chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Malaise, Nausea
Clinical narrative: nausea; hasn't been feeling well since; high heart rate; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information Team. A 61-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 14Jul2021 as dose 1, single (at the age of 61-years-old) for COVID-19 immunization. Patient medical history included allergies. The concomitant medications were not reported. Patient had the first dose of the Pfizer BioNTech COVID-19 vaccine last Wednesday (14Jul2021) and she had not been feeling well since. She went to ER last Sunday because of nausea and high heart rate but her heart rate came down on its own. She mentioned they gave her hydration and anti-nausea medications via IV. She was still not feeling good, she still felt unwell. She wanted to know if these have been reported common side effects with the vaccine since the ER said nothing was wrong with her. She was worried about getting the second dose of the Pfizer BioNTech COVID-19 vaccine because of her experience. They did not give her anything for her heart rate, but it came down. They did give her IV hydration and anti-nausea medicine. She still did not feel good though. She goes to the doctor tomorrow. She feels like slush. She had allergies, but she did not experience anaphylaxis. She was concerned why she is feeling so unwell. On an unspecified date in 2021, the outcome of the event heart rate increased was resolved, of the event feeling unwell was unknown while that of the event nausea was not recovered.   Information on Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: very strong itch all over my body; red balls that bulged until it bled.; This is a spontaneous report from a Pfizer sponsored program, from a contactable consumer, the patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration, on 20Jun2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not provided), on 30May2021, for covid-19 immunization. It was stated that, on an unknown date in Jun2021, five days after the second dose, the patient developed a very strong itch all over the body and small red balls that bulged until it bled. The outcome of the events was unknown at the time of report.  Information about batch/ lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: can hardly walk, he has to drag his feet; His arm has been sore since he got the vaccine; This is a spontaneous report. A contactable consumer (the patient) reported for himself. A male patient of an unspecified age received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were unknown), via unspecified route of administration, in the arm, on an unspecified date, as dose number unknown, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated that, he was having some side effects from the Pfizer Covid vaccine. Patient said, he can hardly walk, he has to drag his feet and his arm has been sore since he got the vaccine. Outcome of the events was unknown.   Information on lot/batch number has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: Daily stomach discomfort; This is a spontaneous report from a contactable consumer (patient). A 17-years-old female patient received BNT162B2, via an unspecified route of administration on 15Jul2021, (at the age of 17-years old), (Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were reported as none. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient experienced daily stomach discomfort on 16Jul2021. Since the vaccination, the patient had not been tested for COVID. No treatment was given for the event. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity, Peroneal nerve palsy
Clinical narrative: Really bad pain on right leg; Burning sensation; Had drop foot, and driving for him was very tough; the muscle that raises your foot up and down wouldn't work at all for him; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 68-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 14Mar2021 as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 21Feb2021 as dose 1, single for COVID-19 immunization. Patient had the first dose of the Pfizer BioNTech COVID-19 vaccine last 21Feb2021 and the second dose last 14Mar2021. He had a really bad pain on right leg with burning sensation and drop foot on same leg. He had drop foot, and driving for him was very tough, the muscle that raised your foot up and down would not work at all for him. He could not move his foot at all, up or down, and it was like his ankle was swollen, and felt almost like wood. He mentioned the nerve damage was so long, he thought is this ever going to get better. Then 3 weeks ago, in about a month, he could start moving his foot up and down and his range had got a little better though it was still tough to move, and he still kind of has a drop foot. He was given Gabapentin. He mentioned he still had 20 percent of needing to get back to how he was before the shot. He said it had gotten better, pain was gone. He mentioned that the burning was like bubbling, boiling, burning, and he could feel his skin doing the same thing, like lava, when he put his hand on it, there was no heat or burning sensation on it, where he felt like it was doing that. He mentioned that it mostly seemed like a lot of nerve issues. He mentioned when he walked in tennis shoes, he could almost walk normal. It was still going to be awhile.This had not happened to him until 2 days after the second shot. Doctor told him it was not related to the vaccine but he was concerned that his experiences were related to the vaccine and that the doctor did not know what he was talking about because a dental hygienist who was a family member sent him something about some of the symptoms he had been having. Family member found something that was similar or exactly like what he experienced and he was convinced that it was Covid related. He wanted recommendations to speed things up with regards to his recovery. On an unspecified date in 2021, the outcome of the event pain in leg was resolved that of burning sensation was unknown while of foot drop was recovering.