chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Hypopnoea, Illness, Nasopharyngitis, Pain
Clinical narrative: Became sick; Sick with overnight cold lots of mucus and chills; Chills; Coughing; Headache; Body pain; Shallow breathing; No energy; Lots of mucus; Sinus ran on; Felt like I was sweating but when I touched the skin it was dry.; Slept for long periods if time.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 13Jun2021 at 10:30 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, neuropathy and acute migraine. The patient had known allergies to Xray dye. Concomitant medications included metformin (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN) and acetylsalicylic acid (BAYER ASPIRIN); all from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 23May2021 at 10:30 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Jun2021 at 08:00, the patient experienced sick with overnight cold, lots of mucus and chills, coughing, headache for 4 days then some of mucus cleared up but headache and sinus ran on, body pain, shallow breathing, felt like she was sweating but when touched the skin it was dry, no energy, slept for long periods of time. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events sick with overnight cold, lots of mucus, chills, coughing, headache, sinus ran on, body pain, shallow breathing, no energy and slept for long periods of time were resolving at the time of this report.    The batch/lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Secretion discharge, Sinusitis
Clinical narrative: Became sick; Sick with overnight cold lots of mucus and chills; Chills; Coughing; Headache; Body pain; Shallow breathing; No energy; Lots of mucus; Sinus ran on; Felt like I was sweating but when I touched the skin it was dry.; Slept for long periods if time.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 13Jun2021 at 10:30 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, neuropathy and acute migraine. The patient had known allergies to Xray dye. Concomitant medications included metformin (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN) and acetylsalicylic acid (BAYER ASPIRIN); all from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 23May2021 at 10:30 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Jun2021 at 08:00, the patient experienced sick with overnight cold, lots of mucus and chills, coughing, headache for 4 days then some of mucus cleared up but headache and sinus ran on, body pain, shallow breathing, felt like she was sweating but when touched the skin it was dry, no energy, slept for long periods of time. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events sick with overnight cold, lots of mucus, chills, coughing, headache, sinus ran on, body pain, shallow breathing, no energy and slept for long periods of time were resolving at the time of this report.    The batch/lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Approximately 4-6 weeks after last vaccination, began to have constant salty taste in my mouth which continues to this day.  It's more pronounced when I eat anything containing lemon juice.; This is a spontaneous report from a non-contactable consumer, the patient. A non-pregnant female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on an unknown date in Apr2021 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included calcium (MANUFACTURER UNKNOWN) and melatonin (MANUFACTURER UNKNOWN) and OTC sleep aid (MANUFACTURER UNKNOWN), all medications taken for an unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG207) via an unspecified route of administration in the left arm on an unknown date in Mar2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in May2021, approximately 4-6 weeks after last vaccination the patient experienced to have constant salty taste in the mouth which continued to the date of this report. It was more pronounced when the patient ate anything containing lemon juice. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event salty taste in the mouth was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: two patients complain of nose bleeds after receiving the Pfizer vaccine; This is a spontaneous report received from a contactable Pharmacist via Pfizer sales representative. This Pharmacist reported similar events for two patients. This is 2nd of two reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was stated that two patients complain of nose bleeds after receiving the pfizer vaccine on an unspecified date. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021786333 same reporter/drug/event, different patient
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hyperhidrosis, Muscular weakness
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 11May2021(at the age of 30-year-old) and second dose of of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 01Jun2021(at the age of 30-year-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient previously received amoxicillin on an unknown date and for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11May2021 the patient experienced  severe muscle weakness, joint pain ever since receiving the first vaccine and also had sweat heavily when sleeping. No therapeutic measures were taken as a result of adverse event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe muscle weakness, joint pain and also sweat heavily when sleeping were not resolved.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Arthritis, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 22Apr2021 at 14:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included ulcer, hypertension and pollen allergy. Concomitant medications included ADVIL, herbal enzyme supplements, and famotidine. The patient previously received fluorescein dye on an unknown date and experienced allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 01Apr2021 at 14:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021 at 12:00, the patient experienced arthritis-like pain in several joints, bilateral. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of these adverse events. On an unknown date, the patient underwent Nasal Swab test and the result was negative. The clinical outcome of the events arthritis-like pain in several joints, bilateral was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood pressure decreased, Blood test, Chills, Computerised tomogram
