chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Reduced facial expression, Thyroid disorder
Clinical narrative: Neurologic symptoms; Body ache; Chills; Extreme fatigue; Tingling in my extremities/like a buzzing sensation, vibrating sensation in my body; Heart palpitation; Cold extremities; Extreme muscle weakness/could barely open my hand muscles; Fluctuating rapid heart beat/heart rate was like 130; Feels like my muscles in my face not working well, especially in my mouth; Thyroid is been out of range; Super light headed/dizzy; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8729; Expiration date was not reported) on the left arm 07Apr2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included hypothyroidism, hypoglycaemia, small intestinal bacterial overgrowth, Epstein-Barr virus infection and sinusitis. Concomitant medications included thyroid (ARMOUR THYROID) for hypothyroidism; valaciclovir hydrochloride (VALTREX) for Epstein-Barr virus infection; and cetirizine hydrochloride (ZYRTEC ALLERGY) for sinusitis. In Apr2021, after the first dose of vaccination, the patient had neurologic symptoms; body ache; chills; extreme fatigue; tingling in the extremities/like a buzzing sensation and vibrating sensation in the body; heart palpitations; cold extremities; extreme muscle weakness that she could barely open her hand muscles, and would feel like she was going to collapse; fluctuating rapid heartbeat where heart rate was like 130; felt like the muscles in the face were not working well especially in the mouth; thyroid has been out of range; and was super light headed/dizzy. The patient had reported the events to be serious side effects (medically significant) of the vaccine. The outcome of the events was unknown. The patient had received the second dose of vaccination on 28Apr2021.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Body temperature, Influenza like illness, Malaise, Nasopharyngitis
Clinical narrative: still didn't feel good; slight fever it was 102; throwing up; anaphylactic allergies, and swell up like her throat, neck and face swelled a little bit; Cold and flu symptoms; Cold and flu symptoms; her arm was really killing her; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 05May2021 (Lot Number: EW0167) as single dose for covid-19 immunisation. Medical history included weird blood pressure (kind of have weird blood pressure, it goes up and down pretty frequently, no treatment), endometriosis, seizure. Concomitant medications included lamotrigine (LAMOTRIGINE) taken for seizure; quetiapine. The patient had an adverse reaction to the first of the two vaccine shot and wanted to know if she can get the second. She had pretty bad cold and flu symptoms and did have anaphylactic allergies, and swell up like her throat, neck and face swelled a little bit on 06May2021. It wasn't enough to go to the emergency room. She took Benadryl and kind of monitored but she thought her doctor would have called it like a pre-anaphylactic sort of reaction. The patient was having the reactions on yesterday (06May2021), still didn't feel good today (07May2021). She started to swell up she took Benadryl and Tylenol because she had slight fever it was 102 (06May2021). So, Tylenol 400 mg (took 2 pills), took 600 mg of Ibuprofen and the Benadryl 200 (200 but not entirely sure). She tried not to take medication unless have to, the moment she started throwing up she took the Benadryl only took that once, her arm was really killing her so she did take the Ibuprofen twice yesterday (06May2021) and twice Wednesday (05May2021). The fever came back yesterday (06May2021). Tylenol, probably the same twice on Wednesday, twice on Thursday, the patient hadn't had to take any today (07May2021). The outcome of events was not recovered.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: still didn't feel good; slight fever it was 102; throwing up; anaphylactic allergies, and swell up like her throat, neck and face swelled a little bit; Cold and flu symptoms; Cold and flu symptoms; her arm was really killing her; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 05May2021 (Lot Number: EW0167) as single dose for covid-19 immunisation. Medical history included weird blood pressure (kind of have weird blood pressure, it goes up and down pretty frequently, no treatment), endometriosis, seizure. Concomitant medications included lamotrigine (LAMOTRIGINE) taken for seizure; quetiapine. The patient had an adverse reaction to the first of the two vaccine shot and wanted to know if she can get the second. She had pretty bad cold and flu symptoms and did have anaphylactic allergies, and swell up like her throat, neck and face swelled a little bit on 06May2021. It wasn't enough to go to the emergency room. She took Benadryl and kind of monitored but she thought her doctor would have called it like a pre-anaphylactic sort of reaction. The patient was having the reactions on yesterday (06May2021), still didn't feel good today (07May2021). She started to swell up she took Benadryl and Tylenol because she had slight fever it was 102 (06May2021). So, Tylenol 400 mg (took 2 pills), took 600 mg of Ibuprofen and the Benadryl 200 (200 but not entirely sure). She tried not to take medication unless have to, the moment she started throwing up she took the Benadryl only took that once, her arm was really killing her so she did take the Ibuprofen twice yesterday (06May2021) and twice Wednesday (05May2021). The fever came back yesterday (06May2021). Tylenol, probably the same twice on Wednesday, twice on Thursday, the patient hadn't had to take any today (07May2021). The outcome of events was not recovered.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blood electrolytes decreased, Dizziness, Ear pain, Gait disturbance