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: missed their menstrual cycle after their second shot of their COVID 19 vaccine.; This is a spontaneous report from a contactable consumer and a contactable nurse (one of which is a colleague). This nurse reported for three adolescent female patients. This is the first one of three reports. An adolescent female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation.  It was unknown whether the patient was diagnosed with covid prior to vaccination or was tested for COVID-19 post vaccination. The patient missed her menstrual cycle after their second shot of their covid 19 vaccine. It was unknown if the patient receives any treatment in response to the event. The outcome of event was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100930370 Same reporter/drug/AE, different patient;US-PFIZER INC-202100930371 Same reporter/drug/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: her joints hurt; muscles hurt; This is a spontaneous report from a contactable consumer (reporting on behalf of his daughter). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history was not reported and concomitant medications was none.  After the first shot, patient experienced her joints and muscles hurt on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Peripheral swelling
Clinical narrative: After the second shot, it really got worse. Hers is not muscles; it's more joints.; Her joints swelled up - feet, hands, ankles; Her joints swelled up - feet, hands, ankles; This is a spontaneous report from a contactable consumer (reporting on behalf of his daughter). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history was not reported and concomitant medications was none. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. After the first shot, the patient experienced her joints and muscles hurt. After the second shot, it really got worse. Hers was not muscles; it was more on the joints. Her joints swelled up, feet, hands, ankles. The reporter's doctor put her on steroid pills, and within the next day, all her symptoms went away. After she got off the steroids, everything came back just the way it was. The events were considered as non-serious by the reporter. The outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, COVID-19, Joint stiffness, SARS-CoV-2 test
Clinical narrative: She got vaccinated, got Covid three days later; Having a lot of stiff joints and joint pain; Having a lot of stiff joints and joint pain; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date 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 were not reported. The patient got COVID three days later after she got vaccinated on an unspecified date. On an unspecified date in Jul2021 (also reported as now), the patient was having a lot of stiff joints and joint pain. It was reported that the patient was wondering if this was a side effect of the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome for the events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, COVID-19, Drug ineffective, Joint stiffness
Clinical narrative: She got vaccinated, got Covid three days later; Having a lot of stiff joints and joint pain; Having a lot of stiff joints and joint pain; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date 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 were not reported. The patient got COVID three days later after she got vaccinated on an unspecified date. On an unspecified date in Jul2021 (also reported as now), the patient was having a lot of stiff joints and joint pain. It was reported that the patient was wondering if this was a side effect of the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome for the events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Hypotension
Clinical narrative: Heart rate got higher like it's skipping and she got lower blood pressure; Heart rate got higher like it's skipping and she got lower blood pressure; This is a spontaneous report from the patient. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration, on 20Jul2021 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 was not provided), on 18Jun2021 as a single dose, for COVID-19 immunization. The patient reported that, after an hour of administration, on 20Jul2021, her heart rate got higher like it was skipping and got lower blood pressure. The outcome of the events was unknown at the time of report.  Information on Lot/Batch information has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Cranial nerve infection, Herpes virus infection, SARS-CoV-2 test
