chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: fever of 103.8; headache; Chills; achy muscles; nausea; weak; dizzy; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9267; expiry date: unknown), via an unspecified route of administration on 18Feb2021 at 15:15 (at the age of 67-years-old) on Right arm at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No Allergies to medications, food, or other products. The patient previously took first dose of BNT162B2 (lot number: EL0142) on 28Jan2021 at 03:45 PM (at the age of 67-years-old) on Right arm for COVID-19 immunisation. It was reported that the patient had experienced chills, fever of 103.8, headache, nausea, achy muscles, dizzy weak on 20Feb2021 at 07:00. The patient did not receive any other medications within 2 weeks of vaccination. 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. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. Outcome of all the events was recovering.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swelling- knot on right side of of left arm at elbow. And is swollen a bit; This is a spontaneous report received from a contactable consumer (reporting for herself). A 68-years-old Non-Pregnant female patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9267 and Expiration date was not reported) via an unspecified route of administration in Arm Left on 19Feb2021 15:00 as single dose for COVID-19 immunization. Medical history included hypertension and drug hyper-sensitivity (Sulfa). Concomitant medication includes prescribed medicine. It was reported that on 21Feb2021 12:00 patient experienced Swelling- knot on right side of left arm at elbow. And is swollen a bit. Patient did not receive any treatment for event. 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 and did not test for covid Since the vaccination. The outcome of the event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: stinging feeling in arm pit; This is a spontaneous report from a contactable other hcp (reported for herself). A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE, dose 1 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 and concomitant medications were not reported. On an unspecified date patient experienced stinging feeling in arm pit.Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient did not received treatment for the adverse event. Outcome of the event was recovering.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: I recently tested positive after both doses.; I recently tested positive after both doses.; This is a spontaneous report from a contactable. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and patient's concomitant medications were not reported. The patient recently tested positive after both doses on an unknown date of Feb2021. On the same day lab tests and procedures included sars-cov-2 with positive result. The outcome of the event was unknown.  No follow-up attempts are needed. Further information not expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I received 2 doses of the pfizer covid vaccine with my last being 1/8./i still got covid; I received 2 doses of the pfizer covid vaccine with my last being 1/8./i still got covid; This is a spontaneous report from a contactable nurse (patient) via the medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first and second dose; both 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's medical history and concomitant medications were not reported. The patient received 2 doses of the pfizer covid vaccine with her last being 8Jan (unspecified date). The patient never take off her N95. The patient was the safest nurse she knew of. The patient didn't go anywhere but work and the store and she still got covid. The patient just wanted to know. The patient couldn't make sense of this. The patient was just diagnosed yesterday (22Feb2021) as tested positive with COVID-19. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccine in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 05Feb2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter is a consumer who received her first dose of Pfizer-BioNTech Covid19 vaccine 05Feb2021, then tested positive for Covid19 infection 20Feb2021. She reports a mild infection, few to no symptoms. She is due for her second dose of vaccine on 26Feb2021 and wants to know if she should receive it as scheduled. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received first dose approximately 6 weeks ago and then got covid at the end of january. Can she receive the second vaccine?; received first dose approximately 6 weeks ago and then got covid at the end of january. Can she receive the second vaccine?; This is a spontaneous report from a contactable other HCP. A female patient of an unspecified age (reported as 28, units unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on Jan2021, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  Patient received first dose approximately 6 weeks ago and then got COVID at the end of January 2021. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had positive covid test on 22Feb2021 and symptoms began on 19Feb2021; had positive covid test on 22Feb2021 and symptoms began on 19Feb2021; This is a spontaneous report from a contactable physician. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date: unknown), intramuscular in the right arm, on 02Feb2021, as single dose, for covid-19 immunisation, at an urgent care center. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and did not receive other vaccines in four weeks. The patient had positive COVID test (nasal swab) on 22Feb2021 and symptoms began on 19Feb2021. The events resulted to physician's office visit. It was unknown if the patient received treatment. The patient recovered from the events on an unspecified date.; Sender's Comments: Based on the information currently available, a lack of efficacy BNT162B2 vaccine in this patient cannot be completely excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable pharmacist. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9262, expiration date: May2021), via an unspecified route of administration at the age of 66-year-old on 10Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were reported as no. It was reported that the patient got the first dose of the Pfizer Covid vaccine on 10Feb2021, states this morning (23Feb2021) she went and got rapid tested for Covid and tested positive for COVID-19. The second dose of vaccine was scheduled on 05Mar2021. The patient underwent lab tests and procedures which included rapid test on 23Feb2021: positive for COVID-19. The outcome of the events was unknown.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 10Feb2021, and tested positive for the virus (COVID-19) on 23Feb2021.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information needed for a full meaningful medical assessment.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: She had her first dose of the COVID Vaccine (COVID19 Vaccine by Pfizer) on the February 3rd and February 20th she had a Positive COVID test done; She had a Positive COVID test; This is a spontaneous report from a contactable consumer reported that a female patient received her first dose of the COVID Vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number not provided), via an unspecified route of administration on 03Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. On 20Feb2021 the patient had a Positive COVID test done. And she is scheduled on the 24th for the Second dose. Patient was wondering if she can still get the second dose or she needs to reschedule it.  Outcome of the events were unknown.  Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Sars-COV-2 positive after first dose; Sars-COV-2 positive after first dose; This is a spontaneous report from a contactable nurse. A female nurse (patient herself) of an unspecified age received bnt162b2 (Pfizer-biontech covid-19 vaccine, formulation: solution for injection), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Caller stated that she was looking for information on second dose following sars-cov-2 positive after first dose. The patient experienced Sars-COV-2 positive after first dose on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on unspecified date. The event covid was assessed as medically significant. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.  There is limited information provided in this report.  This case will be reassessed once additional information is available.  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: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: contracted Covid; contracted Covid; This is a spontaneous report from a non-contactable consumer (patient) reporting on herself.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 07Feb2021 as SINGLE DOSE for covid-19 immunization. Patient medical history and concomitant medications were not reported. It was reported that, patient's first Pfizer Covid vaccine was on Feb 7th and has contracted Covid (drug ineffective). She wants to know if she should receive the second vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive. The outcome for the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive to SARs-COV-2; positive to SARs-COV-2; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Feb2021 (second dose) and on an unspecified date (first dose); both via unspecified routes of administration at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was positive to SARs-COV-2. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive on Rapid COVID-19 Test; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received first dose of bnt162b2 (BNT162B2; Solution for injection) via unspecified route of administration on 13Feb2021 at single dose for covid-19 immunization. Relevant medical history and concomitant medications were not provided. It was reported Tested positive on Rapid COVID-19 Test asking if she should get two more doses as a second dose? Asking about second dose? Agency: attempted to warm transfer the caller. All agents were busy. Due to the long hold time, e-transmitting.  Information about lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Neck pain, Vaccination site pain
Clinical narrative: Sore left arm at injection site; Tingling feeling on forehead; Slight headache; neck pain; This is a spontaneous report from a contactable Pharmacist. A 60-years-old female patient received BNT162B2 ( BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL3247) first dose via an unspecified route of administration, administered in left arm on 18Feb2021 9:15 as single dose for COVID-19 immunization. Vaccination administered facility Workplace clinic. The patient medical history included Osteoporosis; irritable bowl syndrome. The patient concomitant medications included : Citracal; Centrum; Vit D (ergocalciferol); Colace; Evening Primrose (oenothera biennis), ascorbic acid, biotin, calcium carbonate, calcium pantothenate, calcium phosphate dibasic, chromium picolinate, colecalciferol, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, magnesium borate, magnesium oxide, manganese sulfate, nickel sulfate, nicotinamide, panax ginseng root, phytomenadione, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium metavanadate, sodium molybdate, sodium selenate, stannous chloride, thiamine mononitrate, tocopheryl acetate, zinc oxide (CENTRUM ENERGY). On 18Feb2021 10:00 patient experienced with sore left arm at injection site (vaccination site pain), tingling feeling on forehead, slight headache, and sore neck on left side. The outcome of the event was recovering.  Follow-up information was received on (25-MAR-2021): No new medically significant information was received on this case.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report from a contactable consumer reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was tested positive for covid-19 on 24Feb2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Disease recurrence, Drug hypersensitivity, Pruritus
