chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling hot, Heart rate, Heart rate increased, Palpitations
Clinical narrative: chest pain; panic attack; heart palpitation; fast heartbeat; hot sensation; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support via contactable consumer (patient).   A 58-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201), via an unspecified route of administration in arm right on 05Mar2021 at 08:30 (at the age of 58-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included hypertension and obesity from an unknown date and unknown if ongoing. The patient previously took amoxicillin and experienced drug hypersensitivity. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient had no other vaccine in four weeks and no other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID-19. On an unspecified date, the patient experienced chest pain, panic attack and heart palpitation. The patient was asking if it was normal side effect. The patient wanted to know if it was possible to happen on her 2nd dose. On 05Mar2021 08:45 (less than 10 minutes after the injection), the patient felt a hot sensation in my chest and fast heartbeat. On 05Mar2021, the patient underwent lab tests and procedures which included heart rate: fast. On an unspecified date in 2021 (it only lasted a minute or two), the patient had recovered from hot sensation and fast heartbeat and did not happen again. Outcome for all the other events was unknown.   No follow up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack
Clinical narrative: chest pain; panic attack; heart palpitation; fast heartbeat; hot sensation; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support via contactable consumer (patient).   A 58-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201), via an unspecified route of administration in arm right on 05Mar2021 at 08:30 (at the age of 58-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included hypertension and obesity from an unknown date and unknown if ongoing. The patient previously took amoxicillin and experienced drug hypersensitivity. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient had no other vaccine in four weeks and no other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID-19. On an unspecified date, the patient experienced chest pain, panic attack and heart palpitation. The patient was asking if it was normal side effect. The patient wanted to know if it was possible to happen on her 2nd dose. On 05Mar2021 08:45 (less than 10 minutes after the injection), the patient felt a hot sensation in my chest and fast heartbeat. On 05Mar2021, the patient underwent lab tests and procedures which included heart rate: fast. On an unspecified date in 2021 (it only lasted a minute or two), the patient had recovered from hot sensation and fast heartbeat and did not happen again. Outcome for all the other events was unknown.   No follow up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Low-grade fever (100.2); This is a spontaneous report from a contactable consumer or other non hcp. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot Number: EN6206)), dose 2 via an unspecified route of administration, administered in the left arm on 12Mar2021 17:00 as 2nd dose, single for COVID-19 immunisation. The patient's medical history included asthma from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing the "cillins," like penicillin. Concomitant medication included probiotics taken for an unspecified indication, start and stop date were not reported. The patient experienced sore arm and low-grade fever (100.2) on 12Mar2021 20:00. Therapeutic measures were taken as a result of sore arm (pain in extremity), low-grade fever (100.2) (pyrexia). The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature abnormal, Myalgia
Clinical narrative: pain in my left shoulder and I notice that about 3 days after I had my vaccination and the shoulder pain has gotten worsen ever; General muscle pain; My temperature is 95.8 Degrees Fahrenheit; pain in my shoulder has progressively got worse over the last week; This is a spontaneous report from a contactable consumer(patient) or other non hcp. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3249; Expiration Date: 31May2021) via an unspecified route of administration on 01Mar2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication(s) included vitamin b12 injections and blood thinners. The historical vaccine includes BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date, the patient experienced a pain in my left shoulder and I notice that about 3 days after I had my vaccination and the shoulder pain has gotten worsen ever, general muscle pain, my temperature is 95.8 Degrees Fahrenheit, pain in my shoulder has progressively got worse over the last week. The patient further stated that on 01Mar2021 about 3-4 days of second vaccination, patient developed pain in his left shoulder, and it has got progressively worst. The patient also felt like he got some other muscle pain and was just wondering if this was a reaction that he was having. The patient questioned whether it was common, or not a reaction. The patient questioned whether he must call Emergency room. The body temperature was 95.8 Fahrenheit. The events were assessed as non serious. The outcome of all events were reported as unknown.  No follow-up attempts are possible. No further information is expected
