chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Polymorphic light eruption
Clinical narrative: Polymorphic light eruption; This is a spontaneous report from a contactable consumer (patient). A 37-years-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on unspecified date in Mar2021 11:00 am (at the age of 37-years-old) (Batch/Lot Number: EW0150) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included ibuprofen (ADVIL 12 HOUR) taken for cramps, start and stop date were not reported. The patient experienced polymorphic light eruption, it had been diagnosed by patient's dermatologist and been managing it with prescription corticosteroids for about two months. Patient have never had this before. Patient received dose 2 via an unspecified route of administration, administered in Arm Right on 21Apr2021 11:00 am (Batch/Lot Number: EW01j8). The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, the patient received a couple of Advil in between doses for cramps within 2 weeks of vaccination, the adverse event result in doctor or other healthcare professional office/clinic visit, Patient received treatment of corticosteroid. Patient was not hospitalized, prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. The outcome of event was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: he cannot remember if he missed it or not; This is a spontaneous report received from Pfizer sponsored program. A Non-contactable male consumer (patient) reported for himself.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot number: unknown), dose 1 via an unspecified route of administration on an unspecified 2021 as dose 1, single for COVID-19 immunization. No medical and concomitant medication history were reported. Caller would like assistance rescheduling 2nd dose of the COVID-19 vaccine since patient cannot remember if missed it or not (Read FAQ Faxed AE Not taking as prescribed/potential memory issues to Pfizer). The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Pain and restricted movement in his left arm; Pain and restricted movement in his left arm; This is a spontaneous report from a contactable other hcp (patient).  A 53-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 21Jan2021 12:00 as DOSE 1, SINGLE for covid-19 immunisation. Facility type vaccine was Workplace clinic. The patient medical history and concomitant medications were not reported. No other vaccine in four weeks. The patient experienced Pain and restricted movement in his left arm on 21Jan2021 at 12:00. AE resulted In Disability or permanent damage. The outcome was Not recovered. AE treatment included Pain medication. No covid prior vaccination. Covid tested post vaccination. Covid test post vaccination (Nasal Swab, name: Colo) on 02Feb2021 with unknown results.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of pain and restricted movement in his left arm  due to temporal relationship.  Case will be re-assessed upon the additional information provided. 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.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cardiac flutter, Cardiac stress test, Chest pain, Chills
Clinical narrative: heart flutters; rigors; very weak; vomiting for hours; migraine; shaking; full body pain; unable to sit upright/ unable to function; sharp left chest pains; palpitations; This is a spontaneous report from a non-contactable female consumer report for self. A 39-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 03Apr2021 15:30 (Batch/Lot Number: EW0150) (at the age of 39-year-old) as dose 1, single for covid-19 immunisation. Medical historied included allergies: Shellfish, almonds, penicillin, dogs, and asthma. Patient not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In Apr2021, 48 hours after 1st vaccine: rigors, very weak, vomiting for hours, migraine, shaking, full body pain, unable to sit upright. 1.5 days of being unable to function. Few days later: sharp left chest pains (still ongoing 06Jul2021), palpitations and heart flutters. Went in 2 weeks ago, because it won't go away. 2 EKGs abnormal, 2 weeks apart. Getting stress test and heart monitor etc now, working with cardiologist to figure this out. Events result in Doctor office clinic visit. Treatment included pills to lower heart rate as needed for palpitation. The outcome of event was not recovered. Patient received second dose administered in left arm on 30Apr2021 15:30 (Batch/Lot Number: EW0172). Since the vaccination, has the patient has not been tested for COVID-19 since the vaccination.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Loss of personal independence in daily activities, Migraine, Pain, Palpitations