Clinical narrative: Itching in different parts of body; Itching in different parts of body/history of itching; allergic to the combination of the vaccine and that pill; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation; and doxepin hcl (unknown manufacturer and formulation, 10 mg), at 10 mg daily (every evening), route of administration, and start and stop date were not reported for an unspecified indication. The patient's medical history included history of itching. Concomitant medications were not reported. The first dose of bnt162b2 was received on an unknown date for COVID-19 immunization. Patient had the second Pfizer COVID-19 vaccine on Wednesday afternoon at 3:30 (date not provided) and patient have been having itching in different areas of the body. Patient mentioned of having a history of itching. It's not something unusual for the patient. Patient was taking a pill every evening, it's doxepin, 10 mg. As soon as the patient take that doxepin now, the itching begins (dates unspecified). But patient's question was, if patient can take an allergy pill because patient was thinking that patient was allergic to the combination of the vaccine and that pill. The action taken in response to the events for doxepin hcl was unknown. The outcome of the events reported was unknown.   Pfizer is a marketing authorization holder of doxepin hcl in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of doxepin hcl has submitted the same report to the regulatory authorities.  Information on the lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Bone swelling, Rash, X-ray
Clinical narrative: Swollen clavicle; small rash; This is a spontaneous report from a contactable consumer (for herself). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration, administered in left arm on 20Feb2021 14:30 as a SINGLE DOSE for covid-19 immunisation. Medical history included drug Allergies to: Penicillin (Allergies to medications, food, or other products: Penicillin). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Facility where the most recent COVID-19 vaccine was administered was Hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced swollen clavicle (non-serious) on 21Feb2021, small rash (non-serious) on 21Feb2021.  The patient underwent lab tests and procedures which included X-ray: unknown results on unspecified date in 2021. Therapeutic measures were taken as a result of swollen clavicle (bone swelling), small rash (rash). treatment received for the adverse event: Yes: Methylprednisolone. For events, outcome was not recovered.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nightmare
Clinical narrative: woke up from nightmares; When I went to bed Tuesday night, my joints started aching; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL9267, Expiry Date: Unknown), via an unspecified route of administration on left arm on 22Feb2021 12:45 PM at single dose for covid-19 immunization. Patient was not pregnant at the time of vaccination. Patient's medical history included asthma, obesity, and allergies to sulfa, penicillin, most native trees. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's concomitant medications included levocetirizine dihydrochloride (XYZAL),  methylcellulose (CITRUCEL) caplets (medications the patient received within 2 weeks of vaccination). On 22Feb2021 10:30 PM the patient experienced woke up from nightmares and when I went to bed tuesday night, my joints started aching. Event was reported as follows she got the shot on Monday and felt fine. When she went to bed on Tuesday night, her joints started aching. Several times throughout the night, she woke up from nightmares, but they all seemed to be related to the fact that her joints (it felt like all of them) hurt to move. From what she can tell, she did not move the entire night, yet she was fine by the time her alarm went off. Prior to vaccination, the patient was not diagnosed with COVID-19 and also not been tested for COVID-19 after vaccination. Patient reported no for serious, seriousness criteria-results in death, seriousness criteria-Life threatening, seriousness criteria-caused/prolonged hospitalization, seriousness criteria-Disabling/incapacitating, seriousness criteria-congenital anomaly/birth defect. Patient did not received any treatment for events. The outcome of events was recovered.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Chest pain, Diarrhoea, Dizziness
Clinical narrative: chest tightness/ chest tightness worsening slightly; lightheaded; vaccine-related axiety; chest pain; shortness of breath; nausea; vomiting; diarrhea; This is a spontaneous report from a non-contactable health care practitioner (other HCP). A 56-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE solution for injection; Batch/Lot Number: EN6205; Expiry date was not reported) via an unspecified route of administration on an unspecified date (at the age of 56-years-old) at a single dose for covid-19 immunization. Medical history included chronic pain from an unknown date and ongoing. Concomitant medications included glipizide and lisinopril 10mg (taken at night) which were taken for an unspecified indication; and morphine taken two times a day for chronic pain. The start and stop dates of these medications were not reported. The patient previously took pioglitazone hydrochloride (ACTOS) and was taken