chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Taste disorder, Vaccination failure
Clinical narrative: headache; dizzy; getting tired; was trying to catch her breath; She feels like she is getting her taste buds back; Covid after being vaccinated/  Covid: positive/ contracted Covid; Covid after being vaccinated/  Covid: positive/ contracted Covid; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at age of 56 year old, dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 (Batch/Lot Number: BP7534) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 (Batch/Lot Number: SN6205) as DOSE 1, SINGLE for covid-19 immunisation. There were no concomitant medications and medical history. Patient just contracted Covid. She felt like she was getting her taste buds back and reported that she had a headache at the beginning of the week that got worse at night. She said that with standing up and moving she got dizzy. She was getting tired and was trying to catch her breath. She had no fever and she was keeping up with her pulse. She had no infection in the chest or anything. Patient got Covid after being vaccinated on 04Nov2021. The patient underwent lab tests and procedures which included Covid: positive on 04Nov2021. The outcomes of events were unknown.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Ophthalmic herpes zoster
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). The reporter reported similar events for 3 patients, this is the first report of three. A 52-years-old male patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in his left arm on 28Oct2021 (Batch/Lot number was not reported) (at age of 52-year-old) as dose 3 (booster), single for COVID-19 immunisation. There was no medical history. There were no concomitant medications. The patient previously got his Shingrix vaccine two years ago in 2019 for immunization. The patient previously received the first dose of BNT162B2 on 08Mar2021 (at age of 52-year-old) for COVID-19 immunization, received the second dose of BNT162B2 on Mar2021 (at age of 52-year-old) for COVID-19 immunization. The patient is suspecting he is experiencing an adverse reaction with the Pfizer COVID 19 booster. He has experienced ophthalmic herpes zoster. He received the COVID booster last Thursday 28Oct2021. He started having symptoms last night 04Nov2021. It has improved because he started Valtrex. He consulted his optometrist and internal medicine doctor. It is really strange, he got his Shingrix vaccine two years ago in 2019. He has spoken with two other people who have experienced the same thing as him. He knows they haven't reported. He truly believes it was from the vaccine. Event outcome of ophthalmic herpes zoster was recovering.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101529294 same reporter/drug/event, different patient;US-PFIZER INC-202101529295 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Ophthalmic herpes zoster; This is a spontaneous report from a contactable consumer. The reporter reported similar events for 3 patients, this is the second of 3 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 dose number unknown, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced ophthalmic herpes zoster on an unspecified date with outcome of unknown.    The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101529173 same reporter/drug/event, different patient;US-PFIZER INC-202101529295 same reporter/drug/event, different patient
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Hallucination, Pyrexia
Clinical narrative: My son he was 6 year old had the Pfizer vaccine yesterday; My son he was 6 year old had the Pfizer vaccine yesterday; he was hallucinating; fever but it was an extremely high fever; his fever was 104 degrees; he still has the fever; This is a spontaneous report from a contactable consumer. This consumer reported for 6-year-old male Patient (reporter's son) reported that:  A 6 year old male patient received BNT162B2 (PFIZER BIONTECH COVID VACCINE, solution for injection, Lot: FK5127 ) via unspecified route of administration in arm left (deltoid left) on 05Nov2021 at 17:30 dose number unknown, single for covid 19 immunization. The patient medical history none. The concomitant vaccine within 4 weeks of getting the pfizer vaccine Flucelvax quadrivalent( LOT: 308486, Expiration date: 30Jun2022 (INFLUENZA VACCINE INACT SAG 4V) from 26Oct2021 at 15:00 PM to 26Oct2021 at 15:00 PM for unspecified indication. Reporter stated my son was 6 year old had the Pfizer vaccine yesterday (drug use in unapproved population) and I wanted to report side effect. Reporter further stated yes on friday the day before yesterday at 4 pm. Reporter was informed about the role of Pfizer Drug Safety Department. Reporter stated yes, so the two side effect that, I could knew the first one was, on unspecified date in Nov2021 he did get the fever but it was an extremely high fever, his fever was 104 degrees and that was with the maximum dosage alternating. Tylenol and ibuprofen so, barley keeping it in under control and he was hallucinating. Reporter stated now he still had the fever (further not clarified hence not checked in tab) not the hallucinations anymore. Reporter seriousness for fever but it was an extremely high fever; his fever was 104 degrees; he still has the fever, he was hallucinating: unspecified. Patient received treatment with Ibuprofen (Expiry date: Oct2019) and Tylenol (Expiry date: May2022) to decrease the fever. The patient underwent body temperature measurement test : 104 degree centigrade on Nov2021. The outcome of extremely high fever, hallucinating were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-Up (11Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Foot and mouth disease
