chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Muscle spasms, Pain in extremity
Clinical narrative: My legs have felt like lead; Legs aching, hurting like they are recovering from serious muscle cramps; Legs aching, hurting like they are recovering from serious muscle cramps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 3, (booster), single (Lot number: En630J) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthmatics" (unspecified if ongoing); "Allergy" (unspecified if ongoing), notes: to many to name. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: ER8730, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 26Mar2021, when the patient was 60-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: FK9729, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 08Feb2022, when the patient was 60-year-old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 02Aug2021, 4 months 30 days after the suspect product(s) administration, outcome "not recovered", MUSCLE SPASMS (non-serious) with onset 02Aug2021, outcome "not recovered" and all described as "Legs aching, hurting like they are recovering from serious muscle cramps"; LIMB DISCOMFORT (non-serious) with onset 02Aug2021, 4 months 30 days after the suspect product(s) administration, outcome "not recovered", described as "My legs have felt like lead". The events "my legs have felt like lead" and "legs aching, hurting like they are recovering from serious muscle cramps" required physician office visit. Therapeutic measures were taken as a result of limb discomfort, pain in extremity, muscle spasms.  Additional information: The Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient went for consultation another Dr on Monday 25Apr2022 for the treatment of adverse event. seriousness criteria did not leads to death, life threatening, caused/prolonged hospitalization,  disabling/incapacitating and congenital anomaly/birth defect . Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Computerised tomogram, Haematuria, Pyrexia
Clinical narrative: Gross haematuria 24 hours after vaccination.; I still have brown urine from my 4th dose; feverish; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FR9893) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies:Sulfur" (unspecified if ongoing), notes: other medical history : None, known allergies : Sulfur. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: EH8027, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 07Nov2021, when the patient was 63-year-old, for COVID-19 immunization, reaction(s): "Gross haematuria 24 hours after vaccination/This occurred on both the 3rd dose (1st booster on 07Nov2021", "feverish"; Covid-19 vaccine (Dose 2; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 1; unknown manufacturer), for COVID-19 immunization. The following information was reported: HAEMATURIA (non-serious) with onset 20Apr2022 at 07:00, outcome "recovering", described as "Gross haematuria 24 hours after vaccination."; CHROMATURIA (non-serious) with onset 20Apr2022 at 07:00, outcome "recovering", described as "I still have brown urine from my 4th dose"; PYREXIA (non-serious) with onset 20Apr2022 at 07:00, outcome "recovering", described as "feverish". The events "gross haematuria 24 hours after vaccination.", "i still have brown urine from my 4th dose" and "feverish" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of haematuria, chromaturia, pyrexia.  Additional Information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was no. Prior to vaccination, was the patient diagnosed with COVID-19 was no. Since the vaccination, has the patient been tested for COVID-19 was no. List of any other medications the patient received within 2 weeks of vaccination was yes. Gross haematuria 24 hours after vaccination. This occurred on both the 3rd dose (1st booster on 07Nov2021) and the 4th dose (2nd booster on 418Apr2022) of my Covid 19 shots. After the 3rd shot, my urine cleared up after 8-10 days. I still have brown urine from my 4th dose. I was also feverish and down for 36 hours with both these vaccines. What treatment received for the adverse event was CT scan of lower abdomen   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: After my first Pfizer vaccine, I had a high fever of 103.3 for 5-6 hours the day following vaccination.; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol/triglycerides" (unspecified if ongoing); "High cholesterol/triglycerides" (unspecified if ongoing). Concomitant medication(s) included: LIVALO. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "After my first Pfizer vaccine, I had a high fever of 103.3 for 5-6 hours the day following vaccination.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Additional information: Seriousness criteria-Results for death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect was reported as No. After my first Pfizer vaccine, I had a high fever of 103.3 for 5-6 hours the day following vaccination  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia
Clinical narrative: After the 2nd dose of Pfizer vaccine, I had a fever of 102. for a few hours; felt general muscle aching; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol/triglycerides" (unspecified if ongoing); "High cholesterol/triglycerides" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 Immunization, reaction(s): "high fever of 103.3 for 5-6 hours". The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "After the 2nd dose of Pfizer vaccine, I had a fever of 102. for a few hours"; MYALGIA (non-serious), outcome "unknown", described as "felt general muscle aching". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Additional Information: The patient received BNT162b2 (BNT162B2) Intramuscular route administered in Left arm on Mar2022 at 12:00PM, as dose 4, single (Batch/Lot number: unknown) at the for covid-19 immunisation. The patent had no known allergies. Other medical history includes High cholesterol/triglycerides. The patient did not receive any other vaccine in four weeks. The patient received other medications in two weeks Livalo. The patient experienced adverse event on Mar2022 at 06:00 AM. The outcome of event was recovered without treatment. If covid prior vaccination, the patient was not diagnosed. if covid post vaccination, the patient was not tested for covid vaccination. Within 8 hours of receiving 2nd booster, started to feel flu-like symptoms. The following morning, I was so weak and every muscle in my body hurt, that I had to miss a day of work and spent the day in bed. I had no appetite and was so tired I slept most of the day and night. When I awoke the next day, I felt better but was still fatigued for a few hours. After my first Pfizer vaccine, I had a high fever of 103.3 for 5-6 hours the day following vaccination. After the 2nd dose of Pfizer vaccine, I had a fever of 102. for a few hours and felt general muscle aching. After the 1st Pfizer booster, I had a temp of 99 and just felt tired for a few hours the following day. The fourth dose (2nd booster) was the most uncomfortable and I was not able to function the following day. I did not have a fever after that dose. I do not want to receive any further Covid vaccinations.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Fatigue
Clinical narrative: After the 1st Pfizer booster, I had a temp of 99 and just felt tired for a few hours the following day; After the 1st Pfizer booster, I had a temp of 99 and just felt tired for a few hours the following day; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Triglycerides" (unspecified if ongoing). Concomitant medication(s) included: LIVALO. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization, reaction(s): "After my first Pfizer vaccine, I had a high fever of 103.3 for 5-6 hours the day following vaccination"; Bnt162b2 (Dose 2, Single), for COVID-19 immunization, reaction(s): "After the 2nd dose of Pfizer vaccine, I had a fever of 102. for a few hours and felt general muscle aching", "After the 2nd dose of Pfizer vaccine, I had a fever of 102. for a few hours and felt general muscle aching". The following information was reported: BODY TEMPERATURE INCREASED (non-serious), FATIGUE (non-serious), outcome "recovered" and all described as "After the 1st Pfizer booster, I had a temp of 99 and just felt tired for a few hours the following day". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of body temperature increased, fatigue.  Additional information: No known allergies. No other vaccines were received within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was Livalo. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. After the 1st Pfizer booster, patient had a temperature of 99 and just felt tired for a few hours the following day.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: got Covid even after completing the shots; got Covid even after completing the shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got Covid even after completing the shots". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: got Covid.  Clinical course: Caller needed an explanation why he got Covid even after completing the shots, he had the 2 primary doses and about to get the 2nd booster dose, he even wore a mask and kept on washing his hands many times. There were some medical questions addressed by this program forwarded/referred to Medical Information.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant, Pulmonary mass, SARS-CoV-2 test
Clinical narrative: Dormant sarcoma came out - had never had cancer before and now it blew up and had to have surgery; lung nodules grew in size; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 73-year-old male patient received BNT162b2 (BNT162B2), on 22Sep2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 years intramuscular, in left arm for covid-19 immunisation. Lot unknown reason=Not available/provided to reporter at the time of report completion. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVODOPA. Vaccination history included: Bnt162b2 (Dose number=2, Product=COVID 19, Brand=Pfizer, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Product=COVID 19, Brand=Pfizer, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. Other vaccine in four weeks was reported as no. Covid prior vaccination was reported as no and covid tested post vaccination was reported as yes. The following information was reported: NEOPLASM MALIGNANT (hospitalization, disability, medically significant, life threatening) with onset 30Sep2021 at 03:00, outcome "not recovered", described as "Dormant sarcoma came out - had never had cancer before and now it blew up and had to have surgery"; PULMONARY MASS (hospitalization, disability, life threatening) with onset 30Sep2021 at 03:00, outcome "not recovered", described as "lung nodules grew in size". The patient was hospitalized for neoplasm malignant, pulmonary mass (hospitalization duration: 2 day(s)). The event "lung nodules grew in size" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of neoplasm malignant, pulmonary mass. Ae treatment was reported as surgery for removal. It was reported that Ae resulted in: Doctor or other healthcare professional office/clinic visit. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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: Dizziness, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Numb face/ still numb from nose to chin (nose is less numb); Face, tongue & inside mouth numb; Face, tongue & inside mouth numb; light headed & dizzy; light headed & dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 at 17:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Anastrozole is post-operative treatment for breast cancer. Concomitant medication(s) included: ANASTROZOLE taken for breast cancer female. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FC3180), administration date: 11Oct2021, when the patient was 72-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EN6207), administration date: 23Mar2021, when the patient was 72-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL92676), administration date: 03Mar2021, when the patient was 72-year-old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious), DIZZINESS (non-serious) all with onset 11Apr2022 at 16:00, outcome "not recovered" and all described as "light headed & dizzy"; HYPOAESTHESIA ORAL (non-serious), HYPOAESTHESIA ORAL (non-serious) all with onset 14Apr2022, outcome "not recovered" and all described as "Face, tongue & inside mouth numb"; HYPOAESTHESIA (non-serious) with onset 14Apr2022, outcome "not recovered", described as "Numb face/ still numb from nose to chin (nose is less numb)". The events "numb face/ still numb from nose to chin (nose is less numb)", "light headed & dizzy" and "face, tongue & inside mouth numb" required physician office visit. Therapeutic measures were not taken as a result of hypoaesthesia, dizziness, dizziness, hypoaesthesia oral, hypoaesthesia oral.  Additional information- It was reported that Prior to vaccination, the patient was not  diagnosed with COVID-19 and Since the vaccination,  the patient  had not been tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: Fatigue/tiredness; Fatigue/tiredness; Swollen lymph nodes in the left armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2022 at 11:15 as dose 4 (booster), single (Lot number: FL3197) at the age of 53 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FF2589, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM, Route of Administration: Intramuscular), administration date: 16Nov2021, for Covid-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 01:30 PM, Route of Administration: Intramuscular), administration date: 24Mar2021, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 01:30 PM, Route of Administration: Intramuscular), administration date: 03Mar2021, for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious), FATIGUE (non-serious) all with onset 15Apr2022 at 21:00, outcome "recovered" and all described as "Fatigue/tiredness"; LYMPHADENOPATHY (non-serious) with onset 15Apr2022 at 21:00, outcome "recovered", described as "Swollen lymph nodes in the left armpit". Therapeutic measures were not taken as a result of fatigue, fatigue, lymphadenopathy.  Additional information: The patient was not pregnant during the vaccination. The most recent COVID-19 vaccine was administered at workplace in clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment for the adverse events.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Pyrexia, Vaccination site erythema, Vaccination site haematoma
Clinical narrative: large red circle at injection site with edema/hematoma/pain; large red circle at injection site with edema/hematoma/pain; large red circle at injection site with edema/hematoma/pain; large red circle at injection site with edema/hematoma/pain; Muscle aches/generalized; fever; itching over whole body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 at 12:00 as dose 1, single (Lot number: fk9895) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADD" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. Past drug history included: Known allergies: iodine, reaction(s): "Known allergies: iodine". The following information was reported: MYALGIA (non-serious) with onset 22Apr2022 at 22:00, outcome "not recovered", described as "Muscle aches/generalized"; PYREXIA (non-serious) with onset 22Apr2022 at 22:00, outcome "not recovered", described as "fever"; PRURITUS (non-serious) with onset 22Apr2022 at 22:00, outcome "not recovered", described as "itching over whole body"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE OEDEMA (non-serious), VACCINATION SITE HAEMATOMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 22Apr2022 at 22:00, outcome "not recovered" and all described as "large red circle at injection site with edema/hematoma/pain". The events "large red circle at injection site with edema/hematoma/pain", "muscle aches/generalized", "fever" and "itching over whole body" required physician office visit. Therapeutic measures were taken as a result of vaccination site erythema, vaccination site oedema, vaccination site haematoma, vaccination site pain, myalgia, pyrexia, pruritus.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site oedema, Vaccination site pain