Clinical narrative: nausea with vomiting resulting in low electrolytes needing hospital treatment; nausea with vomiting resulting in low electrolytes needing hospital treatment; low electorlytes; Headache; severe dizziness/feeling faint; balance issues/unsteadiness; right ear pain; buzzing ear sounds; inability to visually focus at times; sensitive to light; sensitive to movement; sensitive to sound; listing to the right when trying to walk,; This is a spontaneous report from a contactable consumer (patient). A 54-years-old non-pregnant female patient received the first dose  bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 09Mar2021 at 10:30 (Batch/Lot Number: EN6208) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included vertigo, migraine (as a child). The patient previously took Omnicef, penicillin ad sulfa and  experienced drug hypersensitivity. Concomitant medications included estrogens conjugated (PREMARIN), cetirizine hydrochloride (CETIRIZINE HYDROCHLORIDE);  fluticasone (FLUTICASONE).   No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  On 15Mar2021, The patient experienced Headache, severe dizziness, balance issues, right ear pain, buzzing ear sounds, listing to the right when trying to walk, unsteadiness, feeling faint, inability to visually focus at times, sensitive to light, sound, and movement, nausea with vomiting resulting in low electrolytes needing hospital treatment. The patient was hospitalized due to nausea, vomiting and low electrolytes.  The adverse events resulted in an emergency room visit and physician office visit. Treatment was given for the events which included Meclazine, Droperidol, Electrolytes. The clinical outcome of the events was recovering.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperacusis, Movement disorder, Nausea, Photophobia
Clinical narrative: nausea with vomiting resulting in low electrolytes needing hospital treatment; nausea with vomiting resulting in low electrolytes needing hospital treatment; low electorlytes; Headache; severe dizziness/feeling faint; balance issues/unsteadiness; right ear pain; buzzing ear sounds; inability to visually focus at times; sensitive to light; sensitive to movement; sensitive to sound; listing to the right when trying to walk,; This is a spontaneous report from a contactable consumer (patient). A 54-years-old non-pregnant female patient received the first dose  bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 09Mar2021 at 10:30 (Batch/Lot Number: EN6208) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included vertigo, migraine (as a child). The patient previously took Omnicef, penicillin ad sulfa and  experienced drug hypersensitivity. Concomitant medications included estrogens conjugated (PREMARIN), cetirizine hydrochloride (CETIRIZINE HYDROCHLORIDE);  fluticasone (FLUTICASONE).   No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  On 15Mar2021, The patient experienced Headache, severe dizziness, balance issues, right ear pain, buzzing ear sounds, listing to the right when trying to walk, unsteadiness, feeling faint, inability to visually focus at times, sensitive to light, sound, and movement, nausea with vomiting resulting in low electrolytes needing hospital treatment. The patient was hospitalized due to nausea, vomiting and low electrolytes.  The adverse events resulted in an emergency room visit and physician office visit. Treatment was given for the events which included Meclazine, Droperidol, Electrolytes. The clinical outcome of the events was recovering.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vision blurred, Vomiting
Clinical narrative: nausea with vomiting resulting in low electrolytes needing hospital treatment; nausea with vomiting resulting in low electrolytes needing hospital treatment; low electorlytes; Headache; severe dizziness/feeling faint; balance issues/unsteadiness; right ear pain; buzzing ear sounds; inability to visually focus at times; sensitive to light; sensitive to movement; sensitive to sound; listing to the right when trying to walk,; This is a spontaneous report from a contactable consumer (patient). A 54-years-old non-pregnant female patient received the first dose  bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 09Mar2021 at 10:30 (Batch/Lot Number: EN6208) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included vertigo, migraine (as a child). The patient previously took Omnicef, penicillin ad sulfa and  experienced drug hypersensitivity. Concomitant medications included estrogens conjugated (PREMARIN), cetirizine hydrochloride (CETIRIZINE HYDROCHLORIDE);  fluticasone (FLUTICASONE).   