Clinical narrative: Herpes virus onset and flare up with Bell's Palsy; inflammation of cranial nerve 7; Herpes virus onset and flare up with Bell's Palsy; inflammation of cranial nerve 7; Herpes virus onset and flare up with Bell's Palsy; inflammation of cranial nerve 7; This is a spontaneous report from a contactable other hcp. A 41-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via intramuscular route of administration in Arm Left on 04Apr2021 12:00(age at vaccination:41 Years) as DOSE 2, SINGLE for COVID-19 immunization. Patient didn't received other vaccines within 4 weeks prior to vaccination and patient didn't received within 2 weeks prior to vaccination. Medical history included gluten sensitivity from an unknown date and unknown if ongoing, food allergy was corn and dairy allergy from an unknown date and unknown if ongoing, papilloma viral infection from an unknown date and unknown if ongoing, epidermolysis bullosa from an unknown date and unknown if ongoing. Concomitant medication were not reported. The patient previously received first dose of bnt162b2(BNT162B2, Solution for injection, lot no: unknown) via intramuscular route of the administration in Arm left on 14Mar2021 12:00 (age at vaccination:41 Years) as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced herpes virus onset and flare up with bell's palsy; inflammation of cranial nerve 7 on 07Jul2021. The Patient didn't had COVID-19 prior to vaccination patient was tested to COVID-19 to post vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 25May2021 Nasal Swab. Patient had disability for the events. Therapeutic measures were taken as a result of herpes virus onset and flare up with bell's palsy; inflammation of cranial nerve 7 was antivirals and steroids. The outcome of the events bell's palsy, cranial nerve infection, herpes virus infection was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the events Bell's palsy, Cranial Nerve Palsy, Herpes Viru infection and the suspect BNT162B2.   The impact of this report on the benefit/risk profile of the Pfizer drug 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
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Her son developed symptoms of Covid on 08Apr2021 and on the 09Apr2021 he tested positive; This is a spontaneous report from a contactable Nurse (patient's mom). This case is for the first dose. A 32-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications were not reported. The caller was calling on behalf of her son who was 32 years old. He received his first dose of the vaccine on 02Apr2021 and developed Covid/tested positive for Covid on 09Apr2021. Due to this the second dose was delayed, they were told to wait for a 3 month period to get the second dose. His second dose was on 17Jul2021. Now he got the second dose on 17Jul2021but when he got it the pharmacist told him this would be considered the first dose. The caller wants to know if this was true or not. The pharmacist at (withheld) told him that that second dose would now be considered a first dose. The caller wanted to know if that was true. She also adds that her son lives in Colorado and she calling today for her own knowledge and information, she is just surprised at what the pharmacist said. Her son developed symptoms of Covid on 08Apr2021 and on the 09Apr2021 he tested positive. When queried what type of covid test the patient had caller states that it was not a rapid test but she knows it was a nasal swab test. The outcome of the event was recovered on an unspecified date.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Back pain, Chest discomfort
Clinical narrative: Sore arm; Didn't feel well; Extreme sore throat; Chest discomfort; Joint hurt can't stand / My hip and back hurt so bad; Can't taste or smell; Can't taste or smell; Stuffy nose; Coughed my chest burns; Coughed my chest burns/chest burning; My hip and back hurt so bad; joint hurt can't stand; This is a spontaneous report. A contactable 59-year-old female consumer (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/Lot number was not reported), via an unspecified route of administration on 28Jun2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that, she had an appointment on 19Jul2021 for her 2nd dose but due to her severe reaction she didn't get it. She wasn't feeling well to get the second dose. Patient stated, on an unspecified date in 2021 "She was feeling terrible: sore arm, didn't feel well, extreme sore throat, chest discomfort, joint hurt can't stand, can't taste or smell; stuffy nose and coughed my chest burns. Patient never had this chest burning before. It burns so bad. Patient coughed and coughed. And her hip and back hurt so bad. The patient was taking Aleve for the events and it wasn't helping, and once patient started taking Tylenol and Advil for the events it was better. The outcome of the events was unknown.   Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dysstasia, Malaise, Nasal congestion
Clinical narrative: Sore arm; Didn't feel well; Extreme sore throat; Chest discomfort; Joint hurt can't stand / My hip and back hurt so bad; Can't taste or smell; Can't taste or smell; Stuffy nose; Coughed my chest burns; Coughed my chest burns/chest burning; My hip and back hurt so bad; joint hurt can't stand; This is a spontaneous report. A contactable 59-year-old female consumer (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/Lot number was not reported), via an unspecified route of administration on 28Jun2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that, she had an appointment on 19Jul2021 for her 2nd dose but due to her severe reaction she didn't get it. She wasn't feeling well to get the second dose. Patient stated, on an unspecified date in 2021 "She was feeling terrible: sore arm, didn't feel well, extreme sore throat, chest discomfort, joint hurt can't stand, can't taste or smell; stuffy nose and coughed my chest burns. Patient never had this chest burning before. It burns so bad. Patient coughed and coughed. And her hip and back hurt so bad. The patient was taking Aleve for the events and it wasn't helping, and once patient started taking Tylenol and Advil for the events it was better. The outcome of the events was unknown.   Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity
Clinical narrative: Sore arm; Didn't feel well; Extreme sore throat; Chest discomfort; Joint hurt can't stand / My hip and back hurt so bad; Can't taste or smell; Can't taste or smell; Stuffy nose; Coughed my chest burns; Coughed my chest burns/chest burning; My hip and back hurt so bad; joint hurt can't stand; This is a spontaneous report. A contactable 59-year-old female consumer (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/Lot number was not reported), via an unspecified route of administration on 28Jun2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that, she had an appointment on 19Jul2021 for her 2nd dose but due to her severe reaction she didn't get it. She wasn't feeling well to get the second dose. Patient stated, on an unspecified date in 2021 "She was feeling terrible: sore arm, didn't feel well, extreme sore throat, chest discomfort, joint hurt can't stand, can't taste or smell; stuffy nose and coughed my chest burns. Patient never had this chest burning before. It burns so bad. Patient coughed and coughed. And her hip and back hurt so bad. The patient was taking Aleve for the events and it wasn't helping, and once patient started taking Tylenol and Advil for the events it was better. The outcome of the events was unknown.   Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: sore and achy throughout the body; This is a spontaneous report from a contactable consumer. A consumer (patient) reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on 22Jul2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 22Jul2021, the patient experienced sore and achy throughout the body. It was reported that the caller got the first dose of the Pfizer COVID 19 vaccine this morning and is sore and achy throughout the body. Is it okay to take aspirin and will it effect the effectiveness of the vaccine. The clinical outcome of event was unknown.  Information on batch/Lot number has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Pain in half of his head, like a headache,  after first vaccine; Pain in left arm, after first vaccine; This is a spontaneous report  received from a contactable consumer(patients wife). A 48-year-old male patient received the first dose of BNT162B2 (PFIZER VACCINE FOR COVID 19) via an unspecified route of administration on the left arm on 21Jul2021 at 17:00 (Batch/lot number:FA6780; Expiration Date: Unknown) at the age of 48-year-old as single dose for COVID-19 immunization. Medical history and concomitant medication were none. Investigation Assessment was none. Family Medical History Relevant to AEs was not provided. Because it was requested at the patient workplace thus the patient taking Pfizer vaccine for COVID-19. The patient was not related to a study or programme. Prior vaccination (within 4 weeks), the patient didn't received any other vaccinations. Relevant Test was none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. AEs following prior vaccinations was none. On 22Jul2021 morning, the patient experienced pain in half of head, like a headache and pain in left arm. The events were ongoing. The reporter stated she needs some information because her husband went to work, and he experienced side effect. The reporter stated her husband didn't saw any one doctor at the clinic. The reporter wanted to known whether it would be better to call his doctor and whether this was normal and whether they could prescribe medication. The reporter stated that her husband was calling her asking for some medication for the pain, and she confirmed, that her husband hadn't taken any medication. The events didn't resulted in emergency room and physician office. The outcome of events was not recovered.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Memory impairment, Speech disorder
Clinical narrative: Medical Information Potential AE; The problem is her memory; she doesn't speak very well; This is a spontaneous report from a contactable consumer reported for female patient (reporter's mother). A 69-year-old elderly female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection Batch/Lot Number: ER8734) via an unspecified route of administration in deltoid Left on 29Mar2021(at the age of 69-years-old) as Dose 1,Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient told him she received the second dose of the vaccine at a different hospital in a different county than the first dose, however she had no record of receiving the dose, was not given a vaccination card for either dose, which had been an issue in their area. Patients are being told to get the information from their patient portal. Reporter had contacted both hospitals, local and state health departments, as well as the CDC and no one had record of her receiving the second dose. She is going to be moving into an assisted living