chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Disturbance in attention, Memory impairment, Thinking abnormal
Clinical narrative: She began to have the memory issues and are progressively getting worse; And I cannot think ,I do not want to think; She began to have the memory issues and are progressively getting worse; I have a problem with my attention, cannot pay attention; This is a spontaneous report received from Pfizer sponsored program Support from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported, NDC number was not reported) dose 2 via an unspecified route of administration on 19Apr2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. Historical vaccine included BNT162B2 dose 1 on an unspecified date for COVID-19 immunisation. No other product was given. No investigation assessment was reported. On Jul2021 the patient experienced she began to have the memory issues and are progressively getting worse, and I cannot think, I do not want to think, I have a problem with my attention, cannot pay attention. No PQC was present. The Patient stated that after the second dose, for the last 4 weeks, she had been having memory issues and attention issues. She can't not think and does not want to think but she has lots to do. On her own she did a study where she spoke to 2 friends who are having similar issues. One was a friend and the other was a young healthcare provider. They reported memory issues but not attention problems. These are things she was ashamed of, that she cannot remember what she was supposed to do or not do. She wants us to know there are more side effects other than physical ones. She wanted Pfizer to know that there are other things going on. She never had memory issue until the vaccine. The caller disconnected prior to the conference of the call: Agent explains the caller was reluctant to provide any information on herself for the report, she declined her last name and address. The clinical outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Malaise, Pyrexia
Clinical narrative: chills; I am running like a 99 fever; headache; I don't feel good; This is a spontaneous report from a contactable consumer, the patient. A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0198), via an unspecified route of administration on 05Aug2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 06Aug2021, the patient experienced chills, running like a 99 fever, headache and did not feel good. The reporter stated that she did not feel good hence she go on and took something to get rid of her headache that could lower her fever so she would feel better. The outcome of the events was not recovered.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Autonomic nervous system imbalance, Balance disorder, Blood pressure fluctuation, Chest discomfort
Clinical narrative: Sore arm; fatigued; foggy; Off balance; Diarrhea; Short of breath; chest tightness; dysautonomia; Low BP readings to high BP readings; Feel crummy; High heart rate days 7 onward post vaccine.; High blood pressure; This is a spontaneous report from a contactable consumer or other non hcp. A 54-years-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: Not Known, Expiration Date: not reported), dose 1 via an unspecified route of administration, administered in Arm Right on (Age at vaccination 54 Years) 28Jul2021 11:45 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included blood pressure increased, covid-19 from 27Jul2020 to an unknown date recovered. Concomitant medication(s) included telmisartan (TELMISARTAN) taken for blood pressure measurement. Prior to vaccination, patient diagnosed with COVID-19. Since the vaccination, patient was not been tested for COVID-19. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccin. The patient received other medications within 2 weeks of vaccination is Blood pressure med telemesartan. Clinical course follows as 19 days post vaccine symptoms. I have long covid and this flared my long covid.  First three days were textbook symptoms. Sore arm, fatigued, foggy.  Then starting days 5 onward I literally went through long covid again.  Blood pressure seriously went crazy day 8 onward past vax.  Low BP readings to high BP readings.  Bottom number the systolic moved up 10-18 points for 10 days.  Heart rate increased. About 15 points for 2 weeks.  And I'm on blood pressure medication!!!!    Felt dysautonomia return.  Off balance post shot 1 for a week.  Diarrhea for a few days.  Short of breath returned for 2 days.  Then chest tightness returned for 4 days.  Still have a little.  No this was not psychological.  This was real. Very real.  Start of day 19 post vaccine I'm starting to feel a bit more like Pre vaccine baseline. On 29Jul2021 12:00, The patient experienced high heart rate days 7 onward post vaccine, high blood pressure, On Aug2021, feel crummy and low bp readings to high bp readings, dysautonomia, On 01Aug2021, sore arm, fatigued, foggy, off balance, diarrhea, short of breath, chest tightness. The patient underwent lab tests and procedures which included antibody test: none on I had antibodies going into the vaccine with a lab Corp semi quantitative Covid antibody titer score of 18 going into shot 1, sars-cov-2 test: positive on 27Jul2020. No treatment was received. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events high heart rate days 7 onward post vaccine, high blood pressure, feel crummy was not recovered and remaining events are recovering.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Fatigue, Feeling abnormal, Heart rate increased
