chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Eye infection
Clinical narrative: eye infection; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (wife) reported that a male patient of an unspecified age received the first dose of bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller reported that her husband received the 1st dose of the Pfizer vaccine 2 weeks ago (Jan2021) and he had an eye infection unrelated to the vaccine. Caller was asking if he can take antibiotics and asking if that would be contraindicated with the vaccine that he got. Caller also mentioned that her husband was afraid to take antibiotics and wanted to know if it was okay to take antibiotics which was prescribed by his Doctor. Her husband was also an healthcare professional but he was an Orthopedic Surgeon and it's not his field. The reported wanted to know if that would reduce the immunity that he got from the vaccine. The patient developed the eye infection a week ago (Jan2021). He had not taken the antibiotic before. Second dose would be on 01Feb2021. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: The eye infection is most likely an intercurrent condition and unrelated to suspect vaccine BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Malaise, Skin reaction
Clinical narrative: reaction for 14 days. She went to dermatologists to check about those marks if it's cancerous or something/did a biopsy; she's not feeling well; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient).  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 at SINGLE DOSE for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient got her 1st dose of Covid 19 Vaccine on 11Jan2021 and now already experiencing a reaction for 14 days. She went to dermatologists to check about those marks if it's cancerous or something, she was there 4days ago and did a biopsy, then after that Doctor asked if she took the covid 19 vaccine because they knew about it. She wanted to ask as well if it's Okay if she will not take the 2nd dose because she's not feeling well now and can't take it. The outcome was unknown.  Information about Lot/Batch has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site reaction, Pruritus, Skin lesion, Skin warm
Clinical narrative: Noticed a red lesion around the injection site that didn't show up until 12 days after I got my first shot. It's slightly itchy and warm to the touch. No pain. I  reported it  because I saw that others had the same reaction and it scared me until I found out that it was a known side effect.  * I received a shingrix vaccine on November 23rd 2020 but it wasn't within a month of the Covid vaccine so I didn't mark it on this form. I wanted to give the info just in case it might be helpful.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Nausea, Pain, Tremor
Clinical narrative: Shaking, diaphoretic, head ache, nausea, body aches
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: anaphylactic shock; bleeding disorder (blood clots); atrial fibrillation; little sore arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient calling-in because she received her 1st shot of vaccine earlier today. She claims that it is too late when she reads the fact sheet. she called-in because she has bleeding disorder (blood clots) or atrial fibrillation and taking xarelto. She also reported that she had anaphylactic shock. Reporter stated she never experienced an anaphylactic reaction just a little sore arm, she just called to obtain information as she currently takes an anti-coagulant. Therapeutic measures were taken as a result of bleeding disorder (blood clots), atrial fibrillation. The outcome of the events was unknown.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Orthopnoea
Clinical narrative: Shortness of breath; This is a spontaneous report from a contactable consumer. An 89-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283, Expire Date: Apr2021), via an unspecified route of administration on 15Jan2021 09:00 at single dose, right arm for covid-19 immunization. Indication reported as "Hopes she wouldn't get COVID", Stated that was why she got the Measles vaccination. The patient's medical history and concomitant medications reported as none. The patient previously got flu shot for immunization in Oct2020. The patient experienced shortness of breath on 17Jan2021. Caller told the woman administering it that she had been short of breath and was advised it was alright to receive the COVID-19 Vaccine. The patient had been really short of breath ever since. She wasn't very short of breath before the COVID-19 Vaccine. She was more so short of breath after the COVID-19 Vaccine. Shortness of Breath was noticed increase on 17Jan2021 at night. She was fine during the day, but could not lie down to go to sleep in bed. Sat up all night. Then it just came and went. Sometimes thought it was gone, but shortness of breath came back. The patient called doctor and was advised to go into an urgent care. She was going at time of the report. Relevant tests reported as none, regular check up at doctor. She wanted to know if she could get the second COVID-19 vaccine on 06Feb2021. The outcome of the event was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Diplopia, Visual impairment