off in the last couple of weeks and switched over to Glipizide. On an unspecified date during the patient's 15-minute waiting period after the vaccination, the patient began to experience chest tightness. The patient was transported to emergency department (ED). The patient also experienced lightheadedness and chest tightness worsening slightly while she was being monitored after the treatment was given. The events were reported as non-serious. Differential Diagnosis: Vaccine- Related Anxiety (include misc mental health, unspecified) and Red flag symptoms (CP (Chest pain), SOB (Shortness of breath), NVD (Nausea, vomiting, diarrhea), and unspecified Visual/Neuro concerns. Treatment included antihistamine, Cetirizine (Zyrtec), and water for the event chest tightness. The outcome of event chest tightness was not recovered (reported as worsening); while other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Nausea, Vomiting
Clinical narrative: chest tightness/ chest tightness worsening slightly; lightheaded; vaccine-related axiety; chest pain; shortness of breath; nausea; vomiting; diarrhea; This is a spontaneous report from a non-contactable health care practitioner (other HCP). A 56-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE solution for injection; Batch/Lot Number: EN6205; Expiry date was not reported) via an unspecified route of administration on an unspecified date (at the age of 56-years-old) at a single dose for covid-19 immunization. Medical history included chronic pain from an unknown date and ongoing. Concomitant medications included glipizide and lisinopril 10mg (taken at night) which were taken for an unspecified indication; and morphine taken two times a day for chronic pain. The start and stop dates of these medications were not reported. The patient previously took pioglitazone hydrochloride (ACTOS) and was taken off in the last couple of weeks and switched over to Glipizide. On an unspecified date during the patient's 15-minute waiting period after the vaccination, the patient began to experience chest tightness. The patient was transported to emergency department (ED). The patient also experienced lightheadedness and chest tightness worsening slightly while she was being monitored after the treatment was given. The events were reported as non-serious. Differential Diagnosis: Vaccine- Related Anxiety (include misc mental health, unspecified) and Red flag symptoms (CP (Chest pain), SOB (Shortness of breath), NVD (Nausea, vomiting, diarrhea), and unspecified Visual/Neuro concerns. Treatment included antihistamine, Cetirizine (Zyrtec), and water for the event chest tightness. The outcome of event chest tightness was not recovered (reported as worsening); while other events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: 26 hours after the shot he was too weak; This is a spontaneous report from a contactable consumer reported that a 78-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history included he has moderate to advanced Parkinson's disease and typically suffers from weakness. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for covid-19 immunisation. Twenty-six hours (26) after the shot he was too weak need help getting out of bed. The outcome of the event was unknown.   Information about Lot/batch no has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: He had his second shot and had rashes that have come out on his thighs and his wife said, he had them on his, just above his waistline and on his right shoulder blade; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 12Feb2021 (at the age of 79-years-old) (Batch/Lot Number: EL9262; Expiration Date: 31May2021) as SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism taking levothyroxine. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for hypothyroidism, start and stop date were not reported. The patient previously took bnt162b2 (BNT162B2), dose 1 on 22Jan2021 (at the age of 79-years-old) (Batch/Lot Number: EK9231; Expiration Date: 30Apr2021) as SINGLE DOSE for covid-19 immunisation. Consumer stated, he was not sure but he thought he had a reaction to the Covid shot. He had his second shot and had rashes that have come out on his thighs and his wife said, he had them on his, just above his waistline and on his right shoulder blade and they were approximately of a size of a dime and they were pink but they were not raised and they donot itch. The patient did not receive any treatment for the event. Outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for the Covid-19 virus after 1st dose; Tested positive for the Covid-19 virus after 1st dose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (Pfizer Covid-19 vaccine), dose 1 via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for the COVID-19 virus on 22Feb2021 after 1st dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for the COVID-19 infection; tested positive for the COVID-19 infection; This is a spontaneous report from a contactable consumer (patient's mother).  