chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Laryngitis
Clinical narrative: had trouble breathing; Laryngitis; Fatigue; headache; back aches; Coughing; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9264; Expiration Date: 31May2021), via an unspecified route of administration, administered in arm right on 06Feb2021 (at the age of 71-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced coughing on Feb2021, had trouble breathing, laryngitis, fatigue, headache and back aches on an unspecified date. The clinical course was as follows: Reporter is a consumer, asking, should she get the second dose on Saturday? and should she quarantine with these symptoms? She received her first vaccine dose and about 4-5 days later she began "coughing real bad". Also reported experiencing fatigue, headache and back aches and was diagnosed with laryngitis. She went for her first vaccine with several other people, they had some symptoms but nothing like hers. She is supposed to be due for her second dose of the COVID vaccine on Saturday but is coughing and has fatigue and laryngitis and a headache. It was the coughing that really got to her. She did not develop side effects the same day as the vaccine, it was like 4 or 5 days later, and then she had trouble breathing, and that went away and then she got the laryngitis and then the fatigue. She had no other vaccines on the same day. The outcome of had trouble breathing was recovered on an unspecified date while of the rest was unknown.    No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash papular
Clinical narrative: tiny red bumps in her ankle and breast/little tiny red bumps on different parts of her body and turns into a rash when scratching them; tiny red bumps in her ankle and breast/little tiny red bumps on different parts of her body and turns into a rash when scratching them; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 04Feb2021 (Lot Number: EL9262, unknown expiration; at the age of 85 years old) as dose 1, single for COVID-19 vaccination. Medical history included high cholesterol, blood pressure (abnormal), and glaucoma, all ongoing. Concomitant medications included simvastatin for high cholesterol; labetalol for blood pressure; enalapril for blood pressure; spironolactone for blood pressure; and bimatoprost (LUMIGAN) for glaucoma, all ongoing.  The patient previously took hydrochlorothiazide and it ran the sodium out of her body. The patient received the first dose on 04Feb2021, and second dose is scheduled on 26Feb2021. On 09Feb2021, the patient experienced tiny red bumps in her ankle and breast and when she scratches it, it turns into a rash. Event further described as little tiny red bumps on different parts of her body and turns into a rash when scratching them. Asking if it is safe for her to get the second dose of the vaccine. She has heard the second one is worse than the first, but she does not know. The patient has not yet recovered from the events.  No follow-up attempts are possible; information about batch number was already obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swollen tongue
Clinical narrative: itchy patch on the neck/patch on her neck that was itchy; swollen tongue/tongue swelled some; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she received her first Pfizer shot on 19Feb2021 (Friday). She had to sit after the vaccine for 15 to 20 minutes and had no issue. A couple of hours after she got home on 19Feb2021, the patient experienced itchy patch on the neck and swollen tongue/tongue swelled some after the receipt of the first dose of the Pfizer-BioNTech COVID-19 vaccine. The patch on her neck that was itchy lasted for 15 to 20 minutes. It was just in one area she had the itchiness. The patient confirmed that she had no trouble breathing, she was still able to breath and swallow, but her tongue was bigger than normal. No rash. The patient was concerned because she has an appointment for her second shot. She asked if she should still receive the second dose of the vaccine. The appointment for her second dose is on 12Mar2021. The patient would like to know how much protection she gets from the first dose of the Pfizer-BioNTech COVID-19 vaccine. The patient recovered from the event itchy patch on the neck on 19Feb2021, while unknown outcome for swollen tongue.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Malaise
Clinical narrative: Lymph nodes swelling under arm; Tired; Headache; Feeling tight; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 15Feb2021 as dose number unknown, single for COVID-19 immunisation (at the age of 65-year-old). The patient medical history and concomitant medications were not reported. On an unspecified date, the patient took the shot and like he has lymph nodes under his arm, he was feeling tight. He had a headache that went away, but he has the lymph nodes swelling under his arm and he was still a little tired. The outcome of the events lymph nodes swelling under arm and feeling tight was unknown. The outcome of the event tired was not recovered. The outcome of the event headache was recovered.  Information about Batch/Lot number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Chills, Dizziness, Feeling abnormal, Laboratory test