Clinical narrative: heart flutters; rigors; very weak; vomiting for hours; migraine; shaking; full body pain; unable to sit upright/ unable to function; sharp left chest pains; palpitations; This is a spontaneous report from a non-contactable female consumer report for self. A 39-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 03Apr2021 15:30 (Batch/Lot Number: EW0150) (at the age of 39-year-old) as dose 1, single for covid-19 immunisation. Medical historied included allergies: Shellfish, almonds, penicillin, dogs, and asthma. Patient not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In Apr2021, 48 hours after 1st vaccine: rigors, very weak, vomiting for hours, migraine, shaking, full body pain, unable to sit upright. 1.5 days of being unable to function. Few days later: sharp left chest pains (still ongoing 06Jul2021), palpitations and heart flutters. Went in 2 weeks ago, because it won't go away. 2 EKGs abnormal, 2 weeks apart. Getting stress test and heart monitor etc now, working with cardiologist to figure this out. Events result in Doctor office clinic visit. Treatment included pills to lower heart rate as needed for palpitation. The outcome of event was not recovered. Patient received second dose administered in left arm on 30Apr2021 15:30 (Batch/Lot Number: EW0172). Since the vaccination, has the patient has not been tested for COVID-19 since the vaccination.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: heart flutters; rigors; very weak; vomiting for hours; migraine; shaking; full body pain; unable to sit upright/ unable to function; sharp left chest pains; palpitations; This is a spontaneous report from a non-contactable female consumer report for self. A 39-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 03Apr2021 15:30 (Batch/Lot Number: EW0150) (at the age of 39-year-old) as dose 1, single for covid-19 immunisation. Medical historied included allergies: Shellfish, almonds, penicillin, dogs, and asthma. Patient not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In Apr2021, 48 hours after 1st vaccine: rigors, very weak, vomiting for hours, migraine, shaking, full body pain, unable to sit upright. 1.5 days of being unable to function. Few days later: sharp left chest pains (still ongoing 06Jul2021), palpitations and heart flutters. Went in 2 weeks ago, because it won't go away. 2 EKGs abnormal, 2 weeks apart. Getting stress test and heart monitor etc now, working with cardiologist to figure this out. Events result in Doctor office clinic visit. Treatment included pills to lower heart rate as needed for palpitation. The outcome of event was not recovered. Patient received second dose administered in left arm on 30Apr2021 15:30 (Batch/Lot Number: EW0172). Since the vaccination, has the patient has not been tested for COVID-19 since the vaccination.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cholelithiasis, Gastrooesophageal reflux disease, Haematemesis, Influenza like illness, Nausea
Clinical narrative: not able to take her second dose because of pancreas problems and ulcers; Caller said that she had pancreatitis and she has gull stones and they think it was related to that; She developed nausea and started throwing up blood; It started with like a cold flu type of thing; She developed nausea and started throwing up blood; The ulcer was from all of the stomach acid and was near her esophagus and stated that it developed from the strong acid; Caller said that she had pancreatitis and she has gull stones and they think it was related to that; This is a spontaneous report from a Pfizer Sponsored Program by a contactable consumer reported for self. This 37-years-old female patient received bnt162b2, via an unspecified route of administration injection in the upper left arm on 08May2021 17:30 at age of 37-year-old (Lot Number: EW0179, Expiration Date: 31Aug2021) at DOSE 1, SINGLE for COVID-19 immunisation. Medical history included Blood pressure. Concomitant drugs included ongoing Amlodipine 1 tablet a day by mouth sometimes every other day for Blood pressure. The patient previously received Tetanus vaccine and experienced soreness. None prior vaccinations within 4 weeks. She received her first dose on 08May2021 and she was not able to take her second dose because of pancreas problems/ pancreatitis and ulcers and hospitalization from 22Jun2021 to 25Jun2021. She said that she wants to know if she can take her second dose. She had pancreatitis and she has gull stones (Jun2021) and they think it was related to that. It started with like a cold flu type of thing. She developed nausea and started throwing up blood. The ulcer was from all of the stomach acid and was near her esophagus and stated that it developed from the strong acid. She is on some acid reducers and blood pressure medication she was already on. This started on the weekend prior to her hospitalization. It started with her cold and flu symptoms and just kind of escalated. AEs require a visit to Emergency Room and no Physician Office. Outcome of the event developed nausea and started throwing up blood, ulcer was from all of the stomach acid and was near her esophagus and stated that it developed from the strong acid was recovered. Outcome of other events was recovered on Jun2021.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pancreatitis, Ulcer
