chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis reactive
Clinical narrative: reactive arthritis; joint pain; This is a spontaneous report from a contactable other healthcare professional.  An 80-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient experienced reactive arthritis on an unspecified date with outcome of unknown, and joint pain on an unspecified date with outcome of unknown.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information. 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.,Linked Report(s) : US-PFIZER INC-202101133832 Same Reporter/Patient/AE/Drug, Different Vaccine Dose
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I was diagnosed with COVID-19 yesterday; I was diagnosed with COVID-19 yesterday; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot/batch number and expiration date not reported), via an unspecified route of administration on 15Mar2021 at 17:00 (at the age of 41-year-old) at single dose for COVID-19 immunisation in hospital. Medical history included high blood pressure, restless leg syndrome, and allergy to Sulfa drugs. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included Lisinopril and Ropinirole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she was diagnosed with COVID-19 yesterday on 28Aug2021 at 06:00. Events resulted in emergency room/department or urgent care. Since the vaccination, patient had been tested for COVID-19 via Blood test and nasal swab both on 29Aug2021, the results were Positive for both. Therapeutic measures were taken as a result of the events included regeneron and a lot of medications. The outcome of the events was not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Hypotonia, Movement disorder
Clinical narrative: left hand was flopping like someone had a stroke; no control over his hand or fingers; he had the Pfizer booster shot yesterday; This is a spontaneous report from contactable consumer. 87-years-old male patient received bnt162b2 (BNT162B2), dose 3 (booster shot) via an unspecified route of administration, administered in Arm Left on 29Aug2021 14:00 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation. Medical history included 12 years ago that he had heart surgery and it worked and his heart works. Concomitant medications were not reported.  Stated that that he had the Pfizer booster shot yesterday (29Aug2021), that it was refrigerated yesterday and they had to mix it which he did not know that they had to do. Stated that he got the first two shots in (withheld) in large campus like environment. Stated that he is fine, can open and close fist. Stated that they may want to send him to someone to perform exercises.Caller reports he received the booster dose 29Aug2021 at 1400. Caller says "I would say I am in good health". Caller received his booster dose in his left arm; he reports on 30Aug2021, his left hand was flopping around like someone who has had a stroke, he had no control over his hand or fingers. He reports the "flopping" has resolved today and he wanted to know if this side effect had been reported. Caller wants to know if he is an outlier with this side effect and wanted to ensure he reported this side effect. The outcome of the events was recovered on the same day, while the booster dose was unknown.          The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. .
Sex: M
Vaccine: COVID19
Symptoms: Erection increased
Clinical narrative: when he has sex with his girlfriend his penis stays erect; This is a spontaneous report from a contactable consumer. A 30-Year-old male consumer (patient) reported for himself that:  A 30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 30Aug2021 as DOSE 2, SINGLE for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced when he has sex with his girlfriend his penis stays erect. The clinical outcome of event was unknown.   The caller declines to file a safety report. No further information is provided or obtained.   The lot number for the vaccine, [BNT162B2], was not provided and will be re-quested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Lymphadenopathy, Peripheral swelling, Ultrasound Doppler
Clinical narrative: swollen inguinal lymph nodes; bilateral leg swelling; This is a spontaneous report from a contactable consumer or other non hcp. A 68- Years-old  female patient of received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6201) via an unspecified route of administration, administered in Arm Left on 02Mar2021 13:45 (age at vaccination:67 years) as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination. Medical history included surgery from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EM9809, Expiration: unknown) via unspecified route of administration on 09Feb2021(age at vaccination: 67Years) as DOSE 1, SINGLE for covid-19 immunisation. Patient previously received pneumovax vaccine on 2014 for pneumonia. The patient experienced swollen inguinal lymph nodes on 01Jul2021, bilateral leg swelling on 2021. The patient underwent lab tests and procedures which included computerised tomogram: unknown result on unspecified date, computerised tomogram: the bilateral saphenous veins valves are shut on unspecified date, CT scan for something else and was more of a vascular CT to see if anything could be done with the veins in her leg on unspecified date ultrasound doppler: unknown results on 01Jul2021.Patient stated that the product complaint was patient had other vaccine pneumovax on 2014 and had no complications but had injection site reaction and  had fever of 100 degree and 2020 and had no reaction  The outcome of peripheral swelling was recovered, the outcome of the events lymphadenopathy was not recovered.