chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood cholesterol increased, Chills, Diarrhoea, Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 77-years old female patient received first dose of bnt162b2(COMIRNATY, formulation: solution for injection, lot number: FA6780, Expiration Date: 30Sep2021) via an unspecified route of administration on 08Jul2021 at 11:00 (at the age of 77-year-old) in left arm as dose 1, single for COVID-19 immunisation. The patient medical history included fatigue from 1993 to ongoing, fibromyalgia from 1993 to ongoing , pneumonia bacterial from 1988 to an unknown date had severe bacterial pneumonia and was in the hospital for 2 weeks , blood cholesterol increased, it was genetic, blood cholesterol increased, it was genetic , drug hypersensitivity from 2020, allergies to Penicillin, Codeine, Latex Penicillin and Codeine she was allergic to this was years ago rubber sensitivity, seasonal allergy and she has some seasonal allergies. She stated that she never had a breathing problem or lung issue, she had no rash. The concomitant medications were not reported. The patient previously took Fluzone high dose and experienced illness, codeine and experienced drug hypersensitivity, Fluzone high dose and experienced fatigue and rhinorrhoea. On 09Jul2021, the patient experienced felt like bad case of the flu, felt very sick, tiredness/just exhaustion, headache, muscle pain, chills, joint, the injection site was a little tender, nausea, diarrhea, like her nose ran constantly, it was ongoing, it was like she kept getting a cold and she did not usually get colds. She confirmed that the symptoms began the next day after her firAst shot (09Jul2021). The patient underwent lab tests and procedures which included blood cholesterol increased: extremely high on 2020 sodium chloride was on the low side which she had that happen last year, full blood count: sodium chloride low on 26Jul2021 high cholesterol prior to receiving the COVID vaccine, laboratory test: unknown results on 26Jul2021. The patient not visited Emergency Room and Physician Office. The outcome of the events were not recovered (She was on the only one that still has ongoing symptoms). Follow-up attempts are completed. No further information was expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Full blood count, Headache, Illness, Influenza
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 77-years old female patient received first dose of bnt162b2(COMIRNATY, formulation: solution for injection, lot number: FA6780, Expiration Date: 30Sep2021) via an unspecified route of administration on 08Jul2021 at 11:00 (at the age of 77-year-old) in left arm as dose 1, single for COVID-19 immunisation. The patient medical history included fatigue from 1993 to ongoing, fibromyalgia from 1993 to ongoing , pneumonia bacterial from 1988 to an unknown date had severe bacterial pneumonia and was in the hospital for 2 weeks , blood cholesterol increased, it was genetic, blood cholesterol increased, it was genetic , drug hypersensitivity from 2020, allergies to Penicillin, Codeine, Latex Penicillin and Codeine she was allergic to this was years ago rubber sensitivity, seasonal allergy and she has some seasonal allergies. She stated that she never had a breathing problem or lung issue, she had no rash. The concomitant medications were not reported. The patient previously took Fluzone high dose and experienced illness, codeine and experienced drug hypersensitivity, Fluzone high dose and experienced fatigue and rhinorrhoea. On 09Jul2021, the patient experienced felt like bad case of the flu, felt very sick, tiredness/just exhaustion, headache, muscle pain, chills, joint, the injection site was a little tender, nausea, diarrhea, like her nose ran constantly, it was ongoing, it was like she kept getting a cold and she did not usually get colds. She confirmed that the symptoms began the next day after her firAst shot (09Jul2021). The patient underwent lab tests and procedures which included blood cholesterol increased: extremely high on 2020 sodium chloride was on the low side which she had that happen last year, full blood count: sodium chloride low on 26Jul2021 high cholesterol prior to receiving the COVID vaccine, laboratory test: unknown results on 26Jul2021. The patient not visited Emergency Room and Physician Office. The outcome of the events were not recovered (She was on the only one that still has ongoing symptoms). Follow-up attempts are completed. No further information was expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Myalgia, Nausea, Rhinorrhoea, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 77-years old female patient received first dose of bnt162b2(COMIRNATY, formulation: solution for injection, lot number: FA6780, Expiration Date: 30Sep2021) via an unspecified route of administration on 08Jul2021 at 11:00 (at the age of 77-year-old) in left arm as dose 1, single for COVID-19 immunisation. The patient medical history included fatigue from 1993 to ongoing, fibromyalgia from 1993 to ongoing , pneumonia bacterial from 1988 to an unknown date had severe bacterial pneumonia and was in the hospital for 2 weeks , blood cholesterol increased, it was genetic, blood cholesterol increased, it was genetic , drug hypersensitivity from 