chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph nodes on my collar bone; it is painful, it hurts; This is a spontaneous report received from a contactable consumer (patient).   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0187) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Patient had no medical history and was not taking any other products. On an unspecified date, after receiving vaccination, patient experienced swollen lymph nodes on collar bone, it was painful, and it hurts. Reporter seriousness for Swollen lymph nodes on my collar bone and it is painful, it hurts was unspecified. Consumer asked, "I just need to know if this was normal. Yeah, because it was painful, it hurts."  Consumer was unwilling to share further information. Hence further probing could not be done. Thus, limited information available.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Headache, Hypersensitivity
Clinical narrative: he had a headache the second day after getting vaccine; third day he is having chest pain; he thinks his son is having an allergic reaction to the Pfizer vaccine; This is a spontaneous report from a contactable consumer (patient's father). A 15-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. Patient's 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 and expiry dates were not provided) via an unspecified route of administration, on an unknown date as a single dose for COVID-19 immunization. Reporter (patient's father) reported that he thought his son was having an allergic reaction to the Pfizer vaccine. Patient has received the second dose of the vaccine and he had a headache the second day after getting vaccine and the third day he was having chest pain. Reporter asked if he should take patient to the ER and has not talked with patient's doctor about symptoms. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Erythema migrans, Fatigue, Pain, Paraesthesia
Clinical narrative: Erythema migrans; face is itching a lot and it is starting to tingle; face is itching a lot and it is starting to tingle; experiencing lot of erythema where some basically from shoulder to half way my neck is swollen; erythema is actually, limb erythema is swelling of my limbs throughout of my shoulder and neck; erythema is actually, limb erythema is swelling of my limbs throughout of my shoulder and neck; Tiredness; all over body pain and swelling; all over body pain and swelling; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EW0180 and expiry date was not provided) via an unspecified route of administration on unspecified date at 11:00 as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient had previously received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not provided) on unspecified date as a single dose for COVID-19 immunisation. On an unspecified date, patient had erythema migrans, face was itching a lot and started to tingle, lot of erythema where some basically from shoulder to halfway neck was swollen, erythema was actually, limb erythema was swelling of limbs throughout shoulder and neck, tiredness, all over body pain and swelling. For 4 days patient had normal side effects basically erythema migrans, extreme tiredness and lots of all over body pain then after those side effect went away patient started experiencing lot of erythema where some basically from shoulder to halfway neck was swollen this was the new side effect after those other side effect wore way and today was having lot of, face was itching a lot and started to tingle. Patient wants to know was this something that needs to concern about because this was listed on the normal like this was the week and if getting the new symptoms week after was normal. Reporter seriousness for erythema migrans, face was itching a lot and started to tingle, lot of erythema where some basically from shoulder to halfway neck was swollen, erythema was actually, limb erythema was swelling of limbs throughout shoulder and neck, tiredness, all over body pain and swelling was unspecified. The outcome of events erythema migrans, extreme tiredness and lots of all over body pain was resolved on unspecified date and for other events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Swelling
Clinical narrative: Erythema migrans; face is itching a lot and it is starting to tingle; face is itching a lot and it is starting to tingle; experiencing lot of erythema where some basically from shoulder to half way my neck is swollen; erythema is actually, limb erythema is swelling of my limbs throughout of my shoulder and neck; erythema is actually, limb erythema is swelling of my limbs throughout of my shoulder and neck; Tiredness; all over body pain and swelling; all over body pain and swelling; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EW0180 and expiry date was not provided) via an unspecified route of administration on unspecified date at 11:00 as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient had previously received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not provided) on unspecified date as a single dose for COVID-19 immunisation. On an unspecified date, patient had erythema migrans, face was itching a lot and started to tingle, lot of erythema where some basically from shoulder to halfway neck was swollen, erythema was actually, limb erythema was swelling of limbs