Clinical narrative: Visual problems, diplopia, concerns for left 4th cranial nerve paralysis
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Gait disturbance, Gait inability, Hypersomnia, Vomiting
Clinical narrative: sleeping 40 hrs; Severe diarrhea; vomiting; Unable to walk without help; This is a spontaneous report received from a contactable consumer (patient himself). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: Unknown/ not available at the time of report completion), via an unspecified route of administration on right arm on 23Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included liver disease and "chrons". Patient had no allergies. Concomitant medication included paracetamol (TYLENOL). The patient experienced severe diarrhea, vomiting, unable to walk without help and sleeping 40 hrs on 28Jan2021 01:00. Patient. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The seriousness of the events was reported as non-serious. The patient did not receive any treatment for the events. The outcome of the events was reported as not recovered.  No follow-up attempts are possible; Information about lot/ batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea, Pain
Clinical narrative: Pt reported that she had nausea, dizziness, body ache, subjective fever, fatigue, HA alomost immediately after her 2nd Moderna vaccine on 1/6. Symptoms have persisted over the weekend and pt reported to have been bedridden. Advil helped.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pt reported that she had nausea, dizziness, body ache, subjective fever, fatigue, HA alomost immediately after her 2nd Moderna vaccine on 1/6. Symptoms have persisted over the weekend and pt reported to have been bedridden. Advil helped.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability, Mobility decreased, Musculoskeletal discomfort, Walking aid user
Clinical narrative: Was not able to walk/He could not move his legs, but now he is able to stand; His knees were hurting; This is a spontaneous report from a contactable consumer. A 75-year-old male patient (reporter's brother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:  EL9262), via intramuscular on 22Jan2021 at single dose for COVID-19 vaccination. Medical history included 2 heart attacks, stroke, she said that he had had numerous other things. His physician said that he was doing fine with all of the different things that he had. She said that he did not get enough oxygen when he was born and was a little slow because of that. There were no concomitant medications. The caller said that her brother today 25Jan2021 got up after doing a few little things and said that the paperwork talks about joint discomfort. He was not able to walk after a little while. This was something new. She said that his knees were hurting. She had to use a wheelchair to get him to the car. The cardiologist said that there was nothing wrong with his heart when and said that she made an appointment with his primary care doctor as well. She said that she made an appointment with his primary care for tomorrow evening 26Jan2021. Caller said that she was not saying that it was from the vaccine. She said that he could not move his legs, but now he was able to stand. At 15:00 central time 25Jan2021, he was able to stand up and walk to the chair. She said that it was an improvement. The caller said that her brother took the shot on Friday 22Jan2021. He got up did his regular routine and at about 11:50, he was in the den and was standing with a cane and was holding on to the cane and was not moving his legs. They got the wheelchair out of the car and sat him down. He said that his knees were hurting at that time. He was not able to move his feet at all. She said that he does not complain at all. Caller said that when this happened, her bother He was not slurring his words or having any other symptoms. The outcome of the events was recovering.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Wheelchair user
Clinical narrative: Was not able to walk/He could not move his legs, but now he is able to stand; His knees were hurting; This is a spontaneous report from a contactable consumer. A 75-year-old male patient (reporter's brother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:  EL9262), via intramuscular on 22Jan2021 at single dose for COVID-19 vaccination. Medical history included 2 heart attacks, stroke, she said that he had had numerous other things. His physician said that he was doing fine with all of the different things that he had. She said that he did not get enough oxygen when he was born and was a little slow because of that. There were no concomitant medications. The caller said that her brother today 25Jan2021 got up after doing a few little things and said that the paperwork talks about joint discomfort. He was not able to walk after a little while. This was something new. She said that his knees were hurting. She had to