chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Head discomfort, Headache, Idiopathic intracranial hypertension, Loss of personal independence in daily activities, Lumbar puncture
Clinical narrative: Patient started experiencing headaches and neck pain. She also had trouble seeing She had an MRI on April 21, but results were taking too long to get back to we took her to local Eye clinic. The doctor there sent her to alternate Dr. and the immediately sent her to Specialty Hospital where she spent 5 days in the neuro trauma unit. Patient had IIH with so much pressure in her brain that it damaged her optic nerves permanently. She had a right optic nerve fenestration, 5 lumbar punctures and they were preparing to put a drain in her head but she showed slight improvement after starting high doses of Diamox. Patient developed chemical meningitis, missed 6 weeks of school and
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Meningitis chemical, Neck pain, Optic nerve injury, Optic nerve operation
Clinical narrative: Patient started experiencing headaches and neck pain. She also had trouble seeing She had an MRI on April 21, but results were taking too long to get back to we took her to local Eye clinic. The doctor there sent her to alternate Dr. and the immediately sent her to Specialty Hospital where she spent 5 days in the neuro trauma unit. Patient had IIH with so much pressure in her brain that it damaged her optic nerves permanently. She had a right optic nerve fenestration, 5 lumbar punctures and they were preparing to put a drain in her head but she showed slight improvement after starting high doses of Diamox. Patient developed chemical meningitis, missed 6 weeks of school and
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Visual field defect, Visual impairment
Clinical narrative: Patient started experiencing headaches and neck pain. She also had trouble seeing She had an MRI on April 21, but results were taking too long to get back to we took her to local Eye clinic. The doctor there sent her to alternate Dr. and the immediately sent her to Specialty Hospital where she spent 5 days in the neuro trauma unit. Patient had IIH with so much pressure in her brain that it damaged her optic nerves permanently. She had a right optic nerve fenestration, 5 lumbar punctures and they were preparing to put a drain in her head but she showed slight improvement after starting high doses of Diamox. Patient developed chemical meningitis, missed 6 weeks of school and
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She tested positive and had COVID for a week and a half; She tested positive and had COVID for a week and a half; 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.  A 53-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Smoker" (unspecified if ongoing); "Coughing" (unspecified if ongoing), notes: She was a smoker and states if she noticed she was coughing more than usual; "spinal arthritis" (unspecified if ongoing); "headache" (unspecified if ongoing), notes: headaches often before of her spinal arthritis; "disability" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine, reaction(s): "Got Sick". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "She tested positive and had COVID for a week and a half". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (25Jan2023) Negative.  Clinical course: The patient stated that she waited to get the Pfizer COVID vaccine for 6-7 months after it came out. When she got the first dose of the Pfizer COVID vaccine she lost her taste and smell within 24 hours. She stated it started to come back but then she went to get 2nd dose and taste and smell went away again. Off and on she could taste or smell a little. She thought maybe she had COVID so she tested at home from time to time. She was a smoker and stated if she noticed she was coughing more than usual she would test for COVID. Last summer when Omicron was big she tested positive and had COVID for a week and a half. She stated that her loss of taste and smell as been more consistent. Also mentioned headache but says that she has headaches often before of her spinal arthritis. She tested negative for COVID yesterday. She was on disability and works and she was trying to do a side business of baked goods but it was hard with cant smell or taste. She stated that she does not have any questions but that she was just making a statement in the original.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle atrophy
Clinical narrative: Muscle atrophy; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 71-year-old female patient received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative Colitis" (ongoing); "HTN" (ongoing); "Weakened Immune System" (unspecified if ongoing); "Pain" (ongoing). Concomitant medication(s) included: AZATHIOPRINE oral taken for colitis ulcerative (ongoing); LYRICA oral taken for pain (ongoing); HCTZ oral taken for hypertension (ongoing); ASACOL oral taken for colitis ulcerative (ongoing). Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "COVID-19"; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: MUSCLE ATROPHY (non-serious) with onset 14Apr2022, outcome "not recovered". The event "muscle atrophy" required physician office visit. Therapeutic measures were not taken as a result of muscle atrophy.  Additional information: The patient provide information regarding the reported adverse event(s) with the use of the product and the Pfizer product had a causal effect to the adverse event. Patient received dose 4, anatomical site of injection was left shoulder. Booster dose due to a weakened immune system. Prior vaccinations (Within 4 Weeks) was none reported. Specific relevant test (For Thromboembolic events with Thrombocytopenia) was none reported. Comments/ Narrative: Has had five vaccine only the 4th had an issue. Spot Muscle Atrophy left an indentation in her arm. Gradually happen over months. Suspect due to injection and damaged the nerve.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Infertility, Lichen planus, Maternal exposure before pregnancy, SARS-CoV-2 test