2020, allergies to Penicillin, Codeine, Latex Penicillin and Codeine she was allergic to this was years ago rubber sensitivity, seasonal allergy and she has some seasonal allergies. She stated that she never had a breathing problem or lung issue, she had no rash. The concomitant medications were not reported. The patient previously took Fluzone high dose and experienced illness, codeine and experienced drug hypersensitivity, Fluzone high dose and experienced fatigue and rhinorrhoea. On 09Jul2021, the patient experienced felt like bad case of the flu, felt very sick, tiredness/just exhaustion, headache, muscle pain, chills, joint, the injection site was a little tender, nausea, diarrhea, like her nose ran constantly, it was ongoing, it was like she kept getting a cold and she did not usually get colds. She confirmed that the symptoms began the next day after her firAst shot (09Jul2021). The patient underwent lab tests and procedures which included blood cholesterol increased: extremely high on 2020 sodium chloride was on the low side which she had that happen last year, full blood count: sodium chloride low on 26Jul2021 high cholesterol prior to receiving the COVID vaccine, laboratory test: unknown results on 26Jul2021. The patient not visited Emergency Room and Physician Office. The outcome of the events were not recovered (She was on the only one that still has ongoing symptoms). Follow-up attempts are completed. No further information was expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Lymphadenopathy, Peripheral swelling, Pyrexia
Clinical narrative: Fever; chest pain; swollen arm; tired; swollen node; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 14-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0217 and Expiry date: Unknown), dose 2 intramuscular, administered in Arm Left on 05Jun2021 12:30 at the age of 14-years-old as DOSE 2, SINGLE for covid-19 immunization. Medical history included attention deficit hyperactivity disorder from an unknown date and unknown if ongoing Other medical history: ADD , drug hypersensitivity from an unknown date and unknown if ongoing Known allergies: Penicillin. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination. The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. Concomitant medication included methylphenidate taken for an unspecified indication, start and stop date were not reported.On 05Jun2021 23:45 the patient experienced fever, chest pain, swollen arm, tired, swollen node. Therapeutic measures were taken as a result of fever , chest pain , swollen arm, tired , swollen node. Treatment included Antibiotic and prevacid and ibuprofen and Tylenol.On an unspecified date in 2021, the patient had recovered from the events.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Illness, Mammogram, Nipple pain, Ultrasound breast
Clinical narrative: Breast and nipple soreness; Breast and nipple soreness; sick; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) via a Pfizer sponsored program. A 70-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced breast and nipple soreness and sick. The treatment was received for the adverse event with antibiotic therapy for 10 days. It was further stated that she said that she did not get the 2nd dose of the vaccine that was scheduled last 23Apr because a few days after the 1st dose she was sick and experienced breast and nipple soreness and she went to antibiotic therapy for 10 days. She was asking if it is safe for her to take the 2nd dose of the Covid-19 vaccine. The patient underwent lab tests and procedures which included mammogram: negative, ultrasound breast: negative on an unspecified date in 2021. She added that she sought help from a cancer doctor then underwent mammography and ultrasound procedure and it was negative. The clinical outcome for all the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: mild fatigue; This is a spontaneous report from a contactable consumer, the patient. A 67-years-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown) dose via an unspecified route on 19Feb2021 at single dose (at the age of 67 years) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown) dose via an unspecified route on 29Jan2021 at single dose (at the age of 67 years) for covid-19 immunisation and had no adverse event. The patient experienced mild fatigue on an unknown date in Feb2021. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: She also had pain in her arm; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2) solution for injection, dose 1 (Lot number expiry date was not reported) via an unspecified route of administration at arm on an unspecified date as a single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. While calling to report adverse event for her wife and her wife's pain in arm after the Pfizer Covid 19 Vaccine the reporter mentioned that the vaccine was the same for her. She also had pain in her arm. Stated she had this with her first and second dose. With the second dose she states she also had fever and pain all over her body. Reporter stated she knew this was normal. Reporter stated that she is good and declines to complete a safety report for herself at this time. Reporter stated she has no questions regarding her own experience.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Energy increased, Fatigue
