chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea; Throw up at dinner time; This is a spontaneous report from a non-contactable consumer or other non-health professional.   A patient of unspecified age and gender received dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received a Pfizer vaccination yesterday and he threw up today, still he feels nauseous. He wants to know is that a side effect of the vaccine. He had an assisted living and took resident living to get his first Pfizer vaccination yesterday. Today he said he feels nauseous, and he even throw up at dinner time. So, is that a side effect of the first vaccination, nausea, throwing up. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac discomfort, Dyspnoea, Peripheral swelling
Clinical narrative: He could barely breathe; he felt like his heart it was something involved with his heart, he couldn't even take the normal breath; He could barely breathe; he felt like his heart it was something involved with his heart, he couldn't even take the normal breath; He had a swelling around the calves; This is a spontaneous report from a contactable consumer. The consumer (patient's mother) reported for her son. A 21-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 12May2021 in arm as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccines were administered. The reporter stated that her husband got the first dose (lot number: ER8732) on 03Apr2021 at 11:30 and all of a sudden, his ears started ringing, but in one ear it was like unbearable siren going on and it calm down. He received the second dose on 24Apr2021 at 11:30 (lot number: EW0170; expiry date 31Aug2021) and the events came back with full force again but were gone. She was sure that the events were because of the vaccine. Her husband went for an MRI because he got something going on with his brain and went to a neurologist but later it was gone. She reported that her girlfriend's husband lost hearing in one ear after he got the vaccine. She also reported that her son received the vaccine on 12May2021 and had lot of side effects which were very normal for 21 years old, but the third day he woke up and said he could barely breathe, he felt like something was involved with his heart and he couldn't even take the normal breath. She reported that they almost took him to the hospital, and he started to calm down by the end of the day, the events were gone but he had swelling around calves. The outcome of the events was recovered in 2021.  Information about lot/batch number is requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021694827 Same reporter, different drug/patient/ AE
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia
Clinical narrative: feeling a little "woozy"; fever; This is a spontaneous report from a contactable consumer or other non hcp via internet source. A 13-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown and Expiration date Unknown) second dose, via an unspecified route of administration on an unspecified date, as single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Formulation: Solution for injection, Lot Number: Unknown and Expiration date Unknown) on an unspecified date, as single dose for COVID-19 immunization. The reporter stated that his/her friend mentioned on a zoom that on an unspecified date. The patient had fever after his second shot of vaccine and was feeling a little "woozy". The reporter assumed that he was referring to the Pfizer Vaccine because it was the only authorized one for that age group and that was all the information that reporter had. The outcome of the events was outcome of unknown.  Information on the lot/batch number has been.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cardiac discomfort
Clinical narrative: Pressure on his heart; This is a spontaneous report received from a contactable consumer. This consumer (mom) reported for her male patient (son) who received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunization. The patient's medical history was reported as none. The concomitant medications of the patient included Vitamins (stop date and ongoing status were unknown). Additional vaccines administered on same date of the pfizer suspect and prior vaccinations (within 4 weeks) were reported as none. The patient did not require emergency room and physician office visit. On an unknown date in 2021 the patient had pressure on his heart and have had a couple situations of this occur. They have read up on potential side effects and saw this could be a side effect from the vaccination. It was reported that the patient was peer pressured into getting bnt162b2. Caller stated that she was calling because she was wondering if she could be helped with the cost of any additional testing that needs to be done, medical stuff, things like that to help along the way to pay for the cost of testing since it was a side effect of the vaccine. It was mentioned that the pressure on his heart started within the last two weeks. She does not know the exact date. It has happened a couple of times. The outcome of pressure on heart was unknown. The caller confirmed that she does not know the lot/exp/NDC for either dose. She stated that she was sure her son has the card and that information. She did not know which arm he had received it. She had not had any investigations at this time. They were looking into getting labs and blood work done. However, trying to figure out how will pay. Outcome of the events was unknown. Confirmed have not been yet. They are waiting to call the doctor. Trying to figure out how will pay for it all  Information about batch/lot number has been requested
