as 16-year-old) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 23Sep2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient was not pregnant. The vaccine was administered at Pharmacy or Drug Store. The patient medical history was not reported. The patient did not have COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included methylphenidate hydrochloride (JORNAY PM) taken for an unspecified indication, start and stop date were not reported.  Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 26Aug2021 at the age of 13-year-old at single dose for COVID-19 immunisation. The patient has known allergy to cephalosporins. On 27Sep2021 the patient experienced 'Lipschutz genital ulcers acute, non sexually active teen, no Sexually transmitted disease (STD) no virus no covid nothing'. The event resulted in Doctor or other healthcare professional office/clinic visit and treatment of steroids, 5% lidocaine was administered. The patient underwent cultures, and blood work. The event had not resolved.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow-up.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Lipschutz genital ulcers acute" and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Culture, Genital ulceration
Clinical narrative: Lipschutz genital ulcersAcute Non sexually active teen no STD No virus No Covid nothing; This is a spontaneous report from a contactable other HCP (patient, as reported). A 13-year-old female patient (also reported as 16-year-old) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 23Sep2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient was not pregnant. The vaccine was administered at Pharmacy or Drug Store. The patient medical history was not reported. The patient did not have COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included methylphenidate hydrochloride (JORNAY PM) taken for an unspecified indication, start and stop date were not reported.  Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 26Aug2021 at the age of 13-year-old at single dose for COVID-19 immunisation. The patient has known allergy to cephalosporins. On 27Sep2021 the patient experienced 'Lipschutz genital ulcers acute, non sexually active teen, no Sexually transmitted disease (STD) no virus no covid nothing'. The event resulted in Doctor or other healthcare professional office/clinic visit and treatment of steroids, 5% lidocaine was administered. The patient underwent cultures, and blood work. The event had not resolved.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow-up.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Lipschutz genital ulcers acute" and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Extra dose administered, Headache, Malaise, Neck pain
Clinical narrative: Headache/ mild headache; severe pain in neck and shoulder to shoulder; severe pain in neck and shoulder to shoulder; malaise/general feeling of moderate malaise; swollen lymph nodes that are sore; swollen lymph nodes that are sore; received the booster dose of the Pfizer Covid-19  vaccine/ 3rd dose; received the booster dose of the Pfizer Covid-19  vaccine/ 3rd dose; This is a spontaneous report from contactable consumer (patient) via regulatory authority.  A 79-year-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Arm Right on 27Sep2021 16:45 (lot number: 30145BA; expiry date: unknown) at the age of 79-years-old, as dose 3 (booster), single for Covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient had no known allergies. The patient was not diagnosed with Covid-19 prior vaccination. Concomitant medication included influenza vaccine (FLU) taken for immunization in the left arm on 24Sep2021. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 29Jan2021 (lot number: EN9581); and second dose on 19Feb2021 (lot number: EL9266) in left arm for COVID-19 immunization. On 27Sep2021, at 21:00, the patient experienced mild headache, severe pain in neck and shoulder to shoulder, and malaise/general feeling of moderate malaise, and swollen lymph nodes that were sore. The patient did not receive treatment for the events mild headache, severe pain in neck and shoulder to shoulder, and malaise/general feeling of moderate malaise. Outcome of the event swollen lymph nodes that are sore was unknown, while for events mild headache, severe pain in neck and shoulder to shoulder, and malaise/general feeling of moderate malaise was recovering. Since vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Headache, Immunisation, Lymph node pain, Lymphadenopathy