Clinical narrative: Burst of energy; Tired; This is a spontaneous report from a contactable consumer or other non hcp.   A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration on 01May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Historical Vaccine BNT162B2 first dose for COVID-19 Immunization (Experienced Sore arm). Consumer clarified that he was mistaken, there was no bruising noted. Caller explained that his second dose was early in the morning and he experienced this "burst of energy" as if he had drank caffeinated beverage or a red bull. It was unusual, felt totally energetic but did not have any weird side effects of being over caffeinated.  This lasted from 7-8 hours. It was amazing and a nice feeling. He did house and yard chores. Then at 7pm he just "petered out" no more energy and was tired. He did not feel sick and felt normal the next day and that was it. on 2021 the patient experienced burst of energy, tired. 'The Pfizer-BioNTech COVID-19 Vaccine is administered as a 2-dose series, 3 weeks apart, into the muscle. If you receive one dose of the Pfizer-BioNTech COVID-19 Vaccine, you should receive a second dose of this same vaccine 3 weeks later to complete the vaccination series.1 In an ongoing clinical trial, the Pfizer-BioNTech COVID-19 Vaccine has been shown to prevent COVID-19 following 2 doses given 3 weeks apart. The duration of protection against COVID-19 is currently unknown.1 At this time, a booster dose (an extra or third dose after receiving the two-dose series) is not recommended or authorized.  If you have any further questions on the use of Pfizer-BioNTech COVID-19 Vaccine, ask your healthcare professional. 'The Companies anticipate the clinical studies to begin in August, subject to regulatory approvals. Question: Any data on autoimmune disorders in regard to long term efficacy of Pfizer Covid 19 vaccine? Consumer further explains he has read from multiple sources 39-59% efficacy rate. What does that percentage mean? Any further conclusions? Participants who were healthy or had stable chronic medical conditions were eligible. An active immunocompromising condition or recent immunosuppressive therapy were exclusion criteria. The study excluded participants who were immunocompromised. Outcome of the events was recovered on unspecified date of 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Insomnia, Pruritus
Clinical narrative: Severe itching under my stomach/hips and on both legs; sleepless nights for almost 2 months; Black spots on both of my legs like chicken pox; This is a spontaneous report from a contactable consumer. A 62-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 27May2021 at 15:00 (at the age of 62 year) as dose 1, single for COVID-19 immunisation at Pharmacy or Drug Store. The patient medical history was not reported. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no concomitant medications. On 01Jun2021 at 22:00, patient experienced severe itching under stomach/hips and on both legs, had sleepless nights for almost 2 months and now have black spots on both of legs like chicken pox. It was reported that no therapeutic measures were taken for the events experienced. The adverse events did not result in emergency room and physician office. The outcome of event sleeplessness was recovered on an unspecified date in 2021 while for rest events was recovering.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain, SARS-CoV-2 test
Clinical narrative: severe headache; I have pretty significant and persistent pain in the back of my neck; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 42 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jul2021 20:00 (Batch/Lot Number: FA7485) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included crohn's disease from an unknown date and unknown if ongoing, gastrooesophageal reflux disease from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE) taken for an unspecified indication, start and stop date were not reported; pantoprazole (PANTOPRAZOLE) taken for an unspecified indication, start and stop date were not reported; hydroxyzine (HYDROXYZINE) taken for an unspecified indication, start and stop date were not reported; mesalamine (MESALAMINE) taken for an unspecified indication, start and stop date were not reported; ondansetron (ZOFRAN [ONDANSETRON]) taken for an unspecified indication, start and stop date were not reported; baclofen (BACLOFEN) taken for an unspecified indication, start and stop date were not reported; naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported. The patient previously took levaquin and experienced hypersensitivity, flexeril [cefixime] and experienced hypersensitivity. The patient experienced severe headache on 30Jul2021 22:00 with outcome of not recovered. Also, significant and persistent pain in the back of her neck on 30Jul2021 22:00 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Aug2021.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pruritus, Varicella
