chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: cellulitis under his bandaid; This is a spontaneous report from a contactable Nurse (other hcp). A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 01Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter and her husband both received their first shot on 01Feb2021. Her husband had cellulitis under his bandaid. You could see the injection site puncture for five days (has picture). It looks like a reaction to the adhesive, but it is not he had never bandage reactions. It was an imprint of the bandage and the hole looks large. This has since completely resolved. Neither of them had any reaction to the second shot. The outcome of the event was unknown.The outcome of event was unknown.  Follow-up attempts are needed. Further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Cellulitis. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Flushing, Heart rate, Heart rate increased, Nasal congestion
Clinical narrative: has congestion; felt a niacin flush; heart beating a little fast; burning sensation in her chest area; This is a spontaneous report from a contactable consumer. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date at as a single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication(s) included xylometazoline hydrochloride. On an unspecified date, the patient experienced has congestion and had use a nasal spray. Caller stated as soon as she put nasal spray in each nostril she felt a niacin flush, heart beating a little fast and burning sensation in her chest area. Caller stated she drove back to the facility parking lot and the symptoms stopped right when she got back to the parking lot. Outcome of the events was recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Lymphadenitis, Myalgia, Pyrexia
Clinical narrative: Fever; Muscle soreness; Inflamed lymph node; Light headed; This is a spontaneous report from a non-contactable consumer (patient) via a company representative. A 16-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported) administered via an unspecified route of administration an unspecified date at single dose for COVID-19 immunization. The patient experienced fever, muscle soreness, inflamed lymph node, and was lightheaded on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Some tingling and mild numbness in my hand and fingers only; Some tingling and mild numbness in my hand and fingers only; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in arm on 09Feb2021 (at the age of 73-years-old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported) administered via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. In the arm where the patient received the second dose of the vaccine, she started to get some tingling and mild numbness in the hand and fingers only, not on the arm. The patient was in good health and did not have any conditions that would cause the events. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Sleep disorder, X-ray
Clinical narrative: pain from my elbow to the top of my arm and down to my wrist; pain in his right arm; pain that radiated down his arm; can't sleep on his right side because it hurts to bad; This is a spontaneous report received from a contactable consumer (reporting on himself). A 73-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN5318 and Expiry date was not reported), via an unspecified route of administration in Arm Right on 30Jan2021 13:00 as single dose for COVID-19 immunization. Medical history included hypertension, diabetes mellitus both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had a covid 19 shot the first dose on 30Jan2021. He have pain from my elbow to the top of his arm and down to his wrist. It has been persistent since he got the first vaccine. patient have been to the clinic several times and they did x-rays and mentioned something about physical therapy. It's been four months. The first vaccine created pain that radiated down his arm. He doesn't know what the vaccine did or caused. This pain has been present since he received his first Covid 19 vaccine. He reports the  clinic suggested physical therapy. He's a side sleeper and he can't sleep on his right side because it hurts to bad. He reports he called Pfizer about a month ago and left his phone number and did not receive a call back. He had an x-ray at the clinic and nothing was wrong with his arm. For medical history and concomitant medications he reports he has diabetes and high blood pressure. He takes medicines for those but he does not feel they are relevant to this report. He reports his bones are sound, he has no arthritis. His right arm was still sore and hurting. He received his second vaccine on 20Feb2021 (Lot# EN6200, Expiry 30Jun2021) and I didn't have any side effects from that one. He had no swelling or redness. He need some kind of recommendation of what to do. When he went for his second Covid 19 vaccine, he was close to the emergency room so he went. The emergency room gave him Diclofenac Sodium, an ointment. He uses it on his right arm and it diminishes the pain for about 45 minutes or so. It was Diclofenac Sodium Gel 1%, 16 gram tube, Expiry 14Sep2022. He reports the pain in his right arm is not diminishing, he's having pain ever day. If this was muscle pain it would have repaired itself by now. The outcome of the events was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: tested positive for covid; drug ineffective; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation .The patient medical history,concomitant medications were not reported.On an unspecified date The patient tested positive for covid (covid-19). The caller wanted to know if it was safe for her to get her second covid vaccine after she tested positive for covid after receiving her first covid vaccine.The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feeling unwell; This is a spontaneous report from a contactable consumer or other non HCP.   