chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal hypoaesthesia
Clinical narrative: like having a heart attack; my throat was numb.; It was extreme like after the reflex like pain in my chest; I was having Heart pressure and my heart and my jaw and my throat was numb.; anxiety; my jaw was numb; Booster; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received third dose of bnt162b2 (Batch/Lot Number: FF2587, Expiration date: Unknown, age at the time of vaccination: 71-year-old) via an unspecified route of administration, administered in left upper arm on an unspecified date as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included cancer (have cancer two years ago) and high blood pressure; both from an unknown date and unknown if ongoing. Concomitant medications included letrozole taken for cancer (A chemo pill, To prevent the cancer from coming back), start and stop date were not reported; lisinopril taken for high blood pressure, start and stop date were not reported. The patient previously received bnt162b2 (Batch/Lot Number: EN5318), via an unspecified route of administration, administered in left upper arm on 08Feb2021 (age at vaccination was 70 years) as DOSE 1, SINGLE and bnt162b2 (Batch/Lot Number: EN6198), via an unspecified route of administration, administered in left upper arm on 01Mar2021 (age at vaccination was 71 years) as DOSE 2, SINGLE for covid-19 immunization and experienced like having a heart attack, my throat was numb, It was extreme like after the reflex like pain in my chest, I was having Heart pressure and my heart and my jaw and my throat was numb, my jaw was numb, anxiety. The patient reported that she had adverse reaction Pfizer her second vaccination and exactly the same reaction to the booster. On an unspecified date, the patient received booster dose and the patient was having heart pressure and her heart and jaw and throat was numb. She stated that it was extreme like after the reflex like pain in her chest and numbing in her throat and in her jaw like having a heart attack. When asked about the corrective therapy, the patient reported that she just gave three medication that she was on, because of her cancer. She take Cannabis Mint and anti anxiety at night, a pill, So when she had those adverse effect because at that she was having Heart pressure and her heart and her jaw and her throat was numb so she took a CBD to relax her body to the anxiety after almost a hour it come down. She took Xanax and CBD Mint 2.5 milligram. Petra Kiera Concession Cannabis infused Mint and she have one more pill the anti anxiety pill was Xanax and its 0.5 milligram and alprazolam. The patient underwent lab tests and procedures which included comprehensive metabolic panel, CBC and another differential, Cancer antigen with unknown results on 26Oct2021. Therapeutic measures were taken as a result of the events. Investigation assessment was reported. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Groin pain, Lumbar radiculopathy, Neuropathy peripheral
Clinical narrative: Covid Neuropathy; lumbar radiculopathy; Groin pain; This is a spontaneous report from a contactable other health professional (Pfizer employee) received via COVID-19 Adverse Event Self-Reporting Solution.  A female patient in her 30s received two doses of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) both via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  It was reported that the patient received the injection in her arm and was referred to PT (physical therapist) for groin pain also attributed to the injections. She was told she had developed a "COVID Neuropathy" and was treated for lumbar radiculopathy.  Unspecified therapeutic measures were taken as a result of the events. The patient outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Neuropathy peripheral and BNT162B2.  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: Limb injury, Pruritus, Scratch
Clinical narrative: experience itchiness/ terrible itching; her sister scratches her arms until her arm bleeds/scratched in the middle of the night until her arm bleeds; her sister scratches her arms until her arm bleeds/scratched in the middle of the night until her arm bleeds; This is a spontaneous report from a contactable consumer. A female patient (reporter's sister) of an unspecified age received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced experience itchiness/ terrible itching, her sister scratches her arms until her arm bleeds/scratched in the middle of the night until her arm bleeds on an unspecified date. Caller reported her sister also received the Pfizer covid 19 vaccine and is experience itchiness as well but her sister scratches her arms until her arm bleeds. She talked to her sister, she wound up with terrible itching and scratched in the middle of the night until her arm bleeds. No further details provided. States it must be something, her sister is not as allergic as she is and it must be something in the shot. Caller states she thought she would check what it is to see. The outcome of events was unknown. The case was reported as non-serious.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Ocular vascular disorder, Oedema, Photopsia, Visual impairment