throughout shoulder and neck, tiredness, all over body pain and swelling. For 4 days patient had normal side effects basically erythema migrans, extreme tiredness and lots of all over body pain then after those side effect went away patient started experiencing lot of erythema where some basically from shoulder to halfway neck was swollen this was the new side effect after those other side effect wore way and today was having lot of, face was itching a lot and started to tingle. Patient wants to know was this something that needs to concern about because this was listed on the normal like this was the week and if getting the new symptoms week after was normal. Reporter seriousness for erythema migrans, face was itching a lot and started to tingle, lot of erythema where some basically from shoulder to halfway neck was swollen, erythema was actually, limb erythema was swelling of limbs throughout shoulder and neck, tiredness, all over body pain and swelling was unspecified. The outcome of events erythema migrans, extreme tiredness and lots of all over body pain was resolved on unspecified date and for other events was unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Acute chest pain diagnose as pericarditis, 15 days following the first COVID vaccine.; This is a spontaneous report received from a contactable physician (patient). A 68 years old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 68 years old via an unspecified route of administration, administered in Arm Left on 23Dec2020 (Lot Number: EJ1686) as dose 1, single for covid-19 immunisation.  Medical history included hypothyroidism, osteoarthritis. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included levothyroxine; famotidine; rosuvastatin.  The patient experienced acute chest pain diagnose as pericarditis, 15 days following the first covid vaccine on 07Jan2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 1 days. The treatment was received including Colchicine, indomethacin. The outcome was recovered in 2021.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event "Pericarditis" and the administration of the vaccine 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Tremor
Clinical narrative: Light headed; Shaking; Elevated HR beating so fast it would wake her up in the middle of the night; This is a spontaneous report from a contactable consumer (patient) from Pfizer sponsored program  support via  information team. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization at the age of 55-year-old. The patient medical history and concomitant medications were not reported. The patient experienced light headed, shaking, elevated heart rate (HR), beating so fast it would wake her up in the middle of the night on an unspecified date in Apr2021. The patient stated that the symptoms lasted close to two weeks. The outcome of events was recovered on an unspecified date in Apr2021. Her doctor recommended she wait to receive the second dose of the vaccine.  Information on the lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: This is a solicited report based on the information received by Pfizer. A non-contactable consumer (patient) reported that a 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Injection), dose 1 via intramuscular in Feb2021 at age of 69-year-old single dose for COVID-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneously from an unspecified date to an unspecified date, at unspecified dose for moderate to severe adult Crohn's disease. The patient's medical history and patient's concomitant medications were not reported. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. In Feb2021, the patient experienced bleeding. The event was reported as non-serious.  The action taken in response to the event for adalimumab was unknown. The outcome of the event was resolved on 15Apr2021. The reporter's causality for the event of bleeding with Humira (Adalimumab) was no reasonable possibility.  The reporter's assessment of the causal relationship of the event with the suspect product bnt162b2 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 possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Tenderness, Vaccination site erythema, Vaccination site pain
Clinical narrative: he was looking at his immunization record and they put the same date that he got his vaccine as the date that it expires.; redness, tenderness, and soreness at the injection site; redness, tenderness, and soreness at the injection site; redness, tenderness, and soreness at the injection site; This is a spontaneous report from a a Regulatory Authority. A contactable consumer reported for a 41-years-old male patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration on 24Jun2021 (Batch/Lot Number: EW0180; Expiration Date: 31Aug2021) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history included BNT162B2 (Dose: 01, No events reported.) for Covid-19 immunization. The patient's concomitant medications were not reported. The patient experienced he was looking at his immunization record and they put the same date that he got his vaccine as the date that it expires. (circumstance or information capable of leading to medication error) (non-serious) on 24Jun2021, redness, tenderness, and soreness at the injection site in Jun2021 , red-ness, tenderness, and soreness at the injection site in Jun2021 , redness, tenderness, and sore-ness at the injection site in Jun2021. The action taken in response to the event(s) for bnt162b2 was not applicable. Caller was given the following information from the PI: Across both age groups, 18 through 55 years of age and 56 years and older, the mean duration of pain at the injection site after Dose 2 was 2.5 days (range 1 to 36 days), for redness 2.6 days (range 1 to 34 days), and for swelling 2.3 days (range 1 to 34 days) for participants in the Pfizer-BioNTech COVID-19 Vaccine group. Customer given expiration of lot number EW0180 as given but (Withheld) from Pfizer Customer service: 31Aug2021. The outcome of the events was unknown.Information on the lot/batch number has been requested.