chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). In 2021, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. In 2021, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No treatment medications were reported. Expiration dates are unknown, they only have the 30 day mark which was on 16May2021.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: people in hospital from vaccine adverse effects/shots doing more harm than good; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (people in hospital from vaccine adverse effects/shots doing more harm than good) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (people in hospital from vaccine adverse effects/shots doing more harm than good). At the time of the report, VACCINATION COMPLICATION (people in hospital from vaccine adverse effects/shots doing more harm than good) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment  medication was provided. Consumer mentioned that most people in the hospital have had the COVID vaccine. People end up in the hospital with adverse effects from the vaccines, and these shots are doing more harm than good.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter considered EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) to be not applicable.    No Treatment medication was reported. No concomitant medication was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The vaccines were applied to patients after being refrozen; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (The vaccines were applied to patients after being refrozen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccines were applied to patients after being refrozen). At the time of the report, PRODUCT STORAGE ERROR (The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment information was provided. No concomitant medication was provided
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 22-Apr-2021, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided  Treatment medications were not provided  Once they received the shipment, the vaccines were placed at freezer temperature, at around -20 degree Celsius After that, a vial was removed from the freezer to administer vaccine. Doses that were viable up to 14-Apr-2021, the 30 days since it was thawed were administered to the patient beyond that day.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Illness, Maternal exposure during pregnancy
Clinical narrative: miscarriage when she became sick from the first vaccine; became sick from the first vaccine; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (miscarriage when she became sick from the first vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (miscarriage when she became sick from the first vaccine) (seriousness criterion medically significant), ILLNESS (became sick from the first vaccine) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, ABORTION SPONTANEOUS (miscarriage when she became sick from the first vaccine) and ILLNESS (became sick from the first vaccine) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  This case concerns of a  female patient  with  no age and  no relevant medical history reported  who experienced the unexpected events of spontaneous abortion, illness and Maternal Exposure during pregnancy. The occurrence of these events are unknown as well as the time to onset  from the vaccine administration with Moderna  since the date of the first dose of the vaccine is also unknown.  Other details of the pregnancy was also not reported like the LMP and EDD. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns of a  female patient  with  no age and  no relevant medical history reported  who experienced the unexpected events of spontaneous abortion, illness and Maternal Exposure during pregnancy. The occurrence of these events are unknown as well as the time to onset  from the vaccine administration with Moderna  since the date of the first dose of the vaccine is also unknown.  Other details of the pregnancy was also not reported like the LMP and EDD. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Patient dies of covid-19 related illness weeks afetr receiving second covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Patient dies of covid-19 related illness weeks afetr receiving second covid vaccine) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Pateint dies of covid-19 related illness weeks afetr receiving second covid vaccine) (seriousness criterion death). The reported cause of death was covid related illness. It is unknown if an autopsy was performed.            No concomitant medications were provided. No treatment information was provided.  This case concerns a 36-year-old patient of an unknown gender with no reported medical history of who experienced the unexpected fatal event of covid 19 related illness. The event occurred after an unspecified time after administration of the second dose of mRNA-1273. The rechallenge was not applicable as this event occurred after the second dose with a reported fatal outcome. Causality assessment for the event was not reported. However, covid 19 is considered as not applicable due biologically implausible based on known etiology. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 36-year-old patient of an unknown gender with no reported medical history of who experienced the unexpected fatal event of covid 19 related illness. The event occurred after an unspecified time after administration of the second dose of mRNA-1273. The rechallenge was not applicable as this event occurred after the second dose with a reported fatal outcome. Causality assessment for the event was not reported. However, covid 19 is considered as not applicable due biologically implausible based on known etiology. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: covid related illness
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pyrexia, Vomiting
Clinical narrative: Severe stomach pains; vomiting; fever; This is a spontaneous report from a contactable consumer (Patient). A 13-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 28Jul2021 13:00 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No known allergies. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not provided), via an unspecified route of administration, administered in Arm Right on 07Jul2021 13:00 as dose 1, single for COVID-19 immunisation. On 29Jul2021 01:00, the patient experienced severe stomach pains, vomiting, fever. Prior to vaccination, patient was not diagnosed with Covid-19. Since the vaccination, patient has not been tested for Covid-19. Patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Outcome of all the events was not resolved.  Information about the Lot/batch number has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Dizziness, Fatigue, Feeling of body temperature change
Clinical narrative: Was moderately sick for 4 days with hot and cold chills; Was moderately sick for 4 days with hot and cold chills; Was moderately sick for 4 days with hot and cold chills; mild dizziness; extreme fatigue; whole body aches and soreness; Developed a medium sized (just smaller than half a golf ball) knot at the injection site with itchiness and medium soreness; Had a fairly harsh headache about 3 hours; Developed a medium sized (just smaller than half a golf ball) knot at the injection site with itchiness and medium soreness; Developed a medium sized (just smaller than half a golf ball) knot at the injection site with itchiness and medium soreness; This is a spontaneous report from a non-contactable consumer (patient). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FA7484), via an unspecified route of administration in left arm on 27Jul2021 at 14:15 (at the age of 48-year-old) as dose 1, single for COVID-19 immunisation at public health clinic/veteran's administration facility. Medical history included diabetes from an unknown date and unknown if ongoing, high blood pressure from an unknown date and unknown if ongoing, penicillin (drug hypersensitivity) from an unknown date and unknown if ongoing, broccoli, avocados, bananas (food allergy) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 27Jul2021 at 17:30, was moderately sick for 4 days with hot and cold chills, mild dizziness, extreme fatigue and whole-body aches and soreness. Had a fairly harsh headache about 3 hours after injection that lasted about 4 hours. Developed a medium sized (just smaller than half a golf ball) knot at the injection site with itchiness and medium soreness. Still have the knot after 5 days. The patient underwent lab tests and procedures which included blood pressure was high on an unknown date. The patient did not receive any treatment for the events. The outcome of the events was reported as resolved on an unknown date.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Illness, Pain, Pruritus, Vaccination site mass
Clinical narrative: Was moderately sick for 4 days with hot and cold chills; Was moderately sick for 4 days with hot and cold chills; Was moderately sick for 4 days with hot and cold chills; mild dizziness; extreme fatigue; whole body aches and soreness; Developed a medium sized (just smaller than half a golf ball) knot at the injection site with itchiness and medium soreness; Had a fairly harsh headache about 3 hours; Developed a medium sized (just smaller than half a golf ball) knot at the injection site with itchiness and medium soreness; Developed a medium sized (just smaller than half a golf ball) knot at the injection site with itchiness and medium soreness; This is a spontaneous report from a non-contactable consumer (patient). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FA7484), via an unspecified route of administration in left arm on 27Jul2021 at 14:15 (at the age of 48-year-old) as dose 1, single for COVID-19 immunisation at public health clinic/veteran's administration facility. Medical history included diabetes from an unknown date and unknown if ongoing, high blood pressure from an unknown date and unknown if ongoing, penicillin (drug hypersensitivity) from an unknown date and unknown if ongoing, broccoli, avocados, bananas (food allergy) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 27Jul2021 at 17:30, was moderately sick for 4 days with hot and cold chills, mild dizziness, extreme fatigue and whole-body aches and soreness. Had a fairly harsh headache about 3 hours after injection that lasted about 4 hours. Developed a medium sized (just smaller than half a golf ball) knot at the injection site with itchiness and medium soreness. Still have the knot after 5 days. The patient underwent lab tests and procedures which included blood pressure was high on an unknown date. The patient did not receive any treatment for the events. The outcome of the events was reported as resolved on an unknown date.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Was moderately sick for 4 days with hot and cold chills; Was moderately sick for 4 days with hot and cold chills; Was moderately sick for 4 days with hot and cold chills; mild dizziness; extreme fatigue; whole body aches and soreness; Developed a medium sized (just smaller than half a golf ball) knot at the injection site with itchiness and medium soreness; Had a fairly harsh headache about 3 hours; Developed a medium sized (just smaller than half a golf ball) knot at the injection site with itchiness and medium soreness; Developed a medium sized (just smaller than half a golf ball) knot at the injection site with itchiness and medium soreness; This is a spontaneous report from a non-contactable consumer (patient). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FA7484), via an unspecified route of administration in left arm on 27Jul2021 at 14:15 (at the age of 48-year-old) as dose 1, single for COVID-19 immunisation at public health clinic/veteran's administration facility. Medical history included diabetes from an unknown date and unknown if ongoing, high blood pressure from an unknown date and unknown if ongoing, penicillin (drug hypersensitivity) from an unknown date and unknown if ongoing, broccoli, avocados, bananas (food allergy) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 27Jul2021 at 17:30, was moderately sick for 4 days with hot and cold chills, mild dizziness, extreme fatigue and whole-body aches and soreness. Had a fairly harsh headache about 3 hours after injection that lasted about 4 hours. Developed a medium sized (just smaller than half a golf ball) knot at the injection site with itchiness and medium soreness. Still have the knot after 5 days. The patient underwent lab tests and procedures which included blood pressure was high on an unknown date. The patient did not receive any treatment for the events. The outcome of the events was reported as resolved on an unknown date.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea
Clinical narrative: I feel like vomiting, I have nausea; big headache; I feel like vomiting, I have nausea; This is a spontaneous report from a contactable consumer. A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: not reported), via an unspecified route of administration on 12Aug2021 (at the age of 56-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. It was reported that she received the Pfizer Covid 19 vaccine. At first, she was fine but after some time she feel like vomiting, nausea and a big headache. As a Treatment patient received Tylenol for the headache, but the only thing that works for me is ibuprofen, Tylenol makes me more nauseated. She asked, can I take ibuprofen? The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine headache extreme; This is a spontaneous report from a contactable consumer (patient reported for himself). A 21-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration, in left arm on 14Aug2021 at 09:00 AM (at the age of 21-years-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication was not reported. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 14Aug2021 at 01:00 PM, the patient had experienced migraine headache extreme. Reporter stated that adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with medicine (unspecified) for the adverse event. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Body temperature, Cough, Headache, Paranasal sinus discomfort
Clinical narrative: cough; sinus pressure; fever between 99 and 101; loss of smell; headaches; drowsiness; This is a spontaneous report from a contactable consumer (patient). A 28-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 08Aug2021 at 14:00 (at the age of 28-years) as dose 1, single in the right arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications in two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 13Aug2021 at 16:00, the patient experienced 5 days after shot started having cough and sinus pressure. On day 6 and 7 unspecified date of Aug2021 fever between 99 and 101, loss of smell, major sinus pressure and headaches, drowsiness. Patient visited to doctor or other healthcare professional office/clinic visit. Patient received treatment for events. The patient underwent lab tests and procedures which included fever between 99 and 101 on unspecified date of Aug2021 and nasal swab with unknown results on 14Aug2021. The outcome of the events was not resolved.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Somnolence
