chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: sore arm in shot location (both shots); headache (first shot); This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient had her 2nd COVID-19 dose and had no symptoms of any kind except for sore arm in shot location (both shots) and a headache (first shot) reported on an unspecified date. But she believed it was due to high pressure front coming into their area. She stated that she would like to be part of your 3rd dose COVID-19 vaccine trials if possible. The outcome of both the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm in shot location (both shots); This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A female patient of an unspecified age (Age: 75, Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Unknown) via intramuscular route of administration on 13Feb2021 as dose 2, single for COVID-19 immunization. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and experienced sore arm in shot location and headache. The patient medical history and concomitant medications were not reported. The patient experienced sore arm in shot location on an unspecified date in 2021. Patient would like to be part of 3rd dose Covid19 vaccine trials if possible. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Cold sweat, Nausea
Clinical narrative: stomach upset; Nausea.; Cold sweats; Chills; This is a spontaneous report from a contactable consumer received via Pfizer sponsored program Support. A male patient (consumer's son) of an unspecified age received bnt162b2 (Pfizer Covid 19 Vaccine, Formulation: 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. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced stomach upset, nausea, cold sweats and chills. Outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: Dizzy; Little headache; I was little tired; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267), via an unspecified route, administered in left arm (upper left arm like the shoulder area) on 24Feb2021 (at the age of 58 years) as Dose 2, Single for Covid-19 immunization. There were no medical history and concomitant medications reported. On 27Feb2021, the patient experienced dizzy, little headache, and was little tired. Patient got second vaccine (later clarified as COVID 19 Vaccine) on Wednesday which was the 24Feb2021 and felt great. Everything went great, and patient was little tired. But yesterday she started getting very dizzy and was dizzy today. Reporter stated, she mean she didn't have fever, no chills, her arm really wasn't sore, it's just all that it's dizzy, and like a little headache. So, the patient wasn't really sure if that was normal. She got her card, and she would have to put her glasses on as she could not see very well. Reporter added, "she just took a Motrin and Benadryl today (clarified as treatment)". No investigation assessment was reported. The patient received Motrin and Benadryl as a treatment medication for resulted events. The outcome of dizzy was not recovered and the outcome of other events was unknown.  Follow-up attempts completed. No further information expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Myalgia
Clinical narrative: Muscle soreness in the upper left arm; Lethargy the next day.; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received bnt162b2 first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration, administered Left arm on 05Feb2021 at 02:00 PM (at the age of 33-year-old) as dose 1 and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration, administered Left arm on 26Feb2021 02:00 PM (at the age of 33-year-old) as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included Allergic to morphine, sulpha drugs. The patient's other medications within 2 weeks of vaccination included etonogestrel (NEXPLANON). 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. Since the vaccination, the patient was not tested for Covid-19. New information (04Mar2021): included this is a follow up-spontaneous report from a contactable consumer. This consumer reported in response to consumer letter sent via e-mail which included that she provided a response to the first email, she received this morning. she was aware of the adverse event on 26Feb2021, as stated in her report. On 27Feb2021, they received a report from patient that you experienced some adverse events after the 2nd dose COVID-19 vaccine. In the report it stated the event onset date was on 26Feb2021 Muscle soreness in the upper left arm and Lethargy the next day. The patient did not receive any treatment for the events. The oucome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: sore arm; fatigue/tiredness; severe chills; headache; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a female patient that:  A female patient of an unspecified age (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an unspecified route of administration on Feb2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced sore arm, fatigue, tiredness, severe chills and headache on Feb2021. Acetaminophen and ibuprofen were taken as a treatment. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. On an unspecified date in 2021, the outcome of the events were recovered.  Lot/Batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain, Pain in extremity, Rhinorrhoea
