chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Dizziness, Feeling abnormal, Flushing
Clinical narrative: PT ARRIVED AT THE PHARMACY AND APPEARED SLIGHLTY ANXIOUS BECAUSE SHE ALMOST DIDN'T MAKE IT TO THE PHARMACY IN TIME TO RECEIVE HER VACCINE AND SHE WAS ALSO BEING REQUIRED TO GET THE VACCINE BY HER COLLEGE PROGRAM. ABOUT 2 TO 3 MINUTES AFTER RECEIVING THE VACCINATION THE PT SAID SHE FELT FUNNY. SHE EXPERIENCED FLUSHING OF THE FACE AND CHEST, TACHYCARDIA, HYPERTENTION AND COLD CLAMMY HANDS. SHE ALSO SAID SHE HAD A SLIGHT TINGLING FEELING IN HER HANDS. AFTER ABOUT 10 MINUTES SHE SAID SHE WAS FEELING A LITTLE FAINT SO SHE WAS MOVED TO THE FLOOR BUT NEVER FAINTED. THE PATIENT WAS VISUALLY ANXIOUS AND HAD A FAIRLY FAST RATE OF BREATHNIG.   PT WAS GIVEN PALITIVE CARE INCLUDING COOL WATER AND AN ICE PACK TO HELP WITH THE FLUSHING. PT WAS ALSO ENCOURAGED TO TAKE SLOWER, DEEPER BREATHS TO REDUCE ANXIETY, BLOOD PRESSURE, AND HEART RATE. WE OFFERED TO CALL FOR AN EMT A NUMBER OF TIMES BUT PT REFUSED. AFTER ABOUT 45 MINUTES OF MONITORING PT SAID SHE FELT OK TO LEAVE.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypertension, Paraesthesia, Peripheral coldness, Respiratory rate increased
Clinical narrative: PT ARRIVED AT THE PHARMACY AND APPEARED SLIGHLTY ANXIOUS BECAUSE SHE ALMOST DIDN'T MAKE IT TO THE PHARMACY IN TIME TO RECEIVE HER VACCINE AND SHE WAS ALSO BEING REQUIRED TO GET THE VACCINE BY HER COLLEGE PROGRAM. ABOUT 2 TO 3 MINUTES AFTER RECEIVING THE VACCINATION THE PT SAID SHE FELT FUNNY. SHE EXPERIENCED FLUSHING OF THE FACE AND CHEST, TACHYCARDIA, HYPERTENTION AND COLD CLAMMY HANDS. SHE ALSO SAID SHE HAD A SLIGHT TINGLING FEELING IN HER HANDS. AFTER ABOUT 10 MINUTES SHE SAID SHE WAS FEELING A LITTLE FAINT SO SHE WAS MOVED TO THE FLOOR BUT NEVER FAINTED. THE PATIENT WAS VISUALLY ANXIOUS AND HAD A FAIRLY FAST RATE OF BREATHNIG.   PT WAS GIVEN PALITIVE CARE INCLUDING COOL WATER AND AN ICE PACK TO HELP WITH THE FLUSHING. PT WAS ALSO ENCOURAGED TO TAKE SLOWER, DEEPER BREATHS TO REDUCE ANXIETY, BLOOD PRESSURE, AND HEART RATE. WE OFFERED TO CALL FOR AN EMT A NUMBER OF TIMES BUT PT REFUSED. AFTER ABOUT 45 MINUTES OF MONITORING PT SAID SHE FELT OK TO LEAVE.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: PT ARRIVED AT THE PHARMACY AND APPEARED SLIGHLTY ANXIOUS BECAUSE SHE ALMOST DIDN'T MAKE IT TO THE PHARMACY IN TIME TO RECEIVE HER VACCINE AND SHE WAS ALSO BEING REQUIRED TO GET THE VACCINE BY HER COLLEGE PROGRAM. ABOUT 2 TO 3 MINUTES AFTER RECEIVING THE VACCINATION THE PT SAID SHE FELT FUNNY. SHE EXPERIENCED FLUSHING OF THE FACE AND CHEST, TACHYCARDIA, HYPERTENTION AND COLD CLAMMY HANDS. SHE ALSO SAID SHE HAD A SLIGHT TINGLING FEELING IN HER HANDS. AFTER ABOUT 10 MINUTES SHE SAID SHE WAS FEELING A LITTLE FAINT SO SHE WAS MOVED TO THE FLOOR BUT NEVER FAINTED. THE PATIENT WAS VISUALLY ANXIOUS AND HAD A FAIRLY FAST RATE OF BREATHNIG.   