Clinical narrative: Chills; Feeling abnormal / It has been all day, all day has been terrible; Dizzy; I just feel sick; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 15Feb2021 (at the age of 70-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included diabetes mellitus (verbatim: Diabetes), anaemia (verbatim: Anemia), and blood cholesterol increased (verbatim: High cholesterol). The patient reported to have lot more (unspecified) medical conditions. The concomitant medications for patient were not reported. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown) on 23Jan2021 (at the age of 69-year-old) for COVID-19 immunization. The patient reported that she received both the vaccines. After the first one there was no problem but the second one, the patient really did, 'I really figured about that' (sentence not clear on call). On an unspecified date in 2021, the caller felt chills and touchy and a little dizzy and "I just feel sick", just sick, and "Feeling abnormal / It has been all day, all day has been terrible". The patient underwent lab tests and procedures which included blood cholesterol: high on an unspecified date. Unspecified laboratory test in "January": unknown result. The patient was reported to still experience events a little bit. The patient reported "It is little better, it has been all day, all day has been terrible, now it is a little better". The patient wanted to know, would it be okay to take some medicine like Tylenol or something like that. Consumer was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department. The outcome of the events was resolving.  Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Chills; Feeling abnormal / It has been all day, all day has been terrible; Dizzy; I just feel sick; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 15Feb2021 (at the age of 70-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included diabetes mellitus (verbatim: Diabetes), anaemia (verbatim: Anemia), and blood cholesterol increased (verbatim: High cholesterol). The patient reported to have lot more (unspecified) medical conditions. The concomitant medications for patient were not reported. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown) on 23Jan2021 (at the age of 69-year-old) for COVID-19 immunization. The patient reported that she received both the vaccines. After the first one there was no problem but the second one, the patient really did, 'I really figured about that' (sentence not clear on call). On an unspecified date in 2021, the caller felt chills and touchy and a little dizzy and "I just feel sick", just sick, and "Feeling abnormal / It has been all day, all day has been terrible". The patient underwent lab tests and procedures which included blood cholesterol: high on an unspecified date. Unspecified laboratory test in "January": unknown result. The patient was reported to still experience events a little bit. The patient reported "It is little better, it has been all day, all day has been terrible, now it is a little better". The patient wanted to know, would it be okay to take some medicine like Tylenol or something like that. Consumer was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department. The outcome of the events was resolving.  Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Pain
Clinical narrative: tiny soreness after getting injection; This is a spontaneous report from a contactable consumer(patient) or other non hcp. A 74-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported), administered in left arm on 16Feb2021 15:00 (at the age of 74-year-old) as DOSE UNK, SINGLE for COVID-19 immunization and paracetamol (TYLENOL) and ibuprofen (MOTRIN) for arthritis. Medical history included arthritis from an unknown date and unknown if ongoing. She is healthy and walks daily. Historical vaccine included Flu shot in Sep2020(She does not have NDC, Lot or Expiry to provide). Concomitant medication included atorvastatin (LIPITOR) taken for blood cholesterol. The patient experienced tiny soreness after getting injection on 16Feb2021. Outcome of the event was recovering.    Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: where they gave the shot was red; This is a spontaneous report from a contactable consumer or other non hcp (patient's wife). A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EL9263, Expiry date: Unknown) via an unspecified route of administration on 10Feb2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 10Feb2021, the patient reported that where they gave the shot was red. Therapeutic measures were taken as a result of where they gave the shot was red. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021201075 Same reporter, different patients/ events.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Rhinorrhoea, SARS-CoV-2 test, Tinnitus
