chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fatigue/Tiredness; Body chills/ Chills; Body ache; Headache; Sweat a little bit through the night; Nauseous; Just kind of feel all around not good; This is a spontaneous report via a contactable consumer (patient herself). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot Number: EN6200) via an unspecified route of administration on 13Feb2021 as dose number unknown, single for COVID-19 immunisation. Medical history included Asthma ongoing and patient had suffered from COVID-19 in early November. Patient concomitant medications were reported as unspecified. Patient stated that she received her vaccine on Saturday since then experienced body chills and fatigue on 13Feb2021 and It seems to be better today and on an unspecified date in 2021 patient experienced with body ache and today she had headache, chills, sweat a little bit through the night. She don't think she had a fever, a little nauseous but not terrible just kind of feel all around not good. The fatigue will be the worst part of it." Patient did not received the treatment for all events. Outcome of events (Chills and Fatigue) was recovering and unknown for all other events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: Fatigue/Tiredness; Body chills/ Chills; Body ache; Headache; Sweat a little bit through the night; Nauseous; Just kind of feel all around not good; This is a spontaneous report via a contactable consumer (patient herself). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot Number: EN6200) via an unspecified route of administration on 13Feb2021 as dose number unknown, single for COVID-19 immunisation. Medical history included Asthma ongoing and patient had suffered from COVID-19 in early November. Patient concomitant medications were reported as unspecified. Patient stated that she received her vaccine on Saturday since then experienced body chills and fatigue on 13Feb2021 and It seems to be better today and on an unspecified date in 2021 patient experienced with body ache and today she had headache, chills, sweat a little bit through the night. She don't think she had a fever, a little nauseous but not terrible just kind of feel all around not good. The fatigue will be the worst part of it." Patient did not received the treatment for all events. Outcome of events (Chills and Fatigue) was recovering and unknown for all other events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Night sweats, Pain
Clinical narrative: Fatigue/Tiredness; Body chills/ Chills; Body ache; Headache; Sweat a little bit through the night; Nauseous; Just kind of feel all around not good; This is a spontaneous report via a contactable consumer (patient herself). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot Number: EN6200) via an unspecified route of administration on 13Feb2021 as dose number unknown, single for COVID-19 immunisation. Medical history included Asthma ongoing and patient had suffered from COVID-19 in early November. Patient concomitant medications were reported as unspecified. Patient stated that she received her vaccine on Saturday since then experienced body chills and fatigue on 13Feb2021 and It seems to be better today and on an unspecified date in 2021 patient experienced with body ache and today she had headache, chills, sweat a little bit through the night. She don't think she had a fever, a little nauseous but not terrible just kind of feel all around not good. The fatigue will be the worst part of it." Patient did not received the treatment for all events. Outcome of events (Chills and Fatigue) was recovering and unknown for all other events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: arm soreness; chills; tiredness; This is a spontaneous report from a Pfizer-sponsored program CoVAX US Support (Medical information team) from a contactable male consumer. A male patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route on 14Feb2021 as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medications included lisinopril 10mg, atorvastatin, montelukast 10mg, omperazole 40mg, tamsulosin 0.4mg, trazadone 50mg and acetylsalicylic acid (ASPIRIN LOW, Bayer). On an unknown date, patient experienced arm soreness, chills and tiredness. He states that he did read that these were common symptoms on the fact sheet and would like to know if he can continue taking his daily prescribed medications (trazadone 50mg, lisinopril 10mg, tamsulosin 0.4mg, bayer low dose aspirin, atorvastatin, montelukast 10mg, omperazole 40mg) after receiving the first dose of the Pfizer COVID-19 vaccine yesterday. The clinical outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Severe itching on upper left arm vaccine site a week after receiving injection.; This is a spontaneous report from a contactable consumer reported that. A 79-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 12:00 (Batch/Lot Number: EN5318) as DOSE 1 SINGLE for covid-19 immunization (Age at vaccination 79-years). The patient past Medical history included High cholesterol from an unknown date and unknown if ongoing, low platelets from an unknown date and unknown if ongoing and intrinsic factor deficiency from an unknown date and unknown if ongoing, Known allergies: Penicillin, Erythromycin and Sulfa from an unknown date and unknown if ongoing. Concomitant medication included metoprolol (METOPROLOL) taken for an unspecified indication, atorvastatin (ATORVASTATIN) taken for an unspecified indication, lactulose (LACTULOSE) taken for an unspecified indication and calcium (CALCIUM) taken for an unspecified indication, the patient previously took erythromycin and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 13Feb2021 the patient reported severe itching on upper left arm vaccine site a week after receiving injection and Looks like a rash has developed. No treatment was received. The event outcome was Not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported that.  