Clinical narrative: Moderna Dose Number 3 / Pfizer Dose Number 1; Is pregnant: Yes/Last menstrual date: 22Oct2021/Delivery date: 28Jul2022; Lichen planus on vagina which is now causing infertility; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 20Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation. Date of last menstrual period: 22Oct2021. The patient was 4 weeks pregnant at the time of exposure to BNT162b2. The patient was 45 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 28Jul2022. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna covid-19 vaccine (Dose Number: 1, Batch/Lot No: Not sure), administration date: 09Apr2021, when the patient was 29-year-old, for Covid-19 immunization; moderna covid-19 vaccine (Dose Number: 2, Batch/Lot No: Not sure), administration date: 07May2021, when the patient was 29-year-old, for Covid-19 immunization. The following information was reported: LICHEN PLANUS (non-serious) with onset 07Dec2022, outcome "not recovered", described as "Lichen planus on vagina which is now causing infertility"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Moderna Dose Number 3 / Pfizer Dose Number 1"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Is pregnant: Yes/Last menstrual date: 22Oct2021/Delivery date: 28Jul2022". Therapeutic measures were not taken as a result of lichen planus.  Additional information: If covid prior vaccination: No. If covid tested post vaccination: Yes  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Interchange of vaccine products, Lichen planus, Maternal exposure during pregnancy
Clinical narrative: Moderna Dose Number 3 / Pfizer Dose Number 1; Is pregnant: Yes/Last menstrual date: 22Oct2021/Delivery date: 28Jul2022; Lichen planus on vagina which is now causing infertility; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 20Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation. Date of last menstrual period: 22Oct2021. The patient was 4 weeks pregnant at the time of exposure to BNT162b2. The patient was 45 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 28Jul2022. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna covid-19 vaccine (Dose Number: 1, Batch/Lot No: Not sure), administration date: 09Apr2021, when the patient was 29-year-old, for Covid-19 immunization; moderna covid-19 vaccine (Dose Number: 2, Batch/Lot No: Not sure), administration date: 07May2021, when the patient was 29-year-old, for Covid-19 immunization. The following information was reported: LICHEN PLANUS (non-serious) with onset 07Dec2022, outcome "not recovered", described as "Lichen planus on vagina which is now causing infertility"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Moderna Dose Number 3 / Pfizer Dose Number 1"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Is pregnant: Yes/Last menstrual date: 22Oct2021/Delivery date: 28Jul2022". Therapeutic measures were not taken as a result of lichen planus.  Additional information: If covid prior vaccination: No. If covid tested post vaccination: Yes  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 50.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Head injury, Syncope
Clinical narrative: Passed out; fainting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Jan2023 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization complete; Manufacturer unknown), for Covid-19 Immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 25Jan2023, outcome "recovered", described as "Passed out"; SYNCOPE (medically significant) with onset 25Jan2023, outcome "recovered", described as "fainting". The patient underwent the following laboratory tests and procedures: Body height: About 5 feet 8 inches, notes: Patient Height: About 5 feet 8 inches; Weight: About 160, notes: Patient Weight: About 160 pounds.  Clinical course: Caller wants to know if passing out after receiving the Vaccine has been reported. No information on how long after receiving the vaccine, the patients have been fainting was found. Had the vaccine two days ago. Two nights ago he woke up and was going to the bathroom and passed out in the bathroom. Never passed out before. Passed Out  and it only happened once.   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: 50.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Body height, Loss of consciousness, Syncope, Weight
Clinical narrative: Passed out; fainting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Jan2023 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization complete; Manufacturer unknown), for Covid-19 Immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 25Jan2023, outcome "recovered", described as "Passed out"; SYNCOPE (medically significant) with onset 25Jan2023, outcome "recovered", described as "fainting". The patient underwent the following laboratory tests and procedures: Body height: About 5 feet 8 inches, notes: Patient Height: About 5 feet 8 inches; Weight: About 160, notes: Patient Weight: About 160 pounds.  Clinical course: Caller wants to know if passing out after receiving the Vaccine has been reported. No information on how long after receiving the vaccine, the patients have been fainting was found. Had the vaccine two days ago. Two nights ago he woke up and was going to the bathroom and passed out in the bathroom. Never passed out before. Passed Out  and it only happened once.   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: 0.17
