chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Pain, redness and swelling at the injection site; Pain, redness and swelling at the injection site; Pain, redness and swelling at the injection site. Swelling is about 4" in diameter; Feels warm to the touch even after 3 days after injection; Booster dose; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 29Oct2021 at 19:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of on an unknown date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 30Oct2021, the patient experienced pain, redness and swelling at the injection site. The swelling was about 4" in diameter and felt warm to the touch even after 3 days after injection. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain, redness and swelling at the injection site were unknown, while the clinical outcome of the events felt warm to the touch even after 3 days after injection was not resolved at the time of this report.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: death; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced death on an unspecified date. It was reported as what chemicals are in it that killed my mother. The patient died on an unspecified date.  It was not reported if an autopsy was performed. Case was reported as serious medically significant.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: death
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen and painful lymph nodes armpit; Painful lymph nodes armpit; Booster dose; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the left arm on 27Oct2021 at 15:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. It was not reported if the patient received any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 22Mar2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation and also the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 12Apr2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 28Oct2021 at 04:00, the patient experienced swollen and painful lymph nodes in armpit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swollen and painful lymph nodes armpit was not resolved at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died as a result of the Pfizer BioNTech Covid-19 vaccine; This is a spontaneous report from a contactable consumer received from a Pfizer sponsored program. A 39-year-old male patient (consumer neighbor's son) received BNT162B2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient died as a result of the Pfizer BioNTech Covid-19 vaccine on an unspecified date. It was not reported if an autopsy was performed.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: died as a result of the Pfizer BioNTech Covid-19 vaccine
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gastrointestinal haemorrhage, Rectal haemorrhage
Clinical narrative: Had a bleeding on the rectum, GI bleeding; Had a bleeding on the rectum, GI bleeding; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization and received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications was not reported. On an unspecified date the patient reported she had a bleeding on the rectum, GI bleeding. She was supposed to get the booster dose as well and she has a question regarding the booster dose. The outcome of the events was reported as unknown.  This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Immune system disorder, Overweight, Rectal haemorrhage
Clinical narrative: Had a bleeding on the rectum, GI bleeding; Had a bleeding on the rectum, GI bleeding; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization and received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications was not reported. On an unspecified date the patient reported she had a bleeding on the rectum, GI bleeding. She was supposed to get the booster dose as well and she has a question regarding the booster dose. The outcome of the events was reported as unknown.  This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Body ache; Chills; Fatigue; Weakness; Lightheaded; Nausea; Headache; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable pharmacist, the patient. A 60-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 29Oct2021 at 15:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to vaccination. Concomitant medications included calcium (MANUFACTURER UNKNOWN), ergocalciferol (VITAMIN D) and unspecified multivitamin with minerals; all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received bacitracin (MANUFACTURER UNKNOWN), neomycin (MANUFACTURER UNKNOWN) and cefalexin (CEPHALEXIN) and experienced drug allergy with all these medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified rout of administration in the left arm on 22Dec2020 (at the age of 59-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the left arm on 12Jan2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. On 30Oct2021 at 13:00, the patient experienced body ache, chills, fatigue, weakness, lightheaded, nausea and headache lasting into 01Nov2021, the third day, post vaccine. If scheduled to work, the patient would have needed 2 days off, he was a hospital worker. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body ache, chills, fatigue, weakness, lightheaded, nausea and headache were resolving at the time of this report.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Nausea, Pain
Clinical narrative: Body ache; Chills; Fatigue; Weakness; Lightheaded; Nausea; Headache; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable pharmacist, the patient. A 60-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 29Oct2021 at 15:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to vaccination. Concomitant medications included calcium (MANUFACTURER UNKNOWN), ergocalciferol (VITAMIN D) and unspecified multivitamin with minerals; all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received bacitracin (MANUFACTURER UNKNOWN), neomycin (MANUFACTURER UNKNOWN) and cefalexin (CEPHALEXIN) and experienced drug allergy with all these medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified rout of administration in the left arm on 22Dec2020 (at the age of 59-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the left arm on 12Jan2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. On 30Oct2021 at 13:00, the patient experienced body ache, chills, fatigue, weakness, lightheaded, nausea and headache lasting into 01Nov2021, the third day, post vaccine. If scheduled to work, the patient would have needed 2 days off, he was a hospital worker. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body ache, chills, fatigue, weakness, lightheaded, nausea and headache were resolving at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Neoplasm malignant
Clinical narrative: cancer; Neck was stiff; headache; This is a solicited report based on information received by Pfizer from Johnson & Johnson (Manufacturer control number: 20211019864(0.0)), from an adult female via #: Jansen Database for XARELTO, reporting herself.   A contactable consumer (patient) reported that an adult female patient received bnt162b2 (BNT162B2, reported as "Covid-19 vaccine"), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation; rivaroxaban (RIVAROXABAN, film-coated tablet, oral), via oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for product used for unknown indication. The patient medical history and concomitant medications were not reported. Patient reported that, on an unknown date, she was diagnosed with cancer and also stated that she got a covid shot and her neck was stiff and she had a headache. She was not sure if it was from the shot or not though. The action taken in response to the events for rivaroxaban was unknown. The patient recovered from neck was stiff, and headache, and the outcome of cancer was not reported.  The reporter considered the causality between rivaroxaban and cancer as not related. The reporter did not provide a causality assessment between rivaroxaban and neck was stiff and headache. Company causality between rivaroxaban and cancer, neck was stiff was not related and between rivaroxaban and headache was related. This report was serious (Life Threatening).  The reporter's assessment of the causal relationship of the events with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event (neck was stiff, headache, cancer) and the suspect vaccine BNT162B2 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Altered state of consciousness, Visual impairment, Weight
Clinical narrative: consciousness is different or changed/something in my brain is changed or different, not all there; visually impaired; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included, thyroid disorder from an unknown date and unknown if ongoing, patient also added she has always been the weight of a child 97-103 lbs due to a thyroid problem and was visually impaired. The patient's concomitant medications were not reported. The patient had previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 1, on an unspecified date for covid-19 immunization and was fine. On an unspecified date, the patient reported her side effect is getting worse over time, her consciousness is different or changed, real debilitating. Its like it's not all there, something in my brain is changed or different, not all there and visually impaired. The patient has a tele-interview with her doctor today at 10:30 where they will do a pre-screen. Confirmed no medical inquiry. The patient underwent lab tests and procedures which included weight: 97-103 lbs. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Immunisation, Pain in extremity
Clinical narrative: Sore arm; Chills; Joint pain; Headache; Booster; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old male patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 01Nov2021, (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. It was unknown whether, the patient received any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 22Jan2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 12Feb2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 02Nov2021, the patient experienced sore arm, chills, joint pain and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of events. The clinical outcome of the events sore arm, chills, joint pain and headache were resolving at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Heavy menstrual bleeding, Muscle spasms, Pain
Clinical narrative: Fever; Chills; Aches; Sore arm; Lots of menstrual bleeding; Cramps; Stomach pain; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 23Oct2021 at 12:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. Concomitant medications taken within two weeks of vaccination included ethinylestradiol, norethisterone (LEENA-28) for birth control on an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Oct2021 at 20:00, the patient experienced fever, chills, aches, sore arm. The patient had lots of menstrual bleeding, cramps and stomach pain. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, chills, aches, sore arm, lots of menstrual bleeding, cramps and stomach pain was not resolved at the time of this report.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever; Chills; Aches; Sore arm; Lots of menstrual bleeding; Cramps; Stomach pain; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 23Oct2021 at 12:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. Concomitant medications taken within two weeks of vaccination included ethinylestradiol, norethisterone (LEENA-28) for birth control on an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Oct2021 at 20:00, the patient experienced fever, chills, aches, sore arm. The patient had lots of menstrual bleeding, cramps and stomach pain. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, chills, aches, sore arm, lots of menstrual bleeding, cramps and stomach pain was not resolved at the time of this report.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Decreased appetite, Diarrhoea, Fatigue, Headache
Clinical narrative: Arm hurt from shoulder to wrist; Headache; Diarrhea; Loss of appetite; Chest pain; Tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Oct2021 at 11:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included hydrochlorothiazide, losartan (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Mar2021 at 19:00 (at the age of 51-years-old) and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Mar2021 at 19:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 31Oct2021 at 12:00, the patients arm hurt from shoulder to wrist, she had headache, diarrhea, loss of appetite, chest pain and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events arm hurt from shoulder to wrist, headache, diarrhea, loss of appetite, chest pain and tiredness was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm hurt from shoulder to wrist; Headache; Diarrhea; Loss of appetite; Chest pain; Tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Oct2021 at 11:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included hydrochlorothiazide, losartan (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Mar2021 at 19:00 (at the age of 51-years-old) and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Mar2021 at 19:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 31Oct2021 at 12:00, the patients arm hurt from shoulder to wrist, she had headache, diarrhea, loss of appetite, chest pain and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events arm hurt from shoulder to wrist, headache, diarrhea, loss of appetite, chest pain and tiredness was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Slight stiffness after injection; This is a spontaneous report from a Pfizer-sponsored Program Pfizer from a contact-able consumer or other non hcp. Upon Fu date (08Mar2021) case was upgraded to valid. A 72-year-old female patient received second dose received from BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6193), via intramuscular route, administered in left arm on 21Feb2021 as dose 2, single for COVID-19 immunisation. Medical history included asthma from 01Aug1974 and ongoing no hospitalization or ER ever, cardiomyopathy Non-Ischemic Cardiomyopathy from 30May2008 and ongoing with angiogram- no blockage, atrial fibrillation from 04Oct2014 and ongoing (2 weeks after my husband died and stress related). The patient's concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EM9810), via intramuscular route, administered in right arm on 06Feb2021 at 14:00 as dose 1, single for COVID-19 immunisation. On an unspecified date on Mar2021, the patient experienced slight stiffness after injection 02. No noticeable rise in temperature, aches, pains, tiredness or headache after both shots (Last one almost 48 hours ago). The outcome of the event unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nasal congestion, Rhinorrhoea
Clinical narrative: runny nose; tiredness; congestion; chills; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient) via medical information team.  A 68-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, lot number: not reported), via an unspecified route of administration on an unspecified date (3 weeks ago), as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced runny nose, tiredness, congestion and chills. Reporter asked whether she could take the Johnson and Johnson, Covid-19 for her second vaccination. The outcome of the event was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: After receiving both doses, my skin has cleared up / skin got better; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered on an unspecified date (Batch/ lot number and expiration date were not reported) as dose 1, single and administered on an unspecified date (Batch/ lot number and expiration date were not reported) as dose 2, single both via unspecified route of administration and for COVID-19 immunisation. Medical history included hypereosinophilic syndrome and rash (had 50 percent rash all over her body before getting the shot). The patient's concomitant medications were not reported. It was reported that the patient heard about all the new mutating variants of COVID virus in various countries and was querying if she needed to take a booster shot to be protected against the new variants. The patient wanted to know if the Pfizer vaccine studied and shown effectiveness against these new variants as she was concerned that she maybe more susceptible due to her pre-existing condition. It was also reported that she heard these variants can infiltrate antibodies; she stated that she called after receiving the first shot to report some good side effects; and that she was sent a document by mail in which she was surprised it got to her despite the fact they had her name and her city spelled wrong. It was reported that the patient was diagnosed with hypereosinophilic syndrome and had 50 percent all over her body before getting the shot. On an unspecified date after receiving both doses, the patient's skin has cleared up; it was reported that the lady who vaccinated her noticed her skin got better. It was reported that she was extremely happy and wanted this to be studied further as this disease was rare. The 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Feeling abnormal
Clinical narrative: Brain fog; Confusion; This is a spontaneous report from a contactable nurse (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the left arm) on 30Dec2020 at 16:00 (at the age of 44-years-old) as dose 1, single for COVID-19 immunisation. Medical history included type 1 diabetes and hypothyroid. The patient has no known allergies. Concomitant medications included insulin, levothyroxine, amitriptyline hydrochloride (AMITRIPTYLIN), and escitalopram all taken for an unspecified indication, start and stop date were not reported. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine and has not been diagnosed with COVID-19 prior vaccination. On an unspecified date, the patient experienced brain fog and confusion. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date with duration of 4 weeks. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the right arm) on 20Jan2021 (at the age of 44-years-old) for COVID-19 immunisation. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Vaccination site pain
Clinical narrative: Soreness at injection site (left arm); mild left hand muscle cramping; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL3247), via an unspecified route of administration, administered in left arm on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications in two weeks. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The facility where the most recent COVID-19 vaccine was administered was reported as workplace clinic. On 25Feb2021, the patient experienced soreness at injection site (left arm) and mild left hand muscle cramping. Patient received no treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Body temperature increased, Chest pain
Clinical narrative: temp and it was 101.6; very tired; feel achy (shoulders, upper back and chest); feel achy (shoulders, upper back and chest); feel achy (shoulders, upper back and chest); feel achy (shoulders, upper back and chest); slight pain at injection site; This is a spontaneous report from a contactable consumer (patient) received via COVAES. A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 25Feb2021 at 16:00 (Batch/Lot Number: EN6202) (at the age of 55 years old) as dose number unknown, single for COVID-19 immunisation. Medical history included was diagnosed with COVID-19 prior to vaccination. The patient had not been tested with COVID-19 since the vaccination. The patient had no known allergies. Concomitant medications included VITAMIN D, 5000 IU; "statin 20 mg; both taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccines in 4 weeks. The patient experienced slight pain at injection site on 26Feb2021 at 07:00; feel achy (shoulders, upper back and chest) on 26Feb2021 at 09:00; very tired on 26Feb2021 at 19:00; temp and it was 101.6 on 26Feb2021 at 20:00. The course of the events was as follows: Shot 25Feb2021 at 16:00. No issue that day. 26Feb2021 at 7:00 am slight pain at injection site. 9:00 am began to feel achy (shoulders, upper back and chest. Took temp, was 98.7. Took 800 mg Ibuprofen at 11:00, laid down from 11:30-noon. Got up felt good by 15:30 pm no aches only injection site pain but less than in the am. Took a nap at 15:30 and stayed in bed till 19:00, very tired. Got up had dinner and right after felt achy again. Laid on couch with two blankets. 20:00 took temp and it was 101.6. Took 800 mg Ibuprofen. The outcome of event slight pain at injection site was recovering; while outcome for events feel achy (shoulders, upper back and chest), very tired and temp and it was 101.6 was unknown. No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: temp and it was 101.6; very tired; feel achy (shoulders, upper back and chest); feel achy (shoulders, upper back and chest); feel achy (shoulders, upper back and chest); feel achy (shoulders, upper back and chest); slight pain at injection site; This is a spontaneous report from a contactable consumer (patient) received via COVAES. A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 25Feb2021 at 16:00 (Batch/Lot Number: EN6202) (at the age of 55 years old) as dose number unknown, single for COVID-19 immunisation. Medical history included was diagnosed with COVID-19 prior to vaccination. The patient had not been tested with COVID-19 since the vaccination. The patient had no known allergies. Concomitant medications included VITAMIN D, 5000 IU; "statin 20 mg; both taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccines in 4 weeks. The patient experienced slight pain at injection site on 26Feb2021 at 07:00; feel achy (shoulders, upper back and chest) on 26Feb2021 at 09:00; very tired on 26Feb2021 at 19:00; temp and it was 101.6 on 26Feb2021 at 20:00. The course of the events was as follows: Shot 25Feb2021 at 16:00. No issue that day. 26Feb2021 at 7:00 am slight pain at injection site. 9:00 am began to feel achy (shoulders, upper back and chest. Took temp, was 98.7. Took 800 mg Ibuprofen at 11:00, laid down from 11:30-noon. Got up felt good by 15:30 pm no aches only injection site pain but less than in the am. Took a nap at 15:30 and stayed in bed till 19:00, very tired. Got up had dinner and right after felt achy again. Laid on couch with two blankets. 20:00 took temp and it was 101.6. Took 800 mg Ibuprofen. The outcome of event slight pain at injection site was recovering; while outcome for events feel achy (shoulders, upper back and chest), very tired and temp and it was 101.6 was unknown. No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired/fatigue; This is a spontaneous report from a contactable consumer.   A 81-year-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9266) via an unspecified route of administration on 19Feb2021 (at the age of 81 years old) as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Patient had no concomitant medications. The patient previously received BNT162B2 on 29Jan2021 (Lot number: EL9265) as dose 1, single (at the age of 81 years old) for COVID-19 immunisation. On an unspecified date, the patient experienced tired/fatigue with outcome of unknown. No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back was hurting/back pain; This is a spontaneous report from a contactable consumer (patient's mother). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. On an unspecified date, the patient's back was hurting and missed 2 days of work due to back pain. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fine motor skill dysfunction, Myalgia, Pain in extremity
Clinical narrative: loss of fine motor skills in left hand; severe muscle pain below left elbow radiating down into left hand; loss of strength/hard to grip things safely; severe muscle pain below left elbow radiating down into left hand; This is a spontaneous report from a contactable consumer (patient).   A 57-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported) via an unspecified route of administration, administered in arm left on 20Feb2021 (at the age of 57 years) as dose 2, single for COVID-19 immunization. Medical history included diabetes from an unknown date and unknown if ongoing. The patient had no known allergies. The patient had not experienced covid prior vaccination and the patient had not covid tested post vaccination. No other vaccine was administered in four weeks. The patient received other medications (unspecified) in two weeks. Specific concomitant medication was not reported. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported) via an unspecified route of administration, administered in arm left on 30Jan2021 (at the age of 57 years) as dose 1, single for COVID-19 immunization and the patient experienced severe pain. On 23Feb2021 at 12:00 the patient experienced loss of fine motor skills in left hand, loss of strength/hard to grip things safely, severe muscle pain below left elbow radiating down into left hand. The patient reported that now after dose number two he was experiencing severe muscle pain below left elbow radiating down into left hand. The patient also had a loss of strength and a loss of fine motor skills in her left hand. He found it hard to grip things safely. The patient did not receive treatment for adverse event. The outcome of the events was not recovered.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained. Information on the lot/batch number has been requested.
Age: 10.0
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event, Product dose omission issue, Product origin unknown
Clinical narrative: Paient who was only administered the 1st dose from an unknown HPV vaccine dose series at age 10 years and had missed the remaining corresponding HPV vaccine doses for completing the series; Had missed the remaining corresponding HPV vaccine doses necesary for completing HPV vaccine dose series; No additional AE; Product origin unknown; This spontaneous report was received from a physician referring to a 23-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were not reported.     On an unknown date at the patient's age of 10 years old, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, anatomical location, route of administration, lot #, and expiration date were not reported).       The patient was only administered the 1st dose and had missed the remaining corresponding HPV vaccine doses necessary for completing the HPV vaccine dose series (inappropriate schedule of product administration, product origin unknown and product dose omission).  No adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: recalled shingrix lot was given; recalled shingrixlot was given; This case was reported by a pharmacist via call center representative and described the occurrence of recalled drug administered in a patient who received Herpes zoster (Shingrix) (batch number 9lh3y, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details provided were as follows: Age at vaccination was not reported. Registered pharmacist reported that recalled Shingrix was administered to  patient, which led to recalled drug administered and drug dispensing error. The lot was recalled on 10th February 2021. Health care professional did not have any other details of date of administration. No other information of patient or vaccine available. Reporter did not consented to follow-up. This case was 1 of the 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR226053:same reporter US-GLAXOSMITHKLINE-US2021AMR226054:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: FINGER ARTHRITIS LOOKED LIKE SAUSAGES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced finger arthritis looked like sausages. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from finger arthritis looked like sausages. This report was non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: arm hurt; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt) and FATIGUE (feeling tired) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt) and FATIGUE (feeling tired). On 31-Mar-2021, PAIN IN EXTREMITY (arm hurt) and FATIGUE (feeling tired) had resolved.            No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-366442, MOD-2021-366464 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: The follow up received it contain no new information.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: Had a temperature; Her arm was sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Her arm was sore) and PYREXIA (Had a temperature) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 024M20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Her arm was sore). On 26-Oct-2021, the patient experienced PYREXIA (Had a temperature). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) in October 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Her arm was sore) and PYREXIA (Had a temperature) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Oct-2021, Body temperature: 99 (High) Wife had a temperature of 99°F. On 27-Oct-2021, Body temperature: 101 (High) Wife has a temperature of 101°F.         Concomitant medication list was not provided.