PT WAS GIVEN PALITIVE CARE INCLUDING COOL WATER AND AN ICE PACK TO HELP WITH THE FLUSHING. PT WAS ALSO ENCOURAGED TO TAKE SLOWER, DEEPER BREATHS TO REDUCE ANXIETY, BLOOD PRESSURE, AND HEART RATE. WE OFFERED TO CALL FOR AN EMT A NUMBER OF TIMES BUT PT REFUSED. AFTER ABOUT 45 MINUTES OF MONITORING PT SAID SHE FELT OK TO LEAVE.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Severe nausea and headache, dizziness, continually rising fever (currently 101.7 F by 7:00 pm the next day), exhaustion, swollen painful arm -  red spot has grown from about 1" to 2".   Treatment: ibuprofin at 8:30 am; acetaminophen at 7:00 pm; sleep; cool compress
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Severe nausea and headache, dizziness, continually rising fever (currently 101.7 F by 7:00 pm the next day), exhaustion, swollen painful arm -  red spot has grown from about 1" to 2".   Treatment: ibuprofin at 8:30 am; acetaminophen at 7:00 pm; sleep; cool compress
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling of body temperature change, Seizure, Tremor
Clinical narrative: Patient reports shaking/shivering severely, states she felt like she was having convulsions and her husband had to hold her down. Patient also reported feeling really hot then really cold.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, Erythema, Feeling of body temperature change, Gait inability, Limb discomfort
Clinical narrative: 2 days after vaccine administration, patient began experiencing swelling, redness, and pain in legs from her knees to her ankles.  She also experienced red, painful hands, without any swelling.  This happened for several days with each day progressively getting worse to a point in which she could not walk. She also reports experiencing hot and cold flashes but no fever and had GI upset. Within the last few days she has been starting to feel better and has been able to walk again, but reports that her feet feel like "there in cement". Patient has been elevating her feet and drinking plenty of water to help with the swelling. She has been very against going to the hospital or calling her prescriber, despite being very scared about the situation.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: 2 days after vaccine administration, patient began experiencing swelling, redness, and pain in legs from her knees to her ankles.  She also experienced red, painful hands, without any swelling.  This happened for several days with each day progressively getting worse to a point in which she could not walk. She also reports experiencing hot and cold flashes but no fever and had GI upset. Within the last few days she has been starting to feel better and has been able to walk again, but reports that her feet feel like "there in cement". Patient has been elevating her feet and drinking plenty of water to help with the swelling. She has been very against going to the hospital or calling her prescriber, despite being very scared about the situation.