Clinical narrative: Headache/ mild headache; severe pain in neck and shoulder to shoulder; severe pain in neck and shoulder to shoulder; malaise/general feeling of moderate malaise; swollen lymph nodes that are sore; swollen lymph nodes that are sore; received the booster dose of the Pfizer Covid-19  vaccine/ 3rd dose; received the booster dose of the Pfizer Covid-19  vaccine/ 3rd dose; This is a spontaneous report from contactable consumer (patient) via regulatory authority.  A 79-year-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Arm Right on 27Sep2021 16:45 (lot number: 30145BA; expiry date: unknown) at the age of 79-years-old, as dose 3 (booster), single for Covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient had no known allergies. The patient was not diagnosed with Covid-19 prior vaccination. Concomitant medication included influenza vaccine (FLU) taken for immunization in the left arm on 24Sep2021. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 29Jan2021 (lot number: EN9581); and second dose on 19Feb2021 (lot number: EL9266) in left arm for COVID-19 immunization. On 27Sep2021, at 21:00, the patient experienced mild headache, severe pain in neck and shoulder to shoulder, and malaise/general feeling of moderate malaise, and swollen lymph nodes that were sore. The patient did not receive treatment for the events mild headache, severe pain in neck and shoulder to shoulder, and malaise/general feeling of moderate malaise. Outcome of the event swollen lymph nodes that are sore was unknown, while for events mild headache, severe pain in neck and shoulder to shoulder, and malaise/general feeling of moderate malaise was recovering. Since vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Neck pain, Off label use
Clinical narrative: Headache/ mild headache; severe pain in neck and shoulder to shoulder; severe pain in neck and shoulder to shoulder; malaise/general feeling of moderate malaise; swollen lymph nodes that are sore; swollen lymph nodes that are sore; received the booster dose of the Pfizer Covid-19  vaccine/ 3rd dose; received the booster dose of the Pfizer Covid-19  vaccine/ 3rd dose; This is a spontaneous report from contactable consumer (patient) via regulatory authority.  A 79-year-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Arm Right on 27Sep2021 16:45 (lot number: 30145BA; expiry date: unknown) at the age of 79-years-old, as dose 3 (booster), single for Covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient had no known allergies. The patient was not diagnosed with Covid-19 prior vaccination. Concomitant medication included influenza vaccine (FLU) taken for immunization in the left arm on 24Sep2021. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 29Jan2021 (lot number: EN9581); and second dose on 19Feb2021 (lot number: EL9266) in left arm for COVID-19 immunization. On 27Sep2021, at 21:00, the patient experienced mild headache, severe pain in neck and shoulder to shoulder, and malaise/general feeling of moderate malaise, and swollen lymph nodes that were sore. The patient did not receive treatment for the events mild headache, severe pain in neck and shoulder to shoulder, and malaise/general feeling of moderate malaise. Outcome of the event swollen lymph nodes that are sore was unknown, while for events mild headache, severe pain in neck and shoulder to shoulder, and malaise/general feeling of moderate malaise was recovering. Since vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea exertional, Pain in extremity, Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: I had a blood clot in my right leg; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included blood clot that was several years ago, following a surgical procedure. The patient's concomitant medications were not reported. The patient had a blood clot in the right leg in Sep2021 with outcome of unknown. The clinical course was reported as: A little over a month ago, the patient got the first dose of the Covid-10 Pfizer vaccine. A week ago, the patient had a blood clot in the right leg. The patient has only had a blood clot one other time in the life, and that was several years ago, following a surgical procedure. The patient went to the ER when realized it was a clot and was currently waiting on a follow up appointment with the regular doctor.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: I had a blood clot in my right leg; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included blood clot that was several years ago, following a surgical procedure. The patient's concomitant medications were not reported. The patient had a blood clot in the right leg in Sep2021 with outcome of unknown. The clinical course was reported as: A little over a month ago, the patient got the first dose of the Covid-10 Pfizer vaccine. A week ago, the patient had a blood clot in the right leg. The patient has only had a blood clot one other time in the life, and that was several years ago, following a surgical procedure. The patient went to the ER when realized it was a clot and was currently waiting on a follow up appointment with the regular doctor.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain, Pyrexia, Somnolence