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: He is getting little bit nauseous; This is a spontaneous report from a non-contactable consumer (patient's parent). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jun2021 (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization at the age of 15-year-old. The patient medical history and concomitant medications were not reported. The reporter wanted to know if it was possible to get the vaccine one day other than 21 days and getting exactly on 20 days instead of 21 days. The patient experienced little bit nauseous, it was not major on an unspecified date in Jun2021. No treatment was received for the event. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Hypersensitivity, Rash macular, Urticaria
Clinical narrative: Whole body was covered with hives; She has red splotches all over her body.; pretty bad allergic reaction; This is a spontaneous report from a contactable consumer (patient's mother). A 21-year-old female patient first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EW0198; Expiration date: unknown) via an unspecified route of administration in right arm on 29Jun2021 at 17:00 (at the age of 21-year-old) as single dose for COVID-19 immunization. Medical history of the patient included COVID-19 and patient had no family history (none). Patient does take some concomitant medications (unspecified). Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No other vaccine was administered on same date with the COVID-19 vaccine. On 29Jun2021, at around 18:00 to 18:30 patient experienced hives after taking shower. It was an hour to an hour and a half after the vaccine. Patient had a pretty bad allergic reaction, her whole body was covered with hives, and she had to go to the ER. On an unspecified date in Jun2021, patient developed red splotches all over her body. Adverse events require patient to visit Emergency Room. On 29Jun2021, at ER patient underwent blood work (unspecified) examination, samples were sent to the CDC, results were not reported. Events were improving and patient was released from the ER this morning (date of report: 30Jun2021) at around 06:00. Reporter asked what her daughter should do about the second dose. Reporter stated that the E.R doctor recommended not to take the second dose. Outcome of the events whole body was covered with hives were and she has red splotches all over her body was recovering/Resolving. Outcome for the event pretty bad allergic reaction was unknown.  Follow-up actions are needed. Further actions are needed.
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Headache, Pain, Pain in extremity
Clinical narrative: Second one for the first couple days my arm just hurt; body aches; dehydrated; headache; This is a spontaneous report from a contactable consumer (patient herself) from a Pfizer sponsored program support. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EW0217), via an unspecified route of administration, administered in Arm Left on 25Jun2021 at 09:30, as single dose for covid-19 immunisation. The patient medical history and concomitant medications reported as none. Patient's family history reported as none and no relevant test was performed. Patient's historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0178), via an unspecified route of administration, administered in Arm Left on 04Jun2021 at 09:30 as single dose for covid-19 immunisation and experienced no reaction. Patient's History of all previous immunization with Pfizer vaccine reported as none, prior vaccinations patient received only first dose of covid-19 vaccine. No additional vaccines administered on same date. Patient reported she is experienced headache on an unspecified date in Jun2021 and body aches on 30Jun2021 at 03:00. In her area of the country, they are having extreme heat and she isn't sure if her symptoms are from being dehydrated on 30Jun2021 or if they are from the vaccine. First vaccine I had nothing. Second one for the first couple days on 30Jun2021 at 03:00 my arm just hurt and today the headache started. Patient was wondering if it possible 5 days later to have effects from the vaccine. She could feel it in her sleep, and she woke up with a headache. She is not sure start date of headache is 29Jun2021 or 30Jun2021what time it was started it was in the middle of the night. Events not required visit to Physician Office or Emergency Room. No therapeutic measures were taken as a result of the events. The outcome of the events was reported as not recovered.  Information on batch/lot numbers are available. Further information has been requested.   .