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 47-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm on 24Aug2021 at 15:30 (Batch/Lot Number: Fd8448) as single dose for COVID-19 immunisation in the pharmacy. The patient has no medical history. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient does not have covid prior to vaccination and was not tested positive post vaccination. On 24Aug2021 at 19:15, after experiencing numbness and eye lid not closing, patient visited the emergency room (ER) and Bell's palsy was the diagnosis. The patient was treated with steroids and antivirus medications and had a follow up with neuro. The outcome of the event was unknown.   No follow- up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Oxygen saturation, Pain
Clinical narrative: My heart rate for one months was 170s; Pain in movement; This is a spontaneous report from a contactable consumer.    An adult male patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 23Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included covid-19 from an unknown date. The patient's concomitant medications were not reported. On 23Mar2021 the patient experienced as reported Shot 1 hit me like a truck, it was like being back with Covid again for a day, and the second shot wasn't a lot better. But about a week after the second shot, I saw DRAMATIC improvement. Without any substantial muscle gain I had access to my general strength again, I did not need help lifting or moving every-day objects, and I could even walk my dog again without issue. Pain in movement was greatly reduced to almost nothing. My heart rate now suddenly was topping out at 105 on the minor hill on the way to work after months of maintaining 170s for the same work. O2 has been holding steady in the 97 to 98 range these days. I'm certainly not back to normal, the most I have managed at a stretch was about half a mile for a run before chest pain tilted in, but this is a huge improvement from where I was and I do continue to see incremental increases week to week. The outcome of the events was reported as recovering. No treatment received.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Heart rate, Heart rate increased, Inappropriate schedule of product administration, Movement disorder
Clinical narrative: My heart rate for one months was 170s; Pain in movement; This is a spontaneous report from a contactable consumer.    An adult male patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 23Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included covid-19 from an unknown date. The patient's concomitant medications were not reported. On 23Mar2021 the patient experienced as reported Shot 1 hit me like a truck, it was like being back with Covid again for a day, and the second shot wasn't a lot better. But about a week after the second shot, I saw DRAMATIC improvement. Without any substantial muscle gain I had access to my general strength again, I did not need help lifting or moving every-day objects, and I could even walk my dog again without issue. Pain in movement was greatly reduced to almost nothing. My heart rate now suddenly was topping out at 105 on the minor hill on the way to work after months of maintaining 170s for the same work. O2 has been holding steady in the 97 to 98 range these days. I'm certainly not back to normal, the most I have managed at a stretch was about half a mile for a run before chest pain tilted in, but this is a huge improvement from where I was and I do continue to see incremental increases week to week. The outcome of the events was reported as recovering. No treatment received.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation, Pain
Clinical narrative: My heart rate for one months was 170s; Pain in movement; This is a spontaneous report from a contactable consumer.    An adult male patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 23Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included covid-19 from an unknown date. The patient's concomitant medications were not reported. On 23Mar2021 the patient experienced as reported Shot 1 hit me like a truck, it was like being back with Covid again for a day, and the second shot wasn't a lot better. But about a week after the second shot, I saw DRAMATIC improvement. Without any substantial muscle gain I had access to my general strength again, I did not need help lifting or moving every-day objects, and I could even walk my dog again without issue. Pain in movement was greatly reduced to almost nothing. My heart rate now suddenly was topping out at 105 on the minor hill on the way to work after months of maintaining 170s for the same work. O2 has been holding steady in the 97 to 98 range these days. I'm certainly not back to normal, the most I have managed at a stretch was about half a mile for a run before chest pain tilted in, but this is a huge improvement from where I was and I do continue to see incremental increases week to week. The outcome of the events was reported as recovering. No treatment received.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Feeling abnormal, Pain