A female patient of an unspecified age received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) (Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Feb2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that both she and her husband got their second vaccine shot on Saturday and they had no side effects from it except soreness at the injection site on an unspecified date. The outcome of event 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: Toothache
Clinical narrative: tooth ache; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration as dose 1, single for COVID-19 immunization. Patient medical history was not reported. The patient concomitant medications were not reported. The patient stated he was scheduled for his second dose of the vaccine in two days. The patient asked if he could take Clindamycin, 10-day course for a tooth ache before the vaccine. Patient questioned if any antibiotics interact with the vaccine. He stated that there was no adverse event at the time of reporting and confirmed he would call if there was any adverse event. The event outcome for tooth ache was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Finger deformity, Peripheral swelling, SARS-CoV-2 test, Skin discolouration
Clinical narrative: swelling in her left pointer finger along with black and blue discoloration that is moving down her finger; swelling in her left pointer finger along with black and blue discoloration that is moving down her finger; cant bend finger; 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: EN6201), via an unspecified route of administration, administered in Arm Right on 13Feb2021 15:00 (vaccinated at the age of 61-years old) as dose1, single for COVID-19 immunization. The patient medical history was not reported and concomitant medications were none. On 14Feb2021, the patient experienced swelling in her left pointer finger along with black and blue discoloration that is moving down her finger, cant bend finger. It was reported that it's odd to call about the Covid Vaccine. She had the shot Saturday after noon, then late yesterday her left pointer finger was swelling and turning blue, today it is still black, blue, and swollen. Today it has move it down the finger. It doesn't hurt, she notices that she cant bend it as much. She has not injured the finger some other way. initially on Sunday the blue color was on 1 inch from the tip on her finger, and this morning it has moved down to the 2nd crease in her finger, making it now 2 inches down the finger being blackish blue. Patient stated that the temperature of the finger feels normal, as well as her sensation in the finger was also normal, she was able to feel. She stated that the finger turning bluish black has worsened since she notices it has traveled down the. Doctors offices and urgent care are closed due to the weather, but nobody ever contacted her back. She has already reported this to drug safety. She has had no positive covid or antibody test. Her most recent test was 3 weeks ago, being negative. She has had no vaccines on the same day or the 4 week prior to the covid vaccine. Outcome of events was not resolved.  Follow-up attempts completed. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: headache; dizziness; This is a spontaneous report from a contactable consumer (patient).  A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on 15Feb2021 04.00 (at the age of 56-years) as dose 1, single for covid-19 immunization. Patient had no known allergies and no relevant medical history. The patient concomitant medications were not reported. The caller stated that she received first dose of bnt162b2 vaccine this mornings around 4 am and seven hours later she was experiencing a headache and dizziness on 15Feb2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Pain
Clinical narrative: Feeling queasy; headache; malaise; pain; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) dose number unknown via an unspecified route of administration on unspecified date in Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to the covid vaccination was reported as unknown. Covid tested post vaccination was reported as unknown. On an unspecified date the patient experienced feeling queasy, headache, malaise, pain. The clinical outcome of the event was unknown.  No follow-up attempts are possible. Information about batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: headache; Myalgia; This is a spontaneous report from a Non-contactable consumer. An unspecified age of male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date Feb2021 as a single dose for COVID-19 immunization.The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Myalgia, headache.The outcome of the events was unknown.  Information on the lot/batch number has been requested