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Fever; chills; headache; sore arm at injection site; dizziness; This is a spontaneous report from a Non-contactable consumer (patient). A 57-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3248), via an unspecified route of administration, administered in arm left on 10Mar2021 at 11.15 (at the age of 57-years-old), as dose 2, single for covid-19 immunization. Patient had no known allergies and no relevant medical history. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number-EL3247) via an unspecified route of administration, administered in left arm, on 17Feb2021 at 14:00 PM as a dose 1, single for covid-19 immunization at Workplace clinic. The patient concomitant medications include Rosuvastatin (20 mg 1 multiple/Day), Istalol (ophthalmic solution) in two weeks. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test for covid prior to vaccination. The patient did not receive any vaccination prior to BNT162B2. On 10Mar2021 at 9.00 PM (same day of vaccination), the patient experience fever, chills, headache, sore arm at injection site and dizziness. The patient did not receive any treatment for adverse event. The outcome of the events was recovered on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Pain, Pain in extremity
Clinical narrative: Left arm, shoulder, back soreness; Left arm, shoulder, back soreness; Left arm, shoulder, back soreness; generalized aches; chills; This is a spontaneous report from a contactable consumer (patient).  A 44-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 15Mar2021 13:00 (at the age of 44-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Patient had no known allergies. The patient's concomitant medications were not reported. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 22Feb2021 as dose 1, single for covid-19 immunisation. On 15Mar2021, the patient experienced left arm, shoulder, back soreness, left arm, shoulder, back soreness, left arm, shoulder, back soreness, generalized aches, chills. Therapeutic measures were taken as a result of left arm, shoulder, back soreness, left arm, shoulder, back soreness, left arm, shoulder, back soreness, generalized aches, chills. Patient received treatment with Ibuprofen. The clinical outcome of events were recovering.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Body height, Condition aggravated, Erythema, Laboratory test
Clinical narrative: it was oozing out like some white moisture or something; Sore arm; Another spot on my back about a inch lower than the one that was before and it is red again, looks like a blister under my skin; A blister come up under my skin; It was red and it was itchy; It was red and it was itchy; This is a spontaneous report from a contactable consumer (patient).  A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6207; Expiration Date: Jul2021), via an unspecified route of administration, administered in Arm on an unspecified date as dose number unknown, single for covid-19 immunisation. Medical history included diabetes mellitus, hypertension. Patient reported that got the Pfizer shot at 11:50 on Friday and yesterday down towards shoulder got like a blister come up under skin, it looked like a blister and then patient rubbed it, it burned real bad and then patient put some alcohol on it and it went away, it was red and it was itchy and it was oozing out like some white moisture or something which patient don't know, it look like what comes out of a blister. Patient went to sleep last night, there was no shortness of breath, patient got sore arm like they said and then it is gone away and no other reaction. But again today, patient got another spot on back about a inch lower than the one that was before and it is red again, looks like a blister under patient skin and it is red. The patient underwent unknown laboratory tes.t with unknown result. The outcome of the event was Not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Secretion discharge
Clinical narrative: it was oozing out like some white moisture or something; Sore arm; Another spot on my back about a inch lower than the one that was before and it is red again, looks like a blister under my skin; A blister come up under my skin; It was red and it was itchy; It was red and it was itchy; This is a spontaneous report from a contactable consumer (patient).  