Clinical narrative: her ankle is swelling up again; it is 'hurting a little'; i dont feel great with the heat; This is a spontaneous report from a contactable consumer or other non hcp. A 73-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced her ankle is swelling up again on 2021, it is 'hurting a little' on 2021, I don't feel great with the heat on 2021.Patient wanted to know that she can take Advil for the pain. The outcome of the condition aggravated, pain, feeling abnormal was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: I have experienced something unusual, a sharp pain in my left knee right near the knee cap; Left knee cap; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that. Unspecified age and sex patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date not reported), via an unspecified route of administration on an unspecified anatomical location on 14Jan2021 as a dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient experienced something unusual, a sharp pain in my left knee right near the kneecap, left kneecap on unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Colleague was fully vaccinated and tested positive on 27Aug; Colleague was fully vaccinated and tested positive on 27Aug; This is a spontaneous report from a contactable consumer. A 37-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for Injection, Batch/Lot Number: EN5318), via intramuscular route of administration, administered in right arm on 03Mar2021(at the age of 37-year-old) as Dose 1,Single and received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for Injection, Batch/Lot Number: EN5318) via intramuscular route of administration, administered in Arm Right on 25Mar2021(at the age of 37-year-old) as Dose 2,Single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  Patient allergies were unknown. Patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown. The patient received any other medications within 2 weeks of vaccination was unknown. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 27Aug2021, the patient experienced colleague was fully vaccinated and tested positive on 27aug.  Facility where the most recent COVID-19 vaccine was administered was workplace clinic. The patient underwent lab tests and procedures which included nasal swab: positive on 27Aug2021. Treatment received for the events was unknown. The clinical outcome of events were recovering.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of events Vaccination failure and COVID-19 cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available.
Sex: U
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: Muscle weakness in the hand and close to arm; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient had two doses of vaccine in January and February. The patient experienced muscle weakness in the hand and close to the arm after this almost 8 months, that's some collateral effect or not on an unspecified date in 2021. Outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Colleague was fully vaccinated and tested positive for COVID on 24Aug; Colleague was fully vaccinated and tested positive for COVID on 24Aug; This is a spontaneous report from a contactable other hcp. A 53-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN5318) via intramuscular route of administration in Arm Left on 27Jan2021 (age at vaccination:53 Years) as DOSE 1, SINGLE, second dose bnt162b2 (BNT162B2,Solution for injection, Batch/Lot Number: EN5318) via intramuscular route of administration in Arm Left on 17Feb2021 (age at vaccination:53 Years)as DOSE 2, SINGLE for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. On 24Aug2021 the patient experienced colleague was fully vaccinated and tested positive for covid on 24aug, colleague was fully vaccinated and tested positive for covid on 24aug. Treatment received for the events was reported as unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 24Aug2021 Nasal Swab. The outcome of the events vaccination failure, covid-19 was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available the lack of efficacy of the vaccine BNT162B2 cannot be excluded.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Colleague was fully vaccinated and tested positive for COVID on 8/16; Colleague was fully vaccinated and tested positive for COVID on 8/16; This is a spontaneous report from a contactable other health care professional. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection.), dose 1 intramuscular, administered in right arm on 28Jan2021 (at the age of 51-year-old) (Batch/Lot Number: EN5318) as DOSE 1, SINGLE and dose 2 intramuscular, administered in right arm on 18Feb2021 (Batch/Lot Number: EN5318) (at the age of 51-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine and list of any other medications the patient received within 2 weeks of vaccination reported as unknown. Prior to vaccination, was the patient diagnosed with COVID-19: unknown. Known allergies and other medical history were unknown. Facility where the most recent COVID-19 vaccine was administered at workplace clinic. Patient was fully vaccinated and tested positive for COVID on 16Aug2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive (Nasal swab) on 16Aug2021. Treatment received for the adverse event was unknown. The outcome of the events were recovered on Aug2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events vaccination failure and COVID-19 cannot be totally excluded.