chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Erythema
Clinical narrative: increased blood pressure; reddening of the skin all over her body; This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: US-AMGEN-USASL2021027233). This case was split from master case #2021218108 to capture a 46-year-old female patient taking BNT162B2 and experienced increased blood pressure and skin red.  This non-serious solicited report (USASL2021027233) was reported on 18/FEB/2021 by a consumer from a commercial program (PSP00086) and involves a 46 years old   female patient who experienced increased blood pressure/blood pressure has continued to be elevated 180/100 [PT: blood pressure increased], migraines [PT: migraine] while receiving Enbrel, Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis, increased blood pressure, reddening of the skin all over her body. It was further mentioned that on 08/JAN/2021, the patient had a Covid vaccine and had a reaction to it immediately that including increased blood pressure and reddening of the skin all over her body. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel, Single Dose Prefilled Autoinjector on 28/JAN/2021. On 28/JAN/2021, the patient's blood pressure has continued to be elevated 180/100, even with Enbrel medication. Additionally, on an unknown date in JAN/2021, the patient had migraines and possible fibromyalgia. No treatment information was received. The outcome of the event blood pressure increased was reported as not recovered/not resolved. The outcome of the event migraine was reported as unknown. Action taken with Enbrel, Single Dose Prefilled Autoinjector was continued for the event blood pressure increased. Action taken with Enbrel, Single Dose Prefilled Autoinjector was reported as unknown for the event migraine. The causal relationship between the events blood pressure increased, migraine and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested.  Follow-up (08Mar2021): The following information was received: Narrative states, It was further mentioned that on 08/JAN/2021, the patient had a Covid vaccine and had a reaction to it immediately that including increased blood pressure and reddening of the skin all over her body. Kindly confirm Covid vaccine is co-suspect or concomitant. Response: As per the information in the case: 08/JAN/2021, the patient had a Covid vaccine. The patient began Enbrel, Single Dose Prefilled Autoinjector on 28/JAN/2021. Therefore, the Covid vaccine which was prior to Enbrel start is neither considered as co-suspect nor concomitant medication. The company is performing due diligence, and should further information be received, the case will be updated accordingly.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature, Chills, Constipation, Dizziness
Clinical narrative: facial drooping; facial numbness; fever; chills; swollen lymph nodes; full body aches; dizziness; abdominal and side cramps; abdominal and side cramps; heavy heart beat; constipation; This is a spontaneous report from a contactable consumer. A 39-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. According to the patient, he received the first Pfizer COVID-19 vaccine shot and he was looking for guidance on getting the booster shot. He had no major health issues, however, he experienced the following side effects on an unspecified date: facial numbness/drooping, fever, chills, swollen lymph nodes, full body aches, mild dizziness, abdominal and side cramps, heavy heart beat, and constipation over the last 96 hrs. since the shot. He has not had COVID-19 and they have been isolating for the last year. He was asking for any advise. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis, Heart rate, Heart rate abnormal, Hypoaesthesia, Lymphadenopathy
Clinical narrative: facial drooping; facial numbness; fever; chills; swollen lymph nodes; full body aches; dizziness; abdominal and side cramps; abdominal and side cramps; heavy heart beat; constipation; This is a spontaneous report from a contactable consumer. A 39-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. According to the patient, he received the first Pfizer COVID-19 vaccine shot and he was looking for guidance on getting the booster shot. He had no major health issues, however, he experienced the following side effects on an unspecified date: facial numbness/drooping, fever, chills, swollen lymph nodes, full body aches, mild dizziness, abdominal and side cramps, heavy heart beat, and constipation over the last 96 hrs. since the shot. He has not had COVID-19 and they have been isolating for the last year. He was asking for any advise. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Pain, Pyrexia