No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  On 15Mar2021, The patient experienced Headache, severe dizziness, balance issues, right ear pain, buzzing ear sounds, listing to the right when trying to walk, unsteadiness, feeling faint, inability to visually focus at times, sensitive to light, sound, and movement, nausea with vomiting resulting in low electrolytes needing hospital treatment. The patient was hospitalized due to nausea, vomiting and low electrolytes.  The adverse events resulted in an emergency room visit and physician office visit. Treatment was given for the events which included Meclazine, Droperidol, Electrolytes. The clinical outcome of the events was recovering.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Heart rate, Oxygen saturation
Clinical narrative: BP 202/102; BP 185/106; BP 179/94; BP 199/113; This is a spontaneous report from a non-contactable pharmacist. A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EN6199), intramuscularly in the left arm on 04Mar2021 (at the age of 39-years-old) as a single dose for COVID-19 immunization. The patient's medical history included COVID-19 on an unspecified date. It was unknown if the patient was pregnant at the time of vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EN6199), intramuscularly in the left arm on 10Feb2021 (at the age of 39-years-old) as a single dose for COVID-19 immunization and experienced cardiac and febrile symptoms including chest pain/discomfort, insomnia. The patient consented to receiving the second dose after education with RN, physician Dr. (Name), and pharmacist. The following tests were reported for 04Mar2021: at 1535: BP (blood pressure) 202/102, HR (heart rate) 91, O2 100%, Temp 36.8C; at 1540 BP 185/106, HR 98, O2 100%, Temp 36.8C; at 1545 BP 179/94, HR 90, O2 100%; at 1557 BP 199/113, HR 88, O2 100%, Temp 36.2C. The patient received no medications in the emergency department. The outcome of the event was unknown. It was also reported that the patient was not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of event cannot be 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Oedema, Pain, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis aggravated; Pain aggravated; Edema; This is a solicited report based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163-3883468-00). A contactable female consumer (patient) reported for herself. Solicited report from the USA by a consumer of a 55 year old female with events of non-serious "more pain if patient did not take rinvoq before 12pm each day, Edema, covid shot made rheumatoid arthritis more prevelant and not sure if rinvoq working as well as the humira was doing with rinvoq (upadacitinib)". There was no reported medical history. On unknown dates, the patient experienced more pain. If patient did not take Rinvoq before 12pm each day, covid shot made rheumatoid arthritis more prevalent and not sure if rinvoq working as well as the humira was doing. In 2021, the patient experienced edema. Covid-19 vaccine was also considered suspect. The patient had more pain if she did not took the Rinvoq before 12 pm each day. She was Not sure if Rinvoq was working as well as the Humira was doing. In 2021 she was diagnosed with Edema. Physician could not prescribe any other medications since she was on Lasix and water pills. She had Rheumatoid arthritis pain with Covid shot, covid shot made her Rheumatoid arthritis more prevalent. Symptom Rheumatoid arthritis pain had outcome of recovered. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received COVID-19 Vaccine manufactured by Pfizer.   Causality for RINVOQ(UPADACITINIB) The reporter's causality for the event(s) of more pain if patient did not take rinvoq before 12pm each day,  Edema, covid shot made rheumatoid arthritis more prevelant and not sure if rinvoq working as well as the humira was doing was not provided.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided, A possible contributory role of the suspect product to the development of aggravated Rheumatoid Arthritis cannot be 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: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Computerised tomogram, Dehydration, Dizziness
Clinical narrative: dehydration; dizziness; weakness; This is a spontaneous report from a contactable consumer. An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Mar2021 (Lot Number: EN6208) at age of 87-year-old as 2nd dose, single for COVID-19 immunization.  Medical history included ongoing cognitive impairment. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 19Feb2021 (Lot Number: EN6201) at age of 87-year-old for COVID-19 immunization.  