chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphocyte count, Lymphocyte count decreased, Neutrophil count, Neutrophil count increased, Procalcitonin
Clinical narrative: elevated white blood cell count; elevated neutros PCT/elevated Neutros ABS; lymph % low; This is a spontaneous report from a contactable consumer(patient).A 76-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection), (Batch/Lot Number: EL9269) via an unspecified route of administration, administered in Arm Left on 04Feb2021 at 13:00 (age at vaccination 76-years-old) as dose 2, single for covid-19 immunization. Medical history included diabetes mellitus and hypersensitivity. There were unspecified concomitant medications that patient received within 2 weeks of vaccination. The other vaccines administered within 4 weeks was first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 14Jan2021 (Batch/Lot Number: EL3249) as dose 1, single for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID. In Feb2021, the patient experienced elevated white blood cell count, Neutrophils increased and Lymphocyte count low. The patient underwent lab tests in Feb2021which included elevated White Blood Cell count, elevated neutros PCT, elevated Neutros ABS, lymph % was low and on 08Feb2021 sars-cov-2 test result: negative. Therapeutic measures were taken as a result of events included antibiotic. Outcome of the events was unknown.  Follow-up attempts completed. No further information expected
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, White blood cell count, White blood cell count increased
Clinical narrative: elevated white blood cell count; elevated neutros PCT/elevated Neutros ABS; lymph % low; This is a spontaneous report from a contactable consumer(patient).A 76-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection), (Batch/Lot Number: EL9269) via an unspecified route of administration, administered in Arm Left on 04Feb2021 at 13:00 (age at vaccination 76-years-old) as dose 2, single for covid-19 immunization. Medical history included diabetes mellitus and hypersensitivity. There were unspecified concomitant medications that patient received within 2 weeks of vaccination. The other vaccines administered within 4 weeks was first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 14Jan2021 (Batch/Lot Number: EL3249) as dose 1, single for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID. In Feb2021, the patient experienced elevated white blood cell count, Neutrophils increased and Lymphocyte count low. The patient underwent lab tests in Feb2021which included elevated White Blood Cell count, elevated neutros PCT, elevated Neutros ABS, lymph % was low and on 08Feb2021 sars-cov-2 test result: negative. Therapeutic measures were taken as a result of events included antibiotic. Outcome of the events was unknown.  Follow-up attempts completed. No further information expected
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Pain
Clinical narrative: Achy; Difficulty walking; This is a spontaneous report from a contactable consumer (reported for her husband). A 89-years-old male patient received bnt162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 09Feb2021 as dose 2, single for covid-19 immunisation. Medical history included Immunoglobulins from 01Feb2021 to 01Feb2021 and chronic inflammatory demyelinating polyradiculoneuropathy from Dec2020 to an unknown date (Diagnosed with CIDP (Chronic Inflammatory Demyelinating Polyneuropathy), Diagnosed in Dec2020). The patient's concomitant medications were not reported. The patient previously received first dose bnt162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 19Jan2021as dose 1, single for covid-19 immunisation and experienced no adverse events. On an unspecified date, the consumer reported that the patient was achy and had sharp pain on his left surgical leg 6 inches above the knee to the top of his groin, he had increased pain with walking causing him to have difficulty walking. Reporter asks if there is any information on timing of the Covid vaccine and receiving IVIG treatments or with people who have CIDP, Reporter reports that she already spoke with her husband's Neurologist and the Nurse who instructed her to call Pfizer.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Condition aggravated, Gastrointestinal disorder
Clinical narrative: Abdominal pain; She mentioned that the person had a history of abdominal problems and it may have been exacerbated by the vaccine.; She mentioned that the person had a history of abdominal problems and it may have been exacerbated by the vaccine; This is a spontaneous report from a contactable consumer (friend). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included history of abdominal problems. Patient's concomitant medications were not reported. On an unspecified date, the patient experienced abdominal pain and was wondering if that was related to the vaccine. The consumer mentioned that the patient had a history of abdominal problems and it may have been exacerbated by the vaccine. Caller was looking for percentages of certain side effects (fever, headache, muscle pain). Caller (stated that she used to do medical writing) mentioned an article from the magazine saying that getting the second dose on the same arm where you received the first dose would lead to worse side effects. She is wondering if this is true or if there are any recommendations regarding the site of injection, and if the side effects would be local or systemic in that case. The patient had concern about the duration of side effects, someone mentioned to her 3 days and she wanted to know whether that means 3 days after a dose of the vaccine or on the onset of the side effect. She enquired if there are any updates on the effectiveness of the Pfizer covid vaccine on the variants in other countries. She also wanted to know regarding the 95% efficacy of the covid vaccine, when does that start and any information on using Tylenol after getting the vaccine. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Hyperhidrosis, Tremor