Clinical narrative: facial drooping; facial numbness; fever; chills; swollen lymph nodes; full body aches; dizziness; abdominal and side cramps; abdominal and side cramps; heavy heart beat; constipation; This is a spontaneous report from a contactable consumer. A 39-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. According to the patient, he received the first Pfizer COVID-19 vaccine shot and he was looking for guidance on getting the booster shot. He had no major health issues, however, he experienced the following side effects on an unspecified date: facial numbness/drooping, fever, chills, swollen lymph nodes, full body aches, mild dizziness, abdominal and side cramps, heavy heart beat, and constipation over the last 96 hrs. since the shot. He has not had COVID-19 and they have been isolating for the last year. He was asking for any advise. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test, Blood immunoglobulin E, Blood immunoglobulin E increased, Blood test, Cardiac stress test
Clinical narrative: swelling of lips; swelling of throat; change in voice; IgE (prior to ER trip) was already signif elevated; diffuse itching; hives; Itching became more continuous , hives increased; elevated dimer titer; This is a spontaneous report from a contactable Other-HCP reporting for self. A 70-years-old patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Feb2021 13:00 (Batch/Lot Number: EL9267) as single dose for covid-19 immunisation. Patient received the first dose on 20Jan2021. Medical history included Asthma, allergies to Penicillin, some molds, house dust, cat and dog dander. Concomitant medication included valsartan (DIOVAN); amlodipine; hydrochlorothiazide (HCT); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY); bupropion hydrochloride (WELLBUTRIN). Within about1 week of injection, on 18Feb2021, patient experienced diffuse itching, site moving around, then later 2-3 hives. Patient had to d/c the antihistamine he take routinely (25Feb2021) for an allergy scratch test a week later. Itching became more continuous, hives increased. Had scratch test. Only localized reaction. Then hives increased, by 10Mar2021 hives bloomed all over body -- first on both forearms, then everywhere. Later in evening 10Mar2021, swelling of lips, throat, change in voice went to ER. Multiple Blood tests, chest MRI, neck ultrasound (localized swelling), cardiac stress test, and u/s of legs to r/o DVT because of elevated dimer titer (no clinical symptoms). All tests normal except dimer. IgE (prior to ER trip) was already signif elevated: 471 IU/ml on 25Feb2021 (Norm<114). Patient was hospitalized for these events for one day. Patient also Emergency Room Visit and Physician Office Visit for these events. Treatment included Inject of steroid, Benadryl, Prevacid, IV fluid. Patient had Nasal Swab on12Mar2021 with negative result. Outcome of events was recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events itching, hives, swelling of lips, throat swelling, voice alteration and IgE increased. 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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dysphonia, Fibrin D dimer, Fibrin D dimer increased, Lip swelling
Clinical narrative: swelling of lips; swelling of throat; change in voice; IgE (prior to ER trip) was already signif elevated; diffuse itching; hives; Itching became more continuous , hives increased; elevated dimer titer; This is a spontaneous report from a contactable Other-HCP reporting for self. A 70-years-old patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Feb2021 13:00 (Batch/Lot Number: EL9267) as single dose for covid-19 immunisation. Patient received the first dose on 20Jan2021. Medical history included Asthma, allergies to Penicillin, some molds, house dust, cat and dog dander. Concomitant medication included valsartan (DIOVAN); amlodipine; hydrochlorothiazide (HCT); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY); bupropion hydrochloride (WELLBUTRIN). Within about1 week of injection, on 18Feb2021, patient experienced diffuse itching, site moving around, then later 2-3 hives. Patient had to d/c the antihistamine he take routinely (25Feb2021) for an allergy scratch test a week later. Itching became more continuous, hives increased. Had scratch test. Only localized reaction. Then hives increased, by 10Mar2021 hives bloomed all over body -- first on both forearms, then everywhere. Later in evening 10Mar2021, swelling of lips, throat, change in voice went to ER. Multiple Blood tests, chest MRI, neck ultrasound (localized swelling), cardiac stress test, and u/s of legs to r/o DVT because of elevated dimer titer (no clinical symptoms). All tests normal except dimer. IgE (prior to ER trip) was already signif elevated: 471 IU/ml on 25Feb2021 (Norm<114). Patient was hospitalized for these events for one day. Patient also Emergency Room Visit and Physician Office Visit for these events. Treatment included Inject of steroid, Benadryl, Prevacid, IV fluid. Patient had Nasal Swab on12Mar2021 with negative result. Outcome of events was recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events itching, hives, swelling of lips, throat swelling, voice alteration and IgE increased. 