A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6207; Expiration Date: Jul2021), via an unspecified route of administration, administered in Arm on an unspecified date as dose number unknown, single for covid-19 immunisation. Medical history included diabetes mellitus, hypertension. Patient reported that got the Pfizer shot at 11:50 on Friday and yesterday down towards shoulder got like a blister come up under skin, it looked like a blister and then patient rubbed it, it burned real bad and then patient put some alcohol on it and it went away, it was red and it was itchy and it was oozing out like some white moisture or something which patient don't know, it look like what comes out of a blister. Patient went to sleep last night, there was no shortness of breath, patient got sore arm like they said and then it is gone away and no other reaction. But again today, patient got another spot on back about a inch lower than the one that was before and it is red again, looks like a blister under patient skin and it is red. The patient underwent unknown laboratory tes.t with unknown result. The outcome of the event was Not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: fever/low grade fever; runny nose; This is a spontaneous report from a contactable consumer (parent). A 36-year-old male 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 02Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever/low grade fever, runny nose on Mar2021. Reported as, reporter stated her son also experienced a fever after receiving the vaccine and took Tylenol. Reporter son had a low grade fever and a runny nose that cleared up with Tylenol. Therapeutic measures were taken as a result of fever/low grade fever, runny nose. Outcome of all the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood magnesium, Blood potassium, Chest X-ray, Computerised tomogram, Cough
Clinical narrative: a little bit of nausea; diarrhea; dry cough; fatigue; dizzy headache; This is a spontaneous report from a Pfizer sponsored program via Regulatory Authority support. A 49-year-old female patient received bnt162b2 (PFIZER-COVID-19 VACCINE, formulation: Solution for injection, Lot number EK5730), via an unspecified route of administration, administered in arm left on 29Dec2020 09:00 as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included ethinylestradiol, norethisterone (ORTHO 777) taken for contraception from Aug1989 and ongoing. On an unspecified date, the patient experienced a little bit of nausea, diarrhea and dry cough. On 29Dec2020 09:30, the patient experienced fatigue and dizzy headache. No treatment received for dizzy headache. On an unspecified date in Mar2021, the patient underwent lab tests and procedures which included magnesium: low magnesium, potassium: low potassium, chest x-ray: abnormal lung, CT scan: heat enlargement and electrocardiogram: abnormal. On an unspecified date in Apr2021, magnesium: low magnesium, potassium: low potassium and electrocardiogram: abnormal. The outcome of the events a little bit of nausea, diarrhea and dry cough was not recovered. On 29Dec2020, the patient recovered from fatigue and dizzy headache.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Electrocardiogram, Fatigue, Nausea
Clinical narrative: a little bit of nausea; diarrhea; dry cough; fatigue; dizzy headache; This is a spontaneous report from a Pfizer sponsored program via Regulatory Authority support. A 49-year-old female patient received bnt162b2 (PFIZER-COVID-19 VACCINE, formulation: Solution for injection, Lot number EK5730), via an unspecified route of administration, administered in arm left on 29Dec2020 09:00 as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included ethinylestradiol, norethisterone (ORTHO 777) taken for contraception from Aug1989 and ongoing. On an unspecified date, the patient experienced a little bit of nausea, diarrhea and dry cough. On 29Dec2020 09:30, the patient experienced fatigue and dizzy headache. No treatment received for dizzy headache. On an unspecified date in Mar2021, the patient underwent lab tests and procedures which included magnesium: low magnesium, potassium: low potassium, chest x-ray: abnormal lung, CT scan: heat enlargement and electrocardiogram: abnormal. On an unspecified date in Apr2021, magnesium: low magnesium, potassium: low potassium and electrocardiogram: abnormal. The outcome of the events a little bit of nausea, diarrhea and dry cough was not recovered. On 29Dec2020, the patient recovered from fatigue and dizzy headache.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Mild chills; mild feverishness; moderate fatigue; mild body aches; mild injection site pain; This is a spontaneous report  received from a contactable male consumer. A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EL3247) via an unspecified route of administration, administered in Arm Left on 15Mar2021 15:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included drug hypersensitivity- mild allergy to sulfa-antibiotics - skin reactions, no systemic reactions. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021 08:00, the patient experienced mild chills, mild feverishness, moderate fatigue, mild body aches. The patient did not received the treatment for events. The outcome of the events was all resolved within 24 hours post vaccination on unspecified date in 2021.   No follow-up attempts are needed. No further information is expected
