chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Cyst, Fatigue, Feeling abnormal, Haemorrhagic cyst
Clinical narrative: headache; tiredness; got sleepy; felt a little bad; cysts bleeding; breast pain; knot in the vaginal area right in the fold of pelvis and thigh inside of the pelvis that was painful; cysts in the rectal area; rash on her face and it's itching/ rash started in her face and ear, all on the left side, on her ear half way down the outside of the ear; soreness in arm; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 12May2021 11:30 (Batch/Lot Number: EW0168) as 1st dose, single for covid-19 immunisation. Medical history included acne and migraine. The patient's concomitant medications were not reported. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 12May2021, patient experienced soreness in arm. On 13May2021, she had symptoms of rash on her face and it's itching, and the rash started in her face and ear, all on the left side, on her ear half way down the outside of the ear. She could see all the pimples on the face so she put hot water on it and used rubbing alcohol, which she thought would help curb the itching and dry it up, the bottom of the ear lobe is very much active going into jaw area still. She also had headache, and tiredness following her dose, the doctor told her if headache was severe, take a Tylenol with codeine, she took something with codeine and it went away after about three hours. She also had some breast pain (only in the enfold of her breast closest to the middle of her chest), sore to the touch, and it was very sore for about 24 hours, and that it hasn't fully resolved. Then, while bathing, she noticed a knot in the vaginal area right in the fold of pelvis and thigh inside of the pelvis that was painful, large, and the size of a quarter, if she push on the pelvic bone area, it would be painful. Also, while bathing, she identified cysts in the rectal area; after bathing she was trying to identify what they were, when she touched it, it hurt, it felt like a ball and eventually it went down and she caused them to bleed, not a lot of blood, just a small amount. She also started getting more growths in the vaginal area/bottom area near the rectum. Patient got sleepy and now made herself go lay down and she doesn't usually do that. She felt a little bad, she didn't think it was severe side effects, she knew things were going on that she could pinpoint to what would possibly happen but not these cysts. She was recently seen by her gynecologist, a week ago, and none of these problems were apparent at that time. No Emergency Room or Physician Office visit. Patient had blood work done on 07Apr2021 and 10Apr2021 before the vaccine. The outcome of cysts bleeding and soreness in arm was recovered on 13May2021, itching rash, breast pain, painful knot, cysts in the rectal area was recovering, headache was recovered, other event outcome was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nodule, Pain in extremity, Rash pruritic, Somnolence
Clinical narrative: headache; tiredness; got sleepy; felt a little bad; cysts bleeding; breast pain; knot in the vaginal area right in the fold of pelvis and thigh inside of the pelvis that was painful; cysts in the rectal area; rash on her face and it's itching/ rash started in her face and ear, all on the left side, on her ear half way down the outside of the ear; soreness in arm; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 12May2021 11:30 (Batch/Lot Number: EW0168) as 1st dose, single for covid-19 immunisation. Medical history included acne and migraine. The patient's concomitant medications were not reported. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 12May2021, patient experienced soreness in arm. On 13May2021, she had symptoms of rash on her face and it's itching, and the rash started in her face and ear, all on the left side, on her ear half way down the outside of the ear. She could see all the pimples on the face so she put hot water on it and used rubbing alcohol, which she thought would help curb the itching and dry it up, the bottom of the ear lobe is very much active going into jaw area still. She also had headache, and tiredness following her dose, the doctor told her if headache was severe, take a Tylenol with codeine, she took something with codeine and it went away after about three hours. She also had some breast pain (only in the enfold of her breast closest to the middle of her chest), sore to the touch, and it was very sore for about 24 hours, and that it hasn't fully resolved. Then, while bathing, she noticed a knot in the vaginal area right in the fold of pelvis and thigh inside of the pelvis that was painful, large, and the size of a quarter, if she push on the pelvic bone area, it would be painful. Also, while bathing, she identified cysts in the rectal area; after bathing she was trying to identify what they were, when she touched it, it hurt, it felt