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Feeling abnormal, Heart rate increased, Migraine
Clinical narrative: 4 to 5 days of misery; vomiting; general body aches; a violent reaction of sharp stomach pain; fever/low grade fever; fatigue; very sore arm at the injection site; migraine; elevated heart rate; she couldn't sleep because her heart was pounding or it was an adrenal reaction; This is a spontaneous report from a contactable consumer or other non-HCP. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0187), via an unspecified route of administration, administered in Left Arm on 16Jun2021 13:00 as DOSE 1, SINGLE (at the age of: 64-year-old) for covid-19 immunization. Medical history included , adrenal disorder, diabetes mellitus only thing is diabetes, kidney disease her brother had, her mother did have high blood pressure, she did die of heart, she was older , renal disorder only thing is diabetes, kidney disease her brother had, her mother did have high blood pressure, she did die of heart, she was older , hypertension only thing is diabetes, kidney disease her brother had, her mother did have high blood pressure, she did die of heart, she was older , cardiac disorder only thing is diabetes, kidney disease her brother had, her mother did have high blood pressure, she did die of heart, she was older , covid-19. The patient's concomitant medications were not reported. Historical vaccine included flu shot FLU VACCINE VII. On 16Jun2021 the patient experienced fatigue, very sore arm at the injection site. On 17Jun2021 the patient experienced a violent reaction of sharp stomach pain, general body aches, fever/low grade fever. On 18Jun2021 the patient experienced vomiting. On an unspecified date of Jun2021 the patient experienced migraine, elevated heart rate, she couldn't sleep because her heart was pounding or it was an adrenal reaction. On an unspecified date the patient experienced 4 to 5 days of misery. She was going to get her heart rate checked but it did resolve. The only other vaccines she's had would be a flu shot. Caller states she might get a mild body aches but never like this. This was truthfully much worse than COVID, the vaccine was much worse than COVID itself. Stating in general and sometime no reaction at all. She hasn't had one in 3 years, at least 3-4 years ago. The outcome of event migraine, 4 to 5 days of misery, fever/low grade fever was unknown. The outcome of event fatigue was recovered on an unspecified date. The outcome of rest all events was recovered on 23Jun2021  Follow up attempts are needed. Further information has been requested.  Follow-Up (09Jul2021): Follow-up attempts are completed. No further information is expected fever/low
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Sleep deficit, Vaccination site pain, Vomiting
Clinical narrative: 4 to 5 days of misery; vomiting; general body aches; a violent reaction of sharp stomach pain; fever/low grade fever; fatigue; very sore arm at the injection site; migraine; elevated heart rate; she couldn't sleep because her heart was pounding or it was an adrenal reaction; This is a spontaneous report from a contactable consumer or other non-HCP. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0187), via an unspecified route of administration, administered in Left Arm on 16Jun2021 13:00 as DOSE 1, SINGLE (at the age of: 64-year-old) for covid-19 immunization. Medical history included , adrenal disorder, diabetes mellitus only thing is diabetes, kidney disease her brother had, her mother did have high blood pressure, she did die of heart, she was older , renal disorder only thing is diabetes, kidney disease her brother had, her mother did have high blood pressure, she did die of heart, she was older , hypertension only thing is diabetes, kidney disease her brother had, her mother did have high blood pressure, she did die of heart, she was older , cardiac disorder only thing is diabetes, kidney disease her brother had, her mother did have high blood pressure, she did die of heart, she was older , covid-19. The patient's concomitant medications were not reported. Historical vaccine included flu shot FLU VACCINE VII. On 16Jun2021 the patient experienced fatigue, very sore arm at the injection site. On 17Jun2021 the patient experienced a violent reaction of sharp stomach pain, general body aches, fever/low grade fever. On 18Jun2021 the patient experienced vomiting. On an unspecified date of Jun2021 the patient experienced migraine, elevated heart rate, she couldn't sleep because her heart was pounding or it was an adrenal reaction. On an unspecified date the patient experienced 4 to 5 days of misery. She was going to get her heart rate checked but it did resolve. The only other vaccines she's had would be a flu shot. Caller states she might get a mild body aches but never like this. This was truthfully much worse than COVID, the vaccine was much worse than COVID itself. Stating in general and sometime no reaction at all. She hasn't had one in 3 years, at least 3-4 years ago. The outcome of event migraine, 4 to 5 days of misery, fever/low grade fever was unknown. The outcome of event fatigue was recovered on an unspecified date. The outcome of rest all events was recovered on 23Jun2021  Follow up attempts are needed. Further information has been requested.  Follow-Up (09Jul2021): Follow-up attempts are completed. No further information is expected fever/low
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: I believe that they were left in the freezer longer than the 14 days; This is a spontaneous report from a contactable pharmacist.     A patient of unspecified age and gender received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. During the call, stated, trying to follow up on a report that we sent on the vaccine just to make sure that these vials are still good because I believe that they were left in the freezer longer than the 14 days." Note: The patient's date of birth was not provided on the phone call. Note: The reporter's last name and address were not provided on the phone call. The reporter did not specify which vaccine. Pfizer-BioNTech COVID-19 Vaccine is being reported out of an abundance of caution. The following information was not confirmed during the call, but retrieved from the system: Reporter phone No. The following information was not provided during the call: Patient gender, Patient name. The outcome of the event was unknown.  Information about lot/batch number has been requested. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: started having more like a period, but she was going through menopause before had been spotting only.; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 12Jun2021 (at the age of 60-year-old) as dose 1, single for COVID-19 immunization (to prevent the COVID; at least if patient gets it, she won't get it so hard). The patient medical history was not reported. The patient concomitant medication included vitamins nos (patient takes no prescribed medications, only vitamins) taken for an unspecified indication, start and stop date were not reported. The patient received other vaccine within 4 weeks prior vaccinations. The patient previously took shingles vaccine (both doses, administered in left arm). The patient experienced started having more like a period, but she was going through menopause before had been spotting only on 27Jun2021. Adverse event did not result in emergency room, physician office visit. Patient is a 60-year-old female patient who received her first dose of the Pfizer BioNTech COVID-19 vaccine two weeks ago. Then, four days ago she started having more like a period, but she was going through menopause before had been spotting only. She would like to know if the Pfizer BioNTech COVID-19 vaccine messes with her menstrual period. Patient stated she just turned 60 in February and was just spotting and was told that's part of menopause. Patient has been taking some menopause hormone menstrual support. Patient had her first dose of the vaccine two weeks ago and then maybe 3-4 days ago, she started having more like a period. Patient was talking with a friend who heard on the news two months ago that some Covid vaccines were messing with women's periods. Patient stated her second dose is due on 03Jul2021 and is 21 days after her first dose. Clarified with patient that her first dose was 12Jun2021. Investigations: patient said not yet to any tests, because this is her first experience patient has had. Patient stated she is taking it like it's a period. Patient stated she had the Shingles vaccine three weeks prior to the Covid vaccine. She was told she would have to wait two weeks. By the time she had gotten the Covid vaccine, it had been three weeks. This was her second dose of the Shingles vaccine, the first dose was almost six months before that. Patient stated she was achy and had an achy arm from the Shingles vaccine. The patient received treatment for the event. Outcome of the event was not recovered.  Information about lot/batch number has been requested. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Bad headache; Fever; Chills; This is a spontaneous report from a Pfizer sponsored program COVAX US support via a contactable consumer (patient).   A 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Lot number was not reported), via an unspecified route of administration on 29Jun2021 as dose 2, single, (31-year-old at the time of vaccination) for COVID-19 immunisation. Medical history was not reported. Concomitant medication included paracetamol (TYLENOL). The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Lot number was not reported), via an unspecified route of administration on 08Jun2021 as dose 1, single, (31-year-old at the time of vaccination) for COVID-19 immunisation The reporter reported that he received his second dose of the Pfizer COVID-19 vaccine yesterday, 29Jun2021. On an unspecified date on Jun2021, the patient reported fever, chills, and a bad headache. The reporter reported that he is getting better right now and he took 2 Tylenol. The patient reported that he had fever and is feeling like he as a cold today. He took two Tylenol to manage the symptoms - Asking if the symptoms he has may pass onto his children. Referred to care provider for further medical assessment to rule out SARS COV 2. Therapeutic measures were taken for the events. The outcome of the events were resolving.  Follow-up attempts are needed. Information about lot/batch number has been requested.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Headache
Clinical narrative: Chest pain; Headache; This is a spontaneous report from a contactable consumer (patient mother). A 16-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0180) via an unspecified route of administration on 28Jun2021 (at the age of 16-year-old) as single dose for covid-19 immunization. Medical history included seasonal allergy (with runny nose, he took seasonal allergic medicine Benadryl 25mg on Sunday morning, one day before of vaccination). Concomitant medications included diphenhydramine hydrochloride (BENADRYL) taken for seasonal allergy from an unknown date. On 29Jun2021, the patient experienced chest pain and headache. It was reported that on Monday, he was okay but on Tuesday, he says he started having a headache. The treatment for the events was not reported. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Headache, Hypersomnia, Pyrexia
Clinical narrative: His eyes felt hard and it was hard to focus and he had a little headache and little dizziness; wobbling around; Headache; Dizzy; Sleeping a lot; Fever; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (BNT162B2, Solution for injection, Batch number: Unknown) via an unspecified route of administration, administered in the right arm on 28Jun2021 at 15:30 (at the age of 65-year-old) as 1st dose, single for COVID-19 immunisation. The patient medical history included ongoing blood pressure high (started 20 years ago). Concomitant medications were not provided. On 28Jun2021, the patient experienced fever, on 29Jun2021, he was dizzy and was sleeping a lot, and on 30Jun2021, he had headache. On an unspecified date, his eyes felt hard and it was hard to focus and he had a little headache and little dizziness and wobbling around. The clinical course of the events was reported as: he mentioned he had gotten the COVID-19 shot on Monday 28Jun2021 and had been dizzy for two days since he took it. He was also sleeping a lot. He got up and was dizzy and wobbling around. He wanted to know if this last a while. The events described as: dizzy: he clarified he first felt it when he got out of be yesterday, on Tuesday (as reported). His eyes felt hard and it was hard to focus and he had a little headache and little dizziness. Fever: He also had a fever, initially stated it was when he went to bed on that first night. He clarified while sleeping he woke up with a fever that first night. Headache: He believed he had headache because his eyes cold not focus and clarified he first felt it this morning and he was unable to provide an outcome, stating it just started this morning. Sleeping a lot: he first noticed this yesterday (as reported). He was sleeping all day yesterday and had been sleeping today. He drunk something, drank some tea, and ate, then went back to sleep. Now he had back up. He stated that he had already slept most of the day today, but he was up now. He further explained it seemed to be a little better now. Investigations: He confirmed he had not gone to the doctor's office, emergency room, or had any labs or testing due to events. He stated that was one of the reasons he was calling to determine if he should go. The outcome of the event dizzy was not recovered, sleeping a lot and fever were recovering, and the outcome of the other events was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: His eyes felt hard and it was hard to focus and he had a little headache and little dizziness; wobbling around; Headache; Dizzy; Sleeping a lot; Fever; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (BNT162B2, Solution for injection, Batch number: Unknown) via an unspecified route of administration, administered in the right arm on 28Jun2021 at 15:30 (at the age of 65-year-old) as 1st dose, single for COVID-19 immunisation. The patient medical history included ongoing blood pressure high (started 20 years ago). Concomitant medications were not provided. On 28Jun2021, the patient experienced fever, on 29Jun2021, he was dizzy and was sleeping a lot, and on 30Jun2021, he had headache. On an unspecified date, his eyes felt hard and it was hard to focus and he had a little headache and little dizziness and wobbling around. The clinical course of the events was reported as: he mentioned he had gotten the COVID-19 shot on Monday 28Jun2021 and had been dizzy for two days since he took it. He was also sleeping a lot. He got up and was dizzy and wobbling around. He wanted to know if this last a while. The events described as: dizzy: he clarified