He provided the first Covid 19 vaccine was given on 19Feb2021. Second Covid 19 vaccine given on 20Mar2021. The third Covid 19 vaccine was given on 07May2021. The patient has some cognitive impairment. The patient was recently admitted to hospital for dehydration. That was a week or so ago. He was admitted for dehydration that caused some dizziness and weakness. This hospitalization occurred after the second Covid 19 vaccine and prior to the third Covid 19 vaccine. The patient was better now, he was receiving some physical therapy. The patient had a Covid 19 virus test that was negative. He also had some medical tests that were all negative. He had some blood work, urinalysis, CT scans to rule out anything else. The doctor determined the patient was dehydrated. The events require a visit to emergency room and no physician office. There was no prior vaccinations (within 4 weeks) received and no events following prior vaccinations. The patient underwent lab tests and procedures which included blood work, CT scans, urinalysis: unknown results; Covid 19 virus test: negative; medical tests: all negative.  Therapeutic measures were taken as a result of all events. The outcome of the events was recovering.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, SARS-CoV-2 test, Urine analysis
Clinical narrative: dehydration; dizziness; weakness; This is a spontaneous report from a contactable consumer. An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Mar2021 (Lot Number: EN6208) at age of 87-year-old as 2nd dose, single for COVID-19 immunization.  Medical history included ongoing cognitive impairment. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 19Feb2021 (Lot Number: EN6201) at age of 87-year-old for COVID-19 immunization.  He provided the first Covid 19 vaccine was given on 19Feb2021. Second Covid 19 vaccine given on 20Mar2021. The third Covid 19 vaccine was given on 07May2021. The patient has some cognitive impairment. The patient was recently admitted to hospital for dehydration. That was a week or so ago. He was admitted for dehydration that caused some dizziness and weakness. This hospitalization occurred after the second Covid 19 vaccine and prior to the third Covid 19 vaccine. The patient was better now, he was receiving some physical therapy. The patient had a Covid 19 virus test that was negative. He also had some medical tests that were all negative. He had some blood work, urinalysis, CT scans to rule out anything else. The doctor determined the patient was dehydrated. The events require a visit to emergency room and no physician office. There was no prior vaccinations (within 4 weeks) received and no events following prior vaccinations. The patient underwent lab tests and procedures which included blood work, CT scans, urinalysis: unknown results; Covid 19 virus test: negative; medical tests: all negative.  Therapeutic measures were taken as a result of all events. The outcome of the events was recovering.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Got covid after vaccination; COVID-19; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient got covid (COVID-19) after vaccination on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: a blood clot came out on his stoma; This is a spontaneous report from a contactable consumer (patient's wife) from Pfizer-sponsored program .  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller (Name) is calling on behalf of her Husband (Name). Her husband got the 1st dose on 14Apr2021 (caller not sure with the date) and after the vaccine he experienced a blood clot came out on his stoma in 2021. Caller asking if this is a reaction of the vaccine. Caller also asked if her husband can get the second dose even if he is a blood thinner. Caller also has a question for herself if she can take the 1st dose because she is allergic to Prednisone and Metformin and had a bad reaction with this medication. Therapeutic measures were taken as a result of event (blood thinner). The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dyspnoea, Insomnia, Near death experience, Somnolence
Clinical narrative: Feels like about to die; Feel drowsy/sleepiness/could not stay awake; Feels like wind trying to take breath; hard to go to sleep; feeling in her stomach like it is coming down; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 28Apr2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included schizophrenia. Concomitant medications included unspecified schizophrenia medication. The patient experienced feels like about to die, feel drowsy/sleepiness/could not stay awake, feels like wind trying to take, hard to go to sleep, and feeling in her stomach like it is coming down on 02May2021. The clinical course was reported as follows: The patient reported that she has been drinking lots of water and doodling because doodling flushes it out. She felt like when sleeping and it is hard to go to sleep because it feels like something is trying to take her breath. The patient reported that the drowsiness started on the fourth day after she received the first dose of the vaccine on 28Apr2021. Ever since the 4th day, the drowsiness has been off and on. The patient reported that when it is going to flush out, she has a feeling in her stomach like it is coming down and she drinks a lot of water.  She reported that she will feel drowsy and sleepiness like she cannot stay awake. The patient felt it more when she is laying down for a nap. She had to stop taking her unspecified schizophrenic medication because it was making her drowsier. She felt like she was about to die and has never felt like that before. She did not feel comfortable taking the second dose of the vaccination as she did not want to feel worse than how she was feeling at time of call on 06May2021. The clinical outcome of feels like about to die, feel drowsy/sleepiness/could not stay awake, feels like wind trying to take, hard to go to sleep, and feeling in her stomach like it is coming down was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Chills, Heart rate