Clinical narrative: Really bad headache (described that it was so bad that for 3 days she can barely lift her head); Sweating; Shaking; Difficulty in getting up and walking; This is a spontaneous report from a contactable consumer (Patient). A 63-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient really bad headache (described that it was so bad that for 3 days she can barely lift her head), sweating, shaking, and difficulty in getting up and walking (she described that she had to be very careful when walking because she feels like falling). The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Face oedema, Fluid retention, Periorbital swelling, Peripheral swelling
Clinical narrative: swelling larger an egg under armpit; fluid retention at his chest and back for 2 days; face swelled up and got red; face swelled up and got red; around his eyes it's still swollen and flushed red; This is a spontaneous report from a contactable consumer (patient's wife) via medical information team. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. Enquired that, the caller was called on behalf of her husband, (name withheld). Stated that, her husband had his second covid vaccine shot and had a strange reaction. Stated that, the patient had swelling larger an egg under armpit, fluid retention at his chest and back for 2 days and the following day face swelled up and got red. Today it has subsided but all around his eyes it's still swollen and flushed red. Asked whether this was normal for people to get after getting the covid vaccine. The caller was asking whether there would be issues if ever her daughter will be pregnant. Stated that, the caller's daughter has not yet gotten her first covid vaccine shot. The outcome of the events for swelling larger an egg under armpit and fluid retention at his chest and back for 2 days was recovering while for the other events was not recovered.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Feeling hot, Pain in extremity, Tenderness, Toothache
Clinical narrative: Prophylactic antibiotic therapy of clindamycin 1 hour prior to procedure; Arm ached; Injection site area was tender to the touch.; Toothache really bad; Stated that her arm is kind of warm Is her left arm; This is a spontaneous report from a contactable other health care professional (patient). A 65-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 10Feb2021 (at the age of 65-years-old) as dose 1, single for COVID-19 immunisation. Medical history included bilateral knee replacement (stated that she had bilateral knee replacement previously and always has to take an antibiotic in order to do any pre-procedures), breast cancer female from 1999 to an unknown date (stated that she cannot have the vaccine in her right because she had breast cancer), lumpectomy, radiotherapy (had lumpectomy and radiation therapy prior to the vaccine) from an unknown date and unknown if ongoing. The patient previously took clindamycin for prophylactic antibiotic therapy. Concomitant medication were not reported. Caller got the first Pfizer Covid vaccine yesterday. She is scheduled to see the dentist tomorrow and wanting to know if it would be okay to take her usual course of antibiotics for this dental procedure. On 10Feb2021 she stated that she reported that her arm ached after receiving the vaccine yesterday and the injection site area was tender to the touch. Caller stated that she has an achy sore arm. Stated that she had bilateral knee replacement previously and always has to take an antibiotic in order to do any pre-procedures. Wanted to know if it taking an antibiotic would have anything to do with the Covid vaccine. Stated that she could not find anything in the literature. On Feb2021 stated that she has a toothache really bad and she has to be seen. Stated that her arm is kind of warm Is her left arm. The outcome of the events was reported as unknown.   Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Rash, Rash erythematous
Clinical narrative: Fever; Chills; Aches; Red patches on her back, like a rash; Red patches on her back, like a rash; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown) via an unspecified route of administration on 10Feb2021 at 10:30 AM as dose 1, single for COVID-19 immunisation. The patient states she received the first dose of the Pfizer COVID vaccine yesterday morning at 10:30 am and on an unspecified date in 2021, woke up in the middle of the night with fever, chills, and aches. The patient stated that after receiving the Covid 19 vaccine on an unspecified date in 2021, she noticed red patches on her back, like a rash. The report was non serious. Outcome of the events was unknown.  Information on the batch/lot number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rhinorrhoea