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 22Apr2021 at 14:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included ulcer, hypertension and pollen allergy. Concomitant medications included ADVIL, herbal enzyme supplements, and famotidine. The patient previously received fluorescein dye on an unknown date and experienced allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 01Apr2021 at 14:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021 at 12:00, the patient experienced arthritis-like pain in several joints, bilateral. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of these adverse events. On an unknown date, the patient underwent Nasal Swab test and the result was negative. The clinical outcome of the events arthritis-like pain in several joints, bilateral was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Impaired driving ability, Insomnia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 22Apr2021 at 14:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included ulcer, hypertension and pollen allergy. Concomitant medications included ADVIL, herbal enzyme supplements, and famotidine. The patient previously received fluorescein dye on an unknown date and experienced allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 01Apr2021 at 14:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021 at 12:00, the patient experienced arthritis-like pain in several joints, bilateral. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of these adverse events. On an unknown date, the patient underwent Nasal Swab test and the result was negative. The clinical outcome of the events arthritis-like pain in several joints, bilateral was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint stiffness, Muscular weakness, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 22Apr2021 at 14:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included ulcer, hypertension and pollen allergy. Concomitant medications included ADVIL, herbal enzyme supplements, and famotidine. The patient previously received fluorescein dye on an unknown date and experienced allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 01Apr2021 at 14:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021 at 12:00, the patient experienced arthritis-like pain in several joints, bilateral. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of these adverse events. On an unknown date, the patient underwent Nasal Swab test and the result was negative. The clinical outcome of the events arthritis-like pain in several joints, bilateral was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Moderate to severe Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 02May2021 at 12:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications of the patient was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 05Apr2021 at 12:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 12:00, after the second shot, the patient experienced moderate to severe headache, which lasted longer than a month. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event moderate to severe headache was recovered on an unknown date in Jun2021.   No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Running a mid to high fever and pain in the left arm and body pain as well.; Running a mid to high fever and pain in the left arm and body pain as well.; Running a mid to high fever and pain in the left arm and body pain as well.; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 26Jun2021 at 11:30(at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the right arm on 05Jun2021 at 18:00(at the age of 13-years-old) as a single dose for COVID-19 immunisation. On 17Jun2021, patient received unspecified allergy shot on both arms within four weeks prior to COVID vaccine. 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 27Jun2021 at 03:30, the patient experienced running a mid to high fever and pain in the left arm and body pain as well. Therapeutic measures were not taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events running a mid to high fever and pain in the left arm and body pain as well was not recovered, at the time of this report.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Muscle spasms
Clinical narrative: My periods have been extremely heavy and extremely clotty and I'm on my 3rd cycle now and no improvement; I'm on my 3rd cycle now and no improvements/ I'm also experiencing more cramping; This is a spontaneous report from a non-contactable consumer (patient). The 38-year-old female consumer reported that.  The 38-years-old female patient received dose 2 of bnt162b2 (BNT162B2, solution for injection) (Batch/Lot number: Unknown) via unspecified route of admnistrtaion on 13May2021 at 08:00 AM as single for COVID-19 immunisation. The medical history and concomitant medication were not reported. The historical vaccine included dose 1 of bnt162b2 (BNT162B2, solution for injection) (Batch/Lot number: Unknown) via unspecified route of admnistrtaion on 22Apr2021 at 08:00 AM as single for COVID-19 immunisation. 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. Patient was not diagnosed with COVID-19 Prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. On 28Apr2021 patient reported that since her first dose her periods had been extremely heavy and extremely clotty. She was on her 3rd cycle now and no improvements. She was also experiencing more cramping. She had to change a supersized tampon every 2 hours for the first 2-3 days of her period. Her period was never like this before. Prior to being vaccinated she had change a super tampon every 6-8 hours for the first 2-3 days and had maybe one or two clots. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammatory pain