Clinical narrative: Foot and mouth disease; This is a spontaneous report from contactable nurse (patient). A female patient of an unspecified age received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), intramuscular, administered in arm left on 06Jan2021 at 63-year-old (Lot Number: EL1283) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, dermal filler injection from an unknown date and unknown if ongoing, herpes zoster from an unknown date and unknown if ongoing, guttate psoriasis from an unknown date and unknown if ongoing. Patient was not pregnant and was not pregnant at time of vaccination. Concomitant medications included vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported; niacin (NIACIN) taken for an unspecified indication, start and stop date were not reported; atenolol (ATENOLOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took the 1st dose of  bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) on 16Dec2020 at 63-year-old (Batch/Lot# EJ1685) for COVID-19 immunisation, azithromycin (ZITHROMAX) and experienced drug hypersensitivity.  The patient was diagnosed with suspected foot and mouth disease (non-serious) in Apr2021 with outcome of unknown. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : PFIZER INC-202101529870 Same reporter/patient/drug, different dose/events.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood oestrogen, Blood oestrogen decreased, Depressed mood, Disturbance in attention
Clinical narrative: Low estrogen; cannot sleep; cannot focus; depressed; has anxiety; cannot concentrate; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number and Expiry Date was not reported) via an unspecified route of administration on 30Apr2021 as DOSE 2, SINGLE for COVID-19 immunization and dose 1, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number and Expiry Date was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On unspecified date in 2021, the patient experienced low estrogen, cannot sleep, cannot focus, depressed, has anxiety and cannot concentrate. It was reported that she was tested and test proved that she had low estrogen. She wanted to make sure to notify because this could impact people who want to have babies her two nieces are waiting because they are young. Patient stated that she was thankful that she no longer wants to have children. She went on to state that she was aware of 10 people who experienced the similar reactions. 5 of which are asians and she is chinese and did not mention the nationality of the other 5. On an unspecified date, the patient underwent lab tests and procedures which included blood oestrogen: low. The outcome for the events was unknown.No follow-up attempts are needed; information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) : -PFIZER_INC-202101533633 ;-PFIZER_INC-202101533634 ;-PFIZER_INC-202101533635 ;-PFIZER_INC-202101533636 ;-PFIZER_INC-202101533637 ;-PFIZER_INC-202101533638 ;-PFIZER_INC-202101533639 ;-PFIZER_INC-202101533640 ;-PFIZER_INC-202101533641
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Vision blurred
Clinical narrative: Low estrogen; cannot sleep; cannot focus; depressed; has anxiety; cannot concentrate; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number and Expiry Date was not reported) via an unspecified route of administration on 30Apr2021 as DOSE 2, SINGLE for COVID-19 immunization and dose 1, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number and Expiry Date was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On unspecified date in 2021, the patient experienced low estrogen, cannot sleep, cannot focus, depressed, has anxiety and cannot concentrate. It was reported that she was tested and test proved that she had low estrogen. She wanted to make sure to notify because this could impact people who want to have babies her two nieces are waiting because they are young. Patient stated that she was thankful that she no longer wants to have children. She went on to state that she was aware of 10 people who experienced the similar reactions. 5 of which are asians and she is chinese and did not mention the nationality of the other 5. On an unspecified date, the patient underwent lab tests and procedures which included blood oestrogen: low. The outcome for the events was unknown.No follow-up attempts are needed; information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) : -PFIZER_INC-202101533633 ;-PFIZER_INC-202101533634 ;-PFIZER_INC-202101533635 ;-PFIZER_INC-202101533636 ;-PFIZER_INC-202101533637 ;-PFIZER_INC-202101533638 ;-PFIZER_INC-202101533639 ;-PFIZER_INC-202101533640 ;-PFIZER_INC-202101533641
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Blood oestrogen decreased, Depressed mood, Disturbance in attention, Insomnia
Clinical narrative: Low estrogen; can't concentrate; can't focus; can't sleep; depressed; has anxiety; This is a spontaneous report from a contactable consumer. This consumer reported same events under same suspect product for 10 patients this is 4th of 10 reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 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 experienced low estrogen, can't concentrate, can't focus, can't sleep, depressed and had anxiety. The events were reported as non serious. The outcome of the events was unknown.No follow-up attempts are needed; information about lot/batch number cannot be obtained. Sender's Comments: Linked Report(s) : PFIZER_INC-202101533632.