Clinical narrative: swollen lymph nodes; extreme fatigue/tire easily; difficult to get out of bed in the morning unable to work a full day or do the things that I would like to do; body aches; normal fever the evening after shot was received; This is a spontaneous report from a contactable consumer (patient). A non- pregnant 40-year-old female patient (age at vaccination: 40-year-old) received bnt162b2 (BNT162B2, lot FE3592), via an unspecified route of administration in left arm, on 11Sep2021 15:30 as dose 2, single for Covid-19 immunisation. Medical history included autoimmune thyroiditis, seasonal allergy and allergic to pesticides and cleaning products. She had her dose 1 of bnt162b2 (lot Fd8448) via unknown route in the left arm on 20Aug2021 (age of 40-year-old) for Covid-19 immunisation. There were no concomitant medications. Did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination. On 11Sep2021, she experienced a normal fever the evening after shot was received and a fever the full day after that. She had swollen lymph nodes extreme fatigue/ tire easily, finding it difficult to get out of bed in the morning and was unable to work a full day or do the things that she would like to do and body aches on 13Sep2021. No treatment for the events. She went for a clinic visit to a doctor or other healthcare professional. The outcome of loss of personal independence was recovering; for pyrexia was recovered on unspecified date in Sep2021; for other events was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Loss of personal independence in daily activities, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: swollen lymph nodes; extreme fatigue/tire easily; difficult to get out of bed in the morning unable to work a full day or do the things that I would like to do; body aches; normal fever the evening after shot was received; This is a spontaneous report from a contactable consumer (patient). A non- pregnant 40-year-old female patient (age at vaccination: 40-year-old) received bnt162b2 (BNT162B2, lot FE3592), via an unspecified route of administration in left arm, on 11Sep2021 15:30 as dose 2, single for Covid-19 immunisation. Medical history included autoimmune thyroiditis, seasonal allergy and allergic to pesticides and cleaning products. She had her dose 1 of bnt162b2 (lot Fd8448) via unknown route in the left arm on 20Aug2021 (age of 40-year-old) for Covid-19 immunisation. There were no concomitant medications. Did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination. On 11Sep2021, she experienced a normal fever the evening after shot was received and a fever the full day after that. She had swollen lymph nodes extreme fatigue/ tire easily, finding it difficult to get out of bed in the morning and was unable to work a full day or do the things that she would like to do and body aches on 13Sep2021. No treatment for the events. She went for a clinic visit to a doctor or other healthcare professional. The outcome of loss of personal independence was recovering; for pyrexia was recovered on unspecified date in Sep2021; for other events was not recovered.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthma, Condition aggravated, Cough, Dyspnoea, Malaise
Clinical narrative: Sore throat; cough; shortness of breath; runny nose; chest congestion; stuffy nose; This is a spontaneous report from a contactable consumer (patient). A 12-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm left in Sep2021 (at the age of 12 years old) (Lot Number: FF2587) as single dose for COVID-19 immunization. Medical history included asthma, covid prior vaccination. Concomitant medications included albuterol [salbutamol]; cetirizine hydrochloride (ZYRTEC). No other vaccine in four weeks. The patient experienced sore throat, cough, shortness of breath, runny nose, chest congestion, stuffy nose, all on 24Sep2021 08:00. AEs resulted in Doctor or other healthcare professional office/clinic visit. Treatment included oral Prednisone. Covid test post vaccination on 27Sep2021: Nasal Swab with unknown results. The outcome of the events was not recovered.   Follow-up (01Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Sore throat; cough; shortness of breath; runny nose; chest congestion; stuffy nose; This is a spontaneous report from a contactable consumer (patient). A 12-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm left in Sep2021 (at the age of 12 years old) (Lot Number: FF2587) as single dose for COVID-19 immunization. Medical history included asthma, covid prior vaccination. Concomitant medications included albuterol [salbutamol]; cetirizine hydrochloride (ZYRTEC). No other vaccine in four weeks. The patient experienced sore throat, cough, shortness of breath, runny nose, chest congestion, stuffy nose, all on 24Sep2021 08:00. AEs resulted in Doctor or other healthcare professional office/clinic visit. Treatment included oral Prednisone. Covid test post vaccination on 27Sep2021: Nasal Swab with unknown results. The outcome of the events was not recovered.   