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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Pharyngeal swelling, Pruritus, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: swelling of lips; swelling of throat; change in voice; IgE (prior to ER trip) was already signif elevated; diffuse itching; hives; Itching became more continuous , hives increased; elevated dimer titer; This is a spontaneous report from a contactable Other-HCP reporting for self. A 70-years-old patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Feb2021 13:00 (Batch/Lot Number: EL9267) as single dose for covid-19 immunisation. Patient received the first dose on 20Jan2021. Medical history included Asthma, allergies to Penicillin, some molds, house dust, cat and dog dander. Concomitant medication included valsartan (DIOVAN); amlodipine; hydrochlorothiazide (HCT); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY); bupropion hydrochloride (WELLBUTRIN). Within about1 week of injection, on 18Feb2021, patient experienced diffuse itching, site moving around, then later 2-3 hives. Patient had to d/c the antihistamine he take routinely (25Feb2021) for an allergy scratch test a week later. Itching became more continuous, hives increased. Had scratch test. Only localized reaction. Then hives increased, by 10Mar2021 hives bloomed all over body -- first on both forearms, then everywhere. Later in evening 10Mar2021, swelling of lips, throat, change in voice went to ER. Multiple Blood tests, chest MRI, neck ultrasound (localized swelling), cardiac stress test, and u/s of legs to r/o DVT because of elevated dimer titer (no clinical symptoms). All tests normal except dimer. IgE (prior to ER trip) was already signif elevated: 471 IU/ml on 25Feb2021 (Norm<114). Patient was hospitalized for these events for one day. Patient also Emergency Room Visit and Physician Office Visit for these events. Treatment included Inject of steroid, Benadryl, Prevacid, IV fluid. Patient had Nasal Swab on12Mar2021 with negative result. Outcome of events was recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events itching, hives, swelling of lips, throat swelling, voice alteration and IgE increased. 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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: swelling of lips; swelling of throat; change in voice; IgE (prior to ER trip) was already signif elevated; diffuse itching; hives; Itching became more continuous , hives increased; elevated dimer titer; This is a spontaneous report from a contactable Other-HCP reporting for self. A 70-years-old patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Feb2021 13:00 (Batch/Lot Number: EL9267) as single dose for covid-19 immunisation. Patient received the first dose on 20Jan2021. Medical history included Asthma, allergies to Penicillin, some molds, house dust, cat and dog dander. Concomitant medication included valsartan (DIOVAN); amlodipine; hydrochlorothiazide (HCT); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY); bupropion hydrochloride (WELLBUTRIN). Within about1 week of injection, on 18Feb2021, patient experienced diffuse itching, site moving around, then later 2-3 hives. Patient had to d/c the antihistamine he take routinely (25Feb2021) for an allergy scratch test a week later. Itching became more continuous, hives increased. Had scratch test. Only localized reaction. Then hives increased, by 10Mar2021 hives bloomed all over body -- first on both forearms, then everywhere. Later in evening 10Mar2021, swelling of lips, throat, change in voice went to ER. Multiple Blood tests, chest MRI, neck ultrasound (localized swelling), cardiac stress test, and u/s of legs to r/o DVT because of elevated dimer titer (no clinical symptoms). All tests normal except dimer. IgE (prior to ER trip) was already signif elevated: 471 IU/ml on 25Feb2021 (Norm<114). Patient was hospitalized for these events for one day. Patient also Emergency Room Visit and Physician Office Visit for these events. Treatment included Inject of steroid, Benadryl, Prevacid, IV fluid. Patient had Nasal Swab on12Mar2021 with negative result. Outcome of events was recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events itching, hives, swelling of lips, throat swelling, voice alteration and IgE increased. 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.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dehydration, Eye irritation, Eye pain, Feeling abnormal