A 65-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 17Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in Apr2021, the patient was feeling unwell and she tested for Covid today 21Apr2021. She is due for her second dose on 8May2021. Patient asking for what the recommendations were on receiving the second dose after testing positive for Covid.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had the first vaccine and then 2 weeks later she actually tested positive for COVID/ got COVID and her main symptom was a headache; had the first vaccine and then 2 weeks later she actually tested positive for COVID/ got COVID and her main symptom was a headache; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9264), via an unspecified route of administration administered in the left arm on 04Mar2021 at a single dose for covid-19 immunisation. Medical history included cancer from 2014 (cancer survivor), had a mastectomy, 14 lymph nodes taken out the right side, hypothyroidism (thyroid condition) in 1990, osteopenia, and surgery in Dec2019 for a vaginal prolapse (they had gone in and done reconstruction). Concomitant medications included tamoxifen taken for cancer from an unspecified start date and ongoing; aspirin [acetylsalicylic acid] taken for an unspecified indication, start and stop date were not reported; calcium taken for osteopenia, start and stop date were not reported; vitamin c [ascorbic acid] taken for an unspecified indication, start and stop date were not reported; vitamin d taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for hypothyroidism, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for hypothyroidism, start and stop date were not reported. The patient had the first vaccine on 04Mar2021 and then 2 weeks later, on 18Mar2021, she actually tested positive for COVID. She stated she actually got COVID and her main symptom was a headache, like horrible, horrible headache. The doctors that she spoke with told her to wait 2 weeks ahead of her positive date to get the second vaccine. The outcome of the adverse events was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test, Vulvovaginal pain
Clinical narrative: Had a terrible like pain like at my surgical site, pain was very unexpected, pain in all my vaginal area; Headache; This is a spontaneous report from a contactable consumer (Patient). A 54-years-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 08Apr2021 as a single dose for COVID-19 immunization. Consumer stated, first shot she got was on 04Mar2021 and second one on 08Apr2021. After the second shot and she would say like she got COVID like in between those two shots. Medical history included neoplasm malignant, hypothyroidism, mastectomy and osteopenia. Concomitant medications included tamoxifen taken for neoplasm malignant, aspirin taken for an unspecified indication (as low dose aspirin), calcium taken for osteopenia, vitamin c taken for an unspecified indication, vitamin d (2000 IU) taken for an unspecified indication. The patient experienced terrible like pain like at my surgical site, pain was very unexpected, pain in all my vaginal area and headache on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test as positive on an unspecified date. Patient was on Levothyroxine and Synthroid for hypothyroidism and Ibuprofen 600 mg (for headache) every 6 hours for two days. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm; slight headache; This is a spontaneous report received from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 10Apr2021 as SINGLE DOSE for covid-19 immunisation  .  Medical history included high blood pressure , Allergy.     The patient's concomitant medications were not reported.  The patient experienced sore arm and slight headache on an unspecified date with outcome of recovered. The reported stated that patient has a headache because patient didn't take his blood pressure medication on 10Apr2021.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arterial stenosis, Head discomfort, Headache, Hypersomnia, Magnetic resonance imaging
Clinical narrative: arteries in my head on that side is narrowing, were narrowed.; seizure; it felt like somebody hit me on the head; I am sleeping a lot; violent headache; my body jerked; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8733), via an unspecified route of administration on 06Apr2021 (at the age of 80-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. Consumer stated, "What happened when I came home exactly at 1:50, I had it exactly at 5:15. I thought somebody shot me in the head. I had the TV remote in my hand, and it felt like somebody hit me on the head and remote went flying across the room and on to the floor. That was the first time and a half hour later it happened again I had a teaspoon in my hand at the dinner table, my body jerked and that went across the room than it happened two more times. I had nothing in my hand. But I jerked in my body, body jerked and a violent headache for 6 days now. I have had MRI of the head and I have to see if my