Clinical narrative: pain when I was walking, in my left heel again, one of my feet; the bottom of my feet was giving me problem 10 20 seconds it was throbbing and if I walk too much it hurts me; my nose is running you know runny nose; nose is like a cold; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19 m RNA Vaccine, Solution for injection, Batch/Lot Number: EN6201; Expiration Date: Jun2021, NDC and UPC number was unknown), via an unspecified route of administration, administered in left arm on 23Feb2021 as dose 2, single (at the age of 71-year-old) for COVID-19 immunisation. Medical history included blood pressure (not sure, it was 10 years ago) and prediabetic from unknown to unknown of ongoing. Concomitant medications included linagliptin (Trajenta) and amlodipine, olmesartan for blood pressure. Historical vaccine included patient received BNT162b2 (Pfizer-BioNTech COVID-19 m RNA Vaccine, Solution for injection, Batch/Lot Number: EL8982 and Expiration Date: May2021, NDC and UPC number was unknown), via an unspecified route of administration, administered in left arm on 26Jan2021 as dose 1, single (at the age of 71-year-old) for COVID-19 immunisation and had a little pain on bottom of his feet of heel for days. On 23Feb2021, when patient came home at night, patient had pain when he was walking, in his left heel again, pain in one of his feet/left feet at the bottom of the feet on the heel and last night when patient was sitting the bottom of his feet was giving him problem 10-20 seconds it was throbbing. Patient stated that had pain and when he was talking, he still has pain but that much pain unbearable, also when he was walking had had pain at the bottom of his feet. On Feb2021, after couple of days his nose was running beside that patient did not have anything else, but his nose was like a cold. Patient did not receive any treatment for the events. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Strong pain in her muscles; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Feb2021 (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. The patient experienced strong pain in her muscles on an unspecified date in 2021. The outcome of the event was unknown.   No follow-up attempts are possible. Information on lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain, Chills, Discomfort, Dizziness
Clinical narrative: she started feeling uncomfortable symptoms; feeling really sick; pains in the neck and back; pains in the neck and back; palpitations; stomach upset; stiffness; dizziness; chills; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program Support. A female patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unknown date, the patient experienced started feeling uncomfortable symptoms like, feeling really sick, pains in the neck and back, palpitations, stomach upset, stiffness, dizziness and chills. The outcome of all events was unknown.  Follow-up attempts were completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Musculoskeletal stiffness, Neck pain, Palpitations
Clinical narrative: she started feeling uncomfortable symptoms; feeling really sick; pains in the neck and back; pains in the neck and back; palpitations; stomach upset; stiffness; dizziness; chills; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program Support. A female patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unknown date, the patient experienced started feeling uncomfortable symptoms like, feeling really sick, pains in the neck and back, palpitations, stomach upset, stiffness, dizziness and chills. The outcome of all events was unknown.  Follow-up attempts were completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, 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. The patient experienced not feeling well and dizziness on Feb 25, 2021. The patient due to get her 2nd dose of COVID-19 vaccine today on Feb 25, 2021. But when she woke up she was not feeling well; she was experiencing dizziness. Now she wants to reschedule her appointment because she will not be able to make it. The outcome of the events: unknown. No follow-up attempts needed. No further information expected. Information about batch/lot cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Illness, Malaise
Clinical narrative: ill and not feeling well; ill and not feeling well; bad eye pain; This is a spontaneous report from a Pfizer Sponsored Program  Support via a contactable consumer reported for a patient (Mother). A 85-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 04Feb2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient was ill and not feeling well and experienced bad eye pain. The patient was scheduled for the 2nd dose on 25Feb2021 (exactly 21 days apart). The caller claimed that the patient was unable to make it that day and wanted to reschedule her 2nd dose since the patient was currently ill and not feeling well. The caller asked to reschedule the patient's vaccination schedule that day since the patient experienced bad eye pain. The 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: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: dizziness; arm pain; This is a spontaneous report from a contactable consumer (wife) or other non-health care professional. A 87-year-old male patient received First dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Batch/Lot Number: FL9261) via an unspecified route of administration on 26Jan2021 at the age of 87-year-old as dose 1, single for covid-19 immunization. Medical history included has a pacemaker, Takes heart pills, Takes three pills a day, sick, and Flu. Concomitant therapy mentioned as yes. Family history was none, No relevant tests. No Prior vaccinations within 4 weeks. Last year when they both got home, they were really sick. Both caller and her husband, had to go to the Emergency room. Were sick for 3-4 weeks. Believes they had the COVID virus. Can't say for sure if it was COVID, but was told they both had the Flu. Caller mentioned this to the doctor and some say she and her husband might have had the COVID virus. Confirmed this was a year ago, prior to receiving the COVID vaccines. On an unspecified date the patient experienced dizziness, arm pain. Outcome of the events were unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood glucose increased