Clinical narrative: Severe Itching Under Stomach/Hips/Legs; Severe Itching Under Stomach/Hips/Legs; Sleepless Nights For More Than 45 Days; Black Spots On The Legs. Like Chicken Pox.; This is a spontaneous report from a contactable consumer. This 58-year-old Female consumer (patient) reported. A 58-years-old non-pregnant female patient 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 27May2021 15:00 (at the age of 58-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not have any allergies. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Jun2021 22:00, the patient experienced severe itching under stomach/hips/legs. Sleepless nights for more than 45 days. Black spots on the legs like chicken pox. The patient did not receive any treatment. Outcome of the event was recovering, at the time of this report. Device time stamp was 04Aug2021. Information on the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: She also had pain in her arm; the second dose she states she also had fever; pain all over her body; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications of the patient were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization and experienced pain in arm. On an unspecified date after second dose of vaccination, patient experienced pain in her arm, also had fever and pain all over her body. Caller stated she knew this was normal. Outcome of the events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: My shoulder, it begin to hurt, it is sore and I can't lay on that side; This is a spontaneous report from a contactable consumer. A 75-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on Mar2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. (at the age of 75 years) Medical history included diabetes, Kidney problem, Asthma Bronchitis, High blood pressure from an unknown date and unknown if ongoing. Concomitant medications included glipizide (GLIPIZIDE) taken for diabetes mellitus, start and stop date were not reported; lisinopril (LISINOPRIL) taken for blood pressure measurement, start and stop date were not reported; Lasix (Unclear and not clarified hence not captured in tab) for diabetes one shot a week. Patient may take some over the counter Tylenol for the pain but nothing else (Further not clarified hence not captured in tab). On an unspecified date of Jun2021 Consumer stated my shoulder, it begins to hurt, it is sore, and I can't lay on that side. Consumer stated, Well, I have been feeling for a while but now that I have started doing a lot of stuff it is been hurts bad for the last couple of weeks and I cannot lay on it because I took the shot it was in the March now, I can't lay on it at all. I cannot lay on that side on the arm it hurts bad. Oh god I want to say I do not know what date it is. Maybe it is the 1st of July it started hurting some but June, July last July around middle July it starts hurting bad and now it is hurting even if I take a nap. I don't know what day it was. It was the middle of June. The outcome of the event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Swelling, Throat tightness, Urticaria
Clinical narrative: My whole body broke out in to a rash; I am breaking out in to hives; My neck is just swelling, like my throat closing up; My neck is just swelling, like my throat closing up; This is a spontaneous report from a contactable consumer or other non healthcare professional. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on 03Aug2021 (Batch/Lot number was not reported) as DOSE NUMBER, UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced whole body broke out in to a rash, breaking out in to hives causing urticaria, had the neck swelling, like the throat closing up and throat tightness on Aug2021 with outcome of unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Headache, Malaise, Nausea
Clinical narrative: pain in arm; Severe headache; malaise; nausea; projectile vomiting; diarrhea; severe abdominal cramping for more than 1 week; This is a spontaneous report from a contactable Physician. This 41-year-old female Physician (patient).  A 41-year-old (non-pregnant) female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 22Jul2021 08:30 AM (at the age of 41-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Penicillin allergy from an unknown onset and unknown ongoing and concomitant medications were not reported. On 23Jul2021, after the vaccination, the patient experienced pain in arm, Severe headache, malaise, nausea, and projectile vomiting and diarrhoea for multiple days and severe abdominal cramping for more than 1 week. Treatment was given with fluids, CT scan, Tylenol/Motrin. No other vaccines were taken in four weeks and no other medications were taken in two weeks. Patient was not diagnosed with covid prior vaccination. The patient lab data includes SARS-CoV-2 test on 29Jul2021, and the result was found to be negative. The outcome of the events was recovering.  No follow-up attempts possible. No further information expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Vomiting projectile