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist. A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9261) intramuscular in the right arm on 09Feb2021 (at the age of 73-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 09Feb2021, the patient experienced nausea, chills, and rigors. The patient was given water at 14:35. At 14:39, the patient experienced shaking. The patient's blood pressure (BP) was 180/74, and then when it was retaken at 14:40, it was 190/86. SpO2 was 98%, temperature was 36.8C. At 14:48, the BP was 187/83. At 14:54, the BP was 175/77, heart rate (HR) was 86, temperature was 98.8F. The patient was not treated for the events. The clinical outcome of "BP: 180/74, 190/86, 187/83, 175/77", nausea, chills and rigors, shaking was unknown. No Follow up attempts are possible. No further information expected.; Sender's Comments: Based on the temporal relationship, a causal association between BNT162B2 and the reported blood pressure increased cannot be 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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oxygen saturation, Tremor
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist. A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9261) intramuscular in the right arm on 09Feb2021 (at the age of 73-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 09Feb2021, the patient experienced nausea, chills, and rigors. The patient was given water at 14:35. At 14:39, the patient experienced shaking. The patient's blood pressure (BP) was 180/74, and then when it was retaken at 14:40, it was 190/86. SpO2 was 98%, temperature was 36.8C. At 14:48, the BP was 187/83. At 14:54, the BP was 175/77, heart rate (HR) was 86, temperature was 98.8F. The patient was not treated for the events. The clinical outcome of "BP: 180/74, 190/86, 187/83, 175/77", nausea, chills and rigors, shaking was unknown. No Follow up attempts are possible. No further information expected.; Sender's Comments: Based on the temporal relationship, a causal association between BNT162B2 and the reported blood pressure increased cannot be 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.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Acute kidney injury, Blood test, Computerised tomogram, Culture urine
Clinical narrative: Abdominal pain; Diagnosed with Acute Kidney Failure; This is a spontaneous report from a contactable consumer, reporting for himself.  A 42-year-old male patient received the first dose of the bnt162b2 (BNT162B2), via an unspecified route of administration, administered in the left arm on 13Apr2021 at 10:00 at a single dose for covid-19 immunisation. Medical history included ongoing asthma (diagnosed when he was serving around the year 1999-2000). Concomitant medications included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for asthma. In Apr2021, the patient was diagnosed with acute kidney failure, which required physician office visit and emergency room visit. On 14Apr2021, the patient experienced abdominal pain, which required physician office visit and emergency room visit. As reported, he took the vaccine about 3 weeks ago and immediately the next day he had abdominal pain. The patient reported that he stopped everything when he experienced the pain. The pain started mild and then increased and he went to the emergency room. The patient wasn't admitted to the hospital but after they checked his blood and urine with unknown results, he was given an IV.  When he was released he was told to follow up the next week with his primary care provider. The pain still had not gone away and was in the right side of his abdomen. The pain changed day by day. He had been drinking a lot of water and had maybe 1-2 days where the pain was worse than normal. He had been in and out of the doctor's office and his kidney levels are a little bit high on an unknown date. Every 2 weeks, blood and urine tests were taken to measure his kidney levels to see how it is doing. CAT scan was performed and did not see anything. The patient reported that something was observed in blood and urine and that's how an issue with his kidneys was determined. The clinical outcome of the events was not recovered.   The batch/lot number for the vaccine, btn162b2, was not provided and will be requested during follow up.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Renal function test