like a ball and eventually it went down and she caused them to bleed, not a lot of blood, just a small amount. She also started getting more growths in the vaginal area/bottom area near the rectum. Patient got sleepy and now made herself go lay down and she doesn't usually do that. She felt a little bad, she didn't think it was severe side effects, she knew things were going on that she could pinpoint to what would possibly happen but not these cysts. She was recently seen by her gynecologist, a week ago, and none of these problems were apparent at that time. No Emergency Room or Physician Office visit. Patient had blood work done on 07Apr2021 and 10Apr2021 before the vaccine. The outcome of cysts bleeding and soreness in arm was recovered on 13May2021, itching rash, breast pain, painful knot, cysts in the rectal area was recovering, headache was recovered, other event outcome was unknown.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Haematuria
Clinical narrative: Massive hematuria noticed approximately 10 hr after dosing (10 pm); This is a spontaneous report from a contactable other (patient). A 71-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 26Mar2021 11:30 AM (Lot Number: EN6204) as 2nd dose, single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included diabetes, heart disease, kidney stone, Pine pollens only. Concomitant medications included Clopidogrel bisulfate (PLAVIX); acetylsalicylic acid (ASPIRIN (E.C.)); metoprolol succinate (METOPROLOL); metformin; glimepiride. Historical Vaccine included the first dose of BNT162B2 on 05Mar2021 11:30 AM (Anatomical Location: Left arm, Lot Number: EN6202) for COVID-19 immunization. The patient experienced massive hematuria noticed approximately 10 hr after dosing (10 pm) on 26Mar2021 22:00. Urine was clear immediately before vaccination.  Hematuria resolved by next morning (8 am). No pain or other symptoms. Past history of kidney stones, but event was completely absent severe pain associated with past stone passage. Hematuria not observed after first vaccination, only after 2nd shot. Called doctor but have not done any follow-up given rapid resolution. Just checking to see if the patient should have additional follow up on kidney function, disease etc, and/or if acceptable to get Pfizer vax at some future time. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event was resolved without treatment on 27Mar2021 08:00.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Joint swelling, Pain, Peripheral swelling, Physiotherapy
Clinical narrative: 4 days later woke to weakened joints, severe pain and swelling both knees, upper arms, shoulders.; 4 days later woke to weakened joints, severe pain and swelling both knees, upper arms, shoulders.; 4 days later woke to weakened joints, severe pain and swelling both knees, upper arms, shoulders.; 4 days later woke to weakened joints, severe pain and swelling both knees, upper arms, shoulders.; This is a spontaneous report from a contactable consumer (patient).  A 67-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 16Apr2021 13:45 (Batch/Lot Number: ER8727) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included right lower lobe wedge resection, adenocarcinoma of lung since 2021, Malignant neoplasm upper right lung, hypothyroidism, pure hypercholesterolemia. Facility where the most recent COVID-19 vaccine was administered: Hospital. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included pravastatin (PRAVASTATIN); levothyroxine sodium (SYNTHROID). The patient experienced 4 days later woke to weakened joints, severe pain and swelling both knees, upper arms, shoulders on 24Apr2021 08:00 with outcome of not recovered. The patient underwent lab tests and procedures which included physical therapy: unknown on 2021. Therapeutic measures were taken as a result of events. The events were serious due to disability. The detail clinical course was reported as Reported Event: HAD FIRST VACCINE DOSE 6 weeks following right lower lobe wedge resection, adenocarcinoma of lung. 4 days later woke to weakened joints, severe pain and swelling both knees, upper arms, shoulders. The adverse event result in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included: receiving physical therapy, awaiting blood work. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had Dose Number: 2. Proprietary medicinal product name: Pfizer. Batch/lot number: EW0161. Date of start of drug: 07May202101:45 PM. Anatomical Location: Arm Right. Since the vaccination, the patient has not been tested for COVID-19.   Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Cardiac disorder, Chest discomfort, Chest pain, Dyspnoea at rest