use a wheelchair to get him to the car. The cardiologist said that there was nothing wrong with his heart when and said that she made an appointment with his primary care doctor as well. She said that she made an appointment with his primary care for tomorrow evening 26Jan2021. Caller said that she was not saying that it was from the vaccine. She said that he could not move his legs, but now he was able to stand. At 15:00 central time 25Jan2021, he was able to stand up and walk to the chair. She said that it was an improvement. The caller said that her brother took the shot on Friday 22Jan2021. He got up did his regular routine and at about 11:50, he was in the den and was standing with a cane and was holding on to the cane and was not moving his legs. They got the wheelchair out of the car and sat him down. He said that his knees were hurting at that time. He was not able to move his feet at all. She said that he does not complain at all. Caller said that when this happened, her bother He was not slurring his words or having any other symptoms. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Skin reaction
Clinical narrative: localized injection site reaction: redness, swollen and warm to the touch; localized injection site reaction: redness, swollen and warm to the touch; localized injection site reaction: redness, swollen and warm to the touch; This is a spontaneous report from a contactable Nurse. This Nurse reported similar events for 3 patients. This is 2nd of 3 patients.  A 82-years-old female patient received first dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 21Jan2021 at SINGLE DOSE on right arm for covid-19 immunisation. Medical history and concomitant medications were none. The patient experienced localized injection site reaction: redness, swollen and warm to the touch on 24Jan2021 with outcome of not recovered considered as important medical event. Term highlighted by the reporter: Yes.Outcome of the events  was not recovered. Caller works in an assisted living facility.  Information on Lot/Batch has been requested.; Sender's Comments: Based on temporal association and currently known drug profile, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events 'localized injection site reaction: redness, swollen and warm to the touch'.  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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021093798 Same reporter/drug/AE, different patient;US-PFIZER INC-2021093835 Same reporter/drug, different patient/AE
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Hypoaesthesia eye, Nausea, Pruritus, Rash
Clinical narrative: Systemic: Rash (other than injection site)- Mild, Systemic: Nausea- Mild, Systemic: Vomiting- Mild, Systemic: Other- pt had itchy eyes, arms, neck and numbness around eyes
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Systemic: Rash (other than injection site)- Mild, Systemic: Nausea- Mild, Systemic: Vomiting- Mild, Systemic: Other- pt had itchy eyes, arms, neck and numbness around eyes
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis
Clinical narrative: cellulitis from Right shoulder to Right elbow within 48 hours of shot, necessitating antibiotic therapy for cellulitis.; Fevers to 102 F; chills x 48 hours; severe Right arm swelling; This is a spontaneous report from a contactable physician (patient).  A 44-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number 4121 EL 1283) , via an unspecified route of administration from 19Jan2021 13:15 at single dose on right arm for covid-19 immunization.  Medical history was none.  The patient's concomitant medications were not reported.  The patient experienced cellulitis from right shoulder to right elbow within 48 hours of shot, necessitating antibiotic therapy for cellulitis. The patient experienced fevers to 102 f, chills x 48 hours, severe right arm swelling on 20Jan2021 02:00.  The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit on 20Jan2021. Therapeutic measures taken as a result of the events included Keflex times 10 days. No covid prior vaccination, no covid tested post vaccination, no other vaccine in four weeks. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported events cellulitis, fever, chills and swelling arm. 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast, Chills, Dry skin, Erythema, Injection site rash
Clinical narrative: I had my vaccination on January 15.  Had low grade temperature, body aches, nausea, severe chills starting about 12 hours after injection.  Lasted 24 hours.  Third day after injection, my arm broke out in a rash around injection site, lasted  2 days.   Had 2 breast biopsies on January 20.   Started a breakout on both breasts on January 22.  On  January 27 rash started to spread over my torso.  Went to dermatologist on February 5, started prescription medications and cream.  By February 6, I had a full body breakout with red burning skin, rough red rash, welt/hives and pain.  On Feburary  6  went to the ER for treatment.  Received IV of Benadryl and Prednisone.  ER doctor said she believed the vaccination was the cause.  If it was from the biopsies it should have been contained to the breast area.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Rash, Rash erythematous