Sex: U
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Low estrogen; can't concentrate; can't focus; can't sleep; depressed; has anxiety; This is a spontaneous report from a contactable consumer. This consumer reported same events under same suspect product for 10 patients this is 4th of 10 reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 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 experienced low estrogen, can't concentrate, can't focus, can't sleep, depressed and had anxiety. The events were reported as non serious. The outcome of the events was unknown.No follow-up attempts are needed; information about lot/batch number cannot be obtained. Sender's Comments: Linked Report(s) : PFIZER_INC-202101533632.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood oestrogen, Blood oestrogen decreased, Depressed mood, Disturbance in attention
Clinical narrative: Low estrogen; can't concentrate; can't focus; can't sleep; depressed; has anxiety; This is a spontaneous report from a contactable consumer (patient). This consumer reported same events under same suspect product for 10 patients. This is one of 10 reports.   A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 30Apr2021 as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced low estrogen, cannot sleep, cannot focus, depressed, anxiety and cannot concentrate. The patient was tested and test proved that she had low estrogen (values not reported). The events were non-serious. The patient underwent lab tests and procedures which included blood oestrogen: low on an unspecified date. The outcome of the events was unknown. No follow-up attempts are needed; Information about lot/batch number cannot be obtained. Sender's Comments: Linked Report(s) : -PFIZER_INC-202101533632.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Vision blurred
Clinical narrative: Low estrogen; can't concentrate; can't focus; can't sleep; depressed; has anxiety; This is a spontaneous report from a contactable consumer (patient). This consumer reported same events under same suspect product for 10 patients. This is one of 10 reports.   A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 30Apr2021 as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced low estrogen, cannot sleep, cannot focus, depressed, anxiety and cannot concentrate. The patient was tested and test proved that she had low estrogen (values not reported). The events were non-serious. The patient underwent lab tests and procedures which included blood oestrogen: low on an unspecified date. The outcome of the events was unknown. No follow-up attempts are needed; Information about lot/batch number cannot be obtained. Sender's Comments: Linked Report(s) : -PFIZER_INC-202101533632.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Blood oestrogen, Blood oestrogen decreased, Depressed mood, Disturbance in attention
Clinical narrative: Low estrogen; can't concentrate/can't focus; can't sleep; depressed; has anxiety; This is a spontaneous report from a contactable consumer. This consumer reported same events under same suspect product for 10 patients this is one of 10 reports:  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), 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 experienced low oestrogen, can't concentrate/can't focus, can't sleep, depressed, and has anxiety. It was reported that the reporter who believed that she received the Moderna vaccine, stating that since receiving her 2nd dose in April, she had low estrogen, cannot sleep, cannot focus, depressed, has anxiety and cannot concentrate. She was tested and test proved that she has low estrogen. She went on to state that she was aware of 10 people who experienced the similar reactions. 5 of which are withheld 5 and she is withheld and did not mention the nationality of the other 5. When she was requested the date of vaccination and LOT number/EXP Date for the Moderna vaccine, patient realized that she called the wrong number because she had received both doses of the Pfizer vaccine. On an unspecified date, the patient underwent lab tests and procedures which included Estrogen: low. The outcome of all the events were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER_INC-202101533632
Sex: U