Age: 0.75
Sex: M
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave 6 month vaccines accidentally at 9 months clinic visit.  No negative outcome has been reported to clinic.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Inflammation, Rash
Clinical narrative: Patient experienced rash/inflammation in arm day after receiving vaccination. Doctor diagnosed inflammation as originating from infection. Infection resulting from injection highly likely. Patient was prescribed cephalexin.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Exposure during pregnancy, Fatigue, Nausea
Clinical narrative: I am 27 weeks pregnant when I got the TDAP vaccine.  The following day at work in early afternoon I started feeling lightheaded, fatigued, and I felt as I was going to vomit. I needed to take it easy for the rest of the day and even the next day I felt still slightly fatigued, slightly lightheaded when I was walking around at work and moments during the day I felt I was going to throw up and I knew I needed to take it easy, sit down and try to relax.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pruritic, Skin warm
Clinical narrative: Rash that is growing, itchy, hot
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Dizziness, Hypotension, Myalgia
Clinical narrative: Sudden onset dizziness, hypotension, vomiting, diarrhea, myalgia, chills. Now, several hours later, myalgia, chills, nausea, diarrhea are persisting . Afebrile.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: Sudden onset dizziness, hypotension, vomiting, diarrhea, myalgia, chills. Now, several hours later, myalgia, chills, nausea, diarrhea are persisting . Afebrile.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Tachycardia
Clinical narrative: Reported Symptoms: 10043071: TACHYCARDIA;
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AE; HCP calling to report an AE regarding VAQTA. HCP reported that a patient was administered an expired dose of VAQTA.; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 27-JUN-2023, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #W002889, expiration date: 06-MAR-2023, administered for prophylaxis (dose, frequency, strength, and route of administration were not provided). No additional information or adverse events were reported.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Smear cervix abnormal
Clinical narrative: At age 22 has an abnormal pap.; This spontaneous report was received from a physician via company representative and refers to a 22-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unspecified date (also reported as between 11 and 12 years-old), the patient was given the 3-dose regimen of human papillomavirus (HPV) rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, administered intramuscularly for prophylaxis (strength, lot #, and expiry date were not provided).  On 27-JUN-2023, the patient had an abnormal pap (Smear cervix abnormal). At the reporting time, the outcome of the event was unknown.  The causal relationship between the event and HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: administration of PROQUAD following a temperature excursion; No other AE; This spontaneous report was received from a health business professional (also reported as administrator) referring to a patient of unspecified age and gender. Information regarding the patient's medical history, concurrent conditions, and concomitant therapies was not reported.   On an unspecified date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) as prophylaxis (dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) (product storage error).  No additional events were reported (no adverse event).
Sex: F
Vaccine: COVID19
Symptoms: Infertility
Clinical narrative: trying to get pregnant for 1.5 years with no success despite no suspected fertility issues; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 1, 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: INFERTILITY (non-serious), outcome "unknown", described as "trying to get pregnant for 1.5 years with no success despite no suspected fertility issues". The event "trying to get pregnant for 1.5 years with no success despite no suspected fertility issues" required physician office visit.  Additional Information: It was reported that in a dinner conversation with a friend, she mentioned she had a husband/wife friends who got one dose of the Pfizer Covid vaccine ~2 years ago. Afterward wife had been trying to get pregnant for 1.5 years with no success despite no suspected fertility issues by doctors of either partner. They have begun to wonder if the vaccine affected their fertility.  It was unknown if Covid was prior vaccination and if Covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Rash
Clinical narrative: severe rashes; burning; stinging; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, 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: RASH (non-serious), outcome "unknown", described as "severe rashes"; BURNING SENSATION (non-serious), outcome "unknown", described as "burning"; PAIN (non-serious), outcome "unknown", described as "stinging". The events "severe rashes", "burning" and "stinging" required physician office visit.  Additional information: After patient took the Pfizer Covid shot, she had severe rashes. No dermatologist has been able to find a way to relieve the burning and stinging. And asking if they had found a product that can help her.