Clinical narrative: I had my vaccination on January 15.  Had low grade temperature, body aches, nausea, severe chills starting about 12 hours after injection.  Lasted 24 hours.  Third day after injection, my arm broke out in a rash around injection site, lasted  2 days.   Had 2 breast biopsies on January 20.   Started a breakout on both breasts on January 22.  On  January 27 rash started to spread over my torso.  Went to dermatologist on February 5, started prescription medications and cream.  By February 6, I had a full body breakout with red burning skin, rough red rash, welt/hives and pain.  On Feburary  6  went to the ER for treatment.  Received IV of Benadryl and Prednisone.  ER doctor said she believed the vaccination was the cause.  If it was from the biopsies it should have been contained to the breast area.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation, Urticaria
Clinical narrative: I had my vaccination on January 15.  Had low grade temperature, body aches, nausea, severe chills starting about 12 hours after injection.  Lasted 24 hours.  Third day after injection, my arm broke out in a rash around injection site, lasted  2 days.   Had 2 breast biopsies on January 20.   Started a breakout on both breasts on January 22.  On  January 27 rash started to spread over my torso.  Went to dermatologist on February 5, started prescription medications and cream.  By February 6, I had a full body breakout with red burning skin, rough red rash, welt/hives and pain.  On Feburary  6  went to the ER for treatment.  Received IV of Benadryl and Prednisone.  ER doctor said she believed the vaccination was the cause.  If it was from the biopsies it should have been contained to the breast area.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Palpitations
Clinical narrative: Atrial fibrillation; palpitations; This is a spontaneous report from a contactable other health professional. This other health professional reported similar events for 2 patients. This is the 2nd of 2 reports. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced atrial fibrillation and palpitations on unspecified dates. Caller said that the patient had the atrial fibrillation about the same length of time she developed atrial fibrillation after her vaccine. The outcome of the events were unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event Atrial fibrillation cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021111497 same reporter and product, similar events with different patients
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Injection site pain, Joint range of motion decreased, Sleep disorder
Clinical narrative: This was my second COVID vaccine. During the first vaccine, I felt no pain during injection. During this injection, I felt a very sharp pain. The injector told me that she felt my muscle spasm as she put the needle in. Within one hour, my arm got very sore to the point where I couldn't move it. I am now 6 days later and still have extreme pain in my left arm and have a hard time sleeping due to the discomfort.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Apparent life threatening event, Arrhythmia, Heart rate irregular
Clinical narrative: Patient was put into Irregular Heart rhythm 3 hours post vaccine; This is a spontaneous report from a contactable other healthcare professional (HCP). A 77-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el8982) Intramuscular on 29Jan2021 03:15 PM at single dose for covid-19 immunisation. Medical history included atrial fibrillation, prostate CA and dyslipidemia. No known allergies. No COVID prior vaccination. Concomitant medications were not reported. no other vaccine in four weeks. Patient was put into irregular heart rhythm 3 hours post vaccine on 29Jan2021 06: 15 PM, resulted in Life threatening illness (immediate risk of death from the event). Treatment included medication. No COVID tested post vaccination. Patient was recovered from the event on unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of  arrhythmia  due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient with medical history included atrial fibrillation and dyslipidemia.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline and during subject drug therapy, echocardiogram, cardiac enzymes, electrolytes, chemistry panel and serum toxicology screen, counteractive treatment measures and concomitant medications. This case will be reassessed once additional 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.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Diplopia, Headache, IVth nerve paralysis, Laboratory test normal