Clinical narrative: Sore arm; fatigued; foggy; Off balance; Diarrhea; Short of breath; chest tightness; dysautonomia; Low BP readings to high BP readings; Feel crummy; High heart rate days 7 onward post vaccine.; High blood pressure; This is a spontaneous report from a contactable consumer or other non hcp. A 54-years-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: Not Known, Expiration Date: not reported), dose 1 via an unspecified route of administration, administered in Arm Right on (Age at vaccination 54 Years) 28Jul2021 11:45 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included blood pressure increased, covid-19 from 27Jul2020 to an unknown date recovered. Concomitant medication(s) included telmisartan (TELMISARTAN) taken for blood pressure measurement. Prior to vaccination, patient diagnosed with COVID-19. Since the vaccination, patient was not been tested for COVID-19. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccin. The patient received other medications within 2 weeks of vaccination is Blood pressure med telemesartan. Clinical course follows as 19 days post vaccine symptoms. I have long covid and this flared my long covid.  First three days were textbook symptoms. Sore arm, fatigued, foggy.  Then starting days 5 onward I literally went through long covid again.  Blood pressure seriously went crazy day 8 onward past vax.  Low BP readings to high BP readings.  Bottom number the systolic moved up 10-18 points for 10 days.  Heart rate increased. About 15 points for 2 weeks.  And I'm on blood pressure medication!!!!    Felt dysautonomia return.  Off balance post shot 1 for a week.  Diarrhea for a few days.  Short of breath returned for 2 days.  Then chest tightness returned for 4 days.  Still have a little.  No this was not psychological.  This was real. Very real.  Start of day 19 post vaccine I'm starting to feel a bit more like Pre vaccine baseline. On 29Jul2021 12:00, The patient experienced high heart rate days 7 onward post vaccine, high blood pressure, On Aug2021, feel crummy and low bp readings to high bp readings, dysautonomia, On 01Aug2021, sore arm, fatigued, foggy, off balance, diarrhea, short of breath, chest tightness. The patient underwent lab tests and procedures which included antibody test: none on I had antibodies going into the vaccine with a lab Corp semi quantitative Covid antibody titer score of 18 going into shot 1, sars-cov-2 test: positive on 27Jul2020. No treatment was received. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events high heart rate days 7 onward post vaccine, high blood pressure, feel crummy was not recovered and remaining events are recovering.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Sore arm; fatigued; foggy; Off balance; Diarrhea; Short of breath; chest tightness; dysautonomia; Low BP readings to high BP readings; Feel crummy; High heart rate days 7 onward post vaccine.; High blood pressure; This is a spontaneous report from a contactable consumer or other non hcp. A 54-years-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: Not Known, Expiration Date: not reported), dose 1 via an unspecified route of administration, administered in Arm Right on (Age at vaccination 54 Years) 28Jul2021 11:45 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included blood pressure increased, covid-19 from 27Jul2020 to an unknown date recovered. Concomitant medication(s) included telmisartan (TELMISARTAN) taken for blood pressure measurement. Prior to vaccination, patient diagnosed with COVID-19. Since the vaccination, patient was not been tested for COVID-19. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccin. The patient received other medications within 2 weeks of vaccination is Blood pressure med telemesartan. Clinical course follows as 19 days post vaccine symptoms. I have long covid and this flared my long covid.  First three days were textbook symptoms. Sore arm, fatigued, foggy.  Then starting days 5 onward I literally went through long covid again.  Blood pressure seriously went crazy day 8 onward past vax.  Low BP readings to high BP readings.  Bottom number the systolic moved up 10-18 points for 10 days.  Heart rate increased. About 15 points for 2 weeks.  And I'm on blood pressure medication!!!!    Felt dysautonomia return.  Off balance post shot 1 for a week.  Diarrhea for a few days.  Short of breath returned for 2 days.  Then chest tightness returned for 4 days.  Still have a little.  No this was not psychological.  This was real. Very real.  Start of day 19 post vaccine I'm starting to feel a bit more like Pre vaccine baseline. On 29Jul2021 12:00, The patient experienced high heart rate days 7 onward post vaccine, high blood pressure, On Aug2021, feel crummy and low bp readings to high bp readings, dysautonomia, On 01Aug2021, sore arm, fatigued, foggy, off balance, diarrhea, short of breath, chest tightness. The patient underwent lab tests and procedures which included antibody test: none on I had antibodies going into the vaccine with a lab Corp semi quantitative Covid antibody titer score of 18 going into shot 1, sars-cov-2 test: positive on 27Jul2020. No treatment was received. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events high heart rate days 7 onward post vaccine, high blood pressure, feel crummy was not recovered and remaining events are recovering.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection
Clinical narrative: Ear infection; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 10Jul2021 at 10:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 03Aug2021 the patient experienced an ear infection. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ear infection was not recovered at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Ear pain, Malaise, Pain, Pain in extremity
