chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response decreased
Clinical narrative: Chills; Headache; Nausea; Arm pain; Felt some burning; Subtherapeutic response; This is a spontaneous report from a contactable consumer(patient). A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date, as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The patient also received salicylic acid (GOLD BOND ULTIMATE MULTI SYMPTOM PSORIASIS RELIEF)(Lot Number: 218107) from an unknown date, via an unspecified route of administration at three times per day for an unspecified indication. Medical history included vertigo and the patient had an injury on her back and could only move her arms to a certain point, having arthritis on her hand and had surgery as well. The patient's concomitant medications were not reported. The patient shared her experience with the Pfizer vaccine and had really terrible side effects. On an unknown date, the patient experienced non-serious chills, headache and nausea, arm pain, also felt some burning and sub therapeutic response. The patient stated she had the problem all day long. She said she was in pain but she didn't take any pain killers. she also had the Gold bond ultimate firming neck and chest but it only worked on her neck, doesn't help her chest. It was not reported if the patient received a corrective treatment for the events. Action taken with salicylic acid was unknown. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Fatigue, Headache, Nasopharyngitis
Clinical narrative: I start feeling like i was getting a cold; I was feeling so tired and on tuesday I was whit a full cold runny nose sore throat cough; I was feeling so tired and on tuesday I was whit a full cold runny nose sore throat cough; I was feeling so tired and on tuesday I was whit a full cold runny nose sore throat cough; I was feeling so tired and on tuesday I was whit a full cold runny nose sore throat cough; a litttle bit off pain on my chest; more tired I can even get up my body hurts and anything that I drink is working and today wednesday I have headache; This is a spontaneous report from a contactable consumer. A 32-years-old nonpregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection and Batch/Lot Number: 6w0179), via an unspecified route of administration on 16Aug2021 11:00 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any known allergies. The patient did not have COVID prior vaccination. The patient did not receive any other vaccine in 4 weeks. The patient got her last vaccine on Monday and later that (16Aug2021) day she starts feeling like she was getting a cold and she was feeling so tired and on Tuesday. The patient was whit a full cold runny nose sore throat cough and a little bit off pain on her chest and more tired she can even get up my body hurts and anything that the patient drink was working and today Wednesday she had headache and like she had really bad cold. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Apr2021. The patient received advild and motrin treatment for events.  Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: I start feeling like i was getting a cold; I was feeling so tired and on tuesday I was whit a full cold runny nose sore throat cough; I was feeling so tired and on tuesday I was whit a full cold runny nose sore throat cough; I was feeling so tired and on tuesday I was whit a full cold runny nose sore throat cough; I was feeling so tired and on tuesday I was whit a full cold runny nose sore throat cough; a litttle bit off pain on my chest; more tired I can even get up my body hurts and anything that I drink is working and today wednesday I have headache; This is a spontaneous report from a contactable consumer. A 32-years-old nonpregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection and Batch/Lot Number: 6w0179), via an unspecified route of administration on 16Aug2021 11:00 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any known allergies. The patient did not have COVID prior vaccination. The patient did not receive any other vaccine in 4 weeks. The patient got her last vaccine on Monday and later that (16Aug2021) day she starts feeling like she was getting a cold and she was feeling so tired and on Tuesday. The patient was whit a full cold runny nose sore throat cough and a little bit off pain on her chest and more tired she can even get up my body hurts and anything that the patient drink was working and today Wednesday she had headache and like she had really bad cold. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Apr2021. The patient received advild and motrin treatment for events.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: It's been 5 days after my 2nd dose of Pfizer, and I still have a headache in the back of my head and feel on/off nauseaous . I had arm pain for first few days but that has subsided.; It's been 5 days after my 2nd dose of Pfizer, and I still have a headache in the back of my head and feel on/off nauseaous . I had arm pain for first few days but that has subsided.; It's been 5 days after my 2nd dose of Pfizer, and I still have a headache in the back of my head and feel on/off nauseaous . I had arm pain for first few days but that has subsided.; This is a spontaneous report from a contactable consumer (patient herself). A 50-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: FC3180; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 13Aug2021 15:30 (at age 