Clinical narrative: pain in arm; Severe headache; malaise; nausea; projectile vomiting; diarrhea; severe abdominal cramping for more than 1 week; This is a spontaneous report from a contactable Physician. This 41-year-old female Physician (patient).  A 41-year-old (non-pregnant) female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 22Jul2021 08:30 AM (at the age of 41-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Penicillin allergy from an unknown onset and unknown ongoing and concomitant medications were not reported. On 23Jul2021, after the vaccination, the patient experienced pain in arm, Severe headache, malaise, nausea, and projectile vomiting and diarrhoea for multiple days and severe abdominal cramping for more than 1 week. Treatment was given with fluids, CT scan, Tylenol/Motrin. No other vaccines were taken in four weeks and no other medications were taken in two weeks. Patient was not diagnosed with covid prior vaccination. The patient lab data includes SARS-CoV-2 test on 29Jul2021, and the result was found to be negative. The outcome of the events was recovering.  No follow-up attempts possible. No further information expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia
Clinical narrative: couldn't stand for a day or 2; This is a spontaneous report from a non-contactable consumer (patient). A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 14Jan2021 (at the age of 62-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included inguinal hernia and concurrent condition included prostate too large. Concomitant medications included tamsulosin hydrochloride (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), oxybutynin (OXYBUTYNIN), and ocrelizumab (OCREVUS). The patient reported he "couldn't stand for a day or 2", on an unspecified date in 2021. The patient reported that he did not have the second dose. No further information was reported. The outcome of the event was reported as resolved on an unspecified date in 2021.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Muscular weakness, Pain in extremity
Clinical narrative: Knot under arm; Could not lift arm up after first vaccine; it hurt to lift her arm; This is a spontaneous report received from a contactable consumer for female patient (reporter's daughter) that. A 15-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 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 and concomitant medications were not reported.  Caller states after her first shot, her daughter had a knot under her arm, and it hurt to lift her arm and a week after the vaccine on an unspecified date. The event outcome was unknown.  The lot number for the vaccine, [Pfizer-BioNTech Covid-19 Vaccine], was not provided and will be requested during follow up.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain in extremity, Pyrexia, Restlessness
Clinical narrative: had a restless night; had pain at the site of injection; headache; low grade fever; does not feel well; arm pain, when she lifts her arm up; This is a spontaneous report from a contactable consumer or other non-hcp (Patient's mother). A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 15-year) on 03Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 administered on an unspecified date for COVID-19 immunization; after the first shot the patient experienced, knot under arm, could not lift arm up a week after the vaccine. On an unspecified date in 2021 the patient experienced headache, had a restless night, had pain at the site of injection, low grade fever, does not feel well, arm pain, when she lifts her arm up. Caller stated her daughter got her second shot yesterday. The clinical outcome of the events was unknown.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: had a restless night; had pain at the site of injection; headache; low grade fever; does not feel well; arm pain, when she lifts her arm up; This is a spontaneous report from a contactable consumer or other non-hcp (Patient's mother). A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 15-year) on 03Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 administered on an unspecified date for COVID-19 immunization; after the first shot the patient experienced, knot under arm, could not lift arm up a week after the vaccine. On an unspecified date in 2021 the patient experienced headache, had a restless night, had pain at the site of injection, low grade fever, does not feel well, arm pain, when she lifts her arm up. Caller stated her daughter got her second shot yesterday. The clinical outcome of the events was unknown.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Ear pain, Inflammation
Clinical narrative: ear ache; inflammatory response; This is a spontaneous report from contactable pharmacist. A 34-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 01Jul2021 as dose 1, single for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (she also revealed that, prior to taking the 1st dose of the Pfizer covid vaccine, she was diagnosed with Covid-19, date is unknown). The patient's concomitant medications were not reported.  The patient experienced earache and inflammatory response in 2021 and caller wants to know if this might be related to her body's immune response, because of the high antibodies. Caller stated patient returned last week for the second and revealed that she had an antibody test that resulted in a high titer results, she also revealed that, prior to taking the 1st dose of the Pfizer covid vaccine, she was diagnosed with Covid-19, date is unknown. Caller inquired should the patient receive the second dose of the Pfizer Covid vaccine since her antibodies came back high. Antibody testing was not currently recommended to assess for immunity to SARS-CoV-2 following COVID-19 vaccination because the clinical utility of post-vaccination testing has not been established. Antibody tests currently authorized under an EUA icon have variable sensitivity, specificity, as well as positive and negative predictive values, and were not authorized for the assessment of immune response in vaccinated people. Furthermore, the serologic correlates of protection have not been established, and antibody testing does not evaluate the cellular immune response, which might also play a role in vaccine-mediated protection. Finally, antibody testing against nucleocapsid would not detect immune responses resulting from vaccination, but patients might not always know what type of antibody test was used. If antibody testing was performed following vaccination, additional doses of the same or different COVID-19 vaccines were not recommended based on antibody test results at this time. If antibody testing was done after the first dose of an mRNA vaccine, the vaccination series should be completed regardless of the antibody test result. She does not have number for her titers. She was having earache and inflammatory response after the first dose and went to her PCP and he consulted back to them. They cannot figure out what is causing earache and inflammation. The other pharmacist got all the information yesterday and did not have time to contact Pfizer and only contacted VAER's last night. The patient underwent lab tests and procedures which included antibody test: high titer in 2021. The outcome of events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Pyrexia, Swelling
Clinical narrative: High fevers; Swelling and pain under his left armpit.; Swelling and pain under his left armpit.; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient reported for himself). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of 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 as dose 1, single for COVID-19 immunisation. Caller states that patient received his 2nd dose of the Pfizer COVID-19 vaccination on Tuesday morning. The day after he experienced on unknown date high fevers that have since resolved. His concern today is after receiving the vaccine in his left arm, he now has swelling and pain under his left armpit. Caller would like to know how long to expect the side effects to last. The outcome of the event pyrexia was reported as recovered on unknown date and while other events was unknown.  Information on lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Condition aggravated, Dermatitis contact, Skin swelling, Swelling
Clinical narrative: flares ups; face gets a little puffy; swollen; welts; a lot of cosmetics; lips get cracked; This is a spontaneous report from a  sponsored program . A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as UNKNOWN, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that "she has an allergy to gallates (cant really spell it) something like propyl gallates and like doxyoxy. not really sure, it's like a bunch of gallates they put in preservatives, propeloxidal, like oxyitol?? doxyotol. Patient has seen a list of ingredients, what was says is it that like if you are allergic to PEG, propylene gallates and all that do not get the Pfizer vaccine, the CDC has that list do not get the vaccine if you are allergic to what I am allergic to". Patient Stated that, she has been to a few HCP and no one would tell her not to get it no one would tell her to get it. On an unspecified date, she not had severe reactions but gets flares ups all the time, like an internal, lips get cracked and puffed, face gets a little puffy, swollen sometimes and had welts, usually from a lot of cosmetics and it could be food but over the past year, year and a half has been having a lot more flare ups, so when she has gone to the doctors she said maybe in some of her food it was effecting her a little more. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: flares ups; face gets a little puffy; swollen; welts; a lot of cosmetics; lips get cracked; This is a spontaneous report from a  sponsored program . A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as UNKNOWN, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that "she has an allergy to gallates (cant really spell it) something like propyl gallates and like doxyoxy. not really sure, it's like a bunch of gallates they put in preservatives, propeloxidal, like oxyitol?? doxyotol. Patient has seen a list of ingredients, what was says is it that like if you are allergic to PEG, propylene gallates and all that do not get the Pfizer vaccine, the CDC has that list do not get the vaccine if you are allergic to what I am allergic to". Patient Stated that, she has been to a few HCP and no one would tell her not to get it no one would tell her to get it. On an unspecified date, she not had severe reactions but gets flares ups all the time, like an internal, lips get cracked and puffed, face gets a little puffy, swollen sometimes and had welts, usually from a lot of cosmetics and it could be food but over the past year, year and a half has been having a lot more flare ups, so when she has gone to the doctors she said maybe in some of her food it was effecting her a little more. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; This is a spontaneous report from a  sponsored program . A contactable consumer (Patient's mother) reported for a patient (Reporter's daughter).  