neurologist, but he cannot see me till the 30Apr2021." Lab work: Consumer stated, "I went and had the MRI." When asked for any other help, consumer stated, "No, but I still don't know. I still have to go to my neurologist and my artery doctor because they said my arteries in my head on that side is narrowing, were narrowed. So, I am in for a long holiday. I had to go to a lot of doctors to figure out what they are going to do, and I am sleeping a lot, there is something wrong. I just want Pfizer to know just something not right with that. If you want also my husband but he came with me and he had shot with me. He had headache for five days but nothing else just the headache for 5 days from the same LOT." On 21Apr2021, information due to 2nd shot of Pfizer was again reported. She had a reaction 4 hours after that shot, kind of like a seizure, she had a TV remote in my hand and out of nowhere it when flying out of my hand across the table and onto the floor, this result happened 4 times within two hours that same day. Have had headache for 16 days since. The patient underwent lab tests and procedures which included magnetic resonance imaging: unknown result on an unspecified date. The outcome of the events was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Seizure
Clinical narrative: arteries in my head on that side is narrowing, were narrowed.; seizure; it felt like somebody hit me on the head; I am sleeping a lot; violent headache; my body jerked; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8733), via an unspecified route of administration on 06Apr2021 (at the age of 80-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. Consumer stated, "What happened when I came home exactly at 1:50, I had it exactly at 5:15. I thought somebody shot me in the head. I had the TV remote in my hand, and it felt like somebody hit me on the head and remote went flying across the room and on to the floor. That was the first time and a half hour later it happened again I had a teaspoon in my hand at the dinner table, my body jerked and that went across the room than it happened two more times. I had nothing in my hand. But I jerked in my body, body jerked and a violent headache for 6 days now. I have had MRI of the head and I have to see if my neurologist, but he cannot see me till the 30Apr2021." Lab work: Consumer stated, "I went and had the MRI." When asked for any other help, consumer stated, "No, but I still don't know. I still have to go to my neurologist and my artery doctor because they said my arteries in my head on that side is narrowing, were narrowed. So, I am in for a long holiday. I had to go to a lot of doctors to figure out what they are going to do, and I am sleeping a lot, there is something wrong. I just want Pfizer to know just something not right with that. If you want also my husband but he came with me and he had shot with me. He had headache for five days but nothing else just the headache for 5 days from the same LOT." On 21Apr2021, information due to 2nd shot of Pfizer was again reported. She had a reaction 4 hours after that shot, kind of like a seizure, she had a TV remote in my hand and out of nowhere it when flying out of my hand across the table and onto the floor, this result happened 4 times within two hours that same day. Have had headache for 16 days since. The patient underwent lab tests and procedures which included magnetic resonance imaging: unknown result on an unspecified date. The outcome of the events was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Decreased appetite, Headache, Illness, Nausea
Clinical narrative: big knot there and now its black and blue and it's also like ball/could be a blood clot on her hand; Headache; sickness; felt like little vomit; not having a very good appetite; feeling like sinusy; feeling little nauseas; bruise on the top of her hand and then that bruise move to left part of her upper hand; This is a spontaneous report from a contactable consumer (patient) reported that a 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727), via an unspecified route of administration on 08Apr2021 (at the age of 53-years-old) as a single dose for covid-19 immunisation. The patient medical history included cardiovascular disease. She has had open heart surgery, a double bypass when she was 44. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Mar2021 (at the age of 53-years-old) for covid-19 immunisation, and experienced face got swollen and got red and she think she got wet nose right there swelling a little bit same time her face swollen. Additional medical history included anxiety and depression. Concomitant medications included acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]; atorvastatin; midodrine; metoprolol; clopidogrel; ranolazine; meclozine hydrochloride (MECLIZINE HCL); hydrocortisone; glyceryl trinitrate (NITROGLYCERIN); zinc sulfate (ZINC SULPHATE); gabapentin; colecalciferol (VITAMIN D [COLECALCIFEROL]); and paracetamol (ACETAMINOPHEN); all were taken for an unspecified indication, start and stop date were not reported. Additional concomitant medications included duloxetine taken for depression and anxiety; and alprazolam (XANAX) taken for anxiety; both start and stop date were not reported. On 13Apr2021 5 days after the second vaccination, the patient experienced headache every single day with sickness and felt like little vomit and not having a very good appetite at all. She was feeling "sinusy" but she don't have any sinus issues and then she was feeling little nauseas and then her right hand for some reason she got bruise on the top of her hand and then that bruise move to left part of her upper hand and gotten a big knot there and now its black and blue and it's also like ball; her husband and she think that could be a blood clot on her hand. The outcome of the events was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus disorder, Thrombosis, Vomiting
