chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Palpitations, SARS-CoV-2 RNA, Vertigo
Clinical narrative: Lightheadedness started right after vaccine; severe palpitations; vertigo; This is a spontaneous report from a contactable consumer (patient himself). A 27-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER8735), via an unspecified route of administration, administered in Arm Left on 29May2021 14:15 (age at vaccination: 27 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. There were on known allergies. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8735) via an unspecified route of administration, administered in Arm Left on 08May2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient had no other vaccine in four weeks nor had any other medications in two weeks. On 03Jul2021, the patient experienced lightheadedness started right after vaccine and continued for a few weeks, after 4 weeks severe palpitations rushed to urgent care and vertigo. The patient was prescribed medication for vertigo but later after going to a neural clinic, it was found to be effects of vaccine. On 12Jul2021, the patient underwent sars-cov-2 rna (nasal swab) was negative. The events resulted in physician's office and emergency room visit. The patient received Meclazine as treatment for the adverse events. The outcome of the events was not recovered. The device date was 02Aug2021.   Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Inappropriate schedule of product administration, Metabolic function test normal, White blood cell count decreased
Clinical narrative: INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; OFF LABEL USE; HEADACHES; SICKLE CELL CRISIS; BLURRED VISION; SHORTNESS OF BREATH; SLOWED HEART RATE; This spontaneous report received from a consumer concerned a 22 year old male . The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 09-AUG-2021 between 1 to 2 PM then another dose of Janssen vaccine was received around 5-6 PM for prophylactic vaccination (coded as Inappropriate schedule of vaccine administered and off label use). The batch number was not reported and has been requested. No concomitant medications were reported.  The consumer mentioned that the patient (brother) complained of having headache since and had bloodwork done which showed low white blood cell and was in sickle cell crisis. The patient also complained of reporting blurred vision, shortness of breath and slowed heart rate. The consumer stated that the patient never had sickle cell before, even though the sister (consumer herself) was with the trait. On 22-SEP-2021 patient visited emergency room and for headaches Toradol was prescribed.  Treatment medications (dates unspecified) included: ketorolac tromethamine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sickle cell crisis, headache, blurred vision, shortness of breath, and slowed heart rate, and the outcome of Inappropriate schedule of vaccine administered and off label use was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210949978-COVID-19 VACCINE AD26.COV2.S-Sickle cell crisis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dyspnoea, Headache, Heart rate, Heart rate decreased
Clinical narrative: INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; OFF LABEL USE; HEADACHES; SICKLE CELL CRISIS; BLURRED VISION; SHORTNESS OF BREATH; SLOWED HEART RATE; This spontaneous report received from a consumer concerned a 22 year old male . The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 09-AUG-2021 between 1 to 2 PM then another dose of Janssen vaccine was received around 5-6 PM for prophylactic vaccination (coded as Inappropriate schedule of vaccine administered and off label use). The batch number was not reported and has been requested. No concomitant medications were reported.  The consumer mentioned that the patient (brother) complained of having headache since and had bloodwork done which showed low white blood cell and was in sickle cell crisis. The patient also complained of reporting blurred vision, shortness of breath and slowed heart rate. The consumer stated that the patient never had sickle cell before, even though the sister (consumer herself) was with the trait. On 22-SEP-2021 patient visited emergency room and for headaches Toradol was prescribed.  Treatment medications (dates unspecified) included: ketorolac tromethamine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sickle cell crisis, headache, blurred vision, shortness of breath, and slowed heart rate, and the outcome of Inappropriate schedule of vaccine administered and off label use was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210949978-COVID-19 VACCINE AD26.COV2.S-Sickle cell crisis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Off label use, Sickle cell anaemia with crisis, Vision blurred