he first felt it when he got out of be yesterday, on Tuesday (as reported). His eyes felt hard and it was hard to focus and he had a little headache and little dizziness. Fever: He also had a fever, initially stated it was when he went to bed on that first night. He clarified while sleeping he woke up with a fever that first night. Headache: He believed he had headache because his eyes cold not focus and clarified he first felt it this morning and he was unable to provide an outcome, stating it just started this morning. Sleeping a lot: he first noticed this yesterday (as reported). He was sleeping all day yesterday and had been sleeping today. He drunk something, drank some tea, and ate, then went back to sleep. Now he had back up. He stated that he had already slept most of the day today, but he was up now. He further explained it seemed to be a little better now. Investigations: He confirmed he had not gone to the doctor's office, emergency room, or had any labs or testing due to events. He stated that was one of the reasons he was calling to determine if he should go. The outcome of the event dizzy was not recovered, sleeping a lot and fever were recovering, and the outcome of the other events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Loss of personal independence in daily activities, Neuralgia
Clinical narrative: pain in his stomach and nerves; pain in his stomach and nerves; can't eat or sleep due to the pain; This is a spontaneous report from a Pfizer-Sponsored program. A contactable consumer reported for a 21-year-old male patient (reporter's nephew). A 21-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. It was unknown whether the Reporter a Healthcare Profession (HCP). The patient medical history was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient Concomitant medications were not reported. On an unspecified date, the patient after received the second dose of Pfizer covid vaccine a month and a half ago and immediately began experienced having pain in his stomach and nerves. The reporter that the patient has been in and out of the Emergency department and the doctors can't tell them anything but they said it is because of the vaccine. They were told by their doctors that they were not sure what was causing the pain. It was reported that on an unknown date, the patient can't eat or sleep due to the pain. He has been on pain medication since receiving vaccine. Caller wants to know if these side effects have been reported and what's the duration of the side effects. Therapeutic measures were taken as a result of pain in his stomach and nerves. The outcome of the events was unknown.    Information on the lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Palpitations
Clinical narrative: her heart has been beating fast/Her heart is racing; She got a headache; But this is a strange one, like someone walking inside her head. All she feels bump bump bump; This is a spontaneous report from a contactable consumer or other non hcp.   A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, formulation: Solution for injection, Batch/lot number: ENO158 expiration date: unknown) via an unspecified route of administration in Arm Left on 29Jun2021 14:00 (age at vaccination 72years old) as single dose for covid-19 immunization. The patient did not have any medical history. Concomitant medications were not reported. She received the first dose of the covid vaccine about 14:00, she got home and about an hour and a half at about 17:36, she got headache. It was a big headache, and her head was thumping. It was stated that she would get headaches sometimes, but this was a strange one, like someone walking inside her head. All she felt "bump bump bump". Her heart was racing: After she ate something, her heart started pumping, and it has not stopped. She wanted to know if this was normal. Confirmed that her heart started racing a day prior to this report (yesterday, not today)   It was stated that she just realized it was better to get the vaccine, than to have covid. Her and her husband got vaccinated. Therapeutic measures were taken as a result of a events. The outcome of the event was reported as not resolved.  No follow-up attempts were needed. No further information was expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pruritus, Vaccination site pallor