Clinical narrative: big knot there and now its black and blue and it's also like ball/could be a blood clot on her hand; Headache; sickness; felt like little vomit; not having a very good appetite; feeling like sinusy; feeling little nauseas; bruise on the top of her hand and then that bruise move to left part of her upper hand; This is a spontaneous report from a contactable consumer (patient) reported that a 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727), via an unspecified route of administration on 08Apr2021 (at the age of 53-years-old) as a single dose for covid-19 immunisation. The patient medical history included cardiovascular disease. She has had open heart surgery, a double bypass when she was 44. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Mar2021 (at the age of 53-years-old) for covid-19 immunisation, and experienced face got swollen and got red and she think she got wet nose right there swelling a little bit same time her face swollen. Additional medical history included anxiety and depression. Concomitant medications included acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]; atorvastatin; midodrine; metoprolol; clopidogrel; ranolazine; meclozine hydrochloride (MECLIZINE HCL); hydrocortisone; glyceryl trinitrate (NITROGLYCERIN); zinc sulfate (ZINC SULPHATE); gabapentin; colecalciferol (VITAMIN D [COLECALCIFEROL]); and paracetamol (ACETAMINOPHEN); all were taken for an unspecified indication, start and stop date were not reported. Additional concomitant medications included duloxetine taken for depression and anxiety; and alprazolam (XANAX) taken for anxiety; both start and stop date were not reported. On 13Apr2021 5 days after the second vaccination, the patient experienced headache every single day with sickness and felt like little vomit and not having a very good appetite at all. She was feeling "sinusy" but she don't have any sinus issues and then she was feeling little nauseas and then her right hand for some reason she got bruise on the top of her hand and then that bruise move to left part of her upper hand and gotten a big knot there and now its black and blue and it's also like ball; her husband and she think that could be a blood clot on her hand. The outcome of the events was unknown.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, SARS-CoV-2 test, Urine analysis
Clinical narrative: Tested positive from COVID; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the upper right arm on 15Apr2021 at 15:00 (batch/lot number: ER8731) as a single dose for COVID-19 immunization. Medical history included high blood pressure and diabetes. Concomitant medications included metformin taken for diabetes and losartan taken for high blood pressure; both start and stop dates were not reported. The patient stated he had the vaccine Thursday at 3 o'clock (15Apr2021 at 15:00) and its symptoms were going on but for some reason that night he woke up with fever and chills. So his employee advised him to go and get tested. He went to get tested on Friday noon (16Apr2021) and now he was tested positive from COVID. He asked was that expected with the (incomplete sentence). Even if he was exhibiting some symptoms, he has some body aches and it has already been 4 days since he had the vaccine, he asked if that was normal. On 15Apr2021, he stated probably that evening, so he took the vaccine at 3, he woke up in the middle of the night with chills and fever. He had just a little bit of congestion, body ache, fever. He had a blood work, urine test on Friday (16Apr2021) with unknown results. He stated for treatment, he had one of his coworkers bring him some Tylenol and some Multivitamins high in zinc and vitamin C and D. One of his coworkers brought him some Tylenol, Multivitamin with zinc and vitamin C and vitamin D. He just asked whether this was possible, that it came from the vaccine or maybe it's a false positive or if he does have COVID or he doesn't know what to do. The outcome of the event was unknown.  No follow-up attempts are needed. Information related to batch/lot number was obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Paraesthesia oral, Pruritus, Rash, Swelling face
Clinical narrative: bad itchiness; around her mouth tingling; Painful rash; facial swelling; This is a spontaneous report received from a contactable female consumer. This female consumer (patient) of unspecified age reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on 09Apr2021 as single dose for COVID-19 immunisation. The patient was on sulfadiazine (route of administration, start and stop date, batch/lot number and dose were not reported) for an unspecified indication. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported that after the vaccine which she had on 09Apr2021, she had bad itchiness on the trunk and tingling around her mouth. She had a painful rash on her leg, left shin on the inside of the leg which kind of burned. It was red dots among a pink rash, painful, odd and intense. She took a cup of Benadryl and fell asleep. She was still itchy the next day. She had reactions to IV antibiotics and they had to discontinue them and give her steroid and Benadryl. She was still itchy the next day. Maybe it was something in the suspension she might have been allergic to. She is due for second dose of the vaccine on 30Apr2021. The patient had underlying auto immune issues maybe that was making her more susceptible. She enquired if she had to get the second shot or take Benadryl before. The oral drug she reacted to was a Sulfa drug. She had facial swelling with it. Outcome was unknown for all the events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Eye haemorrhage, Fatigue, Headache, Influenza like illness