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: Had pain in the arm near the site and the neck and the shoulder; Had pain in the arm near the site and the neck and the shoulder; Soreness in her right arm the day of the vaccination which went away; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) from a Pfizer sponsored program. A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: FA7485), via an unspecified route of administration (at the age of 46-years), administered in arm right on 20Aug2021 at 16:15 as dose 1, single for COVID-19 immunization. Medical history included hypertension from 2010 to an unknown date. Concomitant medications included caffeine, paracetamol (EXCEDRIN), paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. On 20Aug2021, the patient experienced soreness in her right arm the day of the vaccination which went away. On 27Aug2021, experienced had pain in the arm near the site and the neck and the shoulder. It was further stated that caller received her first dose of the vaccine on 20Aug2021. Caller said she experienced soreness in her right arm the day of the vaccination which went away. On 27Aug2021, the soreness came back in her right arm, right side of her neck, and right shoulder. Caller asked if this was related to the vaccine. Soreness in the arm, shoulder, and neck all on the right side was reported as worsened. The caller was questioning the side effects of the Pfizer Covid 19 vaccine. On 20Aug2021 the caller got the first dose and she has soreness through her arm where she received the vaccine and in her neck and her shoulder. The caller clarified and confirmed that the first day the caller had soreness in her arm only and took some Advil and it was fine. The pain came back Friday. The caller then had pain in the arm near the site and the neck and the shoulder. The caller does not know if this is shot related or just a coincidence. The soreness in the arm only was immediately after she received the vaccine and it lasted about a half of day. And then this Friday, 27Aug2021, the caller had soreness in the arm, shoulder, and neck all on the right side. The treatment was received for all the adverse events. The adverse event did not resulted in emergency room and physician office visit. The vaccine was not administered at military facility. The clinical outcome for the event Soreness in her right arm the day of the vaccination which went away was reported as unknown while for event had pain in the arm near the site and the neck and the shoulder was reported as not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Malaise
Clinical narrative: he is just not feeling well at all; His blood pressure is 150/110; This is a spontaneous report from a contactable consumer. This consumer reported  for patient(fiance) that:  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced he is just not feeling well at all, his blood pressure is 150/110. The patient underwent lab tests and procedures which included blood pressure: 150/110 on unspecified date. Event occurred in a country different from that of the reporter. The clinical outcome of events were unknown.  QR Comment: Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab.  Information on the lot/batch number has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Malaise, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Covid 19 infection; Covid 19 infection; She was not feeling well; Sore throat; This is a spontaneous report received from a contactable nurse. This nurse reported for a 17-year-old female patient (reporter's granddaughter). A 17-year-old female patient received bnt162b2 (Solution for injection; Batch/lot number and Expiry Date: not provided), dose 1 via an unspecified route of administration on 15Jul2021 (at the age of 17-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not provided. The reporter stated that her granddaughter had her first dose on 15Jul2021, and she was unable to get the second dose of the vaccine, which was schedule on 05Aug2021, because she was not feeling well on an unspecified date in 2021, and so she waited. She tested positive for a mild case of the COVID-19 virus on 10Aug2021, her granddaughter only had a very mild case, they initially thought it was an ear infection as she happened to wear a hearing aide, but she had like a sore throat one day (on an unspecified date in 2021) and would be fine the next day. It sounded like her granddaughter was now doing well, she was feeling well and was back to her normal activities. The patient underwent lab test and procedure which included COVID-19 virus: Positive on 10Aug2021. The outcome of events Covid 19 infection was recovered on an unspecified date in Aug2021 and outcome of events She was not feeling well, and Sore throat was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: As per the information in the case provided, the causal association between the events COVID-19 and Drug Ineffective and the suspect drug bnt162b2 cannot be excluded
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Extra dose administered, Hypertension, Illness, Off label use
Clinical narrative: "I had a vaccine shot yesterday  booster, the third one and I am sick today. At this age my arm had blood pressure, it is little bit of high but it is okay. I don't know what to do."; "I had a vaccine shot yesterday  booster, the third one and I am sick today. At this age my arm had blood pressure, it is little bit of high but it is okay. I don't know what to do."; I am sick; my arm had blood pressure, it is little bit of high; I have terrible pain in my arm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: EN0187) via an unspecified route of administration on an unspecified date as dose 3, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that I had a vaccine shot yesterday booster, the third one and I am sick today. At this age my arm had blood pressure, it is little bit of high, but it is okay. The patient underwent lab tests and procedures which included blood pressure resulted as high on an unknown date. The clinical outcome of the events was unknown.  