chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller had the first dose and experienced a headache, she wanted to know if she can take a pain reliever for it. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Lymphadenopathy, Malaise, Pain
Clinical narrative: Generally unwell; Fever; sever body aches; injection site Pain; Chills; lymph node swelling on side of injection; This is a spontaneous report from a non-contactable consumer.   A 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration (at the age of 33) single dose arm left on 04Feb2021 10:30 for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient received the first dose of BNT162B2 right arm on 14Jan2021 03:00PM. No other vaccine was received in four weeks.  The patient experienced generally unwell, fever, sever body aches, injection site pain, chills, lymph node swelling on side of injection, all on 05Feb2021 12:00. The events outcome was not recovered.  No follow-up attempts are possible. No further information is expected
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Generally unwell; Fever; sever body aches; injection site Pain; Chills; lymph node swelling on side of injection; This is a spontaneous report from a non-contactable consumer.   A 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration (at the age of 33) single dose arm left on 04Feb2021 10:30 for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient received the first dose of BNT162B2 right arm on 14Jan2021 03:00PM. No other vaccine was received in four weeks.  The patient experienced generally unwell, fever, sever body aches, injection site pain, chills, lymph node swelling on side of injection, all on 05Feb2021 12:00. The events outcome was not recovered.  No follow-up attempts are possible. No further information is expected
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dehydration, Heart rate, Heart rate increased
Clinical narrative: Increased heart rate; Feeling very dehydrated; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization and lisinopril, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for hypertension. Medical history included patient was prediabetic. The patient's concomitant medications were not reported. On an unspecified date in 2021, patient was having a little bit of concern, she just had side effects that were a little scary. She have had like an increased heart rate and now, feeling very dehydrated. The action taken in response to the events for lisinopril was unknown. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: arm is sore; little muscle soreness; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 05Feb2021, at single dose, for COVID-19 immunization. Medical history included being disabled. The patient's concomitant medications were not reported. The patient reported he had his shot on 05Feb2021. In Feb2020, his arm was sore and had a little muscle soreness. The patient stated that he goes to the gym and has a hard work out and asked if it was okay to take Tylenol or Motrin. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a Pfizer-sponsored program  from a contactable consumer (patient).  A male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Feb2021 at single dose as Covid-19 Vaccine. The patient's medical history and concomitant medications were not reported. The patient got his 1st dose on 10Feb2021 and he wanted to know if there were any complications because 2 weeks before his 2nd dose appointment he would be having a shot for his shingles. The outcome of event was unknown.  Information about Lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia
Clinical narrative: overall "odd" feeling throughout my entire body; Right leg numbness; This is a spontaneous report from a contactable nurse, the patient. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK4176, first dose) solution for injection intramuscular in the left arm on 04Jan2021 at 12:00 (at the age of 38-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included migraines, PFO with closure, stroke, PNA (pneumonia) in 2002 and Covid on an unknown date. Concomitant medications included ASA and ibuprofen for headaches. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The evening of the initial injection (04Jan2021 at 17:00) the patient had an episode of right leg numbness and an overall "odd" feeling throughout my entire body. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if treatment was provided for the events odd feeling and right leg numbness. The outcome of the events odd feeling and right leg numbness was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vulvovaginal mycotic infection
Clinical narrative: Vaginal Yeast Infection; This is a spontaneous report from a contactable healthcare professional, the patient. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the right arm on 19Jan2021 at 20:15 (at the age of 42-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included multiple sclerosis. Concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient had COVID-19 (date unknown). Lab test included Nasal Swab on 18Jan2021 was negative. On 21Jan2021, the patient experienced vaginal yeast infection. Treatment for the event vaginal yeast infection included miconazole (MONISTAST 3 day). The outcome of the event vaginal yeast infection was recovered in 2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Nausea, Pain
