chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Moderate nausea without vomiting; Mild headache; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EW0158) at single dose on 19Apr2021 in right arm for COVID-19 immunization. The first dose was on 29Mar2021 11:00 AM in right arm (Lot Number: ER8730) and had increased volume of menstrual flow after 1st dose. Medical history included acid reflux; occasional nausea; heavy periods; penicillin allergies. Concomitant medication received within 2 weeks of vaccination included oral contraceptive ethinylestradiol/ferrous fumarate/norethisterone acetate (LOESTRIN FE). 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 had not been tested for COVID 19. Patient experienced moderate nausea without vomiting on 19Apr2021, starting 11 hours after 2nd dose and tapering off by about 36 hours after. Patient also experienced mild headache in Apr2021. Both events considered non-serious, not resulted in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating and not congenital anomaly/birth defect. The outcome of event nausea was recovered on 22Apr2021; outcome of event headache was recovered in Apr2021.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site hypersensitivity
Clinical narrative: vaccination site wouldn't give consumer his second dose due to having an allergic reaction; This is spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient first dose was on 24Mar2021, 15Apr2021 was scheduled for the second dose, vaccination site wouldn't give patient his second dose due to having an allergic reaction, patient did not specify what his allergic reaction was to or from. Outcome of the event was unknown.   No follow-up attempts possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disease recurrence, Migraine, Pain, Pyrexia
Clinical narrative: Fever; chills; body aches; migraine; migraine; This is a spontaneous report from a contactable consumer (patient) received via a sales representative. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: EW0153) as SINGLE DOSE for covid-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. No other health issues. The patient's concomitant medications were not reported.  The patient experienced fever, chills and body aches. Woke up today (15Apr2021) with a migraine as well. Events took place after use of product. The outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Jugular vein thrombosis
Clinical narrative: left jugular left vein thrombosis; This is a spontaneous report from a contactable consumer physician (reporting for herself). This 35- year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EN6208), via an unspecified route of administration, on 12Apr2021 as a single dose for COVID-19 vaccination. No relevant medical history and concomitant medications was reported. States: no past medical history of blood clots, not on birth control pills and had two children with no issues. She received her first dose of the Pfizer BioNTech Covid 19 vaccine on 12Apr2021, she developed symptoms 5 days later, and then went to the ER and was diagnosed with a left jugular left vein thrombosis on 19Apr2021. Patient was released on Xarelto starter pack and then will be on Xarelto 20mg.  The clinical outcome of the events was unknown.  Information about the Lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Jugular vein thrombosis cannot be excluded.  The case will be reassessed if 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Acquired shingles within a week after and am on chemotherapy for multiple sclerosis.; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Lot Number: ER8730) via an unspecified route of administration on 22Mar2021 at 09:45 (at the age of 41-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included multiple sclerosis and trigeminal neuralgia, both from unspecified dates and unspecified if ongoing. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 the patient experienced acquired shingles within a week after and am on chemotherapy for multiple sclerosis. The event required treatment with doxycycline and Valtrex. The clinical outcome of the event acquired shingles within a week after and am on chemotherapy for multiple sclerosis was recovering/resolving. Since the vaccination, the patient has not been tested for COVID-19.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Echocardiogram
Clinical narrative: Had dizzy spell day that lasted about 3-5 seconds; This is a spontaneous report received from a contactable consumer. A 74 years old female patient received the first dose of bnt162b2 (Pfizer COVID 19 vaccine, lot number: EW0153) via unspecified route of administration in left arm on 14Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications was reported as no. The patient experienced dizziness on 15Apr2021 with outcome recovered on 15Apr2021. The day after she received the vaccine, she had dizzy spell day that lasted about 3-5 seconds.  She stated she also had an echocardiogram 15-20 minutes prior to receiving her first vaccine.    No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dehydration, Dizziness, Feeling abnormal, Hyperhidrosis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's fiance). A 46-year-old male patient received the first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 18Apr2021 11:20 (Lot Number: EW0162) (received at the age of 46-years-old) as SINGLE DOSE for COVID-19 immunisation.  