Clinical narrative: Runny nose; has a little "buzz" to his voice; Cold; This is a spontaneous report from a contactable consumer. A 67 year old male patient had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number:not reported) via an intramuscular route of administration on 10Feb2021 as DOSE 2, SINGLE for covid-19 immunization(age at the time of vaccination 67 year). The patient's medical history had included COPD, Osteoarthritis, Osteoporosis, Smoking(He currently still smokes. When he is a 57 years cigarette smoker, used to smoke 8 cigarettes a day), Bipolar Disorder, post traumatic disorder and pain, he has bad sinuses. The patient's concomitant medications had included OXYCODONE(5 mg, 4x/day) for the indication of pain, Cyanocobalmine, folic acid ,iron pentacarbonyl (IRON), Multivitamin, Aripiprazole(ABILIFY 5 mg/day for the indication of Bipolar Disorder & Post Traumatic Stress Disorder. It was reported that the patient had a lot of pain. He had chronic back pain. His shoulder has been broken down 2 months ago and it's still quite painful. He had 2 ruptured discs in his lower pain, sciatica, and a compression fraction of his T9 that occurred last October. He also had titanium rods in his right femur about 8 inches long, maybe 10 inches. The patient took his first dose like 2 or 2.5 weeks before the second dose, maybe like 20 days before 10Feb2021. He received his second dose of the COVID-19 vaccine from Pfizer voluntarily of course on 10Feb2021. It was reported that, starting yesterday, he became a little symptomatic like he had a cold. Caller stated maybe it's just a cold or the flu. He has a runny nose. Caller clarified further he had a usual runny nose, like a post-nasal drip long-term and in the wintertime but stated that was usual. And stated the a little buzz to his voice is pretty much staying the same, it may have improved a little but confirmed its still happening today. It may be due to him smoking too many cigarettes yesterday when he left the facility and went running errands. The patient underwent lab tests and procedures which included Covid-19 Rapid test, SARS-CoV-2 test and was diagnosed as having unknown results on 17Feb2021. The patient did not go to emergency room and physician office. The outcome of the events were unknown.  Follow-up (17May2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: citrus taste, a citrus taste in mouth, a citrus like lemon or lime, oranges or something; 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, Solution for injection, Batch/Lot Number, Expiration date, NDC number and UPC number was unknown), 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. On an unspecified date, patient experienced citrus taste, a citrus taste in mouth, a citrus like lemon or lime, oranges or something. Patient asked what to do. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected, information on the lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A little sore arm; This is a spontaneous report from a contactable consumer (sister). This is report 2 of 2. A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9262), via an unspecified route of administration on 15Feb2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb2021, patient experienced little sore arm. The reporter went with her sister who was 1 year younger than herself. On 15Feb2021, the patient got Pfizer COVID-19 Vaccine. Patient was administered the Pfizer COVID-19 Vaccine on 15Feb2021 and had no reaction to the Pfizer COVID-19 Vaccine, nothing but just a little sore arm. The outcome of the event was unknown.   Follow-up attempts completed. No further information expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: 20 hours from the injection, I started having chills,; headache; fever. The fever went up to 102.1 and the whole event lasted 12 hours.; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in left arm on 22Feb2021 15:00 (at the age of 54-year-old) (Batch/Lot Number: EL3247) as dose 1, single for covid-19 immunisation. Medical history included covid-19 (Prior to vaccination) and allergies to penicillin. The patient's concomitant medications were not reported. On 23Feb2021 11:00, 20 hours from the injection, the patient started having chills, headache and fever. The fever went up to 102.1 and the whole event lasted 12 hours. The patient received treatment of the events and Tylenol tablets for fever. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine and did not any other medications the patient received within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for covid-19. Outcome of events was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: exhausted; her muscles were sore; This is a spontaneous report from a contactable consumer, the patient via Pfizer-sponsored program. An 89-years-old female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on unknown date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced feeling exhausted for two days and her muscles were sore. Patient received unknown treatment for the events. The outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product leakage