Clinical narrative: stroke in eye; lost partial vision in right eye; eye flashes/they were more constant; eye flashes/they were more constant; edema; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Mar2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included bp meds (as reported). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization, and experienced eye flashes, stroke in eye and edema. The patient experienced that after receiving Pfizer shots in Mar2021, he/she had a stroke in eye. After the first dose was given patient was having eye flashes. After the 2nd shot was given shortly after he/she noticed they were more constant and that patient had lost partial vision in right eye. Patient went to the opthalmologist and was told to go to ER because he/she had a stroke in eye. Patient also had edema for months after receiving the vaccine. Patient thought it reacted with his/her bp meds. The outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Ocular vascular disorder, Oedema, Photopsia
Clinical narrative: stroke in eye; lost partial vision in right eye; eye flashes/they were more constant; eye flashes/they were more constant; edema; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Mar2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included bp meds (as reported). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization, and experienced eye flashes, stroke in eye and edema. The patient experienced that after receiving Pfizer shots in Mar2021, he/she had a stroke in eye. After the first dose was given patient was having eye flashes. After the 2nd shot was given shortly after he/she noticed they were more constant and that patient had lost partial vision in right eye. Patient went to the opthalmologist and was told to go to ER because he/she had a stroke in eye. Patient also had edema for months after receiving the vaccine. Patient thought it reacted with his/her bp meds. The outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 5 people in his church got Covid after being vaccinated with Pfizer; 5 people in his church got Covid after being vaccinated with Pfizer; This is a spontaneous report from a contactable consumer or other non-healthcare professional from a Pfizer sponsored program. A contactable consumer reported similar events for 5 patients under the same suspect product(s). This is 1 of 5 reports. A patient of unspecified age and gender received BNT162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient mentioned that 5 people in his church got covid after being vaccinated with Pfizer. The patient underwent lab tests and procedures which included sars-cov-2 test as positive. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 5 people in his church got Covid after being vaccinated with Pfizer; 5 people in his church got Covid after being vaccinated with Pfizer; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported similar events for 5 patients under the same suspect product(s). This is 4 of 5 reports.  A patient of unspecified age and gender received unknown dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The reporter reported that five people in his church got Covid after being vaccinated with Pfizer. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unknown date. The outcome for the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective for unapproved indication, Headache
Clinical narrative: The patient is still having headache; The patient began taking Qulipta 7 days ago, and his headaches are getting better, but he is still having them. The agent stated that the patient has been vaccinated with Pfizer Covid-19 vaccine; This is a spontaneous report from a contactable consumer or other non-health care professional received by an agency (CCDoc ID: AGN276911). A 69-years-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization and also received atogepant (ATOGEPANT), oral from 22Sep2021 (Batch/Lot Number: W05822; Expiration Date: Nov2023) and ongoing, at 60 mg, 1x/day for migraine headaches. The medical history included ­Migraine headaches. The concomitant medications were not reported. On an unknown date the patient experienced The patient is still having headache and The patient began taking Qulipta 7 days ago, and his headaches are getting better, but he is still having them. The agent stated that the patient has been vaccinated with Pfizer Covid-19 vaccine. It was reported that the patient began taking atogepant (QULIPTA) 7 days ago and his headaches were getting better, but he was still having them. The agent stated that the patient had been vaccinated with Pfizer Covid-19 vaccine, but the patient could not remember the dates of vaccination. Patient was not hospitalized as a result of the adverse event. Treatment medications was unknown. The action taken in response to the events for atogepant was dose not changed. The Outcome of the event patient is still having headache was not resolved and outcome of the other event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue
Clinical narrative: Extremely tired; Had a little chest pain; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution of injection, Lot Number: unknown), via an unspecified route of administration, on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history included blood pressure from an unknown date and if ongoing. The patient's concomitant medications were not reported. The patient took unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on an unspecified date as single for COVID-19 immunization. On an unspecified date the patient experienced extremely tired and had a little chest pain. The outcome of the events was recovered on an unspecified date.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Colitis microscopic