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: non-itchy one inch small bright pink slightly raised patch of skin on the side of right hand by thumb, on the inside right leg. Skin pores were red and the skin around it was pink and slightly raised; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6206, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 13Mar2021 13:45 (at the age of 62-year-old) as dose 1, single for COVID-19 immunization, at hospital. The medical history included Known allergies: Garlic (contact allergy), lobster, mussels, latex and Positional Tachycardia. Concomitant medication included fremanezumab (AJOVY [FREMANEZUMAB]) on 20Feb2021 administered in belly (other vaccine in four weeks). The patient had no COVID prior vaccination and had not been tested for COVID post vaccination. The patient did not receive other vaccine on same date as suspect product. On 13Mar2021 15:00, the patient developed "non-itchy one inch small bright pink slightly raised patch of skin on the side of right hand by thumb, on the inside right leg. skin pores were red and the skin around it was pink and slightly raised". The patient reported that she "have sensitive skin and can break out in contact dermatitis easily". No treatment was given for the event. It was reported that the patient received second dose of vaccine on 30Mar2021 01:30 PM in left arm (Lot number: EP6955) and "after 5 days developed an oblong pink rash about 4 inches long and 3 inches wide below the injection site. Doesn't itch feels like sunburn". The outcome of the event was reported as resolving.  Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable other hcp (patient). A 26-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in arm right on 16Mar2021 at 14:45 (02:45 PM) (at the age of 26-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included ADHD, depression, anxiety, all from an unknown date and unknown if ongoing. Patient had no known allergies. The patient concomitant medications included lisdexamfetamine mesilate (VYVANSE) at a dose of 40 mg, once a day; ethinylestradiol, norgestimate (FEMYNOR), both drugs taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in arm right on 23Feb2021 at 02:45 PM as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. Patient was not diagnosed with COVID prior vaccination. Patient had not been COVID tested post vaccination. On 17Mar2021 02:00 AM, the patient experienced body aches, fever, chills. Query: Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. Response: The date of awareness was Wednesday, 17Mar2021. The patient received Tylenol as treatment medication for all the events. Outcome of all the events was recovering. Follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: body pain; fever; This is a spontaneous report from a Pfizer-sponsored program. A contactable (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose 1, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date, after first dose, the patient experienced fever and body pain. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Influenza like illness, Malaise, Pain in extremity
Clinical narrative: Received dose last Friday, "didn't feel so good."  Positive for SARs-COV-2 in early December, takes immunosuppressive medication.; Received dose last Friday, "didn't feel so good."  Positive for SARs-COV-2 in early December, takes immunosuppressive medication.; Didn't feel so good; Coughing; Pulmonary issues; Felt crappy; Flu like symptoms; Arm pain; Fatigue; This is a spontaneous report from a contactable physician (patient himself). A 54-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration in left arm, on 12Mar2021 02:30 (age at vaccination: 54-years) as dose 1, single for covid-19 immunisation. Patients medical history included ulcerative colitis (He was also on an immunosuppressive medication for his ulcerative colitis) from an unspecified date and unknown if ongoing, and positive for SARs-COV-2 since an unspecified date in Dec2020 (It was early December when he was sick. He went to the local hospital) unknown if ongoing. Concomitant medications were not reported. Patient received dose last Friday, and "didnt feel so good." Positive for SARs-COV-2 in early December, takes immunosuppressive medication on an unspecified date. He was not hypoxic or anything and he was never admitted. After getting it he did feel better. However, his lungs were not doing real good. At that time he was also on an immunosuppressive medication for his ulcerative colitis. He mentioned his pulmonary symptoms with the cough, and shortness of breath lasted and continued to persist for a month so he was started on a steroid inhaler. He was also started on Decadron when he received the monoclonal antibodies. He was told he could not get the COVID Vaccine until three months after receiving the antibodies. He received the Pfizer COVID Vaccine on Friday 12Mar2021. There was no emergency room visit or physicians office visit due to the adverse events. After getting the vaccine he felt crappy for several days afterwards. He is wondering if he had to get the second dose of the COVID Vaccine. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Received dose last Friday, "didn't feel so good."  Positive for SARs-COV-2 in early December, takes immunosuppressive medication.; Received dose last Friday, "didn't feel so good."  