Clinical narrative: Chest aches; Legs and whole body hurts; Legs and whole body hurts; Left ear hurts; Not feeling well; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for a male patient (reporter's husband).   A male patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/lot number unknown) via an unspecified route of administration on 05Aug2021 as DOSE 2, SINGLE for COVID-19 Immunisation. The patient's medical history and concomitant medications were not reported. He previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/lot number unknown) via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for COVID-19 Immunisation. The patient was not feeling well, chest aches, legs and whole body hurts and left ear hurts. Reporter agreed that she will contact her husband's healthcare provider and she stated that patient got the second vaccine on the previous day of reporting. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: the arm that I got my shot, in my arm, it just keep shaking; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced the arm that I got my shot, in my arm, it just keep shaking. The patient was having side effects from the shot so, where the arm that the patient got shot started really shaking; The patient got shot, in arm, it just kept shaking. The clinical outcome for the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Overdose, Product preparation issue
Clinical narrative: Patient got a higher dose than the recommended because of the mistake while mixing the diluent to the vaccine; Patient is really nervous about it; Patient got a higher dose than the recommended because of the mistake while mixing the diluent to the vaccine; Patient is really nervous about it; Patient is really nervous about it; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19-19 mRNA VACCINE, Solution for injection, Lot number: FC3181, Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, caller stated, caller had question about the Covid Vaccination that's why was calling and not sure if you can answer it but really need answer for a patient (consumer), the patient got a higher dose than the recommended because of the mistake while mixing the diluent to the vaccine. The patient had been contacted and everything, but the patient wanted to know what she should do. What is the consequence if the higher than the recommended dose was given by mistake, so she trying to find an answer for her because she was really nervous about. She had called earlier they said that had to call back Monday but the patient said that it is an Emergency situation and needed answer and should had a way to find somebody who can answer that question to her. When paraphrased the concern, reporter stated, Yes if there is any evidence on like what happens if it is ok or should she be worried about or shouldn't worry things like that. As reporter was not willing to proceed the call. Caller stated, somebody had already taken her information his name was withheld, so don't think, I really have to go to help the customers. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dysphonia, Malaise, Pain, Pyrexia
Clinical narrative: Low grade fever; Chills; Runny nose; Body aches; Not feeling well right now; voice not clear; This is a spontaneous report from a contactable consumer (patient). An unspecified age and unspecified gender of patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 02Aug2021as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and the patient's concomitant medications were not reported. In 2021 the patient had experienced low grade fever, chills, runny nose, body aches, not feeling well and things that (voice not clear). The reporter wanted to know how long these side effects are going to last. The outcome of the events were not recovered.  QR Comment: Reporter type could not be probed as the consumer was unwilling to share any further information, hence captured by default as Consumer or other non-health professional in tab.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.  Follow Up (26Aug2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Low grade fever; Chills; Runny nose; Body aches; Not feeling well right now; voice not clear; This is a spontaneous report from a contactable consumer (patient). An unspecified age and unspecified gender of patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 02Aug2021as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and the patient's concomitant medications were not reported. In 2021 the patient had experienced low grade fever, chills, runny nose, body aches, not feeling well and things that (voice not clear). The reporter wanted to know how long these side effects are going to last. The outcome of the events were not recovered.  QR Comment: Reporter type could not be probed as the consumer was unwilling to share any further information, hence captured by default as Consumer or other non-health professional in tab.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.  Follow Up (26Aug2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Aug2021 at 16:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included depression and anxiety. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included clonazepam (KLONOPIN), vortioxetine hydrobromide (TRINTELLIX), vitamin d nos (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN) and metoprolol (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. On 05Aug2021 at 07:00, the patient experienced vomiting. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken for the reported event. The clinical outcome of the event vomiting was resolved on an unknown date in Aug2021.
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: she began to have the memory issues and are progressively getting worse; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, in the last 4 weeks she began to have the memory issues and are progressively getting worse. Caller states that prior to taking the Pfizer COVID vaccine she never had issue with memory. Patient describes her issues as follows, she had a problem with her attention and cannot think, do not want to think, and had a lot of things to do. Patient was ashamed that she cannot pay attention or remember what she was supposed to do. Patient had spoken to other people, she did her own study.  Follow-up attempts are needed. Information on the lot/batch number is expected.