Clinical narrative: broken blood vessel in right eye; flu like symptoms; dull headache/ sharp pain on right side of head; slight fever; exhaustion; upset stomach; This is a spontaneous report from a contactable consumer (patient). A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration on 07Apr2021 11:00 as a single dose for COVID-19 immunisation. The patient has no medical history and there were no concomitant medications. The patient has no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 08Apr2021, a day after the vaccine, the patient began experiencing flu like symptoms with dull headache, slight fever, exhaustion and upset stomach. 10 days later, on 17Apr2021, he developed sharp pain on right side of head, and broken blood vessel in right eye. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was given in response to the events. The patient underwent COVID test post vaccination via Nasal swab on 17Apr2021 and was negative. The outcome of the events was not recovered.   Information about lot/batch number has been requested.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: broken blood vessel in right eye; flu like symptoms; dull headache/ sharp pain on right side of head; slight fever; exhaustion; upset stomach; This is a spontaneous report from a contactable consumer (patient). A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration on 07Apr2021 11:00 as a single dose for COVID-19 immunisation. The patient has no medical history and there were no concomitant medications. The patient has no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 08Apr2021, a day after the vaccine, the patient began experiencing flu like symptoms with dull headache, slight fever, exhaustion and upset stomach. 10 days later, on 17Apr2021, he developed sharp pain on right side of head, and broken blood vessel in right eye. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was given in response to the events. The patient underwent COVID test post vaccination via Nasal swab on 17Apr2021 and was negative. The outcome of the events was not recovered.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient states he is calling because he got COVID four days after his first vaccine. He says he just has a question. He does not provide his last name when queried. The caller declines to file a report. The caller asks is it ok for him to get his second dose after the 3 week period. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Neck pain, Pain in extremity
Clinical narrative: It now goes up to her neck, her back, down her arm and her hand; It now goes up to her neck, her back, down her arm and her hand; immense pain travel down her entire left arm into her hand; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 03Apr2021 at 13:45 as a single dose for COVID-19 immunization.  Medical history included migraine and unspecified known allergies both from an unknown date and unknown if ongoing. The patient did not have COVID prior to the vaccination. Concomitant medications included topiramate (manufacturer unknown); sumatriptan (manufacturer unknown); eszopiclone (LUNESTA) and promethazine (manufacturer unknown) all taken for an unspecified indication, start and stop date were not reported. The patient did not have other vaccines in four weeks prior to the COVID vaccine. The patient was not tested for COVID post vaccination. On 03Apr2021, it was reported that within two minutes of receiving the injection, the patient had immense pain travel down her entire left arm into her hand. She knew it wasn't normal. The patient called the paramedics over because the pain got so intense she couldn't even touch her arm nor her hand. The paramedic said this was not a normal reaction and maybe they hit a nerve but he's not sure what's going on. It's been two weeks since her vaccine injection. The pain comes and goes just as bad as that bad. It now goes up to her neck, her back, down her arm and her hand. She can't use it nor touch it. The events result in a doctor or other healthcare professional office visit and was reported to have caused disability/permanent damage. The patient had not recovered from the events.   Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: headache; fatigue; chills; This is a spontaneous report from a contactable consumer reporter reported for herself that she received the second dose of COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection) via an unspecified route of administration as a single dose for COVID-19 immunization. The patients past medical history included the first dose of BNT162B2 for COVID-19 immunization. Concomitant medications was not reported. On an unknown date, the patient experienced headache, fatigue and chills. The reporter also stated that her infant son whom she was nursing was irritable on the evening of her second dose. The clinical outcome for the events was unknown.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : PFIZER INC-2021445201 child