Clinical narrative: Eye pain; headache; nausea; some weakness later; dehydrated; watery eyes; felt horrible; eyes got to burning; This is a spontaneous report from a contactable patient (nursing aid). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 10Mar2021 as single dose for covid-19 immunisation. The patient medical history included Potassium high, she was already sick and she had a sinus infection and was on an antibiotic when she took the first COVID-19 Vaccine shot. The patient concomitant medications were not reported. The patient experienced headache, nausea & some weakness later that day after the vaccine. The following day experienced pain & watery eyes. The patient got her first COVID-19 Vaccine shot on 10Mar2021 shot and had a reaction in her eyes. She said she was on a sinus pill and steroids at the time she received her first COVID-19 Vaccine. She said her doctor told her it was ok for her to take the COVID-19 vaccine. She said her eyes got to burning and running after she got the COVID-19 Vaccine. She said she was dehydrated at the time too. She said she was feeling better. She said she was taking an antibiotic and prednisone to build her body up. She said she was already sick anyway, saying she had high potassium. She said she felt horrible, and her eyes got to running, so her doctor called an antibiotic in and everything for her. She stated her eye doctor told her she was having an adverse effect to the COVID-19 Vaccine shot. She said the person who administered her first COVID-19 Vaccine shot told her she would be sick for 48 hours. She said she felt a little better now, but her eyes were bad. She said she was scheduled to get her second COVID-19 Vaccine on 05Apr2021 and was scared to take the second COVID-19 Vaccine. She said her eyes were runny, burning and painful after she got the first COVID-19 Vaccine shot. The outcome of event headache, nausea, some weakness later, Eye pain, watery eyes, dehydrated, felt horrible, eyes got to burning was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: There is not a reasonable possibility that event dehydration is related to BNT162B2.  It's most likely intercurrent medical condition. 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.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lacrimation increased, Nausea
Clinical narrative: Eye pain; headache; nausea; some weakness later; dehydrated; watery eyes; felt horrible; eyes got to burning; This is a spontaneous report from a contactable patient (nursing aid). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 10Mar2021 as single dose for covid-19 immunisation. The patient medical history included Potassium high, she was already sick and she had a sinus infection and was on an antibiotic when she took the first COVID-19 Vaccine shot. The patient concomitant medications were not reported. The patient experienced headache, nausea & some weakness later that day after the vaccine. The following day experienced pain & watery eyes. The patient got her first COVID-19 Vaccine shot on 10Mar2021 shot and had a reaction in her eyes. She said she was on a sinus pill and steroids at the time she received her first COVID-19 Vaccine. She said her doctor told her it was ok for her to take the COVID-19 vaccine. She said her eyes got to burning and running after she got the COVID-19 Vaccine. She said she was dehydrated at the time too. She said she was feeling better. She said she was taking an antibiotic and prednisone to build her body up. She said she was already sick anyway, saying she had high potassium. She said she felt horrible, and her eyes got to running, so her doctor called an antibiotic in and everything for her. She stated her eye doctor told her she was having an adverse effect to the COVID-19 Vaccine shot. She said the person who administered her first COVID-19 Vaccine shot told her she would be sick for 48 hours. She said she felt a little better now, but her eyes were bad. She said she was scheduled to get her second COVID-19 Vaccine on 05Apr2021 and was scared to take the second COVID-19 Vaccine. She said her eyes were runny, burning and painful after she got the first COVID-19 Vaccine shot. The outcome of event headache, nausea, some weakness later, Eye pain, watery eyes, dehydrated, felt horrible, eyes got to burning was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: There is not a reasonable possibility that event dehydration is related to BNT162B2.  It's most likely intercurrent medical condition. 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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Concussion, Loss of consciousness, Syncope