Positive for SARs-COV-2 in early December, takes immunosuppressive medication.; Didn't feel so good; Coughing; Pulmonary issues; Felt crappy; Flu like symptoms; Arm pain; Fatigue; This is a spontaneous report from a contactable physician (patient himself). A 54-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration in left arm, on 12Mar2021 02:30 (age at vaccination: 54-years) as dose 1, single for covid-19 immunisation. Patients medical history included ulcerative colitis (He was also on an immunosuppressive medication for his ulcerative colitis) from an unspecified date and unknown if ongoing, and positive for SARs-COV-2 since an unspecified date in Dec2020 (It was early December when he was sick. He went to the local hospital) unknown if ongoing. Concomitant medications were not reported. Patient received dose last Friday, and "didnt feel so good." Positive for SARs-COV-2 in early December, takes immunosuppressive medication on an unspecified date. He was not hypoxic or anything and he was never admitted. After getting it he did feel better. However, his lungs were not doing real good. At that time he was also on an immunosuppressive medication for his ulcerative colitis. He mentioned his pulmonary symptoms with the cough, and shortness of breath lasted and continued to persist for a month so he was started on a steroid inhaler. He was also started on Decadron when he received the monoclonal antibodies. He was told he could not get the COVID Vaccine until three months after receiving the antibodies. He received the Pfizer COVID Vaccine on Friday 12Mar2021. There was no emergency room visit or physicians office visit due to the adverse events. After getting the vaccine he felt crappy for several days afterwards. He is wondering if he had to get the second dose of the COVID Vaccine. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash just one spot on her arm since it's spread to her legs and other places; This is a spontaneous report from a contactable Physician reported that. A 27-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 07Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunizations (Age at vaccination 27 years). The patient medical history and concomitant medications were not reported. After 24 hours later she started to get a rash just one spot on her arm since it's spread to her legs and other places on 08Mar2021. She's been on a couch with wool blanket and duck feathers. lying there more allergic to wool or feathers. it started 24 hours after she got the vaccine; not considered severe, not anaphylaxis; not within 4 hours; she went to the dermatologist is on prednisone hate for her not to get the 2nd vaccine, so she said to herself let me call and see if there is any information on migrating rash not coming from the allergic reactions are more systemic. The event outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Malaise, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse. A 94-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date, patient experienced low-grade fever at night-time, diarrhea, fatigued and not feeling well. Caller stated her mother is scheduled to get the second dose of the Pfizer-BioNTech COVID-19 vaccine tomorrow. She received her 1st dose 3 weeks ago. She explained her mother has been experiencing either "stomach flu or COVID-19" symptoms since the last 3 days. She specified her mother has "low-grade fever at nighttime, diarrhea and is kind of fatigued." She asked if her mother should get the second dose of the vaccine tomorrow. Reporter emphasize that Her mother's symptoms not related to the first dose. The outcome of the events unknown. No follow-up attempts possible. Information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: She got a really bad pain on the left side of her chest, She experienced bad pain in her chest going through her lungs 5 hours later; This is a spontaneous report from a Pfizer-sponsored program (159558). A contactable female consumer (patient) reported for herself that, a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on 12Mar2021 as a DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient said, she got a really bad pain on the left side of her chest, she experienced bad pain in her chest going through her lungs 5 hours later on 12Mar2021 at 05:00. Patient reported that, she just got vaccine this morning. She got a really bad pain on the left side of her chest. She wanted to know that's one of the side effects. She further explained, got her first dose of the vaccine last 12Mar2021. She experienced bad pain in her chest going through her lungs 5 hours later. The adverse events lasted for 3 minutes. She wanted to know the time frame when side effects usually appear. Outcome of the event was resolved on 12Mar2021 at 05:03.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Lymphadenopathy, Nausea, Pain