facility and needs proof of receiving both doses and asked would it be safe for her to get a third dose in case she actually had received a second dose for which documentation may not have been entered. We have no safety or efficacy data outside of the dosing schedule followed in the clinical trial, no data is available at this time from the Booster dose study, and Pfizer cannot recommend the use of the vaccine outside of the recommendations in the PI. Reporter stated, height may be 5 feet he guesses. She got the first shot; we do not know if she got the second shot. She may very well have received the second shot, but we just do not know. The problem is her memory (incomplete sentence) she doesn't speak very well (Further clarification was unknown if patient experienced this problem after getting the first dose or not, hence captured as event), so we don't know. Nobody else thinks she got. Reporter stated, she did not have any problem (voice not clear). The clinical outcome of the events was unknown.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pain in extremity
Clinical narrative: Arm pain; Fatigue; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 19Jul2021 (at the age of 26 years old) (Lot Number: FA6780) as single dose for COVID-19 immunization. Medical history included, prior to vaccination, the patient was diagnosed with COVID-19. No known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were not any other medications the patient received within 2 weeks of vaccination. The patient experienced arm pain on 19Jul2021, fatigue on 19Jul2021, diarrhea on 19Jul2021. AE did not result in Emergency Room Visit/Physician Office Visit. No treatment received for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Jul2021.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nasopharyngitis, Pain in extremity, Pyrexia
Clinical narrative: Fever of 101; Headache; Sore arm; Cold symptoms/runny nose like cold; This is a spontaneous report from a contactable consumer or other non hcp. A 15-years-old adolescent male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported),via an unspecified route of administration on 23Jul2021 as  Dose 2 ,Single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported)via unspecified route of administration on 01Jul2021 as  Dose 1,Single for COVID-19 immunization. The patient experienced fever of 101, headache, sore arm and cold symptoms/runny nose like cold in Jul2021. The patient underwent lab tests and procedures which included body temperature with result 101 fahrenheit on an unspecified date. The outcome of the events were reported as unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: Her husband on Monday came back positive with covid/Her 17 year old daughter is also in the house was also vaccinated; This is a spontaneous report from a contactable consumer (parent). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date, as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jul2021, the patient's father was tested positive with COVID-19 and the patient was also in the house. The clinical outcome of the event was reported unknown.  Information about lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Feeling abnormal, Feeling hot, Palpitations
Clinical narrative: Felt  light headed; Within seconds of vaccine, felt very hot.; dry heaved a little; Then throat got tight; lips tingled; Started shaking; couldn't catch breath; Heart was racing; Things were foggy; didn't feel right for rest of night; This is a spontaneous report from a contactable consumer (patient). A non-pregnant female patient of an unspecified age received bnt162b2 (Lot Number: EP7533), dose 1 via intramuscular, administered in left arm on 31Mar2021 07:00 AM as single dose for covid-19 immunization. Medical history included Covid-19 in Dec2020 and known allergies included shellfish, contrast dye, multiple antibiotics. The patient's concomitant medications within 2 weeks of vaccination were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Within seconds of vaccine (31Mar2021), the patient felt very hot. Then dry heaved a little. Then throat got tight and lips tingled. Then pharmacist gave 50 mg of diphenhydramine hydrochloride (BENADRYL). Started shaking and couldn't catch breath. Heart was racing. Felt light headed. Were ready to give epipen, didn't. Things were foggy. Symptoms started to get better after half hour but heart was still racing. Stayed over and hour. Went home, didn't feel right for rest of night- took more diphenhydramine hydrochloride. Woke up next day and felt OK. Treatment received for the adverse events included diphenhydramine hydrochloride. The outcome of events was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Retching, Throat tightness, Tremor, Vision blurred