50-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medications included sertraline (SERTRALINE), vitamin d (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0196; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 21Jul2021 14:00 (at age 50-years-old) for COVID-19 immunization. Patient had previously received codeine and experienced drug hypersensitivity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 13Aug2021 the patient experienced it's been 5 days after my 2nd dose of pfizer, and I still have a headache in the back of my head and feel on/off nauseaous. I had arm pain for first few days but that has subsided. Patient did not receive any treatment for adverse event. Since the vaccination, patient has not been tested for COVID-19. The outcome of event it's been 5 days after my 2nd dose of pfizer, and I still have a headache in the back of my head and feel on/off nauseaous. I arm pain for first few days but that has subsided (Pain in extremity) was resolving while it was not recovered for all other events.  Follow-Up (27Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; This is a spontaneous report from a contactable consumer or other non hcp. A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FC3180), dose 1 via an unspecified route of administration, administered in Arm Left on 10Aug2021 at 11:00 (Age at vaccination: 37 years) as dose 1, single for covid-19 immunisation. Relevant medical history was reported as None. There were no concomitant medications. Prior vaccinations within 4 weeks were None. The patient experienced chest pain on 16Aug2021 at 02:00. It was reported that chest pain has improved, the first time it was too much. Reporter states the chest pain was off and on, that was her concern. The outcome of the event was recovering.  Follow up (19Aug2021): This is a Follow-up spontaneous report from a contactable consumer.  Follow-up activities closed. No further information is expected. .
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Gastric disorder, Myalgia, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 18Aug2021 (Batch/Lot Number: FC3181) as dose 3, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient received first dose and second dose of BNT162B2 on an unknown date for covid-19 immunisation. On an unknown date the patient experienced head spinning, muscle pain, chills, I feel kind of sick in my stomach and feeling lots to vomit. The patient reported that got the Pfizer vaccine the booster yesterday from the Health department. The patient got this shot yesterday guess about 3 or 4 and was about to go in the car and the head spinning and had muscle pain and chills and feels kind of sick in stomach and want know what needs to be done. Patient was going to a graduation today and cant handle the Chills and the headache and feel like going to vomit and muscle pain wondering if needed to get out or not or if needed to quarantine or what. The patient asked whether or not to get out to go to the graduation today. Patient was informed about Pfizer Medical Information Department and Shared the number. Patient asked that if had to quarantine. The outcome of all the events was unknown. Follow-up attempts are completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 18Aug2021 (Batch/Lot Number: FC3181) as dose 3, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient received first dose and second dose of BNT162B2 on an unknown date for covid-19 immunisation. On an unknown date the patient experienced head spinning, muscle pain, chills, I feel kind of sick in my stomach and feeling lots to vomit. The patient reported that got the Pfizer vaccine the booster yesterday from the Health department. The patient got this shot yesterday guess about 3 or 4 and was about to go in the car and the head spinning and had muscle pain and chills and feels kind of sick in stomach and want know what needs to be done. Patient was going to a graduation today and cant handle the Chills and the headache and feel like going to vomit and muscle pain wondering if needed to get out or not or if needed to quarantine or what. The patient asked whether or not to get out to go to the graduation today. Patient was informed about Pfizer Medical Information Department and Shared the number. Patient asked that if had to quarantine. The outcome of all the events was unknown. Follow-up attempts are completed. No further information expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: The day after the vaccine, I started developing a red rash on my right thigh. I dismissed it initially but the rash kept developing further into sores, which turned out to be shingles.; The day after the vaccine, I started developing a red rash on my right thigh. I dismissed it initially but the rash kept developing further into sores, which turned out to be shingles.; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: ew0177, Expiration Date: not reported) via an unspecified route of administration in left arm on 15Aug2021 16:00 as dose 1, single for COVID-19 immunization (at the age of 45-year-old, non-pregnant). Medical history patient had covid prior vaccination from an unknown date and known allergies was none. There were no concomitant medications. Patient did not receive other vaccine in four weeks and other medications in two weeks was none. COVID was not tested post vaccination. The patient experienced the day after the vaccine, she started developing a red rash on her right thigh. She dismissed it initially but the rash kept developing further into sores, which turned out to be shingles on 16Aug2021 13:00. AE resulted in doctor or other healthcare professional office/clinic visit. Patient was prescribed anti-viral medication for shingle. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Off label use, Product use issue