Clinical narrative: Shortness of breath/ woke up at 3am with shortness of breath; felt like he was having an angina attach; chest pain; chest pain and tightness; allergic like reaction; an aching pain; heart disease; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14May2021 as single dose for Covid-19 immunization.  Medical history included heart disease (patient had a history of heart disease and he had heart surgery in 2008. Patient did not take heart disease medications). The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 for Covid-19 immunization and was observed for 15 minutes and he felt fine and when he got home then he started feeling light headed and tired. Patient had the second dose on 14May2021 and patient woke up at 3am on 17May2021 with shortness of breath and he felt like he was having an angina attach which he had had before. Patient had chest pain and tightness, like an allergic like reaction. His chest was still having mild pain but not as severe. He woke up at about 03:00 this morning, on 17May2021 and started feeling shortness of breath. After the Pfizer BioNTech Coronavirus Vaccine shot on 14May2021 he was feeling great, fine. This morning the shortness of breath just hit him, an aching pain. He had heart disease for one thing; and he consulted with the nurse, informed her that he had heart disease; and she mentioned this won't affect anything to do with your heart disease. When he was feeling shortness of breath it was kind of like an allergic reaction so he wanted some more information on this, to see if that had anything to do with the Pfizer BioNTech Coronavirus Vaccine. Patient clarified he was not having the shortness of breath at time of the call, but had ongoing tightness of chest. Outcome of events shortness of breath was recovered and tightness of chest was not recovered and the other events was unknown. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain
Clinical narrative: Shortness of breath/ woke up at 3am with shortness of breath; felt like he was having an angina attach; chest pain; chest pain and tightness; allergic like reaction; an aching pain; heart disease; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14May2021 as single dose for Covid-19 immunization.  Medical history included heart disease (patient had a history of heart disease and he had heart surgery in 2008. Patient did not take heart disease medications). The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 for Covid-19 immunization and was observed for 15 minutes and he felt fine and when he got home then he started feeling light headed and tired. Patient had the second dose on 14May2021 and patient woke up at 3am on 17May2021 with shortness of breath and he felt like he was having an angina attach which he had had before. Patient had chest pain and tightness, like an allergic like reaction. His chest was still having mild pain but not as severe. He woke up at about 03:00 this morning, on 17May2021 and started feeling shortness of breath. After the Pfizer BioNTech Coronavirus Vaccine shot on 14May2021 he was feeling great, fine. This morning the shortness of breath just hit him, an aching pain. He had heart disease for one thing; and he consulted with the nurse, informed her that he had heart disease; and she mentioned this won't affect anything to do with your heart disease. When he was feeling shortness of breath it was kind of like an allergic reaction so he wanted some more information on this, to see if that had anything to do with the Pfizer BioNTech Coronavirus Vaccine. Patient clarified he was not having the shortness of breath at time of the call, but had ongoing tightness of chest. Outcome of events shortness of breath was recovered and tightness of chest was not recovered and the other events was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chorea, Muscular weakness, Polymerase chain reaction
Clinical narrative: R shoulder hemichorea/progressed to R foot/eventually R arm/shoulder/leg/foot hemichorea; R arm weakness; This is a spontaneous report from a contactable consumer reported for herself. A 65-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date (Lot Number: EN6206) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation.  Medical history included allergies PCN, HLD (hyperlipidaemia), GERD (gastrooesophageal reflux disease). Concomitant medication(s) included acetylsalicylic acid (ASPIRIN); omeprazole; simvastatin. The patient previously took the first dose of BNT162B2 (lot EL9267) on 14Feb2021 in left arm for COVID-19 immunisation. The patient experienced right (R) shoulder hemichorea/R arm weakness started 30Mar2021 and progressed to R foot restlessness, and eventually R arm/shoulder/leg/foot hemichorea in the next week.  Seen by Neurology and started on Valbenazine with some relief but no etiology found. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient hospitalized for 6 days. The patient received trial of Amantadine inpatient as treatment but did not help. The patient had Nasal Swab PCR, on 08Apr2021, with negative result. The outcome was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: felt like she was going to lose consciousness. She had this sensation for about 2-3 minutes, then finally did pass out; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in Arm Left on 22Apr2021 09:30 (Lot Number: EW0171) as 1st dose, single dose (at age of 41-years-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history and concomitant medications were not reported. No pregnant at the time of vaccination. On 10May2021 02:00 AM, the patient woke up at night to use bathroom and felt like she was going to lose consciousness. She had this sensation for about 2-3 minutes, then finally did pass out. After her husband found her, and she regained consciousness, she still had a very intense feeling of passing out for about 20 minutes more despite laying down with her feet up. No treatment was received. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The second dose of BNT162B2 was on 13May2021 09:30 AM (Lot Number: EW0173, Vaccine location; Left arm) for covid-19 immunisation. Outcome of the event was recovered.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dementia, Dementia Alzheimer's type, Hallucination, Nervous system disorder
Clinical narrative: hallucinations; neurological disorder classified as early Alzheimer's/dementia; neurological disorder classified as early Alzheimer's/dementia; neurological disorder classified as early Alzheimer's/dementia; This is a spontaneous report from a contactable pharmacist. An 80-year-old female patient (non-pregnant at time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17May2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. Unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. On 17May2021, the patient was admitted to the hospital due to hallucinations, neurological disorder classified as early Alzheimer's/dementia. AE resulted in Emergency room/department or urgent care, Hospitalization. Unknown if patient had treatment received for events. The outcome of the events was unknown. This report was assessed by the reporting pharmacist as serious; the seriousness criteria was caused/prolonged hospitalization.  Information on the lot/batch number has been requested.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment. Based on the limited  information provided, the reported events are likely intercurrent condition that is unrelated to BNT162B2. This case will be reassessed once 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 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.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Eating disorder, Feeling abnormal, Illness, Influenza like illness
Clinical narrative: He cant keep anything down and he keeps running to the toilet; Throwing up; Deathly ill; Gave him nausea pills but they're not helping; Sore arm; Cant even keep soup down/still cannot eat.; Can't lift arms and legs; Start passing out; Sick; Progressed into flu like symptoms 3-4 days after the shot; This is a spontaneous report from a contactable consumer reported for her son. A 32 year old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05May2021 at age of 32 year old (Batch/Lot Number: EM4965) at 2nd dose, single for COVID-19 immunisation. Medical history included ongoing shellfish allergy started in childhood. None family medical history included. Concomitant medications were none. None vaccines administered on same date with the Pfizer vaccine. None other vaccinations within four weeks prior to the first administration date of the suspect vaccines. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation, after he had the first shot, he was fine other than a sore arm. He had the second dose on 05May2021 and it started with a sore arm and then progressed into flu like symptoms 3-4 days after the shot on May2021. He was actually sick on 05May2021. He says that he cannot keep anything down and he keeps running to the toilet. He has been missing work and he never misses work. He cannot even keep soup down. He checked himself into the hospital and they released him yesterday after IV fluids and they gave him nausea pills but they're not helping. If he cannot keep anything down then he's going to start passing out on 05May2021. He went and had a Covid test a week ago to make sure he didn't have Covid.  States he has been throwing up on 05May2021 and deathly ill on 05May2021.  States that it started the first couple of days like flu like symptoms that have kept getting worse.  States he can't lift arms and legs on 05May2021.  She says at the hospital yesterday they gave him anti-nausea pills and hydration.  States he still cannot eat on 05May2021. His symptoms began the evening of 05May2021. They have continued to worsen. She wanted him to go be seen at Urgent Care about a week ago; but he just went and got a Covid test.  States he has been missing work ever since 05May2021. States that he finally couldn't stand it anymore and checked himself into the hospital yesterday.  She says he was admitted on 16May2021, but they discharged him in the evening on 16May2021. AEs require a visit to emergency room. No physician office. He ran tests in the hospital, like blood tests.  No specifics or results provided. Outcome of the event cant keep anything down and he keeps running to the toilet, throwing up, gave him nausea pills but they're not helping, sore arm was unknown. Outcome of other events was unknown. Information about Lot/ batch number has been requested