Clinical narrative: Abdominal pain; Diagnosed with Acute Kidney Failure; This is a spontaneous report from a contactable consumer, reporting for himself.  A 42-year-old male patient received the first dose of the bnt162b2 (BNT162B2), via an unspecified route of administration, administered in the left arm on 13Apr2021 at 10:00 at a single dose for covid-19 immunisation. Medical history included ongoing asthma (diagnosed when he was serving around the year 1999-2000). Concomitant medications included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for asthma. In Apr2021, the patient was diagnosed with acute kidney failure, which required physician office visit and emergency room visit. On 14Apr2021, the patient experienced abdominal pain, which required physician office visit and emergency room visit. As reported, he took the vaccine about 3 weeks ago and immediately the next day he had abdominal pain. The patient reported that he stopped everything when he experienced the pain. The pain started mild and then increased and he went to the emergency room. The patient wasn't admitted to the hospital but after they checked his blood and urine with unknown results, he was given an IV.  When he was released he was told to follow up the next week with his primary care provider. The pain still had not gone away and was in the right side of his abdomen. The pain changed day by day. He had been drinking a lot of water and had maybe 1-2 days where the pain was worse than normal. He had been in and out of the doctor's office and his kidney levels are a little bit high on an unknown date. Every 2 weeks, blood and urine tests were taken to measure his kidney levels to see how it is doing. CAT scan was performed and did not see anything. The patient reported that something was observed in blood and urine and that's how an issue with his kidneys was determined. The clinical outcome of the events was not recovered.   The batch/lot number for the vaccine, btn162b2, was not provided and will be requested during follow up.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Blindness transient, Blood pressure increased, Dizziness, Mydriasis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's parent). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (reported as "this afternoon") (Batch/Lot number was not reported) (at 26-year-old) as first dose, single for COVID-19 immunisation. The patient's medical history was reported as no. Concomitant medications were not reported. Couple minutes into that he got light headed, his vision got blurred and then he had a complete vision loss. They cleared the room and called the paramedics. The paramedics came and said that both of his eyes were dilated and his blood pressure was high. They sat him for couple of minutes, then his vision return. So if they ask them make the total of vision loss lasted for seven minutes. His blood pressure went down. They kept him there and had a given a bottle of water and two container of fruit juice to bring his sugar level up. They made sure everything seems alright. And paramedics left and said that they thought it would be cause from some sort of blood reaction and allergic reaction to vaccine. And told them not to get the second shot. And let us want to he felt ok that it would be alright to go home. They did keep him there for about half an hour longer just to make sure he was alright and then sent him home. That was just a reaction and he should be ok now. No treatment received. The outcome of the events was resolved on an unspecified date. Information about batch/lot number has been requested.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's parent). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (reported as "this afternoon") (Batch/Lot number was not reported) (at 26-year-old) as first dose, single for COVID-19 immunisation. The patient's medical history was reported as no. Concomitant medications were not reported. Couple minutes into that he got light headed, his vision got blurred and then he had a complete vision loss. They cleared the room and called the paramedics. The paramedics came and said that both of his eyes were dilated and his blood pressure was high. They sat him for couple of minutes, then his vision return. So if they ask them make the total of vision loss lasted for seven minutes. His blood pressure went down. They kept him there and had a given a bottle of water and two container of fruit juice to bring his sugar level up. They made sure everything seems alright. And paramedics left and said that they thought it would be cause from some sort of blood reaction and allergic reaction to vaccine. And told them not to get the second shot. And let us want to he felt ok that it would be alright to go home. They did keep him there for about half an hour longer just to make sure he was alright and then sent him home. That was just a reaction and he should be ok now. No treatment received. The outcome of the events was resolved on an unspecified date. Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Magnetic resonance imaging, Malaise, Multiple sclerosis, Muscular weakness