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: raised blood pressure/blood pressure has gone up some/elevated blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 85-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Jun2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 85 years for covid-19 immunisation. The patient's relevant medical history included: "had a fall" (unspecified if ongoing), notes: He is bent over, he had a fall; "permanently bent over" (ongoing), notes: He is permanently bent over and is walking around on a cane.; "walking around on a cane" (unspecified if ongoing), notes: He is permanently bent over and is walking around on a cane.; "bad hearing" (unspecified if ongoing), notes: He says I'm an older person and have bad hearing, and speak a little slower.; "speak a little slower" (unspecified if ongoing), notes: He says I'm an older person and have bad hearing, and speak a little slower.; "elevated blood pressure" (ongoing), notes: his medication hasn't changed for 15-20 years. Concomitant medication(s) included: ATENOLOL taken for blood pressure increased. The following information was reported: HYPERTENSION (non-serious) with onset Jun2023, outcome "unknown", described as "raised blood pressure/blood pressure has gone up some/elevated blood pressure". Relevant laboratory tests and procedures are available in the appropriate section. Clinical information: Patient received bivalent pfizer covid vaccine on 20Jun and since then he had experienced raised blood pressure after that. Patient was asking could that be a side effect and will it go back to normal? Patient stated he was on mild blood pressure medication for years. Reported it happened right after he got the shot. Later on 26Jun2023 patient reported he has had no problem with blood pressure until he got the shot, it had gone up some. His doctor said don't be worried yet. He would like to know, would it return soon to normal? He said he was an older person and have bad hearing, and spoke a little slower. He took Atenolol, he had elevated blood pressure, his medication hasn't changed for 15-20 years, until got Pfizer bivalent shot. He wanted to report it to Pfizer and find out if his blood pressure will fall back down. He was bent over, he had a fall, so he had no idea of height. Clarified this happened years ago before getting the vaccine, he was permanently bent over and was walking around on a cane. He had wonderful medical care so that was not a problem. He just wanted somebody to tell him that elevated blood pressure after having Pfizer bivalent shot is not unusual.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Atrial tachycardia
Clinical narrative: heart issues Atrial tachycardia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the parent.  A 21-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, 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: ATRIAL TACHYCARDIA (non-serious), outcome "unknown".  Clinical information: Patient was having heart issues, Atrial tachycardia, after research this can lead to cardiomyopathy. Reporter, as a mother knew it was the vaccine and this was push on us that it was completely safe there was disregard for the potential side effects and it was all about the money. It should not have been shoved down people's throats. They should acknowledge that the vaccine was bad and we never should've gotten it. Reporter said there was nothing else that would've caused this heart issue in reporters daughter. It was forced on them and people were forced to get it for their job and people would not have gotten the vaccine if they knew all the side effects that could happen.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2022 as dose 1, single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicilin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included Paxlovid (from 20Jun2023 to 24Jun2023).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: steroids" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Demerol, reaction(s): "Known allergies: Demerol", notes: Known allergies: Demerol. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid for COVID 19 Treatment. Known allergies: Demerol and steroids. Other medical history was No.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Return of symptoms and positive test 7 days after negative test; Positive, notes: Return of symptoms and positive test 7 days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Joint pain; Muscle pain; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 02Oct2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 66 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "GERD gastrointestinal" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1; Lot Number: EL8982; left arm), administration date: 08Jan2021, when the patient was 66-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2; Lot Number: EM9809; left arm), administration date: 08Feb2021, when the patient was 66-year-old, for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 10Aug2022, outcome "not recovered", described as "Joint pain"; MYALGIA (non-serious) with onset 10Aug2022, outcome "not recovered", described as "Muscle pain". The events "joint pain" and "muscle pain" required physician office visit. Therapeutic measures were not taken as a result of arthralgia, myalgia.   Additional Information: The patient had no known allergies. Other medications were given in two weeks. No other vaccine was administered in four weeks. The facility type where the vaccine was administered was a hospital. The patient was having very bad joint and muscle pain as long-term side effects since vaccination.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: enlarged lymph node on the left side of my neck; This case has been considered Invalid as Unspecified AE and Unspecified product. The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on 27Jun2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EL1284) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "never smoked" (unspecified if ongoing); "have not drunk alcohol", stop date: 1975, notes: since 1975; "never used illegal recreational drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "enlarged lymph node on the left side of my neck".  