Sex: F
Vaccine: RV5, RV5
Symptoms: Diarrhoea, Laboratory test
Clinical narrative: A "GI pathogen test" was done on 1/25/2022 and it came back positive for rotavirus.; patient developed gastrointestinal symptoms; patient developed gastrointestinal symptoms including loose watery stools after receiving first dose of ROTATEQ.; This spontaneous report was received from a pharmacist regarding a 3-month-old female patient. The patient's medical history and concurrent conditions were not reported. Her concomitant medications included pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) and diphtheria vaccine toxoid (+) hepatitis b vaccine rhbsag (yeast) (+) hib vaccine conj (menigococcal protein) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (VAXELIS).   On 29-DEC-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dose, lot #1908330, expiration date: 18-NOV-2023, taken orally for prophylaxis (To prevent rotavirus gastroenteritis) (strength and dosage regimen were not provided).  On 15-JAN-2023, the patient developed gastrointestinal symptoms (Gastrointestinal disorder) including loose watery stools (Diarrhoea) after receiving  the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). On 25-JAN-2023 (also reported as "25-JAN-2022", conflicting information), a Gastrointestinal (GI) pathogen test showed positive for rotavirus (Rotavirus test positive). The patient was treated with paracetamol (TYLENOL) and switched from breast feeding to formula for the events. At the time of reporting, she was recovering from the events of gastrointestinal disorder, diarrhoea, and rotavirus test positive. She sought medical attention and she saw the physician.  The causal relationship between gastrointestinal disorder, diarrhoea, rotavirus test positive, and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was unknown.
Age: 0.17
Sex: F
Vaccine: RV5, RV5
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Gastrointestinal disorder, Gastrointestinal pathogen panel, Rotavirus test positive
Clinical narrative: A "GI pathogen test" was done on 1/25/2022 and it came back positive for rotavirus.; patient developed gastrointestinal symptoms; patient developed gastrointestinal symptoms including loose watery stools after receiving first dose of ROTATEQ.; This spontaneous report was received from a pharmacist regarding a 3-month-old female patient. The patient's medical history and concurrent conditions were not reported. Her concomitant medications included pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) and diphtheria vaccine toxoid (+) hepatitis b vaccine rhbsag (yeast) (+) hib vaccine conj (menigococcal protein) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (VAXELIS).   On 29-DEC-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dose, lot #1908330, expiration date: 18-NOV-2023, taken orally for prophylaxis (To prevent rotavirus gastroenteritis) (strength and dosage regimen were not provided).  On 15-JAN-2023, the patient developed gastrointestinal symptoms (Gastrointestinal disorder) including loose watery stools (Diarrhoea) after receiving  the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). On 25-JAN-2023 (also reported as "25-JAN-2022", conflicting information), a Gastrointestinal (GI) pathogen test showed positive for rotavirus (Rotavirus test positive). The patient was treated with paracetamol (TYLENOL) and switched from breast feeding to formula for the events. At the time of reporting, she was recovering from the events of gastrointestinal disorder, diarrhoea, and rotavirus test positive. She sought medical attention and she saw the physician.  The causal relationship between gastrointestinal disorder, diarrhoea, rotavirus test positive, and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; 14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date) and NO ADVERSE EVENT (no adverse event) in a 66-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 19-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date).    No concomitant and treatment medication were reported. 14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date. No patients have been administered monovalent vaccine after the beyond use date. Doses were administered from 8DEC2022 to 10JAN2023. This case belongs to 8th adult  out of 14 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-703586 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2023: Live follow-up received include patient demographics, vaccine administration added, event onset updated. On 24-Jan-2023: Live Follow-up no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703586:Master case
Age: 70.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19-2, FLU4
Symptoms: Cerebrovascular accident
Clinical narrative: She got her vaccine, she had body aches and a headache for a day and a half.  Then it went away.  Then in December she started having headaches which she is not prone to.  On 12/30/22 she went to the ER, but did not see any evidence of a stroke.  The next day the headache was worse, had numbness down her left side and did more testing and diagnosed with an ischemic stroke.  The adverse reaction only lasted for about 20 minutes.  Then they sent her to a hospital who had a neurologist on staff, who sent her to Hospital where they did an MRI of her head and saw the evidence of the stroke.  She was put on another blood pressure medicine Norvasc 2.5 mg.  She did have some blurriness and did go to the eye doctor twice and it has improved.    She went to Hospital ER first.  She was then transferred by ambulance to Hospital.    She will not get two vaccines at the same time again.