Sex: U
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Pyrexia, Rhinorrhoea
Clinical narrative: Had temperature going on and off that wont stop; Have been running a temperature on and off since I received the shot; Chills; Dry cough; Very fatigue; I had a runny nose.; This is a spontaneous report from a contactable consumer. A patient with unspecified age and gender received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0177, Expiration date: unknown), via unspecified route, administered on 09Jun2021 as unknown dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 09Jan2021, after the vaccination, the patient experienced temperature going on and off, chills, dry cough, very fatigue and runny nose. Consumer asked whether the events normal for several days. No treatment options were taken. Further information could not be probed as the consumer was unwilling to share any further information. The events assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Arm where she got the shot is on and off numb; This is a spontaneous report from a contactable consumer (patient's spouse). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA , Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05May2021 as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date as 1st dose for covid-19 immunisation. On 05May2021, the patient experienced arm where she got the shot is on and off numb. Patient got her second shot from Pfizer, the first one was no side effect. Now it was10Jun2021 or 11Jun2021, patient was that normal because she called the doctor and do not have appointment right away as we have to stand in line. So as said it was better to ask Pfizer, it could tell if this was normal or not normal. The clinical outcome of event was not recovered.  Information on lot/batch has been requested.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal pain, Pain in extremity, Polymerase chain reaction
Clinical narrative: Pain in the thighs and legs, in the lower part of the buttocks; Pain in the thighs and legs, in the lower part of the buttocks; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 19Mar2021 10:00 (Lot Number: EN6207) as single dose for covid-19 immunization at the age of 60-year-old. The patient medical history and known allergies were none. Concomitant medications included atorvastatin taken for an unspecified indication, start and stop date were not reported; verapamil taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pain in the thighs and legs, in the lower part of the buttocks on 20Mar2021 01:00 and resulted in visit to doctor/other health care professional (HCP) office. The outcome of the events was not recovered. Therapeutic measures for events included Prednisone. The patient further received second dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 30Apr2021 11:15 (Lot Number: EW0179) as single dose for covid-19 immunisation. The patient underwent Covid Test post vaccination (polymerase chain reaction: Nasal Swab) which was negative on 07May2021.
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Dyspnoea, Feeling abnormal, Oropharyngeal discomfort, Swelling
Clinical narrative: patient feels like she has a ball on her throat.; Today the patient and the caller were driving and the same thing happened again so the patient took 2 benadryl within 3 hours; couldn't breathe; swelled; nasty reaction; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0179), dose 2 via an unspecified route of administration on 08Jun2021 as 2nd single dose for COVID-19 immunization. Patient's medical and concomitant medication history were not reported. Patient had allergy of penicillin. Historical vaccine included 1st of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0179) as 1st single dose on 18May2021. It was reported that, "got the second shot on tuesday, 08Jun2021 and waited 15 minutes. The first time they made them wait 30 minutes but the second time it was 15 minutes. On the way home, patient had a nasty reaction and couldn't breathe and that was 45 minutes after the vaccine. Reporter stopped the paramedic in the middle of the road and they took patient to the hospital, patient was swelled. Patient was released. Tuesday, took the patient to the emergency room, gave the patient Benadryl in the ambulance and when patient got to the hospital gave epi pen and steroid. The patient was admitted 2:00 am yesterday 10Jun2021, and discharged that afternoon, 10Jun2021. When the patient was admitted they did an x-ray and blood work. Today the patient and the caller were driving and the same thing happened again so the patient took 2 benadryl within 3 hours. The caller drove the patient to the hospital and they are gong to do a CT of her throat because the patient feels like she has a ball on her throat. They are also going to look for blood clots in the patient's lungs. Patient gets the results from the CT scan and stuff. The outcome of the event was unknown.   PSCC Communication: Original report reference number provided to caller. Caller unable to continue with call. Full details not obtained. MI filed in initial report. Report 2 of 3.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: flu like symptoms; fatigue; Fever of 101.4 by the morning; significant full body aches; skin tenderness to the touch all over; headache; soreness at the injection site; This is a spontaneous report from a Non-contactable consumer (patient). A 36- year-old female received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot: EW0179) via unspecified route of administration on 21May2021 at 09:30 AM (36-year-old age at vaccination) in right arm for COVID-19 immunization in Workplace clinic. Medical history and concomitant medications were not reported. patient previously took first dose of bnt162b2 (lot: ER8736) on 30Apr2021 09:00 am in right arm for Covid-19 immunization. No known allergies were reported. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient not diagnosed with COVID-19 neither since the vaccination patient been tested for COVID-19. After the first shot had mild hot flash like symptoms and soreness at injection site. On 21May2021, after the second shot (9:30 am) about 12 hours after receiving the shot had onset of flu like symptoms, fatigue (9:30 pm). Fever of 101.4 by the morning and significant full body aches, skin tenderness to the touch all over and headache. Were more than moderate symptoms but not so severe as I sought additional medical attention. This was in addition to soreness at the injection site. Symptoms subsided after 2 full days. Received her shot on a Friday morning and did not start to feel near normal until Sunday evening.No treatment was received by patient in response to the events. Outcome of the event soreness at the injection site was unknown and for remaining events it was recovered on 23May2021.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Pyrexia, Vaccination site pain
Clinical narrative: flu like symptoms; fatigue; Fever of 101.4 by the morning; significant full body aches; skin tenderness to the touch all over; headache; soreness at the injection site; This is a spontaneous report from a Non-contactable consumer (patient). A 36- year-old female received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot: EW0179) via unspecified route of administration on 21May2021 at 09:30 AM (36-year-old age at vaccination) in right arm for COVID-19 immunization in Workplace clinic. Medical history and concomitant medications were not reported. patient previously took first dose of bnt162b2 (lot: ER8736) on 30Apr2021 09:00 am in right arm for Covid-19 immunization. No known allergies were reported. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient not diagnosed with COVID-19 neither since the vaccination patient been tested for COVID-19. After the first shot had mild hot flash like symptoms and soreness at injection site. On 21May2021, after the second shot (9:30 am) about 12 hours after receiving the shot had onset of flu like symptoms, fatigue (9:30 pm). Fever of 101.4 by the morning and significant full body aches, skin tenderness to the touch all over and headache. Were more than moderate symptoms but not so severe as I sought additional medical attention. This was in addition to soreness at the injection site. Symptoms subsided after 2 full days. Received her shot on a Friday morning and did not start to feel near normal until Sunday evening.No treatment was received by patient in response to the events. Outcome of the event soreness at the injection site was unknown and for remaining events it was recovered on 23May2021.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: she woke up at midnight with a headache that lasted for a week and a half; This is spontaneous report from contactable consumer. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unknown date single dose (at the age of 72-year-old) and second dose around 12:30 in the afternoon for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that when she received the first dose of the vaccine (on an unspecified date) she woke up at midnight with a headache that lasted for a week and a half. The event assessed as non-serious. On an unspecified date, headache was resolved.  Information on the Lot/Batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Conjunctivitis, Eye colour change, Eye swelling, Eyelid irritation, Periorbital swelling
Clinical narrative: she woke up at midnight with a headache that lasted for a week and a half; This is spontaneous report from contactable consumer. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unknown date single dose (at the age of 72-year-old) and second dose around 12:30 in the afternoon for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that when she received the first dose of the vaccine (on an unspecified date) she woke up at midnight with a headache that lasted for a week and a half. The event assessed as non-serious. On an unspecified date, headache was resolved.  Information on the Lot/Batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling of eyelid, Visual impairment
Clinical narrative: she woke up at midnight with a headache that lasted for a week and a half; This is spontaneous report from contactable consumer. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unknown date single dose (at the age of 72-year-old) and second dose around 12:30 in the afternoon for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that when she received the first dose of the vaccine (on an unspecified date) she woke up at midnight with a headache that lasted for a week and a half. The event assessed as non-serious. On an unspecified date, headache was resolved.  Information on the Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Thermal burn, Vaccination site erythema
Clinical narrative: This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration in left arm on 11Jun2021 as 2nd dose, single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation and no reaction on previous exposure to vaccine. On 11Jun2021, the patient experienced couple of burns on neck and arm red patch on left arm where the patient had vaccine. The patient stated that, after second vaccination on 11Jun2021 when the patient got home had couple of burns on the neck and the patient thought they were mosquito bites and then 12Jun2021, the patient noticed burns on arm and then 13Jun2021, noticed two more burns on neck and then the patient got a red patch on left arm where the patient had the vaccine. The patient don't feel it is a serious enough to call 911 but is there something can do. The reporter asked should just keep putting alcohol or anti-itch on it or what (treatment). The outcome of the events were not resolved. Information on lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Two people now have Covid and are quarantined after they were vaccinated.; Two people now have Covid and are quarantined after they were vaccinated.; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that there were people on the cruise ship and everyone had to be vaccinated except for the ones under the age limit. They had to be tested for Covid before the cruise but two people now had Covid and were quarantined after they were vaccinated. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021690810 same reporter/drug/event different patient
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyskinesia, Fatigue, Headache, Pain in extremity
Clinical narrative: Arm being swollen but underneath the arm in my armpit I notice it's pretty swollen; Under my arms it's swollen; Arm being swollen but underneath the arm in my armpit I notice it's pretty swollen; Under my arms it's swollen; Arm is sore; Chills; Headache; Fever; Tired; First it started of with I think it was tiredness, 'jerking' and then fever."; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0217) via an unspecified route of administration in Arm on 11Jun2021 as second dose, single for COVID-19 immunization. Medical history included Blood pressure high from an unknown date and unknown if ongoing. Concomitant medications included vitamin d, paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported, since patient had the shot. Consumer stated Dose of Vitamin D as it for High blood pressure medicine further clarification was unknown. It was reported that the patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0177) via unspecified route of administration on 18th May 2021 as 1st dose, single for covid-19 immunization. It was reported that the patient did not receive any vaccine within 4 weeks prior to the COVID 19 Vaccine. Consumer stated she was calling regarding a side effect that she noticed after she had her shot-on Friday the 11th of this month (11th june2021) and stated she had all the symptoms except for a few started Saturday on 12jun2021, her arm was sore and she had the chills and when she went to bed, had headache. First it started off with she thinks it was tiredness, jerking and then fever and still experiencing. On 13jun2021, she noticed that her arm being swollen but underneath the arm in her armpit she noticed it was pretty swollen under her arms and confirmed the name of the vaccine as Pfizer Covid 19 vaccine and patient stated no treatment was received and took Tylenol before vaccination. Reporter seriousness for all the reported events as unspecified. There was no investigation assessment. The outcome of the events was not recovered.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Swelling
Clinical narrative: Arm being swollen but underneath the arm in my armpit I notice it's pretty swollen; Under my arms it's swollen; Arm being swollen but underneath the arm in my armpit I notice it's pretty swollen; Under my arms it's swollen; Arm is sore; Chills; Headache; Fever; Tired; First it started of with I think it was tiredness, 'jerking' and then fever."; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0217) via an unspecified route of administration in Arm on 11Jun2021 as second dose, single for COVID-19 immunization. Medical history included Blood pressure high from an unknown date and unknown if ongoing. Concomitant medications included vitamin d, paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported, since patient had the shot. Consumer stated Dose of Vitamin D as it for High blood pressure medicine further clarification was unknown. It was reported that the patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0177) via unspecified route of administration on 18th May 2021 as 1st dose, single for covid-19 immunization. It was reported that the patient did not receive any vaccine within 4 weeks prior to the COVID 19 Vaccine. Consumer stated she was calling regarding a side effect that she noticed after she had her shot-on Friday the 11th of this month (11th june2021) and stated she had all the symptoms except for a few started Saturday on 12jun2021, her arm was sore and she had the chills and when she went to bed, had headache. First it started off with she thinks it was tiredness, jerking and then fever and still experiencing. On 13jun2021, she noticed that her arm being swollen but underneath the arm in her armpit she noticed it was pretty swollen under her arms and confirmed the name of the vaccine as Pfizer Covid 19 vaccine and patient stated no treatment was received and took Tylenol before vaccination. Reporter seriousness for all the reported events as unspecified. There was no investigation assessment. The outcome of the events was not recovered.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased, Fatigue, Palpitations
Clinical narrative: This is a spontaneous report received from a contactable Pharmacist (patient). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EW0191 and Expire Date: unknown) (at the age of 44 years) via unspecified route of administration in left arm on 07Jun2021 at 19:30 as 1st dose, single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had known allergies of sulfa. Medical history was none and concomitant medications were not reported. After vaccination, on 09Jun2021 at 01:00, the patient experienced dropping blood sugar, severe exhaustion, heart palpitations. The patient underwent lab test which blood glucose measurement, result was decreased. She did not receive any treatment for the adverse events. The outcome of the events was not recovered. Information on the lot/batch was available, Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash macular, Swelling face
Clinical narrative: Face is swollen up and its all red and blotchy; Face is swollen up and it's all red and blotchy; Face is swollen up and it's all red and blotchy; This is a spontaneous report from a contactable consumer (patient's parent). A female patient (reporter's daughter) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 13Jun2021 as unknown, single dose for COVID-19 immunization. Medical history and concomitant medications of the patient were not reported. Reportedly, patient had no allergies to any other medicines. On 13Jun2021, after vaccination patient experienced her face was swollen up and its all red and blotchy. Reporter stated "My daughter had the COVID Vaccine today, and her face is swollen up and its all red and blotchy. Reporter don't know what to do. If it is an allergic reaction or what, Reporter don't know because she has not had any allergies to any other medicines, that's they put on the thing." Outcome of the events were unknown.  Information on Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Swelling, Vaccination site pain
Clinical narrative: I am having swelling under the arm; It is in my left arm where I got the shot, it is kind of sore; Where I had the shot in my left arm, there is swelling underneath my arm; It is underneath my armpit; I am having swelling under the arm; It is in my left arm where I got the shot, it is kind of sore; Where I had the shot in my left arm, there is swelling underneath my arm; It is underneath my armpit; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0177, NDC number, UPC number and Expiration date are unknown), via an unspecified route of administration, administered in Left arm on 11Jun2021 as unknown, single dose for covid-19 immunisation. Medical history included Blood pressure from unspecified date. Concomitant medications included Vitamin D (VITAMIN D NOS) taken for an unspecified indication on an unspecified date and unspecified blood pressure medicine, on an unspecified date. It was reported that patient was calling regarding a side effect that is not written on the paper. The patient had several of them and had shot on Friday and just noticed having swelling under the arm, it is in left arm where patient got the shot, it is kind of sore and where patient had the shot in left arm, there was swelling underneath arm on an unspecified date in Jun2021. The patient wanted to report it and also wanted to know if it was normal, the swelling and the " Consumer stated, "Not my hand, my arm where the shot was and also underneath my arm." It was reported that the patient did not take any medication for adverse events. Reporter seriousness for adverse events was unspecified. The outcome of events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: In a short time, he was infected; In a short time, he was infected.; This is a follow-up spontaneous report from a non-contactable consumer via pfizer product quality group providing investigation results. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8727; Expiration Date: 31Jul2021), via intramuscular on 01May2021 as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient in a short time, he was infected and the patient wants to know when the 2nd dose of the vaccine should be applied. Conclusion: The complaint for an adverse event requested by Safety with the use of the PFIZER-BIONTECH COVID-19 VACCINE lot ER8727 was investigated. The investigation included reviewing the manufacturing and packaging batch records, retained reference samples, deviation investigations and an analysis of the complaint history for the reported lot and product type. The final scope was expanded to include the reported finished goods lot ER8727, the fill lot EP8679, and the bulk formulated drug product lot EP8566. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. The complaint was not confirmed. The clinical outcome of the patient in a short time, he was infected and the patient wants to know when the 2nd dose of the vaccine should be applied were recovered.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal
Clinical narrative: I had Pain in my right shoulder/tired but mostly wandering joint pain; foggy; tired but mostly wandering joint pain; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in arm left (reported as left shoulder) on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced pain in right shoulder, even though had the shot in the left shoulder, since then patient had a variety of symptoms foggy, tired but mostly wandering joint pain. Patient described the condition was horrid and it's been three months can hardly lift a small pan full of water and stated this was from that vaccine. Patient had second Pfizer shot was 08Mar2021. The outcome of events was unknown.  Information about lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: She has like little hives; Severe allergic reaction on her face and her neck; This is a spontaneous report received from a contactable consumer. This consumer reported for a patient (Reporters mother).  A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical and concomitant medications were not reported. It was reported that, patient got her second dose of the Pfizer vaccine yesterday. Right now, she recently had a severe allergic reaction on her face and her neck, and she had like little hives and her breathing was fine. Reporter was just worried if needed to go to the hospital. The outcome of events was unknown.  Information on lot/batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever; Chills; Fatigue; This is a spontaneous report from a contactable consumer. A 15-years-old female consumer (patient) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. Medical history included type 1 diabetes mellitus and she was on insulin pump. The patient's concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on an unspecified date for COVID-19 immunization. As per the description it was reported that two sisters experienced similar symptoms. 15 years old with type 1 diabetes mellitus experienced fever, chills and fatigue on an unspecified date. The outcome of all the events was recovered in 48 hours (for 15 years old).  Follow-up activities closed: as reporter denied for further contact. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue
Clinical narrative: Stomach ache; fatigue; This is a spontaneous report from a contactable pharmacist. A 13-years-old female patient received BNT162B2 (BNT162B2, Solution for injection, Lot number was not reported) via an unspecified route of administration in an unknown date in 2021 as 2nd dose, single dose for covid-19 immunization. Medical history was none. The patient previously took first dose of BNT162B2 (BNT162B2, Solution for injection) for covid-19 immunization and no reaction on exposure to vaccine. The concomitant medications were not reported. The patient experienced stomach ache, fatigue in an unknown date in 2021. Reported that, event took place after use of product. Outcome of the events were recovered on an unknown date in 2021.  Reporter does not wish to be contacted for follow-up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Tooth infection
Clinical narrative: Tooth infection; This is a spontaneous report received from a contactable consumer. A patient with unspecified age and gender received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on unspecified date as unknown dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date after the vaccination, the patient experienced tooth infection. Consumer stated that he took the first short of vaccine and on antibiotics for tooth infection. Second dose is planned on 18. He took his last pill of antibiotic. He was going back to his dentist for more care for tooth infection. Patient asked weather to take antibiotics if doctor prescribed before second shot or to leave couple of days and to take second shot. When probed if antibiotics were started prior the vaccine, consumer stated, I just finished taking 6 antibiotics. Today I just took my last antibiotics. The event was considered as medically significant. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pyrexia
Clinical narrative: Fever; It has not worsened but he cannot go to work; This is a spontaneous report from a Pfizer sponsored program (CEP ID: 159558). A contactable 53-year-old male consumer (patient) reported that: A 53-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EWO186), via an unspecified route of administration, administered in Deltoid Left (reported as left shoulder) on 13Jun2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation (reported as because everybody should take it). The patient's medical history and family medical history relevant to adverse event was reported as none. There were no concomitant medications. No prior vaccinations within 4 weeks. The patient previously received flu shot (unspecified manufacturer) on an unspecified date and experienced itches and fever (anytime when he has the flu shot he had a fever). On 14Jun2021, midnight around 01:00, the patient experienced fever and was suffering. It has not worsened but he cannot go to work. He can't make it to work. It was persisting and staying the same. The patient did not receive treatment and stated he was calling to get treatment for fever. The outcome of event fever was not recovered and the outcome of other event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: lip & face swelling; lip & face swelling; This is a spontaneous report from a Contactable consumer. This consumer reported for Female patient.   