Sex: U
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: I did my own study and spoke to a few people and, my friend has a problem/ memory issues too; This is a spontaneous report from a contactable consumer or other non-HCP (patient friend) via Medical Information Team. A patient of unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient experienced problem/memory issues but not attention problems on an unspecified date. The outcome of the event was unknown.    Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Nervousness, Pruritus, Rash
Clinical narrative: I am freaking out and a little concerned; I can't be that bad when I am nervous; Rash; I noticed itching in my arm; This is a spontaneous report from a contactable consumer or other non hcp.    A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot Number: EW0176) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient had experienced that rash, I noticed itching in my arm and I am freaking out and a little concerned; I can't be that bad when I am nervous. Consumer stated that on Wednesday around 2 pm, patient started to develop a rash like just within last couple of hours with lot of itching, the itching was being going on. Patient did not know a few hours, he/she did not even notice it at first might be it 6 hours, but there was like 2 days ago basically, he/she was a little bit freaking out but not completely did not worry. Consumer stated that It had been itching about several hours at least 6 hours, probably before that patient noticed he/she had itching in his/her arm. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: A little bit of trouble breathing; not breathing as I was/some problems with breathing/I need to deep breathe; Heaviness in my chest/tightness of the chest; This is a spontaneous report from a contactable consumer (Patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0175 and Expiry date was not reported), via an unspecified route of administration on 06Aug2021 (at the age of 60-years-old), in Arm left as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient did not receive any prior vaccination within 4 weeks. Patient received first dose of Pfizer Covid Vaccine on 06Aug2021 and since then she have heaviness in her chest and a little bit of trouble breathing. She was not breathing as well as she was just wondering if that was something that will go away within a few days or should she be concerned that this was going to be continuous. Patients weight was around 140 pounds. (Further not clarified. Hence, not captured in the tab). She had been having some problems with breathing and tightness of the chest. Patient was calling because she have been having short heaviness in her chest. She have been having some difficulties. Ever so often she need to deep breathe and have been yawning a lot. She was asking if this was normal, will it continue and how long will it last. States it started right after the shot. The patient was not received the treatment for the adverse events. The outcome for the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sometime just have aches and some pains like in your feet and like in legs may be; Sometimes I have ache and pains like in your feet your legs, and something like that; This is a spontaneous report from a contactable consumer. This was reported by consumer (patient). A patient of an unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified rout of administration on 05Aug2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced aches and some pains like in your feet and like in legs may be, sometimes had ache and pains like in feet and reported that "aches and some pains like in your feet and like in legs may be; Sometimes I have ache and pains like in your feet your legs, and something like that  and stated that was just wondering to people sometimes tells, I had a one of your first Covid shot Pfizer and I was, on Thursday and I was wondering the sometime just have aches and some pains like in your feet and like in legs may be. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: My injection site is really swollen on my arm; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that:  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration, administered on Arm on 05Aug2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Aug 2021, the patient had my injection site is really swollen on my arm. At the time of reporting, the outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Oligomenorrhoea
Clinical narrative: menstrual cycle has been very long and heavy; menstrual cycle has been very long and heavy; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FC3180) via an unspecified route of administration on 30Jul2021 as single dose for COVID-19 immunisation. Patient medical history and concomitant medications was not reported. The patient had first (dose) Vaccine shot on Friday (30Jul2021). She received her menstrual cycle that following week (Aug2021) and her menstrual cycle had been very long and heavy and she was not sure if it was because of the Pfizer vaccine. The patient was calling to figure out this. Outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: under my arm on the lymph node are swollen; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was Unknown), via an unspecified route of administration on 05Aug2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced under my arm on the lymph node are swollen. The patient stated that "I had a Pfizer shot on Thursday and under my arm on the lymph node were swollen and I know was that was it was normal for do that and how long its takes for that swelling to go away or do I need to have it checked". Reporter seriousness for under my arm on the lymph node are swollen was unspecified. The patient stated will just call regular physician. The case is not related to a study or programme. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pyrexia
Clinical narrative: my fever spikes up to like 102; Diarrhea; Headache; This is a spontaneous report from a contactable consumer (patient).  A patient of an unspecified age and gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 03Aug2021 (lot number: EW0171), at an unknown route, dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced my fever spikes up to like 102, diarrhea and headache. The patient laboratory investigation included fever was 102 on Aug2021 date. The patient started spiking a fever like four days after took the shot. Took the COVID-19 shot on Tuesday and had headache since then and then started spiking the fever yesterday which is four days after taking the shot and some like passing diarrhea but fever spikes up to like 102. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine with aura