The information on the batch/lot number for drug, unspecified has been requested and will be submitted if and when received.  Follow-up (27Jun2023): This is a spontaneous follow-up report from same contactable Consumer. Updated Information Included: Case processed as valid. New reporter, Patient information, Relevant Medical History added. Suspect vaccine information updated. Best doctor. Vaccine Facility Information and New event added.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300234680 Same patient and similar event, different vaccine dose (Dose 4);US-PFIZER INC-202300234679 Same patient and similar event, different vaccine dose (Dose 3);US-PFIZER INC-202300234678 Same patient and similar event, different vaccine dose (Dose 2);
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: her daughter got the COVID shot and she's having heart issues; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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 (Primary immunization: series completed, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "her daughter got the COVID shot and she's having heart issues".  Additional information: The caller was asking if there were any side effects in particular to heart Arrhythmias in relation to cardiomyopathy since her daughter got the COVID shot and she's having heart issues that she never had in her life.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune haemolytic anaemia, Blood bilirubin, Blood lactate dehydrogenase, Coombs direct test, Haematocrit
Clinical narrative: Cold Antibody Autoimmune Hemolytic Anemia; This is a literature report for the following literature source(s): (WITHHELD).   An 87-year-old female patient received BNT162b2 (BNT162B2), as dose 3, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CYANOCOBALAMIN; CALCIUM CITRATE; LATANOPROST ophthalmic. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Unknown manufacturer), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2, SINGLE; Unknown manufacturer), for COVID-19 Immunisation. The following information was reported: AUTOIMMUNE HAEMOLYTIC ANAEMIA (hospitalization, medically significant, life threatening), outcome "unknown", described as "Cold Antibody Autoimmune Hemolytic Anemia". The patient underwent the following laboratory tests and procedures: Blood bilirubin: 7.2; Blood lactate dehydrogenase: 567; Coombs direct test: Positive; Haematocrit: 13.4; Haemoglobin: 5.4; Haptoglobin: less than 30; Physical Exam: Within normal limit; Smear test: agglutinated erythrocytes; Vital signs measurement: Within normal limit. Therapeutic measures were taken as a result of autoimmune haemolytic anaemia. She received 5 units of Packed RBCs and was started on Rituximab and discharged home. Rituximab was later replaced by cyclophosphamide due to failure in therapy. Patient was then readmitted for worsening anemia and was discharged to home hospice.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the event is related to the vaccine administration cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin, Haptoglobin, Physical examination, Smear test, Vital signs measurement
Clinical narrative: Cold Antibody Autoimmune Hemolytic Anemia; This is a literature report for the following literature source(s): (WITHHELD).   An 87-year-old female patient received BNT162b2 (BNT162B2), as dose 3, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CYANOCOBALAMIN; CALCIUM CITRATE; LATANOPROST ophthalmic. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Unknown manufacturer), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2, SINGLE; Unknown manufacturer), for COVID-19 Immunisation. The following information was reported: AUTOIMMUNE HAEMOLYTIC ANAEMIA (hospitalization, medically significant, life threatening), outcome "unknown", described as "Cold Antibody Autoimmune Hemolytic Anemia". The patient underwent the following laboratory tests and procedures: Blood bilirubin: 7.2; Blood lactate dehydrogenase: 567; Coombs direct test: Positive; Haematocrit: 13.4; Haemoglobin: 5.4; Haptoglobin: less than 30; Physical Exam: Within normal limit; Smear test: agglutinated erythrocytes; Vital signs measurement: Within normal limit. Therapeutic measures were taken as a result of autoimmune haemolytic anaemia. She received 5 units of Packed RBCs and was started on Rituximab and discharged home. Rituximab was later replaced by cyclophosphamide due to failure in therapy. Patient was then readmitted for worsening anemia and was discharged to home hospice.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the event is related to the vaccine administration cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia
Clinical narrative: Anemia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 7-year-old female patient received BNT162b2 (BNT162B2), on 06Dec2021 as dose 2 (orange cap), single (Lot number: FK5127) at the age of 7 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma", start date: 15Dec2017 (unspecified if ongoing); "Atopic dermatitis", start date: 19Jun2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, Batch/Lot number: FK5127, Anatomical Site of injection: Left arm, Route of administration: Intramuscular), administration date: 15Nov2021, for COVID-19 immunisation. The following information was reported: ANAEMIA (non-serious) with onset 16Feb2022, outcome "unknown", described as "Anemia".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300157513 Same patient/same product, different dose/event;