Medical history included right knee pain. Concomitant medications were not reported. The patient received the Pfizer 1st shot 18Apr2021 11:20 am. On 19Apr2021, at midnight, he had low grade fever then swelling right leg. On the day of the report, 20Apr2021, he had swelling to both legs. The patient had taken ibuprofen as treatment beside propping legs up. The reporter wanted more information on the swelling and if it's related to taking ibuprofen. It was further reported that the patient experienced severe swelling from the knees down to the calves on both legs on 19Apr2021. He also experienced night sweats, fever, lightheadedness and dizziness on 19Apr2021. They want to know if there are any reports regarding the swelling side effects and if it is from the vaccine. The first dose of the vaccine was given 2 days ago (18Apr2021) and the second dose is due on 09May2021. The patient got his first shot on 18Apr2021 about 11:20am. After about 15 hours he developed swelling in one leg, she later clarified this to be his right leg, and now reports that both of his legs are swollen at the time of report (20Apr2021). She noted that patient told her his legs are not painful. She doesn't know if it's a blood clot or if they needed to go to the hospital. She also wanted to know if there is information about this as a side effects or if other people are having this too. She then reported that the patient started experiencing a fever, profuse sweating, and was spacey about 12 hours after the vaccine, a little after midnight 19Apr2021.  She doesn't know if the dehydration made it worse.  His fever was low-grade 99.8 degrees and lasted 4 and a half to 5 hours and has now resolved.  When asked if patient received any treatment for fever, caller said it was so recent, and that was listed as a common side effect that goes away. Reported the patient drank fluids and she kept an eye on him. Leg swelling was about 15 hours after the vaccine, early morning 19Apr2021. She noted that the swelling in the right leg got bigger and didn't go down, but the left leg did. But today the left was more swollen and more prominent today. She further clarified that the patient takes ibuprofen for pre-existing right knee pain. Caller also reported that the patient propped his legs to alleviate the swelling, it has improved some but the swelling did not go away. The adverse events did not require a visit to the physician office or emergency room. Outcome of the event fever was resolved on 19Apr2021 (lasted 4 and a half to 5 hours); outcome of the event "severe swelling from the knees down to the calves on both legs" was not resolved; outcome of the remaining events was unknown.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Peripheral swelling, Pyrexia, Thrombosis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's fiance). A 46-year-old male patient received the first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 18Apr2021 11:20 (Lot Number: EW0162) (received at the age of 46-years-old) as SINGLE DOSE for COVID-19 immunisation.  Medical history included right knee pain. Concomitant medications were not reported. The patient received the Pfizer 1st shot 18Apr2021 11:20 am. On 19Apr2021, at midnight, he had low grade fever then swelling right leg. On the day of the report, 20Apr2021, he had swelling to both legs. The patient had taken ibuprofen as treatment beside propping legs up. The reporter wanted more information on the swelling and if it's related to taking ibuprofen. It was further reported that the patient experienced severe swelling from the knees down to the calves on both legs on 19Apr2021. He also experienced night sweats, fever, lightheadedness and dizziness on 19Apr2021. They want to know if there are any reports regarding the swelling side effects and if it is from the vaccine. The first dose of the vaccine was given 2 days ago (18Apr2021) and the second dose is due on 09May2021. The patient got his first shot on 18Apr2021 about 11:20am. After about 15 hours he developed swelling in one leg, she later clarified this to be his right leg, and now reports that both of his legs are swollen at the time of report (20Apr2021). She noted that patient told her his legs are not painful. She doesn't know if it's a blood clot or if they needed to go to the hospital. She also wanted to know if there is information about this as a side effects or if other people are having this too. She then reported that the patient started experiencing a fever, profuse sweating, and was spacey about 12 hours after the vaccine, a little after midnight 19Apr2021.  She doesn't know if the dehydration made it worse.  His fever was low-grade 99.8 degrees and lasted 4 and a half to 5 hours and has now resolved.  When asked if patient received any treatment for fever, caller said it was so recent, and that was listed as a common side effect that goes away. Reported the patient drank fluids and she kept an eye on him. Leg swelling was about 15 hours after the vaccine, early morning 19Apr2021. She noted that the swelling in the right leg got bigger and didn't go down, but the left leg did. But today the left was more swollen and more prominent today. She further clarified that the patient takes ibuprofen for pre-existing right knee pain. Caller also reported that the patient propped his legs to alleviate the swelling, it has improved some but the swelling did not go away. The adverse events did not require a visit to the physician office or emergency room. Outcome of the event fever was resolved on 19Apr2021 (lasted 4 and a half to 5 hours); outcome of the event "severe swelling from the knees down to the calves on both legs" was not resolved; outcome of the remaining events was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fibromyalgia, Limb discomfort, Vomiting