Clinical narrative: microscopic lymphocytic colitis; This is a spontaneous report from a Pfizer sponsored program COVAX US Support from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (COMIRNATY mRNA, formulation: solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and dose 2 via an unspecified route of administration on an unspecified date (lot number was not reported) as dose 2, single for covid-19 immunisation; bismuth subsalicylate (PEPTO-BISMOL), via an unspecified route of administration from 02Nov2021 13:00 (lot number was not reported) to 02Nov2021 13:00, at unspecified dose for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date patient experienced microscopic lymphocytic colitis. Patient also stated that normally she had to be on a corticosteroid, Budesonide, to get rid of a flare up and her doctor was trying to treat it with something over the counter to see if it will help. Patient was taking Pepto-Bismol and not budesonide. Her doctor wants her to get the booster vaccine. She will be scheduled for the booster dose and has already had the first two doses of the Pfizer covid vaccine. Patient took her last dose of Pepto-Bismol at 13:00 and she was supposed to take it again before dinner. She could walk in at 10:00 03Nov2021 or at 5:00 02Nov2021 to the pharmacy for her booster dose but needs know if there was an interaction and if there was how much time was needed between the last time, she took Pepto-Bismol before she can get the booster dose. The action taken in response to the event(s) for bismuth subsalicylate was unknown. Therapeutic measures were taken as a result of microscopic lymphocytic colitis. The outcome of event was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vestibulitis
Clinical narrative: vestibulitis; significant dizziness; This is a spontaneous report from a contactable Other-HCP. This Other-HCP reported for a 43-year-old-male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 04Jun2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient was given the Pfizer COVID vaccine on 04Jun2021 four days later on 08Jun2021 he developed significant dizziness and increasing the stipulate us he had been followed by ear nose and throat physician he took eight weeks for this problem to resolve he never had problems with this or any other problems in the past he have seen him for an infectious diseases consultations. AEs resulted in physician office visit. The outcome of both the vents was recovered on an unspecified date in 2021  No follow-up attempts are needed; information about lot/batch number can not be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: The reporter who just lost his 16 years old son with a Pfizer shot; This is a spontaneous report from a non-contactable consumer (parent of patient). A 16-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated the COVID vaccine was not a vaccine, it was a big experimental medication and it was also killing people. The reporter who just lost his 16 years old son with a Pfizer shot because he taught him government told him it was safe. The outcome of the event was fatal. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: The reporter who just lost his 16 years old son with a Pfizer shot
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: had a family member die 3 days after getting COVID-19 vaccine; This is a spontaneous report from a Pfizer sponsored program PFIZER support from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated they had a family member die 3 days after getting COVID-19 vaccine. The outcome of the event was fatal. The patient died on an unspecified date.  It was not reported if an autopsy was performed.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: had a family member die 3 days after getting COVID-19 vaccine
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Swelling face
Clinical narrative: Woke the following morning with extremely swollen face.; The patient received third/ booster dose of BNT162B2; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3590) via an unspecified route of administration in the left arm on 29Oct2021 at 14:30 (age at vaccination of 65-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as patient had a good health. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 20Mar2021 at 09:00 (age at vaccination of 64-years-old) and received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0153), via an unspecified route of administration in the left arm on 10Apr2021 at 09:00, as a single dose for COVID-19 immunisation. On 30Oct2021 at 04:00, the patient woke up the following morning with extremely swollen face. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extremely swollen face was resolved on an unknown date in 2021.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Movement disorder
Clinical narrative: Severe aching and pulsation-like pains in left and right side lower back (kidney area); I cannot comfortably bend over (sitting or standing) for more than 30 seconds at a time, because of the pain; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via an unspecified route of administration in the right arm on 05Nov2021 at 12:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were reported as not applicable. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: FF2587) via an unspecified route of administration in the right arm on 06Oct2021 at 12:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 06Nov2021 at 08:00, approximately 24 hours after receiving the second dose of the Pfizer COVID-19 vaccine, the patient experienced severe aching and pulsation-like pains in his left and right side lower back (kidney areas). He could not comfortably bend over (sitting or standing) for more than 30 seconds at a time, because of the pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe aching and pulsation-like pains in left and right side lower back (kidney area) and he could not comfortably bend over (sitting or standing) for more than 30 seconds at a time, because of the pain was not resolved at the time of report.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Retching