Clinical narrative: cough; sinus pressure; fever between 99 and 101; loss of smell; headaches; drowsiness; This is a spontaneous report from a contactable consumer (patient). A 28-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 08Aug2021 at 14:00 (at the age of 28-years) as dose 1, single in the right arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications in two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 13Aug2021 at 16:00, the patient experienced 5 days after shot started having cough and sinus pressure. On day 6 and 7 unspecified date of Aug2021 fever between 99 and 101, loss of smell, major sinus pressure and headaches, drowsiness. Patient visited to doctor or other healthcare professional office/clinic visit. Patient received treatment for events. The patient underwent lab tests and procedures which included fever between 99 and 101 on unspecified date of Aug2021 and nasal swab with unknown results on 14Aug2021. The outcome of the events was not resolved.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Illness, Neck pain, Pain
Clinical narrative: my neck is all swollen; Diarrhea; my neck is all swollen and it hurts; I have been sick; Fever; Headache; just like been sleeping a lot; my body is achy; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 12Aug2021 (at the age of 49-year-old) as dose number unknown, single for covid-19 immunisation. Medical history included heart problems. The other medication included baby Tylenol. On an unspecified date in Aug2021, the patient stated that not affecting her heart or giving her an infection or anything because she having every symptom that there was. She had diarrhea, have been sick and had a bad fever, she have a bad headache you know just like been sleeping a lot, body was achy and now even on the fourth day her freaking neck was all swollen and it hurts. The patient did not take treatment for the events. The outcome of events were unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence, Swelling
Clinical narrative: my neck is all swollen; Diarrhea; my neck is all swollen and it hurts; I have been sick; Fever; Headache; just like been sleeping a lot; my body is achy; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 12Aug2021 (at the age of 49-year-old) as dose number unknown, single for covid-19 immunisation. Medical history included heart problems. The other medication included baby Tylenol. On an unspecified date in Aug2021, the patient stated that not affecting her heart or giving her an infection or anything because she having every symptom that there was. She had diarrhea, have been sick and had a bad fever, she have a bad headache you know just like been sleeping a lot, body was achy and now even on the fourth day her freaking neck was all swollen and it hurts. The patient did not take treatment for the events. The outcome of events were unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching on both of her arms, not at the injection site, and on her neck; This is a spontaneous report from a contactable Nurse.   A 59-year-old female patient who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 14Aug2021 (past Saturday) as dose 2, single for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not provided. On an unspecified date in 2021, after receiving the vaccination, patient experienced itching on both of her arms, not at the injection site, and on her neck since then. Nurse would like to know if that was normal or if they should be worried. As per attached cons document there will be a severe allergic reaction would usually occur with in a few minutes to one hour after getting a dose of the Pfizer vaccine. The outcome of the event was reported as unknown.  The lot/batch number was not available despite the follow-up attempts made. Follow-up attempts completed. No further information was expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I developed a rash on the back of my left arm. Since then, the rash has spread to the palms of my hands, ankles and soles of my feet.; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 55-years-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 10Apr2021 08:00 (Age at vaccination: 55-years-old) as single dose for covid-19 immunization. Medical history included diabetes mellitus from an unknown date and unknown if ongoing, Lichen Planus from an unknown date and unknown if ongoing (I have an autoimmune skin disorder called Lichen Planus. It was in remission for the last 15 years). Concomitant medication included metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 on 20Mar2021 08:00 in left arm for covid-19 immunization. Patient was not diagnosed with covid prior vaccination. Patient had no Known allergies. It was reported as patient have an autoimmune skin disorder called Lichen Planus. It was in remission for the last 15 years until after he received the second dose of the Pfizer vaccine. Approximately two weeks after receiving the second dose, On 23Apr2021 12:00 AM patient developed a rash on the back of his left arm. Since then, the rash has spread to the palms of his hands, ankles and soles of his feet. Patient was not tested for covid post vaccination. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events with Topical Cream. The outcome for the event was reported as not resolved at the time of this report.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  Follow-up (24Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chills, Diarrhoea, Ear pain, Feeling hot