Clinical narrative: sickness to her stomach; fibromyalgia flared up; heaviness in the muscle of her arm; vomiting; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, lot number: EN6206), via an unspecified route of administration in left arm on 08Mar2021 at single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, fibromyalgia, diabetes diagnosed almost 10 years before, obese, knee replacements 10 years before on both knees, and Sjogren's disease. Concomitant medications included loratadine from 13Mar2021, hydrochloorthiazide for Sjogren's disease from little over a year before, fluoxetine, cetirizine hydrochloride (ZYRTEC) for years like 20 years for asthma, and montelukast sodium (SINGULAIR) for years for asthma. Patient previously received varicella zoster vaccine (shingles shot) 2 years before. The patient experienced sickness to her stomach, fibromyalgia flared up, heaviness in the muscle of her arm and vomiting within 24 hours after the vaccination. After the 1st dose she was really sick and it affected her fibromyalgia and rheumatoid arthritis and she was just a mess and ended up vomiting and this took about three days which was normal. Patient was on a lot of medicines that counter act anything the Pfizer COVID Vaccine could do to her regarding side effects and thought the vaccine was too much for her body. Patient took several different asthma medicines and made the reported event not as severe. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to chemicals
Clinical narrative: This consumer (Patient's mother) reported that a female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date single dose for COVID-19 immunization.  Medical history included hair color. Historical vaccine included 1st dose of BNT162B2 for COVID-19 immunization. The patient had her second dose 3 weeks ago, her mother did her hair color today and she had an allergic reaction to it. There was not anything different her mother done the same color for 3 years. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness
Clinical narrative: Little Dizzy; He felt some chills; This is a spontaneous report from a contactable consumer. This 49-year-old male consumer (patient) reported for himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation on unknown date. Relevant history and concomitant drug was unknown.  The patient felt some chills, a little dizzy for a little but it only lasted a day to 1.5 days.  The outcome of events was resolved.  The patient would like to know if it is okay to take Aspirin or Tylenol before or after the covid vaccine.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: Little Dizzy; He felt some chills; This is a spontaneous report from a contactable consumer. This 49-year-old male consumer (patient) reported for himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation on unknown date. Relevant history and concomitant drug was unknown.  The patient felt some chills, a little dizzy for a little but it only lasted a day to 1.5 days.  The outcome of events was resolved.  The patient would like to know if it is okay to take Aspirin or Tylenol before or after the covid vaccine.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Herpes virus infection, Pyrexia, Vaccination site joint pain
Clinical narrative: Had a herpes infection that was healing up, day after the first dose, he had a flare up; had a herpes infection that was healing up, day after the first dose, he had a flare up; At the site of injection I had joint pain; slight fever night after vaccine; This is a spontaneous report from a non-contactable consumer (patient). This male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunization. Medical history included herpes infection, presented as sores, patient had a chronic history with reoccurrences was healing before the vaccine. Concomitant medication was not reported. Patient took first dose of Pfizer covid vaccine, had a herpes infection that was healing up, day after the first dose, he had a flare up, was on herpes medication. Patient asked if valacyclovir was contraindicated with vaccine. Patient stated the sores, he had a chronic history with reoccurrences, was healing before the vaccine. Then it really was a strong reaction. At the site of injection patient had joint pain, slight fever night after vaccine, then there were new sores that came up, that had never happened before. The outcome of events was unknown.  Patient asked if there was any information on this response in people with herpes after the vaccine. Patient asked the vaccine prompted the immune system to rev up, if there were any reports or information on this reaction in others. Patient also asked people who had suppressed immune system, if the first shot was making more vulnerable. Patient did not have a suppressed immune system. Patient wanted to get his second dose, asked if there was any contraindication for taking antiviral medications.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality sleep, Vaccination site pain
Clinical narrative: he doesn't go to sleep well; having pain at the injection site/like a burning sensation inside like where the shot was; This is a spontaneous report from a Pfizer sponsored program COVAX US support from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 24Mar2021 14:10 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history was not reported. Patient didn't drink, didn't smoke, didn't do anything. Maybe the end of the year, he got a physical and nothing, everything came back normal. The patient's concomitant medications were not reported. Patient experienced pain at the injection site and stated it was like he had like a burning sensation inside like where the shot was on and he still had it. It began about 2 days after the shot (27Mar2021). Sometimes he didn't go to sleep well because he woke up every hour or so. He didn't sleep well because of the pain. He was supposed to get the second one this coming Saturday (24Apr2021). Outcome of having pain at the injection site/like a burning sensation inside like where the shot was not resolved. Outcome of didn't go to sleep well was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dyspnoea, Dyspnoea exertional, SARS-CoV-2 test