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Malaise, Muscular weakness, Nausea, Pain in extremity
Clinical narrative: He cant keep anything down and he keeps running to the toilet; Throwing up; Deathly ill; Gave him nausea pills but they're not helping; Sore arm; Cant even keep soup down/still cannot eat.; Can't lift arms and legs; Start passing out; Sick; Progressed into flu like symptoms 3-4 days after the shot; This is a spontaneous report from a contactable consumer reported for her son. A 32 year old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05May2021 at age of 32 year old (Batch/Lot Number: EM4965) at 2nd dose, single for COVID-19 immunisation. Medical history included ongoing shellfish allergy started in childhood. None family medical history included. Concomitant medications were none. None vaccines administered on same date with the Pfizer vaccine. None other vaccinations within four weeks prior to the first administration date of the suspect vaccines. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation, after he had the first shot, he was fine other than a sore arm. He had the second dose on 05May2021 and it started with a sore arm and then progressed into flu like symptoms 3-4 days after the shot on May2021. He was actually sick on 05May2021. He says that he cannot keep anything down and he keeps running to the toilet. He has been missing work and he never misses work. He cannot even keep soup down. He checked himself into the hospital and they released him yesterday after IV fluids and they gave him nausea pills but they're not helping. If he cannot keep anything down then he's going to start passing out on 05May2021. He went and had a Covid test a week ago to make sure he didn't have Covid.  States he has been throwing up on 05May2021 and deathly ill on 05May2021.  States that it started the first couple of days like flu like symptoms that have kept getting worse.  States he can't lift arms and legs on 05May2021.  She says at the hospital yesterday they gave him anti-nausea pills and hydration.  States he still cannot eat on 05May2021. His symptoms began the evening of 05May2021. They have continued to worsen. She wanted him to go be seen at Urgent Care about a week ago; but he just went and got a Covid test.  States he has been missing work ever since 05May2021. States that he finally couldn't stand it anymore and checked himself into the hospital yesterday.  She says he was admitted on 16May2021, but they discharged him in the evening on 16May2021. AEs require a visit to emergency room. No physician office. He ran tests in the hospital, like blood tests.  No specifics or results provided. Outcome of the event cant keep anything down and he keeps running to the toilet, throwing up, gave him nausea pills but they're not helping, sore arm was unknown. Outcome of other events was unknown. Information about Lot/ batch number has been requested
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vomiting
Clinical narrative: He cant keep anything down and he keeps running to the toilet; Throwing up; Deathly ill; Gave him nausea pills but they're not helping; Sore arm; Cant even keep soup down/still cannot eat.; Can't lift arms and legs; Start passing out; Sick; Progressed into flu like symptoms 3-4 days after the shot; This is a spontaneous report from a contactable consumer reported for her son. A 32 year old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05May2021 at age of 32 year old (Batch/Lot Number: EM4965) at 2nd dose, single for COVID-19 immunisation. Medical history included ongoing shellfish allergy started in childhood. None family medical history included. Concomitant medications were none. None vaccines administered on same date with the Pfizer vaccine. None other vaccinations within four weeks prior to the first administration date of the suspect vaccines. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation, after he had the first shot, he was fine other than a sore arm. He had the second dose on 05May2021 and it started with a sore arm and then progressed into flu like symptoms 3-4 days after the shot on May2021. He was actually sick on 05May2021. He says that he cannot keep anything down and he keeps running to the toilet. He has been missing work and he never misses work. He cannot even keep soup down. He checked himself into the hospital and they released him yesterday after IV fluids and they gave him nausea pills but they're not helping. If he cannot keep anything down then he's going to start passing out on 05May2021. He went and had a Covid test a week ago to make sure he didn't have Covid.  