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Low estrogen; can't concentrate/can't focus; can't sleep; depressed; has anxiety; This is a spontaneous report from a contactable consumer. This consumer reported same events under same suspect product for 10 patients this is one of 10 reports:  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), 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 experienced low oestrogen, can't concentrate/can't focus, can't sleep, depressed, and has anxiety. It was reported that the reporter who believed that she received the Moderna vaccine, stating that since receiving her 2nd dose in April, she had low estrogen, cannot sleep, cannot focus, depressed, has anxiety and cannot concentrate. She was tested and test proved that she has low estrogen. She went on to state that she was aware of 10 people who experienced the similar reactions. 5 of which are withheld 5 and she is withheld and did not mention the nationality of the other 5. When she was requested the date of vaccination and LOT number/EXP Date for the Moderna vaccine, patient realized that she called the wrong number because she had received both doses of the Pfizer vaccine. On an unspecified date, the patient underwent lab tests and procedures which included Estrogen: low. The outcome of all the events were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER_INC-202101533632
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Blood oestrogen, Blood oestrogen decreased, Depressed mood, Disturbance in attention
Clinical narrative: Low estrogen; can't concentrate/can't focus; can't sleep; depressed; has anxiety; This is a spontaneous report from a contactable consumer or other non hcp (patient). This consumer reported same events under same the suspect product for 10 patients. This is 1st out of 10 reports.  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number was not reported) via an unspecified route of administration on 30Apr2021 as dose 2, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number was not reported) via an unspecified route of administration on unspecified date as dose 1, single dose for covid-19 immunization. On unspecified date in Apr2021, the patient experienced low estrogen, can't sleep, can't focus, depressed, has anxiety and can't concentrate. Call received from patient who believe that she received the modern vaccine stating that since receiving her 2nd dose in April she has low estrogen cannot sleep, focus, depressed has anxiety and cannot concentrate she was tested and test prove that she has low estrogen she wanted to make sure to notify because this could impact people who want to have babies. her two nieces are waiting because they are young. Patient stated that she is thankful that she no longer wants to have children she went on to state that she is aware of 10 people who experienced the similar reaction and did not mention the nationality of other 5 upon request of the date of vaccination and lot number expiration date for the moderna vaccine patient realized that she called the wrong number because she received both losses of Pfizer vaccine first dose on 07Oct2021 and 2nd dose on 30Apr2021. Patient also stated that she called, because doctor does not believe her. Reported seriousness of the events was not life threatening, no intervention or medically important, not resulted in death, hospitalization prolonged, disabling or incapacitating, congenital anomaly or birth defect and no hospitalization required and also no other. The patient underwent lab tests and procedures which included estrogen results low on unspecified date in Apr2021. There is no product complaint associated with this case. 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. Sender's Comments: Linked Report(s) :-PFIZER_INC-202101533632.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Low estrogen; can't concentrate/can't focus; can't sleep; depressed; has anxiety; This is a spontaneous report from a contactable consumer or other non hcp (patient). This consumer reported same events under same the suspect product for 10 patients. This is 1st out of 10 reports.  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number was not reported) via an unspecified route of administration on 30Apr2021 as dose 2, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number was not reported) via an unspecified route of administration on unspecified date as dose 1, single dose for covid-19 immunization. On unspecified date in Apr2021, the patient experienced low estrogen, can't sleep, can't focus, depressed, has anxiety and can't concentrate. Call received from patient who believe that she received the modern vaccine stating that since receiving her 2nd dose in April she has low estrogen cannot sleep, focus, depressed has anxiety and cannot concentrate she was tested and test prove that she has low estrogen she wanted to make sure to notify because this could impact people who want to have babies. her two nieces are waiting because they are young. Patient stated that she is thankful that she no longer wants to have children she went on to state that she is aware of 10 people who experienced the similar reaction and did not mention the nationality of other 5 upon request of the date of vaccination and lot number expiration date for the moderna vaccine patient realized that she called the wrong number because she received both losses of Pfizer vaccine first dose on 07Oct2021 and 2nd dose on 30Apr2021. Patient also stated that she called, because doctor does not believe her. Reported seriousness of the events was not life threatening, no intervention or medically important, not resulted in death, hospitalization prolonged, disabling or incapacitating, congenital anomaly or birth defect and no hospitalization required and also no other. The patient underwent lab tests and procedures which included estrogen results low on unspecified date in Apr2021. There is no product complaint associated with this case. 