No follow attempts are possible, no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: "I had a vaccine shot yesterday  booster, the third one and I am sick today. At this age my arm had blood pressure, it is little bit of high but it is okay. I don't know what to do."; "I had a vaccine shot yesterday  booster, the third one and I am sick today. At this age my arm had blood pressure, it is little bit of high but it is okay. I don't know what to do."; I am sick; my arm had blood pressure, it is little bit of high; I have terrible pain in my arm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: EN0187) via an unspecified route of administration on an unspecified date as dose 3, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that I had a vaccine shot yesterday booster, the third one and I am sick today. At this age my arm had blood pressure, it is little bit of high, but it is okay. The patient underwent lab tests and procedures which included blood pressure resulted as high on an unknown date. The clinical outcome of the events was unknown.  No follow attempts are possible, no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Body temperature, Chills, Fatigue, Feeling abnormal
Clinical narrative: headache; fatigue; aches; general brain fog; nausea; tiny fever. maybe up 1.5 points; arthritic feeling in her left shoulder; Severely underweight 68 pounds; sick; chills; This is a spontaneous report from a contactable consumer reported for herself. A 75-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: ER8732), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included colitis ulcerative and colon operation (Colon surgery) from an unknown date and unknown if ongoing. Patient still have some problems with that since colon has been removed, kind of hurts a little bit otherwise patient was ok. Concomitant medication was not reported. No any prior vaccinations (within 4 weeks). On 29Mar2021, after receiving the first dose patient got sick and had quite a few side effects almost all of them like chills, headache, fatigue, aches, general brain fog, little bit of nausea, a very very tiny fever maybe up 1.5 points. The headache had not gone away and Patient had it all summer. Patient had an arthritic feeling in left shoulder, which was the same arm that received the injection. Patient severely underweight and did not even feel well, not terrible or bad but mild to moderate. Patient stated, they did not cause patient to stay in bed or anything. Patient was able to get up and function. They were sort of moderate and they lasted at least 3 days. They got better each day and on 4th day it was quite a bit better, the 2nd day had some fatigue, nausea, achiness, body aches, headache and the fogginess but on 3rd day a little better, like 4th day it got about a week. Patient know that had side effects to the vaccine, they were pretty moderate. Did not even feel well, they were not terrible or bad, so anyhow they were mild to moderate. The patient underwent lab tests and procedures which included body temperature: up to 1.5 point very very tiny fever on 2021. Patient stated, the first day when patient had the achiness and whatever, patient may have taken some Tylenol, patient did not remember. The outcome of the event headache was not recovered and underweight was unknown while other events were recovering.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Nausea, Pain, Pyrexia
Clinical narrative: headache; fatigue; aches; general brain fog; nausea; tiny fever. maybe up 1.5 points; arthritic feeling in her left shoulder; Severely underweight 68 pounds; sick; chills; This is a spontaneous report from a contactable consumer reported for herself. A 75-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: ER8732), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included colitis ulcerative and colon operation (Colon surgery) from an unknown date and unknown if ongoing. Patient still have some problems with that since colon has been removed, kind of hurts a little bit otherwise patient was ok. Concomitant medication was not reported. No any prior vaccinations (within 4 weeks). On 29Mar2021, after receiving the first dose patient got sick and had quite a few side effects almost all of them like chills, headache, fatigue, aches, general brain fog, little bit of nausea, a very very tiny fever maybe up 1.5 points. The headache had not gone away and Patient had it all summer. Patient had an arthritic feeling in left shoulder, which was the same arm that received the injection. Patient severely underweight and did not even feel well, not terrible or bad but mild to moderate. Patient stated, they did not cause patient to stay in bed or anything. Patient was able to get up and function. They were sort of moderate and they lasted at least 3 days. They got better each day and on 4th day it was quite a bit better, the 2nd day had some fatigue, nausea, achiness, body aches, headache and the fogginess but on 3rd day a little better, like 4th day it got about a week. Patient know that had side effects to the vaccine, they were pretty moderate. Did not even feel well, they were not terrible or bad, so anyhow they were mild to moderate. The patient underwent lab tests and procedures which included body temperature: up to 1.5 point very very tiny fever on 2021. Patient stated, the first day when patient had the achiness and whatever, patient may have taken some Tylenol, patient did not remember. The outcome of the event headache was not recovered and underweight was unknown while other events were recovering.