Clinical narrative: Both of my knees and both of my hips have really bad painful inflammation after the 2nd dose of the Pfizer vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 26Jun2021 at 13:00 as a single dose for COVID-19 immunisation. The patient medical history was unknown. The patient did not have any allergies to food, medications or other products. The patient did not receive any other concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications or vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on 05Jun2021 at 13:00 as a single dose for COVID-19 immunisation. On 27Jun2021, the day after second dose the patient both knees and both hips had bad painful inflammation. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event both knees and both hips had bad painful inflammation was not recovered at the time of this report.    No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac stress test, Dyspnoea
Clinical narrative: shortness of breath; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported. A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and Expiration date was not reported), via an unspecified route of administration, on an unknown date, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number and Expiration date was not reported), via an unspecified route of administration, on an unspecified date in Mar2021, as a single dose for covid-19 immunization and felt unwell. The patient reported that I got your Covid 19 vaccine in Mar2021. I had been exercising an hour a day prior to the vaccine for the past several years. However, after the vaccine when I felt unwell I stopped exercising. After the second vaccine I tried to start exercising again and had shortness of breath while doing so. I went to the doctor who sent me for a nuclear stress test. The results are that I have a "fixed defect" in my heart! I never had any heart problems with my heart prior to the vaccine. Outcome of the event was reported as unknown.  Follow-up attempts are possible. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Both of us feel pretty bad for 3days; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0217, NDC number and Expiration date: Unknown), via an unspecified route of administration, administered on Arm left on 23Jun2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient reported as both of us feel pretty bad for 3 days on an unspecified date in Jun2021. Treatment medication included Tylenol. Outcome of the event was recovered on an unspecified date in Jun2021.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: a little bit difficulty on breathing; 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, Expiration date, NDC and UPC number was unknown), via an unspecified route of administration on 25Jun2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date, NDC and UPC number was unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation and had no reaction. On Jun2021, patient experienced a little bit difficulty on breathing. Patient asked should he/she go to the hospital right now. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Somnolence
Clinical narrative: Has been miserable for 4 months being sick with the shot; For the first three weeks all the caller did was asleep; This is a spontaneous report from a contactable other healthcare professional (patient). A 83-years-old female patient received bnt162b2 (PFIZER COVID 19, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 06Mar2021 (at the age of 83-years-old) as dose 1, single for covid-19 immunisation. Medical history included osteoporosis (caller has osteoporosis. Caller states her mother had osteoporosis too) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Investigation Assessment was no. The caller was a retired Advanced Nurse Practitioner who states she has been miserable for 4 months being sick with this Pfizer Covid 19 shot. For the first three weeks all, the caller did was asleep. The caller could not hold eyes open. She received the first shot on 06Mar2021, and the caller was sleepy for the whole three weeks before getting the second dose Pfizer Covid 19 shot. The caller states she shrunk to 5 feet. The caller has osteoporosis. The caller clarifies this occurred prior to receiving the Pfizer Covid 19 shot. The caller had osteoporosis prior to receiving the Pfizer Covid 19 shot. The caller states her mother had osteoporosis too. The caller was still sleepy now. The caller states the sleepiness was getting better now. The caller gave her vaccine card to her daughter and the caller's daughter was at work. The outcome of event has been miserable for 4 months being sick with the shot was unknown and for the first three weeks all the caller did was asleep was resolving.  The batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Muscle disorder, Muscle tightness, Myalgia
Clinical narrative: all the caller's muscles didn't want to work; After receiving the second dose Pifzer Covid 19 shot a pain hit the caller's muscles./ muscles all sore and tightened up.; The caller could hardly walk.; muscles all sore and tightened up; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported, Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Left arm on an unspecified date in 2021 (at the age of 83-year-old) as single for covid-19 immunisation. Patient's medical history included osteoporosis from an unknown date and unknown if ongoing, she had osteoporosis prior to receiving the Pfizer Covid 19 shot. Patient's mother had osteoporosis. Historical vaccine included bnt162b2 (BNT162B2, solution for injection), dose 1, administered in Left arm on 06Mar2021 as single for COVID-19 immunisation, was being sick and all the first three weeks patient did was asleep. The patient's concomitant medications were not reported. The patient stated that after receiving the second dose Pfizer Covid 19 shot, a week after on an unspecified date in 2021, all the caller's muscles didn't want to work: The second shot did not effect the caller until a week after the caller received the second dose Pfizer Covid 19 shot. After receiving the second dose Pifzer Covid 19 shot a pain hit the caller's muscles. The caller couldn't straighten her arm out, nothing worked. The caller could hardly walk. Everything muscles all sore and tightened up. The muscle relaxer was the only thing that helped the caller move, because the caller lives alone. After receiving the second dose Pfizer Covid 19 shot, a week after, all the caller's muscles didn't want to work: The caller's right arm didn't want to work at all. The caller stated this has improved because it wasn't all over, it was just the caller's one extremity The caller reported that taking Tylenol because the caller was hurting an awful lot after receiving the Pfizer Covid 19 Shot. The caller states she started taking the Tylenol a few weeks after receiving the Pfizer Covid 19 Shot thinking the hurting would go away. Outcome of the events was reported as resolving.  