Clinical narrative: sniffles; sore arm; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A female patient (Age: 73; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EL9265) via an unspecified route of administration on 10Feb2021 as dose 1, single for COVID-19 immunization. Medical history included sinus and cold, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in Feb2021 the patient experienced sniffles, and sore arm. It was reported that "Caller stated that she had her number one shot yesterday. Stated that she woke up Tuesday before having the shot with a cold. Caller says she had a sinus or cold Tuesday morning, no fever, took 2 generic Advil. Caller contacted immunization location to ask if she was able to get 1st dose with symptoms. Stated that she was told that she should take Tylenol. Caller did not take Tylenol before vaccine. Stated that she read online that one is not supposed to have the shot if one has a cold or sinus. Stated that she does not know if it will affect her shot or not. Caller says on day of vaccine (yesterday), she felt fine and got her dose. Caller says after dose, she had the sniffles, a sore arm and just want to stay cozy and warm and just want to go to sleep. She said she was feeling better than she did yesterday afternoon too. Stated that she is supposed to have the second one on 03Mar2021, clarified that it's for the Pfizer Corona shot." The clinical outcome of the events was recovering.  Description of complaint: Pfizer Corona shot: Questions if her having a cold or sinus when she got the shot affected it.  Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Loss of hair; This is a spontaneous report from a contactable 51-year-old male patient reported for himself that:  A 51-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EK4176) via an unspecified route of administration, administered in Arm Right on 07Jan2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included alopecia, known allergies: pollen. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EH9899) via an unspecified route of administration, administered in Arm Left on 17Dec2021 02:00 as DOSE 1, SINGLE for covid-19 immunisation. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not received any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On, 11an2021, the patient experienced loss of hair. The clinical outcome of event was recovering.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: s
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Fatigue
Clinical narrative: diarrhea; abdominal pain; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date were not reported), via an unspecified route of administration on 26Jan2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced diarrhea, abdominal pain, and fatigue on an unspecified date in 2021 and was reported to be ongoing. Patient asked what is the efficacy of the vaccine after just one dose and if she can get the second vaccine. She also reported that her doctor did not know how to advise her. The outcome of events was not recovered.  No follow-up attempts are possible; information on the lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Balance disorder, Blood pressure measurement, Body temperature, Chills
Clinical narrative: chills; fell; headache; his was balance off; throat hurt; sinuses were running; lightheaded/dizziness; loss of taste; cough; This is a spontaneous report from a contactable consumer (Consumer himself). A 64-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unknown route injected in the left arm on 04Feb2021 (Batch/Lot Number: EL3249) (age at vaccination 64-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history included diabetes and blood pressure high since years ago. The patient concomitant medications were not reported. The patient experienced cough on 04Feb2021, loss of taste, lightheaded/dizziness, throat hurt, sinuses were running on 05Feb2021, chills, headache, balance was off, coughed so hard he blacked out and fell down. The laboratory investigation which included temperature was low grade, 96.6 degrees Fahrenheit on 04Feb2021. The patient stated he got the first dose of the Pfizer COVID-19 vaccine last Thursday. He says when he got home afterwards he started coughing, and the next morning when he woke up he couldn't taste anything and was lightheaded. He says his throat hurt and his sinuses were running, and he was coughing up phlegm. He says his balance was off, and a couple times he coughed so hard that he blacked out and fell down. He says he thinks maybe he had the virus before he got the shot. He says he doesn't know, he is supposed to get bloodwork soon and maybe he shouldn't be around those people if he has COVID. He says he asked his doctor, who told him to call Pfizer. AE Treatment was he has been taking something like the Vicks things you put up in your nose, called Benzedrex. He says that the LOT for this product looks like 835 with a weird c with something else in it, EXP Aug2022. He says he sticks it up his nose and breathes, it is mentholated. He says he has also been gargling salt water and putting saline in his nostrils, and using an oral rinse that his doctor gave him when he had a tooth pulled 6 months ago called Peridex chlorhexidine, he thinks that is the name brand. LOT 473XTTRI, he says that there is no EXP on there, it says 0.12% clarified to 1.2% rinse. He says he doesn't see a NDC, he does see a UPC that starts with a small 3, then is 011620016, then has a small 5 past it. He says that the rinse is probably bad, but it helped. He says he had no injuries after he blacked out and fell. The patient received treatment for cough, throat hurt and did not received treatment to other events. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness, Fall, Headache, Oropharyngeal pain