Follow-up (01Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Nasal congestion, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Sore throat; cough; shortness of breath; runny nose; chest congestion; stuffy nose; This is a spontaneous report from a contactable consumer (patient). A 12-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm left in Sep2021 (at the age of 12 years old) (Lot Number: FF2587) as single dose for COVID-19 immunization. Medical history included asthma, covid prior vaccination. Concomitant medications included albuterol [salbutamol]; cetirizine hydrochloride (ZYRTEC). No other vaccine in four weeks. The patient experienced sore throat, cough, shortness of breath, runny nose, chest congestion, stuffy nose, all on 24Sep2021 08:00. AEs resulted in Doctor or other healthcare professional office/clinic visit. Treatment included oral Prednisone. Covid test post vaccination on 27Sep2021: Nasal Swab with unknown results. The outcome of the events was not recovered.   Follow-up (01Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Sore throat; cough; shortness of breath; runny nose; chest congestion; stuffy nose; This is a spontaneous report from a contactable consumer (patient). A 12-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm left in Sep2021 (at the age of 12 years old) (Lot Number: FF2587) as single dose for COVID-19 immunization. Medical history included asthma, covid prior vaccination. Concomitant medications included albuterol [salbutamol]; cetirizine hydrochloride (ZYRTEC). No other vaccine in four weeks. The patient experienced sore throat, cough, shortness of breath, runny nose, chest congestion, stuffy nose, all on 24Sep2021 08:00. AEs resulted in Doctor or other healthcare professional office/clinic visit. Treatment included oral Prednisone. Covid test post vaccination on 27Sep2021: Nasal Swab with unknown results. The outcome of the events was not recovered.   Follow-up (01Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Gait inability, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Guillain-Barre Syndrome; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient (Height: 183 cm, Weight: 300 pounds) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot Number: FC3181) via an unspecified route of administration, administered in Arm Left on 19Aug2021 (at 35-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient stated that he developed guillain-barre syndrome two weeks after the first vaccine (hospitalization) on 01Sep2021. The patient was hospitalized from 02Sep2021 to 07Sep2021. Caller clarifies that he was admitted to the hospital and then discharged to a Rehabilitation Facility. Caller states he was readmitted to the hospital briefly on 12Sep2021, and then released back to the Rehabilitation Facility on 13Sep2021. Caller took first vaccine on 19Aug2021, and has not taken second vaccine. Caller states that the symptoms initially worsened and now that he is in a Rehabilitation Facility, the symptoms are getting better. The outcome of the event was recovering.   Follow-Up (04Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient (Height: 183 cm, Weight: 300 pounds) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot Number: FC3181) via an unspecified route of administration, administered in Arm Left on 19Aug2021 (at 35-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient stated that he developed guillain-barre syndrome two weeks after the first vaccine (hospitalization) on 01Sep2021. The patient was hospitalized from 02Sep2021 to 07Sep2021. Caller clarifies that he was admitted to the hospital and then discharged to a Rehabilitation Facility. Caller states he was readmitted to the hospital briefly on 12Sep2021, and then released back to the Rehabilitation Facility on 13Sep2021. Caller took first vaccine on 19Aug2021, and has not taken second vaccine. Caller states that the symptoms initially worsened and now that he is in a Rehabilitation Facility, the symptoms are getting better. The outcome of the event was recovering.   Follow-Up (04Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Herpes gestationis, Rash, Rash vesicular, Swelling
Clinical narrative: A dermatologist diagnosed me with Pemphigoid Gestationis after conducting a biopsy; This is a spontaneous report from a contactable consumer who reported for herself, a 37-year-old female patient who received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EWO196), via an unspecified route of administration, administered in left arm on 08Aug2021 (at the age of 37 years old) as dose 1, single for COVID-19 immunization. Medical history included bleed on the pituitary gland, and pregnancy (not ongoing). The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination and was not COVID tested post vaccination. She had no known allergies. Concomitant medication included prednisone. The patient had no other vaccine in four weeks. The patient was 3 weeks postpartum. 