Clinical narrative: not able to take her second dose because of pancreas problems and ulcers; Caller said that she had pancreatitis and she has gull stones and they think it was related to that; She developed nausea and started throwing up blood; It started with like a cold flu type of thing; She developed nausea and started throwing up blood; The ulcer was from all of the stomach acid and was near her esophagus and stated that it developed from the strong acid; Caller said that she had pancreatitis and she has gull stones and they think it was related to that; This is a spontaneous report from a Pfizer Sponsored Program by a contactable consumer reported for self. This 37-years-old female patient received bnt162b2, via an unspecified route of administration injection in the upper left arm on 08May2021 17:30 at age of 37-year-old (Lot Number: EW0179, Expiration Date: 31Aug2021) at DOSE 1, SINGLE for COVID-19 immunisation. Medical history included Blood pressure. Concomitant drugs included ongoing Amlodipine 1 tablet a day by mouth sometimes every other day for Blood pressure. The patient previously received Tetanus vaccine and experienced soreness. None prior vaccinations within 4 weeks. She received her first dose on 08May2021 and she was not able to take her second dose because of pancreas problems/ pancreatitis and ulcers and hospitalization from 22Jun2021 to 25Jun2021. She said that she wants to know if she can take her second dose. She had pancreatitis and she has gull stones (Jun2021) and they think it was related to that. It started with like a cold flu type of thing. She developed nausea and started throwing up blood. The ulcer was from all of the stomach acid and was near her esophagus and stated that it developed from the strong acid. She is on some acid reducers and blood pressure medication she was already on. This started on the weekend prior to her hospitalization. It started with her cold and flu symptoms and just kind of escalated. AEs require a visit to Emergency Room and no Physician Office. Outcome of the event developed nausea and started throwing up blood, ulcer was from all of the stomach acid and was near her esophagus and stated that it developed from the strong acid was recovered. Outcome of other events was recovered on Jun2021.  Follow-up attempts are completed. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Face swelling/ face is still swollen/ swelling on the face; This is a spontaneous report received from a contactable consumer (daughter of patient). An 83-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unspecified route in the arm on 28Jan2021 (LOT: EL9265) and the second dose on 19Feb2021 (LOT: EN6198) in the arm, both as single doses, both at the age of 83-years-old, for COVID-19 immunization. Medical history included kidney condition, heart issue, liver problems, hard of hearing, and he's getting older and shrinking. Concomitant medications were not reported. The patient experienced swelling on the face right after receiving the first dose of the vaccine, since Feb2021. It's been 4-5 months and it's growing bigger and bigger. Reporter described that if she put a big plate on patient's face, his face would look like that, it's huge. She reported that the swelling is so much to the point she can't even see his eyes; his eyes are so small right now, she can hardly see his eyes. The lady who took the patient to get the second vaccine, saw his face was a little bit bigger, but she thought he had gained weight. The patient has seen the doctor and per doctor he is fine, doctor told him there's nothing wrong, it's normal. Reporter added that patient didn't tell the doctor about the vaccine. The reporter (daughter) stated that her dad was normal, his body was fine until he got the (company) vaccine and time after time he is starting to get worse. The clinical outcome of face swelling was not recovered.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Syncope
Clinical narrative: Fainting with seizure-like appearance not before experienced.; Fainting with seizure-like appearance not before experienced.; This is a spontaneous report from a contactable consumer (patient) reported for herself. This 17-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 26May2021 09:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Patient was not pregnancy at time of vaccination.  Medical history was none.  No known allergies.   Concomitant medication included sertraline hydrochloride (ZOLOFT). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fainting with seizure-like appearance not before experienced on 26May2021 09:00 with outcome of unknown.  The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received.  Patient received second dose on 16Jun2021 09:00 AM in left arm. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on lot/batch number has been requested.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Hypothyroidism