Clinical narrative: chills; fell; headache; his was balance off; throat hurt; sinuses were running; lightheaded/dizziness; loss of taste; cough; This is a spontaneous report from a contactable consumer (Consumer himself). A 64-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unknown route injected in the left arm on 04Feb2021 (Batch/Lot Number: EL3249) (age at vaccination 64-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history included diabetes and blood pressure high since years ago. The patient concomitant medications were not reported. The patient experienced cough on 04Feb2021, loss of taste, lightheaded/dizziness, throat hurt, sinuses were running on 05Feb2021, chills, headache, balance was off, coughed so hard he blacked out and fell down. The laboratory investigation which included temperature was low grade, 96.6 degrees Fahrenheit on 04Feb2021. The patient stated he got the first dose of the Pfizer COVID-19 vaccine last Thursday. He says when he got home afterwards he started coughing, and the next morning when he woke up he couldn't taste anything and was lightheaded. He says his throat hurt and his sinuses were running, and he was coughing up phlegm. He says his balance was off, and a couple times he coughed so hard that he blacked out and fell down. He says he thinks maybe he had the virus before he got the shot. He says he doesn't know, he is supposed to get bloodwork soon and maybe he shouldn't be around those people if he has COVID. He says he asked his doctor, who told him to call Pfizer. AE Treatment was he has been taking something like the Vicks things you put up in your nose, called Benzedrex. He says that the LOT for this product looks like 835 with a weird c with something else in it, EXP Aug2022. He says he sticks it up his nose and breathes, it is mentholated. He says he has also been gargling salt water and putting saline in his nostrils, and using an oral rinse that his doctor gave him when he had a tooth pulled 6 months ago called Peridex chlorhexidine, he thinks that is the name brand. LOT 473XTTRI, he says that there is no EXP on there, it says 0.12% clarified to 1.2% rinse. He says he doesn't see a NDC, he does see a UPC that starts with a small 3, then is 011620016, then has a small 5 past it. He says that the rinse is probably bad, but it helped. He says he had no injuries after he blacked out and fell. The patient received treatment for cough, throat hurt and did not received treatment to other events. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus congestion
Clinical narrative: chills; fell; headache; his was balance off; throat hurt; sinuses were running; lightheaded/dizziness; loss of taste; cough; This is a spontaneous report from a contactable consumer (Consumer himself). A 64-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unknown route injected in the left arm on 04Feb2021 (Batch/Lot Number: EL3249) (age at vaccination 64-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history included diabetes and blood pressure high since years ago. The patient concomitant medications were not reported. The patient experienced cough on 04Feb2021, loss of taste, lightheaded/dizziness, throat hurt, sinuses were running on 05Feb2021, chills, headache, balance was off, coughed so hard he blacked out and fell down. The laboratory investigation which included temperature was low grade, 96.6 degrees Fahrenheit on 04Feb2021. The patient stated he got the first dose of the Pfizer COVID-19 vaccine last Thursday. He says when he got home afterwards he started coughing, and the next morning when he woke up he couldn't taste anything and was lightheaded. He says his throat hurt and his sinuses were running, and he was coughing up phlegm. He says his balance was off, and a couple times he coughed so hard that he blacked out and fell down. He says he thinks maybe he had the virus before he got the shot. He says he doesn't know, he is supposed to get bloodwork soon and maybe he shouldn't be around those people if he has COVID. He says he asked his doctor, who told him to call Pfizer. AE Treatment was he has been taking something like the Vicks things you put up in your nose, called Benzedrex. He says that the LOT for this product looks like 835 with a weird c with something else in it, EXP Aug2022. He says he sticks it up his nose and breathes, it is mentholated. He says he has also been gargling salt water and putting saline in his nostrils, and using an oral rinse that his doctor gave him when he had a tooth pulled 6 months ago called Peridex chlorhexidine, he thinks that is the name brand. LOT 473XTTRI, he says that there is no EXP on there, it says 0.12% clarified to 1.2% rinse. He says he doesn't see a NDC, he does see a UPC that starts with a small 3, then is 011620016, then has a small 5 past it. He says that the rinse is probably bad, but it helped. He says he had no injuries after he blacked out and fell. The patient received treatment for cough, throat hurt and did not received treatment to other events. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: Soreness at injection site; stiffness/ache in shoulderblade; stiffness/ache in shoulderblade; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EL 3247) via an unspecified route of administration (age at vaccination 53-year) in Right Arm on 10Feb2021 at 09:00 AM as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]); amlodipine besilate (NORVASC); hydrochlorothiazide; lisinopril; all taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes first dose of BNT162B2 (lot number: EL3247) administered in left arm on 21Jan2021 for COVID-19 immunization. No COVID prior vaccination was reported. The patient not tested COVID post vaccination. The patient received no other vaccine in four weeks. On 10Feb2021 at 02:00 PM the patient experienced soreness at injection site, stiffness/ache in shoulderblade. No treatment was received by the patient for the adverse events. It was reported that "the report submitted was for herself. she received the vaccination on 10Feb, developed symptoms late that day and reported on 11Feb within 24 hrs of symptoms first developing". The clinical outcome of the events was recovered on an unspecified date in Feb2021.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Severe cough and cold after the first dose; Severe cough and cold after the first dose; This is a spontaneous report from a contactable Consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated she received the first dose of the vaccine 3 weeks ago and is due for her second dose tomorrow morning. Patient stated in the past week ended up getting sick. The patient experienced a severe cough and cold after the first dose on an Unspecified date Jan2021. The patient tested negative for Covid on 10Feb2021. Patient stated she is getting conflicting information about whether she should receive the vaccine tomorrow. She just wants to know if she will take the second shot. The event outcome was Unknown.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Myalgia, Vaccination site pruritus
Clinical narrative: Itchiness at the injections site; sore muscles; headache; diarrhea; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 42-year) in Left Arm on 10Feb2021 at 10:30 AM as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications. Historical vaccine includes first dose of BNT162B2 administered in left arm on 22Jan2021 at 11:00 AM for COVID-19 immunization. As reported Facility type vaccine was Hospital. No known allergies were reported. No COVID prior vaccination was reported. The patient was not tested COVID post vaccination. The patient received no other vaccine in four weeks; and no other medications in two weeks. On 10Feb2021 at 07:00 PM the patient experienced itchiness at the injections site, sore muscles, headache, diarrhea. No treatment was received by the patient for the adverse events. The clinical outcome of the events was recovering.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Body aches; fatigue; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL3247, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 10Feb2021 at 14:30 (at the age of 45-years-old) as dose 2, single for COVID-19 immunisation. Medical history included known allergies to ketamine. The patient has no other concomitant medications in two weeks. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient was previously vaccinated with the first dose of BNT162B2 (COMIRNATY, Solution for injection; Lot number: EL3247, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 20Jan2021 at 13:00 (at the age of 45-years-old) for COVID-19 immunisation. On 11Feb2021 at 02:30, the patient experienced body aches and fatigue. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Oropharyngeal pain, Pain
Clinical narrative: sore throat; headache; 101.5 fever; chills; whole body hurts; short of breath; This is a spontaneous report from a contactable consumer or other HCP. A 41-year-old non-pregnant female patient received bnt162b2 (Pfizer BioN Tech Covid-19 MRNA vaccine, Formulation: Solution for injection, Batch/Lot number: Unknown ) via unspecified route of administration on anatomical location left arm on 09Feb2021 (age at the time of vaccination was 41-year-old)  (at 03:30) Dose number Unknown Single for covid-19 immunization. Medical history included lupus and epilepsy. The patient had no known allergies. The patient received other medication Gabapentin in two weeks. The patient did not receive other vaccine four weeks. The patient had no covid prior vaccination and did not tested for covid post vaccination. On 10Feb2021 (at 15:00), the patient experienced 101.5 fever, chills, whole body hurts, short of breath, sore throat and headache. The patient did not receive any treatment for the events. The outcome of the events was recovering.    Information on the lot/batch number has been requested  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: sore throat; headache; 101.5 fever; chills; whole body hurts; short of breath; This is a spontaneous report from a contactable consumer or other HCP. A 41-year-old non-pregnant female patient received bnt162b2 (Pfizer BioN Tech Covid-19 MRNA vaccine, Formulation: Solution for injection, Batch/Lot number: Unknown ) via unspecified route of administration on anatomical location left arm on 09Feb2021 (age at the time of vaccination was 41-year-old)  (at 03:30) Dose number Unknown Single for covid-19 immunization. Medical history included lupus and epilepsy. The patient had no known allergies. The patient received other medication Gabapentin in two weeks. The patient did not receive other vaccine four weeks. The patient had no covid prior vaccination and did not tested for covid post vaccination. On 10Feb2021 (at 15:00), the patient experienced 101.5 fever, chills, whole body hurts, short of breath, sore throat and headache. The patient did not receive any treatment for the events. The outcome of the events was recovering.    Information on the lot/batch number has been requested  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Pain in extremity