Clinical narrative: chills; pressure on her chest; she was not able to breath when walking; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2, via an unspecified route of administration on 06Apr2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 from Dec2020 (she contracted the infection on December). When she had the infection the first time she presented no symptoms but found out that she was infected because she had a positive PCR lab test, after that she developed sever tiredness and shortness of breath. Patient also had pressure on her chest. The patient's concomitant medications were not reported. The patient wanted to know if she should receive the second dose of the Pfizer COVID-19 vaccine taking into consideration her reaction to the first dose, she received the first dose on 06Apr2021, 5 days later she started to develop chills (on 11Apr2021) that lasted for about 8 days, she also presented pressure on her chest similar to when she had COVID-19 and shortness of breath (she was not able to breath when walking), her physician indicated that the reaction that she was presenting could be due to her previous COVID-19 diagnose. Patient had presented these side effects for more than 12 days, patient had taken ibuprofen and acetaminophen to treat the chills, thanked to that the chills stopped on Sunday and she was able to go to work. When the chills were present the sensation was so bad that she could not get warm during the day or night even having 3 blanquettes on top. Outcome of event chills was resolved, and of other events was unknown.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Furuncle, Oral herpes, Pyrexia
Clinical narrative: had a boil that may have gotten infected. It's still draining 3 days later; fever blisters; high fever; This is a spontaneous report from contactable consumer. This 67-Year-old female consumer (patient) reported that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Apr2021 single dose for COVID-19 immunization.  Medical history and concomitant drugs were not provided. On 17Apr2021, she had a high fever but she didn't think it's anything to do with the vaccine. She had a boil that may have gotten infected. It's still draining 3 days later. Since then she got fever blisters. The virus was running through her body now. Her 2nd dose of the vaccine was scheduled for this Friday. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal relationship and known drug safety profiles, a possible contributory role of suspect vaccine  BNT162B2 cannot be excluded for the reported event fever.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: she experienced a minor headache; This is a spontaneous report from a non contactable consumer. This female consumer(Patient) reported that she received the 2nd dose of the PFIZER-BIONTECH COVID-19 VACCINE at single dose for COVID-19 Immunization on unknown date. Relevant history and concomitant drug was unknown. The patient received the first dose of BNT162B2 for COVID-19 Immunization on unknown date. After receiving the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine, she experienced a minor headache. She wanted to know what medication she should take to treat the symptoms, if she should take Aleve, Ibuprofen or Aspirin. Outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm for a little bit; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient received the Pfizer BioNTech covid vaccine and had no other reaction than a sore arm for a little bit. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Presyncope, Vaccination site pruritus
Clinical narrative: his blood pressure dropped; feeling itchy at the injection site/My son also had this feeling but it went away; almost fainted; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported similar events for three patients. This is one of the three reports.  A 17-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The mother stated that she has been feeling itchy at the injection site. The mother's son and cousin also had this feeling but it went away. The mother also stated that that her son almost fainted when he got the shot. The EMT told them that his blood pressure dropped but it went back up after 10 minutes. The patient was a very fit child. The EMT gave him water and some candy and he felt better. They said it could have been his nerves. The mother asked how to prepare the patient for the second shot so it doesn't happen again. They are scheduled for the next shot on April 28. They hydrated all week before the vaccine but that morning the patient didn't want to drink anything. As for the itching, it was once in a while, and asked if it was normal. Therapeutic measures were taken as a result of all events. On an unspecified date, the patient recovered from "feeling itchy at the injection site/My son also had this feeling but it went away" and his blood pressure dropped while outcome of the event almost fainted was unknown.  Information about lot/batch has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021437157 same reporter/drug/similar event, different patient;US-PFIZER INC-2021438948 same reporter/drug/similar event, different patient