Clinical narrative: swelling under my left arm; nausea; soreness at injection site; fever; chills; body ache; swollen neck gland; stomach cramp; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 44-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 16Mar2021 10:45 (at the age of 44-year-old) as dose 2, single for covid-19 immunisation. Medical history included blood triglycerides increased from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported; chondroitin sulfate sodium, glucosamine (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE SODIUM; GLUCOSAMINE]) taken for an unspecified indication, start and stop date were not reported; calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported. Patient was allergic to penicillin, aspirin, sulfa, biaxin. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 23Feb2021 10:45 AM (at the age of 44-year-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, patient experienced nausea, soreness at injection site, fever, chills, body ache, swollen neck gland, stomach cramp. On 18Mar2021, patient experienced swelling under my left arm. Therapeutic measures were taken as a result of fever included Tylenol. No treatment was taken as a result of events included nausea, soreness at injection site, chills, body ache, swollen neck gland, stomach cramp. The events was reported as non serious. The outcome of the event swelling under my left arm was unknown and all other events was not recovered.    No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling under my left arm; nausea; soreness at injection site; fever; chills; body ache; swollen neck gland; stomach cramp; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 44-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 16Mar2021 10:45 (at the age of 44-year-old) as dose 2, single for covid-19 immunisation. Medical history included blood triglycerides increased from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported; chondroitin sulfate sodium, glucosamine (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE SODIUM; GLUCOSAMINE]) taken for an unspecified indication, start and stop date were not reported; calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported. Patient was allergic to penicillin, aspirin, sulfa, biaxin. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 23Feb2021 10:45 AM (at the age of 44-year-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, patient experienced nausea, soreness at injection site, fever, chills, body ache, swollen neck gland, stomach cramp. On 18Mar2021, patient experienced swelling under my left arm. Therapeutic measures were taken as a result of fever included Tylenol. No treatment was taken as a result of events included nausea, soreness at injection site, chills, body ache, swollen neck gland, stomach cramp. The events was reported as non serious. The outcome of the event swelling under my left arm was unknown and all other events was not recovered.    No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: malaise/ moderate malaise; fever of 99 to 100.7/low grade fever of 99 to 100.7; headaches/Headache; fatigue; This is a spontaneous report from a contactable physician via medical information team. A 50-years-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 11Mar2021 (at the age of 50-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took ibuprofen and experienced allergy to Ibuprofen. On unspecified date, the patient experienced malaise or moderate malaise, fever or lowgrade fever or persistent fever of 99 to 100.7, headache and fatigue. The patient underwent lab tests and procedures which included body temperature: 99 to 100.7 on unspecified date. Reporter asking for guidance for a patient with persistent symptoms following their first vaccination. He inquired how long symptoms may last following vaccination from the first dose. Reporter also stated that he had never seen someone complain of symptoms from a vaccine six days later and wants to ask have we seen anyone who symptoms have persisted six days or more. Adds he had the Moderna vaccine and only had symptoms for a day. Clarifies he had flu like symptoms of one day after the second dose and asking what the criteria for a report is advised caller that we document our patient's experience with our product and anything that occurs after the product is administered may be reported. The outcome of the event's moderate malaise, fever, headache was not recovered and for fatigue outcome was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Neck pain, Pain in extremity
Clinical narrative: Patient had soreness in the neck and elbow after getting the 1st dose; Patient had soreness in the neck and elbow after getting the 1st dose; soreness as his whole muscle area.; soreness on his arm from his elbow up to his neck; This is a spontaneous report from a contactable consumer, the patient. A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; EN6202), dose 1 via an unspecified route of administration, administered in Arm Right (stuck it in his arm, he was not sure if it was in a muscle) on 01Mar2021 between 1:00 to 2:00 pm (age at vaccination 66-Years-old) as dose 1 single for covid-19 immunisation. The patient did not had any medical history and concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. On an unknown date in Mar2021, patient had soreness on his arm from his elbow up to his neck. His second dose is due in three days. Later patient clarified soreness as his whole muscle area. Soreness on his elbow up to his neck started about two weeks ago (Mar2021). Patient stated that it was painful bit was not excruciating. It was about the same from when it started. Patient received ibuprofen as a treatment drug which was not working. It was reported that patient will have the 2nd dose of the PFIZER-BIONTECH COVID-19 VACCINE on 22Mar2021. No Prior Vaccinations within 4 weeks and did not have any adverse event following prior vaccinations. No family medical history relevant to adverse event. the reporter assessed as non serious. The outcome of the event soreness as his whole muscle area was unknown and for rest all it was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: rash showed up; hives; This is a spontaneous report from a contactable consumer (Patient). A 67-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in Arm Left on 12Mar2021 11:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included diabetes II. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 20Feb021 11:00 as DOSE 1, SINGLE for covid-19 immunisation. Patient had no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 15Mar2021, the patient experienced hives. On an unspecified date, rash showed up in the evening. Caller would like to know how many days after the covid vaccine could side effects show up. Caller reported having no reaction on the 1st dose of the covid vaccine. However, 3 days after she received the 2nd dose, she broke out in hives. She saw her doctor, and she currently took over the counter stuff. She was told that if no improvement she should go back to see the doctor tomorrow. On monday evening the caller broke out in hives all over her body. Could it take that long for this to show up. They do not run any tests yesterday when the caller went to her primary care provider. The caller doctor told her to get Claritin and Benadryl to see if it would help. All her family members have had no side effects from their Moderna vaccine. The clinical outcome of events hives was not recovered and rash showed up in the evening was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Insomnia
Clinical narrative: Dizziness; I can't breathe either; It's very hard to sleep/can't sleep/insomnia; This is a spontaneous report from a contactable consumer (patient) reporting himself. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6205), via an unspecified route of administration in left arm on 12Mar2021 11:00 AM (age at vaccination was 60 years) as DOSE 1, SINGLE for Covid-19 immunisation. Medical history included bipolar disorder from an unknown date and unknown if ongoing. Concomitant medication included clonazepam (CLONAPAM) 0.5 mg orally every day taken for anxiety from an unspecified start date and ongoing. The patient previously took Depakote for sleep disorder. On an unspecified date the patient was feeling how long the dizziness from taking the vaccine lasted. How long can a dizziness from the vaccine lasted. She also felt like she could not breathe either. The patient also reported that she should not be dizzy and informed she did not take anything to be dizzy. She was feeling very dizzy. On 12Mar2021 at night he could not sleep; It was very hard to sleep. The doctor added Trazodone three days ago and he still could not sleep. He felt energized but he was only getting two to three hours of sleep at night. He was scheduled to get the next dose of the vaccine on 01Apr2021. Patient had not received any other vaccine within 4 weeks. No investigation assessment reported. Outcome of the event very hard to sleep/can't sleep was not recovered and other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A 61-year-old non-pregnant 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 12Mar2021 (at the age of 61-year-old ) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 13Mar2021, the patient experienced chills, fever and muscle aches. No treatment was received by the patient for the events. The outcome of all the events was recovering. No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Rash
Clinical narrative: Chills; Fever (99.8); Aches that night; Rash and some hives on my right chest area; Rash and some hives on my right chest area; Two dime size red blotches on my back, right side again; This is a spontaneous report from a contactable consumer (patient).  A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA, solution for injection, Batch/Lot Number: EN6198) (at the age of 61-years), via an unspecified route of administration, administered in arm left on 11Mar2021 01:15 PM as dose 2, single for covid-19 immunization. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (at the age of 61-years-old), dose 1, on 18Feb2021 01.15 PM for covid-19 immunization. Patient had no known allergies. The patient relevant medical history includes multiple sclerosis. The patient concomitant medications includes glatiramer acetate (Daily injections (20mg/ml)). The patient was not pregnant at the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient got the 2nd vaccine on Thursday and felt fine until Saturday night. The patient had chills, fever (99.8), aches that night and on Sunday, the patient developed a rash and some hives on her right chest area, directly under the right breast. The patient also had two dime size red blotches on her back and right side again. The patient had no problems with breathing. The patient did not received any treatment for adverse event. Prior to vaccination, patient did not diagnosed with covid-19. Since the vaccination, the patient did not tested for covid-19. On 14Mar2021, the patient went to lab test which includes: body temperature 99.8 (unit not reported). The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.