Sex: F
Vaccine: COVID19
Symptoms: Underweight
Clinical narrative: headache; fatigue; aches; general brain fog; nausea; tiny fever. maybe up 1.5 points; arthritic feeling in her left shoulder; Severely underweight 68 pounds; sick; chills; This is a spontaneous report from a contactable consumer reported for herself. A 75-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: ER8732), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included colitis ulcerative and colon operation (Colon surgery) from an unknown date and unknown if ongoing. Patient still have some problems with that since colon has been removed, kind of hurts a little bit otherwise patient was ok. Concomitant medication was not reported. No any prior vaccinations (within 4 weeks). On 29Mar2021, after receiving the first dose patient got sick and had quite a few side effects almost all of them like chills, headache, fatigue, aches, general brain fog, little bit of nausea, a very very tiny fever maybe up 1.5 points. The headache had not gone away and Patient had it all summer. Patient had an arthritic feeling in left shoulder, which was the same arm that received the injection. Patient severely underweight and did not even feel well, not terrible or bad but mild to moderate. Patient stated, they did not cause patient to stay in bed or anything. Patient was able to get up and function. They were sort of moderate and they lasted at least 3 days. They got better each day and on 4th day it was quite a bit better, the 2nd day had some fatigue, nausea, achiness, body aches, headache and the fogginess but on 3rd day a little better, like 4th day it got about a week. Patient know that had side effects to the vaccine, they were pretty moderate. Did not even feel well, they were not terrible or bad, so anyhow they were mild to moderate. The patient underwent lab tests and procedures which included body temperature: up to 1.5 point very very tiny fever on 2021. Patient stated, the first day when patient had the achiness and whatever, patient may have taken some Tylenol, patient did not remember. The outcome of the event headache was not recovered and underweight was unknown while other events were recovering.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer or other non hcp.   A 93-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FF2588), via an unspecified route of administration on 28Aug2021 15:00 as single dose for covid-19 immunization. No medical history and no concomitant medications were not reported. It was reported that caller would like to ask you what medication to take when my mom got a first dose of vaccine yesterday and today, she is having a headache. further stated her temperature is normal but she experiences headache. It was asked that Should mother take any medication. The patient underwent lab tests and procedures which included body temperature: normal. The outcome for the event was reported as unknown at the time of this report.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Pain, Renal pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date in Aug2021 (reported as 'first dose almost three weeks ago' at the time of report) (Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was calling about the Pfizer COVID 19 vaccine. He got his first dose almost three weeks ago (Aug2021) and he didn't feel well/not feeling well, he had a headache, felt very tired, and his waist hurts but he thought it's the kidneys that were affected (it was his kidneys that were hurting). He was just calling because he was due for the second dose of the vaccine on 01Sep2021 and he was not going to go anymore until he felt better from the vaccine. The outcome of all the events was unknown. Follow-up attempts are completed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue
Clinical narrative: He feels like he is coughing like when he had pneumonia; She stated he is short of breath; tired; This is a spontaneous report from a contactable hcp (LPN and patient's girlfriend).   A 54-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in left arm, on 25Aug2021 (Batch/Lot Number: F3180) as a single dose, for covid-19 immunisation. Medical history included pneumonia. Concomitant medications were not reported.  The caller stated she wanted to find out if the reaction or side effects that that her boyfriend is having are normal. She stated they are not really on the list but she is not sure if it could still be potentially from the vaccine. She stated it is related to breathing issues. She stated he is short of breath on 29Aug2021. He feels like he was coughing like when he had pneumonia, but he was cold then and he is not cold now. She stated he was coughing and is tired. She stated the shortness of breath was not that prevalent but the coughing is making him feel short of breath. She stated he still went to work today and was really run down but he did alright at work. She stated this could be something new after he got back from traveling. He received the vaccine on "the 25Aug2021" but didn't have symptoms until last night and this morning. She stated she was not sure if those go under shortness of breath like an allergic reaction or whether this is normal. His cough was worsening, and its like he was more tired, it takes him more time, like a minute or 2, to get back to normal, he's winded and  he doesn't feel right, he said it feels like back when he had pneumonia before, but that was when the weather was cold. Caller states that she has tried to hear him and she cant hear anything, it feels like he needs to expel something, caller clarified she tried to hear her boyfriend with a stethoscope and she was not able to hear anything, she listening while he was doing normal breathing. She did not hear anything wet.  The outcome of the events was unknown.          .