Clinical narrative: Teeth chattering/ chills; Nausea/ Had a queasy stomach and did not eat until Sunday; Shaking was bad; Upper body was just burning really, really bad and hot; Her ears, everything hurt; Diarrhea; Started getting sick; Headache; Fever/ high fever; Aching; This is a spontaneous report from a contactable consumer. A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; (Batch/Lot number: FE3180 or FE3181, it could be a 0 maybe, or a 1, she is not sure), via an unspecified route of administration, administered in Arm Left on 13Aug2021 at 14:00 or 14:30 as DOSE 1, SINGLE for covid-19 immunisation (age at the time of vaccination was 67 years). Medical history included patient did have Covid a year ago, in Aug2020. It has been one year, Cholesterol, which was a little bit high from Mar2021 to an unknown date, Weight/has gained, anxiety and Hair fell out last year with Covid from unknown date. Concomitant medications included ZINC 50 mg started a year ago, VITAMIN D3 6,000 units per day from Aug2020 and ongoing; BIOTIN 5000 ug one per day taken for Hair fell out last year with Covid from Aug2020; VITAMIN E 4,000Iu each day ongoing. Not received any vaccinations within 4 weeks before receiving covid vaccine. On Aug2021, the patient experienced After the vaccine she experienced fever, aching, headache for approximately 48 hours, on 13Aug2021 23:00 teeth chattering, chills and had nausea/ started feeling nauseous. Not long after that, she started shaking. As the night went on, she got shaking more and more. Her teeth were chattering really, really hard, it was uncontrollable. It was hard to hold anything in her hands, she was shaking so bad. It was very hot all night long, in her face. On Aug2021 It wasn't her whole body, but her upper body was just burning really, really bad and hot. She had one of the worst headaches she think she had every had. She did that again that day and again the next night. After waking up, her clothes were wet and was not like that anymore. She still had a queasy stomach and really didn't eat anything until probably Sunday. On Aug2021 Her ears, everything hurt. On 13Aug2021 She had the injection, and was sick all weekend, She was very sick/ Started getting sick, with high fever, nausea and shaking was bad. On Aug2021, The last symptom she was diarrhea and has been fine since. Treatment: She took Tylenol and Nauzene chewable tablets for nausea. Patient did not have any AE(s) require a visit to Emergency room, Physician's office. No prior vaccinations (within 4 weeks). The patient underwent lab tests and procedures which included Blood work: pretty good (cholesterol, which was a little bit high) on Mar2021 for cholesterol, which was a little bit high; Covid test: did have covid on Aug2020. The outcome of the event was recovered on Aug2021.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Nausea, Pain, Pyrexia
Clinical narrative: Teeth chattering/ chills; Nausea/ Had a queasy stomach and did not eat until Sunday; Shaking was bad; Upper body was just burning really, really bad and hot; Her ears, everything hurt; Diarrhea; Started getting sick; Headache; Fever/ high fever; Aching; This is a spontaneous report from a contactable consumer. A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; (Batch/Lot number: FE3180 or FE3181, it could be a 0 maybe, or a 1, she is not sure), via an unspecified route of administration, administered in Arm Left on 13Aug2021 at 14:00 or 14:30 as DOSE 1, SINGLE for covid-19 immunisation (age at the time of vaccination was 67 years). Medical history included patient did have Covid a year ago, in Aug2020. It has been one year, Cholesterol, which was a little bit high from Mar2021 to an unknown date, Weight/has gained, anxiety and Hair fell out last year with Covid from unknown date. Concomitant medications included ZINC 50 mg started a year ago, VITAMIN D3 6,000 units per day from Aug2020 and ongoing; BIOTIN 5000 ug one per day taken for Hair fell out last year with Covid from Aug2020; VITAMIN E 4,000Iu each day ongoing. Not received any vaccinations within 4 weeks before receiving covid vaccine. On Aug2021, the patient experienced After the vaccine she experienced fever, aching, headache for approximately 48 hours, on 13Aug2021 23:00 teeth chattering, chills and had nausea/ started feeling nauseous. Not long after that, she started shaking. As the night went on, she got shaking more and more. Her teeth were chattering