Clinical narrative: INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; OFF LABEL USE; HEADACHES; SICKLE CELL CRISIS; BLURRED VISION; SHORTNESS OF BREATH; SLOWED HEART RATE; This spontaneous report received from a consumer concerned a 22 year old male . The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 09-AUG-2021 between 1 to 2 PM then another dose of Janssen vaccine was received around 5-6 PM for prophylactic vaccination (coded as Inappropriate schedule of vaccine administered and off label use). The batch number was not reported and has been requested. No concomitant medications were reported.  The consumer mentioned that the patient (brother) complained of having headache since and had bloodwork done which showed low white blood cell and was in sickle cell crisis. The patient also complained of reporting blurred vision, shortness of breath and slowed heart rate. The consumer stated that the patient never had sickle cell before, even though the sister (consumer herself) was with the trait. On 22-SEP-2021 patient visited emergency room and for headaches Toradol was prescribed.  Treatment medications (dates unspecified) included: ketorolac tromethamine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sickle cell crisis, headache, blurred vision, shortness of breath, and slowed heart rate, and the outcome of Inappropriate schedule of vaccine administered and off label use was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210949978-COVID-19 VACCINE AD26.COV2.S-Sickle cell crisis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Pt lost sense of smell and taste of some foods after a couple days after getting the 2nd dose. He could taste some foods and then no taste eating certain other foods. Has no sense of smell at all. No other symptoms and is feeling fine otherwise
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test negative
Clinical narrative: Pt lost sense of smell and taste of some foods after a couple days after getting the 2nd dose. He could taste some foods and then no taste eating certain other foods. Has no sense of smell at all. No other symptoms and is feeling fine otherwise
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Gait disturbance, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Injection site pain; tiredness; leg/thigh muscle pain; stumbling when walking; leg pain; fever spiked 101.6/ 15Aug2021 her highest temperature was 100.1; This is a spontaneous report from a contactable consumer (parent). A 12-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 13Aug2021 18:30 (age at vaccination 12-years -old) as dose 1, single for covid-19 immunization. Medical history included covid-19 Prior to vaccination and no known allergies. Concomitant medication include Children's Multivitamin Gummies was taken within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Aug2021 11:00 am, patient experienced injection site pain, tiredness, leg/thigh muscle pain, stumbling when walking and leg pain, fever spiked 101.6. After treatment with Tylenol her symptoms improved. On 15Aug2021 her highest temperature was 100.1 and she has improved. AE resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature and result was 101.6 on 14Aug2021 and body temperature 100.1 on 15Aug2021. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of the events was recovered.  Follow-up attempts are completed. Batch/lot number not available for BNT162B2. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Fatigue, Gait disturbance, Myalgia, Pain in extremity
Clinical narrative: Injection site pain; tiredness; leg/thigh muscle pain; stumbling when walking; leg pain; fever spiked 101.6/ 15Aug2021 her highest temperature was 100.1; This is a spontaneous report from a contactable consumer (parent). A 12-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 13Aug2021 18:30 (age at vaccination 12-years -old) as dose 1, single for covid-19 immunization. Medical history included covid-19 Prior to vaccination and no known allergies. Concomitant medication include Children's Multivitamin Gummies was taken within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Aug2021 11:00 am, patient experienced injection site pain, tiredness, leg/thigh muscle pain, stumbling when walking and leg pain, fever spiked 101.6. After treatment with Tylenol her symptoms improved. On 15Aug2021 her highest temperature was 100.1 and she has improved. AE resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature and result was 101.6 on 14Aug2021 and body temperature 100.1 on 15Aug2021. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of the events was recovered.  Follow-up attempts are completed. Batch/lot number not available for BNT162B2. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Injection site pain; tiredness; leg/thigh muscle pain; stumbling when walking; leg pain; fever spiked 101.6/ 15Aug2021 her highest temperature was 100.1; This is a spontaneous report from a contactable consumer (parent). A 12-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 13Aug2021 18:30 (age at vaccination 12-years -old) as dose 1, single for covid-19 immunization. Medical history included covid-19 Prior to vaccination and no known allergies. Concomitant medication include Children's Multivitamin Gummies was taken within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Aug2021 11:00 am, patient experienced injection site pain, tiredness, leg/thigh muscle pain, stumbling when walking and leg pain, fever spiked 101.6. After treatment with Tylenol her symptoms improved. On 15Aug2021 her highest temperature was 100.1 and she has improved. AE resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature and result was 101.6 on 14Aug2021 and body temperature 100.1 on 15Aug2021. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of the events was recovered.  Follow-up attempts are completed. Batch/lot number not available for BNT162B2. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Injection site pain, Pain