Clinical narrative: Chills; tiredness; periodic dry heaves over 2.5 day period; This is a spontaneous report from a non-contactable consumer or other non healthcare professional. A 62 year old female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on 06Nov2021 at 12:48 PM (Batch/Lot Number: FF2590) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills on an unspecified date with outcome of unknown, tiredness on an unspecified date with outcome of unknown and periodic dry heaves over 2.5 day period causing retching on an unspecified date with outcome of unknown.    No follow-up attempts are possible; No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: losing their hair/lost hair; This spontaneous report from two contactable consumers reporting same event under the same suspect product for 7 patients. This is one of 7 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 (Batch/Lot number was not reported) as singe dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Reporter stated seven patients off the top of head that were losing their hair since they had the vaccine, also reported these seven patients were having hair changing or falling out right after Pfizer vaccination, 7 patient who have lost hair. The outcome of the event was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101342968 same drug/event, different patient
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Started menstrual cycle while perimenopausal; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2593) via an unspecified route of administration in the left arm on 03Nov2021 at 18:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, high blood pressure (HBP) and high cholesterol. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included first dose of influenza vaccine (FLU) in left arm on an unknown date for immunisation and metformin (MANUFACTURER UNKNOWN), rosuvastatin calcium (CRESTOR), venlafaxine hydrochloride (EFFEXOR), losartan potassium (LOSARTIN) and dapagliflozin propanediol monohydrate (FARXIGA), all for an unknown indication from an unknown date and unknown if ongoing. The patient received other vaccine within four weeks prior to COVID vaccine. The patient previously received doxycycline (MANUFACTURER UNKNOWN) and experienced drug allergy. On 05Nov2021 at 11:30, the patient started menstrual cycle while perimenopausal. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event started menstrual cycle while perimenopausal was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: No menstrual cycle since vaccine 11 months as of 11/2021. I was 150% regular and ovulate for 18 months of documentation prior to vaccine.; This is a spontaneous report from a contactable nurse, the patient. A 42-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 04Jan2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Dec2020 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. It was reported that from 13Jan2021, patient had no menstrual cycle since vaccine 11 months as of 11/2021. She was 150 percentage regular and ovulate for 18 months of documentation prior to vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event had no menstrual cycle since vaccine 11 months as of 11/2021 and she was 150 percentage regular and ovulate for 18 months of documentation prior to vaccine was not resolved at the time of reporting.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: Administration date 06Nov2021, dose number=3; Supraclavicular lymphadenopathy; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 23Mar2021 (at the age of 49-years-old), received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 19Apr2021 (at the age of 50-years-old) and also received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 06Nov2021 (at the age of 50-years-old) as a single dose of COVID-19 immunisation. Medical history included that she had an axillary lymph node removed from her left arm 10 years ago. The patient had known allergies to sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 24Mar2021, with each dose of the Pfizer vaccine, the patient experienced supraclavicular lymphadenopathy within 24 hours. The lymph node had shrunk over time but had never returned to normal size. The event supraclavicular lymphadenopathy resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event supraclavicular lymphadenopathy. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event supraclavicular lymphadenopathy was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Foetal growth restriction, Foetal heart rate abnormal, Foetal heart rate decreased, Heart rate, Maternal exposure during pregnancy