Clinical narrative: Felt  light headed; Within seconds of vaccine, felt very hot.; dry heaved a little; Then throat got tight; lips tingled; Started shaking; couldn't catch breath; Heart was racing; Things were foggy; didn't feel right for rest of night; This is a spontaneous report from a contactable consumer (patient). A non-pregnant female patient of an unspecified age received bnt162b2 (Lot Number: EP7533), dose 1 via intramuscular, administered in left arm on 31Mar2021 07:00 AM as single dose for covid-19 immunization. Medical history included Covid-19 in Dec2020 and known allergies included shellfish, contrast dye, multiple antibiotics. The patient's concomitant medications within 2 weeks of vaccination were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Within seconds of vaccine (31Mar2021), the patient felt very hot. Then dry heaved a little. Then throat got tight and lips tingled. Then pharmacist gave 50 mg of diphenhydramine hydrochloride (BENADRYL). Started shaking and couldn't catch breath. Heart was racing. Felt light headed. Were ready to give epipen, didn't. Things were foggy. Symptoms started to get better after half hour but heart was still racing. Stayed over and hour. Went home, didn't feel right for rest of night- took more diphenhydramine hydrochloride. Woke up next day and felt OK. Treatment received for the adverse events included diphenhydramine hydrochloride. The outcome of events was recovered.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymph node pain, Peripheral swelling, SARS-CoV-2 test, Tenderness
Clinical narrative: arm was slightly tender; arm was slightly tender, red, with a rash and itching at the injection site with no pain; arm was slightly tender, red, with a rash and itching at the injection site with no pain; arm was slightly tender, red, with a rash and itching at the injection site with no pain; lymph nodes under her armpit are sore; Slightly swollen; Left arm-red; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6201) via intramuscularly administered in arm left on 11Feb2021 13:30 (at the age of 74-years-old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 in Oct2020 and heart issues. The patient's concomitant medications were not reported. On 11-FEB-2021 19:00 patient experienced left arm-red, slightly swollen, itchy- then went into Lymph nodes under arm & side of left breast, red with a rash and itching at the injection site with no pain. On 12Feb2021 (the next day), the patient experienced arm was slightly tender. On the day of reporting, these lymph nodes really hurt. She would like to know how long these symptoms should last. The patient did not have nausea, dizziness or rash all over her body. All events were reported as non-serious by the reporter. No therapeutic measures were taken as a result of events. The patient underwent lab tests and procedures which included sars-cov-2 test result was positive on 05Oct2020 and second sars-cov-2 test result was negative on 19Oct2021. The outcome of all the events was reported as recovered.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.  Follow-up (25Mar2021): This is a follow up spontaneous report from a contactable consumer in response to Non-HCP letter sent which included, age of the patient during vaccination, suspect product details (start date, lot number, route of administration, anatomical location), new events (arm swollen and redness) onset time for other events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: arm was slightly tender; arm was slightly tender, red, with a rash and itching at the injection site with no pain; arm was slightly tender, red, with a rash and itching at the injection site with no pain; arm was slightly tender, red, with a rash and itching at the injection site with no pain; lymph nodes under her armpit are sore; Slightly swollen; Left arm-red; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6201) via intramuscularly administered in arm left on 11Feb2021 13:30 (at the age of 74-years-old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 in Oct2020 and heart issues. The patient's concomitant medications were not reported. On 11-FEB-2021 19:00 patient experienced left arm-red, slightly swollen, itchy- then went into Lymph nodes under arm & side of left breast, red with a rash and itching at the injection site with no pain. On 12Feb2021 (the next day), the patient experienced arm was slightly tender. On the day of reporting, these lymph nodes really hurt. She would like to know how long these symptoms should last. The patient did not have nausea, dizziness or rash all over her body. All events were reported as non-serious by the reporter. No therapeutic measures were taken as a result of events. The patient underwent lab tests and procedures which included sars-cov-2 test result was positive on 05Oct2020 and second sars-cov-2 test result was negative on 19Oct2021. The outcome of all the events was reported as recovered.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.  Follow-up (25Mar2021): This is a follow up spontaneous report from a contactable consumer in response to Non-HCP letter sent which included, age of the patient during vaccination, suspect product details (start date, lot number, route of administration, anatomical location), new events (arm swollen and redness) onset time for other events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Limb injury, Pain in extremity