Clinical narrative: sore arm; fever up to 101.3 (fever dropped to 99 with tylenol, was still at 100 30 hours after injection); full body chills and aches; full body chills and aches; nausea; loss of appetite; 1 instance of vomiting after eating a banana; This is a spontaneous report from a non-contactable healthcare professional.  A 29-year-old female patient received second dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN5318), via an unspecified route of administration on the right arm on 04Feb2021 08:00 at single dose for COVID-19 immunisation.  Medical history included chronic lung illness and sulfa allergy.  Patient has unspecified concomitant medication. The patient previously took BNT162B2 on 13Jan2021 first dose (lot number=EL3249) on the right arm; Allergies: CEFZIL, amoxycillin and NEOSPORIN.  The patient experienced sore arm, fever up to 101.3 (fever dropped to 99 with TYLENOL, was still at 100, 30 hours after injection), full body chills and aches, nausea, loss of appetite, 1 instance of vomiting after eating a banana on 04Feb2021 04:00. Other events does not received treatment.  The outcome of the events were recovered on Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: sore arm; fever up to 101.3 (fever dropped to 99 with tylenol, was still at 100 30 hours after injection); full body chills and aches; full body chills and aches; nausea; loss of appetite; 1 instance of vomiting after eating a banana; This is a spontaneous report from a non-contactable healthcare professional.  A 29-year-old female patient received second dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN5318), via an unspecified route of administration on the right arm on 04Feb2021 08:00 at single dose for COVID-19 immunisation.  Medical history included chronic lung illness and sulfa allergy.  Patient has unspecified concomitant medication. The patient previously took BNT162B2 on 13Jan2021 first dose (lot number=EL3249) on the right arm; Allergies: CEFZIL, amoxycillin and NEOSPORIN.  The patient experienced sore arm, fever up to 101.3 (fever dropped to 99 with TYLENOL, was still at 100, 30 hours after injection), full body chills and aches, nausea, loss of appetite, 1 instance of vomiting after eating a banana on 04Feb2021 04:00. Other events does not received treatment.  The outcome of the events were recovered on Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This is a spontaneous report from a contactable consumer (the patient). A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9264), via an unspecified route of administration on 03Feb2021 07:00 (at the age of 68-years-old) as a single dose for COVID-19 immunization. There was no medical history and no concomitant medications. On 04Feb2021, the patient had two side effects, fever and chills. The patient got his shot about 7 am (03Feb2021), and about 1 or 2 O'clock the next morning (04Feb2021), he woke up with fever and chills. He did not receive any treatment. He will get the second shot. The clinical outcome of fever and chills was recovered on an unspecified date.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Tremor, Vaccination site pain
Clinical narrative: Severe chills/shakes; tremors; body aches; soreness at injection site; This is a spontaneous report from a contactable consumer.  A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL9266), via an unspecified route of administration into the left arm on 16Feb2021, at 14:30 as single dose for covid-19 immunization.  Medical history included pacemaker since an unknown date, stent from an unknown date.  Concomitant medication included rosuvastatin calcium (CRETOR), metoprolol (METOPROLOL).  The patient previously received the first dose of BNT162B2 (Lot number EL9262)on 26Jan2021 for covid-19 immunization. The patient experienced severe chills/shakes on 17Feb2021, at 09:00 with outcome of recovered in Feb2021; tremors on 17Feb2021, at 09:00 with outcome of recovered in Feb2021; body aches on 17Feb2021, at  09:00 with outcome of recovered in Feb2021; soreness at injection site in Feb2021 with outcome of recovered in Feb2021.  No treatments were given for the events. The patient recovered from all of the events in Feb2021.   No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: developed shingles after getting the Covid-19 vaccine; This is a spontaneous report from a contactable nurse. This nurse reported for a 72-year-old male patient (husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9269, Expiry Date: 31May2021), via an unspecified route of administration in the left arm on 02Feb2021 10:30am at single dose for because he was old (covid-19 immunisation). No other products taking. Patient History was No. Patient's Medical History (including any illness at time of vaccination) reported as none. There were no concomitant medications. The patient developed shingles after getting the covid-19 vaccine on 06Feb2021 with outcome of not recovered. The patient developed shingles after getting the Covid-19 vaccine was reported as worsened. Reporter seriousness for developed shingles after getting the Covid-19 vaccine was not serious. Developed shingles after getting the Covid-19 vaccine was related to Covid-19 vaccine. Caller was speaking on behalf of her husband. She was a retired registered nurse. She was reporting that her husband developed shingles after getting the Covid-19 vaccine. He broke out on his right flank. Her husband went to the urgent care. He was prescribed Valacyclovir. She was asking if he should get the second dose. The event not required to emergency room, but required Physician Office visited as he went to the urgent care after breaking out with shingles. None history of all previous immunization with the Pfizer vaccine considered as suspect. None additional Vaccines Administered on Same Date of the Pfizer Suspect. Prior no vaccinations (within 4 weeks) administered. No investigation assessment. No relevant tests.