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. Sender's Comments: Linked Report(s) :-PFIZER_INC-202101533632.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood oestrogen, Blood oestrogen decreased, Depressed mood, Disturbance in attention
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient). This consumer reported same events under same the suspect product for 10 patients. This is 1st out of 10 reports. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number was not reported) via an unspecified route of administration on 30Apr2021 as dose 2, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number was not reported) via an unspecified route of administration on unspecified date as dose 1, single dose for covid-19 immunization. On unspecified date in Apr2021, the patient experienced low estrogen, can't sleep, can't focus, depressed, has anxiety and can't concentrate. Call received from patient who believe that she received the modern vaccine stating that since receiving her 2nd dose in April she has low estrogen cannot sleep, focus, depressed has anxiety and cannot concentrate she was tested and test prove that she has low estrogen she wanted to make sure to notify because this could impact people who want to have babies. her two nieces are waiting because they are young. Patient stated that she is thankful that she no longer wants to have children she went on to state that she is aware of 10 people who experienced the similar reaction and did not mention the nationality of other 5 upon request of the date of vaccination and lot number expiration date for the moderna vaccine patient realized that she called the wrong number because she received both losses of Pfizer vaccine 2nd dose on 30Apr2021. Patient also stated that she called, because doctor does not believe her. Reported seriousness of the events was not life threatening, no intervention or medically important, not resulted in death, hospitalization prolonged, disabling or incapacitating, congenital anomaly or birth defect and no hospitalization required and also no other. The patient underwent lab tests and procedures which included estrogen results low on unspecified date in Apr2021. There is no product complaint associated with this case. 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. Sender's Comments: Linked Report(s) : -PFIZER_INC-202101533633 ;-PFIZER_INC-202101533634 ;-PFIZER_INC-202101533635 ;-PFIZER_INC-202101533636 ;-PFIZER_INC-202101533637 ;-PFIZER_INC-202101533638 ;-PFIZER_INC-202101533639 ;-PFIZER_INC-202101533640 ;-PFIZER_INC-202101533641.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Vision blurred
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient). This consumer reported same events under same the suspect product for 10 patients. This is 1st out of 10 reports. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number was not reported) via an unspecified route of administration on 30Apr2021 as dose 2, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number was not reported) via an unspecified route of administration on unspecified date as dose 1, single dose for covid-19 immunization. On unspecified date in Apr2021, the patient experienced low estrogen, can't sleep, can't focus, depressed, has anxiety and can't concentrate. Call received from patient who believe that she received the modern vaccine stating that since receiving her 2nd dose in April she has low estrogen cannot sleep, focus, depressed has anxiety and cannot concentrate she was tested and test prove that she has low estrogen she wanted to make sure to notify because this could impact people who want to have babies. her two nieces are waiting because they are young. Patient stated that she is thankful that she no longer wants to have children she went on to state that she is aware of 10 people who experienced the similar reaction and did not mention the nationality of other 5 upon request of the date of vaccination and lot number expiration date for the moderna vaccine patient realized that she called the wrong number because she received both losses of Pfizer vaccine 2nd dose on 30Apr2021. Patient also stated that she called, because doctor does not believe her. Reported seriousness of the events was not life threatening, no intervention or medically important, not resulted in death, hospitalization prolonged, disabling or incapacitating, congenital anomaly or birth defect and no hospitalization required and also no other. The patient underwent lab tests and procedures which included estrogen results low on unspecified date in Apr2021. There is no product complaint associated with this case. 