Clinical narrative: Extreme pain in the elbow and inflammation/ pain in the elbows and also inflammation in her wrists; Had broken her arm and it is still hurting but not with that intensity; Extreme pain in the elbow and inflammation/ pain in the elbows and also inflammation in her wrists; This is a spontaneous report from a non-contactable consumer (patient herself). A female patient 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 10Feb2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient called for information about if extreme pain in the elbow and inflammation are common side-effects. She reported that she was administered with the first dose of the vaccine on 10Feb2021 and she reported that she experienced an extreme pain in the elbow that she reported to be like she had broken her arm and it was still hurting but not with that intensity.  She reported that a friend of her also developed pain in the elbows and also inflammation in her wrists. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in Feb2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient got up and went to the bathroom and used to bathroom and when came back to lay down, patient had shortness of breath from the shot. Patient got shot on Thursday, maybe Wednesday(in Feb2021) something around it. Outcome of event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Headache, Swelling
Clinical narrative: She noticed swelling on the left side 24 hours later.; Headache; Lump the size of an orange under her right arm; This is a spontaneous report from a contactable consumer (patient).   A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection, Batch/Lot Number: EL3247 expiration date: unknown), via an unspecified route of administration, administered in Arm Right on 25Feb2021 14:00 (at the age of 62-year-old) as dose 2, single for covid-19 immunization. The patient did not have any medical history (was reported as none). There were no concomitant medications. History of previous immunizations was not provided. There were no additional vaccines administered on same date of Pfizer suspect. Prior vaccinations within 4 weeks or any adverse events following prior vaccinations. After second dose of COVID vaccine, patient had a giant lump the size of an orange under her arm. It went down from there and felt like when her milk came in after having a baby, but not as bad. Her breast hurt and she could not use the injection arm. She had the second COVID Vaccine on Thurs-day. She had some soreness on Friday (26Feb2021), but thought it was no big deal. By Friday evening, it was not just a little sore. On Saturday (27Feb2021), she looked at it and noticed the lump the size of an orange. The swelling was down to the size of a golf ball. She also had a headache on an unspecified date. Patient was asking if the agent thought she needed to see a doctor. Patient was assuming the lump would eventually go away. It was clarified the lump and swelling began in the right arm. The swelling did spread to the left side, but not nearly as bad. She noticed swelling on the left side 24 hours later. The outcome of outcome of headache was reported as resolving, and outcome of lump the size of an orange under her right arm and swelling was unknown.  No follow-up attempts were possible. No further information was expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: urticaria, improved with Benadryl
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity, Rash, Vaccination site mass, Vaccination site warmth
Clinical narrative: Rash; lump and fever at injection site; lump and fever at injection site; Pain at top of right leg; Slight bruise on leg; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 70-year-old non-pregnant female second dose of BNT162B2 (COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration on 25Feb2021 (age at the time of vaccination 70-years-old), as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162B2 (COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 04Feb2021 11:30 AM (age at the time of vaccination 70-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. Patient had known allergies. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. On 25Feb2021 16:45, the patient experienced Rash, lump and fever at injection site, Pain at top of right leg, and Slight bruise on leg. No treatment was received. The outcome for all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Injection site mass, Injection site pain
Clinical narrative: Extreme body aches muscles and joints; Extreme body aches muscles and joints; Headache; extreme swollen lymph nodes in axil area traveling to Brest and back; Nausea; vomiting; Dizziness; lethargy; Unable to move arm with injection site huge lump; Unable to move arm with injection site huge lump; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female non-pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 at 14:15 (at the age of 43-years-old) as a DOSE 2, SINGLE for covid-19 immunisation. Patient medical history included fibromyalgia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took ace inhibitors and experienced drug hypersensitivity. No other vaccine was received in four weeks. The patient did not have covid prior vaccination and not tested for covid post vaccination. On 05Mar2021, the patient experienced extreme body aches muscles and joints, headache, extreme swollen lymph nodes in axil area traveling to breast and back, nausea, vomiting, dizziness, lethargy, unable to move arm with injection site huge lump. It was reported that, on 05Mar2021 at 04:00 PM the patient had extreme body aches muscles and joints. Headache extreme swollen lymph nodes in axil area traveling to breast and back. Nausea and vomiting. Dizziness and lethargy. Unable to move arm with injection site huge lump. No treatment was received for the events. Outcome of the events were recovered with sequelae in 2021(Recovered with lasting effects).  No follow-up attempts are possible; information about lot/batch number cannot been obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021168274 same patient, different shot/event