Clinical narrative: lower heart rate; no heartbeat; At an ultrasound at 8 weeks 4 days the baby was measuring small (about 7 weeks) / at 10 weeks the baby measured 7 weeks and 1 day; Maternal exposure during pregnancy, first trimester; This is a spontaneous report from a contactable consumer (the parent). This consumer reported information for both mother (self) and fetus/baby. This is the second of two reports. This is a fetus report.  A fetus patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 transplacental on 06Oct2021 at 18:45 (Batch/Lot Number: FF8839) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient's mother (34 year-old female) previously received bnt162b2, dose 1 on 24Aug2021 at 12:45 (Batch/Lot Number: FC3183) as dose 1, single for COVID-19 immunisation.  The patient experienced maternal exposure during pregnancy, first trimester, at an ultrasound at 8 weeks 4 days the baby was measuring small (about 7 weeks) and had a lower heart rate, at an ultrasound at 10 weeks the baby measured 7 weeks and 1 day with no heartbeat, resulting in a miscarriage on an unknown date in 2021. The events were serious for congenital anomaly and death. The events resulted in doctor or other healthcare professional office/clinic visit. The mother underwent doctor visits and follow ups. The patient died on an unknown date it 2021.  It was not reported if an autopsy was performed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101463694 Same reporter/drug, different patient and event (Mother case).; Reported Cause(s) of Death: no heartbeat; At an ultrasound at 8 weeks 4 days the baby was measuring small (about 7 weeks) / at 10 weeks the baby measured 7 weeks and 1 day; lower heart rate
Sex: U
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: lower heart rate; no heartbeat; At an ultrasound at 8 weeks 4 days the baby was measuring small (about 7 weeks) / at 10 weeks the baby measured 7 weeks and 1 day; Maternal exposure during pregnancy, first trimester; This is a spontaneous report from a contactable consumer (the parent). This consumer reported information for both mother (self) and fetus/baby. This is the second of two reports. This is a fetus report.  A fetus patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 transplacental on 06Oct2021 at 18:45 (Batch/Lot Number: FF8839) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient's mother (34 year-old female) previously received bnt162b2, dose 1 on 24Aug2021 at 12:45 (Batch/Lot Number: FC3183) as dose 1, single for COVID-19 immunisation.  The patient experienced maternal exposure during pregnancy, first trimester, at an ultrasound at 8 weeks 4 days the baby was measuring small (about 7 weeks) and had a lower heart rate, at an ultrasound at 10 weeks the baby measured 7 weeks and 1 day with no heartbeat, resulting in a miscarriage on an unknown date in 2021. The events were serious for congenital anomaly and death. The events resulted in doctor or other healthcare professional office/clinic visit. The mother underwent doctor visits and follow ups. The patient died on an unknown date it 2021.  It was not reported if an autopsy was performed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101463694 Same reporter/drug, different patient and event (Mother case).; Reported Cause(s) of Death: no heartbeat; At an ultrasound at 8 weeks 4 days the baby was measuring small (about 7 weeks) / at 10 weeks the baby measured 7 weeks and 1 day; lower heart rate
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Nausea
Clinical narrative: super dizzy; hard to walk; nausea; This is a spontaneous report from a non-contactable consumer (patient) received via the Medical Information Team. A female patient of an unspecified age (reported as patient's age: 64; unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, on 27Feb2021 (Batch/Lot number was not reported) as single dose, for COVID-19 immunisation. Medical history included ongoing blood thinner use (reported as for many years, decades). Concomitant medications included unspecified blood thinner. On 28Feb2021, the patient felt super dizzy, hard to walk at all, and has nausea. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: felt nauseous; This is a spontaneous report from a non-contactable consumer (patient) received via the Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, on 27Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient felt nauseous on 28Feb2021. The patient wanted to know if she could take promethazine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in his right leg; This is a spontaneous report from a contactable consumer (patient).   A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient experienced pain in his right leg on an unspecified date with outcome of unknown.  He would like to ask if he can take Ibuprofen for it. He mentioned that his doctors won't know so he decided to call Pfizer.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single, for COVID-19 immunization. The patient's medical history included vertigo (in the past, before her COVID-19 vaccination). The patient's concomitant medications were not reported. On an unspecified date, the patient felt dizzy after her second dose of Pfizer-BioNTech COVID-19 vaccine. The patient asked for treatment recommendations using vertigo medicine and paracetamol (TYLENOL). The event was considered non-serious. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram pancreas, Pain in extremity
Clinical narrative: little soreness in her arm.; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 01Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included pancreatic carcinoma (she has pancreatic cancer and gets abdominal CT scans every 3 months). The patient's concomitant medications were not reported. Patient received her first Pfizer Covid vaccine yesterday and felt fine except for a little soreness in her arm on an unspecified date with outcome of unknown. Patient was scheduled to receive her second vaccination in 3 weeks but has a CT scan scheduled for 2 days after this second vaccination. The patient underwent lab tests and procedures which included computerised tomogram pancreas: unknown results on unknown date (she has pancreatic cancer and gets abdominal CT scans every 3 months). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Vomiting