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: His blood pressure was up just a bit; This is a spontaneous report from a contactable consumer (patient). This 80-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6023) via an unspecified route of administration in the top part of the left arm on 27Feb2021 (at the age of 80-years-old) as a single dose for COVID-19 immunisation. Medical history included COPD from an unknown date and unknown if ongoing, reported as diagnosed 3 to 4 years ago and the patient was not taking any medication for it; and blood pressure from an unknown date and unknown if ongoing. The patient reported no family medical history and no adverse events following prior vaccinations. Concomitant medications included atenolol from an unknown date for blood pressure. The patient reported he received his second dose of BNT162B2 on 20Mar2021 for COVID-19 immunisation. The patient reported he did not have any trouble with the first vaccine and that one other thing had happened, and he was unsure if it had anything to do with it or not. He reported he went back to his doctor and had been taking atenolol for blood pressure at a dose of 50/25; his blood pressure went up just a bit and he could not verify who the girl was that changed it to 100/25; also reporting he didn't like the way he felt and eliminated it and went back to the previous dose taking two over a period of 2 to 3 days. The atenolol was in a pharmacy vial and he didn't have the lot or expiration date. The date his blood pressure was up was for the past couple times; further stating it usually was 120/60-70 and then it jumped up to 150/60-70 and that was why it needed to be changed. The patient reported it was filled on 18Mar2021 which was after the first vaccine but before the second dose. The clinical outcome of his blood pressure was up just a bit was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Laboratory test, Pruritus, Rash
Clinical narrative: Really bad itchy sensation on my face. Started itching really bad. Then my arms, my whole body started basically itching; itching non stop for the last 2 and a half hours; Like a racing heartbeat, heart is racing; Dizzy; Have a rash almost all over my body; This is a spontaneous report  from a contactable consumer (patient). A 39-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose  via an unspecified route of administration, administered in arm right on 15Apr2021 (Batch/Lot Number: EW0162) at single dose for COVID-19 immunization. Medical history included asthma and hypertension. The patient's concomitant medications were not reported. The patient was calling because the patient had first dose of vaccine in the morning of 15Apr2021. And after contacting patient's healthcare provider because the patient went to a walking clinic. They advised that patient needed to call this number regarding side effects the patient had. On 15Apr2021, 25 minutes after patient got vaccine, because the site where patient got it at when the patient waited there for 15 minutes. The patient started experiencing like really bad itchy sensation on the face. It started itching really bad. Then patient's arms, whole body started basically itching. And from there it just, it got, like a racing heartbeat. The patient haven't had type of difficulty in breathing (not clarified further), but at time of the report, the patient like was dizzy, the patient had a rash almost all over the body and patient's heart was racing. They told patient to report it, but they don't know that if patient can get the second dose. The due date of second shot of COVID-19 Vaccine is on  06May2021. The patient had lab test done in Mar2021, but not in last 15 days. The patient contacted primary care doctor. The patient took some diphenhydramine hydrochloride (BENADRYL) because the patient had been itching non stop for the last 2 and a half hours, 25 ml. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: perfused runny nose; Severe sneezing; This is a spontaneous report from a contactable consumer (patient). This male patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 18Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on 26Feb2021 for COVID-19 immunisation and experienced severe sneezing, runny nose and cough. The patient reported that after the first shot for four days he had severe sneezing and a runny nose that really went away, the second shot he "really" noticed that he had a shot or anything and now (as of 05Apr2021) with the second one about two weeks he had severe sneezing again and got a runny nose, nothing seemed to stop. He inquired if these were side effects. He reported that with the first shot for four days severe sneezing night and day, and a runny nose for a few days and the second shot he did not have any problems until 2 weeks after and now (as of 05Apr2021) he had developed sneezing again and had it for 5 days stating "it does not seem to be holding," and he had a perfused runny nose again. The clinical outcomes of severe sneezing and "perfused" runny nose were not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: I've developed bell's Palsey; This is a spontaneous report from a contactable consumer.   A 40-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 10Apr2021 (Batch/Lot Number: EW0162) as a single dose for covid-19 immunisation. Medical history and  concomitant medications were not reported.  The patient did not have any other vaccinations within 4 weeks. The patient reported that on 17Apr2021, he developed bell's palsey. The outcome of the event was not reported. The patient did not have COVID prior to vaccination not was tested post vaccination.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: patient tested positive for COVID 19 after received both shots; COVID-19 PCR test positive; This is a spontaneous report from a contactable nurse. This 47-year-old male nurse (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 13Jan2021 19:30 (Batch/Lot Number: EL3248) as SINGLE DOSE, dose 2 intramuscular, administered in Arm Left on 03Feb2021 06:30 (Batch/Lot Number: EL3248) as SINGLE DOSE for covid-19 immunisation  .  