Clinical narrative: I experienced a "break through" period bleed; have been exclusively breastfeeding; have been exclusively breastfeeding; This is a spontaneous report from a non-contactable consumer or other non hcp.     A 32 years old female Non-Pregnant patient 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 19Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. The patient previously took thyroid therapy. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was Reported that, the patient experienced a "breakthrough" period bleed, on have been exclusively breastfeeding on 12Aug2021 with outcome of recovered on unknown date of Aug2021  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Pain in extremity
Clinical narrative: a slightly tight chest and it hurts a little bit around my chest area; a slightly tight chest and it hurts a little bit around my chest area; sore arm; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received first bnt162b2 (Solution injection, Batch/Lot Number: EW0172), via an unspecified route of administration on 20Aug2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 21Aug2021, patient experienced after the first shot, sore arm but that was fine But today patient like a slightly tight chest and it hurts a little bit around patient's chest area. Patient questioned if this should be a concerned or was normal. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Postural orthostatic tachycardia syndrome
Clinical narrative: very bad reaction to vaccine/Postural orthostatic hypotension; very bad reaction to vaccine/Postural orthostatic tachycardia syndrome; very bad reaction to vaccine/blood pressure fluctuated so much; This is a spontaneous report from a contactable consumer (patient's mother). A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history included postural orthostatic hypotension from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date, patient had a very bad reaction with the second dose of Pfizer COVID vaccine, patient had postural orthostatic hypotension (had this prior to the vaccine as well), Postural Orthostatic Tachycardia Syndrome (POTS syndrome) and his blood pressure fluctuated so much. Patient's mother asked can he take the booster dose, what precautions he should take and also asked that they say do not switch to Moderna for booster dose if you have received Pfizer, is that correct. The outcome of all the events was unknown.  The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow-up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: sever Sciatica pain; pain on my right side affecting my buttocks; difficult to walk; my lower back and legs making it very difficult to walk; legs making it difficult to walk; Sciatica pain; This is a spontaneous report from a contactable other HCP (patient). A non-pregnant 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 19Aug2021 at 13:00 (Batch/Lot Number: EVV0181) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Medical history included diabetes mellitus. There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks. No known allergies. The patient did not have Covid prior vaccination. The patient was not tested Covid post vaccination. The patient received the shot on 19Aug2021 and on 21Aug2021 in the evening (16:00 PM) she began to have sever sciatica pain on her right side affecting her buttocks, her lower back and legs making it very difficult to walk and she had to use a wheelchair. On the 23Aug2021 it alternated to her left side and today (24Aug2021) it was back on her right side although today it was beginning to diminish slowly. The events onset date reported as 21Aug2021 at 16:00 PM. The events did not result in physician office visit or emergency room visit. The patient was recovering from the events. The patient did not receive treatment for the events.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the temporal relationship, the association between the reported events with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: sever Sciatica pain; pain on my right side affecting my buttocks; difficult to walk; my lower back and legs making it very difficult to walk; legs making it difficult to walk; Sciatica pain; This is a spontaneous report from a contactable other HCP (patient). A non-pregnant 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 19Aug2021 at 13:00 (Batch/Lot Number: EVV0181) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Medical history included diabetes mellitus. There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks. No known allergies. The patient did not have Covid prior vaccination. The patient was not tested Covid post vaccination. The patient received the shot on 19Aug2021 and on 21Aug2021 in the evening (16:00 PM) she began to have sever sciatica pain on her right side affecting her buttocks, her lower back and legs making it very difficult to walk and she had to use a wheelchair. On the 23Aug2021 it alternated to her left side and today (24Aug2021) it was back on her right side although today it was beginning to diminish slowly. The events onset date reported as 21Aug2021 at 16:00 PM. The events did not result in physician office visit or emergency room visit. The patient was recovering from the events. The patient did not receive treatment for the events.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the temporal relationship, the association between the reported events with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin disorder