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. Sender's Comments: Linked Report(s) : -PFIZER_INC-202101533633 ;-PFIZER_INC-202101533634 ;-PFIZER_INC-202101533635 ;-PFIZER_INC-202101533636 ;-PFIZER_INC-202101533637 ;-PFIZER_INC-202101533638 ;-PFIZER_INC-202101533639 ;-PFIZER_INC-202101533640 ;-PFIZER_INC-202101533641.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Started developing hives on inner forearms, thighs and buttocks; worse in the evenings.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Bronchitis, Computerised tomogram, Dyspnoea, Electroencephalogram
Clinical narrative: Immediately after first dose at clinic needed Epi pen shot ego recognition could leave cuz couldn't breath. Both does was sick as hell, has progressively gotten worse, currently have pneumonia, bronchitis and blood clots and  "elevated risk of more"; To an extent that the er doctor says I should be concerned. This vaccine poisoned me, there no "possibly" no "allegedly" , these vaccines are why I am sick.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Malaise, Pneumonia, Thrombosis
Clinical narrative: Immediately after first dose at clinic needed Epi pen shot ego recognition could leave cuz couldn't breath. Both does was sick as hell, has progressively gotten worse, currently have pneumonia, bronchitis and blood clots and  "elevated risk of more"; To an extent that the er doctor says I should be concerned. This vaccine poisoned me, there no "possibly" no "allegedly" , these vaccines are why I am sick.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: I?m waiting on an appointment at clinic for not only my Ovaries because of a ovarian cyst but also because my period has not stopped since 4 November 2021. This is not normal for me I?ve always had a light menstrual cycle since a teen. It would only last me 3 days. I?ve never had an irregular. Not even after marina or the death of birth controls.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Immunisation, Ocular vascular disorder
Clinical narrative: vision loss; Patient suffered and eye stroke with vision loss; Booster; This is a spontaneous report from a contactable consumer. A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Oct2021 (Lot Number: Unknown) (at the age of 72-year-old) as dose 3 (booster), single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient's known allergies was unknown. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. The patient previously took dose 1 and dose 2 of bnt162b2 (Lot Number: unknown) on an unspecified date for COVID-19 immunization. On 04Nov2021, patient suffered eye stroke with vision loss. The seriousness criteria of events was disabling or incapacitating. These event resulted in Doctor or other healthcare professional office/clinic visit and emergency room /department or urgent care. Patient's doctor commented that he was the second person he had seen had an eye stroke about 3 weeks after receiving the booster shot. Treatment was given for events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The outcome of events was resolved with sequelae (Resolved with lasting effects as reported) on an unspecified date in Nov2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis reactive, Immunisation, Palpitations, SARS-CoV-2 test
Clinical narrative: reactive arthritis in both hands; heart palpitations; booster; This is a spontaneous report from a contactable other HCP (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 3 via an unspecified route of administration, administered in Arm Right at the age of 29-year-old on 06Oct2021 (Lot Number: FE3590) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation.  Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Medical history included none (other medical history: No). Prior to vaccination, the patient was not diagnosed with COVID-19. No Known Allergies. Patient was not pregnant. The patient's concomitant medications were not reported.  The patient previously took first dose BNT162B2 (Batch/Lot No: Ez0140, Location of injection: Arm Right) at the age of 28-year-old on 28Dec2020 for COVID-19 immunization, second dose BNT162B2 (Batch/Lot No: EL3248, Location of injection: Arm Right) at the age of 28-year-old on 18Jan2021 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had experienced reactive arthritis in both hands since the day after receiving patient's booster. Patient also had heart palpitations that were occurring consistently post vaccine, but now only happen intermittently. The reactive arthritis has not lessen in intensity or frequency. Adverse event start date 07Oct2021. AE resulted in: [Disability or permanent damage].  The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Oct2021 (Nasal Swab).  No treatment received for events reactive arthritis in both hands and heart palpitations. The outcome of events reactive arthritis in both hands and heart palpitations was not recovered. The outcome of event booster was unknown.; Sender's Comments: Based on available information and the close drug event temporal association, a possible contributory role of suspect product BNT162B2 to the development of event Immunisation, Arthritis reactive, Palpitations cannot be totally 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Laziness, Movement disorder, Paraesthesia, Sleep disorder
Clinical narrative: just felt kind of lazy; She states it is just enough pain to keep her awake at night; pins and needles; shoulder pain; whole right arm and into her hand it is completely asleep all of the time; At the injection site, she still has the side effects, it is very painful in her right arm, the whole right arm; This is a spontaneous report from a contactable consumer. This 73-year-old female patient (consumer) reported for herself that: A 73-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in Arm Right on 25Feb2021 08:15 (Lot Number: EL9266) (at the age of 73-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included fibromyalgia which had for about 20 years, plaque shift, sleep disorder. The patient previously took BNT162B2 (first dose, lot number: EL3247) administrated in arm left on 03Feb2021 (at the age of 73-year-old) for covid-19 immunization. Concomitant medications included lisinopril (LISINOPRIL) 0.5mg once a day, in the morning taken for plaque shift; alprazolam (XANAX) (NDC, LOT, EXP unknown) 1 mg and upped to 2mg 6 months ago taken for sleep disorder. The patient experienced very painful in her right arm (at the injection site) on 27Feb2021 with outcome of not recovered; felt kind of lazy, awake at night, felt pins and needles, shoulder pain, Movement disorder on an unspecified date with outcome of unknown. Patient took Tylenol every once in a while during the day if pain got really bad. Vaccination site pain required a physician office visit. Patient stated that she did not had other additional vaccines on the same date of the Pfizer vaccine and no prior vaccinations. No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: just felt kind of lazy; She states it is just enough pain to keep her awake at night; pins and needles; shoulder pain; whole right arm and into her hand it is completely asleep all of the time; At the injection site, she still has the side effects, it is very painful in her right arm, the whole right arm; This is a spontaneous report from a contactable consumer. This 73-year-old female patient (consumer) reported for herself that: A 73-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in Arm Right on 25Feb2021 08:15 (Lot Number: EL9266) (at the age of 73-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included fibromyalgia which had for about 20 years, plaque shift, sleep disorder. The patient previously took BNT162B2 (first dose, lot number: EL3247) administrated in arm left on 03Feb2021 (at the age of 73-year-old) for covid-19 immunization. Concomitant medications included lisinopril (LISINOPRIL) 0.5mg once a day, in the morning taken for plaque shift; alprazolam (XANAX) (NDC, LOT, EXP unknown) 1 mg and upped to 2mg 6 months ago taken for sleep disorder. The patient experienced very painful in her right arm (at the injection site) on 27Feb2021 with outcome of not recovered; felt kind of lazy, awake at night, felt pins and needles, shoulder pain, Movement disorder on an unspecified date with outcome of unknown. Patient took Tylenol every once in a while during the day if pain got really bad. Vaccination site pain required a physician office visit. Patient stated that she did not had other additional vaccines on the same date of the Pfizer vaccine and no prior vaccinations. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Got covid although he was vaccinated; Got covid although he was vaccinated; This is a spontaneous report from a contactable consumer or other non hcp.  An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported), both as single dose for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported. It was reported that the patient got covid in Sep2021 although he was vaccinated . It was informed that he said it was like having a cold. Since the vaccination, the patient been has tested for COVID-19. The outcome of the events was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Dizziness, Fatigue, Immunisation