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Haemorrhage
Clinical narrative: bleeding restarted; back pain identical to the pain during labor; This is a spontaneous report from a non-contactable consumer (patient). A 36-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (batch/lot number and expiry date not reported) as single dose for covid-19 immunization. Medical history was none. The patient has no covid prior vaccination. The patient's concomitant medications were not reported. The patient informed that 2nd dose was received at the end of period (4th day) (unspecified). The following day (unspecified date), bleeding restarted and back pain identical to the pain during labor (so called "back labor"). The patient reported bleeding restarted was non-significant. The patient was asking to investigate if causes cramps or affects reproductive system. The patient was not covid tested post vaccination. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk, Irritability
Clinical narrative: My infant son whom I am nursing was irritable on the evening of my second dose.; My infant son whom I am nursing was irritable on the evening of my second dose.; This is a spontaneous report from a contactable Pharmacist. This contactable Pharmacist reported for her son that, she received the second dose of COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection, lot# and expiration date not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. The patients past medical history were not reported. Concomitant medication was not reported. On an unknown date, the reporter (mother) experienced headache, fatigue and chills. The reporter also stated that her infant son whom she was nursing was irritable on the evening of her second dose. The clinical outcome for the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021445156 mother
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blindness, Chills, Cough, Fatigue
Clinical narrative: coughing; loss of vision comes and goes; Chills; body and back pain; body and back pain; Fatigue: he has been in his bed and falling asleep in his chair for the past few days; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8131), via an unspecified route of administration on 14Apr2021 at 09:20 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The first vaccine has been experiencing loss of vision, chills, body and back pain, and fatigue for the past 3 days, from 14Apr2021. He wanted to know if he should go to the ER. The patient was audibly coughing while on the call. He went to the appointment at 09:20 on 14Apr2021 and while driving back he noticed the loss of vision at about 10:15 on 14Apr2021. He said that the loss of vision comes and goes but is still persisting. On fatigue: Patient has been in his bed and falling asleep in his chair for the past few days. Chills, body and back pain and fatigue were reported as worsened. The outcome of the events loss of vision, chills, body and back pain, and fatigue was not recovered, while of coughing was unknown.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: coughing; loss of vision comes and goes; Chills; body and back pain; body and back pain; Fatigue: he has been in his bed and falling asleep in his chair for the past few days; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8131), via an unspecified route of administration on 14Apr2021 at 09:20 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The first vaccine has been experiencing loss of vision, chills, body and back pain, and fatigue for the past 3 days, from 14Apr2021. He wanted to know if he should go to the ER. The patient was audibly coughing while on the call. He went to the appointment at 09:20 on 14Apr2021 and while driving back he noticed the loss of vision at about 10:15 on 14Apr2021. He said that the loss of vision comes and goes but is still persisting. On fatigue: Patient has been in his bed and falling asleep in his chair for the past few days. Chills, body and back pain and fatigue were reported as worsened. The outcome of the events loss of vision, chills, body and back pain, and fatigue was not recovered, while of coughing was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Pain, Vaccination site erythema, Vaccination site swelling
Clinical narrative: having I think allergic reaction; It's red and it's raised all the way down to her, close to her elbow but it's not all the way; welt and a lump under the skin" where she received her injection; welt and a lump under the skin" where she received her injection; its been hurting her; This is a spontaneous case is received from a contactable consumer (boyfriend).   A 29-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history included allergic reaction for flu shots. The patient's concomitant medications were not reported.  On an unspecified date the patient had allergic reaction. Its red and raised all the way down to her, close to her elbow but not all the way. It had been hurting her and reporter was wanted some information and requested for call back. On call back, it was reported that she had a welt and a lump under the skin where she received her injection. Reporter wanted to know if allergic reaction was normal for vaccine and also duration for the same. The reporter was informed about the listed events and duration. Outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Circumstance or information capable of leading to medication error, Fear, SARS-CoV-2 test positive