Clinical narrative: Medicine was leaking out around syringe and leaking down patients' arm; Unsure if patient received full dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer or other non hcp reported that a patient unspecified age and gender (No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date 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. The patient's concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration as dose 1, single for COVID-19 immunization. The patient experienced medicine was leaking out around syringe and leaking down patient's arm and Unsure if patient received full dose. Patient was looking for recommendations. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer or other non hcp. A unspecified age of male patient received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain in my hip; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included inflamed swollen hip. The patient's concomitant medications were not reported. On an unspecified date, it was reported that the patient experienced pain in the hip, and it is hurting. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Is really sore/He is experiencing some arthritis pain; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Feb2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included surgery on an unknown date and rheumatoid arthritis. The patient's concomitant medications were not reported. The patient previously took etanercept (ENBREL) for rheumatoid arthritis from unspecified date to 15Feb2021 (also reported as 16Feb2021). The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021 for COVID-19 immunisation. In Feb2021 after the second dose vaccination, the patient reported sore though it was maybe due from arthritis or the vaccine. Patient reported he had difficulty getting out of bed. The patient stated he had surgery on an unspecified date and will see his hand doctor. The patient was not sure if he needs cortisone shot in the fingers and was asking if he can take the steroid shot or other medication for pain such as Advil Motrin or Tylenol. The patient reported that he receives an Enbrel shot once a week for rheumatoid arthritis,  but was told to skip these injections a week before and a week after the doses. He did have an Enbrel shot on 15Feb2021 or 16Feb2021. After the second vaccination, he was experiencing some arthritis pain and wanted to know when he can take another Enbrel shot and wanted to know what other pain relievers he can take right now. Outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache
Clinical narrative: dull, nagging headache that is in the top of her head that is moving down; She does not feel the way she normally feels.; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. Medical history included unspecified surgery on an unknown date in Dec2020. Patient was on low dose aspirin 81mg from a surgery. Concomitant medication included acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication. On an unknown date, patient woke up with a dull, nagging headache that was in the top of her head that was moving down. Patient did not feel the way she normally feels. The clinical outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Joint stiffness
Clinical narrative: This is a spontaneous report from a contactable male consumer via a Pfizer-sponsored program. A male patient, of an unspecified age, received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via unknown route of administration, on Feb 16, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. After the second shot of vaccine, patient was home and his leg below the knee had a little bit of a problem. His ankle had trouble like stiffness. The outcome of the event: unknown (at the time of this report). Information on the lot/batch number requested. Follow-up (May 12, 2021): Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Cystitis, Rash pruritic
Clinical narrative: very itchy rash/ feels itchy/ she had rashes on and off anyway prior to the vaccine/ have gotten worse over period of time; very itchy rash/ feels itchy/ she had rashes on and off anyway prior to the vaccine/ have gotten worse over period of time; bladder infection; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 17Feb2021 (Batch/Lot Number: EL8982) (at the age of 68 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included eczema (she has some skin allergies anyway and she has them worse in the wintertime like eczema stuff), rashes, skin allergy. Concomitant medication included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. Patient previously took Nitrofurantoin Mono MCR and experienced no reactions. The patient experienced very itchy rash/ feels itchy/ she had rashes on and off anyway prior to the vaccine/ have gotten worse over period of time and bladder infection. The events resulted to physician office visit. The course of events was as follows: Patient noticed a very itchy rash that goes from her legs to her stomach and back. She stated she feels itchy all the way to the top of her head. She then said she had rashes on and off anyway prior to the vaccine and her dermatologist gave her a cream to use on the rash. She wants to know could that possibly related the vaccine. She got the vaccine last Wednesday which was 17Feb2021. It has been quite a few days since it started. She sometimes has skin allergies anyway and she has them worse in the winter time like eczema stuff so she didn't think too much about it when it started, she thinks it had started by Friday 19Feb2021 but it