Age: 70.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19-2, FLU4
Symptoms: Blood test, Computerised tomogram, Headache, Hypoaesthesia, Ischaemic stroke
Clinical narrative: She got her vaccine, she had body aches and a headache for a day and a half.  Then it went away.  Then in December she started having headaches which she is not prone to.  On 12/30/22 she went to the ER, but did not see any evidence of a stroke.  The next day the headache was worse, had numbness down her left side and did more testing and diagnosed with an ischemic stroke.  The adverse reaction only lasted for about 20 minutes.  Then they sent her to a hospital who had a neurologist on staff, who sent her to Hospital where they did an MRI of her head and saw the evidence of the stroke.  She was put on another blood pressure medicine Norvasc 2.5 mg.  She did have some blurriness and did go to the eye doctor twice and it has improved.    She went to Hospital ER first.  She was then transferred by ambulance to Hospital.    She will not get two vaccines at the same time again.
Age: 70.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19-2, FLU4
Symptoms: Magnetic resonance imaging head abnormal, Pain, Vision blurred
Clinical narrative: She got her vaccine, she had body aches and a headache for a day and a half.  Then it went away.  Then in December she started having headaches which she is not prone to.  On 12/30/22 she went to the ER, but did not see any evidence of a stroke.  The next day the headache was worse, had numbness down her left side and did more testing and diagnosed with an ischemic stroke.  The adverse reaction only lasted for about 20 minutes.  Then they sent her to a hospital who had a neurologist on staff, who sent her to Hospital where they did an MRI of her head and saw the evidence of the stroke.  She was put on another blood pressure medicine Norvasc 2.5 mg.  She did have some blurriness and did go to the eye doctor twice and it has improved.    She went to Hospital ER first.  She was then transferred by ambulance to Hospital.    She will not get two vaccines at the same time again.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 at 12:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Jan2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jan2023) Positive, notes: Originally tested positive on 15Jan; (22Jan2023) Negative, notes: After testing negative for Covid on 22Jan; (24Jan2023) Positive, notes: I tested positive again on 24Jan. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical courses is as follows: Originally tested positive on 15Jan. After testing Negative for Covid on Jan22, the patient tested positive again on 24Jan after waking up feeling quite sick again. 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: HPV4
Symptoms: Food allergy
Clinical narrative: allergic to peanuts; This spontaneous report was received from a consumer, physician and via a company representative and refers to a female patient of unknown age.  The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection,administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  The reporter stated that the patient became severely allergic to peanuts (food allergy) six months after receiving the vaccine. Their mother had indicated that her daughter had never had these allergies before receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  The causal relationship between food allergy and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was unknown.  This is one of two reports received from the same source.; Sender's Comments:  US-009507513-2210USA008546:
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Accidental overdose, No adverse event
Clinical narrative: no adverse event; Report of concomitant administration of PROQUAD and MMRII; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 18-JAN-2023, the patient was inadvertently administered concomitantly with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) lot #W028564, expiration date: 06-MAR-2024 (formulation, exact dose, administration site and route of administration were not provided); and a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot #W009107, expiration date: 04-DEC-2023 (formulation, exact dose, administration site and route of administration were not provided) both administered for prophylaxis (accidental overdose). No additional adverse events (AE) were reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Medical assistant reports patient was accidently administered an expired dose of VAQTA on Jan 19, 2023. Product expired on Jan 14, 2023. Product had no prior temperature excursions. No further information provided. No additional AE reported. No PQC r; This spontaneous report was received from medical assistant and refers to an unknown age and gender patient.  The patient's pertinent medical history, concurrent conditions, previous drug reactions allergies, and concomitant therapies were not reported.  On 19-JAN-2023, the patient was accidently administered an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, once, lot #U021561, expiration date: 14-JAN-2023, administered intramuscularly (strength, dose and indication were not provided) (expired product administered). It was mentioned that the product had no prior temperature excursions. No additional adverse event was reported.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 2-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 12-DEC-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, in right thigh, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009110: US-009507513-2301USA009112:
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 12-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 12-DEC-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, in right thigh, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes . Digital data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009024: US-009507513-2301USA009096:
Age: 0.25
Sex: F
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 3-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 13-DEC-2022, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ)  intramuscular injection, in left thigh, lot #U031544, expiration date: 23-JUN-2023, administered intramuscularly for prophylaxis (strength was not provided). and with and Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) orally, Lot# 1892784 with expiration date on 03-DEC-2023.  The administered doses of the vaccines experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009024: US-009507513-2301USA009088:
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 15-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 13-DEC-2022, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in right thigh, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes . Data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009878: US-009507513-2301USA009918:
Age: 1.75
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 21-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 13-DEC-2022, the patient was vaccinated with a second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, in right thigh, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009088: US-009507513-2301USA009113:
Age: 1.42
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 12-month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 13-DEC-2022, the patient was vaccinated with a first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, in left thigh, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009088: US-009507513-2301USA009112: US-009507513-2301USA009927:
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; multiple TEs for PNEUMOVAX 23 dating back to 12/1/22 and confirms that vaccines were administered; This spontaneous report was received from a medical assistant and refers to a 78-year-old male patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 05-JAN-2023, the patient was vaccinated with improperly stored (product storage error) dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe, injection, 0.5 ml, once, lot # was reported and confirmed as: W004863, expiration date was reported and upon lot validation confirmed as: 21-AUG-2023 (dose number, site and route of administration were not provided) for prophylaxis. The vaccine experienced multiple temperature excursion dating back to 01-DEC-2022. No additional adverse event reported.  This is one of two reports received from the same reporter.
Age: 0.33
Sex: M
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 4-month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 14-DEC-2022, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in left thigh, lot #W006596, expiration date: 11-OCT-2024, administered intramuscularly for prophylaxis (strength was not provided), and with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ)  lot #1892784, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength was not provided).   The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009896:
Age: 0.33
Sex: F
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 4-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 14-DEC-2022, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in left thigh, lot #W006596, expiration date: 11-OCT-2024, administered intramuscularly for prophylaxis (strength was not provided), and with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ)  lot #1892784, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength was not provided). 1 min   The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009904:
Age: 0.33
Sex: M
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 4-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 14-DEC-2022, the patient was vaccinated with the second dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in left thigh, lot #W006596, expiration date: 11-OCT-2024, administered intramuscularly for prophylaxis (strength was not provided), and with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ)  lot #1892784, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength was not provided).   The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009896:
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 15-month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 14-DEC-2022, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in right thigh, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes . Data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009943: US-009507513-2301USA009933:
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 2 year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 14-DEC-2022, the patient was vaccinated with a second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, in right thigh, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009088: US-009507513-2301USA009112: US-009507513-2301USA009113: US-009507513-2301USA010889: