chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Thyroid function test, Thyroid function test abnormal
Clinical narrative: Caller states her thyroid test results came back spiked; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient would like to know if the Pfizer COVID vaccine would affect the results of blood work for a thyroid test. The patient stated that her thyroid test results came back spiked on an unspecified date. The outcome of the event was unknown.  Information on lot number/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity
Clinical narrative: sore arm; first dose of Pfizer-Biontech Covid19 vaccine on 24Feb2021, and contracted Covid19 on 02Mar2021.; This is a spontaneous reported from a contactable female consumer (patient herself) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an un-specified route of administration on 24Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization.The patient's historic vaccine included Shingrix, which "almost killed me" and when completing the Shingrix series stated the "second one was horrible and The concomitant medications were not reported. The patient received her first dose of Pfizer-Biontech Covid19 vaccine on 24Feb2021, and contracted Covid19 on 02Mar2021. She mentioned she was pleasantly surprised to have just a sore arm. she was glad it was nothing like her experience with Shingrix. She wants to know if she can get her next dose on 17Mar2021 as scheduled. She wants to know if she needs to restart the series, after she gets well. The outcome of the events was un-known. Information on the lot/batch number has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling cold, SARS-CoV-2 test
Clinical narrative: cold feeling in her chest; bordering on chills; lightheaded; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 14Feb2021 (Batch/Lot Number: EL9263) as single dose for covid-19 immunisation. The first dose was received on 24Jan2021 13:15 (lot number: EL3247) on the left arm. There were no medical history. Concomitant medication included curcuma longa (TURMERIC), ubidecarenone (CO-Q10-CHLORELLA), ergocalciferol (VIT D), monascus purpureus (RED YEAST RICE) and vitamin b complex. Patient had not received any other vaccine 4 weeks prior to COVID vaccine. About 2 days after the shot on 16Feb2021 13:15, patient experienced a cold feeling in her chest that lasted all day, bordering on chills, but not to that point. Eventually, the cold feeling was isolated in the center of her chest, and present, off and on during the day. While playing tennis 3-4 times, the cold feeling returned, and patient became lightheaded and had to lie down. It was like a wave that went away and she could return to play. Patient reported that she still have that feeling just under her breastbone. No treatment was received for the events. Outcome of the events was not recovered. Patient was not diagnosed with COVID-19 prior to vaccination and has been tested post-vaccination (nasal swab) on 25Feb2021: negative.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: His husband tested positive after his 1st shot; His husband tested positive after his 1st shot; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 19Feb2021 (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 (husband) tested positive after his 1st shot on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was unknown. The patient was scheduled to receive their second dose on 22Mar2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Fatigue, Neuralgia, Pain, Pain in extremity
Clinical narrative: 44 days post covid positive; 44 days post covid positive; Arm soreness; Body aches; Fatigue; Random nerve pain on sides; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that Covid vaccine given to the patient, 44 days post covid positive. The reported side effects were arm soreness, body aches, fatigue, random nerve pain on sides. Events took place after use of product. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: 44 days post covid positive; 44 days post covid positive; Arm soreness; Body aches; Fatigue; Random nerve pain on sides; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that Covid vaccine given to the patient, 44 days post covid positive. The reported side effects were arm soreness, body aches, fatigue, random nerve pain on sides. Events took place after use of product. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Malaise, Musculoskeletal stiffness, Pain in extremity, Rhinorrhoea
Clinical narrative: her arm was extremely sore; unable to move left side of neck/unable to move arm; She felt unwell like she had the flu/sick; nose running; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), an unspecified route of administration, administered in left arm on 25Feb2021 (at the age of 60-years-old), as single dose for COVID-19 immunisation.  Medical history included lupus from 2018 to an unknown date, Cushing's syndrome from 2018 to an unknown date and ongoing Hashimoto's disease. The patient had also allergies. Concomitant medications included ibuprofen (ADVIL). Patient reported that within 2 minutes of getting the vaccine her nose was running. Two hours later she started to feel unwell. Her nose was still running. She was not sure if this was from the vaccine or because of her allergies. She felt unwell like she had the flu. She was sick and progressively getting worst. She was having reaction to the injection. On 26Feb2021 she woke up around 3:00 am and was unable to move the left side of her neck or her left arm. She still has some neck stiffness. She had small incidences for 3 days after. She felt paralyzed. She was unable to move her arm because it was completely painful. She didn't panic that her arm was extremely sore. She was able to move it. Caller added that she though she had Covid when she got the vaccine and didn't know it. She was sent t an EMS station to be tested. She was given the rapid test on 03Mar2021. Within 15 minutes she was told the result was negative. They sent out another test the same day. On 06Mar2021 she received negative results. She was scheduled to get the second dose on 18Mar2021 at 11:00am. The outcome of events 'she felt unwell like she had the flu/sick' was not recovered, nose running was resolving, unable to move left side of neck was resolved on 28Feb2021, unable to move arm was not resolved, the outcome of other event was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: her arm was extremely sore; unable to move left side of neck/unable to move arm; She felt unwell like she had the flu/sick; nose running; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), an unspecified route of administration, administered in left arm on 25Feb2021 (at the age of 60-years-old), as single dose for COVID-19 immunisation.  Medical history included lupus from 2018 to an unknown date, Cushing's syndrome from 2018 to an unknown date and ongoing Hashimoto's disease. The patient had also allergies. Concomitant medications included ibuprofen (ADVIL). Patient reported that within 2 minutes of getting the vaccine her nose was running. Two hours later she started to feel unwell. Her nose was still running. She was not sure if this was from the vaccine or because of her allergies. She felt unwell like she had the flu. She was sick and progressively getting worst. She was having reaction to the injection. On 26Feb2021 she woke up around 3:00 am and was unable to move the left side of her neck or her left arm. She still has some neck stiffness. She had small incidences for 3 days after. She felt paralyzed. She was unable to move her arm because it was completely painful. She didn't panic that her arm was extremely sore. She was able to move it. Caller added that she though she had Covid when she got the vaccine and didn't know it. She was sent t an EMS station to be tested. She was given the rapid test on 03Mar2021. Within 15 minutes she was told the result was negative. They sent out another test the same day. On 06Mar2021 she received negative results. She was scheduled to get the second dose on 18Mar2021 at 11:00am. The outcome of events 'she felt unwell like she had the flu/sick' was not recovered, nose running was resolving, unable to move left side of neck was resolved on 28Feb2021, unable to move arm was not resolved, the outcome of other event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Was tested positive to Covid-19 twice; Was tested positive to Covid-19 twice; This is a spontaneous report from a Pfizer Sponsored Program. A contactable female consumer (patient) reported for herself that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Feb2021 single dose for COVID-19 immunization. Medical history and concomitant drugs were not provided. The patient was scheduled to get her second shot for Pfizer vaccine on 09Mar2021 but she didn't want to take the Pfizer vaccine in the same facility where she had her first dose because it's too far and she mentioned that she was tested positive to Covid-19 twice. The event outcome was unknown.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: re-occurring shingles that has existed for 20 years/shingles; This is a spontaneous report from a contactable consumer.   A 72-year-old male patient received bnt162b2 (BNT162B2), via an unknown route of administration on Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included ongoing Plaque psoriasis, ongoing Brace user, ongoing Psoriatic arthritis, ongoing Heart disorder, ongoing Pacemaker complication, ongoing guttate psoriasis. Concomitant medications included etanercept (ENBREL) taken for psoriasis, psoriatic arthropathy, ankylosing spondylitis from 2001 to an unspecified stop date; loratadine (LORTAB) taken for an unspecified indication, start and stop date were not reported; clonazepam (KLONOPIN) taken for an unspecified indication, start and stop date were not reported. On an unknown date in Jan2021, the patient received the shingles vaccine for immunisation. On an unknown date in Feb2021 (three weeks ago prior to this report), the patient received the first dose of COVID-19 (coronavirus disease). On 27Feb2021, the patient was diagnosed with shingles. The patient had a case of re-occurring shingles that existed for 20. The patient stated that it always occurred at the base of his spine with a size of a golf ball and he had extreme pain and a deep itch with it. The patient consulted a doctor and he was prescribed acyclovir which he started taking on 28Feb2021. The patient stated that he was now wondering if he should have the second dose of COVID-19 vaccine. It was also reported on an unknown date, the patient was treated with an unspecified antiviral medication. The outcome of the event was recovered on an unspecified date in 2021.  Information regarding lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Rash, SARS-CoV-2 test
Clinical narrative: Severe rash all over body, admitted to hospital; This is a spontaneous report from a contactable other health professional (HCP). A 71-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via intramuscular route in left arm on 09Mar2021 at 12:00 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Feb2021 for COVID-19 immunization. On an unspecified date, the patient experienced severe rash all over body, admitted to hospital. The patient underwent lab tests and procedures which included computerized tomogram: unknown result on an unspecified date, and sars-cov-2 test: negative on 09Mar2021. The patient received an unspecified treatment for the event. The outcome of the event was unknown.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product, a possible contributory role of the suspect product BNT162B2 to the development of event Rash generalised cannot be excluded.  The case will be reassessed if additional information becomes 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: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dehydration, Discomfort, Feeling hot
Clinical narrative: Dehydration; perceived fever. I actually did not have any fever when I checked.; I am toughing it out but it was so uncomfortable; This is a spontaneous report from a contactable consumer (patient himself). A 37-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 11Mar2021 08:30 am (at age of 37-year-old) (Lot Number: EN6203) at single dose  for COVID-19 immunisation. Medical history included obesity and allergic to Penicillin. The patient was diagnosed with COVID-19 prior to vaccination. There were no concomitant medications. The patient experienced dehydration and perceived fever.The patient  actually did not have any fever when he checked. The patient reported 'I am toughing it out but it was so uncomfortable I wanted to make sure I reported it. I feel near where I did my worse days of COVID when I was on oxygen'.  The events start date was 12Mar2021 02:00 am.  The events were reported as non-serious. No treatment received for the events. Since the vaccination, the patient has not  been tested for COVID-19. The outcome of the events was not resolved.          .
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Arm hurt; Chills; Fever; Aches; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose of bnt162b2 (BNT162B2, Pfizer/Biontech Covid-19 Vaccine) via an unspecified route of administration, administered in Arm Left on 09Feb2021 14:00 (Lot Number: EN6201) at single dose for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (Hospital for Covid: Apr2019 - 05May2020), pneumonia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient previously took first dose of bnt162b2 (BNT162B2, Pfizer/Biontech Covid-19 Vaccine, lot number: EJ1686) via an unspecified route of administration, on 19Jan202110:00 AM at single dose for covid-19 immunization and Past drug reaction included night of shot arm hurt so bad I could not sleep, arm still sore, achy, chills, heavy sweat from 19Jan2021 with no Admission to hospital due to event , no treatment received and outcome of recovered. The patient experienced arm hurt on an unspecified date with outcome of unknown , chills on an unspecified date with outcome of unknown, fever on an unspecified date with outcome of unknown, aches on an unspecified date with outcome of unknown. Vaccination facility type was senior Independent Living. No vaccine administered at Military facility. There is no other product(s) that were taken together with those indicated above.   The clinical course was reported as follows: Second shot on 09Feb2021 was a lot worse. Arm hurt but not as bad as first shot. Chills, fever, aches a lot worse. 36 hours very bad.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Malaise, Oropharyngeal discomfort, Peripheral swelling
Clinical narrative: It became very hot and it became black and blue; it bleed and went black and blue; It became very hot and it became black and blue; it bleed and went black and blue; It became very hot and it became black and blue; it bleed and went black and blue; My arm had gotten very swollen; I wasn't feeling well but I was light headed; I felt very fatigue; I wasn't feeling well but I was light headed; I felt very fatigue; I wasn't feeling well but I was light headed; I felt very fatigue; I might have a Strep throat for me; I began to feel my throat bothering me as of today my throat feels raspy; This is a spontaneous report from a contactable consumer (reporting for herself). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6205, expiration date: unknown), via an unspecified route of administration in her right arm on 05Mar2021 as single dose for COVID-19 immunization. The patient medical history included allergy and had prosthetic left knee. Concomitant medications were not reported. The patient previously took tobramycin (NEBRACIN) for unspecified indication and experienced sensitivity. On an unspecified date, the patient reported that when she took the inoculation at that moment she developed a form of a response or reaction rather and they had to put her into the medical cubicle for observation and to treat her at that moment. Her arm had gotten very swollen. It became very hot and it became black and blue, it bleed and went black and blue and she was sitting in the medical cubicle for approximately an hour and a half until the medical staff said that she was really not to be and when she did leave she wasn't feeling well and she was light headed, her breathing was not anyway affected but she felt very fatigue. That itself now was not an issue. They started giving her ice on that particular area where the inoculation took place and she consistently for that an hour and a half used the ice on her right arm until she finally left an hour and a half later. As the weekend preceded, the patient began to feel that her throat bothering her as of today and her throat felt raspy. It was reported that she might and she was not sure because she has not gone to the doctor yet that she might have a Strep throat when she has an allergic reaction to something that her body does not accept very well. The outcome of the events was not recovered.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngitis streptococcal, Vaccination site bruising, Vaccination site haemorrhage, Vaccination site warmth
Clinical narrative: It became very hot and it became black and blue; it bleed and went black and blue; It became very hot and it became black and blue; it bleed and went black and blue; It became very hot and it became black and blue; it bleed and went black and blue; My arm had gotten very swollen; I wasn't feeling well but I was light headed; I felt very fatigue; I wasn't feeling well but I was light headed; I felt very fatigue; I wasn't feeling well but I was light headed; I felt very fatigue; I might have a Strep throat for me; I began to feel my throat bothering me as of today my throat feels raspy; This is a spontaneous report from a contactable consumer (reporting for herself). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6205, expiration date: unknown), via an unspecified route of administration in her right arm on 05Mar2021 as single dose for COVID-19 immunization. The patient medical history included allergy and had prosthetic left knee. Concomitant medications were not reported. The patient previously took tobramycin (NEBRACIN) for unspecified indication and experienced sensitivity. On an unspecified date, the patient reported that when she took the inoculation at that moment she developed a form of a response or reaction rather and they had to put her into the medical cubicle for observation and to treat her at that moment. Her arm had gotten very swollen. It became very hot and it became black and blue, it bleed and went black and blue and she was sitting in the medical cubicle for approximately an hour and a half until the medical staff said that she was really not to be and when she did leave she wasn't feeling well and she was light headed, her breathing was not anyway affected but she felt very fatigue. That itself now was not an issue. They started giving her ice on that particular area where the inoculation took place and she consistently for that an hour and a half used the ice on her right arm until she finally left an hour and a half later. As the weekend preceded, the patient began to feel that her throat bothering her as of today and her throat felt raspy. It was reported that she might and she was not sure because she has not gone to the doctor yet that she might have a Strep throat when she has an allergic reaction to something that her body does not accept very well. The outcome of the events was not recovered.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, T-lymphocyte count, T-lymphocyte count increased
Clinical narrative: blood tests, T-cells are up high; she's having a hard time; This is a spontaneous report from a Pfizer- sponsored program from a contactable consumer (patient). An 85 years old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 09Mar2021 at age of 85 years old at single dose for COVID-19 immunization. Medical history included she had pancreatic cancer 10 years ago and a breast cancer 5 years ago. Concomitant medications were not reported. Patient called to know if it was okay to undergo the following tests namely, CT scan with Dye and Nuclear bone scan as prescribed by her Oncologists due to readings on her blood tests, her T-cells are up high after getting her first dose of the Covid-19 vaccine today morning, 09Mar2021. According to patient she had pancreatic cancer 10 years ago and a breast cancer 5 years ago. Patient was very scared to undergo the Nuclear bone scan as it was something new to her and did not know how her body will react to such tests aside from the fact, she was having a hard time, making an appointment too. Outcome of events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: hurts on his side; This is a spontaneous report received from a Pfizer sponsored Program Support from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient scheduled for the 2nd shot 29Mar2021 (can't drive a car). The 1st shot had side effects (hurts on his side). He wanted to know if he can reschedule. The outcome of the event was unknown.      Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: serious reaction and is on disability. She described it as continuous anaphylaxis; This is a spontaneous report received from a non-contactable consumer. An unspecified aged female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Lot Number: unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history was not provided. Concomitant medications were reported as none. On an unspecified date patient was reported as she received her first Pfizer COVID vaccine and had a serious reaction and is on disability. She described it as continuous anaphylaxis. It was unknown if the patient received any treatment. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen, Prostatic specific antigen increased
Clinical narrative: PSA scores showed an increase to 1.2; This is a spontaneous report from a contactable consumer. This 71-year-old male consumer reported for himself that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose for COVID-19 immunisation. Relevant history included prostate cancer which was previously diagnosed and was undergoing treatment. The patient received his 1st dose of the vaccine (BNT162B2) on 03Feb2021. Relevant concomitant drug was unknown. The patient noted that he had routine blood work done to check the PSA score for his prostate cancer, his previous PSA scores had been 0.1, 0.1, 0.3 respectively, however his most recent score from bloodwork done on 25Feb2021, showed an increase to 1.2. The patient asked if it was possible that the vaccine could have caused an increase or resulted in an incorrect number in his PSA score. The outcome of event 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 COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer (patient) and from a Pfizer-sponsored program. This consumer reported similar events for two patients. This is the first of two reports.  A female patient of an unspecified age (reported as "51", no unit) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included autoimmune disease and "don't have spleen". The patient's concomitant medications were not reported. The patient already previously received flu shot, pneumonia shot. The patient and her husband received the COVID vaccine at the end of Feb2021, on 25Feb2021. Then they recently tested positive for COVID (in 2021) and patient wants to know when they will be able to receive the 2nd dose of the vaccine. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on an unspecified date in 2021. The outcome of the events was unknown. The events are serious (medically significant). Second dose is scheduled between 18 days, 3 days before or days after.  Information about Lot/Batch number is requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021289695 same reporter, product, events, different patient
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; This is a spontaneous report from contactable consumer. This consumer reported for a 52-year-old male patient (reporter's husband). A 52-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6200, expiration date: unknown ) an unspecified route of administration in right arm on 04Mar2021 as SINGLE DOSE for covid-19 immunization. The patient had no medical history and concomitant medications were not reported. The consumer reported that she and her husband received the vaccine on 04Mar2021, clarified as Pfizer Covid-19 vaccine. And stated that her husband woke up with a scratchy throat on thursday but did not think anything of it because moved to a new house surrounded by trees and allergies some days. A lot of mango trees around them. However, apparently he was coming down with COVID. Her husband tested positive for Covid on Monday, 08Mar2021 and that she tested positive for Covid on Tuesday, 09Mar2021. She reported that her husband began to have body aches and headaches on Monday, 08Mar2021. She stated that he began to have all of the normal Covid symptoms, clarified as congestion, cold/flu like symptoms. The body aches started sunday evening and she believes they had resolved completely by tuesday morning as her husband didn't say anything about them. She reported that the headache lasted maybe a day and that she doesn't think it was much of a headache. Her husband just had a little bit of a cough, like a single cough and runny nose resolved when the congestion began. She reported that her husband had stated that he can taste some sweets but can't taste much of anything else. She reported that she believes that the symptoms of not being able to smell or taste have remained the same. Tested positive for covid: The consumer reported that her husband is feeling better already, but he still can't smell or taste anything. She also said that her husband took Tylenol and that one night, either Monday 08Mar2021 or Tuesday 09Mar2021, he took Nyquil. Caller reported that her husband probably took the Nyquil on Monday, 08Mar2021. She stated that it helped his symptoms. The event considered non-serious by the reporter. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 08Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
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 from a Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, on 23Feb2021, as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient was scheduled for knee surgery. Prior to having knee surgery, the patient had to get a COVID test. The patient got the COVID test and on 08Mar2021 he tested positive for COVID. Therefore, they had to cancel the knee surgery. The patient was scheduled to have the next COVID shot on 16Mar2021 and they are calling to get advice. They want to know what they should do about the next vaccine and if they should reschedule. Outcome was unknown.  Information about Batch/Lot number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in hands and feet Intermittent; This is a spontaneous report from a contactable other health care professional reported for herself. A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot unknown) via unspecified route of administration in left arm on 19Feb2021 12:30 AM at age of 51 years old at single dose for COVID-19 Immunization. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies reported. Other medications the patient received within 2 weeks of vaccination included Natasia (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previous received the first dose of BNT162B2 in left arm on 22Jan2021 12:30 AM at age of 51 years old for Covid-19 Immunization. Patient experienced numbness in hands and feet intermittent on 22Feb2021. Since the vaccination, the patient had not been tested for COVID-19. The report was reported as non-serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Patient was not received treatment for the adverse event. Outcome of events was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain in his hip joint; This is a spontaneous report received from a contactable other HCP via Pfizer sales representative.A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. His father experienced pain in his hip joint within one week of his BNT162b2 vaccination. Outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: skin asthma; This is a spontaneous report from a Pfizer- sponsored program via a contactable consumer (patient). 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 at single dose for COVID-19 immunization. Medical history included hypertension and diabetes, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced skin asthma on an unspecified date with outcome of unknown. Clinical course reported as follow: patient received his first dose of the vaccine 2 weeks ago and he was scheduled for his second dose on 11Mar2021. He was taking medication for his hypertension and diabetes. As per him, he didn't stop taking these medications even though he received the 1st dose of the vaccine. Aside from this, he experienced skin asthma from the past two weeks after taking the 1st dose of the vaccine and he took medication for his skin asthma yesterday (08Mar2021).  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got the first dose then got positive to Covid-19; got the first dose then got positive to Covid-19; This is a spontaneous report received from Pfizer sponsored program. A contactable consumer (patient's sister) reported that a male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiry date unknown) via an unspecified route of administration on an unknown date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter was calling on behalf of her brother (patient) and inquiring if you got the first dose and after you got positive to Covid-19 are you allowed to get the vaccine. Her brother got the first dose then got positive to Covid-19 on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: After the 1st shot I notice the rash started to go away.By the time I got the second the rash was gone; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Feb2021 (as first dose) at single dose, on 03Mar2021 (as second dose) at single dose for COVID-19 immunisation. Medical history included rash on arms and scalp. The patient's concomitant medications were not reported. The patient had a rash on arms and scalp that would come and go for over a year that doctors were just giving patient assorted creams for. It never went away. The patient took 1st COVID vaccine on 10Feb2021 and the 2nd on 03Mar2021. After the 1st shot the patient notice the rash started to go away. By the time the patient got the second the rash was gone and so far had not returned. The patient did not know if it was coincidence or something to do with the vaccine. The outcome of event was recovered on unknown date.  Information related to batch/lot number could not be requested; No follow-up attempts are needed.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sponsored program .  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Mar2021 at single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient experienced allergic reaction on Mar2021. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Heart rate, Heart rate increased, Hypertension
Clinical narrative: allergic reaction; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sponsored program .  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Mar2021 at single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient experienced allergic reaction on Mar2021. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: allergic reaction; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sponsored program .  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Mar2021 at single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient experienced allergic reaction on Mar2021. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Stress
Clinical narrative: shingles after first dose; stress; This is a spontaneous report from Pfizer sponsored program. A non-contactble consumer (patient) reported that a patient of unspecified age and gender received bnt162b2 (BNT162B2), 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 patient experienced shingles after first dose on an unspecified date with outcome of unknown, stress on an unspecified date with outcome of unknown. Reported patient was due to receive the second dose of the covid-19 vaccine, patient was diagnosed with shingles after first dose, caller thought shingles was due to stress, caller was inquiring if patient can receive vaccine for shingles and the second dose of the covid-19 vaccine.       No follow-up attempts possible Information related to batch/lot no. could not be requested
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Pyrexia
Clinical narrative: She was experiencing headaches, joint pain, and fever; She was experiencing headaches, joint pain, and fever; She was experiencing headaches, joint pain, and fever; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer reported for a female patient of an unspecified age received COVID-19 vaccine (UNSPECIFIED TRADE NAME), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was experiencing headaches, joint pain, and fever on an unspecified date with outcome of 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: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a Pfizer-sponsored program Covax US Support. A contactable consumer (patient herself) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unknown date (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was  due to have 2nd dose on Sunday (14Mar2021) but tested positive (05Mar2021). She wanted to know when she can take the 2nd dose.  The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 05Mar2021. The event outcome was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received 1st shot on 24Feb and went COVID-19 positive; Received 1st shot on 24Feb and went COVID-19 positive; This is a spontaneous report received from a Pfizer sponsored program from a contactable consumer (wife). A male patient of an unspecified age, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 24Feb2021 as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. On an unknown date in 2021 after receiving the first dose, the patient was COVID-19 positive. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer.   A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), dose 2 via an unspecified route of administration on 04Mar2021, at 13:15 as single dose for covid-19 immunization.  Medical history included Crohn's disease from an unknown date. Concomitant medication included adalimumab (HUMIRA AC) taken for an unspecified indication, start and stop date were not reported.  The patient previously took codeine and experienced allergy and BNT162B2  for covid-19 immunization on 11Feb2021.  On 04Mar2021, the patient experienced sore arm approximately six hours after injection. Prior to vaccination, the patient had not been diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19. The outcome of sore arm was recovered in Mar2021.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site; This is a spontaneous report from a contactable consumer reported for herself. This 58-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3247) via an unspecified route of administration in the left arm on 01Mar2021 02:45 PM at 58 years old at single dose for COVID-19 immunisation.  Medical history was unknown. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included daily vitamins received within 2 weeks of vaccination. The patient experienced pain at injection site on 02Mar2021 at 12:00 PM. No treatment was received for the adverse event. Since the vaccination, the patient had not been tested for COVID-19. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of the event was recovered. Seriousness was reported as non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Lingering lower back pain /My back hurts; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 11Mar2021 (at the age of 37 years old) at a single dose for COVID-19 immunization.  Vaccination was done in a hospital. Medical history was reported as none. Concomitant medications included acetylsalicylic acid, caffeine (BC), biotin, vitamin d [vitamin d nos], zinc, selenium and cyanocobalamin (B12), all taken for an unspecified indication, start and stop date were not reported. On 12Mar2021, the patient experienced lingering lower back pain/my back hurts. It was reported that the patient's back hurts and she did not want to get up to get her card. She experienced lingering lower back pain. Today was 5 days later. Still painful. It was also reported that the event has caused disability/permanent damage. No treatment was received. There was no other vaccine in four weeks, no COVID prior vaccination, not COVID tested post vaccination, and has no known allergies. The outcome of the event was not recovered.  Information about lot/batch number has been requested.