Clinical narrative: fainted; lost consciousness; weakness; concussion; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6198) on 09Feb2021 in left arm at single dose for COVID-19 immunisation. Medical history was none, unknown if known allergies. No covid prior vaccination. Concomitant medications were none (no other medications in two weeks). No other vaccine in four weeks. The patient was not pregnant, was not pregnant at time of vaccination. No covid tested post vaccination.  The patient received first dose on 09Feb2021, on 28Feb2021 05:00 PM, experienced weakness fainted, lost consciousness, diagnosed with concussion. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for one day. Unknown if treatment for the events. Outcome of the event was not recovered.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Patient has substantial bilateral lung PE 12 days post vaccination; This is a spontaneous report from a contactable other health professional. A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05Mar2021 (at the age of 65 years) as single dose for covid-19 immunisation.  Medical history included allergies: penicillin and testim. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 on an unspecified date for covid-19 immunization. The patient had substantial bilateral lung PE (pulmonary embolism) 12 days post vaccination on 14Mar2021 (as reported, pending clarification). The event resulted in emergency room/department or urgent care and hospitalization in Mar2021. Treatment of heparin infusion with rivaroxaban (XARELTO) initiation planned was received for the event. The patient had no covid prior vaccination and had not tested post vaccination. Outcome of event was recovering.   Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of event pulmonary embolism cannot be 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Meningitis viral, Vertigo, Vestibular neuronitis
Clinical narrative: viral meningitis; vertigo; dizziness; headache; vestibular neuritis; This is a spontaneous report from a non-contactable consumer (patient's daughter). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown), via an unspecified route of administration on 25Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient developed vertigo, vestibular neuritis, dizziness, and headaches. She is currently in the hospital for viral meningitis, all on an unspecified date in 2021. The reporter found a website where five other people reported this. Outcome of 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
Symptoms: Blindness, Burning sensation, Muscular weakness, Optic neuritis, Paraesthesia
Clinical narrative: lost vision in one eye; had eye pain and was diagnosed with optic neuritis; burning, tingling in both legs; burning, tingling in both legs; general muscle weakness; This is a spontaneous report received from a contactable pharmacist. A 42-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date in 2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. HCP calling regarding a patient, who reached out to the Pharmacist inquiring about treatment recommendations and any information regarding her diagnosis, that received her 2nd Pfizer Vaccine dose 2 weeks ago and started with reactions after 2 days. The patient reported burning, tingling in both legs and general muscle weakness. She also had eye pain and she was diagnosed with optic neuritis and had lost vision in one eye as a result. Reporter was asking if there have been any reports of this. The outcome of the events was unknown. HCP was asking if any "post market research" has shown any reports of "multi system inflammatory syndrome as seen in children post Covid 19 illness." HCP also inquiring about Guillain-Barre syndrome reports in post EUA reports.; Sender's Comments: Based on the information provided, and on plausible temporal association,  the Company  assessed that a reasonable possibility could not be completely excluded that the reported events optic neuritis and lost vision were related to the  PFIZER-BIONTECH COVID-19 VACCINE.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Paraesthesia oral
Clinical narrative: My heart rate was around 115/120. Heart rate still elevated even now nearly 10 hrs later; my lips and in my mouth was tingly; This is a spontaneous report from a contactable consumer (patient).   A 39-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 39-year-old via an unspecified route of administration, administered in Arm Left on 16Mar2021 09:00 (Lot Number: EP7534) as single dose for covid-19 immunisation.  Medical history included Asthma, high blood pressure, anxiety, allergies: Peanuts, tree nuts, cantaloupe, watermelon, imitrex. Concomitant medications included sertraline hydrochloride (ZOLOFT); amlodipine besilate (NORVASC); budesonide, formoterol fumarate (SYMBICORT); salbutamol sulfate (ALBUTEROL).  The patient previously took first dose of BNT162B2 at the age of 39-year-old in Left arm on 23Feb2021 10:15 for covid-19 immunisation, lot number=EN6203. There were no covid prior vaccination, no other vaccine in four weeks, and no covid tested post vaccination. About 10 mins after vaccine the area around patient's lips and in her mouth was tingly. The patient's heart rate was around 115/120. Heart rate still elevated even now nearly 10 hrs later. Called Her primary dr. He sent patient to ER. The event onset date and time were 16Mar2021 09:30. Treatments were received including IV Fluids, Ativan. The events outcome was Not recovered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Hallucination, visual, Hypoaesthesia, Photophobia, Tinnitus