Clinical narrative: first major MS exacerbation; legs went weak; I knew something else did not feel right; showed so many lesions that it is sad. I only had 2 lesions 15 years ago; This is a spontaneous report from a contactable consumer (patient herself). This is one of the two report from same reporter. A 45-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: unknown, via an unspecified route of administration approximately in 2021 as a single dose for COVID-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown, via an unspecified route of administration in left arm on 27Jan2021 at 12:00 pm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's 2 weeks prior vaccination was none. Patient's medical history included Multiple Sclerosis and codeine allergy. The patient's concomitant medication was not reported. On 03Feb2021, at 12:45 pm (One week after the first shot), the patient stated that her legs went weak and gave out. The patient also stated that she fell while she was walking at work and got a concussion because I hit my head. The patient also stated that 3-4 weeks after the second shot, she had the first major MS exacerbation in 15 years. The patient stated that it was the worst she ever had. The patient also stated that her legs went weak when she stood up at home and her teenage son caught her so she would not fall and hit her head again. The patient stated that her son took her to the Emergency room 2 days later because she felt something was not right. The neurologist at the hospital took a 2-hour MRI scan which showed so many lesions. The patient lab test and investigation results included Magnetic resonance imaging (MRI) scan which showed so many lesions and Blood test on 02Apr2021 with (Covid negative) result. The patient felt horrible and sad as she had only 2 lesions 15 years ago. The patient did not take any treatment medication for the events. The outcome of the events was not resolved.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: first major MS exacerbation; legs went weak; I knew something else did not feel right; showed so many lesions that it is sad. I only had 2 lesions 15 years ago; This is a spontaneous report from a contactable consumer (patient herself). This is one of the two report from same reporter. A 45-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: unknown, via an unspecified route of administration approximately in 2021 as a single dose for COVID-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown, via an unspecified route of administration in left arm on 27Jan2021 at 12:00 pm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's 2 weeks prior vaccination was none. Patient's medical history included Multiple Sclerosis and codeine allergy. The patient's concomitant medication was not reported. On 03Feb2021, at 12:45 pm (One week after the first shot), the patient stated that her legs went weak and gave out. The patient also stated that she fell while she was walking at work and got a concussion because I hit my head. The patient also stated that 3-4 weeks after the second shot, she had the first major MS exacerbation in 15 years. The patient stated that it was the worst she ever had. The patient also stated that her legs went weak when she stood up at home and her teenage son caught her so she would not fall and hit her head again. The patient stated that her son took her to the Emergency room 2 days later because she felt something was not right. The neurologist at the hospital took a 2-hour MRI scan which showed so many lesions. The patient lab test and investigation results included Magnetic resonance imaging (MRI) scan which showed so many lesions and Blood test on 02Apr2021 with (Covid negative) result. The patient felt horrible and sad as she had only 2 lesions 15 years ago. The patient did not take any treatment medication for the events. The outcome of the events was not resolved.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Brain stem syndrome, Central nervous system lesion, Concussion, Fall
Clinical narrative: first major MS exacerbation; legs went weak; I knew something else did not feel right; showed so many lesions that it is sad. I only had 2 lesions 15 years ago; This is a spontaneous report from a contactable consumer (patient herself). This is one of the two report from same reporter. A 45-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: unknown, via an unspecified route of administration approximately in 2021 as a single dose for COVID-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown, via an unspecified route of administration in left arm on 27Jan2021 at 12:00 pm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's 2 weeks prior vaccination was none. Patient's medical history included Multiple Sclerosis and codeine allergy. The patient's concomitant medication was not reported. On 03Feb2021, at 12:45 pm (One week after the first shot), the patient stated that her legs went weak and gave out. The patient also stated that she fell while she was walking at work and got a concussion because I hit my head. The patient also stated that 3-4 weeks after the second shot, she had the first major MS exacerbation in 15 years. The patient stated that it was the worst she ever had. The patient also stated that her legs went weak when she stood up at home and her teenage son caught her so she would not fall and hit her head again. The patient stated that her son took her to the Emergency room 2 days later because she felt something was not right. The neurologist at the hospital took a 2-hour MRI scan which showed so many lesions. The patient lab test and investigation results included Magnetic resonance imaging (MRI) scan which showed so many lesions and Blood test on 02Apr2021 with (Covid negative) result. The patient felt horrible and sad as she had only 2 lesions 15 years ago. The patient did not take any treatment medication for the events. The outcome of the events was not resolved.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head abnormal, Muscular weakness, Reflex test, Spinal cord disorder