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in right arm on 04Nov2021 14:30 (at the age of 51 years old) (Lot Number: FF2593) as dose 3 (booster), single for COVID-19 immunisation. The patient medical history was not reported. No pregnancy at time of Vaccination. Concomitant medication included influenza vaccine (FLU) on 12Oct2021. No other medications the patient received within 2 weeks of vaccination. The patient previously received the BNT162B2, first dose (Batch/Lot No: EN6208) on 12Mar2021, second dose (Batch/Lot No: EW0150) on 02Apr2021, both in left arm at the age of 50 years old for Covid-19 immunization. The patient experienced felt extremely dizzy on 05Nov2021, the vertigo (dizziness) was accompanied with vomiting on 05Nov2021, nausea on 05Nov2021, fever on 05Nov2021, chills on 05Nov2021, injection site pain on 05Nov2021, body aches on 05Nov2021, physical inability to get out of bed on 05Nov2021, feeling tired on 05Nov2021. Clinical course: She took her Covid booster shot at around 2:30 on Thursday afternoon (04Nov2021). About 10 hours later, she felt extremely dizzy. The dizziness continued the whole of the next day where she was unable to get out of bed. The vertigo (dizziness) was accompanied with vomiting every time she stood up to go to the bathroom. She was unable to keep down any food or water for the entire next day. She is an otherwise healthy person but she needed physical help to get to the bathroom all of Friday (05Nov2021). On Saturday (06Nov2021), the nausea went away but the vertigo persisted mildly. It is now Monday (08Nov2021) and she is still feeling tired and not back to her usual self. In addition to the vertigo and nausea, she did have fever, chills, injection site pain and body aches. The most debilitating symptom was the vertigo and nausea. Her husband informed the primary care doctor about the reaction and they wanted me to get admitted in the hospital for IV fluids. But, they decided against it due to her physical inability to get out of bed. No treatment received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been has not tested for COVID-19. The outcome of the event nausea was recovered on 06Nov2021, of the other events was recovered with sequel. Follow-up (11Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vaccination site pain, Vertigo
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in right arm on 04Nov2021 14:30 (at the age of 51 years old) (Lot Number: FF2593) as dose 3 (booster), single for COVID-19 immunisation. The patient medical history was not reported. No pregnancy at time of Vaccination. Concomitant medication included influenza vaccine (FLU) on 12Oct2021. No other medications the patient received within 2 weeks of vaccination. The patient previously received the BNT162B2, first dose (Batch/Lot No: EN6208) on 12Mar2021, second dose (Batch/Lot No: EW0150) on 02Apr2021, both in left arm at the age of 50 years old for Covid-19 immunization. The patient experienced felt extremely dizzy on 05Nov2021, the vertigo (dizziness) was accompanied with vomiting on 05Nov2021, nausea on 05Nov2021, fever on 05Nov2021, chills on 05Nov2021, injection site pain on 05Nov2021, body aches on 05Nov2021, physical inability to get out of bed on 05Nov2021, feeling tired on 05Nov2021. Clinical course: She took her Covid booster shot at around 2:30 on Thursday afternoon (04Nov2021). About 10 hours later, she felt extremely dizzy. The dizziness continued the whole of the next day where she was unable to get out of bed. The vertigo (dizziness) was accompanied with vomiting every time she stood up to go to the bathroom. She was unable to keep down any food or water for the entire next day. She is an otherwise healthy person but she needed physical help to get to the bathroom all of Friday (05Nov2021). On Saturday (06Nov2021), the nausea went away but the vertigo persisted mildly. It is now Monday (08Nov2021) and she is still feeling tired and not back to her usual self. In addition to the vertigo and nausea, she did have fever, chills, injection site pain and body aches. The most debilitating symptom was the vertigo and nausea. Her husband informed the primary care doctor about the reaction and they wanted me to get admitted in the hospital for IV fluids. But, they decided against it due to her physical inability to get out of bed. No treatment received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been has not tested for COVID-19. The outcome of the event nausea was recovered on 06Nov2021, of the other events was recovered with sequel. Follow-up (11Nov2021): Follow-up attempts are completed. No further information is expected.