Clinical narrative: Diagnosed with sixth nerve palsy; Diarrhea; Headache; Nausea; This is a spontaneous report from a contactable consumer. A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686 and expiry date: Mar2021), via an unspecified route of administration on 02Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included hypertension.  Concomitant medication included cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), calcium (CALCIUM), rosuvastatin (ROSUVASTATIN). The patient experienced double vision and diagnosed with sixth nerve palsy on Jan2021, diarrhea and headache and nausea on 2021. The reporter stated "I am calling in reference to reporting possible side effect or adverse reaction to the vaccine. It is in reference to my mother, she had the first dose on 02Jan2021 and 14 days later, she started with double vision, ended up in the hospital. She was in the hospital 4 days (4 nights), diagnosed with sixth nerve palsy." The patient was hospitalization from 18Jan2021 to 22Jan2021. Reporter stated, "She was in hospital, she has visiting nurse now for physical therapy that comes to house and they going to redraw her labs tomorrow Wednesday. They were basically normal, all the lab results were normal." Therapeutic measures were taken as a result of double vision, diagnosed with sixth nerve palsy. Outcome of the events was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, VIth nerve paralysis
Clinical narrative: Diagnosed with sixth nerve palsy; Diarrhea; Headache; Nausea; This is a spontaneous report from a contactable consumer. A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686 and expiry date: Mar2021), via an unspecified route of administration on 02Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included hypertension.  Concomitant medication included cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), calcium (CALCIUM), rosuvastatin (ROSUVASTATIN). The patient experienced double vision and diagnosed with sixth nerve palsy on Jan2021, diarrhea and headache and nausea on 2021. The reporter stated "I am calling in reference to reporting possible side effect or adverse reaction to the vaccine. It is in reference to my mother, she had the first dose on 02Jan2021 and 14 days later, she started with double vision, ended up in the hospital. She was in the hospital 4 days (4 nights), diagnosed with sixth nerve palsy." The patient was hospitalization from 18Jan2021 to 22Jan2021. Reporter stated, "She was in hospital, she has visiting nurse now for physical therapy that comes to house and they going to redraw her labs tomorrow Wednesday. They were basically normal, all the lab results were normal." Therapeutic measures were taken as a result of double vision, diagnosed with sixth nerve palsy. Outcome of the events was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itch on arm of injection about 8 days after the injection.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Central nervous system lesion, Diarrhoea, Dizziness, Emotional distress
Clinical narrative: I had a violent reaction; lesion on my brain and found everything once I was in hospital; I am upset; Dizziness; Vomiting; the "rungs" (not clarified) and the stomach after giving me something it stopped. I went from both ends when I had to throw up I just went out from both ends, (it was) bad; This is a spontaneous report from a contactable consumer (patient).  An 88-year-old female patient received first dose of bnt162b2 (BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 23Jan2021 at single dose for covid-19 immunization. Medical history included diabetes, blood pressure high, thyroid. Concomitant medication included amlodipine, valsartan (DIOVAN), metformin, levothyroxine sodium (LEVOXYL) for thyroid, atorvastatin (LIPITOR). The patient had the shot on Saturday and Sunday, she had a violent reaction and she just want to report it. It was first shot she had the first on Saturday and it happened (incomplete sentence). Her follow up was that she found other problems. She found lesion on her brain, she found everything else once she was in the hospital. So actually this reaction was (incomplete sentence). She known never she was little upset today. She was not right why not follow up latter she was little upset today, so she just want to let you know she had a problem. When probed for the vaccination date, consumer stated, the date was 23Jan2021. When probed for start date of the events, consumer stated, it was 24Jan. When probed for the side effects, consumer stated, she had extreme dizziness, she had extreme vomiting and "run" (not clarified) and that was about it Dizziness she went to 12 o'clock noon she started with the dizziness and it was over in about 5 in the afternoon and the "rungs" (not clarified) and the stomach after giving her something it stopped. She went from both ends when she had to throw up she just went out from both ends, (it was) bad. They did not give her anything for that. They did all sorts of test and found out that she had other problems. When probed for any Laboratory test, consumer stated, "Yes, she did it and she was fine." When probed for laboratory results, consumer stated, "No, she did not have the results. Her doctor just gave them to her over the phone and said that she was good. Her A1C was 5.9." The event lesion on her brain was reported as serious per hospitalization. The patient underwent lab tests and procedures which included glycosylated haemoglobin: 5.9 on an unspecified date. The outcome of events was unknown.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Vomiting