really, really hard, it was uncontrollable. It was hard to hold anything in her hands, she was shaking so bad. It was very hot all night long, in her face. On Aug2021 It wasn't her whole body, but her upper body was just burning really, really bad and hot. She had one of the worst headaches she think she had every had. She did that again that day and again the next night. After waking up, her clothes were wet and was not like that anymore. She still had a queasy stomach and really didn't eat anything until probably Sunday. On Aug2021 Her ears, everything hurt. On 13Aug2021 She had the injection, and was sick all weekend, She was very sick/ Started getting sick, with high fever, nausea and shaking was bad. On Aug2021, The last symptom she was diarrhea and has been fine since. Treatment: She took Tylenol and Nauzene chewable tablets for nausea. Patient did not have any AE(s) require a visit to Emergency room, Physician's office. No prior vaccinations (within 4 weeks). The patient underwent lab tests and procedures which included Blood work: pretty good (cholesterol, which was a little bit high) on Mar2021 for cholesterol, which was a little bit high; Covid test: did have covid on Aug2020. The outcome of the event was recovered on Aug2021.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tremor
Clinical narrative: Teeth chattering/ chills; Nausea/ Had a queasy stomach and did not eat until Sunday; Shaking was bad; Upper body was just burning really, really bad and hot; Her ears, everything hurt; Diarrhea; Started getting sick; Headache; Fever/ high fever; Aching; This is a spontaneous report from a contactable consumer. A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; (Batch/Lot number: FE3180 or FE3181, it could be a 0 maybe, or a 1, she is not sure), via an unspecified route of administration, administered in Arm Left on 13Aug2021 at 14:00 or 14:30 as DOSE 1, SINGLE for covid-19 immunisation (age at the time of vaccination was 67 years). Medical history included patient did have Covid a year ago, in Aug2020. It has been one year, Cholesterol, which was a little bit high from Mar2021 to an unknown date, Weight/has gained, anxiety and Hair fell out last year with Covid from unknown date. Concomitant medications included ZINC 50 mg started a year ago, VITAMIN D3 6,000 units per day from Aug2020 and ongoing; BIOTIN 5000 ug one per day taken for Hair fell out last year with Covid from Aug2020; VITAMIN E 4,000Iu each day ongoing. Not received any vaccinations within 4 weeks before receiving covid vaccine. On Aug2021, the patient experienced After the vaccine she experienced fever, aching, headache for approximately 48 hours, on 13Aug2021 23:00 teeth chattering, chills and had nausea/ started feeling nauseous. Not long after that, she started shaking. As the night went on, she got shaking more and more. Her teeth were chattering really, really hard, it was uncontrollable. It was hard to hold anything in her hands, she was shaking so bad. It was very hot all night long, in her face. On Aug2021 It wasn't her whole body, but her upper body was just burning really, really bad and hot. She had one of the worst headaches she think she had every had. She did that again that day and again the next night. After waking up, her clothes were wet and was not like that anymore. She still had a queasy stomach and really didn't eat anything until probably Sunday. On Aug2021 Her ears, everything hurt. On 13Aug2021 She had the injection, and was sick all weekend, She was very sick/ Started getting sick, with high fever, nausea and shaking was bad. On Aug2021, The last symptom she was diarrhea and has been fine since. Treatment: She took Tylenol and Nauzene chewable tablets for nausea. Patient did not have any AE(s) require a visit to Emergency room, Physician's office. No prior vaccinations (within 4 weeks). The patient underwent lab tests and procedures which included Blood work: pretty good (cholesterol, which was a little bit high) on Mar2021 for cholesterol, which was a little bit high; Covid test: did have covid on Aug2020. The outcome of the event was recovered on Aug2021.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2
Sex: U
Vaccine: COVID19
Symptoms: Toxicity to various agents
Clinical narrative: Lithium toxicity; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter has read viable reports of son man, another with 2 people who got lithium toxicity after receiving the vaccine on unknown date. The reporter also after over a decade on lithium, no changes had lithium toxicity. It was horrifying, delusions, physical, mental. Seizures, kidney injury, pancreatitis. No doctor knew what was happening, family was called in about reporter long-term care, possibly death. The consumer doesn't know if this vaccine had any part or not, if it was, consumer want to be able to help, the doctors, and others with this. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101077401 Same reporter/ drug/ event for different patients;US-PFIZER INC-202101077402 Same reporter/ drug/ event for different patients