Medical history included seasonal allergy from an unknown date and unknown if ongoing , shift work disorder from an unknown date and unknown if ongoing, Acid reflux from an unknown date and unknown if ongoing. Patient did not have COVID prior to vaccination. Concomitant medication(s) included levocetirizine dihydrochloride (XYZAL) taken for seasonal allergy, start and stop date were not reported; armodafinil (ARMODAFINIL) taken for shift work disorder, start and stop date were not reported; dexlansoprazole (DEXILANT) taken for acid reflux, start and stop date were not reported; ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER) taken for an unspecified indication, start and stop date were not reported; glucosamine, methylsulfonylmethane (GLUCOSAMINE WITH MSM) taken for arthropathy, start and stop date were not reported.  The patient tested positive for COVID 19 after received both shots on 20Apr2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 20Apr2021.  No treatment received for reported events.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected Vaccination failure. There is limited information provided in this report.  This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for the Covid virus, after the first Covid vaccine; Tested positive for the Covid virus, after the first Covid vaccine; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date two weeks ago as SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient will be due for his second dose of vaccine, but tested positive for the covid virus on 18Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive, tested positive for the Covid viruson 18Apr2021, after the first Covid vaccine. The outcome of tested positive for the covid virus was unknown.  Information about the Lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Hypertension, SARS-CoV-2 test
Clinical narrative: the blood pressure went up to 220/110; the blood pressure was going up and down; This is a spontaneous report from a contactable consumer, the patient. This 74-year-old (non-pregnant) female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in right arm on 01Apr2021 12:30 (at the age of 74-year-old) as single dose for COVID-19 immunization. There was no relevant medical history was reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within 2 weeks of vaccination. On 01Apr2021 around 20:00, the patient's blood pressure went up to 220/110. Since then the blood pressure was going up and down, she had been to an emergency room (ER) 3 times and was hospitalized for one day. Her doctor prescribed 3 blood pressure medications, but the blood pressure is still not under control. The patient stated that she never had these issues before. On 08Apr2021, post vaccination SARS-CoV-2 test via Nasal Swab was negative. This upcoming Saturday (24Apr2021) is supposed to be her second vaccine, but with this blood pressure she cannot take it and her doctor recommends delaying it. The clinical outcomes of the "blood pressure went up to 220/110" and "the blood pressure was going up and down" were not resolved.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable consumer, the patient. This 43-year-old male patient, height: 66.22 cm & weight: 175 kg, received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734), via an unspecified route of administration in the left arm on 10Apr2021 17:00 (at the age of 43-year-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not enrolled in the clinical trial. Medical history included LASIK eye surgery. Concomitant medication(s) included prednisolone acetate (manufacturer unknown) and moxifloxacin (manufacturer unknown) both were taken after LASIK eye surgery. On 19Apr2021 12:30, the patient experienced Bell's palsy. The clinical course was described as follows: On 19Apr2021 at 12:30, the patient was eating lunch and he noticed the left side of his face was a little numb. The patient states he thought originally that he might be having an allergic reaction, but he was eating the same food that he always eats so it couldn't have been that and sort of ignored it. About 21:30, 22:00 at night (19Apr2021), he realized in the shower that he could not open his right eye, right eyelid, then his face was numb and he couldn't form his mouth to make a whistle, and he still can't, and he thought he was having a stroke because his face was all messed up. So that's when he went to the emergency room and they did a CAT scan that determined it was not a stroke, it is Bell's Palsy. The patient stated they prescribed him medications to take, and he was not hospitalized and discharged home. The patient stated his eyelids, they don't blink at the same rate and his left eye doesn't close all the way, he had to force it closed and it's very annoying. The patient verified that all his symptoms began on 19Apr2021 at 12:30 and all symptoms have worsened. The patient stated that he is perfectly healthy, not overweight and he's never had it before, and it came right out of the blue. The clinical outcome of the Bell's palsy was not resolved.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given an expired dose
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Hyperhidrosis, Nausea
Clinical narrative: Dizziness, mild fever, total body weakness, sweating, body aches, headache, nausea.  Symptoms lasted for 48 hours
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Dizziness, mild fever, total body weakness, sweating, body aches, headache, nausea.  Symptoms lasted for 48 hours
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Passed out after shot