A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified it was reported that the mother received the second dose of the vaccine 3 weeks ago on 31Jan, last week (17Feb or 18th) her daughter (who was 33 years old) tested positive for the COVID-19 infection, the mother calling has not presented any symptoms apart from "feeling like coming down" for a short period of time, she was not sure if the vaccine was working, doctors have suggested that her daughter should isolate, caller wanted to know if there was any studies on how patients who received the second dose of the vaccine react to the exposure of the virus. She has been in contact with her daughter for 5 days, caller has been tested for the infection and she resulted negative. Caller received the second dose of the BNT162B2 vaccine and wanted to know how to participate as part of the clinical trials of the vaccine. Outcome of the events were unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she tested  positive she is recovering from Covid-19; This is a spontaneous report from a contactable consumer (Patient) reported via a Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine: Formulation: solution for injection), via an unspecified route of administration on 08Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. At the moment she is recovering from Covid-19 virus and supposedly the 2nd dose will be on 01Mar2021. On 18Feb2021 she received an antibody infusion and was advised that she can't get the 2nd dose on the schedule and could only get the 2nd dose on 90 days after antibody infusion. The patient received first dose on 08feb2021 and the following day (09Feb2021) she tested positive, she tested positive she is recovering from covid-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Feb2021. The outcome of event was recovering.  Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Drug ineffective, Fatigue, Headache
Clinical narrative: Drug ineffective; covid test result=Positive; fever; chills; body ache; headache; fatigue; Rash/red splotches on stomach, worsening; red splotches on stomach, worsening; This is a spontaneous report from a contactable other health care professional reported for a 31-Year-old non-pregnant female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EK5730), via intramuscular on 28Jan2021 at 15:15 as single dose in left arm for covid-19 immunization. The patient's medical history included anemia, scoliosis, and anxiety.  Concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMIN) and ethinylestradiol, norgestimate (MONO-LINYAH).  Historical vaccine included BNT162B2 (administration date-07Jan2021, administration time-12:15 PM, administrator route-Intramuscular, vaccine location-Left arm, dose number-1 and Lot number-EL3248). On 28Jan2021, the patient experienced fever, chills, body ache, headache, fatigue, red splotches on stomach and worsening over time. On an unknown date, she experienced rash. The patient experienced events at Doctor or other healthcare professional office/clinic visit. Laboratory details included Nasal Swab (PCR) with results positive on 22Feb2021. It was unknown if patient was received treatment for the events. The outcome of the events was not recovered whereas the event drug ineffective was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and suspected LOE.   There is limited information provided in this report.  This case will be reassessed once additional information is available.  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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Drug ineffective; covid test result=Positive; fever; chills; body ache; headache; fatigue; Rash/red splotches on stomach, worsening; red splotches on stomach, worsening; This is a spontaneous report from a contactable other health care professional reported for a 31-Year-old non-pregnant female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EK5730), via intramuscular on 28Jan2021 at 15:15 as single dose in left arm for covid-19 immunization. The patient's medical history included anemia, scoliosis, and anxiety.  Concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMIN) and ethinylestradiol, norgestimate (MONO-LINYAH).  Historical vaccine included BNT162B2 (administration date-07Jan2021, administration time-12:15 PM, administrator route-Intramuscular, vaccine location-Left arm, dose number-1 and Lot number-EL3248). On 28Jan2021, the patient experienced fever, chills, body ache, headache, fatigue, red splotches on stomach and worsening over time. On an unknown date, she experienced rash. The patient experienced events at Doctor or other healthcare professional office/clinic visit. Laboratory details included Nasal Swab (PCR) with results positive on 22Feb2021. It was unknown if patient was received treatment for the events. The outcome of the events was not recovered whereas the event drug ineffective was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and suspected LOE.   There is limited information provided in this report.  This case will be reassessed once additional information is available.  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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid test and their rapid test came back positive; Covid test and their rapid test came back positive; This is a spontaneous report from a contactable Pharmacist reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 10Feb2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that a patient who got their 1st dose on 10Feb2021 and went to go and get a Covid test and their rapid test came back positive. They were wanting to know if the patient could get their 2nd dose on 05Mar2021. It was suggested to the patient that to wait times, since caller tested positive after the 1st dose. Outcome of the events were unknown.  Information about the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 vaccine in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she had been tested positive after the first dose of Covid-19 vaccine.; she had been tested positive after the first dose of Covid-19 vaccine.; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had been tested positive after the first dose of COVID-19 vaccine. Outcome of the events was unknown.  Information about lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid-19 on 12Feb2021; This is a spontaneous report from a Pfizer-sponsored program COVAX US SUPPORT. A non-contactable consumer (patient) reported that female patient of unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 04Feb2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient reported, she had her first dose of the covid-19 vaccine on 04Feb2021, tested positive for covid-19 on 12Feb2021, questioning if should receive second dose on 25Feb2021. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received 1st dose of Covid vaccine and then 14 days later tested positive for Covid; received 1st dose of Covid vaccine and then 14 days later tested positive for Covid; This is a spontaneous report from a contactable pharmacist reported a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 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's medical history and concomitant medications were not reported. The pharmacist reported the patient received 1st dose of Covid vaccine and then 14 days later tested positive for Covid. They are wondering if patient can take 2nd dose. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) and then 14 days later tested positive for COVID.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information needed for a full meaningful medical assessment.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable consumer (patient reported himself) reported that a male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 06Feb2021 at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was tested positive for Covid on an unspecified date in Feb2021. The patient underwent lab tests and procedures which included Covid: positive in Feb2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Joint swelling
Clinical narrative: trace bogginess noted in 3 small joints of the hands; This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported that a 77-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), via an unspecified route of administration from an unspecified date at 11 mg for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for covid-19 immunisation. Per clinical notes, reporter stated that she has received both doses of Covid vaccination. She held tofacitinib citrate for 7 days after the first vaccination. She was currently holding after the second dose. Also stated that she was doing well on tofacitinib citrate monotherapy. There was trace bogginess noted in 3 small joints of the hands on an unspecified date. The action taken in response to the event for tofacitinib citrate was post-therapy. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disease recurrence, Nausea, Neuralgia, Pyrexia
Clinical narrative: nausea; fever; chills; Nerve pain has come back; Nerve pain has come back; This is a spontaneous report from a contactable consumer (patient). An elderly female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: 9264)), via an unspecified route of administration, administered in the left arm on 10Feb2021 08:15 as a single dose for covid-19 immunization. The patient's medical history included trigeminal nerve damage (nerve pain) from an unknown date. The patient has no known allergies. There were no concomitant medications. On 14Feb2021, the patient's nerve pain has come back. Previous pain was dormant for almost a year. She had history with trigeminal nerve damage and the nerve pain was active again after having the vaccines. Patient also had the normal fever, chills and nausea. The patient was treated with pain medication for the events. The outcome of the events was not recovered. The patient has not had covid prior to vaccination and was not tested post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Hangover, Headache, Malaise, Nausea, Pain
Clinical narrative: Got sick after the vaccine/all over sick feeling/ felt horrible; Head hurt; Nausea; Hurt to sit up; Really bad hangover; This is a spontaneous report received from a contactable consumer (patient). This male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6201; expiration 30Jun2021) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter called to obtain more information to try and figure out if the vaccine caused him to get sick or if it was something else. The reporter stated he got sick about six days after vaccination; further stating he got an all-over sick feeling, like a really bad hangover that never "let up" and lasted 6 days straight. He reported that his head hurt constantly, he had nausea, and it hurt to sit up; he felt horrible. The patient considered going to the emergency room (ER) and ended up seeing his physician yesterday (as of 03Mar2021). He reported that he had not gotten sick in 20 years. The clinical outcomes of got sick after the vaccine/all over sick feeling/felt horrible, head hurt, nausea, hurt to sit up, and really bad hangover were unknown.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at the injection site; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) via an unspecified route of administration on 03Mar2021 at 11:40 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. In Mar2021, the patient experienced soreness at the injection site and no other symptoms. The outcome of the event was unknown.  Information on the batch and lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: she had redness in her face/next day redness in her neck; a little itchy; This is a spontaneous report received from a Pfizer-sponsored program COVAX US Support. A contactable consumer reported a female patient of unspecified age received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date in 2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced redness in her face and slept for the day. The following day the patient had redness in her neck- a little itchy but no bumps. The patient was treated with allergy medications. "It" was gone for about a week and came back again. The outcomes of redness in her face, redness in her neck- a little itchy were unknown.  No follow-up attempts are possible. Information about lot number cannot be obtained.