Clinical narrative: Little rashes, bumps like little bumps all over my arms, my body and they itch; Little rashes, bumps like little bumps all over my arms, my body and they itch; Little rashes, bumps like little bumps all over my arms, my body and they itch; This is a spontaneous report from a contactable consumer (patient). A patient of unknown age and gender received bnt162b2 (BNT162B2, solution for injection, (Batch/Lot number: not reported) via an unspecified route of administration on 17Aug2021 as dose number unknown, single for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date in Aug2021, the patient experienced little rashes, bumps like little bumps all over my arms, my body and they itch. The patient stated that couple of days after the vaccination started getting in little rashes, bumps like little bumps all over arms, body and they itch and patient was trying to get to know like what can I put on to stop the itching and how long does these usually last. The outcome of the events was reported as unknown. Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female (not pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left at age of 57 years on 18Jul2021 15:00 (Lot Number: EW0178) as dose 1, single for covid-19 immunisation. Medical history included took meds for diabetes. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient previously allergy to Codeine.  After the first shot, patient had a sore arm but there was no bump like there was after the second shot. Patient did not have more than sore arm after first shot. No COVID prior vaccination, no COVID tested post vaccination. Unknown if treatment was received. The patient hadn't go to a doctor because she didn't know if this was normal or not. The outcome of the event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Feeling abnormal, Off label use
Clinical narrative: he got his booster dose on Friday; he got his booster dose on Friday; had a bad day Saturday; This is a spontaneous report from a contactable consumer (patient) via medical information team.   A 77-year-old male patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unknown date (age at vaccination: 77 years), as a dose number unknown single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. Reporter was frustrated that Pfizer does not have specific qualitative measured numbers for antibody testing available for the clinical trial data. Reporter stated that he talked at length about the booster dose and argued that it must be approved for everyone, because the pharmacies are just making people check a box and giving it to them. He has been told the booster dose was for anyone. Reporter states that he has never seen anything published by Pfizer as to whether or not pfizer had antibodies. Somebody told reporter yesterday that there was a test from that was a titer test that showed the number of antibodies and a scale to determine that. His doctor told him there was no such test. Reporter stated that he would had assumed during trials, they must had measured efficiency and effectiveness. Reporter stated that he read that Pfizer was 43% effective against delta, and Moderna 80%; in (privacy), it was a little bit different. Further reporter stated that Pfizer determined the minimum number of antibodies needed to achieve the 94 or 96% efficacy. Reporter stated that he got his booster dose on Friday. He had a bad day Saturday, on Sunday things got better, and by Monday it was gone. Reporter later mentioned that someone he knows had their first dose of the vaccine and had no side effects other than a sore arm that she couldn't lift above her head for a day or so. Outcome of event had a bad day Saturday was recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pain; This is a spontaneous report from a contactable consumer. A 25-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 26Jul2021 (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. It was reported that for the first 2 days after the first dose, the patient experienced chest pain which felt like someone was sitting on him. The patient needed a confirmation if it was okay for him to get the second dose of the vaccine as he was suggested by his doctor to confirm if he could get the second dose. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: I had some chest pain and for about 2 days; it feel as someone was sitting on top of me; 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, Batch/Lot number: unknown, Expiration date: unknown), dose 1 via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunization. The patient medical history and patient's concomitant medications were not reported. Reported that I done the COVID shot a couple weeks ago and I had informed my doctor when I took the first COVID shot, I had some chest pain and for about 2 days, it felt as someone was sitting on top of me (2021) and then, but I did not go to the hospital. I did not go to the ER. Patient wanted to know when I went for my second shot and it was good if I got the shot or not. The clinical outcome of event was unknown.  Follow-up activities closed. Batch/lot number not available for [BNT162B2].