Clinical narrative: first major MS exacerbation; legs went weak; I knew something else did not feel right; showed so many lesions that it is sad. I only had 2 lesions 15 years ago; This is a spontaneous report from a contactable consumer (patient herself). This is one of the two report from same reporter. A 45-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: unknown, via an unspecified route of administration approximately in 2021 as a single dose for COVID-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown, via an unspecified route of administration in left arm on 27Jan2021 at 12:00 pm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's 2 weeks prior vaccination was none. Patient's medical history included Multiple Sclerosis and codeine allergy. The patient's concomitant medication was not reported. On 03Feb2021, at 12:45 pm (One week after the first shot), the patient stated that her legs went weak and gave out. The patient also stated that she fell while she was walking at work and got a concussion because I hit my head. The patient also stated that 3-4 weeks after the second shot, she had the first major MS exacerbation in 15 years. The patient stated that it was the worst she ever had. The patient also stated that her legs went weak when she stood up at home and her teenage son caught her so she would not fall and hit her head again. The patient stated that her son took her to the Emergency room 2 days later because she felt something was not right. The neurologist at the hospital took a 2-hour MRI scan which showed so many lesions. The patient lab test and investigation results included Magnetic resonance imaging (MRI) scan which showed so many lesions and Blood test on 02Apr2021 with (Covid negative) result. The patient felt horrible and sad as she had only 2 lesions 15 years ago. The patient did not take any treatment medication for the events. The outcome of the events was not resolved.  No follow-up attempts possible. No further information expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Drug abuser, Feeling hot, Hyperhidrosis, Lack of vaccination site rotation, Pain in extremity
Clinical narrative: this second dose it is like he wants another shot, it is like he is addicted to the thing.; He says the first time his arm hurt a little and the second time was the same as the first.; He felt hot through his body for about an hour / head felt hot; he got sweaty; both in the left arm; This is a spontaneous report from a contactable consumer(patient).    A 65-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 06May2021 as 2nd DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on an unspecified date, as SINGLE for covid-19 immunisation and had arm hurt a little. Patient stated, yesterday he took his final dose, and he did not have a problem with it but he does not understand. He says the first time his arm hurt a little and the second time was the same as the first. But after this second dose it is like he wants another shot; it is like he is addicted to the thing. He feels really good. He felt hot through his body for about an hour, his head got hot and then he got sweaty but then he felt really good, and it did not last long. He thought the first shot was worse than second one but when he woke up today, he wants another shot. He has never felt anything like it, he is dying for another shot, he has never felt anything like it and he is going to be 66 years old. He also called his pharmacist, and they gave him a number and he called his doctors, and he is waiting for them to call him back. He says he had to drink a whole pot of coffee today, he just has this urge that he wants another shot, like it is amazing, he feels really good, He says he is on the same medications as the first one and the same thing, he is on the same medications and the doctor took it all and looked through everything and said it would not cause anything. It just made him feel really good in his body, it is really weird, it is like he is superman, and he wants another shot, he is scared and has been drinking coffee all morning. He hopes he does not turn into mighty mouse. He says he is not worried, this happened with the first one too but not as much as the second one. The next day woke up and he felt okay and had these urges, like his arm hurt a little but it went right through him, like it did not bother him at all, his head just got hot and he got a little sweaty and then it was gone. He does not know if he is immune to it or not because his body ate it up fine. He had no side effects. The clinical outcome of all events was unknown