13 days after her first dose of Pfizer, on 21Aug2021, she broke out in a blistering rash on her arms and legs with severe swelling. A dermatologist diagnosed the patient with Pemphigoid Gestationis after conducting a biopsy (21Aug2021). This was her third pregnancy and she'd never previously dealt with PG. She had a bleed on the pituitary gland during this pregnancy, but the neurologist and endochronologist did not believe the PG was connected. PG was rare and usually occurred during 2nd or 3rd trimester. The patient asked if it could have been triggered by the vaccine. The patient was on a low dosage of prednisone but was told by her endocrinologist to temper it down enough to get the vaccine. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received included medication through the patient's dermatologist. The outcome of the event was recovered with sequelae on an unspecified date in 2021.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Herpes gestationis
Clinical narrative: A dermatologist diagnosed me with Pemphigoid Gestationis after conducting a biopsy; This is a spontaneous report from a contactable consumer who reported for herself, a 37-year-old female patient who received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EWO196), via an unspecified route of administration, administered in left arm on 08Aug2021 (at the age of 37 years old) as dose 1, single for COVID-19 immunization. Medical history included bleed on the pituitary gland, and pregnancy (not ongoing). The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination and was not COVID tested post vaccination. She had no known allergies. Concomitant medication included prednisone. The patient had no other vaccine in four weeks. The patient was 3 weeks postpartum. 13 days after her first dose of Pfizer, on 21Aug2021, she broke out in a blistering rash on her arms and legs with severe swelling. A dermatologist diagnosed the patient with Pemphigoid Gestationis after conducting a biopsy (21Aug2021). This was her third pregnancy and she'd never previously dealt with PG. She had a bleed on the pituitary gland during this pregnancy, but the neurologist and endochronologist did not believe the PG was connected. PG was rare and usually occurred during 2nd or 3rd trimester. The patient asked if it could have been triggered by the vaccine. The patient was on a low dosage of prednisone but was told by her endocrinologist to temper it down enough to get the vaccine. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received included medication through the patient's dermatologist. The outcome of the event was recovered with sequelae on an unspecified date in 2021.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Nausea, Pain, Pyrexia, Tremor
Clinical narrative: achy; nausea; throwing up 5 to 6 times a day. It was horrible; horrible feeling/ violent vomiting; fever; chills; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced nausea and violent vomiting with the 1st Pfizer vaccine. She was a little hesitant because she had nausea and was throwing up 5 to 6 times a day. It was horrible feeling for her. On top of that she had all other side effects: achy, fever, chills, and diarrhoea. It was a lot at once. It was so intense all at the same time. At least when she had covid it was more gradual as opposed to having all the symptoms at the same time at a level 10. She asked if vomiting was a side effect or an allergy. She also asked does it outweigh getting the second dose as she was schedule for second dose on Saturday. She had the virus so that was the problem as no one had the answer. It was frustrating for her. She had covid so closer to getting the vaccine. She asked going forward if there are booster will it have to be the same manufacturer. Her mom told her for the Moderna vaccine. She asked for any information on how many deaths are with the Pfizer vaccine as 2000 people died after the vaccine and that's why people are not taking it. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting, Weight, Weight fluctuation
Clinical narrative: achy; nausea; throwing up 5 to 6 times a day. It was horrible; horrible feeling/ violent vomiting; fever; chills; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced nausea and violent vomiting with the 1st Pfizer vaccine. She was a little hesitant because she had nausea and was throwing up 5 to 6 times a day. It was horrible feeling for her. On top of that she had all other side effects: achy, fever, chills, and diarrhoea. It was a lot at once. It was so intense all at the same time. At least when she had covid it was more gradual as opposed to having all the symptoms at the same time at a level 10. She asked if vomiting was a side effect or an allergy. She also asked does it outweigh getting the second dose as she was schedule for second dose on Saturday. She had the virus so that was the problem as no one had the answer. It was frustrating for her. She had covid so closer to getting the vaccine. She asked going forward if there are booster will it have to be the same manufacturer. Her mom told her for the Moderna vaccine. She asked for any information on how many deaths are with the Pfizer vaccine as 2000 people died after the vaccine and that's why people are not taking it. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Diarrhoea, Nausea, Pain, Pyrexia