Clinical narrative: large red circle at injection site with edema/hematoma/pain; large red circle at injection site with edema/hematoma/pain; large red circle at injection site with edema/hematoma/pain; large red circle at injection site with edema/hematoma/pain; Muscle aches/generalized; fever; itching over whole body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 at 12:00 as dose 1, single (Lot number: fk9895) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADD" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. Past drug history included: Known allergies: iodine, reaction(s): "Known allergies: iodine". The following information was reported: MYALGIA (non-serious) with onset 22Apr2022 at 22:00, outcome "not recovered", described as "Muscle aches/generalized"; PYREXIA (non-serious) with onset 22Apr2022 at 22:00, outcome "not recovered", described as "fever"; PRURITUS (non-serious) with onset 22Apr2022 at 22:00, outcome "not recovered", described as "itching over whole body"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE OEDEMA (non-serious), VACCINATION SITE HAEMATOMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 22Apr2022 at 22:00, outcome "not recovered" and all described as "large red circle at injection site with edema/hematoma/pain". The events "large red circle at injection site with edema/hematoma/pain", "muscle aches/generalized", "fever" and "itching over whole body" required physician office visit. Therapeutic measures were taken as a result of vaccination site erythema, vaccination site oedema, vaccination site haematoma, vaccination site pain, myalgia, pyrexia, pruritus.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Fatigue, Heart rate increased, Influenza like illness, Nausea
Clinical narrative: I had a rapid pulse rate; Nausea; I just had flu like symptoms without a temperature; my blood pressure is not as crazy but it scared that hell out of me; I am extremely tired and wiped out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old patient received BNT162b2 (BNT162B2), on 19Apr2022 as dose 4, (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, MANUFACTURER UNKNOWN), administration date: Feb2021, for COVID-19 Immunization, reaction(s): "I was fine for all three"; Covid-19 vaccine (Dose: 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "I was fine for all three"; Covid-19 vaccine (Dose: 3, First Booster, MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "I was fine for all three". The following information was reported: FATIGUE (non-serious) with onset Apr2022, outcome "recovering", described as "I am extremely tired and wiped out"; BLOOD PRESSURE ABNORMAL (non-serious) with onset Apr2022, outcome "recovering", described as "my blood pressure is not as crazy but it scared that hell out of me"; HEART RATE INCREASED (non-serious) with onset 20Apr2022, outcome "recovering", described as "I had a rapid pulse rate"; INFLUENZA LIKE ILLNESS (non-serious) with onset 20Apr2022, outcome "recovering", described as "I just had flu like symptoms without a temperature"; NAUSEA (non-serious) with onset 20Apr2022, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Consumer was informed about the role and was informed that is the concerned department to answer the question. Consumer was also informed that Pfizer Medical Information works from Monday to Friday. Consumer further stated, "I have to wait till Monday to find out if this is normal?" Further probing could not be initiated as consumer hung up abruptly. Hence, product details (LOT#, expiration date, NDC#, UPC#), purchase details and other details were unknown and limited information was available over the call.  QR Comment: Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Myalgia
Clinical narrative: Muscle aches and heavy menstrual flow 3 weeks after 3rd dose; Muscle aches and heavy menstrual flow 3 weeks after 3rd dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Brand: Pfizer Covid-19 Vaccine, Batch/Lot No: Unknown), for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Brand: Pfizer Covid-19 Vaccine, Batch/Lot No: Unknown), for Covid-19 Immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), MYALGIA (non-serious), outcome "unknown" and all described as "Muscle aches and heavy menstrual flow 3 weeks after 3rd dose". The events "muscle aches and heavy menstrual flow 3 weeks after 3rd dose" required physician office visit. It was unknown if therapeutic measures were taken as a result of heavy menstrual bleeding, myalgia. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First Dose: Sore Arm/Second Dose: Sore Arm/First Booster Dose: Sore Arm; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 02Jan2021 as dose 1, single (Lot number: EJ1685), on 21Jan2021 as dose 2, single (Lot number: EL1283) and on 30Sep2021 as dose 3 (booster), single (Lot number: FC3183) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Influenza vaccines (Influenza Vaccines: Caller states her arm gets warm and a little sore with it in all of the years she had gotten those. Dates, NDC, Lot, Expiration: Unknown), reaction(s): "arm gets warm and a little sore", "arm gets warm and a little sore"; Shingles vaccine (Shingles Vaccine or Pneumococcal Vaccine: Caller states her arm really bothered her but nothing out of the ordinary. Caller states she thinks it was the Shingles Vaccine. Caller states she was not that concerned about it other than it hurt for a long time but nothing to be alarmed about. Date, NDC, Lot, Expiration: Unknown), reaction(s): "her arm really bothered her/it hurt for a long time"; Small pox vaccine (Small Pox Vaccine at 17yrs old: Caller states she was really, really sick and her arm was angry and it drained and she was febrile for about a week. Date, NDC, Lot, Expiration: Unknown), reaction(s): "really, really sick", "arm was angry and it drained", "febrile". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered", described as "First Dose: Sore Arm/Second Dose: Sore Arm/First Booster Dose: Sore Arm". Therapeutic measures were taken as a result of pain in extremity. No follow-up attempts are needed. No further information is expected.