Clinical narrative: Dizziness; throwing up; fatigued; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN6201, Expiration Date: not reported) via an unspecified route of administration on 25Feb2021 (at the age of 54 years old) as dose 1, single for COVID-19 immunisation. Medical history included menopause from an unknown date. Concomitant medications included vitamins taken for an unspecified indication and unspecified drug taken for menopause - both start and stop date were not reported. On an unspecified date, the patient experienced dizziness, was throwing up and was fatigued. No treatment was received for the adverse events. The reporter was asking if this was normal. Outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: just felt a little tired; This is a spontaneous report from a contactable consumer (patient) received via the Medical Information Team. A female patient of an unspecified age (reported as patient's age: 81; unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19. The patient's concomitant medications were not reported. The patient just felt a little tired on an unspecified date, after receiving the first BNT162B2 vaccine. The patient asked if it's possible to overdose from the second dose of the vaccine if someone already had COVID and were the side effects more severe. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: left arm is very hurt; Headache; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN6198, Expiration Date: not reported) via an unspecified route of administration, administered in left arm on 25Feb2021 (at the age of 39 years old) as dose 1, single for COVID-19 immunisation. The patient has no relevant medical history. The patient's concomitant medications were not reported. On 25Feb2021, the patient experienced that his left arm was very hurt and had a headache. No treatment was received for the adverse events. Outcome of all events was not recovered. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: tiredness; nausea; This is a spontaneous report from a non-contactable consumer (patient's daughter), a Pfizer colleague. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. Medical history included COVID-19 on Nov2020. The patient's concomitant medications were not reported. The patient experienced tiredness and nausea on an unspecified date after the vaccination. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a contactable other healthcare professional (patient). A 30-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 29Jan2021 14:00 (Batch/Lot Number: EN5318), at the age of 30 years old, as dose 1, single for covid-19 immunisation.  Medical history included chronic migraine from an unknown date and unknown if ongoing. No known allergies. No COVID prior to vaccination and has not been tested for COVID post vaccination. Concomitant medications included cannabis (reported as medical marijuana) taken for an unspecified indication, start and stop date were not reported and sildenafil (VIAGRA) taken for an unspecified indication, start and stop date were not reported. On 16Feb2021 21:00, the patient experienced tinnitus. The event was further described as almost constant ringing in ears/white noise. Unknown if treatment was given. The event resulted in doctor or other healthcare professional office/clinic visit. The patient has not recovered from the event.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: throat started hurting; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program, Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, on 27Jan2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that her throat started hurting on the night of 25Feb2021. The patient was wondering if she can still take second dose scheduled on 28Feb2021. The outcome of event throat started hurting was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: lightheadedness and dizziness; This is a spontaneous report from a non-contactable consumer for a female patient (consumer's mother) received via a Pfizer-sponsored program, SUPPORT. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, on 11Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced lightheadedness and dizziness on 12Feb2021. The patient went to the emergency room and was prescribed with meclizine. The outcome of events lightheadedness and dizziness was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; This is a spontaneous report from a Pfizer-sponsored program Support. A contactable consumer (patient herself) reported that a female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient historically received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. On 25Feb2021, the patient experienced flu-like symptoms, overnight after she took the second dose of COVID-19 vaccine and wanted to know how long the said symptoms are going to last. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urine abnormality, Urine odour abnormal
Clinical narrative: urine was cloudy and had a smell; urine was cloudy and had a smell; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program, support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 25Feb2021 at dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 25Feb2021 (also reported as "last night"), the patient noticed that her urine was cloudy and had a smell. She wondered if those were possible side effects of the vaccine. She then mentioned that she was better at the time of reporting. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.