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Injection site pain, Pain, Pain in extremity, Viral test
Clinical narrative: My left arm and back, injection site, has been hurting since first dose.; My left arm and back, injection site, has been hurting since first dose.; My left arm and back, injection site, has been hurting since first dose.; it was even painful to sleep on and sore to movement; This is a spontaneous report from a contactable other hcp (Nurse) reported for herself. A 41-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via intramuscular, administered in Arm Left on 23Dec2020 10:00 (at the age of 41-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. No known allergies. Concomitant or other medications in two weeks included none. No other vaccine in four weeks. The patient experienced left arm and back, injection site, had been hurting since first dose, it was even painful to sleep on and sore to movement on 23Dec2020. AE resulted in none of the above (details unspecified). No covid prior vaccination and covid was tested post vaccination. The patient underwent lab tests and procedures which included nasal swab: negative on 09Feb2021. Clinical outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 12Feb2021 15:45 at the age of 45 years old (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization. The patient was not pregnant at time of vaccination. The patient has not been COVID-9 tested since the vaccination.  The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included breast cancer from an unknown date treated in 2017, egg, lobster, contrast dye and wasps/hornets allergy from an unknown date. Concomitant medication included tamoxifen, escitalopram, colecalciferol (VITAMIN D), docosahexaenoic acid, eicosapentaenoic acid (OMEGA-3); and bifidobacterium breve, bifidobacterium infantis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus bulgaricus, lactobacillus paracasei, lactobacillus plantarum, streptococcus thermophilus (VISBIOME)' all taken for an unspecified indication, start and stop date were not reported.  The patient previously took neomycin and experienced allergy. On 12Feb2021 18:30, the patient experienced nausea and vomiting three hours after getting the first shot, lasting for approximately 4-5 hours on 12Feb2021. No treatment was given to the patient for the events. The outcome of the events was recovered on 12Feb2021.  No follow-up attempts are possible. Information about lot/Batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: abdominal pain; This is a spontaneous report from a non-contactable pharmacist. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On Feb2021, the patient experienced abdominal pain. The patient did not have COVID prior vaccination. The patient was not COVID tested post vaccination. The patient did not receive treatment for the event. The outcome of the event was recovered.     No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: small lump on her left arm where she received the vaccine; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced small lump on her left arm where she received the vaccine, and it is not a lymph node. The outcome of event was unknown.   Information about the Lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Blood pressure measurement, Chills, Fatigue, Lymphadenopathy
Clinical narrative: aches and pains; chills; tiredness; under arm swelling/swelling under her arm like the size of an orange/saw on the papers that swollen lymph nodes were a side effect; dull ache under her arm; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9266; Expiration Date: 31May2021, NDC number was unknown), via an unspecified route of administration, administered in left arm on 14Feb2021 at 13:00 hours as dose 2, single (at the age of 47-years-old) for COVID-19 immunisation. Medical history included diabetes from 2011 to an unknown date, high blood pressure (caused by birth control taken at age 24, unable to provide the name, NDC, Lot or Expiry) from an unknown date and unknown if ongoing and thyroid cancer (has half of a thyroid) from 2011 to an unknown date. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9262; Expiration Date: 31May2021), via an unspecified route of administration, administered in left arm on 24Jan2021 as dose 1, single (at the age of 47-years-old) for COVID-19 immunisation. Patient had no history of previous immunization with the Pfizer vaccine considered as suspect. Patient received no additional vaccines administered on same date of the Pfizer suspect. Patient stated that she takes a lot of daily medications/concomitant medications but declines to provide details. On 15Feb2021, patient experienced aches and pains, chills and tiredness, under her arm was huge, it was like the size of an orange. Patient saw on the papers that swollen lymph nodes were a side effect. Patient had a dull ache under her arm which caused her to look at her arm. It had not gotten any smaller. Patient saw her doctor yesterday (15Feb2021) for a blood pressure check. The doctor checked her blood pressure on the same arm, and it was not swollen. Patient does not know if that may have something to do with it. Patient feels well rested today (16Feb2021). Patient asked what she should do, was there any treatment recommendations and how long will it last. Patient had no emergency room and physician office visit for the events. No relevant tests were performed for the events. The outcome of chills was recovered on 15Feb2021, tiredness and aches and pains was recovered on 16Feb2021, unknown for under arm swelling/swelling under her arm like the size of an orange/saw on the papers that swollen lymph nodes were a side effect and dull ache under her arm.   Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: aches and pains; chills; tiredness; under arm swelling/swelling under her arm like the size of an orange/saw on the papers that swollen lymph nodes were a side effect; dull ache under her arm; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9266; Expiration Date: 31May2021, NDC number was unknown), via an unspecified route of administration, administered in left arm on 14Feb2021 at 13:00 hours as dose 2, single (at the age of 47-years-old) for COVID-19 immunisation. Medical history included diabetes from 2011 to an unknown date, high blood pressure (caused by birth control taken at age 24, unable to provide the name, NDC, Lot or Expiry) from an unknown date and unknown if ongoing and thyroid cancer (has half of a thyroid) from 2011 to an unknown date. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9262; Expiration Date: 31May2021), via an unspecified route of administration, administered in left arm on 24Jan2021 as dose 1, single (at the age of 47-years-old) for COVID-19 immunisation. Patient had no history of previous immunization with the Pfizer vaccine considered as suspect. Patient received no additional vaccines administered on same date of the Pfizer suspect. Patient stated that she takes a lot of daily medications/concomitant medications but declines to provide details. On 15Feb2021, patient experienced aches and pains, chills and tiredness, under her arm was huge, it was like the size of an orange. Patient saw on the papers that swollen lymph nodes were a side effect. Patient had a dull ache under her arm which caused her to look at her arm. It had not gotten any smaller. Patient saw her doctor yesterday (15Feb2021) for a blood pressure check. The doctor checked her blood pressure on the same arm, and it was not swollen. Patient does not know if that may have something to do with it. Patient feels well rested today (16Feb2021). Patient asked what she should do, was there any treatment recommendations and how long will it last. Patient had no emergency room and physician office visit for the events. No relevant tests were performed for the events. The outcome of chills was recovered on 15Feb2021, tiredness and aches and pains was recovered on 16Feb2021, unknown for under arm swelling/swelling under her arm like the size of an orange/saw on the papers that swollen lymph nodes were a side effect and dull ache under her arm.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: citrus taste" in her mouth; This is a spontaneous report from a contactable consumer (patient). A 77-old female patient (Unit: Unknown) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 25Jan2021 as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunisation. She stated that she received her second dose of the Pfizer BioNTech COVID-19 vaccine on 25Jan2021 and was calling to report a "citrus taste" in her mouth. She would like to know what to do about this side effect. Informed caller that the reported "citrus taste" was not listed as a commonly reported side effect and referred her back to her Health Care Professional for guidance. The reporter considered events as non-serious. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Illness, Pain, Vomiting
Clinical narrative: he was sick all night; threw up once or twice; he said his head is aching; aches all over; This is a spontaneous report from a non-contactable consumer (patient's spouse). A male 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 number unknown, single, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient was sick all night and threw up once or twice. His head was aching, then aches all over. He woke up this morning and spouse gave him 2 Tylenol. Outcome of the events was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Dysphonia, Fatigue, Hypoacusis
Clinical narrative: couldn't hardly hear from congestion; voice has changed; tempt reached 96.7 and 98.6; congestion; runny nose; fatigue; tiredness; body ache; Sniffles; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN5318), via intramuscular route of administration in left arm on 05Feb2021 at 16:30 (at the age of 72 years old) as single for covid-19 immunisation. Medical history included heart attack was 20 years ago, neoplasm malignant from 2011 to an unknown date, transient ischaemic attack (TIA) from 2015 to an unknown date. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive additional vaccines on same date of the Pfizer suspect. On 11Feb2021, about 3:30 in the afternoon, he felt real tired. He went to bed. Then from 12Feb2021 until today, he started taking his temperature. The one point at her forehead, and press the trigger. The lowest temperature reading was 96.7 degrees, and the highest was 98.6 degrees. He had some sniffles on an unspecified date in 2021. On 11Feb2021, he reported he felt fatigue, woke up next morning and tempt reached 96.7 and 98.6, body ache, congestion, runny nose, tiredness (started 11Feb2021, lasted for 3 days) and couldn't hardly hear from congestion. Right now, he has no more sniffles. He was just congested on 12Feb2021. He did have fatigue and body aches the first day. He did have a runny nose for a couple of days, but mainly, starting yesterday on 12Feb2021, on 15Feb2021 his voice has changed. He can hardly hear on 15Feb2021. The caller wanted to know why he can't hear and why his voice changed? Is that part of the symptoms of the COVID-19 vaccine? When probed to determine the outcome of the fatigue and body aches, the caller stated he can run a mile right now. For the last 2 days, he has had no sniffles, just the congestion. Even when blowing his nose, nothing really comes out. He was hoping blowing his nose would open up his ears, like when on a plane and chew gum and it opens ears. The caller explained he has a couple of doctor's appointments coming up, the caller wanted to know can he get bloodwork done? The patient underwent lab tests and procedures which included body temperature: 96.7 degrees, 98.6 on 12Feb2021. No family medical history relevant to adverse events was provided and no relevant tests were performed. The patient did not visit emergency room or physician office. The outcome of congestion was not recovered, tiredness was recovered on 14Feb2021, sniffles was recovered on an unspecified date in 2021, while with other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, Rhinorrhoea
Clinical narrative: couldn't hardly hear from congestion; voice has changed; tempt reached 96.7 and 98.6; congestion; runny nose; fatigue; tiredness; body ache; Sniffles; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN5318), via intramuscular route of administration in left arm on 05Feb2021 at 16:30 (at the age of 72 years old) as single for covid-19 immunisation. Medical history included heart attack was 20 years ago, neoplasm malignant from 2011 to an unknown date, transient ischaemic attack (TIA) from 2015 to an unknown date. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive additional vaccines on same date of the Pfizer suspect. On 11Feb2021, about 3:30 in the afternoon, he felt real tired. He went to bed. Then from 12Feb2021 until today, he started taking his temperature. The one point at her forehead, and press the trigger. The lowest temperature reading was 96.7 degrees, and the highest was 98.6 degrees. He had some sniffles on an unspecified date in 2021. On 11Feb2021, he reported he felt fatigue, woke up next morning and tempt reached 96.7 and 98.6, body ache, congestion, runny nose, tiredness (started 11Feb2021, lasted for 3 days) and couldn't hardly hear from congestion. Right now, he has no more sniffles. He was just congested on 12Feb2021. He did have fatigue and body aches the first day. He did have a runny nose for a couple of days, but mainly, starting yesterday on 12Feb2021, on 15Feb2021 his voice has changed. He can hardly hear on 15Feb2021. The caller wanted to know why he can't hear and why his voice changed? Is that part of the symptoms of the COVID-19 vaccine? When probed to determine the outcome of the fatigue and body aches, the caller stated he can run a mile right now. For the last 2 days, he has had no sniffles, just the congestion. Even when blowing his nose, nothing really comes out. He was hoping blowing his nose would open up his ears, like when on a plane and chew gum and it opens ears. The caller explained he has a couple of doctor's appointments coming up, the caller wanted to know can he get bloodwork done? The patient underwent lab tests and procedures which included body temperature: 96.7 degrees, 98.6 on 12Feb2021. No family medical history relevant to adverse events was provided and no relevant tests were performed. The patient did not visit emergency room or physician office. The outcome of congestion was not recovered, tiredness was recovered on 14Feb2021, sniffles was recovered on an unspecified date in 2021, while with other events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Vision blurred
Clinical narrative: blood pressure got elevated; blurred vision; This is a spontaneous report from a contactable female consumer via Medical Information Team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She has taken both doses of the Pfizer BioNTech COVID-19 vaccine. After the first dose, she called 911, 3 days after the shot because her blood pressure got elevated and she had blurred vision. The paramedics checked her, and she was fine. After the second dose, she got the same reaction but it occurred for a longer period and she went to urgent care. She said that she has already notified Pfizer about these adverse events. Despite these reactions, she said that she likes the Pfizer COVID-19 vaccine and wanted to register her son for the vaccine. The patient underwent lab tests and procedures which included blood pressure measurement: elevated. The events resulted in a visit to emergency room. The outcome of events unknown.