Clinical narrative: I had a violent reaction; lesion on my brain and found everything once I was in hospital; I am upset; Dizziness; Vomiting; the "rungs" (not clarified) and the stomach after giving me something it stopped. I went from both ends when I had to throw up I just went out from both ends, (it was) bad; This is a spontaneous report from a contactable consumer (patient).  An 88-year-old female patient received first dose of bnt162b2 (BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 23Jan2021 at single dose for covid-19 immunization. Medical history included diabetes, blood pressure high, thyroid. Concomitant medication included amlodipine, valsartan (DIOVAN), metformin, levothyroxine sodium (LEVOXYL) for thyroid, atorvastatin (LIPITOR). The patient had the shot on Saturday and Sunday, she had a violent reaction and she just want to report it. It was first shot she had the first on Saturday and it happened (incomplete sentence). Her follow up was that she found other problems. She found lesion on her brain, she found everything else once she was in the hospital. So actually this reaction was (incomplete sentence). She known never she was little upset today. She was not right why not follow up latter she was little upset today, so she just want to let you know she had a problem. When probed for the vaccination date, consumer stated, the date was 23Jan2021. When probed for start date of the events, consumer stated, it was 24Jan. When probed for the side effects, consumer stated, she had extreme dizziness, she had extreme vomiting and "run" (not clarified) and that was about it Dizziness she went to 12 o'clock noon she started with the dizziness and it was over in about 5 in the afternoon and the "rungs" (not clarified) and the stomach after giving her something it stopped. She went from both ends when she had to throw up she just went out from both ends, (it was) bad. They did not give her anything for that. They did all sorts of test and found out that she had other problems. When probed for any Laboratory test, consumer stated, "Yes, she did it and she was fine." When probed for laboratory results, consumer stated, "No, she did not have the results. Her doctor just gave them to her over the phone and said that she was good. Her A1C was 5.9." The event lesion on her brain was reported as serious per hospitalization. The patient underwent lab tests and procedures which included glycosylated haemoglobin: 5.9 on an unspecified date. The outcome of events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Arrhythmia, Cardiac flutter, Feeling hot, Heart rate increased, Hyperhidrosis
Clinical narrative: I could feel flutters that I was having; he tells me that my heart has got out of rhythm when I took that shot; my blood pressure started coming down but my heart rate stayed not like that but somewhere 140-150 till 3rd morning; blood pressure and it was 204/108/The blood pressure is high and it still goes up to the 60s and 180 but I have no symptoms of whatsoever that anything is wrong; He said that was causing an allergic reaction and got my heart out of rhythm; I woke up and I was just really hot; My head was wringing wet; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiration date: May2021), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Consumer stated that the patient just wanted to let them know because they had told in patient's thread on the paper if you have any kind of allergic reaction to let them know. The patient went over to get the shot last Friday (22Jan2021) and about the time the patient got somewhere in the eastern area the patient could feel flutters that the patient was having so the patient came back home, the patient took his/her blood pressure and it was 204/108 and the patient heart rate was 140 something. So, the patient called the doctor and he told the patient to take a Benadryl, lay down for 2 hours. It did not go away.  The patient needed to go to the ER. Well, the patient's blood pressure started coming down but the patient heart rate stayed not like that but somewhere 140-150 till 3rd morning (in Jan2021). The blood pressure was high and it still went up to the 60s and 180 but the patient had no symptoms of whatsoever that anything was wrong. Other than there in the night, that Friday night (22Jan2021), the patient woke up and the patient was just really hot. The patient's head was wringing wet. But he/she got no fever. The patient got up and she/he stood up 30 minutes and the patient took his/her blood pressure and the patient thought it was maybe 180 and the pulse was still high and now when the patient took it, it went like start out at 80 and goes around like 66. Consumer stated that the patient did not go because she/he had got an appointment with a doctor Thursday (Jan2021) and the patient did not go. The patient did not feel bad but he told the patient that his/her heart had got out of rhythm when the patient took that shot. He said that was causing an allergic reaction and got the patient heart out of rhythm. So, the patient was just concerned about the 2nd shot. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: I could feel flutters that I was having; he tells me that my heart has got out of rhythm when I took that shot; my blood pressure started coming down but my heart rate stayed not like that but somewhere 140-150 till 3rd morning; blood pressure and it was 204/108/The blood pressure is high and it still goes up to the 60s and 180 but I have no symptoms of whatsoever that anything is wrong; He said that was causing an allergic reaction and got my heart out of rhythm; I woke up and I was just really hot; My head was wringing wet; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiration date: May2021), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Consumer stated that the patient just wanted to let them know because they had told in patient's thread on the paper if you have any kind of allergic reaction to let them know. The patient went over to get the shot last Friday (22Jan2021) and about the time the patient got somewhere in the eastern area the patient could feel flutters that the patient was having so the patient came back home, the patient took his/her blood pressure and it was 204/108 and the patient heart rate was 140 something. So, the patient called the doctor and he told the patient to take a Benadryl, lay down for 2 hours. It did not go away.  The patient needed to go to the ER. Well, the patient's blood pressure started coming down but the patient heart rate stayed not like that but somewhere 140-150 till 3rd morning (in Jan2021). The blood pressure was high and it still went up to the 60s and 180 but the patient had no symptoms of whatsoever that anything was wrong. Other than there in the night, that Friday night (22Jan2021), the patient woke up and the patient was just really hot. The patient's head was wringing wet. But he/she got no fever. The patient got up and she/he stood up 30 minutes and the patient took his/her blood pressure and the patient thought it was maybe 180 and the pulse was still high and now when the patient took it, it went like start out at 80 and goes around like 66. Consumer stated that the patient did not go because she/he had got an appointment with a doctor Thursday (Jan2021) and the patient did not go. The patient did not feel bad but he told the patient that his/her heart had got out of rhythm when the patient took that shot. He said that was causing an allergic reaction and got the patient heart out of rhythm. So, the patient was just concerned about the 2nd shot. The outcome of the events was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site reaction
Clinical narrative: Red arm near shot site of MODERNA vaccine Also supraclavicular lympg node swollen Mild side effects Have photograph if needed
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram
Clinical narrative: light headed, dizzy; blood pressure was taken and registered at 235/105; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 03Feb2021 12:00 at single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included allopurinol (ALLOPURINOL). No other vaccine in four weeks. The patient previously took morphine and experienced allergies. Immediately upon receiving the vaccine (03Feb2021 12:00), The patient became light headed, dizzy. Her blood pressure was taken and registered at 235/105 (on 03Feb2021), she was taken to the emergency room. She remained there for 2-3 hours then sent home. Events treatment: EKG. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization for 1 day, Life threatening illness (immediate risk of death from the event). The outcome of events was not recovered. The patient was not pregnant. No covid prior vaccination. No covid tested post vaccination.  information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Passed away; This is a spontaneous report from a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms.  This is a spontaneous report from a  contactable consumer reporting for friend's mother.   A 50-years-old female patient  received the second dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation .  The patient medical history and  concomitant medications were not reported.  The patient received the first dose of BNT162B2 vaccine on an unknown date. The patient passed away  on an unspecified date.    The patient was a healthy woman, who just got her 2nd dose of the vaccine a couple of days before. The patient died in her sleep. Doctor labeled her death as 'natural causes'.  It was not reported if an autopsy was performed.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.; Reported Cause(s) of Death: Passed away
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Autopsy, Coronary artery thrombosis, Sudden cardiac death
Clinical narrative: Sudden cardiac death.  Autopsy report: right coronary artery thrombosis.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Sudden cardiac death.  Autopsy report: right coronary artery thrombosis.