Clinical narrative: very bad arm pain in the middle of the night; gets very tired; feeling very dizzy; weak; This is a spontaneous report from a contactable consumer or other non hcp via medical information team. A 96-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 06Feb2021 (at the age of 96-years-old) as single dose for covid-19 immunisation. The patient's medical history included covid-19 from 08Jan2021 to an unknown date and experienced a bad sore throat as a first symptom and felt very weak and tired. They called the department of health and they said to wait for 10 days before she can be cleared from quarantine, and they consulted with her primary care physician and pulmonologist since she has a history of COPD among other conditions) and they all said that she should go ahead and take the vaccine. The patient's concomitant medications were not reported. On 07Feb2021 Sunday at around 12:30, patient experienced feeling very dizzy and weak (lasted for about an hour) and weak (lasted until evening time that day, has subsequently passed but a bit of weakness is still notable), and in the middle of the night, the patient experienced very bad arm pain on an unspecified date. On Monday, most of the symptoms have disappeared but she still gets very tired on an unspecified date. Reporter concerned since she feels that these side effects are too much at this point, considering the patient's age. She stated that it was listed on the fact sheet that dizziness and weakness is a symptom of a potential severe allergic reaction, and she is not sure whether her mom should get the second dose of the vaccine with this in mind. The outcome of the event feeling very dizzy was recovered on 07Feb2021, event weak and very bad arm pain in the middle of the night was recovered on an unknown date while, the outcome of the event gets very tired was unknown.  Information on Lot /Batch Number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Product administered at inappropriate site, Vaccination site pain
Clinical narrative: experienced: "the very moment the needle was into my arm, when she begin to put it into... she either put it into a muscle or a nerve because it hurt, I had pain very hard to cope with; experienced: "the very moment the needle was into my arm, when she begin to put it into... she either put it into a muscle or a nerve because it hurt, I had pain very hard to cope with; pain moved down to my elbow; This is a spontaneous report from a contactable consumer. This female consumer reported that:  A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 07Feb2021 14:10 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  The patients medical history included brain operation and ongoing limb deformity have not control on the arm, Right arm and it's considered a disability, that's why the patient took the vaccine on the left arm. Patient concomitant medication includes allergy shot. The patient reported that she gave herself allergy shots since the 80's I know how this should feel but this didn't feel like that, felt like they took their fist and hit her. Previously patient received first dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration, administered on 17Jan2021 14:30 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation and experienced sore arm 4-5 hours. On 07Feb2021, at 2:10, the patient stated that, the very moment the needle was into the arm, when she begin to put it into she either put it into a muscle or a nerve because it hurt, i had pain very hard to cope with (product administered at inappropriate site), pain moved down to my elbow. The outcome of the events was unknown.  Information on Lot /Batch Number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Lip pruritus, Tongue pruritus
Clinical narrative: This is a spontaneous report from a contactable Nurse. A 39-year-old female (non-pregnant) patient received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number: EL9269, Expiration date: Not reported), via an unspecified route of administration, administered in Arm Left on 10Feb2021 09:15 as DOSE 1 SINGLE for covid-19 immunisation. The patient medical history included ibs-c, allergies: Shellfish. The patient's concomitant medications included diphenhydramine hydrochloride (BENADRYL), ranitidine hydrochloride (ZANTAC) reported. No other vaccine was received in four weeks. Covid prior vaccination was No and Covid tested post vaccination: No. It was reported that about 50 minutes after the vaccine. I developed severe itching of the lips and tongue as well as dizziness all. It lasted approximately one hour all on 10Feb2021 at 10.15. No Treatment was received for the events. The outcome of the events were recovered on an unspecified date.  No Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: jaw tenderness; This is a spontaneous report from a non-contactable consumer (patient) via the Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced jaw tenderness on an unspecified date. The patient wanted to know if this was normal for her to experience after getting the covid vaccine. The 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: Flushing, Headache, Rash