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 15-year-old female patient received BNT162b2 (BNT162B2), on 14Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 14 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 24Jul2021, when the patient was 14-year-old, for COVID-19 immunisation. The following information was reported: RASH (non-serious) with onset 15Dec2021, outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300151562 Same patient, same product, different events (dose 4);
Sex: F
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: developed a knot on my arm and then under my left armpit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, 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: NODULE (non-serious) with onset 2021, outcome "unknown", described as "developed a knot on my arm and then under my left armpit".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300234293 Same patient/product, different dose (dose 2)/event;US-PFIZER INC-202201391338 Same patient, different product/event;
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body mass index, Body temperature, COVID-19, Heart rate
Clinical narrative: Rapid covid-19 self test, date: 03Jul2022, result : positive; Rapid covid-19 self test, date: 03Jul2022, result : positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 at 08:05 as dose 1, single (Lot number: ER2613) intramuscular, in left arm, on 06Apr2021 at 09:25 as dose 2, single (Lot number: EW0151) intramuscular, in left arm, on 08Oct2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 27May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Cho (cholesterol)" (ongoing); "Are you allergic to any medications, food or other products: Bee Stings" (unspecified if ongoing); "Are you allergic to any medications, food or other products: Oysters" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN CALCIUM oral taken for blood cholesterol increased, start date: 12Apr2021 (ongoing); BENADRYL taken for dermatitis contact, start date: 21Apr2023, stop date: 01May2023; VITAMIN D3; VITAMIN B12 [CYANOCOBALAMIN]. Past drug history included: Oxycodone, reaction(s): "Are you allergic to any medications, food or other products: Oxycodone"; Doxycycline, reaction(s): "Are you allergic to any medications, food or other products: Doxycycline". None prior vaccinations within 4 weeks. No history of reactions to Covid vaccines. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jul2022, outcome "recovered" and all described as "Rapid covid-19 self test, date: 03Jul2022, result : positive". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 137/89; Body mass index: (unspecified date) 28.95; Body temperature: (unspecified date) 97.9 Fahrenheit; Heart rate: (unspecified date) 74; Oxygen saturation: (unspecified date) 98 %; Pulmonary function test: (unspecified date) 16; SARS-CoV-2 test: (01Jul2022) Negative, notes: Comments: Tested due to cough and cold symptoms (slight fever 100 degree F); (03Jul2022) Positive, notes: Comments: Hives developed fever increases to 103 degree F; (14Jul2022) Negative, notes: cold symptoms resolved and temperature returned to normal, no longer had any symptoms; (04May2023) Negative, notes: Comments: Tested when hives began to develop post 2nd Bivalent booster; (04May2023) Negative, notes: Comments: Tested when hives began to develop post 2nd Bivalent booster; (05May2023) Negative, notes: Comments: Tested when hives and welts continued to develop; (05May2023) Negative, notes: Comments: Tested when hives and welts continued to develop.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300182799 Same patient/Vaccine, different event, different vaccine dose;
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation, Pulmonary function test, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Rapid covid-19 self test, date: 03Jul2022, result : positive; Rapid covid-19 self test, date: 03Jul2022, result : positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 at 08:05 as dose 1, single (Lot number: ER2613) intramuscular, in left arm, on 06Apr2021 at 09:25 as dose 2, single (Lot number: EW0151) intramuscular, in left arm, on 08Oct2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 27May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Cho (cholesterol)" (ongoing); "Are you allergic to any medications, food or other products: Bee Stings" (unspecified if ongoing); "Are you allergic to any medications, food or other products: Oysters" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN CALCIUM oral taken for blood cholesterol increased, start date: 12Apr2021 (ongoing); BENADRYL taken for dermatitis contact, start date: 21Apr2023, stop date: 01May2023; VITAMIN D3; VITAMIN B12 [CYANOCOBALAMIN]. Past drug history included: Oxycodone, reaction(s): "Are you allergic to any medications, food or other products: Oxycodone"; Doxycycline, reaction(s): "Are you allergic to any medications, food or other products: Doxycycline". None prior vaccinations within 4 weeks. No history of reactions to Covid vaccines. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jul2022, outcome "recovered" and all described as "Rapid covid-19 self test, date: 03Jul2022, result : positive". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 137/89; Body mass index: (unspecified date) 28.95; Body temperature: (unspecified date) 97.9 Fahrenheit; Heart rate: (unspecified date) 74; Oxygen saturation: (unspecified date) 98 %; Pulmonary function test: (unspecified date) 16; SARS-CoV-2 test: (01Jul2022) Negative, notes: Comments: Tested due to cough and cold symptoms (slight fever 100 degree F); (03Jul2022) Positive, notes: Comments: Hives developed fever increases to 103 degree F; (14Jul2022) Negative, notes: cold symptoms resolved and temperature returned to normal, no longer had any symptoms; (04May2023) Negative, notes: Comments: Tested when hives began to develop post 2nd Bivalent booster; (04May2023) Negative, notes: Comments: Tested when hives began to develop post 2nd Bivalent booster; (05May2023) Negative, notes: Comments: Tested when hives and welts continued to develop; (05May2023) Negative, notes: Comments: Tested when hives and welts continued to develop.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300182799 Same patient/Vaccine, different event, different vaccine dose;