Clinical narrative: Auras in both eyes occurred followed by a headache.; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Apr2021 at 15:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included Grave's disease. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and prenatal vitamins (unspecified); both for unknown indication from unknown date and unknown if ongoing. On 22Apr2021 at 12:30 (also reported as one day after vaccination), the patient experienced auras in both eyes that occurred followed by a headache. This happened once a day for the next three days. Four days passed and then it happened again. The patient stated sometimes weeks go by before it happened again. It still happened as of today (at the time of the report). The patient never had migraines and this had never happened before the vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event auras in both eyes occurred followed by a headache was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Colonoscopy, Mammogram, Neck mass, Neck pain
Clinical narrative: Caller states soon after the vaccine, she had a painful lump on her neck; Caller states soon after the vaccine, she had a painful lump on her neck; This is a spontaneous report from a contactable consumer or other non-healthcare professional reported about herself (patient).    A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration as dose 1, single on unspecified date in Mar2021 (at the age of 48-year-old) for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date in 2021, the patient experienced painful lump on her neck soon after the vaccine. As per reporter, patient had already received both shots of the Covid vaccine a few months ago and completed the vaccine last on unspecified date in Mar2021. Patient experienced a painful lump on her neck soon after the vaccine. Around Mar2021 or Apr2021, there had already been a lump and it won't go away, so she went to the doctor. Patient had many tests and had ruled had out everything, including a mammogram, colonoscopy, and a biopsy and all were negative for cancer, but the lump was still there. The patient reported that she wasn't bothered by the lump but instead of the pain. Patient also felt strain and pain in the arm where she got the 2nd shot. Patient reported she felt non-stop pain at back of her neck, head, shoulder blades, and the arm and was not going away. Patient had every test possible. The patient took ADVIL and tried warm compress to relive the pain, but it still would not go away. The patient informed that this has been affecting her day to day in general and had concern if this was a lifelong pain. Patient asked if she can be on the clinical trial mentioned -How long side effects last (v3.0) from the paragraph which read "The safety evaluation of participants was still ongoing. The report was not related to a study or program. Patient questioned do other people have this, how long do they have it, was this a short term or long-term effect. Treatment was received for the events. At the time of this report, outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Rash
Clinical narrative: Rash under his eyes and on his feet/broke out in a rash under his eyes/ his feet; face feels like it's on fire; This is a spontaneous report received from a contactable consumer (patient's girl friend) reported that. A 38-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection) via an unspecified route of administration on Aug2021 (at the age of 38-year-old) (Batch/Lot number: Not provided) as single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. It was mentioned that consumer was calling on behalf of her boyfriend who received his first dose of the Pfizer COVID-19 vaccine last week and he developed rash under his eyes and on his feet, and his face feels like it's on fire on 08Aug2021. Caller was seeking information on treatment recommendations and if this was normal. Informed caller that company was unable to make treatment recommendations for individual patients and referred to HCP for medical advice. Informed caller that I can verify if this AE has been reported per Prescribing Information, but caller declined and stated that she will just call his doctor. The events was non-serious. Outcome of events was unknown.  Follow-up attempts are completed. No further information is expected; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: I am feeling like I have a sinus infection; This is a spontaneous report from a contactable consumer (patient).  A patient of an unspecified age and gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at an unknown route, 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced feeling like I had a sinus infection. The outcome of event was unknown.  Information on the lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Feeling abnormal, Headache, Heart rate, Heart rate increased
Clinical narrative: Extreme headache; Vomiting; fast heart rate; Chest pain; having a bad reaction; This is a spontaneous report from a contactable consumer. A male patient (son) of unspecified age and gender received Pfizer Covid 19 (BNT162B2) (Batch/Lot number: FA7484, Expiration date: Unknown), on 06Aug2021 on left upper arm as Dose 2 single for covid 19 immunization. The patient had not affected with covid19 before or after vaccination. Medical history and Concomitant medications were not reported. Patient previously received first dose of BNT162B2 on an unspecified date as Dose 1,Single for Covid 19 immunisation. On an unspecified date in Aug2021 patient experienced Extreme headache, vomiting, fast heart rate, chest pain and also having a bad reaction and also stated if they can spend the time to go through all that and they did not know where the pen was at it was middle of night and were not at home as they were travelling on vacation. Reporter also mentioned they were not sure that they should take their son to the emergency room or not. Reporter stated that patient had not experienced nausea. No therapeutic treatments were received. On an unspecified date in Aug2021 Lab test included heart rate(fast). The outcome of the events were reported as unknown.  Follow-up attempts completed. No further information expected