Clinical narrative: She adds that she has a very uneasy feeling about getting the 2nd vaccine, she will not g; she is fearful,; She is worried that she only has 1 vaccine on the card, is Pfizer able to provide an excuse not for her ?; This is a spontaneous report from a contactable consumer reported for herself. A 55-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. She had the covid virus last year on 13Mar2020, she again confirms it was in 2020 when she came down with it. She was moderately to severely sick, but she just had telehealth appointments there was no hospitalization, she has asthma and diabetes, it lasted 3 weeks, and she did not have long lasting effects from the virus. She was Allergic to tree nuts. The patient's concomitant medications were not reported.  The patient stated that she has a very uneasy feeling about getting the 2nd vaccine, she will not get it, she is fearful, she feels like she would be hospitalized with the second, she though it would kill her, she doesnt know how to be protected. She is scheduled for the second dose on 19Apr2021 at 10:15. She had the positive covid result in Mar2020, it was a deep nasal swab. She has had 3 covid test in total, being the 1 positive one last year and she did 2 this year. Caller clarifies that the 2 tests this year were not due to symptoms or anything. She only took the test to be able to visit her mom in the group home. Outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021404399 same reporter/patient/drug, different event in separate dose
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is so sore, I can hardly move it; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 (lot number: EM9809) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included blood pressure, ongoing diabetes (probably 10 years or more). Concomitant medication included metformin for diabetes, unspecified medicine at one every day for blood pressure. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208) on 22Mar2021  for COVID-19 Immunization. The patient stated, "I was calling because I had my second shot on Monday and my arm, yesterday and today my arm is so sore, I can hardly move it. I have been massaging and I took Tylenol (treatment) but I was wondering should I put a heat pad on it, do I need call my doctor, it is just unusual sore, it's not just a little sore in my arm, I can even hardly use it and I just want to make sure it's going to get better or not. Now, I do know when he put my shot he did it all the way up at the top of my arm, I never had a shot on my arm almost at my shoulder." The patient stated, there is no Laboratory test, she haven't had any kind of treatment or anything lately." She added, "I was wondering to put a heating pad on my arm for the pain that is what I was trying to find out." The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Concussion, Head injury, Loss of consciousness, SARS-CoV-2 test
Clinical narrative: noting large bump after hour later a large Boulder size bump on forehead same eve as lost of I remembered loss consciousnes; noting large bump after hour later a large Boulder size bump on forehead same eve as lost of I remembered loss consciousnes; Large brown circle surround site of shot; bruising surrounding it; some welting. Some tenderness; some welting. Some tenderness; Mild concussion with symptoms. Amnesia at time of loss of consciousness.; Mild concussion with symptoms. Amnesia at time of loss of consciousness.; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 31Mar2021 12:30 (at the age of 71-years-old) (Batch/Lot Number: ER8732) as SINGLE DOSE for covid-19 immunisation. Medical history included, neuropathy peripheral, drug hypersensitivity, diarrhoea, vision blurred blurred/double vision since Feb, hypertension Mild high blood pressure. Drop in blood pressure and increase in blood pressure month after Covid, chills, MGUS, non symptomatic ascending aorta aneurysm, pronounced cough, fever, sore throat, flu symptom. I had the virus on 30Nov after being unknowingly infected with virus by someone unknowingly with virus, some 8 feet away, with no direct interaction. Experienced fever 4 days later. tested. Virus positive. Excessive flu symptom-pronounced cough, fever, sore throat. treated w/antibodies some 8 days later. The patient received first dose of BNT162B2 for COVID-19 immunization on 10Mar2021 ({Product=COVID 19, brand=Pfizer, Lot number=EN6199, Lot unknown=False, Administration date=10Mar2021, Administration time=12:30 PM, Vaccine location=Left arm, Dose number=1}]. Concomitant medication included hydrochlorothiazide, lisinopril (ZESTORETIC); bupropion hydrochloride (WELLBUTRIN); naproxen (NAPROXEN). Large brown circle surround site of shot, with additional bruising surrounding it. Not noticed until 18 days after 2nd shot, some welting. Some tenderness. Don't know when first appeared, does not appear to be fading. No reaction after first shot. (There was sudden unexpected loss of consciousness after sudden slumping. Wednesday eve before noting large bump after hour later a large Boulder size bump on forehead same eve as lost of I remembered loss consciousnes. Mild concussion with symptoms. Amnesia at time of loss of consciousness. Do not know if two are related. Deep brown circle on left arm noted 2 day later. The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 30Nov2020. The outcome of the events was not recovered.