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine, Pruritus, Swelling
Clinical narrative: itching; Swelling; Allergies: Prevnar 13; This is a spontaneous report received from contactable reporter(s) (Physician).  An 80-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "itching"; SWELLING (non-serious), outcome "unknown"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Allergies: Prevnar 13". Additional information: Allergies: Prevnar 13 - Itching, Swelling.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: U
Vaccine: DTAPIPV
Symptoms: Rash
Clinical narrative: Rash on the leg; Initial information received on 26-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient of an unknown age and gender who experienced rash on the leg after receiving 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.   On an unknown date, the patient received a unknown dose of suspect diphtheria-15/tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine suspension for injection (strength, expiry date and lot number: not reported) via unknown route in unknown administration site for Prophylactic vaccination (immunization). Information on the batch number was requested.  On an unknown date the patient developed rash on the leg (rash) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Daptacel is administered, with no reported adverse event; Initial information received on 26-Jun-2023 regarding an unsolicited valid  non-serious case received from a consumer.  This case involves an unknown age and unknown gender patient, reporter reported expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] is administered, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection (lot number, strength: unknown) (expiry date: 21-Jun-2023)  not reported via unknown route in unknown administration site and expired daptacel is administered, with no reported adverse event (expired product administered) (latency: same day) following the administration of diphtheria-15/tetanus/5 AC pertussis vaccine.  Action taken with diphtheria, tetanus and acellular pertussis vaccine (Daptacel) was 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 guidelines. 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: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Daptacel was administered to a 6 month old patient, with no reported adverse event; Initial information received  on 27-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old female patient and it was reported expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] was administered to a 6 month old patient, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); POLIO VACCINE; and ROTAVIRUS VACCINE all for Prophylactic vaccination.  On 22-JUN-2023, 0.5 mL of expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] Suspension for injection (batch/lot number: C5893AA; expiry date: 21-Jun-2023; frequency: once; strength: standard) was administered to a 6 month old patient intramuscular route in the right thigh for immunization, with no reported adverse event (expired product administered) (latency: same day).  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 guidelines. 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.
Sex: U
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: mixing YF-VAX with a different diluent and administrating it to a patient with no reported adverse event; Initial information received on 28-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves patient of unknown age and gender who took Yellow Fever Vaccine [YF-VAX] mixed with a different diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 mL dose of suspect Yellow Fever Vaccine  Solution for injection(Strength = standard) (lot number, route, batch lot: requested, expiry date was unknown) for immunization and mixed with a different diluent with no reported adverse event (product preparation error) (unknown latency). Information on the batch number was requested.  Action taken was 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 guidelines. 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: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: nurse gave a daptacel vaccine this morning and it had expired a few days ago with no reported adverse event; Initial information received on 28-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old male was given a diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] vaccine this morning and it had expired a few days ago with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine for Immunisation.  On 28-Jun-2023, the patient received a dose of 0.5 ml once of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: C5893AA; strength: standard) (expiry date: unknown) via intramuscular route in the left vastus lateralis for Immunisation.  On 28-Jun-2023, the patient was given a daptacel vaccine this morning and it had expired a few days ago with no reported adverse event (expired product administered) (latency: same day).  Action taken was 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 guidelines. 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.