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: injection site pain; Nausea; fatigue; joint and muscle pain; joint and muscle pain; headache; chills; This is a spontaneous report from a non-contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6201), via an unspecified route of administration on 20Feb2021 at 08:45 at a single dose in the right arm for COVID-19 immunization. Medical history included stage 4 breast cancer and thyroid cancer. Concomitant medications included levothyroxine sodium (SYNTHROID) and lorazepam. The patient previously took sulfur and experienced allergies and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 21Feb2021 at 04:30, the patient experienced injection site pain, nausea, fatigue, joint and muscle pain, headache, and chills. The patient did not receive any treatment for the reported events. The patient underwent lab tests and procedures which included Nasal Swab/COV-2 RNA (RT-PCR) NAAT with negative result on 09Oct2020. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: injection site pain; Nausea; fatigue; joint and muscle pain; joint and muscle pain; headache; chills; This is a spontaneous report from a non-contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6201), via an unspecified route of administration on 20Feb2021 at 08:45 at a single dose in the right arm for COVID-19 immunization. Medical history included stage 4 breast cancer and thyroid cancer. Concomitant medications included levothyroxine sodium (SYNTHROID) and lorazepam. The patient previously took sulfur and experienced allergies and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 21Feb2021 at 04:30, the patient experienced injection site pain, nausea, fatigue, joint and muscle pain, headache, and chills. The patient did not receive any treatment for the reported events. The patient underwent lab tests and procedures which included Nasal Swab/COV-2 RNA (RT-PCR) NAAT with negative result on 09Oct2020. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haematoma
Clinical narrative: Hematoma at injection site on arm; This is a spontaneous report from a non-contactable consumer (patient). An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had hematoma at injection site on the arm. The adverse event resulted in emergency room/department or urgent care. It was unknown if the patient received treatment for the adverse event. The outcome of the event, hematoma at injection site on the arm, was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Pharyngeal swelling, Urticaria
Clinical narrative: did not have full anaphylaxis; a sense of her throat swelling; hives; This is a spontaneous report from a contactable physician. A 39-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient experienced "a sense of her throat swelling" and hives 1 hour after the vaccination occurred. The patient received 1 dose of Benadryl and Tylenol and "felt ok." The physician commented that the patient did not have full anaphylaxis and was asking if it would be safe for the patient to receive the second dose of the vaccine at the time of report. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Eye pain, Headache
Clinical narrative: Fever; chills; soreness at injection spot; body and joint aches; body and joint aches; headache; nausea; eye ache and watery; eye ache and watery; This is a spontaneous report received from a non-contactable consumer (patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9267, expiry date: unknown), via an unspecified route of administration in the left arm, on 13Feb2021 09:30, at single dose, for COVID-19 immunization, at the hospital. There were no medical history and concomitant medications.  The patient has no allergies to medications, food, or other products and was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9261, expiry date: unknown) received at 42 years of age, via an unspecified route of administration in the left arm, on 23Jan2021 09:30, at single dose, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 13Feb2021 at 18:00, the patient experienced fever, chills, soreness at injection spot, body and joint aches, headache, nausea, and eye ache and watery. No treatment was given for the events. The patient recovered on an unspecified date in Feb2021. The reporter assessed the events as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Nausea, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Fever; chills; soreness at injection spot; body and joint aches; body and joint aches; headache; nausea; eye ache and watery; eye ache and watery; This is a spontaneous report received from a non-contactable consumer (patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9267, expiry date: unknown), via an unspecified route of administration in the left arm, on 13Feb2021 09:30, at single dose, for COVID-19 immunization, at the hospital. There were no medical history and concomitant medications.  The patient has no allergies to medications, food, or other products and was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9261, expiry date: unknown) received at 42 years of age, via an unspecified route of administration in the left arm, on 23Jan2021 09:30, at single dose, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 13Feb2021 at 18:00, the patient experienced fever, chills, soreness at injection spot, body and joint aches, headache, nausea, and eye ache and watery. No treatment was given for the events. The patient recovered on an unspecified date in Feb2021. The reporter assessed the events as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Two days after receiving the vaccination, experienced two seizures about 2 hours apart; This is a spontaneous report from a contactable consumer(patient). A 18-year-old male patient received the first dose of BNT162B2 (lot number: E13249), via an unspecified route of administration in right arm, on 15Feb2021 11:00 AM at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Adult Residential Facility. The patient's medical history included developmentally disabled, seizures, malaria at birth. Known allergies included Shrimp, Penicillin and Amoxicillin. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications included aripiprazole 5 mg, aripiprazole 10 mg, escitalopram. Two days after receiving the vaccination, the patient experienced two seizures about 2 hours apart on 17Feb2021 14:00. The patient had not had a seizure in 6 months. No treatment was received for the event. The outcome of the event was recovered in Feb2021.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Peripheral neuropathy in his feet/Tingling and burning sensation around the end of his fingertips; This is a spontaneous report from a contactable consumer from the medical information team. A 69-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration, on the left arm, on 27Jan2021 at a single dose (at the age of 69-years-old) for COVID prevention. The patient had no medical history and no concomitant medications. The patient had no other vaccines on the same day as his COVID vaccine. On 09Feb2021, the patient experienced peripheral neuropathy in his feet with a tingling and burning sensation and also reported a tingling and burning sensation around the end of his fingertips. The patient wanted to know if Pfizer has seen this as a side effect to the product and if he should get his second dose or not. The peripheral neuropathy has improved but it was also persisting and stated that it was persisting at a lesser level. The patient was recovering from the event.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive between doses 1 and 2 of the vaccine; tested positive between doses 1 and 2 of the vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported same events for six patients. This is 1st of Six reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The pharmacist was giving Covid vaccinations in a nursing home. It was reported that the patient was tested positive between doses 1 and 2 of the vaccine, in which the patient was hospitalized and had received antibodies. And had tested negative upon and continuously since returning to the nursing home. Those patients were tested every day. The pharmacist started administering the second doses. One patient was administered the second dose and then somebody said, "Oh, they were given antibodies in the hospital''. A fellow pharmacist in which they said, we're under the impression you wait 90 days if they've been given antibodies after that to give the second dose. One of the patients inadvertently received a second dose, not knowing that they received antibody therapy prior to administering the vaccine. The rest who were hospitalized did not receive their second injection. Caller asked, "What is the policy on antibodies and the second dose? When is the earliest date they can administer that second dose? The individual who was given it inadvertently, should they be given a third injection? Do you give them shot number two or do you start over and give them both shots?'' The outcome of event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and drug ineffective due to temporal relationship.  This case will be reassessed once additional information is available.,Linked Report(s) : US-PFIZER INC-2021222954 same drug/reporter/event, different patient;US-PFIZER INC-2021222956 same drug/reporter/event, different patient;US-PFIZER INC-2021222957 same drug/reporter/event, different patient;US-PFIZER INC-2021222953 same drug/reporter/event, different patient;US-PFIZER INC-2021222955 same drug/reporter/event, different patient
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: IVth nerve paralysis, Physical examination
Clinical narrative: Left 4th Nerve Palsy; This is a spontaneous report from a contactable physician. A 75-year-old non-pregnant female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number: PfEL9Ue2), intramuscularly on 08Feb2021 12:30 at age of 75 years old no pregnant at time of vaccination at single dose in right arm for COVID-19 immunisation. Medical history included diabetes, hypertension, allergies to Penicillin, Sulfa drugs. The patient did not have COVID prior vaccination also not had COVID tested post vaccination. No other vaccine in four weeks. Concomitant medication (other medications in two weeks) included Metoprolol, Metformin, Vitamins. It was reported 6 days after vaccine developed severe diplopia on 14Feb2021 10:00. Exam on 16Feb2021 revealed, Left 4th Nerve Palsy. Left Hypertropia, Esotropia and Torsional strabismus. Events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. No treatment received.; Sender's Comments: Based on the information provided, a causal association between BNT162B2 and IVth nerve palsy cannot be completely excluded in the basis of temporal relation. Note however, that patient has history of diabetes and hypertension which may have contributed to the event. Note also that the event is resolving without treatment received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Developed Covid pneumonia and admitted to hospital; Developed Covid pneumonia and admitted to hospital; This is a spontaneous report from a contactable physician. An 85-year-old male patient received first dose of bnt162b2 (brand: Pfizer, lot number: EL3247), intramuscularly in right arm on 27Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced developed covid pneumonia and admitted to hospital on 10Feb2021, the event was reported as serious per hospitalization. The patient underwent lab tests and procedures which included nasal swab: positive on 15Feb2021. Therapeutic measures were taken as a result of developed covid pneumonia and admitted to hospital. The outcome of event was unknown. Facility type vaccine: Doctor's office/urgent care. The event resulted in hospitalization. No covid prior vaccination. Covid test post vaccination: nasal swab on 15Feb2021 showed positive.; Sender's Comments: Considering the plausible temporal association, the possibility that the reported COVID-19 pneumonia in a setting of drug ineffective is related BNT162B2 vaccine cannot be completely excluded.
Age: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood test, Electrocardiogram, Heart rate, Heart rate increased, Rash
Clinical narrative: Rash; Fast heart beat; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 20Feb2021 (at the age of 71 years old) at a single dose for covid-19 immunisation; and paracetamol (TYLENOL), via an unspecified route of administration from an unspecified date at unknown dose and frequency for an unspecified indication. Medical history included high blood pressure, rheumatoid arthritis, tinnitus, vertigo, blood cholesterol. Concomitant medications included amlodipine for high blood pressure, lovastatin for blood cholesterol, meclizine [MECLOZINE] for vertigo, dipyridamole for tinnitus, prednisone for rheumatoid arthritis, and folic acid. On 21Feb2021, the patient experienced rash (hospitalization) and fast heart beat. "If this is the reaction, I guess I shouldn't take the second dose, right? I just think that I am not going to take second dose." Both the events required emergency room visit. The patient underwent lab tests and procedures which included blood work, electrocardiogram (EKG) and x-ray and everything came back normal on 21Feb2021. Therapeutic measure was taken as a result of the rash which included hydrocortisone. The action taken in response to the events with paracetamol was unknown. Outcome of both events was recovering.   Information on the batch/lot number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: X-ray
Clinical narrative: Rash; Fast heart beat; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 20Feb2021 (at the age of 71 years old) at a single dose for covid-19 immunisation; and paracetamol (TYLENOL), via an unspecified route of administration from an unspecified date at unknown dose and frequency for an unspecified indication. Medical history included high blood pressure, rheumatoid arthritis, tinnitus, vertigo, blood cholesterol. Concomitant medications included amlodipine for high blood pressure, lovastatin for blood cholesterol, meclizine [MECLOZINE] for vertigo, dipyridamole for tinnitus, prednisone for rheumatoid arthritis, and folic acid. On 21Feb2021, the patient experienced rash (hospitalization) and fast heart beat. "If this is the reaction, I guess I shouldn't take the second dose, right? I just think that I am not going to take second dose." Both the events required emergency room visit. The patient underwent lab tests and procedures which included blood work, electrocardiogram (EKG) and x-ray and everything came back normal on 21Feb2021. Therapeutic measure was taken as a result of the rash which included hydrocortisone. The action taken in response to the events with paracetamol was unknown. Outcome of both events was recovering.   Information on the batch/lot number has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Suspected COVID-19
Clinical narrative: Patient hospitalized 10 days later with covid like symptoms, with negative covid test results; This is a spontaneous report received from a contactable consumer (patient's daughter). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot/Batch number: Unknown) on an unknown date via an unspecified route of administration at single dose for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. It was unknown if the patient received other vaccine in four weeks, other medications in two weeks. In Feb2021, the patient hospitalized 10 days later with COVID-19 like symptoms, with negative COVID-19 test results. It was unknown if the patient received treatment for the event. It was unknown if the patient had COVID-19 prior to vaccination and post vaccination. The seriousness of the event was reported as hospitalization. The outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: developed refractory seizures on 04Feb2021 after receiving covid-19 vaccine dose #2; This is a spontaneous report from a contactable physician. A 65-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), intramuscular on 30Jan2021 at a single dose for COVID-19 immunization. Medical history included diabetes, breast cancer, rheumatoid arthritis and known allergies with penicillin. Concomitant medications included metformin (METFORMIN), hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ), letrozole (FEMARA). The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), intramuscular in Jan2021 at the age of 65 years old for COVID-19 immunization. It was unknown if the patient had other vaccines in four weeks. The patient developed refractory seizures on 04Feb2021, after receiving the second dose of BNT162B2 on approximately 30Jan2021. The patient was hospitalized for 5 days, in the ICU and received anti-seizure meds among others. The patient had no COVID prior vaccination and it was unknown if tested post-vaccination. The event resolved on an unspecified date in 2021.   Information on the batch/lot number has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Thrombocytopenia
Clinical narrative: Severe thrombocytopenia; This is a spontaneous report from a contactable Nurse. A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Jan2021 at single dose for Covid-19 immunisation. Medical history included rheumatoid arthritis (RA). The patient had known allergies: methotrexate. There were no concomitant medications. No other vaccine in four weeks. The patient experienced severe thrombocytopenia on 17Feb2021. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for severe thrombocytopenia for 2 days. Patient was referred to hematology proactive for severe thrombocytopenia, likely ITP. Platelet (Plts) 5 and then 1. He was sent to the Emergency room (ED) and received plt transfusion w/ minimal effect. He was started on Intravenous Immune Globulin (IVIG) as well as high dose steroids. Plts currently w/i normal range after above treatment. The outcome of event was recovering.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information provided, and on a positive drug-event temporal association,  the Company  assessed that a reasonable possibility could not be excluded that the suspect product BNT162B2 contributed to the occurrence of the reported event Severe thrombocytopenia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: hurting was felt during injection while using pre-filled pen; Initial information was received on 20-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer or non-health care via voicemail.  This case involves a 49 year-old female patient who felt hurting during injection while using pre-filled pen (vaccination site pain), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient felt hurting during injection while using pre-filled pen (vaccination site pain) (Unknown latency) following the administration of INFLUENZA VACCINE.  At the time of the report, it was unknown whether the unknown medication was continued or discontinued. Additional information: the dosage, route, frequency, start date, indication, lot number and expiration date were not provided in the voicemail. Limited information obtained from the voicemail. No additional information at the time of the report.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, patient had recovered from the event (immediately resolved afterwards).  There will be no information available on batch number for this case.
Sex: F
Vaccine: DTP, TTOX
Symptoms: Sleep disorder
Clinical narrative: she cannot sleep; Initial information was received on 25-Feb-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves female patient (of an unknown demographics) whom it was reported she cannot sleep, while she received TETANUS TOXOID and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE, TETANUS VACCINE TOXOID [DTP].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date in 1959 and in 1972, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in 1972, the patient received a dose of suspect DTP not produced by Sanofi Pasteur (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious she cannot sleep (sleep disorder) (unknown latency) following the administration of TETANUS TOXOID and DTP.  The patient stated that, she would like to know the ingredients in the DTP vaccine in 1972 as well as the Tetanus vaccine of 1959 and 1972 and she is wanting to know how that would interaction with the COVID vaccine. She said that she had blood poisoning and has a pacemaker. She said her pacemaker is set at 99. Patient does not know the names of the 2 vaccines she got in 1959 and 1972 and is not sure if they were Pasteur either. She said she had a reaction to those and wants to check on ingredients in those 2 vaccines from 1959 and 1972. She mentioned that she cannot sleep. Caller said that she had blood poisoning and has a pacemaker. She does not have names of these vaccines. She is somewhat sure they were Pasteur but not completely sure. Explained to caller that without a brand name we cannot look up ingredients and ingredient list from 1959 and 1972 might be hard to get anyways. Caller said she is wanting to know how that would interaction with the COVID vaccine.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome was unknown.  There will be no information available on the lot number for this case.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: ADSM received Moderna outside of the recommended age range
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash itching over body worse second dose and continues at present
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Rash erythematous, Skin warm
Clinical narrative: First 2-3 days there was soreness around the injection site. Ten days after (2/25/2021) I developed a red rash, warm to the touch, around the injection site, about 3 inches in diameter. It was also slightly itchy around and in the area. After four days, the rash went away.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal discomfort, Influenza like illness, Malaise, Nausea
Clinical narrative: sick to stomach, nauseaus, felt like flu for 3 days
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Death, Dyspnoea, Eye movement disorder, Foaming at mouth
Clinical narrative: Patient had been feeling dyspneic for 1.5 weeks to 1 month prior to his death on 2/28/21.  He received vaccine on 2/25/21.  On his family found him leaning on the couch with eyes rolled back and foaming at the mouth. He was making noises  (like grunting sounds?). EMS was called. He had cardiac arrest while in ambulance enroute to EMS. Resuscitation efforts continued in ED. Family was informed about his status and resuscitation efforts were stopped.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Grunting, Resuscitation
Clinical narrative: Patient had been feeling dyspneic for 1.5 weeks to 1 month prior to his death on 2/28/21.  He received vaccine on 2/25/21.  On his family found him leaning on the couch with eyes rolled back and foaming at the mouth. He was making noises  (like grunting sounds?). EMS was called. He had cardiac arrest while in ambulance enroute to EMS. Resuscitation efforts continued in ED. Family was informed about his status and resuscitation efforts were stopped.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Body temperature increased, Extrasystoles, Pain, Pyrexia, Tachycardia
Clinical narrative: Tachycardia  with HR 120's and skipped beats,fever ,body aches and pains , elevated temperature,
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This is the 9th day after being injected.  My injection site is still swollen, tender, warm, red, hard lump.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: Mild fever, fatigue, nausea,
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Reports he fainted for few minutes. History of same symptom to injection or venipuncture Refused to go to ER, refusal form signed
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Inflammation, Pain, Tenderness
Clinical narrative: No reaction at first. Then, approximately 2 weeks later began with inflammation and heat, sore to the touch. Starting to hurt not touching it.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Mobility decreased, Pain
Clinical narrative: Patient said that after vaccine that within 3 hours she was in tremendous pain and said she felt the site was to high on her arm. She said she was unable to move her arm. She went to ER  and was given pain medication. She said injection site was sore for 3 weeks. She asked to be reimbursed for ER visit.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: 102.9 degree fever for about 8 hours and pretty bad body aches for 12 hours. both starting at 6am.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Movement disorder, Pyrexia
Clinical narrative: Severe Diarrhea and fever (about 100) started on day of injection (2-2-21) and lasted about 1 week.  During this time I noticed loss of movement and strength in both legs.  This continued to worsen. By about 2-23-21 (day I received 2nd dose) muscles in legs were very constricted making it difficult to walk.  Plus I have lost strength in both hands. Contacted my doctor who refereed me to a Neurologist  .  The Neurologist ran tests on 3-5-21 that indicate that I have nerve damage.  Doing physical therapy in an attempt to loosen muscle constriction and regain strength.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis, Erythema, Fatigue, Pain in extremity, Tenderness
Clinical narrative: Sore arm, fatigue, inflammation on bottom of all toes causing serious redness (almost purple) and serious pain in right small toe. Painful to the touch.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine, Blood creatinine increased, Dehydration
Clinical narrative: Received call from doctor that labs drawn on 1/27/2021 showed low filtration rate and high creatinine. Was told to report to  urgent care. Was admitted to observation unit and given IV fluids over 16 hours.  Repeated labs until improvement and discharged.  Was told cause of lab values was dehydration. I did not feel ill at any time prior to or after being notified by doctor.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Malaise, Pulse abnormal, Snoring, Urinary incontinence
Clinical narrative: Approximately ten minutes following vaccination patient decided to check his blood pressure at the automated machine because he didn't feel well. Patient passed out sitting at the machine and lost control of his bladder. Patient's eyes were open and he was making snoring noises. Upon checking pulse, it was faint. Patient was breathing. Team moved patient to lying position on the floor. Pulse became more prominent and patient woke up. EMS arrived and took patient to local hospital for precautionary testing. Patient discharge home 2 hours later.