Sex: U
Vaccine: FLUX
Symptoms: Adverse drug reaction, Condition aggravated, Pain
Clinical narrative: pain never gets better gets worse; severe reaction; Initial information was received on 30-Jan-2021 regarding an unsolicited valid serious case from a consumer or other non-professional via media.  This case involves an elderly patient (age and gender unspecified) who had suffered terribly severe reaction (adverse drug reaction) and pain never got better, got worse (pain), after patient received INFLUENZA VACCINE.  At the time of event patient had ongoing pain.   The patient had no other medical history, concomitant disease or risk factor.  Past medical treatment, vaccination, family history and concomitant medication were not provided.  In 2018, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details not reported] for prophylactic vaccination.  On an unknown date, the patient suffered a non-serious terribly severe reaction (adverse drug reaction) and her pain never got better, got worse (pain), (unknown latency) following the administration of INFLUENZA VACCINE.  These events were assessed as medically significant as per the reporter.  It was reported that, patient received over 65 flu vaccine and patient was afraid to get the corona virus (COVID) vaccine.  It was unknown if the patient experienced any additional symptoms/events.  There were no laboratory data/results available.  It was not reported if the patient received any corrective treatment.  At the time of reporting, patient was not recovered from the reported events.   There will be no information available on the batch number for this case.; Sender's Comments: This media case involved an elderly patient (age and gender unspecified) who had adverse drug reaction and pain (pain aggravated), after administration of INFLUENZA VACCINE (unknown manufacturer). Time of onset is unknown. At the time of vaccination, patient had ongoing pain and no other medical history, concomitant disease or risk factor. Further information regarding past vaccination, treatment, concomitant medication and their tolerance also the laboratory investigation results were not reported and required for complete assessment of case. Based on reported information, role of suspect vaccine can not be assessed.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: First 2 days, redness and swelling at spot of injection. Chills for 3 hours the night of injection. Redness cleared up and swelling went down. 8:00 p.m. February 5th, the redness returned the size of a quarter. It has been itchy for the past 4 days. The redness and swelling has been increasing in size. It is now about 4 inches in diameter. The injection spot looks like I had a bee sting.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: the night of getting the vaccine I developed body aches, chills/feverish, arm pain, fatigue
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: the night of getting the vaccine I developed body aches, chills/feverish, arm pain, fatigue
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 8 days after getting the first dose of Moderna Vaccine I woke to a hot swollen left arm with a huge red, itchy patch and pain in my arm.  It is now 7 days later and I still have redness and a bit of heat.  I read all about Covid Arm and I am assuming that is what it is.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Feeling cold, Pyrexia
Clinical narrative: It's been over three weeks and he still gets chills and a fever anywhere from 99.9 to 100.2.  (His normal temp. is usually around 97.0. If he gets the least bit chilled he can't seem to warm up.  We give him Tylenol and bundle him in blankets and put him to bed.  Has no desire to eat when this happens but we do manage to get some hot broth into him.  The next morning he is fine and we go ahead with  with his Dialysis treatment  and then it happens every few evenings again.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Pain, Photophobia
Clinical narrative: Fever 102.2, chills, extreme body aches, stomach cramps, headache with light sensitivity.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 102.2, chills, extreme body aches, stomach cramps, headache with light sensitivity.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Eye swelling, Headache, Rash
Clinical narrative: 4 days following injection, onset of severe headache..days 5-6, headache untouched by Sumatriptin...day 6 made appointment with Neurologist...days 6-7, headache again untouched by Sumatriptin...day 7 awoke with rash on right side of forehead, right eye swollen, right ear painful...day 8 saw neurologist and internist and started on antiviral and prednisone...day 9,  slight improvement, enough to be encouraged
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Systemic: Other- Fainting only
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Description: I received the first Covid vaccine and within thirty minutes I was having an allergic reaction. I was wheezing and very short of breath. I was in the waiting area when this occured and the caregivers walked me over to the emergency department and immediately started treatment for my symptoms. I was at he ER about seven hours before I was allowed to go home. I was still having symptoms a couple days later and returned to emergency room.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Muscle aches @ 11:00pm day of injection  Low grade fever & headache starting at 9:00am following day
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: numbness and weakness of right leg (right knee down to right foot).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: headache, fatigue, joint pain, feel like I got run over
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Influenza like illness, Injection site pain, Pain in extremity
Clinical narrative: Moderna COVID-19 Vaccine EUA - 2nd shot - Pain in L Arm at injection siterna COVID-19 Vaccine EUA - General weakness, flu-like symptoms
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Flushing, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Patient described having a "mild reaction" to first dose Pfizer BioNTech vaccine, and pre-mediated with 50 mg diphenhydramine as well as her morning cetirizine 10 mg before the second dose. Approximately 10 minutes s/p second dose the patient experienced dizziness, facial tingling, anxiety, hard and soft palate numbness, and flushing. She was helped to a stretcher and her BP was 204/94. The patient was taken to the ED for further monitoring.  In the ED, she denied any throat swelling, tongue swelling, or difficulty breathing on arrival. She also denied any chest pain and palpitations. She received methylprednisolone 125 mg IV x 1 and a liter of normal saline, underwent observation, then discharged home uneventfully.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Pruritus
Clinical narrative: Ran a temp of 105.2 and face itching without the rash