could have before then. It seems to have gotten worse over period of time. She had an ointment that the dermatologist had given her for a similar situation, but it doesn't seem to be as effective as it was back then when she first got it. She had also been taking Benadryl. She was having bladder infection symptoms and Friday she went to her primary care and he gave her Nitrofurantoin Mono MCR, 100 mg. She says he gave her the prescription Friday 19Feb2021. She says she believes the rash had begun before starting that and she has taken it before with no reactions. The outcome of events very itchy rash/ feels itchy/ she had rashes on and off anyway prior to the vaccine/ have gotten worse over period of time was not recovered while for other event was unknown. Therapeutic measures were taken as a result of events.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Musculoskeletal stiffness
Clinical narrative: headache, body stiff and tired; headache, body stiff and tired; headache, body stiff and tired; This is a spontaneous report from a contactable pharmacist reported for a patient. A female patient of an unspecified age (patient was not pregnant at the time of vaccination) received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 15Feb2021 (age at vaccination was unknown) as dose number unknown, single for COVID-19 immunization. The patient's medical history was not reported. It was unknown if the patient received any concomitant medications or other medications in two weeks. It was unknown if the patient received any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 16Feb2021, the patient experienced headache, body stiff and tired. No treatment was received for the adverse events. The outcome of the events was unknown.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: little arm pain which she figured was normal side effects; This is a spontaneous report from a contactable consumer or other non-hcp (patient herself). A female patient of an unspecified age received bnt162b2 (BNT162B2, formulation: solution for injection, lot number: unknown, expiration date: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced little arm pain which she figured was normal side effects. Therapeutic measures were not taken as a result of the events. The outcome of the events was unknown.  Information about Lot/Batch has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Fatigue, Headache
Clinical narrative: temperature of 100.6F; Chills; headache; injection site pain; fatigue; This is a spontaneous report from a non-contactable consumer (patient). An adult non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 16Feb2021 as dose 2, single for covid-19 immunization. Medical history included drug hypersensitivity and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 26Jan2021 as dose 1, single for covid-19 immunization. Past drug allergies included penicillin. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 post the vaccination. On 17Feb2021, the patient experienced temperature of 100.6 Fahrenheit, chills, headache, injection site pain and fatigue. The patient underwent lab tests and procedures which included body temperature: 100.6 Fahrenheit on 17Feb2021. The patient did not receive any treatment for the events. Outcome of the event temperature of 100.6 Fahrenheit was recovering and for rest all events outcome was recovered on an unspecified date in 2021.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: temperature of 100.6F; Chills; headache; injection site pain; fatigue; This is a spontaneous report from a non-contactable consumer (patient). An adult non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 16Feb2021 as dose 2, single for covid-19 immunization. Medical history included drug hypersensitivity and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 26Jan2021 as dose 1, single for covid-19 immunization. Past drug allergies included penicillin. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 post the vaccination. On 17Feb2021, the patient experienced temperature of 100.6 Fahrenheit, chills, headache, injection site pain and fatigue. The patient underwent lab tests and procedures which included body temperature: 100.6 Fahrenheit on 17Feb2021. The patient did not receive any treatment for the events. Outcome of the event temperature of 100.6 Fahrenheit was recovering and for rest all events outcome was recovered on an unspecified date in 2021.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program, Corporate (Pfizer) Social Media Platforms. A 67-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EL9269), via an unspecified route of administration, administered in the left arm on 09Feb2021 16:00 (at the age of 67-years-old) as dose 1, single for COVID-19 immunization. Medical history included blood pressure high. Concomitant medications included amlodipine, clonazepam, lamotrigine (LAMICTAL), and hydrochlorothiazide/valsartan (VALSARTAN & HCTZ). The patient previously took codeine and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks of the COVID vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20Feb2021 22:00, the patient experienced itching. The patient has been itching for days. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as result of the event. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Headache, Vaccination site pain, Vision blurred