States he has been throwing up on 05May2021 and deathly ill on 05May2021.  States that it started the first couple of days like flu like symptoms that have kept getting worse.  States he can't lift arms and legs on 05May2021.  She says at the hospital yesterday they gave him anti-nausea pills and hydration.  States he still cannot eat on 05May2021. His symptoms began the evening of 05May2021. They have continued to worsen. She wanted him to go be seen at Urgent Care about a week ago; but he just went and got a Covid test.  States he has been missing work ever since 05May2021. States that he finally couldn't stand it anymore and checked himself into the hospital yesterday.  She says he was admitted on 16May2021, but they discharged him in the evening on 16May2021. AEs require a visit to emergency room. No physician office. He ran tests in the hospital, like blood tests.  No specifics or results provided. Outcome of the event cant keep anything down and he keeps running to the toilet, throwing up, gave him nausea pills but they're not helping, sore arm was unknown. Outcome of other events was unknown. Information about Lot/ batch number has been requested
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Rash, Rash pruritic
Clinical narrative: The rash turned into blisters in areas and would not alleviate without heavy doses of steroids.; rash on my abdomen that was extremely itchy and it spread all over my body like wild fire.; rash on my abdomen that was extremely itchy and it spread all over my body like wild fire.; This is a spontaneous report from a contactable consumer (patient). A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 30Apr2021 (Batch/Lot Number: EW0164) as single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing. No known allergies. The patient took other medication for the severe rash that appeared within 2 weeks of vaccination. Patient was not pregnant at the time of vaccination. The patient previously took BNT162B2, dose 1 administered in arm left on 09Apr2021 10:30 (Batch/Lot Number: EW0151) for COVID-19 immunization. The patient experienced the rash turned into blisters in areas and would not alleviate without heavy doses of steroids; rash on abdomen that was extremely itchy and it spread all over body like wild fire on 12May2021 06:00 with outcome of recovering. The adverse event result in Emergency room/department or urgent care. Treatment received for the adverse event included Steroids', rx histamines. Since the vaccination, the patient has not been tested for COVID-19. Clinical course reported as follow: On 12May2021, patient woke up with a rash on abdomen that was extremely itchy and it spread all over body like wild fire. The rash turned into blisters in areas and would not alleviate without heavy doses of steroids. Information on lot/batch number was available. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Fatigue, Heart rate, Heart rate increased
Clinical narrative: Arm soreness; fatigue; Rapid Heart Beat; Hot Flush over body; dizziness; This is a spontaneous report from a contactable other health professional. This consumer (patient) reported that a 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 39-years, via an unspecified route of administration in left arm on 15May2021 at 11:15 at single dose for COVID-19 immunization, in hospital. Medical history included penicillin allergy, epidural caused severe hypotension/allergic reaction, demoral adverse reaction (as reported). Patient was not pregnant at time of vaccination. Concomitant medications included ibuprofen, cetirizine hydrochloride (ZYRTEC) and multi vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15May2021 12:00, rapid heart beat, hot flush over body, dizziness. Started 40 minutes after vaccination. EMS called since she was driving at the time. Arrived 10 minutes later. Oxygen stable entire time. Blood pressure normalized and heart rate lowered to normal by the time they left 20 minutes later and diphenhydramine hydrochloride (BENADRYL) administered. Arm soreness and fatigue next day on 16May2021. BENADRYL taken again 6 hours later. Back to normal 2 full days later. The events result in emergency room/department or urgent care. Outcome of the events was recovered/resolved. Since the vaccination, the patient has not been tested for COVID-19.   Information on lot/batch number has been requested.; Sender's Comments: There is a reasonable possibility that the events arm soreness and fatigue were related to BNT162b2 based on known drug safety profile Based on the close temporal relationship, the association between the events rapid heart beat, hot flush over body, and dizziness can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Oxygen saturation, Pain in extremity