Clinical narrative: Three hours post vaccination, I experienced for 30 minutes visual hallucinations left eye, the lower half the visual field (as though I had rubbed my eye hard.; I had photophobia as well; I also had left sided facial numbness that lasted 30minutes.; My tinnitus became much louder and that is continuing.; felt confused; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 11Mar2021 12:00 as SINGLE DOSE for covid-19 immunisation. Patient was not pregnant. Facility type vaccine was clinic. Medical history included fibromyalgia, chronic fatigue syndrome, non-specific autoimmune disorder, allergies to Sulfa, Penicillin-light rash each. Concomitant medications included fenofibrate and tizanidine, both taken for an unspecified indication, start and stop date were not reported. There was no other vaccine in four weeks. Three hours post vaccination, patient experienced for 30 minutes visual hallucinations left eye, the lower half the visual field as though she had rubbed eye hard. Patient had photophobia as well. She also had left sided facial numbness that lasted 30 minutes. She noticed no drooping of eye lid or mouth. Her tinnitus became much louder and that is continuing. She felt confused for the rest of the day of vaccination. The events onset date were reported as 11Mar2021 03:00 PM. The adverse events (AE) resulted in doctor or other healthcare professional office/clinic visit. Patient didn't received treatment for the events. The outcome of events was recovering. Patient have no Covid prior vaccination nor tested Covid post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Dizziness postural, Fatigue
Clinical narrative: nausea; chills; headache; low grade fever; muscle aches; could not eat; but still very tired; dizzy when standing; blurred vision; It is now the 8th day since shot and still weak not quite well, but better; It is now the 8th day since shot and still weak not quite well, but better; Was ill for 6 days; This is a spontaneous report received from Pfizer sponsored program. A contactable consumer (patient reported for herself) reported that a 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included tested positive for covid from 30Dec2020; obese. The patient's concomitant medications were not reported. Customer reported was tested positive for covid on 30Dec2020. She had a very mild case. First Pfizer shot, 04Mar2021. In Mar2021, the patient was ill for 6 days. In bed first 3, with nausesa, chills, low grade fever, headache, muscle aches, could not eat in Mar2021. 4th day better, but still very tired and dizzy when standing, blurred vision in Mar2021. It was now the 8th day since shot and still weak, not quite well, but better in Mar2021. The patient did not want second dose. Terrible reaction to the first injection. The outcome of Weakness and Feeling unwell was recovering, of the other events was unknown.    Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Headache, Illness, Malaise, Myalgia
Clinical narrative: nausea; chills; headache; low grade fever; muscle aches; could not eat; but still very tired; dizzy when standing; blurred vision; It is now the 8th day since shot and still weak not quite well, but better; It is now the 8th day since shot and still weak not quite well, but better; Was ill for 6 days; This is a spontaneous report received from Pfizer sponsored program. A contactable consumer (patient reported for herself) reported that a 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included tested positive for covid from 30Dec2020; obese. The patient's concomitant medications were not reported. Customer reported was tested positive for covid on 30Dec2020. She had a very mild case. First Pfizer shot, 04Mar2021. In Mar2021, the patient was ill for 6 days. In bed first 3, with nausesa, chills, low grade fever, headache, muscle aches, could not eat in Mar2021. 4th day better, but still very tired and dizzy when standing, blurred vision in Mar2021. It was now the 8th day since shot and still weak, not quite well, but better in Mar2021. The patient did not want second dose. Terrible reaction to the first injection. The outcome of Weakness and Feeling unwell was recovering, of the other events was unknown.    Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test positive, Vision blurred