Clinical narrative: Headache; Injection site pain; haziness; lack of focus; This is a spontaneous report from a contactable consumer (patient). A 23-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN5318) via an unspecified route of administration on 16Feb2021 at 11:15 AM (at the age of 23-year-old) in left arm as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN5318) via an unspecified route of administration on 26Jan2021 at 11:15 AM in left arm as dose 1, single for COVID-19 immunisation and experienced felt very dizzy, severe headache for 2-3 days, lips turned blue but returned to normal color an hour later. No COVID prior vaccination. Not tested for COVID post vaccination. On unspecified date in Feb 2021, the patient experienced haziness, lack of focus, headache and injection site pain. No treatment was received for the events. The events resulted in Doctor or other healthcare professional office/clinic visit. The clinical outcome of the events were recovering.  Follow-up attempts was completed. No further information was expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Vaccination site pain
Clinical narrative: Chills; persistent headache; soreness at injection site; fatigue; This is a spontaneous report from a contactable consumer. A 27-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247) dose 1 via an unspecified route of administration (age at vaccination: 27) in Left arm on 17Feb2021 2:00 PM as dose 1, single (at the age of 27 year) for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included (amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate) ADDERALL, Bupropion SR, (CETIRIZINE HYDROCHLORIDE) ZYRTEC No known allergies. No other vaccine was taken in four weeks. Patient reported that COVID test prior and post vaccination was no. On 18Feb2021 07:00 the patient experienced chills, persistent headache, soreness at injection site, fatigue. Treatment was not received for the events. The clinical outcome of all events was recovered on an unspecified date of 2021.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: mild headache; generalized fatigue; This is a spontaneous report from a contactable consumer (Patient) via Pfizer sales representative. A 39-Years-old female patient received BNT162b2 (COMIRNATY, Formulation: solution for injection, Batch/lot number: not reported, Expiry date: Not reported), via an unspecified route of administration on an unspecified date  as dose 1, single for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. Patient had no known allergies. On an unspecified date, patient had mild headache and generalized fatigue for 48 hours. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm was sore for day and a half; This is a spontaneous report from a contactable consumer (patient). This is the second case out of two cases. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9269, Expiration date: unknown) via an unspecified route of administration on 05Feb2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had shot of the Pfizer vaccine (Clarified as Covid vaccine) on 05Feb2021 and so her arm was sore for day and a half. Outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: mild  left upper arm soreness; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EL3247; Expiration Date: May2021), via an unspecified route of administration, administered in Left arm on an unspecified date as single dose for covid-19 immunisation. Medical history included cardiac valve disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, 9 hours after receiving the vaccine, the patient experienced mild left upper arm soreness. No other symptoms. Event took place after use of product. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dry mouth, Fatigue, Lymphadenopathy
Clinical narrative: Blurry vision; dry mouth; light sensitivity; migraine headache; swollen lymph nodes on right side of collarbone; diarrhea; infrequent chills; injection site pain; injection site muscle pain; tired; This is a spontaneous report from a contactable consumer. This 49-year-old adult non pregnant Caucasian female patient reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, batch/lot number: EN6200) via unknown route of administration in Right arm on 16Feb2021 at 01:45 PM (at the age of 49 years old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included asthma, copd, pre-diabetes and allergic to walnuts, pecans, cottonseed, blue cheese, feta cheese, portabella, mushrooms. The concomitant medications in two weeks included montelukast, budesonide, formoterol fumarate (SYMBICORT), levonorgestrel (MIRENA). The patient was non pregnant. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, batch/lot number: EL9264) via unknown route of administration in Right arm on 26Jan2021 at 01:45 PM as DOSE 1, SINGLE for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. The patient not had COVID prior vaccination. On 16Feb2021 at 03:00 PM, the patient experienced blurry vision periodically, migraine headache, light sensitivity, tired, swollen lymph nodes on right side of collarbone, diarrhea, infrequent chills, injection site pain, injection site muscle pain, dry mouth. No treatment was received. The patient was not tested COVID post vaccination. At the time of this report the outcome of the events were reported as recovering.  Follow-up (27May2021): Follow-up attempts completed. No further information expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Photophobia, Vaccination site pain, Vision blurred