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling and pain at injection site.; Swelling and pain at injection site.; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810), via an unspecified route of administration, administered in Arm Left on 06Feb2021 14:30 (at the age of 29-year-old) as dose 1, single for covid-19 immunisation. Medical history included hypothyroidism and allergy to adhesive in band aids. Concomitant medication(s) included spironolactone (ALDACTONE) taken for an unspecified indication, start and stop date were not reported, citalopram taken for an unspecified indication, start and stop date were not reported, levothyroxine taken for an unspecified indication, start and stop date were not reported, retinol acetate (VITAMIN A) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine in four weeks. Other medications in two weeks included Aldactone, citalompram, levothyroxine, vit. A. The patient experienced swelling and pain at injection site on 15Feb2021 at 12:00AM. Symptoms started Monday the 15th, 10 days after the injection. Patient did not have covid prior vaccination and covid was not tested post vaccination. Patient did not receive treatment for adverse events. The outcome of swelling and pain at injection site was recovering.   Follow-up attempts completed. No further information expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Diarrhoea, Headache, Vomiting
Clinical narrative: throwing up all night, vomiting; massive headache; diarrhea; constipation problems; This is a spontaneous report from a contactable consumer (parent). A 33-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number: EN5318, Expiry Date: unknown), via an unknown route of administration on 04Feb2021 (at the age of 33-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patients medical history was none. Concomitant medication was not reported. On 10Feb2021 (wednesday), the patient started having constipation problems, sometimes this happens, and she would take a stool softener or laxative and everything was fine. She did have little bit of diarrhea through the weekend but mainly the onset was on the 14Feb2021 but mainly right now she was throwing up on 15Feb2021. It was confirmed that patient received vaccine they were 11 days out and she had been throwing up since last night. She said medical information was not any help only had it happening about 7 days out. The vomiting and massive headache began 15Feb2021. She also had a massive headache that she started complaining about yesterday. The outcome of the event throwing up all night was not recovered. The outcome of the event constipation problems was recovered on an unknown date in 2021; while the outcome of the remaining events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Vomiting
Clinical narrative: nausea for a couple of minutes; felt sick; threw up flem; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162b2 (COMIRNATY, Formulation: solution for injection, Batch/lot number: not reported, Expiry date: Not reported), via an unspecified route of administration on 10Feb2021 as dose 1, single for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. Patient had no known allergies. On an unspecified date,  Patient was feeling nausea for a couple of minutes. She was sitting still and all of a sudden, she felt sick and she threw up flem. But after that, she was fine. The outcome of the events was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiration date 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. The patient experienced little sore on arm (a little blue and black) on an unspecified date. Caller would like to know if taking Tylenol was allowed after the Pfizer COVID-19 vaccine. Caller also wanted to know if experiencing no side effects after the 1st dose of the Pfizer COVID-19 vaccine means she will not have side effects after the 2nd dose as well. The outcome of event: unknown. Follow-up attempts completed. No further information expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: tiredness; headache; shivers; terrible muscles aches and pains; This is a spontaneous report from a contactable other HCP (patient). 38-years-old male patient received second dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EL3248), via an unknown route of administration in left arm on 15Feb2021 at 09:00 (at the age of 38-years-old) as single for COVID-19 immunisation at  clinic. The patient's medical history and known allergies were reported as none. Concomitant medication was not reported. No other vaccine in four weeks. The patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EL3248), via an unknown route of administration in left arm on 25Jan2021 at 09:00 as single as historical vaccine for COVID-19 immunisation. On 16Feb2021 at 02:00, the patient woke up in middle of night with shivers. Had to get into shower just to keep warm. Muscles kept locking on whole body. Woke the next day with terrible muscles aches and pains. Along with great tiredness and headache. No COVID prior vaccination. No COVID tested post vaccination. No treatment received. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: large ringing in his right ear; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3248, Expiration Date: Apr2021), via an unspecified route of administration, administered in Arm Left on 15Feb2021 15:00 (at the age of 71-year-old) as dose 1, single for covid-19 immunisation at Hospital. Medical history included defibrillator was placed from Oct2020 to an unknown date (had a defibrillator so was seeing his Cardiologist and his heart was fine). Concomitant medication included on a series of holistic medication and prescribed medication. Other products were none. Additional vaccines administered on same date of the Pfizer suspect was reported as none. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was reported as none. Family medical history relevant to event none. The caller reported that on 15Feb2021 18:00, he experienced large ringing in the right (R) ear and didn't know if this could be related. Caller stated that it has not gotten any better nor gotten any worse. He also stated he has had 12 in a row negative Covid tests. No emergency room/physician office visit. The patient underwent lab tests and procedures which included Covid tests: negative on an unspecified date (Stated he had 12 in a row negative Covid tests). Relevant tests none. Seriousness was reported as no by the reporter. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness
Clinical narrative: Headaches; Feeling kind of sick; This is a spontaneous report from a Pfizer-sponsored program regulatory authority Support. A contactable consumer reported for a 6-decade-old female patient (reporter's daughter) who received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date in 2021 as SINGLE dose for covid-19 immunization. Historical vaccine included received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 29Jan2021 as SINGLE dose for covid-19 immunization and experienced arm soreness. Medical history included breast cancer and had a lump and everything removed on an unknown date in 2013 and it was unknown if ongoing. Concomitant medication was not reported. The caller stated that her daughter experienced headaches and feeling kind of sick (caller stated that her daughter never gets sick, however immediately after she got a second Covid shot, she got headache). The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pain
Clinical narrative: Body ache; Feeling weak; 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; Lot Number was not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second shot of the COVID-19 vaccine. The patient went to bed okay but woke up with body ache and feeling weak on an unspecified date, no fever. The patient asked what the company recommends for this. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Nausea
Clinical narrative: Nauseous; had pains across my stomach/doubled up in pain; "I was sicker than a dog, throwing up, diarrhea (medicine which helped 'backed up' on me), and had sharp pains across my stomach".; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration on 13Feb2021 as single dose for COVID-19 immunisation. Medical history included visual impairment from an unknown date and unknown if ongoing. The concomitant medications of patient were not reported. Caller reported that on Monday (15Feb2021) she was sicker than a dog, throwing up, diarrhea (medicine which helped backed up on her), and had sharp pains across her stomach. Consumer stated by Monday she started getting really sick and was doubled up in pain from everything. She reported she doesn't take a lot of medications they make her sick, she thought she was going to throw up or have diarrhea. She said that this morning (16Feb2021) she got up, she was very nauseous, more than usual, she took some pills for it, she did not have diarrhea, this was what she had going on and she was just really sick to her stomach and was right now too. She stated she had pains across her stomach that she had never had before, it was severe. The patient took some pills for nausea. The outcome of diarrhea was resolved, nausea and stomach pain were unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Caller states they experienced a sore arm for a few days; slight pressure headache; This is a spontaneous report from a contactable nurse (patient). A 72-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. Historical vaccine of BNT162B2 as dose 1, single for covid-19 immunisation was taken. The patient experienced a sore arm for a few days and slight pressure headache on an unspecified date. 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: Pain in extremity
Clinical narrative: his arm is fairly sore; This is a spontaneous report from a contactable consumer. This consumer reported for a 67 Years-Old male patient (husband). A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration on 15Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  on an unspecified date the who received the second dose of the Pfizer vaccine yesterday and his arm is fairly sore. Can he take Motrin. Outcome of the event was unknown.  Information on the lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Muscle twitching, Weight, Weight decreased
Clinical narrative: muscle twitching; lack of energy; weight loss; This is a spontaneous report from a contactable other hcp (patient). A 39-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: el3248, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 11Jan2021 09:45 (age at vaccination 39 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The had no allergies reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient's concomitant medications were not reported. On an unspecified date the patient experienced uncontrollable muscle twitching, lack of energy, weight loss. The patient underwent lab tests and procedures which included weight was loss. Patient visited doctor or other healthcare professional office/clinic visit for reported events. The patient did not receive any treatment for reported events. The outcome of event was not recovered.  Follow-up attempts completed. No further information expected.