Clinical narrative: hypothyroidism; This is a spontaneous report from a non-contactable consumer (patient). This 28-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 22Mar2021 12:00 (Lot Number: EN6208) at single dose for COVID-19 immunisation.  Medical history included COVID prior vaccination.   The patient's concomitant medications were not reported. Patient did not have other vaccine in four weeks. The patient previously took cefdinir and experienced allergies.  The patient experienced hypothyroidism on 09Jun2021 10:30 with outcome of unknown.  Therapeutic measures were taken as a result hypothyroidism. Event was resulted in doctor or other healthcare professional office/clinic visit. Patient was not tested COVID post vaccination.  No follow-up attempts possible. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for the COVID-19 Virus on 27Mar2021; This is a spontaneous report received from a contactable consumer (husband). A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) at 51 years old as DOSE 1, SINGLE for covid-19 immunisation. Relevant medical history was none. There were no additional vaccines administered on same date of the pfizer suspect. Prior Vaccinations (within 4 weeks) was none. Concomitant medications were not reported. The patient wife tested positive for the COVID-19 Virus on 27Mar2021, and on 02Apr2021, his wife had the monoclonal antibodies to treat the COVID-19 Virus. The patient did not receive her second COVID-19 Vaccine dose at this time. She had a really bad experience with the COVID-19 Virus. Reporter clarified the patient spent the day in the hospital Emergency Room, and was not admitted to the hospital. The husband wanted to get to the bottom of this, and get his wife fully vaccinated. The patient went to the Emergency Room on the morning on 27Mar2021, and was in the Emergency Room at the hospital all day. The doctors got the patient breathing, saying the doctors did whatever they do. She was discharged home from the hospital Emergency Room late in the day on 27Mar2021. On 02Apr2021, the patient had the monoclonal antibodies given to her. She received only one treatment of the monoclonal antibodies, and recovered completely from the COVID-19 Virus. The patient had no side effects from her first COVID-19 Vaccine dose. Diagnosed with COVID-19 Virus required a visit to Emergency Room and Physician Office. The outcome was recovered.   Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Mixed connective tissue disease, Rash, SARS-CoV-2 test
Clinical narrative: Mixed connective Tissue Disease; Started with a rash on the back and arms in February and and March and then in April I had a Thyroid Ablation; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received bnt162b2 (BNT162B2, brand: Pfizer) at the age of 40-years-old, dose 1 via an unspecified route of administration, administered in Arm Right on 21Jan2021 14:00 (Batch/Lot Number: EL8982) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant. Medical history included Graves Disease. No other vaccine in four weeks. No Covid prior vaccination. Concomitant medication included atenolol (ATENOLOL) taken for an unspecified indication, start and stop date were not reported. Reported adverse event: Started with a rash on the back and arms in Feb and March and then in April in 2021, the patent had a Thyroid Ablation. Developed Mixed connective Tissue Disease on 03May2021. She understand this was not related to the thyroid disorder and was just curious if anyone else has reported a new diagnosis of MCTD. Is very rare and she had no reason to suddenly have it. But its been confirmed through an ANA test for RNP antibody. The patient underwent lab tests and procedures which included ANA test: rnp antibody on 2021. No treatment received. The event outcome was not recovered. The report was provided as serious due to Disabling/Incapacitating. Ae resulted in: Emergency Room Visit/ Physician Office Visit. Covid test post vaccination: Nasal Swab on 05Apr2021 was Negative.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Urticaria
Clinical narrative: Shingles and hives all over; Shingles and hives all over; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29May2021 (Batch/Lot number was not reported) at 56 years old as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were none. The patient experienced shingles and hives all over (Disability) on 28Jun2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient received Antiviral medicine as treatment. Since the vaccination, the patient has not been tested for COVID-19. The outcome was not recovered.  Information on lot/batch number has been requested.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Received vaccine after point; This is a spontaneous report from a contactable pharmacist. A 54-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 06Jul2021 at 10:30(Batch/Lot Number: EW0198; Expiration Date: Sep2021) as dose number unknown, 0.3ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient was given a Pfizer's COVID-19 vaccine "beyond its appropriate time of use". Yesterday vaccine was diluted and put in a syringe in the fridge by 07:30pm, today patient received it by 10:30am. After dilution, store vials between 2°C to 25°C (35°F to 77°F) and use within 6 hours from the time of dilution. Any vaccine remaining in vials must be discarded after 6 hours. There is no additional excursion time for diluted vaccine in syringes. They drew the covid vaccine up in syringes and put them in the refrigerator, but the syringe was given to a patient beyond it's use time, so they are wanting to know what Pfizer recommends. Caller states this occurred around 1030 this morning and reports the vaccine was probably drawn up yesterday around or after 1900, and it was left overnight. Caller states, she guesses when the person came in to get their shot, the technician thought it was a new vaccine that had been drawn up, and they gave that one. Caller confirms the syringe had been drawn up and left in the refrigerator overnight. It was medically significant. Outcome was unknown.; Sender's Comments: Based on the narrative and the known safety profile of the suspect drug, the reported Poor quality product administered was considered possible. its  role in the reported event could not be excluded
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy
Clinical narrative: noticed palpable supraclavicular swollen lymph nodes/swelling of supraclavicular lymph nodes on the right side; soreness in her right shoulder; This is a spontaneous report from contactable nurses.  A 34-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Deltoid Right at age of 34-years-old on 26Jun2021 (Lot Number: EW0182) as DOSE 1, SINGLE for covid-19 immunisation. Family history included Lupus. There were no concomitant medications. The patient previously received flu shot in Oct2019 at age of 32 years old for immunization and experienced allergies, weak and rashes on the leg. The patient experienced noticed palpable supraclavicular swollen lymph nodes/swelling of supraclavicular lymph nodes on the right side and soreness in her right shoulder in 2021. Clinical course reported as: nurse confirmed she received the vaccine on 26Jun2021, and the symptoms began about five days after, she was unsure of exact date or time of day, but reported she woke up and felt it, her shoulder was sore, and she thought ok because she just had the vaccine, and shoulder was sore, so it could be, and caller clarifies it was the right shoulder, and then she noticed the swelling. Nurse stated the swelling was persistent, it's not tender, but it's palpable and mobile, and added, when you feel it, it's slightly tender, but it's mobile and palpable, and small like a pea. No treatment received for the events. Outcome of soreness in her right shoulder was recovered in Jul2021, other event was not recovered. Event swelling of supraclavicular lymph nodes on the right side was reported as serious due to medically significant. Event soreness in her right shoulder was reported as non-serious.  The nurse classified the events as related to bnt162b2.; Sender's Comments: A contributory role of BNT162B2 to event noticed palpable supraclavicular swollen lymph nodes/swelling of supraclavicular lymph nodes on the right side and soreness in her right shoulder is considered possibly based on temporal association and known safety profile. 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: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she received her first dose in March of this year and then developed COVID; she received her first dose in March of this year and then developed COVID; This is a spontaneous report from a contactable pharmacist via Medical Information Team. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on and unspecified date in Mar2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Pharmacist stated that he had a patient who stated she received her first dose in March of this year and then developed COVID and that was why she had not been back to receive her second dose. She came back yesterday and did not have her vaccination card with her or any documentation proving that she was diagnosed with COVID. Pharmacist was not sure about her story and had not spoken with her doctor about it either. Stated that this patient did receive a second dose of the vaccine yesterday at his pharmacy. He was asking what was Pfizer input regarding longer intervals of dosing. Pharmacist states that the patient told the pharmacy staff she had not returned after her first dose of the Pfizer COVID-19 vaccine in March because she developed COVID-19. Caller states that the patient told his staff she waited this amount of time to receive her second dose of the Pfizer COVID-19 vaccine due to this diagnosis. Patient had not returned after her first dose of the Pfizer COVID-19 vaccine in March because she developed COVID-19. She waited this amount of time to receive her second dose of the Pfizer COVID-19 vaccine due to this diagnosis. Response to this was given as vaccination of people with known current SARS-CoV-2 infection should be deferred until the person has recovered from the acute illness (if the person had symptoms) and they have met criteria to discontinue isolation. Response regarding the efficacy of the COVID-19 vaccine was given as the second dose of Pfizer-BioNTech COVID-19 vaccine may be administered up to 6 weeks (42 days) after the first dose. Currently, only limited data are available on efficacy of mRNA COVID-19 vaccines administered beyond this window. Also informed the pharmacist that at this time antibody testing is not recommended as a means for testing immunity after vaccination. The outcome of the events was unknown.   Follow-up attempts are needed; information about lot/batch number has been requested.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Depression, Feeling abnormal
Clinical narrative: Depression; would not be unhappy if they died but not suicidal; This is a spontaneous report received from a non-contactable nurse. A 61-year-old female patient (non-pregnant at time of vaccination) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date as DOSE 2, SINGLE as single dose for COVID-19 immunization. The patient medical history was not provided. Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date as single dose for COVID-19 immunization. On unspecified date, patient experienced depression, would not be unhappy if they died but not suicidal; lasted 24 hours. Started 24 hours after the second injection. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient did not test for COVID-19. No covid prior vaccination. No covid tested post vaccination. No treatment received for events. Outcome of events was recovered on unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: There is not a reasonable possibility that reported events are related to BNT162B2 base on current available information.  The events are more likely intercurrent medical conditions. 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.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Arthralgia, COVID-19, Pain in extremity
Clinical narrative: Pain in heart; Pain in left arm; Pain in left shoulder; This is a spontaneous report received from a contactable consumer (patient). This 64-year-old female patient (non-pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 10Mar2021 at 14:45 PM (Lot number: EN6199) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included hypertension; lower lumbar stenosis; right renal artery stenosis; known allergies to latex. No covid prior vaccination. Concomitant medication included amlodipine besylate. None other vaccine same date. No other vaccine in four weeks. The patient previously took dicloxacillin and experienced drug hypersensitivity. On 26Mar2021 at 07:00 AM, the patient experienced pain in heart, left shoulder and left arm. Lab data included VitalAxis Covid19 (nasal swab) was negative on 10Jun2021. Treatment received for events including 81 mg Aspirin. Outcome of events was recovered on unspecified date in 2021. This report was assessed by the reporting consumer as non-serious.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine, Postmenopausal haemorrhage
Clinical narrative: blood in her urine; Bringing on a period once again seems odd after having this inoculation; This is a spontaneous report from a contactable consumer (patient). This 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; NDC number: 59267-1000-01), via an unspecified route of administration in the right arm on 05Jul2021 at 19:15 (Lot Number: EW0198) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included patient had not had a period in probably 3 years. The patient had never been vaccinated before other than her childhood vaccinations. Patient stated she didn't get flu shots. None of family medical history relevant to event(s). Concomitant medications reported as none. No prior vaccinations (within 4 weeks). No history of previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional vaccines administered on same date of the Pfizer suspect. The patient received first dose yesterday on 05Jul2021. About three hours after receiving vaccine, when she came home after doing some shopping, she used the bathroom and there was blood in her urine on 05Jul2021 at 22:00. By the time she got home, 3 hours later she went to bathroom and that's when she noticed blood in the toilet. Patient stated it may have occurred sooner, but she hadn't used the bathroom. She stated she had not had a period in 3 years. Patient stated she had not heard of that adverse reaction, blood in the urine, she thought it was kind of a concern and bringing on a period once again seemed odd after having this inoculation on 05Jul2021. Events did not require a visit to emergency room or physician office. The patient asked if should seek professional advice. Patient stated she actually went online and was reading that people were reporting irregularities and reporting heavy bleeding, abnormal bleeding and also post-menopausal women reported getting a period again. Patient asked if this was something that Pfizer had been hearing about. Outcome of the event blood in her urine was not recovered, while of the other event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain near big toe on left foot/joint pain left foot; This is a spontaneous report from a contactable consumer reported for self. This 63-year-old patient of unspecified gender received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9261) intramuscular in the right arm on 05Apr2021 at age of 63 years old for COVID-19 immunization. Medical history diabetes, hypothyroidism, acid reflux, cholesterol abnormal, high blood pressure, depression; all ongoing since several years ago. Concomitant medications were none. The patient had no vaccinations (within 4 weeks). The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN5318) intramuscular in the right arm on 15Mar2021 at age of 63 years old for COVID-19 immunization, experiencing gout on right foot, joint pain on right foot 3 days later, acid reflux, bunion redness, bunion swelling, bunion soreness, inflamed big toe area, lots of pain, bunion, the pain got worse, aggravated her arthritis. The patient experienced joint pain near big toe on left foot/joint pain left foot on 21Apr2021. Treatment was received for the event. AE required visit to Physician Office. Outcome of the event was not recovered. Seriousness Criteria was reported as Important Medical event.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: tingling in the extremities; burning sensation; This is a spontaneous report from a contactable pharmacist. A 21-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 Immunization and no reaction on previous exposure to vaccine. The patient was hospitalized after the second dose of the COVID-19 vaccine. The person has been two weeks in the hospital. Initial symptoms were tingling in the extremities that turned into burning sensation. Patient was much better with minimal, sporadic symptoms. The patient was hospitalized for the events for 14 days. The outcome of the event was recovered with sequel.   Information on lot/batch number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of tingling in the extremities and burning sensation cannot be excluded. 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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Headache, Pain
Clinical narrative: pain daily kidney area up to my shoulders to mid back; pain daily kidney area up to my shoulders to mid back; pain daily kidney area up to my shoulders to mid back; Headache; pain; exhaustion; This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old [non-pregnant] adult female received the second dose of intramuscular BNT162B2 (solution for injection; batch/lot and expiry information not provided) as a single dose in the left arm on 12Apr2021 at 11:15 (at 55-years-old) for COVID-19 immunization. Relevant medical history included endometriosis, cysts, tumors, food allergy (bell pepper) and drug allergies (ciprofloxacin and nitrofurantoin). Concomitant medications included letrozole from unspecified date for an unspecified indication; and unspecified thyroid medications. The patient previously received COVID-19 immunization with the first dose of intramuscular BNT162B2 (solution for injection; batch/lot and expiry information not provided) as a single dose in the left arm on 22Mar2021 at 11:15 (at 55-years-old). The patient was not pregnant at the time of vaccination and the patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccine within four weeks of this vaccine. The patient reported that on 13Apr2021 at 06:00 she experienced headache, pain, and exhaustion. The patient explained that now she has pain daily in the kidney area up to her shoulders and mid back. The patient stated that she is currently on an anti-inflammatory intravenous (IV) serious to try to stop the pain. The patient reported the events resulted in visit to doctor's office though denied that the events resulted in death, was life-threatening, caused/prolonged hospitalization, was disabling/incapacitating or resulted in congenital anomaly/birth defect. The outcome of the events headache, pain, exhaustion, and pain daily in the kidney area up to her shoulders and mid back was not recovered.   Information regarding the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: pain daily kidney area up to my shoulders to mid back; pain daily kidney area up to my shoulders to mid back; pain daily kidney area up to my shoulders to mid back; Headache; pain; exhaustion; This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old [non-pregnant] adult female received the second dose of intramuscular BNT162B2 (solution for injection; batch/lot and expiry information not provided) as a single dose in the left arm on 12Apr2021 at 11:15 (at 55-years-old) for COVID-19 immunization. Relevant medical history included endometriosis, cysts, tumors, food allergy (bell pepper) and drug allergies (ciprofloxacin and nitrofurantoin). Concomitant medications included letrozole from unspecified date for an unspecified indication; and unspecified thyroid medications. The patient previously received COVID-19 immunization with the first dose of intramuscular BNT162B2 (solution for injection; batch/lot and expiry information not provided) as a single dose in the left arm on 22Mar2021 at 11:15 (at 55-years-old). The patient was not pregnant at the time of vaccination and the patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccine within four weeks of this vaccine. The patient reported that on 13Apr2021 at 06:00 she experienced headache, pain, and exhaustion. The patient explained that now she has pain daily in the kidney area up to her shoulders and mid back. The patient stated that she is currently on an anti-inflammatory intravenous (IV) serious to try to stop the pain. The patient reported the events resulted in visit to doctor's office though denied that the events resulted in death, was life-threatening, caused/prolonged hospitalization, was disabling/incapacitating or resulted in congenital anomaly/birth defect. The outcome of the events headache, pain, exhaustion, and pain daily in the kidney area up to her shoulders and mid back was not recovered.   Information regarding the lot/batch number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blindness, Feeling abnormal, Headache, Hypertension
Clinical narrative: Vision loss; Severe Vertigo; Headaches; insomnia; High blood pressure; Tinnitis; Sleep issues; Anxiety; Absolutely feel horrible/Had not feel himself in 90 days; Possible diagnosis of post vaccine psychosis.; Migraine; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received bnt162b2 (BNT162B2) at the age of 59-years-old, dose 2 via an unspecified route of administration, administered in Arm Left on 08Apr2021 15:30 (Batch/Lot Number: ew0162) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The COVID-19 vaccine was administered in Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The medications the patient received within 2 weeks of vaccination included Trilogy, Flownase Sensimist. Historical Vaccine included BNT162B2 for COVID-19 immunization on 18Mar2021 at the age of 59-year-old (dose 1, product=COVID 19, brand=Pfizer, lot number=ER2613, administration time=16:30, vaccine location=Left arm). The patient experienced vision loss, severe vertigo, headaches, insomnia, high blood pressure, tinnitis, sleep issues, anxiety, absolutely feel horrible, possible diagnosis of post vaccine psychosis on 11Apr2021 07:30, migraine in 2021, with outcome of not recovered. Detail information was as following reported Event: Severe Vertigo, headaches, insomnia, high blood pressure, vision loss, Tinnitis. Vertigo just about 3 days after 2 nd vaccine. Had not feel himself in 90 days. Still experiencing headaches, sleep issues, anxiety. Absolutely feel horrible.  Blood pressure up significantly over historical levels. Being treated for high blood pressure, sleep, anxiety, headaches. Currently seeing a neurologist. Possible diagnosis of post vaccine psychosis. The report was reported as non-serious. The events resulted in Doctor or other healthcare professional office clinic visit Emergency room department or urgent care. Treatment received included Vertigo treatment, Migraine treatment, Ongoing. Since the vaccination, the patient has not been tested for COVID-19.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Migraine, Psychotic disorder, Sleep disorder, Tinnitus
Clinical narrative: Vision loss; Severe Vertigo; Headaches; insomnia; High blood pressure; Tinnitis; Sleep issues; Anxiety; Absolutely feel horrible/Had not feel himself in 90 days; Possible diagnosis of post vaccine psychosis.; Migraine; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received bnt162b2 (BNT162B2) at the age of 59-years-old, dose 2 via an unspecified route of administration, administered in Arm Left on 08Apr2021 15:30 (Batch/Lot Number: ew0162) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The COVID-19 vaccine was administered in Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The medications the patient received within 2 weeks of vaccination included Trilogy, Flownase Sensimist. Historical Vaccine included BNT162B2 for COVID-19 immunization on 18Mar2021 at the age of 59-year-old (dose 1, product=COVID 19, brand=Pfizer, lot number=ER2613, administration time=16:30, vaccine location=Left arm). The patient experienced vision loss, severe vertigo, headaches, insomnia, high blood pressure, tinnitis, sleep issues, anxiety, absolutely feel horrible, possible diagnosis of post vaccine psychosis on 11Apr2021 07:30, migraine in 2021, with outcome of not recovered. Detail information was as following reported Event: Severe Vertigo, headaches, insomnia, high blood pressure, vision loss, Tinnitis. Vertigo just about 3 days after 2 nd vaccine. Had not feel himself in 90 days. Still experiencing headaches, sleep issues, anxiety. Absolutely feel horrible.  Blood pressure up significantly over historical levels. Being treated for high blood pressure, sleep, anxiety, headaches. Currently seeing a neurologist. Possible diagnosis of post vaccine psychosis. The report was reported as non-serious. The events resulted in Doctor or other healthcare professional office clinic visit Emergency room department or urgent care. Treatment received included Vertigo treatment, Migraine treatment, Ongoing. Since the vaccination, the patient has not been tested for COVID-19.