Clinical narrative: 07/31/2021- I immediately experienced arm numbness after the shot all the way to my fingertips. I could not move my arm for 48 hours. To this day my arm feels heavy and my fingertips are completely numb. I went ahead and got second dose 08/25/2021 despite my lingering symptoms from the first dose. I had no new or worsening symptoms with Dose 2.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site hypoaesthesia, Joint range of motion decreased, Limb discomfort
Clinical narrative: 07/31/2021- I immediately experienced arm numbness after the shot all the way to my fingertips. I could not move my arm for 48 hours. To this day my arm feels heavy and my fingertips are completely numb. I went ahead and got second dose 08/25/2021 despite my lingering symptoms from the first dose. I had no new or worsening symptoms with Dose 2.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Heart rate irregular
Clinical narrative: I had a rapid heartbeat and a skipped heartbeat for 2 months. I went to my primary care physician because I was scared...I have not ever had any heart related problems. In fact I am in good health. Th; I had a rapid heartbeat and a skipped heartbeat for 2 months. I went to my primary care physician because I was scared...I have not ever had any heart related problems. In fact I am in good health. Th; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old non-pregnant female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EN6206, Expiration Date: Unknown) via an unspecified route of administration in left arm on 25Feb2021 as dose 2, single for COVID-19 immunisation. The patient's medical history included type 2 diabetes mellitus (in excellent control A1c: 6.0) and allergic to mycins from an unspecified date and unknown if ongoing. Concomitant medications included metformin, start and stop date were not reported, bifidobacterium infantis (Align) taken for an unspecified indication, start and stop date were not reported. Patient previously received first dose of (Pfizer COVID-19, Lot Number: EN6198, Expiration date: Unknown) via an unspecified route of administration in left arm on an unspecified date as dose 1, single for COVID-19 immunisation. No other vaccine taken in four weeks. No COVID prior vaccination. COVID not tested post vaccination. On an unspecified date in Mar2021, the patient experienced rapid heartbeat and a skipped heartbeat for 2 months. Patient went to her primary care physician because she was scared. Patient have not ever had any heart related problems. Infact she was in good health. The skipped heartbeat went like this boom, boom boom. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment for events. The outcome of event was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extrasystoles, Heart rate increased
Clinical narrative: I had a rapid heartbeat and a skipped heartbeat for 2 months. I went to my primary care physician because I was scared...I have not ever had any heart related problems. In fact I am in good health. Th; I had a rapid heartbeat and a skipped heartbeat for 2 months. I went to my primary care physician because I was scared...I have not ever had any heart related problems. In fact I am in good health. Th; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old non-pregnant female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EN6206, Expiration Date: Unknown) via an unspecified route of administration in left arm on 25Feb2021 as dose 2, single for COVID-19 immunisation. The patient's medical history included type 2 diabetes mellitus (in excellent control A1c: 6.0) and allergic to mycins from an unspecified date and unknown if ongoing. Concomitant medications included metformin, start and stop date were not reported, bifidobacterium infantis (Align) taken for an unspecified indication, start and stop date were not reported. Patient previously received first dose of (Pfizer COVID-19, Lot Number: EN6198, Expiration date: Unknown) via an unspecified route of administration in left arm on an unspecified date as dose 1, single for COVID-19 immunisation. No other vaccine taken in four weeks. No COVID prior vaccination. COVID not tested post vaccination. On an unspecified date in Mar2021, the patient experienced rapid heartbeat and a skipped heartbeat for 2 months. Patient went to her primary care physician because she was scared. Patient have not ever had any heart related problems. Infact she was in good health. The skipped heartbeat went like this boom, boom boom. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment for events. The outcome of event was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Cough, Dyspnoea, SARS-CoV-2 test
Clinical narrative: Pt came to ER c/o SOB, onset 4 weeks prior.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Dyspnoea, Laboratory test, SARS-CoV-2 test
Clinical narrative: Pt came to ER c/o SOB, onset 4 weeks prior.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Cough, Dyspnoea, Lung opacity
Clinical narrative: Pt came to ER c/o difficulty breathing, cough, SOB onset 1 day ago.  Pt covid positive 5 days ago.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Pt came to ER c/o difficulty breathing, cough, SOB onset 1 day ago.  Pt covid positive 5 days ago.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest X-ray, Cough, Dyspnoea, Laboratory test
Clinical narrative: Pt came to ER c/o difficulty breathing, cough, SOB onset 1 day ago.  Pt covid positive 5 days ago.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neoplasm malignant, Vaccination site discomfort
Clinical narrative: having slight discomfort at the site of injection; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: not reported, expiry date: not reported), via an unspecified route of administration on Mar2021 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced having slight discom-fort at the site of injection and reported having no other side effects. Clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: having slight discomfort at the site of injection; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: not reported, expiry date: not reported), via an unspecified route of administration on Mar2021 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced having slight discom-fort at the site of injection and reported having no other side effects. Clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neoplasm malignant
Clinical narrative: having slight discomfort at the site of injection; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: not reported, expiry date: not reported), via an unspecified route of administration on Mar2021 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced having slight discom-fort at the site of injection and reported having no other side effects. Clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: eye styes; eye inflammation; swelling of eye; This is a spontaneous report from a contactable pharmacist (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 06Sep2021 15:15 (Lot Number: FC3182) as dose 2, single at the age of 59-years-old for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. No prior other vaccinations (within 4 weeks). No family medical history relevant to the events. The patient previously took first dose of bnt162b2 (Lot Number: FA7485, Expiration Date: 30Oct2021) in right arm on 06Aug2021 05:00 PM and experienced rapid heart rate (heart rate went up to 140) on 07Aug2021 with outcome of not recovered. The patient experienced eye styes, eye inflammation, swelling of eye, all on 07Sep2021 07:00 with outcome of not recovered. Seriousness criteria for all events was disability, medically significant. AE required visit to: physician office. Relevant tests: Eye exam on 09Aug2021: Eye sty (Floaters-Eye sty).
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye inflammation, Eye swelling, Hordeolum, Ophthalmological examination
Clinical narrative: eye styes; eye inflammation; swelling of eye; This is a spontaneous report from a contactable pharmacist (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 06Sep2021 15:15 (Lot Number: FC3182) as dose 2, single at the age of 59-years-old for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. No prior other vaccinations (within 4 weeks). No family medical history relevant to the events. The patient previously took first dose of bnt162b2 (Lot Number: FA7485, Expiration Date: 30Oct2021) in right arm on 06Aug2021 05:00 PM and experienced rapid heart rate (heart rate went up to 140) on 07Aug2021 with outcome of not recovered. The patient experienced eye styes, eye inflammation, swelling of eye, all on 07Sep2021 07:00 with outcome of not recovered. Seriousness criteria for all events was disability, medically significant. AE required visit to: physician office. Relevant tests: Eye exam on 09Aug2021: Eye sty (Floaters-Eye sty).
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysstasia, Gait inability, Muscular weakness
Clinical narrative: Lost all use of legs; legs were like Jell-O; Feet are swollen; Tired; Nauseous; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: PC3182), via an unspecified route of administration on 02Sep2021 (reported given in the morning, at the age of 52-years-old) at dose 2, single in the right arm for COVID-19 immunisation. Medical history included ongoing diabetes mellitus. No vaccine was administered at the same day Pfizer COVID-19 vaccine was given. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number reported as being either FA7435 or FA7485) received on 03Aug2021 (at the age of 52-years-old) at dose 1, single in the right arm for COVID-19 immunisation and experienced COVID-19 a week after the first dose vaccination and was admitted to a hospital for 4 days. The patient underwent COVID-19 test on Aug2021 with positive result. The patient had a doctor's appointment on 03Sep2021 and walked fine into that appointment. Then on 04Sep2021, 2 days after the vaccination, the patient lost all use of his leg. The patient stated that his legs were like Jell-O. The patient's feet are swollen 04Sep2021. Due to these, the patient went to the hospital. He was not admitted and came home the same day. The patient stated that these are getting better as time goes on. On Sep2021, the patient experienced tired and nauseous. The patient stated that these lasted for about 24 hours and then was gone. It was reported that the events "lost all use of legs", "legs were like Jello-O", and "feet are swollen" resulted in emergency room visit, and the events "lost all use of legs" and "legs were like Jello-O" also resulted in physician office visit. Outcome of the events "lost all use of legs", "legs were like Jello-O", and "feet are swollen" was recovering, and for events "tired" and "nauseous" was recovered on Sep2021.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Motor dysfunction, Muscular weakness, Nausea, Peripheral swelling
Clinical narrative: Lost all use of legs; legs were like Jell-O; Feet are swollen; Tired; Nauseous; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: PC3182), via an unspecified route of administration on 02Sep2021 (reported given in the morning, at the age of 52-years-old) at dose 2, single in the right arm for COVID-19 immunisation. Medical history included ongoing diabetes mellitus. No vaccine was administered at the same day Pfizer COVID-19 vaccine was given. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number reported as being either FA7435 or FA7485) received on 03Aug2021 (at the age of 52-years-old) at dose 1, single in the right arm for COVID-19 immunisation and experienced COVID-19 a week after the first dose vaccination and was admitted to a hospital for 4 days. The patient underwent COVID-19 test on Aug2021 with positive result. The patient had a doctor's appointment on 03Sep2021 and walked fine into that appointment. Then on 04Sep2021, 2 days after the vaccination, the patient lost all use of his leg. The patient stated that his legs were like Jell-O. The patient's feet are swollen 04Sep2021. Due to these, the patient went to the hospital. He was not admitted and came home the same day. The patient stated that these are getting better as time goes on. On Sep2021, the patient experienced tired and nauseous. The patient stated that these lasted for about 24 hours and then was gone. It was reported that the events "lost all use of legs", "legs were like Jello-O", and "feet are swollen" resulted in emergency room visit, and the events "lost all use of legs" and "legs were like Jello-O" also resulted in physician office visit. Outcome of the events "lost all use of legs", "legs were like Jello-O", and "feet are swollen" was recovering, and for events "tired" and "nauseous" was recovered on Sep2021.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Lost all use of legs; legs were like Jell-O; Feet are swollen; Tired; Nauseous; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: PC3182), via an unspecified route of administration on 02Sep2021 (reported given in the morning, at the age of 52-years-old) at dose 2, single in the right arm for COVID-19 immunisation. Medical history included ongoing diabetes mellitus. No vaccine was administered at the same day Pfizer COVID-19 vaccine was given. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number reported as being either FA7435 or FA7485) received on 03Aug2021 (at the age of 52-years-old) at dose 1, single in the right arm for COVID-19 immunisation and experienced COVID-19 a week after the first dose vaccination and was admitted to a hospital for 4 days. The patient underwent COVID-19 test on Aug2021 with positive result. The patient had a doctor's appointment on 03Sep2021 and walked fine into that appointment. Then on 04Sep2021, 2 days after the vaccination, the patient lost all use of his leg. The patient stated that his legs were like Jell-O. The patient's feet are swollen 04Sep2021. Due to these, the patient went to the hospital. He was not admitted and came home the same day. The patient stated that these are getting better as time goes on. On Sep2021, the patient experienced tired and nauseous. The patient stated that these lasted for about 24 hours and then was gone. It was reported that the events "lost all use of legs", "legs were like Jello-O", and "feet are swollen" resulted in emergency room visit, and the events "lost all use of legs" and "legs were like Jello-O" also resulted in physician office visit. Outcome of the events "lost all use of legs", "legs were like Jello-O", and "feet are swollen" was recovering, and for events "tired" and "nauseous" was recovered on Sep2021.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Deafness neurosensory, Deafness unilateral, Dizziness, Nausea
Clinical narrative: hearing loss in right ear; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 04Sep2021 12:30 (at the age of 62-year-old) (Batch/Lot Number: FC3184) as dose 2, single for covid-19 immunisation. Medical history included diabetes, high blood pressure, left nephrectomy and known allergies: peanuts. The patient was not pregnant. Concomitant medications included hydralazine, losartan, and metoprolol. The patient previously took Demerol and morphine and experienced allergies. The patient received first dose of bnt162b2 for covid-19 immunisation on 14Aug2021. On 05Sep2021 08:00, the patient experienced hearing loss in right ear. It was reported that the patient woke up the next morning with hearing loss in right ear. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and assessed as disability or permanent damage. Therapy for the event included prednisone. There was no other vaccine in four weeks. The patient had no covid prior vaccination and was not covid tested post vaccination. Outcome of event was not recovered.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Tympanometry
Clinical narrative: hearing loss in right ear; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 04Sep2021 12:30 (at the age of 62-year-old) (Batch/Lot Number: FC3184) as dose 2, single for covid-19 immunisation. Medical history included diabetes, high blood pressure, left nephrectomy and known allergies: peanuts. The patient was not pregnant. Concomitant medications included hydralazine, losartan, and metoprolol. The patient previously took Demerol and morphine and experienced allergies. The patient received first dose of bnt162b2 for covid-19 immunisation on 14Aug2021. On 05Sep2021 08:00, the patient experienced hearing loss in right ear. It was reported that the patient woke up the next morning with hearing loss in right ear. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and assessed as disability or permanent damage. Therapy for the event included prednisone. There was no other vaccine in four weeks. The patient had no covid prior vaccination and was not covid tested post vaccination. Outcome of event was not recovered.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral
Clinical narrative: hearing loss in right ear; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 04Sep2021 12:30 (at the age of 62-year-old) (Batch/Lot Number: FC3184) as dose 2, single for covid-19 immunisation. Medical history included diabetes, high blood pressure, left nephrectomy and known allergies: peanuts. The patient was not pregnant. Concomitant medications included hydralazine, losartan, and metoprolol. The patient previously took Demerol and morphine and experienced allergies. The patient received first dose of bnt162b2 for covid-19 immunisation on 14Aug2021. On 05Sep2021 08:00, the patient experienced hearing loss in right ear. It was reported that the patient woke up the next morning with hearing loss in right ear. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and assessed as disability or permanent damage. Therapy for the event included prednisone. There was no other vaccine in four weeks. The patient had no covid prior vaccination and was not covid tested post vaccination. Outcome of event was not recovered.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: she had a sore arm after the vaccine on the injection site; This is a spontaneous report from a contactable consumer (patient) from a sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 20Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she had a sore arm after the vaccine on the injection site on Feb2021. Outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood urine present
Clinical narrative: she had a sore arm after the vaccine on the injection site; This is a spontaneous report from a contactable consumer (patient) from a sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 20Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she had a sore arm after the vaccine on the injection site on Feb2021. Outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Age: 88.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Biopsy skin normal, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Rash on back of my body and has progressed to arms, breast, neck (front and back), chest and face; itching is very bad; This is a spontaneous report from a contactable consumer (patient). This 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06May2021 at 10:00 AM, at the age of 88 years, as the first single dose, in left arm, for COVID-19 immunization. No other vaccine was administered in four weeks. Medical history included penicillin allergy, sulfa allergy and COVID-19 prior vaccination. The patient was not pregnant. Concomitant medications were not reported. On 17May2021 at 09:00 the patient experienced rash and itching. Rash developed 10 days after the first vaccine on back of her body and had progressed to arms, breast, neck (front and back), chest and face. Itching was very bad. The events resulted in Doctor or other healthcare professional office/clinic visit and required treatment with cream to put on rash and steroid shot. The patient received the second dose of vaccine on 28May2021. Rash was still on body after 4 months. COVID was not tested after vaccination. The events had not yet resolved.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101210733 same pt/drug, event from diff dose
Age: 88.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash on back of my body and has progressed to arms, breast, neck (front and back), chest and face; itching is very bad; This is a spontaneous report from a contactable consumer (patient). This 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06May2021 at 10:00 AM, at the age of 88 years, as the first single dose, in left arm, for COVID-19 immunization. No other vaccine was administered in four weeks. Medical history included penicillin allergy, sulfa allergy and COVID-19 prior vaccination. The patient was not pregnant. Concomitant medications were not reported. On 17May2021 at 09:00 the patient experienced rash and itching. Rash developed 10 days after the first vaccine on back of her body and had progressed to arms, breast, neck (front and back), chest and face. Itching was very bad. The events resulted in Doctor or other healthcare professional office/clinic visit and required treatment with cream to put on rash and steroid shot. The patient received the second dose of vaccine on 28May2021. Rash was still on body after 4 months. COVID was not tested after vaccination. The events had not yet resolved.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101210733 same pt/drug, event from diff dose
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Hospitalized 9/28/21 - Recent hospitalization at outside hospital where symptoms initially started on 9/10/2021 it was noted to be COVID-19 positive on 9/15/2021.  Patient did receive Johnson & Johnson vaccine in April 2021.  Patient completed 5 days of remdesivir on 9/21/2021 along with 8 out of 10 days of Decadron.  Her hospital course was complicated by staph hominis bacteremia and concerns for port infection.  Her port was removed on 9/22/2021.   Patient was discharged to complete dexamethasone.  Patient states that she had been doing well up until 9/27.  She began having joint pain in which she thought was secondary to the weather but then shortly after she had chills, nausea headache and a fever of 102.  9/28 she reports waking up and feeling more short of breath therefore she checked her O2 saturation and it was noted to be 77%.  CTA of chest shows extensive bilateral infiltrates consistent with COVID-19 pneumonia.  No evidence of pulmonary embolus