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Investigation, Nausea
Clinical narrative: difficulty of breathing; first dose: a little nausea; This is a spontaneous report from a contactable consumer (patient).  A 75-year-old female patient had received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, lot FA7485) via unknown route at the left arm on 07Aug2021.  Relevant medical history included lung disease ongoing and COVID-19 in Jan2021. She didn't have any reaction at first, and noticed after 4 days, on 11Aug2021 she had difficulty of breathing and after it got worse and a little nausea. The outcome of the event difficulty of breathing was reported as not recovered, the outcome of the event nausea was recovering.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Heart rate, Pain
Clinical narrative: Tachycardia, Heart rate went as high as 160 / heart started rising; Dizziness / started getting little dizzy; Weakness; Throwing up; Fever; Chills; Body aches; Hands started shaking; This is a spontaneous report received from a contactable nurse (patient).   A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, in the left arm, on 29Aug2021, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 29Aug2021, she experienced tachycardia, her heart rate went as high as 160 (her heart started rising). On the same date, on 29Aug2021, she also experienced little dizzy, weakness, throwing up, fever, chills, body aches and her hands started shaking. Patient reported that didn't had any problem before the vaccine and it started about 30 minutes after the vaccine. Clinical outcome of the adverse events was unknown at time of this report. Treatment: she took her topiramate (TROKENDI) last night (further clarification unknown).  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia, Tremor, Vomiting
Clinical narrative: Tachycardia, Heart rate went as high as 160 / heart started rising; Dizziness / started getting little dizzy; Weakness; Throwing up; Fever; Chills; Body aches; Hands started shaking; This is a spontaneous report received from a contactable nurse (patient).   A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, in the left arm, on 29Aug2021, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 29Aug2021, she experienced tachycardia, her heart rate went as high as 160 (her heart started rising). On the same date, on 29Aug2021, she also experienced little dizzy, weakness, throwing up, fever, chills, body aches and her hands started shaking. Patient reported that didn't had any problem before the vaccine and it started about 30 minutes after the vaccine. Clinical outcome of the adverse events was unknown at time of this report. Treatment: she took her topiramate (TROKENDI) last night (further clarification unknown).  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: sick with COVID-19 after getting fully vaccinated with the Pfizer COVID-19 vaccine; sick with COVID-19 after getting fully vaccinated with the Pfizer COVID-19 vaccine; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. The consumer reported same events for 2 patients. This is the 1st of 2 reports. A 64-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Batch/Lot number: Unknown), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single; dose 1 via an unspecified route of administration on an unspecified date as dose 1, single  for covid-19 immunization. The patient's medical history and concomitant medications were not reported. According to the reporter the patient was sick with covid-19 after getting fully vaccinated with the Pfizer covid-19 vaccine on an unspecified date. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101129857 Same reporter/ drug/ event for different patients
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Myocarditis
Clinical narrative: Myocarditis; High blood pressure/ blood pressure remained high for several days.; This is a spontaneous report from a contactable consumer (patient). A 26-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09May2021 09:30 (Batch/Lot Number: ER8732) (at the age of 26 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included anxiety disorder, asthma, food allergy (almonds) from an unknown date and unknown if ongoing. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 15Apr2021 08:00 in the Left arm (Batch/Lot Number: EW0158) (at the age of 26 years) for covid-19 immunisation. Patient did not have COVID prior vaccination. Patient was not tested for COVID post vaccination. There were no other vaccines in four weeks. Concomitant medications included escitalopram (ESCITALOPRAM) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, etonogestrel (NUVARING) taken for an unspecified indication, start and stop date were not reported. On 10May2021, patient experienced severe chest pain and pressure, and difficulty breathing. Myocarditis and high blood pressure. Patient's blood pressure remained high for several days. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient recovered with lasting effects/sequel on 2021. Patient did not receive treatment.   No follow-up attempts are possible. No further information is expected.