A 14-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date(at the age of 14 years old) as 2nd dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation and patient had no reaction on previous exposure to Vaccine. On an unspecified date, the patient experienced lip and face swelling 7 days post second dose of Pfizer COVID-19. Event was occurred after use of product. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis flair still hasn't gotten uncontrol like it was before the vaccine; increase in joint pain; This is a spontaneous report from a contactable other hcp. A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient reports stopping therapy for 4-5 days for each of the covid-19 vaccine doses, and patient reports an increase in joint pain during this time. patient states this rheumatoid arthritis flair still hasn't gotten uncontrol like it was before the vaccine. MD was not aware. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of rheumatoid arthritis flare up But also consider relevant medical history of rheumatoid arthritis. 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
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Urticaria, Vaccination site hypersensitivity, Vaccination site urticaria
Clinical narrative: Vaccination site urticaria; Vaccination site hypersensitivity; Joint pain; Welts/ where arms touch the desk got hives, that moves up arms/ worse at night/ hives on chest; This is a spontaneous report from a contactable consumer. This is a spontaneous report based on information received by Pfizer.  A 45-years-old male patient received second dose of bnt162b2 (TOZINAMERAN, Formulation: Solution for injection, Batch/Lot number was not reported), intramuscularly on 2021 as a single dose for COVID-19 immunization. alimumab (HUMIRA, Formulation: Solution for injection in pre-filled pen), subcutaneously from an unspecified date (Batch/Lot number was not reported) to May2021, at unspecified dose for colitis ulcerative. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (TOZINAMERAN, Formulation: Solution for injection, Batch/Lot number was not reported), intramuscularly on 2021 as a single dose for COVID-19 immunisation with no reaction on previous exposure to drug. On an unspecified date in 2021, the patient experienced vaccination site urticaria, vaccination site hypersensitivity, joint pain, welts/ where arms touch the desk got hives, that moves up arms/ worse at night/ hives on chest. The consumer reported that "Allergic reaction / patient stopped Humira after second Covid vaccine. Due to bad reaction/ next morning had Welts/ where arms touch the desk got hives, that moves up arms/ worse at night/ hives on chest and joint pain. The outcome of event welts/ where arms touch the desk got hives, that moves up arms/ worse at night/ hives on chest was unknown and rest all events were not recovered.  The reporter's causality for the events of Allergic reaction / patient stopped Humira after second Covid vaccine. Due to bad reaction/ next morning had Welts/ where arms touch the desk got hives. That moves up arms/ worse at night/ hives on chest  onset in 2021, Joint pain was not reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First vaccine she had a little bit of pain in arm; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: ER8729, Expiration date: 31Jul2021, Pfizer NTEC), via an unspecified route of administration in left arm on 11Apr2021 09:15 as 1st dose, 0.3 ml single dose for covid-19 immunization (at the age of 63-years-old). The patient medical history was not reported. Concomitant medication(s) included telmisartan (TELMISARTAN) taken for hypertension, she started taking it about 7 years ago. They lowered her dosage because she lost so much weight and then they removed HCT- she was no longer taking that anymore. She used to have a little elevated blood pressure but it was not high, and that is why they gave her the medication On an unknown date, the patient experienced a little bit of pain in arm after the first dose. The clinical outcome of the event was unknown.  No Information on Lot/Batch has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat; This is a spontaneous report from a contactable consumer. A 25-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 14Jun2021 as UNKNOWN, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had a bad sore throat in morning on 15Jun2021. It was asked if it was common effect of the vaccine. Treatment was not received for adverse event. The outcome of the event was unknown.  Follow-up attempts are needed. Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Poor quality product administered
Clinical narrative: One of their employees administered a full dose of the vaccine without reconstituting the medication; One of their employees administered a full dose of the vaccine without reconstituting the medication; This is a spontaneous report from a contactable Other Health Care Professional. A patient of unspecified age and gender received 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 unknown, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 15Jun2021, reporter stated that this morning one of their employees administered a full dose of the vaccine without reconstituting the medication, reporter has reported it and filed a report, now asking for guidance recommendations. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information provided in the narrative, the causal association between the suspect drug and the events cannot be excluded.