Clinical narrative: Arm soreness; fatigue; Rapid Heart Beat; Hot Flush over body; dizziness; This is a spontaneous report from a contactable other health professional. This consumer (patient) reported that a 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 39-years, via an unspecified route of administration in left arm on 15May2021 at 11:15 at single dose for COVID-19 immunization, in hospital. Medical history included penicillin allergy, epidural caused severe hypotension/allergic reaction, demoral adverse reaction (as reported). Patient was not pregnant at time of vaccination. Concomitant medications included ibuprofen, cetirizine hydrochloride (ZYRTEC) and multi vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15May2021 12:00, rapid heart beat, hot flush over body, dizziness. Started 40 minutes after vaccination. EMS called since she was driving at the time. Arrived 10 minutes later. Oxygen stable entire time. Blood pressure normalized and heart rate lowered to normal by the time they left 20 minutes later and diphenhydramine hydrochloride (BENADRYL) administered. Arm soreness and fatigue next day on 16May2021. BENADRYL taken again 6 hours later. Back to normal 2 full days later. The events result in emergency room/department or urgent care. Outcome of the events was recovered/resolved. Since the vaccination, the patient has not been tested for COVID-19.   Information on lot/batch number has been requested.; Sender's Comments: There is a reasonable possibility that the events arm soreness and fatigue were related to BNT162b2 based on known drug safety profile Based on the close temporal relationship, the association between the events rapid heart beat, hot flush over body, and dizziness can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Muscle injury, Nerve injury
Clinical narrative: Has all those nerve damage in her intestine and they are not working; She has nerve and muscle damage in intestine and that is why she cannot eat; Has all those nerve damage in her intestine and they are not working; She has nerve and muscle damage in intestine and that is why she cannot eat; She hasn't been able to eat; This is a spontaneous report from a contactable consumer.  A 76-year-old female patient (reporter's mother) at the age of 76 years old received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. patient previously had first dose of BNT162B2 for covid-19 immunisation. patient had the Pfizer Covid vaccine about a month ago and about 10 days after her second vaccine, she is in hospital and she hasn't been able to eat since. She is probably going to die this week. They say that there is no blockage but she has all those nerve damage in her intestine and they are not working. reporter don't know if it is related to the vaccine or not but reporter wanted to ask if anybody else is having this problem. She has nerve and muscle damage in intestine and that is why she cannot eat. She has been fed with an IV for a month now. reporter stated it just happened 10 days after her second shot, she was fine before that. She had some other health problems and issues and other things as she is an old lady, she has had some other health things but reporter don't know if it is related or not but reporter wanted to call and see if one are getting other calls about this, about nerve damage or maybe information or what was going on. Outcome of the events was unknown.   Information on lot number/batch number was requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Muscle spasms, Postmenopausal haemorrhage
Clinical narrative: excessive menstrual bleeding for 5 days. This is medically unusual as I have not had ANY period in 5 years, as I have been in menopause since 41 years old; cramps; heavy period; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 23Apr2021 13:15 (Lot Number: ew0175) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included CVID, hypothyroid and asthma from an unknown date and unknown if ongoing. Concomitant medications included immunoglobulin human normal (CUTAQUIG), montelukast sodium (SINGULAIR) and thyroid (ARMOUR THYROID); all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, via unspecified route in the left arm on 30Mar2021 04:45 as 1ST DOSE, SINGLE (lot number: er8733) for COVID-19 immunization at 46 years old. The patient was not pregnant at time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in the Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient stated that on 11May2021 12:00, "I got a very heavy period, cramps for three days, excessive menstrual bleeding for 5 days. This is medically unusual as I have not had ANY period in 5 years, as I have been in menopause since 41 years old." The outcome of the events was not recovered. No treatment was given to the patient for the events.  Follow up attempts are needed. Further information has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Eye irritation, Eye pain, Facial paralysis, Vision blurred