Clinical narrative: Blurry vision; dry mouth; light sensitivity; migraine headache; swollen lymph nodes on right side of collarbone; diarrhea; infrequent chills; injection site pain; injection site muscle pain; tired; This is a spontaneous report from a contactable consumer. This 49-year-old adult non pregnant Caucasian female patient reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, batch/lot number: EN6200) via unknown route of administration in Right arm on 16Feb2021 at 01:45 PM (at the age of 49 years old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included asthma, copd, pre-diabetes and allergic to walnuts, pecans, cottonseed, blue cheese, feta cheese, portabella, mushrooms. The concomitant medications in two weeks included montelukast, budesonide, formoterol fumarate (SYMBICORT), levonorgestrel (MIRENA). The patient was non pregnant. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, batch/lot number: EL9264) via unknown route of administration in Right arm on 26Jan2021 at 01:45 PM as DOSE 1, SINGLE for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. The patient not had COVID prior vaccination. On 16Feb2021 at 03:00 PM, the patient experienced blurry vision periodically, migraine headache, light sensitivity, tired, swollen lymph nodes on right side of collarbone, diarrhea, infrequent chills, injection site pain, injection site muscle pain, dry mouth. No treatment was received. The patient was not tested COVID post vaccination. At the time of this report the outcome of the events were reported as recovering.  Follow-up (27May2021): Follow-up attempts completed. No further information expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site - pain, sore; This is a spontaneous report from a non-contactable consumer or other non-HCP (patient himself). A 40-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration in left arm on 18Feb2021 08:45 (at the age of 40-years-old) as dose 1, single for COVID-19 immunization. Vaccination facility type was reported as Clinic. Patient medical history included peanut allergy. The concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received any other medication within two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. The reported seriousness of the case was non-serious. On 18Feb2021 at 10:00, the patient experienced injection site pain/sore. Therapeutic measures were taken as a result of injection site pain/sore included Tylenol. The outcome of the event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Rash, SARS-CoV-2 test, Scar
Clinical narrative: very red scar; strange rashes; rash on her neck that was so painful; This is a spontaneous report from a contactable healthcare professional (patient). A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 13Jan2021 (Batch/Lot number was not reported), at the age of 34 years old, as dose 2, single for covid-19 immunisation The patient was not pregnant at the time of vaccination. There were no relevant medical history and concomitant medications. The patient previously received dose 1 of BNT162B2 intramuscular in left arm on 25Dec2020 15:00, at the age of 34 years old, for COVID-19 immunization. No COVID prior to vaccination, underwent COVID test (nasal swab) on 16Jan2021 with negative result. On 27Jan2021, about 2-3 weeks after her 2nd vaccine, she became covered in strange rashes. She had a rash on her neck that was so painful and unidentifiable that it had to be biopsied. She was having another strange unidentifiable rash in her groin area, which also had to be biopsied. She had a rash between her eyes as well that has heal but was so deep that it left a very red scar. The event rash resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment unknown. The patient was recovering from rash, while unknown for scar.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia
Clinical narrative: Muscle aches; malaise beginning approximately 24 hrs after the 2nd dose; This is a spontaneous report from contactable consumer or other non-HCP via Pfizer Colleague. A 42-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- EM9809) via an unspecified route of administration on 17Feb2021 as dose 2, single (at the age of 42-years-old) 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- EL9263) via an unspecified route of administration on 27Jan2021 as dose 1, single for COVID-19 immunization. Event took place after use of product. The patient experienced muscle aches, malaise beginning approximately 24 hours after the second dose of the COVID-19 vaccine on an unspecified date in Feb2021. The outcome of the event was unknown.     Follow-up attempts are completed. No further information is expected.