Clinical narrative: flush all over with a fine rash in it; flush all over with a fine rash in it; headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (age: 70; unit: unknown, as reported) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection, lot number was not reported, expiration date 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 and concomitant medications were not reported. The patient previously took morphine [morphine sulfate] and experienced same flushing/rash, took histamine and experienced flushing. It was reported that, patient received 1st dose on friday, approximately one hour after injection- body became flush all over with a fine rash in it. Patient says it took 4 hrs for the flushing to go away, and the rash went away by Saturday. Patient also experienced, headache. Patient says IV morphine causes: same flushing/rash (40 years ago). With histamine injections, had flushing. Patient asks, can the same thing happen with the 2nd dose or could it be worse, should she get the 2nd dose. Patient asks there wasn't an expiration date on my card, should she ask them for an expiration date after her 2nd dose. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Loss of personal independence in daily activities, Motion sickness, Neurological symptom
Clinical narrative: neurological symptoms; difficult to drive and manage work/life; motion sickness; dizziness; headaches; This is a spontaneous report from a contactable nurse (patient). A 61-year-old non pregnant female 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 12Jan2021 (at the age of 61 years old) as dose 2, single for COVID-19 immunisation. Medical history included rheumatoid arthritis, allergies to penicillin, autoimmune disorder (have existing auto immune condition), shingles (has shingles 18 months ago which affected the vestibular and ocular nerves). Concomitant medication(s) included losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 23Dec2020 (at the age of 61 years old) as single for COVID-19 immunisation. Patient did not received other vaccine in four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient experienced neurological symptoms, difficult to drive and manage work/life, motion sickness, dizziness, headaches on 2021. Reported as, after the second dose patient experienced neurological symptoms. It was very difficult to drive and manage work/life. With motion patient have feeling of motion sickness, dizziness, headaches. Patient did not tested for COVID post vaccination. Outcome of all the events were unknown.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Extremely itchy red rash that covered entire upper torso and head; left arm at injection sight was itchy and sore; left arm at injection sight was itchy and sore; This is a spontaneous report from a contactable other hcp (patient). A 51-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: El9261) via intramuscular route of administration, administered in arm left on an unspecified date at dose 2, single for covid-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. Patient had no Known allergies. Patient did not have Covid prior vaccination. Patient has not tested covid post vaccination. Patient did not have other vaccine in four weeks, other medications in two weeks. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported) via intramuscular route of administration, administered in arm left on 02Feb2021 07:15 at dose 1, single for covid-19 immunisation and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: El1284) via unspecified route of administration, administered in arm left on 12Jan2021 at dose 1, single for covid-19 immunisation. On 05Feb2021 the patient experienced extremely itchy red rash that covered entire upper torso and head, left arm at injection site was itchy and sore. Adverse event: Extremely itchy red rash that covered entire upper torso and head. Started on third day after 2nd dose, my left arm at injection site was itchy and sore and after i scratched it the rash quickly covered my upper torso within an hour. I have been to the Emergency room twice and am on steroids for this now, but the rash does not seem to be getting any better. Adverse events resulted in Emergency room/department or urgent care. Patient received treatment with Antihistamines and steroids for the adverse events. Outcome of the events was not resolved.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: Blood Sugar spike; This is a spontaneous report from a non-contactable consumer. A non-pregnant female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 11Feb2021 (Batch/Lot number were not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On 11Feb2021, the patient experienced blood sugar spike. The patient underwent lab tests and procedures which included blood sugar with a result of "spike" on 11Feb2021. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Rash pruritic, Urticaria
Clinical narrative: allergic reaction; hives; itchy rash; rash in the lower back that spread to the body over the course of 3 days.; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for an COVID-19 immunization. The patient medical history and concomitant medications were not reported. A Physician called for information about if a patient that developed an allergic reaction to the first dose of the Pfizer's COVID-19 vaccine. The Physician reports that there was a patient that developed hives and an itchy rash in the lower back that spread to the body over the course of 3 days. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.