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Full blood count normal, Groin pain, Musculoskeletal discomfort
Clinical narrative: Began with symptoms of a pulled groin, after a week went to the doctor.  Gave me meloxicam and told to have no exercise for two weeks, then within a week had same symptoms on right groin.  Next both shoulders, elbows, knees, all painful.  Blood work showed nothing extraordinary.  Extreme pain Tuesday, May 4.  Appointment to go back tomorrow, May 6 for another type of blood test.  Doctor felt I should report symptoms.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Pyrexia
Clinical narrative: Patient reports experiencing shortness of breath that started within the week after her first dose of COVID vaccination and continues to this day. (She also reports experiencing fever and chills that started the evening after vaccination and was gone within 24 hr, which was expected.) Pt has hx of COVID (June 2020). Pt talked to Dr. about her SOB and completed a steroid and antibiotic course from prescriber. She was advised to follow up w/ her Dr. concerning her continued SOB.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives began appearing between thirty minutes and an hour after injection was given. They were each about the size of a business card and went away a couple days later after Benadryl was taken.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cataract
Clinical narrative: cataract; This is a spontaneous report from a contactable consumer (patient) via a  sponsored program. This 59-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left upper arm on 26Mar2021 09:30 (at the age of 59-year-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. She was not enrolled in the clinical trial. Medical history included ongoing diabetes mellitus for 2 years (2019), heart attack occurred 6 years ago (2015), and she has had the following conditions for probably about 5 or 6 years: ongoing blood cholesterol increased, ongoing blood potassium decreased, ongoing heartburn, and ongoing high blood pressure. Family Medical History included her mom died of cancer and her dad died of a massive heart attack. Concomitant medications included metformin (manufacturer unknown) taken for diabetes mellitus, metoprolol (manufacturer unknown) taken for heart attack, ezetimibe (manufacturer unknown) taken for blood cholesterol, prasugrel hydrochloride (EFFIENT) taken for stent placement, losartan (manufacturer unknown) taken for hypertension, potassium chloride (manufacturer unknown) taken for blood potassium decreased, omeprazole (PROTONIX) taken for heartburn; all ongoing from an unspecified start date. On an unspecified date in 2021, the patient developed cataract. As reported, the patient just had her eye cataracts removed, one at a time: she had one done 05Apr2021 for the left eye, and one done yesterday, 19Apr2021 for the right one. She had a scheduled second dose due last 16Apr2021, but she missed it, so she was asking how to re-schedule the second dose. The clinical outcome of the cataract was not reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given an expired dose
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hot flush
Clinical narrative: Hot flashes that continue throughout the day, and at night. Started about week after taking the first dose of the vaccine. Followed by spells of tiredness that lasts from a few minutes to maybe 45 minutes and then goes away.  Also, I missed my period, which was due around 4/22.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Strong headache, slight fever
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: Extreme muscle pain in my hips,knees,groin,and lower back. Basically the lower extremities of my body. I kept thinking that it would go away after a couple of days. It?s been almost three months. I also have stiffness in my neck and shoulders many days. But the lower extremity pain is every day, all day. It is difficult to go up and down stairs.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: I had the vaccine at 1pm. Exclusively Breastfed 8 month old baby had diarrhea (very smelly loose stools)  around 3:30pm. (He has had diarrhea after his infant vaccinations). By evening he also had a temperature of 99.5.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: The day after receiving my second Pfizer dose, I had a fever of approximately 100 degrees.  Three days later, I noticed a ringing in my ears.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: 8 days after receiving my second dose, I had  mid cycle menstrual bleeding, just like a period  and have now missed my regular period. Seems to be a direct correlation to the vaccine as I have never experienced this in my life.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Gingival swelling, Headache, Toothache, X-ray
Clinical narrative: Tooth ache and gum swelling with vibrating pain and headache
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral normal, Balance disorder, Computerised tomogram normal, Dizziness, Echocardiogram normal
Clinical narrative: Symptoms began 2/5 which initially started with high blood pressure. Dizziness, motion sickness, migraines, vertigo, impaired balance followed. Diagnosis was Vestibular neuritis related to inflammation from vaccine.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Electroencephalogram normal, Hypertension, Magnetic resonance imaging head normal, Migraine, Motion sickness
Clinical narrative: Symptoms began 2/5 which initially started with high blood pressure. Dizziness, motion sickness, migraines, vertigo, impaired balance followed. Diagnosis was Vestibular neuritis related to inflammation from vaccine.