Clinical narrative: sugar level increased; This is a spontaneous report from a Pfizer sponsored program Support from a contactable female consumer (patient). A female patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced that her sugar level increased on 24Feb2021 after the vaccine. Patient was inquiring if it is normal to have that side effect and how long it will last. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: felt faint; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sales representative. A male patient of an unspecified age 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 24Feb2021 as dose 1, single for covid-19 immunisation. Medical history included AFIB (atrial fibrillation) on an unknown date, complex cardiac history from an unknown date and recent hospitalization on an unknown date. The patient's concomitant medications were not reported. It was reported that patient had 1st vaccine the previous day afternoon. This morning on 25Feb2021 at about 9:30 AM, the patient felt faint and his defibrillator went off. Has a follow up with cardiology tomorrow. It was reported that event took place after use of product. The outcome of event was unknown.  Follow-up attempts completed. No further information expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Fatigue, Limb discomfort, Vaccination site pain
Clinical narrative: Overall slight fatigue; increased body temperature; unable to lift my arm; Extreme soreness in left arm centered on injection site; This is a spontaneous report from a contactable consumer (patient) via medical information team.   A 25-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 02Mar2021 at 10:00 (at the age of 25-year-old) as single dose for COVID-19 immunisation. The patient's medical history included Childhood Pneumonia (caused slight damage to lungs, Body temperature fluctuations common due to medication). The patient's concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication. The patient previously took penicillin B for drug hypersensitivity and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Mar2021 at 10:00, the patient experienced extreme soreness in left arm centered on injection site, unable to lift my arm. On 03Mar2021 the patient experienced overall slight fatigue, increased body temperature. It was reported that light soreness began within 30 minutes after injection and increased gradually throughout the day on March 2nd 2021. Extreme soreness to the point of being unable to lift my arm the following day caused me to miss work. These symptoms regressed with rest and stretching until the evening, at which point the patient was fully functional again. The other symptoms were very light and only occurred from Wednesday March 3rd to Thursday March 4th. No further symptoms have developed since. The patient underwent lab tests and procedures which included body temperature: increased on 03Mar2021. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. Patient did not receive treatment for the events. Outcome of the events fatigue, increased body temperature was recovered on 4Mar2021 and outcome of the other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This is a spontaneous report from a contactable consumer (patient) received through.  A female patient of an unspecified age received BNT162B2 (BioNTech/Pfizer vaccine solution for injection), 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 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. on an unspecified date the patient experienced sore throat. Caller schedule for second dose wants to know if it is okay to take the second dose. The event outcome was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: muscle sore at the injection site; This is a spontaneous report from a 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) via an unspecified route of administration on 24Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After first dose of vaccine the patient experienced muscle sore at injection site on 25Feb2021. The outcome of the event was unknown.  Information about batch/lot number is requested.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Slight bump at site of vaccination; Quite tired.; This is a spontaneous report from a contactable consumer. This 70 Years Old female consumer reported. A 70-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 11:00 (at the age of 70-years-old) as a single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included multiple sclerosis. Concomitant medication(s) in two weeks included venlafaxine (VENLAFAXINE) taken for multiple sclerosis. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 (at the age of 70-years-old) as a single dose for covid-19 immunization. The patient did not have any allergies. The patient had no other vaccine within four weeks. 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 experienced slight bump at site of vaccination, quite tired on an unspecified date. The patient did not receive any treatment. Outcome of the event was recovered, at the time of this report. Information about lot/batch number has been requested. Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021239805 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Sinus disorder