Age: 1.5
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: quadracel is not approved for patient's under the age of 4y/o with no reported adverse events; Initial information received on 15-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 months old and unknown gender patient who experienced quadracel is not approved for patient's under the age of 4y/o with no reported adverse events while receiving vaccine diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (dtap) for immunisation; and polio vaccine (Polio vaccine) for Immunisation.  On an unknown date, the patient received a  dose of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine  (unknown strength, dosage, formulation, batch lot number and expiry date) via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event of quadracel is not approved for patient's under the age of 4y/o with no reported adverse events (off label use) (latency :same day) following the administration ofdiphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event .
Age: 0.42
Sex: F
Vaccine: HIBV, UNK
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: Used sterile water as the diluent for Acthib instead of the 0.4% normal saline with no reported adverse event; Initial information received on 14-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 month old female patient who used sterile water as the diluent for acthib instead of the 0.4% normal saline with no reported adverse event while receiving vaccine hib (prp/t) vaccine (Act-Hib) and water for injection (Sterile Water).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel); polio vaccine inact 3v (vero) (Ipol)and Rotavirus Vaccine.  On an unknown date, the patient started taking sterile water (water for injection) with unknown dose (route, strength, formulation, frequency, batch number, expiry date, indication was unknown). On 13-Apr-2022, the patient received 0.5 ml dose of suspect hib (prp/t) vaccine (strength, frequency, , formulation was unknown, lot UJ604AA and expiry date: 13-Mar-2023) via intramuscular route in unknown administration site for prophylactic vaccination.  On 13-Apr-2022, (Latency: same day) stating that an RN(registered nurse) at the clinic used sterile water as the diluent for ACTHIB instead of the 0.4% normal saline with no reported adverse event (product preparation error)   Action taken with water for injection (Sterile Water) and haemophilus type b (hib) vaccine (Act-Hib): not applicable.  Outcome: Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 19.0
Sex: F
Vaccine: IPV, UNK
Symptoms: Medication error, Product storage error
Clinical narrative: Caller stated the excursion lasted for 4 hours and 36 minutes. The maximum temperature of the refrigerator reached 53.6 degrees; Initial information received on 15-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 19 years old female patient who experienced excursion that lasted for 4 hours and 36 minutes. the maximum temperature of the refrigerator reached 53.6 degrees for tuberculin test [Tubersol] .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Apr-2022, the patient received tuberculin test solution for injection 0.1 mL (batch lot - C58408A expiry date :30-Jun-2023)(unknown strength, route of administration and site of administration) for Immunization.  On 11-Apr-2022 excursion lasted for 4 hours and 36 minutes the maximum temperature of the refrigerator reached 53.6 degrees (product storage error) for poliomyelitis vaccine (inactivated) (IPOL). On an unknown date on Monday the patient received the vaccine and a non-serious event of excursion lasted for 4 hours and 36 minutes (unknown latency)the maximum temperature of the refrigerator reached 53.6 degrees (product storage error) following the first dose intake of tuberculin test.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event .  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: product administered after temperature excursion from 07-Mar-2022 to 31-Mar-2022 at 2.1C with no reported adverse event; Initial information was received on 19-Apr-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 46years old female to whom product was administered after temperature excursion from 07-Mar-2022 to 31-Mar-2022 at 2.1C with no reported adverse event while receiving vaccine Diphtheria-2/TetanuS/5 AC Pertussis Vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation.  On 18-Mar-2022, the patient received 0.5 ml dose of suspect Diphtheria-2/TetanuS/5 AC Pertussis Vaccine (formulation, strength: unknown) via intramuscular route (batch/lot number: C5854AA, expiration date: 14-Apr-2023) in the right deltoid for immunization.  On 18-Mar-2022, the patient received Diphtheria-2/TetanuS/5 AC Pertussis Vaccine after temperature excursion from 07-Mar-2022 to 31-Mar-2022 at 2.1C with no reported adverse event (product temperature excursion issue) (latency: same day).  Action taken: not applicable  At time of reporting, the outcome was Unknown for the event (product temperature excursion issue).; Sender's Comments:  01068813: 01068814: 01068816: 01068817: 01068825: 01068827: 01068828: 01068830: 01068831: 01068832: 01068834: 01068835: 01068838:
Age: 82.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: reported as a medication error due to administering dose post temperature excursion outside acceptable guidelines for excursion standards with no reported adverse event; Initial information received on 19-Apr-2022 regarding an unsolicited valid non-serious case received via physician.  This case concerns a 82 years old female patient who reported as a medication error due to administering dose post temperature excursion outside acceptable guidelines for excursion standards with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Adacel).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (Shingrix) for Prophylactic vaccination.  On 18-Mar-2022, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at a dose of 0.5 ml with lot C5873AA via intramuscular route in the left deltoid for Immunization.  On 18-Mar-2022 (latency : same day) the patient developed reported as a medication error due to administering dose post temperature excursion outside acceptable guidelines for excursion standards with no reported adverse event (product storage error) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Reportedly negative 2.1 C from 07-Mar2022 until 31-Mar-2022 Did it occur due to a human error: No. Does extended stability data cover the excursion: No and in case of negative advice: was the product used by/ administered to the patient: Yes-14   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (reported as a medication error due to administering dose post temperature excursion outside acceptable guidelines for excursion standards with no reported adverse event).  At time of reporting, the outcome was Unknown for the event reported as a medication error due to administering dose post temperature excursion outside acceptable guidelines for excursion standards with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: temperature reached negative 2.1c from 07Mar2022 until 31Mar2022: no adverse events; Initial information received on 19-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a 57 years old female patient who experienced temperature reached negative 2.1c from 07-Mar-2022 until 31-Mar-2022: no adverse events  while receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included varicella zoster vaccine rge (cho) (Shingrix)for Immunisation.  On 22-Mar-2022, the patient received a dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine(batch lot C5873AA Expiry date :30-June-2023)(unknown strength and formulation)0.5 ml via intramuscular route in the right deltoid for immunization.  On 22-MAR-2022 (latency :same day) the patient developed a non-serious event of temperature reached negative 2.1c from 07-Mar-2022 until 31-Mar-2022: no adverse events (product storage error) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event .  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: Caller reporting a temperature excursion at -2.1C due to a refrigerator malfunction with no adverse event; product with inappropriate storage administered to the patient with no reported adverse event; Initial information received on 19-Apr-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case is linked to case 2022SA143416(CLUSTER).  This case involves a 52 years old female patient who was reporting a temperature excursion at -2.1c due to a refrigerator malfunction with no adverse event and product with inappropriate storage administered to the patient with no reported adverse event while receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine rge (cho) (Shingrix).  On 23-Mar-2022, the patient received a dose of 0.5 ml suspect diphtheria-2/tetanus/5 ac pertussis vaccine lot C5873AA, expiry date 30-Jun-2023 ( strength, formulation - not reported) via intramuscular route in the right deltoid for Immunization.  On 23-Mar-2022, the patient reported a temperature excursion at -2.1c due to a refrigerator malfunction with no adverse event (product temperature excursion issue) and product with inappropriate storage administered to the patient with no reported adverse event (product administration error) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  Action taken with diphtheria, tetanus and acellular pertussis vaccine was not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01068650: 01068813: 01068814: 01068816: 01068817: 01068827: 01068828: 01068830: 01068831: 01068832: 01068834: 01068835: 01068838:
Sex: M
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: temperature excursion due to a refrigerator malfunction, dose post temperature excursion outside acceptable guidelines for excursion standards with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received via health professional received on 19-Apr-2022.  This case concerns a 43-year-old female patient who experienced administering dose post temperature excursion outside acceptable guidelines per stability standard with no reported adverse event while receiving vaccine Diphtheria-2/Tetanus/5 AC Pertussis Vaccine (Adacel).  The patient's past medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.  On 24-Mar-2022, the patient received a dose of suspect Adacel vaccine at a dose of 0.5 ml once with lot C5963AA expiry date 18-Jan-2024 via intramuscular route in the right deltoid for Immunization.  On 18-Mar-2022 the patient developed administering dose post temperature excursion outside acceptable guidelines per stability standard with no reported adverse event (product storage error) following the administration of Adacel vaccine. Reportedly negative 2.1 C from 07-Mar2022 until 31-Mar-2022 Did it occur due to a human error: No. Does extended stability data cover the excursion: No and in case of negative advice was the product used by/ administered to the patient: Yes-14   Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.