Information on Lot/Batch information has been requested.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: Pain at injection site; Swelling at injection site; Rash around injection site; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 26Jun2021 at 16:45 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety disorder. The patient was not allergic to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Jun2021 at 00:00, the patient experienced pain at injection site, swelling at injection site and rash around injection site. Therapeutic measures were taken as a result of the events which included treatment with BENADRYL and ibuprofen. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The clinical outcome of the events of pain at injection site, swelling at injection site and rash around injection site was not resolved at the time of this report.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Extreme swelling in lymph node in arm pit; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 24Jun2021 at 16:00 (at the age of 42-years) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications included Birth control unspecified medications in two weeks. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 03Jun2021 at 04:15 (at the age of 42-years) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Jun2021 at 02:00, the patient experienced extreme swelling in lymph node in arm pit. The patient did not receive treatment for event. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Lip erythema, Lip swelling, Oropharyngeal discomfort, Oropharyngeal pain
Clinical narrative: I also starting coughing last night; Swelling of lips; tongue is swollen; Tingling tongue and lips; redness around her lips and tongue; redness around her lips and tongue; my throat is sore; my throat is sore, itchy and force like I am talking for the long time and I feel force; My throat is tired you know when you are taking for long time and you cant talk/ I  feel force; This is a spontaneous report received from a Pfizer Sponsored program. A contactable female consumer (patient) of an unspecified age reported that she received bnt162b2 (BNT162B2 Solution for injection), dose 2 via an unspecified route of administration on 24Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced i also starting coughing last night on 25Jun2021, swelling of lips, tongue is swollen, tingling tongue and lips, redness around her lips and tongue, my throat is sore and  my throat is sore, itchy and force like i am talking for the long time and i feel force and my throat is tired you know when you are taking for long time and you cant talk/ i  feel force on Jun2021. The outcome of the events was unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Swollen tongue, Throat irritation, Tongue erythema
Clinical narrative: I also starting coughing last night; Swelling of lips; tongue is swollen; Tingling tongue and lips; redness around her lips and tongue; redness around her lips and tongue; my throat is sore; my throat is sore, itchy and force like I am talking for the long time and I feel force; My throat is tired you know when you are taking for long time and you cant talk/ I  feel force; This is a spontaneous report received from a Pfizer Sponsored program. A contactable female consumer (patient) of an unspecified age reported that she received bnt162b2 (BNT162B2 Solution for injection), dose 2 via an unspecified route of administration on 24Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced i also starting coughing last night on 25Jun2021, swelling of lips, tongue is swollen, tingling tongue and lips, redness around her lips and tongue, my throat is sore and  my throat is sore, itchy and force like i am talking for the long time and i feel force and my throat is tired you know when you are taking for long time and you cant talk/ i  feel force on Jun2021. The outcome of the events was unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain; This is a spontaneous report from a contactable Other HCP ( Specialty Pharmacy). This Other HCP reported for a female patient that: A 47-years-old female patient received first dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 1, single on an unspecified date for covid-19 immunisation. The patient's medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. Patient's past drug event history included Xeljanz XR at 11mg daily orally for Rheumatoid Arthritis in 2019. On unspecified date, the patient experienced pain. At the time of this report, outcome of the event was unknown.  Information on lot/batch number has been requested.  No Follow up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Muscle spasms
Clinical narrative: Irregular menstrual cycle; Heavier bleeding than normal; Debilitating cramps; This is a spontaneous report received from a contactable consumer reported herself (Patient).  A 29-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration at left arm on 11Jun2021 11:45 (at the age of 29-year-old) (Batch/Lot number: Not provided) as single dose for COVID-19 immunisation. Medical history included allergies, asthma, cats allergy, nut allergy, latex allergy, pollen allergy, celery allergy and apples allergy. Concomitant medication included loratadine (CLARITINE). The patient other medications in two weeks included allergy shots. The patient previously took ciprofloxacin and experienced known allergies. Patient was not pregnant at the time vaccination. Patient did not receive any other vaccines within the 4 weeks. Patient do not have COIVD prior to vaccination. The patient experienced Irregular menstrual cycle. Spotting within 48 hours of vaccine (taken before ovulation). Period two weeks earlier than normal and was lasting much longer. Heavier bleeding than normal. Debilitating cramps on 12Jun2021 at 12:00 AM. Patient did not receive any treatment for the events. Outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hypoaesthesia, Paraesthesia