Clinical narrative: nausea; chills; headache; low grade fever; muscle aches; could not eat; but still very tired; dizzy when standing; blurred vision; It is now the 8th day since shot and still weak not quite well, but better; It is now the 8th day since shot and still weak not quite well, but better; Was ill for 6 days; This is a spontaneous report received from Pfizer sponsored program. A contactable consumer (patient reported for herself) reported that a 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included tested positive for covid from 30Dec2020; obese. The patient's concomitant medications were not reported. Customer reported was tested positive for covid on 30Dec2020. She had a very mild case. First Pfizer shot, 04Mar2021. In Mar2021, the patient was ill for 6 days. In bed first 3, with nausesa, chills, low grade fever, headache, muscle aches, could not eat in Mar2021. 4th day better, but still very tired and dizzy when standing, blurred vision in Mar2021. It was now the 8th day since shot and still weak, not quite well, but better in Mar2021. The patient did not want second dose. Terrible reaction to the first injection. The outcome of Weakness and Feeling unwell was recovering, of the other events was unknown.    Information about batch/lot number has been requested.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got real sick; Initial information was received on 10-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (demographics unknown) who got real sick (illness), when received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got real sick (illness) (unknown latency, non-serious) following the administration of INFLUENZA VACCINE.  The patient never had flu before that nor since 15 years. The reporter will never get another one.  No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown.  There will be no information available on the batch number for this case. .
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test
Clinical narrative: 7 days later tested positive for the COVID-19 infection/Patient is not showing any symptoms; This is a spontaneous report from a contactable consumer (patient's mother).  A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient's mother was asking in regards of her son who received first dose of the COVID-19 vaccine and 7 days later (the next Monday) tested positive for the COVID-19 infection, she wants to know if the patient could receive the second dose, is been 14 days since he tested positive with the PCR test. Patient is not showing any symptoms. Outcome of the events was unknown. As of 15Mar2021, the reporter stated that she was trying to obtain information about the 2nd dose. She confirmed, patient did receive the 2nd dose with no reactions.  Information on the lot/batch number has been requested.  Follow up (15Mar2021): New information received from the same contactable consumer (patient's mother) includes: event onset date details and confirmed that patient did receive the 2nd dose with no reactions. This is also a follow-up report to notify that the case 2021298800 and 2021025717 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 2021298800.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: HEP, HEPA, HEPA, HIBV, HPV9, HPV9, RV5, UNK, UNK, UNK, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: ROTATEQ, PEDV AX HIB, RECOMBIV AX HB, GARDASIL 9 and VAQTA that went out of range were potentially administered; No additional adverse effect reported; Information has been received from a nurse istant and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On unknown dates, the patient was potentially vaccinated with doses of the following vaccines that were out of range: hepatitis b vaccine (recombinant)(RECOMBIVAX HB), lot # R028529 and expiration date of 09-JUN-2021, lot # T004378 and expiration date of 01-NOV-2022 and lot # R021372 and expiration date of 25-MAY-2021, hepatitis a vaccine, inactivated(VAQTA) lot # T020442 and expiration date of 26-JAN-2022 and lot # T014835 and expiration date of 17-JUL-2021, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T001208 and expiration date of 09-JUN-2022 and lot # T020615 and expiration date of 13-MAR-2023, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number 1621926 and expiration date of 28-NOV-2021 and lot # 1602284 and expiration date of 26-SEP-2021 (route of administration and anatomical location were not reported) and with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1676322 and expiration date of 21-APR-2021, lot # 1688822 and expiration date of 20-NOV-2021 and lot # 1691301 and expiration date of 12-DEC-2021 per oral route, all for prophylaxis, which were stored in the following ranges: 9 Celsius degrees to 25 Celsius degrees (8.53 Celsius degrees) for 15 minutes and 9 Celsius degrees to 25 Celsius degrees (11.6 Celsius degrees) for 45 minutes.  No previous temperature excursion was reported. No additional adverse effects were reported.  Digital data logger was involved.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2103USA003717: US-009507513-2103USA005236: US-009507513-2103USA005238: US-009507513-2103USA005239: US-009507513-2103USA005240: US-009507513-2103USA005241: US-009507513-2103USA005234: US-009507513-2103USA005233: US-009507513-2103USA005235:
Sex: U
Vaccine: HEP, HEPA, HEPA, HIBV, HPV9, HPV9, RV5
Symptoms: Product storage error
Clinical narrative: ROTATEQ, PEDV AX HIB, RECOMBIV AX HB, GARDASIL 9 and VAQTA that went out of range were potentially administered; No additional adverse effect reported; Information has been received from a nurse istant and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On unknown dates, the patient was potentially vaccinated with doses of the following vaccines that were out of range: hepatitis b vaccine (recombinant)(RECOMBIVAX HB), lot # R028529 and expiration date of 09-JUN-2021, lot # T004378 and expiration date of 01-NOV-2022 and lot # R021372 and expiration date of 25-MAY-2021, hepatitis a vaccine, inactivated(VAQTA) lot # T020442 and expiration date of 26-JAN-2022 and lot # T014835 and expiration date of 17-JUL-2021, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T001208 and expiration date of 09-JUN-2022 and lot # T020615 and expiration date of 13-MAR-2023, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number 1621926 and expiration date of 28-NOV-2021 and lot # 1602284 and expiration date of 26-SEP-2021 (route of administration and anatomical location were not reported) and with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1676322 and expiration date of 21-APR-2021, lot # 1688822 and expiration date of 20-NOV-2021 and lot # 1691301 and expiration date of 12-DEC-2021 per oral route, all for prophylaxis, which were stored in the following ranges: 9 Celsius degrees to 25 Celsius degrees (8.53 Celsius degrees) for 15 minutes and 9 Celsius degrees to 25 Celsius degrees (11.6 Celsius degrees) for 45 minutes.  No previous temperature excursion was reported. No additional adverse effects were reported.  Digital data logger was involved.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2103USA003717: US-009507513-2103USA005236: US-009507513-2103USA005237: US-009507513-2103USA005239: US-009507513-2103USA005240: US-009507513-2103USA005241: US-009507513-2103USA005234: US-009507513-2103USA005233: US-009507513-2103USA005235:
Sex: U
Vaccine: HEP, HEPA, HEPA, HIBV, HPV9, HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: ROTATEQ, PEDV AX HIB, RECOMBIV AX HB, GARDASIL 9 and VAQTA that went out of range were potentially administered; No additional adverse effect reported; Information has been received from a nurse istant and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On unknown dates, the patient was potentially vaccinated with doses of the following vaccines that were out of range: hepatitis b vaccine (recombinant)(RECOMBIVAX HB), lot # R028529 and expiration date of 09-JUN-2021, lot # T004378 and expiration date of 01-NOV-2022 and lot # R021372 and expiration date of 25-MAY-2021, hepatitis a vaccine, inactivated(VAQTA) lot # T020442 and expiration date of 26-JAN-2022 and lot # T014835 and expiration date of 17-JUL-2021, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T001208 and expiration date of 09-JUN-2022 and lot # T020615 and expiration date of 13-MAR-2023, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number 1621926 and expiration date of 28-NOV-2021 and lot # 1602284 and expiration date of 26-SEP-2021 (route of administration and anatomical location were not reported) and with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1676322 and expiration date of 21-APR-2021, lot # 1688822 and expiration date of 20-NOV-2021 and lot # 1691301 and expiration date of 12-DEC-2021 per oral route, all for prophylaxis, which were stored in the following ranges: 9 Celsius degrees to 25 Celsius degrees (8.53 Celsius degrees) for 15 minutes and 9 Celsius degrees to 25 Celsius degrees (11.6 Celsius degrees) for 45 minutes.  No previous temperature excursion was reported. No additional adverse effects were reported.  Digital data logger was involved.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2103USA003717: US-009507513-2103USA005236: US-009507513-2103USA005237: US-009507513-2103USA005238: US-009507513-2103USA005240: US-009507513-2103USA005241: US-009507513-2103USA005234: US-009507513-2103USA005233: US-009507513-2103USA005235: