chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Immune thrombocytopenia, Platelet count, Thrombocytopenia
Clinical narrative: thrombocytopenia/After second dose, platelet count on 9/23/21 was 21000; Recurrent ITP; Recurrent ITP; This is a spontaneous report from a contactable other HCP (nurse) who reported for a patient.  A 31-year-old male patient received BNT162B2 (COMIRNATY), intramuscularly on 20Sep2021 (Lot Number: 301308a) at the age of 31-year-old, as dose 2, single for COVID-19 immunization. The vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Medical history included Immune thrombocytopenic purpura (ITP). The patient had no known allergies. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY, Lot number=FC3184), administered intramuscularly on 29Aug2021 at the age of 31-year-old as dose 1 single for COVID-19 immunization. The patient experienced thrombocytopenia/after second dose covid shot. Platelet count on 17Sep2021 was 141000. After second dose, platelet count on 23Sep2021 was 21000. The patient had recurrent ITP on 23Sep2021 after Covid vaccination. The events were reported as non serious. The events resulted in Doctor or other healthcare professional office/clinic visit and required treatment with Rituxan. The outcome of the events was unknown.; Sender's Comments: Based on the information available and a close temporal association  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Thrombocytopenia, Immune thrombocytopenic purpura and Disease recurrence.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Cardiac monitoring, Dizziness, Inflammation, Pain
Clinical narrative: Inflammation/inflammation in the face and fingers/ hands were inflamed/ her arms, heart and mouth are still inflamed; Palpitations in the heart/heart is thumping; Dizzy; She had pain in her heart/chest pain; Had swelling in the face, arms, and fingers; Had swelling in the face, arms, and fingers; Pain; This is a spontaneous report from a contactable consumer (patient herself).  This 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route of administration, on 09Sep2021 (at the age of 74-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), administered on 08Aug2021 at single dose for COVID-19 immunisation and developed palpitations in the heart/her heart was thumping so hard. No relevant medical history and concomitant medications were provided. On 09Sep2021, a couple of minutes after second dose, she had a reaction where her face was inflamed, and her fingers and hands were inflamed. In Sep2021, after the second dose, she had swelling in the face, arms, and fingers. She went to the hospital and was given naproxen to reduce pain and inflammation. They checked her heart and everything was fine. She presented chest pain, palpitations in the heart/heart is thumping, inflammation in the face and fingers. She went to the hospital again and she was told that everything was normal and there was nothing to do. The patient asked how long will take to the symptoms leave her body. She stated her heart was thumping and she had pain in her heart and was dizzy; she stated her face feels inflammation and her arms and fingers feel inflammation and she went to the hospital to check her heart and face and they did not find anything; she stated that was why she went into the hospital two times and it was for this same problem; she stated everything they check was ok and they checked her heart on a machine; she stated she had the same symptoms yesterday in the shower and she has had the symptoms for 14 days already; she stated she wanted to know what to do about those things and how will the symptoms go away in her body and she went to the hospital and they did not find anything and her arms, heart and mouth were still inflamed; the patient asked what to do to get this to go away and was aware that Pfizer unable to offer treatment recommendations or medical advice. The events were reported serious per hospitalization. The patient had not recovered from the events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101258765 same patient, different event, different dose (first dose) of vaccine
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Peripheral swelling, Swelling face
Clinical narrative: Inflammation/inflammation in the face and fingers/ hands were inflamed/ her arms, heart and mouth are still inflamed; Palpitations in the heart/heart is thumping; Dizzy; She had pain in her heart/chest pain; Had swelling in the face, arms, and fingers; Had swelling in the face, arms, and fingers; Pain; This is a spontaneous report from a contactable consumer (patient herself).  This 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route of administration, on 09Sep2021 (at the age of 74-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), administered on 08Aug2021 at single dose for COVID-19 immunisation and developed palpitations in the heart/her heart was thumping so hard. No relevant medical history and concomitant medications were provided. On 09Sep2021, a couple of minutes after second dose, she had a reaction where her face was inflamed, and her fingers and hands were inflamed. In Sep2021, after the second dose, she had swelling in the face, arms, and fingers. She went to the hospital and was given naproxen to reduce pain and inflammation. They checked her heart and everything was fine. She presented chest pain, palpitations in the heart/heart is thumping, inflammation in the face and fingers. She went to the hospital again and she was told that everything was normal and there was nothing to do. The patient asked how long will take to the symptoms leave her body. She stated her heart was thumping and she had pain in her heart and was dizzy; she stated her face feels inflammation and her arms and fingers feel inflammation and she went to the hospital to check her heart and face and they did not find anything; she stated that was why she went into the hospital two times and it was for this same problem; she stated everything they check was ok and they checked her heart on a machine; she stated she had the same symptoms yesterday in the shower and she has had the symptoms for 14 days already; she stated she wanted to know what to do about those things and how will the symptoms go away in her body and she went to the hospital and they did not find anything and her arms, heart and mouth were still inflamed; the patient asked what to do to get this to go away and was aware that Pfizer unable to offer treatment recommendations or medical advice. The events were reported serious per hospitalization. The patient had not recovered from the events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101258765 same patient, different event, different dose (first dose) of vaccine
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blister, Chest pain, Erythema, Herpes zoster
Clinical narrative: pain on the right side of my chest and upper right side of my back; pain on the right side of my chest and upper right side of my back; rash; blisters; Shingles; redness; swelling; Pain; This is a spontaneous report from a contactable Consumer (patient). A 48-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0191), via an unspecified route of administration, administrated in right arm on 13Jul2021 12:00 (age at the time of vaccination 47-years-old), as a single dose for COVID-19 immunization. The patient medical history included Chronic fatigue, and tinnitus. The patient concomitant medications included Metoprolol, Montelukast, Atorvastatin, and Zolpidem. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW01a1), via an unspecified route of administration, administrated in right arm on 22Jun2021 14:00 (age at the time of vaccination 47-years-old), as a single dose for COVID-19 immunization and experienced the first vaccine caused pain at the injection site. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. No known allergies. On 20Jul2021 15:00, the patient experienced pain on the right side of my chest and upper right side of my back, rash, blisters, Shingles; and on an unspecified date 2021 redness, swelling, pain. Patient's doctor diagnosed with Shingles. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient took Tramadol and Pregabalin as a treatment for adverse events. The outcome for all the events was recovering.  Follow-Up (29 Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash, Swelling
Clinical narrative: pain on the right side of my chest and upper right side of my back; pain on the right side of my chest and upper right side of my back; rash; blisters; Shingles; redness; swelling; Pain; This is a spontaneous report from a contactable Consumer (patient). A 48-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0191), via an unspecified route of administration, administrated in right arm on 13Jul2021 12:00 (age at the time of vaccination 47-years-old), as a single dose for COVID-19 immunization. The patient medical history included Chronic fatigue, and tinnitus. The patient concomitant medications included Metoprolol, Montelukast, Atorvastatin, and Zolpidem. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW01a1), via an unspecified route of administration, administrated in right arm on 22Jun2021 14:00 (age at the time of vaccination 47-years-old), as a single dose for COVID-19 immunization and experienced the first vaccine caused pain at the injection site. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. No known allergies. On 20Jul2021 15:00, the patient experienced pain on the right side of my chest and upper right side of my back, rash, blisters, Shingles; and on an unspecified date 2021 redness, swelling, pain. Patient's doctor diagnosed with Shingles. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient took Tramadol and Pregabalin as a treatment for adverse events. The outcome for all the events was recovering.  Follow-Up (29 Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Vaginal haemorrhage
Clinical narrative: Heavy vaginal spotting; Cramping; This is a spontaneous report from a contactable Other HCP (patient reporting for herself).   A 32-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Sep2021 at 11:00 (Lot Number: 30130BA), at the age of 32 years old, as 1st single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination and at the time of the event. Prior to vaccination, the patient had not been diagnosed with COVID-19, and since the vaccination, the patient had not been tested positive for COVID-19. On 18Sep2021, the patient started having heavy vaginal spotting and cramping as well, continuing for 6 days in a row and still present at the time of the reporting. The patient had not recovered from the heavy spotting and cramping.  According to the reporter, the events were judged as a serious medically important event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Spotting vaginal and Cramps menstrual.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Nasopharyngitis, Respiratory tract congestion
Clinical narrative: covid test result Positive; covid test result Positive; Head cold/ like; congestion; Tired; Chills; This is a spontaneous report from a contactable pharmacist. A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Right Arm on 13Jan2021 (Batch/Lot Number: EL3248) at dose 1, single and administered in Arm Right on 03Feb2021 (Batch/Lot Number: EN5318) (at the age of 58-years-old) at dose 2, single for covid-19 immunization. Medical history included cardiovascular disorder. The patient did not receive other medications within 2 weeks of vaccination. Patient had no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient experienced tired, head cold/ like, congestion, chills on 18Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: Nasal Swab: positive on 21Sep2021. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. No treatment was given for the events. The outcome of the event covid test result Positive was unknown and outcome of rest of the events was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Vaccination Failure and COVID-19 cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test result Positive; covid test result Positive; Head cold/ like; congestion; Tired; Chills; This is a spontaneous report from a contactable pharmacist. A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Right Arm on 13Jan2021 (Batch/Lot Number: EL3248) at dose 1, single and administered in Arm Right on 03Feb2021 (Batch/Lot Number: EN5318) (at the age of 58-years-old) at dose 2, single for covid-19 immunization. Medical history included cardiovascular disorder. The patient did not receive other medications within 2 weeks of vaccination. Patient had no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient experienced tired, head cold/ like, congestion, chills on 18Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: Nasal Swab: positive on 21Sep2021. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. No treatment was given for the events. The outcome of the event covid test result Positive was unknown and outcome of rest of the events was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Vaccination Failure and COVID-19 cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Drug ineffective, SARS-CoV-2 test
Clinical narrative: hospital for covid, then pneumonia; hospital for covid, then pneumonia; This is a spontaneous report from a contactable consumer.    This 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unspecified route of administration, on unknown date in 2021 at single dose (dose number unknown) for COVID-19 immunisation. Relevant medical history included rheumatoid arthritis (with rheumatoid factor of unspecified site without organ/system involvement). Relevant concomitant medications included salbutamol sulfate (PROAIR HFA), pregabalin, budesonide, formoterol fumarate (SYMBICORT TURBOHALER), tramadol hydrochloride, escitalopram oxalate (LEXAPRO), prednisone, gabapentin and metformin HCL. Past drug history included tofacitinib citrate (XELJANZ) taken for rheumatoid arthritis and stopped 1-2 months before COVID-19 vaccine as per medical order due to potential interaction between COVID vaccine and XELJANZ. On unknown date, the patient was hospitalized due to COVID-19, then pneumonia.  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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a solicited report from a contactable consumer (patient) via the Regulatory Authority based on information received by Pfizer from Regulatory Authority (manufacturer control number: 21K-163-4035772-00).  A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 on 10Mar2021 (Batch/Lot number was not reported), and dose 1 on 02Feb2021 (Batch/Lot number was not reported): both intramuscular  as single dose (at the age of 66-years-old) for COVID-19 immunization. Medical history included Moderate to severe rheumatoid arthritis and Moderate to severe chronic plaque psoriasis. The patient's concomitant medications were not reported. The patient experienced COVID-19 on Aug2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on Aug2021. The outcome of the events was recovering. The events were considered as serious (medically significant).  Solicited report from the Regulatory Authority by a consumer of a 66-year-old female with event of COVID-19. There was no reported medical history (as reported). In Aug2021, the patient experienced COVID-19. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 02Feb2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer, lot number Unknown. On 10Mar2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer, lot number Unknown.  Causality for PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN): The reporter's causality for the event of COVID-19 was possible.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Vaccination failure and COVID-19 and the suspect drug bnt162b2.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasal congestion
Clinical narrative: congested; feeling sick; This is a spontaneous report from a contactable pharmacist. This report was not related to a study or programme. A 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The reporter stated the patient did not provide any product information. Medical history included ongoing difficult for her to move up and down the stairs and ongoing psoriasis from an unknown date. The reporter explained the first thing the patient stated was she was waiting for a spinal fusion because it was difficult for her to move up and down the stairs. He stated it was unclear when this started. Concomitant medications included ongoing otrexup (METHOTREXATE) for psoriasis from an unknown date. She stated the Otrexup was working well. The patient previously received first and second doses of BNT162B2 on unspecified dates for covid-19 immunisation. Investigation assessment included none. The patient experienced congested and feeling sick on an unspecified date. The caller stated he was a pharmacist and Medical Information Specialist. Reporter had a call with a patient on the day of this report regarding one of their products. In the middle of the call, the patient and him talked about previous products she had used, and she mentioned two of Pfizer's products. The caller clarified he had an adverse event(s) to report for COVID-19 vaccine. Did not provide mailing address when probed. No further patient details were known. Full address unknown, but she was in (withheld). Patient added later in the call was that she was congested on the day of this report, she was feeling sick and didn't know why because she had booster of the COVID-19 vaccine three weeks ago. The caller stated she had the booster shot due to being on Otrexup. The patient did not specifically state any outcomes for the AEs mentioned. The reporter stated he had no further information to provide. Clinical outcome of events was unknown.  Information about lot/batch number will be obtained during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pneumonia, SARS-CoV-2 test
Clinical narrative: Classroom Hospitalized From COVID; Classroom Hospitalized From COVID; pneumonia in his lungs; This is a spontaneous report from a contactable consumer.  An adult male patient received three doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), all via unspecified route of administration, on unspecified dates as single doses for covid-19 immunisation.  Medical history included kidney transplant in 2011 (10 years before) and he was immunocompromised. The patient's concomitant medications were not reported. The patient got covid although had 3 doses of Pfizer vaccine. COVID test showed he got covid. The reporter learned this information from a Newsweek article. Patient had fever, pneumonia in his lungs and was hospitalized. He's being treated with remdesivir and sleeping with an oxygen tube. Events required emergency room/department or urgent care.  Final outcome of the events was unknown.The lot numbers for the vaccine, [BNT162B2], were not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dizziness, Dyspnoea, Eye swelling
Clinical narrative: Shortness of breath; Chest pain; Swollen eyes; Hives; rash on arms and face; Dizziness; Sleppy; Headache; Arm and muscle pain; Arm and muscle pain; Chills; Fever; Nausea; Feeling sick overall; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: 30130BA), via an unspecified route of administration on 22Sep2021 13:45 (at the age of 51-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccine in four weeks. The patient experienced shortness of breath, chest pain, swollen eyes, hives, rash on arms and face, dizziness, sleepy, headache, arm and muscle pain, chills, fever, nausea, feeling sick overall on 22Sep2021 17:00. Seriousness of the events was reported as non-serious. Patient did not have covid prior vaccination and covid was not tested post vaccination. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for adverse event in the form of unspecified medication. The outcome of all events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea, Pain in extremity
Clinical narrative: Shortness of breath; Chest pain; Swollen eyes; Hives; rash on arms and face; Dizziness; Sleppy; Headache; Arm and muscle pain; Arm and muscle pain; Chills; Fever; Nausea; Feeling sick overall; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: 30130BA), via an unspecified route of administration on 22Sep2021 13:45 (at the age of 51-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccine in four weeks. The patient experienced shortness of breath, chest pain, swollen eyes, hives, rash on arms and face, dizziness, sleepy, headache, arm and muscle pain, chills, fever, nausea, feeling sick overall on 22Sep2021 17:00. Seriousness of the events was reported as non-serious. Patient did not have covid prior vaccination and covid was not tested post vaccination. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for adverse event in the form of unspecified medication. The outcome of all events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Somnolence, Urticaria
Clinical narrative: Shortness of breath; Chest pain; Swollen eyes; Hives; rash on arms and face; Dizziness; Sleppy; Headache; Arm and muscle pain; Arm and muscle pain; Chills; Fever; Nausea; Feeling sick overall; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: 30130BA), via an unspecified route of administration on 22Sep2021 13:45 (at the age of 51-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccine in four weeks. The patient experienced shortness of breath, chest pain, swollen eyes, hives, rash on arms and face, dizziness, sleepy, headache, arm and muscle pain, chills, fever, nausea, feeling sick overall on 22Sep2021 17:00. Seriousness of the events was reported as non-serious. Patient did not have covid prior vaccination and covid was not tested post vaccination. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for adverse event in the form of unspecified medication. The outcome of all events was not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Tachycardia
Clinical narrative: feeling like tachycardia in my left side in my heart, arm then go up; took the two dose but I feeling like something wired after that; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0187, and Expiration date: Aug2021), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced "feeling like tachycardia in my left side in my heart, arm then go up" was really wired and "took the two dose but I feeling like something wired after that". The caller stated that, the effect was in her body, that was why she was afraid to put third vaccine and she wanted to know what will happen if she put third vaccine. The patient received no treatment for tachycardia. The outcome of events was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immune system disorder, Psoriasis
Clinical narrative: Immune system disorder; Psoriasis was back; This is a spontaneous based on the information received by Pfizer from another company (MFR control no.: 21K-163-4079417-00). A contactable 56-year-old female consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date were not reported) via intramuscular on 23Apr2021 (at the age 56-years-old) as dose 1, single and dose 2 intramuscular on 14May2021 (Batch/Lot number was not reported) as dose 2, single both for covid-19 immunization. Patient had also received adalimumab (HUMIRA), subcutaneous from 2010 (Batch/Lot number was not reported) to an unspecified date, for unknown indication. Medical history included psoriasis from an unknown date to 2021. The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unknown date, in 2021 the patient experienced immune system disorder; Humira killed Immune System. And also experienced Psoriasis was back on unknown date in 2021. The action taken in response to the events for adalimumab was unknown. The outcome of event immune system disorder was unknown, and it was not recovered for event psoriasis was back. The reporter's causality for the events of humira killed immune system and psoriasis was back with suspect products was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ear congestion, Fatigue, Influenza like illness, Pain, Pain in extremity
Clinical narrative: Within approx. 48-hrs. of first vaccine I was overcome by flu-like symptoms that were very similar when I had COVID in May 2020.; Fever; fatigue; body-aches (especially my hands); body-aches (especially my hands); ears became very congested and are ringing; ears became very congested and are ringing; This is a spontaneous report from a contactable consumer (Patient). A 62-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: FC3183), via an unspecified route of administration on 14Sep2021 at 11:30 (at the age of 62-years-old) administered in Arm Left as a single dose for COVID-19 immunisation. Medical history included hypothyroid from an unknown date and unknown if ongoing, COVID-19 from May2020 to an unknown. Concomitant medication(s) included levothyroxine; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) (all taken for an unspecified indication, start and stop date were not reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 17Sep2021 at 17:00 PM, approx. 48-hrs. of first vaccine the patient overcome by flu-like symptoms that were very similar when she had COVID in May 2020. Fever, fatigue, body-aches (especially her hands) lasting 2-days. The next days my ears became very congested and are ringing. She still having congestion problems with my ears and fatigue on day 9. She thought this was supposed to happen on the second vaccine. She nervous to have the second shot. The patient underwent lab tests and procedures which included sars-cov-1 test negative on 21Sep2021 Nasal Swab. No treatment was given for the events. The outcome of the events was not recovered.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-1 test, Tinnitus
Clinical narrative: Within approx. 48-hrs. of first vaccine I was overcome by flu-like symptoms that were very similar when I had COVID in May 2020.; Fever; fatigue; body-aches (especially my hands); body-aches (especially my hands); ears became very congested and are ringing; ears became very congested and are ringing; This is a spontaneous report from a contactable consumer (Patient). A 62-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: FC3183), via an unspecified route of administration on 14Sep2021 at 11:30 (at the age of 62-years-old) administered in Arm Left as a single dose for COVID-19 immunisation. Medical history included hypothyroid from an unknown date and unknown if ongoing, COVID-19 from May2020 to an unknown. Concomitant medication(s) included levothyroxine; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) (all taken for an unspecified indication, start and stop date were not reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 17Sep2021 at 17:00 PM, approx. 48-hrs. of first vaccine the patient overcome by flu-like symptoms that were very similar when she had COVID in May 2020. Fever, fatigue, body-aches (especially her hands) lasting 2-days. The next days my ears became very congested and are ringing. She still having congestion problems with my ears and fatigue on day 9. She thought this was supposed to happen on the second vaccine. She nervous to have the second shot. The patient underwent lab tests and procedures which included sars-cov-1 test negative on 21Sep2021 Nasal Swab. No treatment was given for the events. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis
Clinical narrative: diagnosed with Hashimoto's Thyroiditis; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program.   A female patient of an unspecified age received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), both via an unspecified route of administration on unspecified dates as single doses for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient was recently diagnosed with Hashimoto's Thyroiditis on an unspecified date. The patient stated she has started taking medication for the Hashimoto's Thyroiditis but did not disclose the medication name. Patient was interested in getting a Covid 19 booster but wanted more information. Outcome of the event was unknown. The lot numbers for the vaccine, BNT162B2, were not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Chills, Cough, Drug ineffective, Gastrointestinal tract irritation
Clinical narrative: Sick with covid; Sick with covid; Sick with Covid; extreme chills; no taste; sore; can't really move; GI issues; headache; slight cough; This is a spontaneous report from a non-contactable consumer (patient). This is the first of two reports with events experienced under the first dose. A patient of unspecified age and gender received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 04May2021 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On 06Aug2021 patient experienced sick with covid, extreme chills, no taste, sore, can't really move, Gastrointestinal (GI) issues, headache and slight cough. It was reported that on 06Aug2021 patient was sick with Covid and following symptoms: No fever but extreme chills, no taste, sore, can't really move, GI issues, headache, and slight cough. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101265501 Same patient and drug, different event and dose
Sex: U
Vaccine: COVID19
Symptoms: Headache, Illness, Movement disorder, Pain, Suspected COVID-19
Clinical narrative: Sick with covid; Sick with covid; Sick with Covid; extreme chills; no taste; sore; can't really move; GI issues; headache; slight cough; This is a spontaneous report from a non-contactable consumer (patient). This is the first of two reports with events experienced under the first dose. A patient of unspecified age and gender received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 04May2021 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On 06Aug2021 patient experienced sick with covid, extreme chills, no taste, sore, can't really move, Gastrointestinal (GI) issues, headache and slight cough. It was reported that on 06Aug2021 patient was sick with Covid and following symptoms: No fever but extreme chills, no taste, sore, can't really move, GI issues, headache, and slight cough. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101265501 Same patient and drug, different event and dose
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Chills, Dizziness, Fatigue
Clinical narrative: chills; fever 102; headache; stomach; fatigue; arm pain; immediatly felf dizzy; nausea after shot; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration, in right arm on 23Feb2021 (at the age of 46-years-old) as dose 2, single for COVID-19 immunization. Medical history included covid-19 from 03Jan2021 to 24Jan2021. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date (at the age of 45-years-old) as dose 1, single for COVID-19 immunization after which the patient experienced chills, fever, headache, stomach discomfort, fatigue and arm pain. The patient experienced chills, fever 102, headache, stomach discomfort, fatigue, arm pain on an unspecified date and dizzy and nausea after shot on 23Feb2021. The outcome of all the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: chills; fever 102; headache; stomach; fatigue; arm pain; immediatly felf dizzy; nausea after shot; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration, in right arm on 23Feb2021 (at the age of 46-years-old) as dose 2, single for COVID-19 immunization. Medical history included covid-19 from 03Jan2021 to 24Jan2021. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date (at the age of 45-years-old) as dose 1, single for COVID-19 immunization after which the patient experienced chills, fever, headache, stomach discomfort, fatigue and arm pain. The patient experienced chills, fever 102, headache, stomach discomfort, fatigue, arm pain on an unspecified date and dizzy and nausea after shot on 23Feb2021. The outcome of all the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dehydration, Diarrhoea, Fatigue, Headache
Clinical narrative: Vomiting; Diarrhea; Fever; Knee and ankle pain; Fatigue; Headaches; Dehydrated; This is my 3rd dose; This is my 3rd dose; This is a spontaneous report from a contactable consumer. A 45-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FL 3183), via an unspecified route of administration, administered in Arm Left on 25Sep2021 13:45 as DOSE 3, SINGLE for covid-19 immunisation (at the age of 45 years). Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. Medical history included rubber sensitivity from Latex , drug hypersensitivity from Penicillin and Sulphate. Concomitant medications included doxycycline and tessalon perle. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. The patient previously took first and second dose of BNT162B2 for covid-19 immunisation. The patient experienced vomiting, diarrhoea, fever, knee and ankle pain, fatigue, headaches, dehydration, off label use and immunisation on 25Sep2021 16:45. Since the vaccination, the patient had not been tested for COVID-19. Treatment received was unknown. The clinical outcome of the events was recovered for vomiting, diarrhoea, fever, knee and ankle pain, headaches, dehydration and unknown for Off label use, booster, fatigue.  Follow-up (28Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Pyrexia, Vomiting
Clinical narrative: Vomiting; Diarrhea; Fever; Knee and ankle pain; Fatigue; Headaches; Dehydrated; This is my 3rd dose; This is my 3rd dose; This is a spontaneous report from a contactable consumer. A 45-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FL 3183), via an unspecified route of administration, administered in Arm Left on 25Sep2021 13:45 as DOSE 3, SINGLE for covid-19 immunisation (at the age of 45 years). Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. Medical history included rubber sensitivity from Latex , drug hypersensitivity from Penicillin and Sulphate. Concomitant medications included doxycycline and tessalon perle. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. The patient previously took first and second dose of BNT162B2 for covid-19 immunisation. The patient experienced vomiting, diarrhoea, fever, knee and ankle pain, fatigue, headaches, dehydration, off label use and immunisation on 25Sep2021 16:45. Since the vaccination, the patient had not been tested for COVID-19. Treatment received was unknown. The clinical outcome of the events was recovered for vomiting, diarrhoea, fever, knee and ankle pain, headaches, dehydration and unknown for Off label use, booster, fatigue.  Follow-up (28Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Headache, Immunisation, Off label use
Clinical narrative: He and his wife received the third dose of the Covid-19vaccine; He and his wife received the third dose of the Covid-19vaccine; They have also received the Influenza Flu vaccine on the same day; His wife can barely walk; Weak; Headache; This is a spontaneous report from a non-contactable physician reported from a Pfizer 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 22Sep2021 as dose 3 (booster), single for COVID-19 immunisation; influenza vaccine (INFLUENZA) via an unspecified route of administration on 22Sep2021 (Batch/Lot number was not reported) as single for immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 1 via an unspecified route of administration on an unspecified date as single, and dose 2 via an unspecified route of administration on an unspecified date as single, both for COVID-19 immunisation. The patient experienced as, he and his wife received the third dose of the covid-19vaccine, they have also received the influenza flu vaccine on the same day on 22Sep2021, his wife can barely walk, weak, headache on Sep2021. Reported as, reporter and his wife (patient) received the third dose of the Covid- 19 vaccine yesterday. They have also received the Influenza Flu vaccine on the same day. Reporter told that his wife (patient) can barely walk, was weak and has a headache. Outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Product use issue
Clinical narrative: He and his wife received the third dose of the Covid-19vaccine; He and his wife received the third dose of the Covid-19vaccine; They have also received the Influenza Flu vaccine on the same day; His wife can barely walk; Weak; Headache; This is a spontaneous report from a non-contactable physician reported from a Pfizer 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 22Sep2021 as dose 3 (booster), single for COVID-19 immunisation; influenza vaccine (INFLUENZA) via an unspecified route of administration on 22Sep2021 (Batch/Lot number was not reported) as single for immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 1 via an unspecified route of administration on an unspecified date as single, and dose 2 via an unspecified route of administration on an unspecified date as single, both for COVID-19 immunisation. The patient experienced as, he and his wife received the third dose of the covid-19vaccine, they have also received the influenza flu vaccine on the same day on 22Sep2021, his wife can barely walk, weak, headache on Sep2021. Reported as, reporter and his wife (patient) received the third dose of the Covid- 19 vaccine yesterday. They have also received the Influenza Flu vaccine on the same day. Reporter told that his wife (patient) can barely walk, was weak and has a headache. Outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.