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Arthralgia, COVID-19, COVID-19 pneumonia, Chills
Clinical narrative: Hospitalized 9/28/21 - Recent hospitalization at outside hospital where symptoms initially started on 9/10/2021 it was noted to be COVID-19 positive on 9/15/2021.  Patient did receive Johnson & Johnson vaccine in April 2021.  Patient completed 5 days of remdesivir on 9/21/2021 along with 8 out of 10 days of Decadron.  Her hospital course was complicated by staph hominis bacteremia and concerns for port infection.  Her port was removed on 9/22/2021.   Patient was discharged to complete dexamethasone.  Patient states that she had been doing well up until 9/27.  She began having joint pain in which she thought was secondary to the weather but then shortly after she had chills, nausea headache and a fever of 102.  9/28 she reports waking up and feeling more short of breath therefore she checked her O2 saturation and it was noted to be 77%.  CTA of chest shows extensive bilateral infiltrates consistent with COVID-19 pneumonia.  No evidence of pulmonary embolus
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Headache, Lung infiltration, Nausea, Pyrexia
Clinical narrative: Hospitalized 9/28/21 - Recent hospitalization at outside hospital where symptoms initially started on 9/10/2021 it was noted to be COVID-19 positive on 9/15/2021.  Patient did receive Johnson & Johnson vaccine in April 2021.  Patient completed 5 days of remdesivir on 9/21/2021 along with 8 out of 10 days of Decadron.  Her hospital course was complicated by staph hominis bacteremia and concerns for port infection.  Her port was removed on 9/22/2021.   Patient was discharged to complete dexamethasone.  Patient states that she had been doing well up until 9/27.  She began having joint pain in which she thought was secondary to the weather but then shortly after she had chills, nausea headache and a fever of 102.  9/28 she reports waking up and feeling more short of breath therefore she checked her O2 saturation and it was noted to be 77%.  CTA of chest shows extensive bilateral infiltrates consistent with COVID-19 pneumonia.  No evidence of pulmonary embolus
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Staphylococcal bacteraemia
Clinical narrative: Hospitalized 9/28/21 - Recent hospitalization at outside hospital where symptoms initially started on 9/10/2021 it was noted to be COVID-19 positive on 9/15/2021.  Patient did receive Johnson & Johnson vaccine in April 2021.  Patient completed 5 days of remdesivir on 9/21/2021 along with 8 out of 10 days of Decadron.  Her hospital course was complicated by staph hominis bacteremia and concerns for port infection.  Her port was removed on 9/22/2021.   Patient was discharged to complete dexamethasone.  Patient states that she had been doing well up until 9/27.  She began having joint pain in which she thought was secondary to the weather but then shortly after she had chills, nausea headache and a fever of 102.  9/28 she reports waking up and feeling more short of breath therefore she checked her O2 saturation and it was noted to be 77%.  CTA of chest shows extensive bilateral infiltrates consistent with COVID-19 pneumonia.  No evidence of pulmonary embolus
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Headache-Mild, Systemic: Vomiting-Mild
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site pain, Vomiting
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Headache-Mild, Systemic: Vomiting-Mild
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Loss of personal independence in daily activities, Mental disorder, Photopsia, Vitreous floaters
Clinical narrative: Seeing a round black speck stuck in the center of my right eye's vision; Little white lights that flash and float around when I go out in daylight or look at black surfaces; Hard to see from my right eye; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FP7533; Expiration date was not reported) on the right arm on 06Apr2021 (18:45) as dose 1, single, with route of administration unspecified date, for COVID-19 immunization at the pharmacy/drug store. Medical history included asthma. The patient's concomitant medications were not reported. On 17Apr2021 (22:00), the patient had was seeing a round black speck stuck in the center of the right eye's vision; had little white lights that flashed and floated around when the patient went out in daylight or look at black surfaces; and it was hard to see from the right eye. The events had led to doctor or other healthcare professional office/clinic visit, and were reported to be serious (causing disability or permanent damage). The patient did not receive any treatment for the events. the outcome of the events was not recovered. The patient did not have COVID-19 prior to vaccination, and was not tested post-vaccination. The patient had received the second dose of vaccination on 30Apr2021.  Follow-up attempts are completed. No further information is expected.