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Influenza like illness, Pyrexia, Rhinorrhoea, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) reported for herself. A 58-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN6201), at the age of 58, via an unspecified route of administration, left arm, on Apr 7, 2021, single dose, for COVID-19 immunisation. The patient's medical history: unknown. The patient's concomitant medications not reported. The patient experienced flu for 2 days, nose was runny, fever, shaky and sweating on Apr 7, 2021. 2 days later she was fine. The events started on the same night after the 1st vaccine. The outcome of the event sweating recovered on Apr 7, 2021. The outcome of all the other events recovered on Apr 9, 2021. Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: knows others that have gained as well after receiving the Pfizer vaccine, one about 30 pounds; This is a spontaneous report from a contactable consumer. A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history included underlying thyroid condition. The patient's concomitant medications were not reported. The patient experienced weight gain and knows others that have gained as well after receiving the Pfizer vaccine, one about 30 pounds on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101097977 same reporter/product, different patient / event.;US-PFIZER INC-202101099308 same reporter/product, different patient / event.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Throat tightness
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (Patient herself). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 22Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced horrible reaction where her throat closed up, unable to swallow on Mar2021. The consumer said that she was vaccinated in on 22Mar2021 and had an immediate and horrible reaction where her throat closed up and was unable to swallow. She also said that she was almost hospitalized. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriatic arthropathy, Serum sickness
Clinical narrative: Possible flare of psoriatic arthritis; Possible serum sickness; This is a spontaneous report from a contactable consumer (patient).  A 42-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17Aug2021 16:45 (Lot Number: Fc3181) at age of 42-year-old as single dose for covid-19 immunisation.  Medical history included psoriatic arthropathy, known allergies sulfa. No Covid prior vaccination. Concomitant medications included sertraline hydrochloride (SERTRALINE); pantoprazole; famotidine.  No other vaccine in four weeks. The patient experienced Possible serum sickness, Severe myalgias, joint swelling, Possible flare of psoriatic arthritis on 17Aug2021 21:00. Adverse events resulted in [Doctor or other healthcare professional office/clinic visit]. Patient received NSAISA as treatment. Covid was not tested post vaccination. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching; This is a spontaneous report from a contactable consumer or other non hcp.   A patient of unspecified age and gender received BNT162b2 (CONMINTARY, Solution for injection, Lot No was not reported, NDC and UPC number was unknown), via an unspecified route of administration on 23Aug2021 as dose number unknown, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced itching on 23Aug2021.Outcome of the event was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Ovarian neoplasm, Polyp, SARS-CoV-2 test, Ultrasound scan vagina
Clinical narrative: polyps on ovaries; Prolonged period; polyps; This is a spontaneous report from a contactable consumer (patient). A 32-year-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/Lot Number: EWO165), dose 2 via an unspecified route of administration, administered in Arm Right on 26Apr2021 at 10:30 (at the age of 32-years-old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included allergies from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing and chronic back spasms from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/Lot Number: ER8729), dose 1, via an unspecified route of administration in Arm Right on 07Apr2021 at 12:15 as DOSE 1, SINGLE for COVID-19 immunization with no reported adverse effects. The patient did not receive any other vaccines within four weeks prior to the vaccination. No other medications were received within 2 weeks of the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05May2021, the patient experienced polyps on ovaries and prolonged period that lasted for 5.5 weeks and didn't stop until she was put on a hormone (unspecified). She had several transvaginal ultrasounds found with fluid and polyps on ovaries. She was also informed that, she would not be able to get pregnant with out help from a specialist. The patient underwent lab tests and procedures which included sars-cov-2 test (Jun2021): negative (rapid test, nasal swab) and ultrasound scan vagina (Unknown date): found with fluid and polyps on ovaries. The adverse events resulted in a Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Clinical outcome of the events was resolved with sequelae (reported as lasting effects).   Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Heavy menstrual bleeding, Ovarian cyst, Polyp, Ultrasound pelvis