Clinical narrative: half of face is paralyzed; vision blurry and can't see; eyes hurt and are burning; eyes hurt and are burning; vision blurry and can't see; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09May2021 (Lot Number: ER8735) as 2nd dose, single for covid-19 immunisation (reported as does not want to die) in Pharmacy. The patient medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (Lot number: W0L61 or W0161) at age of 57 years old on 18Apr2021 at right arm for Covid-19 immunization. Caller state she received the first and second shot Covid. Clarified that she is referring to the Pfizer Covid vaccine. She got the shot last Sunday, a week ago. Patient experienced half of face is parlayzed: States that it is the left side or the right, she doesn't even know any more. It started the same day she got the vaccine, last Sunday 09May2021. It is getting worse. No treatment (nothing) for it. Also reported hard to read (lot number) because her eyes hurt and are burning. Caller states that she cannot see and that her eyes hurt very bad and they are burning. She cannot see and her vision is blurry (all on 09May2021). Wanted to know what to do. Outcome of the events was not recovered.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal uterine bleeding, Dizziness, Fatigue, SARS-CoV-2 test
Clinical narrative: Prolonged abnormal irregular uterine bleeding >11 days with large clots accompanied by fatigue and lightheadedness; Prolonged abnormal irregular uterine bleeding >11 days with large clots accompanied by fatigue and lightheadedness; Prolonged abnormal irregular uterine bleeding >11 days with large clots accompanied by fatigue and lightheadedness; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6202), via an unspecified route of administration at the age of 34-year-old administered in arm left on 02Mar2021 09:00 AM at single dose for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder, post-traumatic stress disorder, anxiety, depression. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hcl, birth control, alprazolam and trazodone, all received within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EM9810), at the left arm at the age of 34-year-old on 03Feb2021 09:00 AM for COVID-19 immunisation. The patient experienced Prolonged abnormal irregular uterine bleeding >11 days with large clots accompanied by fatigue and lightheadedness on 16Mar2021. The adverse event result in Doctor or other healthcare professional office/clinic visit. The events were serious for being medical significant. Facility where the most recent COVID-19 vaccine was administered in Hospital. Since the vaccination, the patient hasn't been tested for COVID-19. The patient underwent lab tests included COVID PCR: positive on 12Feb2021. The patient received treatment for events. The outcome of events was recovered.; Sender's Comments: Based on the temporal relationship, the association between the events abnormal uterine bleeding, fatigue, and lightheadedness with BNT162b2 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody positive, Computerised tomogram, Laboratory test, Noninfective sialoadenitis
Clinical narrative: severe shooting pains up both arms, her hands hurt really bad; ANA positive; enlarged parotid glad on the left side and inflamed parotid glands; enlarged parotid glad on the left side and inflamed parotid glands; sciatica pain of the right side; This is a spontaneous report from a contactable consumer (patient). A 46-year old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8735) via an unspecified route of administration at left arm on 19Apr2021 16:30 (46-year old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history depression, thrombocytopenia, severe IBS, carpal tunnel right extremity, and allergies to Penicillin, Sulfa drugs. Concomitant medications that the patient received within 2 weeks of vaccination included ONDANSETRON. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on 29Mar2021 (46-year old at time of vaccination), at single dose, for COVID-19 immunization and experienced "there was a hole inside her left ear/ ear abscess", "thick yellow, clear puss and blood was oozing out of her left ear", "sciatica pain", and "nerve pain". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Doctor Visit 24Apr2021 for sudden onset sciatica pain of the right side this time and got a cortisone injection that helped. CT Scan 25Apr2021 to figure out what is happening in patient's ear and showed enlarged parotid glad on the left side and inflamed parotid glands. Patient has severe shooting pains up both arms, her hands hurt really bad. Doctor visit 27Apr2021 followed up with ENT and he indicated patient needed to see rheumatologist for ANA positive test. Doctor visit 03May2021 Rheumatologist. 09May2021 labwork. Urgent care Doctor visit 14May2021 for severe sciatica pain that continues. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the event sciatica and included cortisone injections, deep muscle massage/exercise. The outcome of the events was not recovered.