Clinical narrative: Brain fog; Fatigue; Numbness; Tingling in my left arm and left side of my face.; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 30Apr2021 at 11:00(at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and allergy to penicillins, latex, sulfas, shellfish. Concomitant medications included vitamins nos (MULTIVITAMIN) started on an unknown date for unspecified indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01May2021 at 08:00, two months after the first vaccine, the patient still experience brain fog, fatigue and numbness and tingling in her left arm and left side of her face. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events brain fog, fatigue, numbness and tingling in left arm and left side of face were not recovered at the time of this report.   The lot/batch number for the vaccine (BNT162b2) was not provided and will be requested during follow up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; The initial safety information received was reporting only a non-serious adverse drug reaction, upon receipt of follow-up information on 13Aug2021, this case now contains a serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), intramuscular, administered in the left arm (also reported as 'left upper arm) on 03Mar2021 at 12:00 (Lot Number: EN6202) as dose 2, single for COVID-19 immunization. Medical history included high BP from an unknown date, ongoing Lichen sclerosis from 1987, cholesterol (as reported) from an unknown date, Differentiated VIN- 3 from 01Jan2017 to 20Jan2018 (wide excision vulva), hormone replacement from an unknown date and herpes from an unknown date. The patient did not have COVID-19 prior to vaccination. The patient has not been tested for COVID-19 prior to vaccination. Concomitant medications included atorvastatin (manufacturer unknown) taken for cholesterol abnormal from 2009 and ongoing; metoprolol (manufacturer unknown) taken for blood pressure from 2009 and ongoing; zolpidem (manufacturer unknown) taken for an unspecified indication, start and stop date were not reported; estradiol (manufacturer unknown) taken for hormone replacement from 2016 and ongoing; aciclovir (manufacturer unknown) taken for herpes from 2009 and ongoing and clobetasol (manufacturer unknown) taken for lichen sclerosis from 2000 and ongoing.  The patient previously received simvastatin and experienced deep muscular pain and topical Retin A and experienced allergy. The patient previously received the first dose of BNT162B2 on 08Feb2021 at 03:00 (lot number: EL9269) in the left upper arm for COVID-19 immunization. The patient experienced sudden onset of tinnitus on 05Mar2021 at 08:00. The event required a visit to the Physician's office and did not receive treatment for the event. The outcome of the event was not recovered. The event was considered as serious (important medical event).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Sleepy; This is a spontaneous report from a non-contactable nurse, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 19Jun2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Jun2021, the patient experienced sleepy. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sleepy was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Had several episodes of heart palpitations; This is a spontaneous report from a non-contactable consumer, the patient. A 14-year-old non-pregnant female patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within two 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. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient had none known allergies to medications, food or other products. On an unknown date, second day after second dose, the patient had several episodes of heart palpitations, which ended after third day. There was no pain or shortness of breath. The event had resulted in a visit to the doctors or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event several episodes of heart palpitations was recovered on an unknown date, at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Head discomfort, Headache, Nasal congestion, Pain
Clinical narrative: Severe Headache; Severe Chest Pain; head and nose congestion; head and nose congestion; body aches; arm pain; This is a spontaneous report from a contactable consumer (patient). A 65-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection Lot Number: EW0187), via an unspecified route of administration, administered in Arm Right on 25Jun2021 14:30 as dose 1, single for COVID-19 immunization. Patient medical history included asthma, Afib (atrial fibrillation), HTN, cholesterol, overweight and patient had known allergies. The concomitant medications were not reported. It was stated that, she did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She had received other medications within 2 weeks of vaccination. She was not diagnosed with COVID-19, prior to vaccination and tested for COVID-19 since the vaccination. On 26Jun2021 02:30, the patient experienced severe headache, severe chest pain, head and nose congestion, body aches and arm pain. Patient did not receive any treatment for the events. The seriousness of the event was considered as non-serious. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe Headache; Severe Chest Pain; head and nose congestion; head and nose congestion; body aches; arm pain; This is a spontaneous report from a contactable consumer (patient). A 65-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection Lot Number: EW0187), via an unspecified route of administration, administered in Arm Right on 25Jun2021 14:30 as dose 1, single for COVID-19 immunization. Patient medical history included asthma, Afib (atrial fibrillation), HTN, cholesterol, overweight and patient had known allergies. The concomitant medications were not reported. It was stated that, she did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She had received other medications within 2 weeks of vaccination. She was not diagnosed with COVID-19, prior to vaccination and tested for COVID-19 since the vaccination. On 26Jun2021 02:30, the patient experienced severe headache, severe chest pain, head and nose congestion, body aches and arm pain. Patient did not receive any treatment for the events. The seriousness of the event was considered as non-serious. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.