Clinical narrative: polyps on ovaries; Prolonged period; polyps; This is a spontaneous report from a contactable consumer (patient). A 32-year-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/Lot Number: EWO165), dose 2 via an unspecified route of administration, administered in Arm Right on 26Apr2021 at 10:30 (at the age of 32-years-old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included allergies from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing and chronic back spasms from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/Lot Number: ER8729), dose 1, via an unspecified route of administration in Arm Right on 07Apr2021 at 12:15 as DOSE 1, SINGLE for COVID-19 immunization with no reported adverse effects. The patient did not receive any other vaccines within four weeks prior to the vaccination. No other medications were received within 2 weeks of the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05May2021, the patient experienced polyps on ovaries and prolonged period that lasted for 5.5 weeks and didn't stop until she was put on a hormone (unspecified). She had several transvaginal ultrasounds found with fluid and polyps on ovaries. She was also informed that, she would not be able to get pregnant with out help from a specialist. The patient underwent lab tests and procedures which included sars-cov-2 test (Jun2021): negative (rapid test, nasal swab) and ultrasound scan vagina (Unknown date): found with fluid and polyps on ovaries. The adverse events resulted in a Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Clinical outcome of the events was resolved with sequelae (reported as lasting effects).   Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes virus infection, Inappropriate schedule of product administration, Malaise, Pain, Scar pain
Clinical narrative: I felt very sick for the first 24 hours and it went away.; I experienced the worst herpes outbreak of my life.; I experienced the worst herpes outbreak of my life. Lasted 3+ weeks and was very painful.; It left painful scar tissue and I struggle with intimacy now; 1st dose on 16Mar2021 and 2nd dose on 30Mar2021; This is a spontaneous report from a contactable consumer. A 28-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in left arm on 30Mar2021 at 13:00 (at the age of 28-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included drug hypersensitivity (Known allergies: had some poor reactions to some antibiotics) from an unknown date and unknown if ongoing. Asthma and gastrooesophageal reflux disease (GERD) from an unknown date and unknown if ongoing. No concomitant medication was reported. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported) as dose 1, single administered in right arm on 16Mar2021 at 13:00 for COVID-19 immunization. No COVID prior vaccination. No other vaccine in four weeks. No other medications in two weeks. Facility type vaccine reported as other. On 02Apr2021 at 13:00, the patient felt very sick for the first 24 hours and it went away. Shortly after, patient experienced the worst herpes outbreak of life. Lasted 3+ weeks and was very painful. Patient was recovered but it was very scary. It left painful scar tissue and struggle with intimacy now. Had not reported because patient was so embarrassed. Was urged by a friend to report. Adverse event resulted in: Disability or permanent damage. If patient recovered: Recovered with lasting effects. No treatment received for the adverse event. No COVID tested post vaccination. The outcome of the event inappropriate schedule of vaccine administered was unknown while other events were recovered on 2021.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Anxiety, Diarrhoea, Oropharyngeal discomfort
Clinical narrative: Stomach cramps; Diarrhea; My stomach is so sore and I cannot stand it, it is like the nervous stomach; My stomach is so sore and I cannot stand it; Some anxiety with the taste, it is kind of like something stuck in my throat and still going on; it is kind of like something stuck in my throat; it's like something in your throat; anxiety; arm got sore; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 07Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. About 3 or 4 days after vaccine, took on the 07Aug2021 and was due to take the next one on the 28th. On an unspecified date, the patient experienced stomach cramps, diarrhea, my stomach is so sore and i cannot stand it, it is like the nervous stomach, my stomach is so sore and i cannot stand it, some anxiety with the taste, it is kind of like something stuck in my throat and still going on, it is kind of like something stuck in my throat, it's like something in your throat, anxiety and arm got sore. The outcome of the event taste abnormality was unknown and rest 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: Pain in extremity, Taste disorder, Throat tightness