Clinical narrative: but four months later 31May2021 I woke up at 2 am to a burning arm and red arm; I had a white area where shot was given.; About two minutes after injection, my hands and feet started burning and itching.; itching; This is a spontaneous report received from a contactable healthcare professional (herself as patient) reported that a 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 22Feb2021 07:30 (age at the time of vaccination 44-years-old), (Batch/Lot Number: EL9262) in the arm left as a DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included hypothyroidism and allergies: coconut oil; both since from an unknown date and unknown if ongoing. Concomitant medications included omeprazole (Strength: 40 mg), levothyroxine and zoloft. The patient previously took moxifloxacin and avelox and experienced allergies. The patient was not pregnant at time of vaccination. The patient was not requiring Hospitalization Prolonged. The most recent COVID-19 vaccine was administered in the hospital. The patient does not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. On 22Feb2021 07:32, it was reported that about two minutes after injection, my hands and feet started burning and itching, itching. On 31May2021 02:00 it was reported that but four months later 31May2021 I woke up at 2 am to a burning arm and red arm and I had a white area where shot was given. The clinical outcome of event extremities burning sensation of and pruritus was recovered on an unknown date in 2021. The outcome of the events erythema and vaccination site pallor was recovered on 01Jun2021.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore upperarm; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in shoulder on 22Jan2021 09:45 (Lot Number: EK9231) as a single dose at the age of 46-year-old for covid-19 immunisation from doctor's office/ urgent care, hospital. Patient's medical history, concomitant medications and prior vaccinations were none. The patient experienced sore upper arm after the first dose. The outcome of event was unknown.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Suppressed lactation
Clinical narrative: I was pumping 10-16oz in a session. After the first dose I noticed my milk decreasing within a 24hour period. By the next day I was only producing 3 or 4 oz in a single session; I was Breastfeeding when I received the covid 19 vaccine.; I was Breastfeeding when I received the covid 19 vaccine.; This is a spontaneous report from a contactable consumer(patient). A 24-year-old non pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8730) via an unspecified route of administration in left arm on 30Mar2021 at 15:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation at a Clinic. The patient medical history included glaucoma, aphakic, known allergies: latex, mild mold/fungial allergy. Concomitant medications within two weeks included latanoprost, dorzolamide hydrochloride, timolol maleate (COSOPT) eye drops. Patient did not receive other vaccine in four weeks. Patient had no covid prior vaccination, and patient did not tested covid post vaccination. The patient was breastfeeding when she received the covid 19 vaccine. She was pumping 10-16oz in a session. After the first dose on 31Mar2021 at 15:00, she noticed her milk decreasing within a 24hour period. By the next day she was only producing 3 or 4 oz in a single session. Patient struggled over the next few weeks to get her milk supply up to 6oz. Patient had consulted for lactation and received treatment for the event. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Lactation disorder, Off label use, Product use issue, Suppressed lactation
Clinical narrative: I was Breastfeeding when I received the covid 19 vaccine; I was Breastfeeding when I received the covid 19 vaccine; I was Breastfeeding when I received the covid 19 vaccine. After the first dose I noticed my milk decreasing within a 24hour period. After the second dose my milk was depleted completely within a 24; I was Breastfeeding when I received the covid 19 vaccine. After the first dose I noticed my milk decreasing within a 24hour period. After the second dose my milk was depleted completely within a 24; This is a spontaneous report from a contactable consumer (Patient). A 24-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 23Apr2021 15:00 (at the age of 24-years-old) (Batch/Lot Number: EW0172) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included glaucoma, aphakic, allergy of latex and mild mold/fungal allergy from an unknown date and unknown if ongoing. Concomitant medications included latanoprost (LATANOPROST, eyedrops) and dorzolamide hydrochloride/timolol maleate (COSOPT) taken for an unspecified indication, start and stop date were not reported. Patient previously received first dose of bnt162b2 (Lot number: ER8730, Vaccine location: Left arm) on 30Mar2021 03:00 PM for covid 19 immunization and had reaction noticed my milk decreasing within a 24hour period. The patient was breastfeeding when she received the covid 19 vaccine. She was pumping 10-16oz in a session. After the first dose she noticed her milk decreasing within a 24hour period. By the next day she was only producing 3 or 4 oz in a single session. She struggled over the next few weeks to get her milk supply up to 6oz. After the second dose her milk was depleted completely within a 24-hour period. The patient was not pregnant. The patient had treatment by lactation consultation, the patient had no covid prior vaccination and patient had no covid test post vaccination. Outcome of the events I was Breastfeeding when I received the covid 19 vaccine was unknown and outcome of other events was not recovered.