Clinical narrative: achy; nausea; throwing up 5 to 6 times a day. It was horrible; horrible feeling/ violent vomiting; fever; chills; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced nausea and violent vomiting with the 1st Pfizer vaccine. She was a little hesitant because she had nausea and was throwing up 5 to 6 times a day. It was horrible feeling for her. On top of that she had all other side effects: achy, fever, chills, and diarrhoea. It was a lot at once. It was so intense all at the same time. At least when she had covid it was more gradual as opposed to having all the symptoms at the same time at a level 10. She asked if vomiting was a side effect or an allergy. She also asked does it outweigh getting the second dose as she was schedule for second dose on Saturday. She had the virus so that was the problem as no one had the answer. It was frustrating for her. She had covid so closer to getting the vaccine. She asked going forward if there are booster will it have to be the same manufacturer. Her mom told her for the Moderna vaccine. She asked for any information on how many deaths are with the Pfizer vaccine as 2000 people died after the vaccine and that's why people are not taking it. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: achy; nausea; throwing up 5 to 6 times a day. It was horrible; horrible feeling/ violent vomiting; fever; chills; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced nausea and violent vomiting with the 1st Pfizer vaccine. She was a little hesitant because she had nausea and was throwing up 5 to 6 times a day. It was horrible feeling for her. On top of that she had all other side effects: achy, fever, chills, and diarrhoea. It was a lot at once. It was so intense all at the same time. At least when she had covid it was more gradual as opposed to having all the symptoms at the same time at a level 10. She asked if vomiting was a side effect or an allergy. She also asked does it outweigh getting the second dose as she was schedule for second dose on Saturday. She had the virus so that was the problem as no one had the answer. It was frustrating for her. She had covid so closer to getting the vaccine. She asked going forward if there are booster will it have to be the same manufacturer. Her mom told her for the Moderna vaccine. She asked for any information on how many deaths are with the Pfizer vaccine as 2000 people died after the vaccine and that's why people are not taking it. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrioventricular block complete, Blood lactic acid, Cardiac arrest, Chest X-ray, Computerised tomogram abdomen
Clinical narrative: cardiac arrest/ her heart was barely beating; hypothermia; unable to speak or keep her eyes open; unable to speak or keep her eyes open; unable to stand; She appeared incoherent; terrible dizziness; headache; stomach pain; This is a spontaneous report from a contactable consumer. An 89-year-old female patient (reporter's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: FF8841) via an unspecified route of administration, administered on the left arm on 01Oct2021 14:00 (at the age of 89-year-old) as dose 3 (booster), single for COVID-19 immunization. Medical history included hypertension. Concomitant medications included tramadol; meprobamate; and amlodipine. The patient previously received first dose of Comirnaty on 21Jan2021 03:00 PM (Batch/Lot No: EL1283) at the left arm and second dose on 15Feb2021 02:30 PM (Batch/Lot No: EW18909) at the left arm for COVID-19 immunisation. By 5:30pm on 01Oct2021 the patient began having terrible dizziness, headache and stomach pain. Those symptoms did not subside and by 11:30am on 02Oct2021 the reporter went to her house (her sister was there) and her mom was hunched over, unable to speak or keep her eyes open, and she was unable to stand. They could not get her to take in any fluids or eat. She appeared incoherent. They called her doctor who suggested they call the number. The paramedics came and her heart was barely beating. They did CPR and got a faint beat. By the time she arrived at (Hospital name/city name) she had cardiac arrest and hypothermia. Thankfully, they revived her. She was given antibiotics, electrolytes and was put on a ventilator and transducer pacemaker. Their concern was on 01Oct2021 at 1:59pm their mom was perfectly fine. By 5:30pm on 01Oct2021 everything changed. No one should have to suffer like this because of a shot. The events resulted in Emergency room/department or urgent care visit and Hospitalization for 3 days. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. The facility where the vaccine was administered was in a Pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.