Clinical narrative: Stomach cramps; Diarrhea; My stomach is so sore and I cannot stand it, it is like the nervous stomach; My stomach is so sore and I cannot stand it; Some anxiety with the taste, it is kind of like something stuck in my throat and still going on; it is kind of like something stuck in my throat; it's like something in your throat; anxiety; arm got sore; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 07Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. About 3 or 4 days after vaccine, took on the 07Aug2021 and was due to take the next one on the 28th. On an unspecified date, the patient experienced stomach cramps, diarrhea, my stomach is so sore and i cannot stand it, it is like the nervous stomach, my stomach is so sore and i cannot stand it, some anxiety with the taste, it is kind of like something stuck in my throat and still going on, it is kind of like something stuck in my throat, it's like something in your throat, anxiety and arm got sore. The outcome of the event taste abnormality was unknown and rest events was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Computerised tomogram, Pancreatic disorder
Clinical narrative: Abdominal pain resulting in hospital visit. CAT scan showed inflamed pancreas; Abdominal pain resulting in hospital visit. CAT scan showed inflamed pancreas; This is a spontaneous report from a contactable consumer (reported for himself). A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 21Aug2021 at 11:00 (at the age of 43-years-old) as dose number unknown, single for COVID-19 immunisation at Workplace clinic. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included omeprazole (OMEPRAZOLE), high blood pressure med and advanced, taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received benadryl and experienced drug hypersensitivity, wellbutrin and experienced drug hypersensitivity. On 23Aug2021 at 07:00, the patient experienced abdominal pain resulting in hospital visit. cat scan showed inflamed pancreas. The event assessed as serious (hospitalization). The reporter stated the events result in Emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included computerised tomogram: inflamed pancreas on 23Aug2021 (inflamed pancreas). Therapeutic measures were taken as a result of events included treatment with CAT scan, morphine, pancreatic diet. The outcome of the events was resolving.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Immunoglobulins, Platelet count, Platelet count decreased, SARS-CoV-2 test
Clinical narrative: His platelets dropped 40 points to 123 thousand; This is a spontaneous report from contactable nurse. This nurse (patient's mother) reported for her 22-year-old son (patient).  A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 21Aug2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Patient age at vaccination was 22-year-old. Medical history included when he was little, like 11-years-old, he had issues with an allergic reaction, it was hives, and his platelets dropped but he had never had any problems with that. He had played contact sports, like hockey, and was fine. He had the disease, COVID, 10 months ago (Oct2020) and it was just like a bad cold, the worst part for him was that he lost his taste and his smell for 3 weeks. She obviously checked his platelets after he had COVID and everything was fine, it was 140 to 143 which was not that bad but it did drop a little. The patient's concomitant medications were not reported.  Due to patient had history of COVID-19, reporter's husband who was a physician monitored patient's antibodies because obviously the antibodies were better than the vaccine. And up until 3 weeks ago he was negative for IVGG. They made the choice to get the Pfizer COVID vaccine. The hematologist said to check her son's platelets before and after he had the COVID vaccine, like 48 hours to 72 hours afterwards because it may drop between that time period. They tested with two different labs. Patient's level was 168, which was before the COVID vaccine and which was a low normal and the other lab said it was 163. Reporter was fine with that since it was normal. So patient got the COVID vaccine. Also, before her son was tested for COVID with a blood test and a PCR to make sure that he didn't have COVID. They did his blood work yesterday (24Aug2021) and his platelets dropped 40 points to 123 thousand. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable nurse (patient's wife) from a Pfizer Sponsored Program Regulatory Authority. A 66-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, and second dose via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. A 61-year-old registered nurse and her 66-year-old husband (patient) said they received both doses of the Pfizer-BioNTech Covid-19 Vaccine in March 2021. Yesterday, 5 months after their 2nd dose, they both tested positive for Covid. Patient was "pretty darn ill" and has a fever of 102. The outcome of event was unknown.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided the lack of efficacy of the vaccine BNT162B2 cannot be completely excluded. The case will be reassessed if there is any new information available.