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Extreme headache; Vomiting; fast heart rate; Chest pain; having a bad reaction; This is a spontaneous report from a contactable consumer. A male patient (son) of unspecified age and gender received Pfizer Covid 19 (BNT162B2) (Batch/Lot number: FA7484, Expiration date: Unknown), on 06Aug2021 on left upper arm as Dose 2 single for covid 19 immunization. The patient had not affected with covid19 before or after vaccination. Medical history and Concomitant medications were not reported. Patient previously received first dose of BNT162B2 on an unspecified date as Dose 1,Single for Covid 19 immunisation. On an unspecified date in Aug2021 patient experienced Extreme headache, vomiting, fast heart rate, chest pain and also having a bad reaction and also stated if they can spend the time to go through all that and they did not know where the pen was at it was middle of night and were not at home as they were travelling on vacation. Reporter also mentioned they were not sure that they should take their son to the emergency room or not. Reporter stated that patient had not experienced nausea. No therapeutic treatments were received. On an unspecified date in Aug2021 Lab test included heart rate(fast). The outcome of the events were reported as unknown.  Follow-up attempts completed. No further information expected
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen armpits on the side of his injections site; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution of injection Lot Number: UNKOWN), via an unspecified route of administration, administered in Arm Left 06Aug2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. In Aug 2021, had swollen armpits on the side of his injection site which was his left arm (lymphadenopathy). He stated that he had the packet that mentioned swollen lymph nodes and wanted to know how he could treat it. The clinical outcome of the armpits on the side of his injections site was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pain in extremity, Tremor
Clinical narrative: Initially she had only hurt in her arm; came down with shaking; she started having all of the pain in her upper stomach and her lower stomach that had escaladed; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 03Aug2021 as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included surgery from Dec2020 to an unknown date she had surgery in DEC2020 that turned into a nightmare and it took her 3.5 months before making some progress, vaginal lesion from an unknown date and unknown if ongoing, precancerous lesion of digestive tract from an unknown date and unknown if ongoing, immunodeficiency from an unknown date and unknown if ongoing, hysterectomy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient previous received flu vaccine for influenza and pneumonia vaccine for pneumonia (STREPTOCOCCUS PNEUMONIAE) on unspecified date for immunisation. On 03Aug2021 the patient experienced initially she had only hurt in her arm, came down with shaking, she started having all of the pain in her upper stomach and her lower stomach that had escaladed.  The outcome of the events pain in extremity, tremor, abdominal pain upper was recovered.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Reading disorder
Clinical narrative: I can't read; My back has been hurting really bad; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, , Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced i can't read, my back has been hurting really bad. After vaccination they gave me a list of side effects, but I can't read. My back has been hurting really bad since then. Is that a side effect to the shot?" The outcome of both events was not recovered.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pain in extremity
Clinical narrative: My stomach was hurting pretty bad, it's kind of like if you have gas; My left arm, it's got sore for about 3 days went away; This is a spontaneous report from a contactable consumer (patient). An 84-years-old patient of unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0167, expiry date: un-known) via unspecified route of administration, on 05Aug2021, as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 via unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation, and got sore (my first and second shot in my left arm, it's got sore for about 3 days went away). Patients medical history and concomitant medications were not reported. After second dose, on an unspecified date in Aug2021, patient got sore for about 3 days went away. This morning five days from last shot, patient woke up and stomach was hurting pretty bad, it's kind of like if you have gas, your stomach will be when you have gas, okay and patient never had a stomach ache in morning. Patient was 84 years old and was just curious as to whether a similar problem might have been reported on this, as such. The outcome of event for pain in arm was recovered on an unspecified date in Aug2021, and stomach ache it was unknown.    .
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My left arm, it's got sore for about 3 days went away; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). An 84-year-old patient of an unspecified gender received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (Lot Number: EW0167, Expiration date: unknown), as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after the first dose of vaccination, the patient experienced left arm got sore for about 3 days went away. The clinical details of the event as follows: Patient had been doing very well all the time, first and second shot in, patient left arm, it is got sore for about 3 days went away and that is all patient had experienced. The patient outcome of the event was resolved on an unspecified date in 2021.  QR Comment: Reporter type could not be probed as the consumer was unwilling to share any further information, hence captured by default as Consumer or other non-health professional in tab.  No follow-up attempts are possible. No further information is expected.