A female patient of an unspecified age received first dose of bnt162b2 (Pfizer Covid-19 Vaccine, Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller reported that her daughter got the first dose 4 months ago. She was not able to get the 2nd dose because she was sick. Caller wanted to know if her daughter can take the second dose or does she have to go all over again with the first dose. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I have been having a pain in same section, in same area where the needle was inserted; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), dose 2 via an unspecified route of administration on 31Mar2021 (at the age of 63-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (at the age of 62-year-old) on an unspecified date in 2021 for COVID-19 immunization. Patient stated, I had been having some side effects I believe from the vaccine. I received it from, four months ago but almost every night after a month of it, I had been having a pain in same section, in same area where the needle was inserted on an unspecified date in 2021. It became more intense right now it more intense, every evening when I came home, I was having that serious pain when I go to bed. Patient stated date of first shot "It was 3 weeks before that" and further not clarified. Consumer stated date of adverse event "May be a month after the vaccine (Confirmed as second dose) was administered." Patient again stated, "No, I had not taking any medication for it, I was just concerned every night same problem, we are right now speaking, I was still feeling the same." Patient stated I went to a hospital. It was general hospital, government facility. Patient stated I know persons who are facing the same thing, but they are not family, but they are friends have the same problem. There was no investigation assessment. The clinical outcome of event was not recovered.  Follow-up activities closed. Batch/lot number not available for [Vaccine, BNT162B2].
Sex: U
Vaccine: COVID19
Symptoms: Petechiae, SARS-CoV-2 test
Clinical narrative: petechial rash; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on 28Apr2021 as a DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced petechial rash on an unspecified date in 2021. The patient said that, was currently working on Covid diagnostics. I received my first Covid vaccine on 28Apr2021. Right after, my arm displayed a severe 'petechial rash', as diagnosed by my PCP, and I was recommended not to take the booster shot. Three months later, my whole family got sick with Covid (all of them symptomatic with fever, vomit and lethargic), probably with delta variant because of the RNA amplification display. And I stayed confined at home with all three of them, taking care of them, for two weeks. And against all odds, I did NOT get the disease. Patient said, I keep testing myself several times a week (qPCR), and I always come back negative. The patient underwent lab tests and procedures which included sars-cov-2 test that was negative on an unspecified date. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: she is breaking out hives; This is a spontaneous report from a contactable Consumer or other non-HCP (mother of patient) reported for a female patient (daughter). A 15-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Lot Number: UNKNOWN) 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 breaking out hives. Reported stated that her daughter who is fifteen and half just got her first Pfizer Covid shot(Further not clarified hence captured as Unspecified vaccine) and she was breaking out hives. It did not seem to wear and was asking if she could put her daughter on Benadryl. The patient outcome of the event was unknown at the time of this report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Cough, Decreased appetite, Gait disturbance
Clinical narrative: fever of 103; every muscle and joint in her body is hurting; every muscle and joint in her body is hurting; difficult to walk with the pain; coughing; sneezing; no appetite; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 04Aug2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced fever of 103, every muscle and joint in her body is hurting, difficult to walk with the pain, coughing, sneezing and no appetite. Patient took vaccine yesterday 04Aug2021. Stated everything that she read basically said after the first dose you will get a headache and a sore arm. She was sitting there now with a fever of 103, it had been going up; every muscle and joint in her body is hurting; and it was difficult to walk with the pain; she was coughing and sneezing and has no appetite. She asked should she take the second does? that was three weeks from now and this was just the first dose, asking with these side effects. Call sound was broken but sounds like caller asked if these are side effects? Another voice was heard stating, he already reported and she should go to the emergency room. Patient then stated looks like she should go to the emergency room. The patient underwent lab tests and procedures which included body temperature: 103 on Aug2021. The outcome of events was unknown.   Follow-up attempts are completed. No further information is expected.