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional (patient) via Pfizer-sponsored program Support. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date (batch or lot number was not reported) as dose 1, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sinus drainage, sore throat. It was reported that she scheduled for second shot this morning was not able to take it because she has some sinus drainage and sore throat but still confirming if she can take it. The outcome of the events was unknown. Follow-up attempts completed. No further information expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Photophobia
Clinical narrative: Light sensitivity; Swollen arm; Achy body; This is a spontaneous report from a contactable consumer (Patient herself). A 61-years-old nonpregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot Number: dn6202), via an unspecified route of administration, administered in Arm Left on 24Feb2021 at 12:15 (at the age of 61 years old) as single dose for covid-19 immunisation. Medical history included hbp, heart murmur, slight narrowing of heart valve, anemia , arthritis, osteopenia, cutaneous lupus, allergies, uterine fibroids and known_allergies: sulfites in food from an unknown date and unknown if ongoing, The patient previously took first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot Number: em9810), via an unspecified route of administration, administered in Arm Left on 03Feb2021 at 12:15 as dose 1, single for COVID-19 immunisation and recived flonase and experienced known allergies. The patient had no other vaccine in four weeks. It was reported that patient took concomitant medications in two weeks. On 25Feb2021 at 08:00, the patient experienced light sensitivity, swollen arm, achy body. The patient not had covid prior vaccination; not tested covid post vaccination. The patient did not receive any treatment for the events. The outcome of light sensitivity, swollen arm, achy body was not recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder, Tongue spasm, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient, of an unspecified age, received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, in left arm, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unknown date, the reporter read an article dated Jan 12, 2021 about a woman who had "uncontrollable shaking and tongue spasms" after receiving the vaccine. It was called "some kind of conversion thing to do with the nervous system." The reporter stated she read the woman also received her injection in the same arm as she did. Reporter would like to know if tingling and muscle spasms are a side effect of the vaccine. The reporter was concerned because in her research she has not seen a breakdown of any specific adverse events occurring with specific ethnicities. The outcome of events reported unknown for all. No follow-up attempts possible. Information about batch/lot number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain
Clinical narrative: I have pain in my upper back radiating up the right side of my neck and down my right arm.; I have pain in my upper back radiating up the right side of my neck and down my right arm.; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown (Not available/not provided to reporter at the time of report completion)) via an unspecified route of administration, administered in Arm Left on 27Feb2021 at 10:15 (Age at Vaccination: 38-year-old) as dose 1, single for covid-19 immunization at workplace clinic. The patient took no other vaccine in four weeks, had not covid prior vaccination and was not covid tested post vaccination. Medical history included obese and overweight. The patients known allergy was codeine Patient took other medications (unspecified) in two weeks. On 28Feb2021 at 03:00, the patient stated that she had pain in her upper back radiating up the right side of her neck and down her right arm. It was unknown if the treatment for adverse events was taken by the patient. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Vaccination site pain
Clinical narrative: left hand pinky finger and ring finger tingling and ache/pain all day; left hand pinky finger and ring finger tingling and ache/pain all day; site injection and shoulder pain in left arm; This is a spontaneous case received from a contactable consumer (patient herself). A 42-year-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247, Expiration date: May2021), via an unspecified route of administration, administered on 02Mar2021 as DOSE 1, SINGLE (age at vaccination 42-year-old) for COVID-19 immunization. The patient medical history included allergies to steroids, allergy/contact dermatitis from latex, allergy/sensitivity to dairy, diagnosed with eczema in teens and with IBS (irritable bowel syndrome) in 2018. Concomitant medications were reported as none. On 02Mar2021, the patient experienced site injection and shoulder pain in left arm. On 03Mar2021, the patient experienced left hand pinky finger and ring finger tingling and ache/pain all day. The outcome of the event on was recovering (04Mar2021 symptoms subsiding). No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: has red spot the size of a baseball at the injection site; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 17Feb2021 (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. The patient experienced has red spot the size of a baseball at the injection site on an unspecified date in Feb2021. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable Physician (patient) reporting for himself. A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6203), intramuscularly, administered in Left arm on 25Feb2021 14:45 at the age of 56-years-old as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were none. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809), intramuscularly, administered in Left arm on 04Feb2021 15:45 at the age of 56-years-old as single dose for covid-19 immunisation. Relevant tests were none. 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 has not been tested for COVID-19 since the vaccination. On 25Feb2021 at 20:00, the patient experienced arm soreness, headache and fatigue. No treatment was received for adverse events. Seriousness criteria for events was reported as non-serious. The outcome of events was recovered on an unspecified date in 2021. No follow attempts are possible; No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: Muscle pains in right arm, both of my sides, right above the breast lining; Body ache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6200) via an unspecified route of administration on 25Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On an unspecified date, patient experienced side effects like the muscle pains in right arm, both of sides, right on the sides, right above the breast lining, sometimes get it in the back, in the back it comes and goes but this was higher on the sides and had the body aches. Patient was just wondering what is the length of time of recovery or how would it go. Outcome of the events was unknown at the time of reporting.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Pain
Clinical narrative: This is spontaneous report received from a contactable consumer. This consumer (other non-HCP) reported for 48-year-old male patient that who received bnt162b2 (BNT162B2) solution for injection, dose 2 (Batch/Lot Number: EN6203) via an unspecified route of administration in arm left on 28Feb2021 08:00 (at the age of 48-years-old) as dose 2 single for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. 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. No seriousness criteria results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Disabling/Incapacitating, Congenital anomaly/birth defect. Historical Vaccine dose 1 BNT162B2 (Lot number=EM9809) via unspecified route of administration on 07Feb2021 08:30 AM as a dose 1 single for COVID-19 immunisation. The patient reported the symptoms to me when he started experiencing the symptoms on Sunday night, Feb28th (on 28Feb2021 22:00) and also when they worsened by Monday, Mar1. He is still experiencing some fatigue, and dizziness/light-headedness today, but says symptoms have improved. On 01Mar2021 we received a safety report from you for a patient named (initial) about experiencing some adverse event after COVID-19 vaccination. As the awareness date sometimes is not specified in the reporting system; he is asking could you please confirm on which date you became aware of the events and. who provided the first-hand knowledge of the events to you. This will help with the processing of Pfizer safety report and follow up activities. Please refer to the report in attachment for more information. Thanks in advance. Outcome off the events was not recovered. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Myalgia, Somnolence
Clinical narrative: light muscle and bone aches; light muscle and bone aches; felt like taking naps for a week; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, 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. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced light muscle and bone aches and felt like taking naps for a week. It was unknown if patient was diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 since the vaccination. The outcome of the events was unknown.  No follow-up attempts were needed, information about lot/batch number could not be obtained.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Headache, Neck pain
Clinical narrative: Anxiety; pain from top back of his head to bottom of neck; pain from top back of his head to bottom of neck; This is a spontaneous report from a contactable consumer (Patient) or other non HCP.  A 71-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9266, expiration date: May2021), via an unspecified route of administration in arm left on 22Feb2021 (at the age of 71-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. Historical vaccine included the first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number unknown), via an unspecified route of administration on an unspecified anatomical location on unspecified date as dose 1, single for covid-19 immunisation. On an unknown date, the patient experienced anxiety. on 23Sep2021, after 1 day vaccination the patient experienced pain from top back of his head to bottom of neck. Consumer reported that he had some effects after he had his last shot which he got last on the 22Feb. He says that the day after he had reaction to it where the top of the back of his head to the bottom of his neck felt like someone hit him like something real hard. He said that the second dose also altered his nerves, meaning anxiety, quite a bit. He said that he did not have the pain to the top of his head down to the bottom of his neck before getting the second dose, it was new. Patient received treatment for event back of his head down to the bottom of his neck pain for treatment Tylenol two to three days after that. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: experienced stiffness and body ache after the 1st dose and the caller mentioned that he also experienced the same thing yesterday; experienced stiffness and body ache after the 1st dose; This is a spontaneous report from a contactable consumer reporting for a patient (wife) received from a Pfizer-sponsored program. A female patient of an unspecified age 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 unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that on an unspecified date, his wife has experienced stiffness and body ache after the 1st dose and the reporter asked if his wife can take a Tylenol. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore soft tissue around injection site for about 18 hours after injection; This is a spontaneous report from a contactable consumer or other non hcp.   A 47-years-old male patient received bnt162b2 (BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EL3248), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 07:30 as SINGLE DOSE for covid-19 immunisation. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. Medical history included gout, nephrolithiasis. Concomitant medication(s) included multivitamins (MULTIVITAMINS; probiotics (PROBIOTICS); cholecalciferol, ubidecarenone (COQ10 + D3); fish oil (FISH OIL); ergocalciferol (VIT D). It was Reported that, the patient experienced sore soft tissue around injection site for about 18 hours after injection on 02Mar2021 with outcome of recovered. Follow-up (10Mar2021): This is a follow-up spontaneous report in response to mail trail sent regarding the confirmation of below mentioned query. This reported included   Follow-up (11Mar2021): This is a follow-up spontaneous report in response to mail trail sent regarding the confirmation of below mentioned query. This reported included that.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash on her injection arm; This is a spontaneous report from a Pfizer-sponsored program with Regulatory Authority SUPPORT via contactable consumer or other non HCP (Patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 formulation; Solution for injection), dose 1 via an unspecified route of administration on 14Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash on her injection arm on 17Feb2021 (three days later after vaccination). It was reported that symptoms went away in 2-3 days. The outcome of event reported as recovered (went away in 2-3 days) on an unknown date of Feb2021.  Follow-up attempts completed. No further information expected, information about batch/ lot number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history included psoriasis (Patient had chronically Psoriatic spots on leg for years, the size of the spot was 1 square centimetre). The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 1, single for COVID-19 immunization. On an unspecified date, three weeks after 2nd Pfizer vaccine, the spot disappeared & the skin has healed itself. Intuitively patient think it is dues to the vaccine raising immune system level. The outcome of the event was unknown. No follow-up attempts are needed. Information about Lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod sting, Burning sensation, Contusion, Dizziness, Feeling hot
Clinical narrative: felt like a node like where the earring would be; on the back of her ear like a lump; it was burning and hot; it was burning and hot; it stings; Nausea; Lightheadedness; bruise; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration, administered in Arm Right on 18Feb2021 18:00 (at the age of 54 years old) as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. No history of any previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. Adverse event did not require a visit to Emergency Room/Physician Office. No vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine. No Adverse events following prior vaccinations. No relevant medical history (including any illness at time of vaccination). No relevant family medical history to adverse event. No relevant tests done. On 19Feb2021, the patient experienced felt like a node like where the earring would be, on the back of her ear like a lump, it was burning and hot, it stings, Nausea, Lightheadedness, and bruise. She thought it was from her glasses and she was putting Neosporin and Vaseline on it. She asked if it was a coincidence or was it from the vaccine? She said that it was a lot better. It was burning and it stung just on that one ear. It had gone down tremendously though. It was black and blue where her glasses touched. The heat was around the top of the ear. She clarified that it was her left ear. The swelling went down, and she did not really feel it yesterday, but she felt it today. She said that it started to bother her again after she had her haircut. She said that it was like a throbbing on her ear. She said that before she could not even keep her glasses on because it was bothering her. She said that she thought her ear was irritated from her haircut last night. She still went to work, and it was not so bad that she could not handle it. She said that she had her energy back as of yesterday. Her second dose is scheduled for the 18Mar2021. Therapeutic measures were taken as a result of felt like a node like where the earring would be, on the back of her ear like a lump, it was burning and hot. The outcome of the events felt like a node like where the earring would be, on the back of her ear like a lump, Nausea, Lightheadedness were recovered on 04Mar2021; and other events it was burning and hot, it stings, Nausea, bruise were recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.