chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Headache, Nausea
Clinical narrative: After recreational activity in the morning and showering, I came home and around 130PM started to feel a bit light headed. This progressed to feeling dizzy, with mild nausea and headache. After about 15 minutes, I decided to lay down in my bed and I slept for about 2 hours.  I got up, but these feelings persisted. My pulse was normal with no fever, but my blood pressure was elevated.  (My normal BP is 120/70) These feeling persisted, with BP reading in the 140-150/85-90 range over the next few days. The associated feelings seemed to diminish over the course of 4 days, and the BP seemed to be dropping as well. I the medical doctor at the clinic (May 10th) just to make sure everything was OK, and my pressure there was 125/75 when tested. I subsequently felt better each day and by the 12th was pretty much back to normal.  There has been no subsequent sequela to this event.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Patient stated that he passed out 5 days after he took second booster of Moderna vaccine.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: NO Adverse Event: On 4-29-2022  patient came to clinic for office visit. According to his chart he was due for his First Shingles shot.  Patient agreed to have vaccinations Later that day his wife called and reported that he had his first shingles shot one at another clinic on 03-25-2022.  No reactions were reported.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Severe urticaria, severe eczema, very bad itching and skin rashes everyday
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Cholelithiasis, Dyspnoea, Erythema, Pharyngeal oedema
Clinical narrative: Severe urticaria, severe eczema, very bad itching and skin rashes everyday
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Rash, Urinary cystectomy, Urticaria
Clinical narrative: Severe urticaria, severe eczema, very bad itching and skin rashes everyday
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eczema, Pruritus, Rash, Urticaria
Clinical narrative: Severe urticaria, severe eczema, very bad itching and skin rashes everyday
Sex: U
Vaccine: VARCEL, UNK, VARCEL
Symptoms: Extra dose administered
Clinical narrative: No additional AE; Medical assistant reported that a patient received additional VARIVAX.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age or gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was properly vaccinated with measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (MMR II) (strength, dose, route of administration, lot # and expired date were not provided) and varicella virus vaccine live (OKA/MERCK) (VARIVAX) (strength, dose, route of administration, lot # and expired date were not provided); however on 26-APR-2022, the patient received another dose of varicella virus vaccine live (OKA/MERCK) (VARIVAX) (Extra dose administered) (valid lot #U026207, expiration date: 24-AUG-2023) for prophylaxis (strength and route of administration were not provided) which was reconstituted with a sterile diluent (valid lot #T015779, expiration date: 02-DEC-2022). No additional adverse events were reported, no further information was provided.
Sex: U
Vaccine: VARCEL, UNK, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; Medical assistant reported that a patient received additional VARIVAX.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age or gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was properly vaccinated with measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (MMR II) (strength, dose, route of administration, lot # and expired date were not provided) and varicella virus vaccine live (OKA/MERCK) (VARIVAX) (strength, dose, route of administration, lot # and expired date were not provided); however on 26-APR-2022, the patient received another dose of varicella virus vaccine live (OKA/MERCK) (VARIVAX) (Extra dose administered) (valid lot #U026207, expiration date: 24-AUG-2023) for prophylaxis (strength and route of administration were not provided) which was reconstituted with a sterile diluent (valid lot #T015779, expiration date: 02-DEC-2022). No additional adverse events were reported, no further information was provided.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, RV1, DTAPHEPBIP, RV1
Symptoms: Blood test, Opsoclonus myoclonus, Scan, Urine analysis, Vision blurred
Clinical narrative: Opsoclonus - Irregular eye movements and fussiness.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, RV1, DTAPHEPBIP, RV1
Symptoms: Visual impairment
Clinical narrative: Opsoclonus - Irregular eye movements and fussiness.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, RV1, DTAPHEPBIP, RV1
Symptoms: Coronavirus infection, Coronavirus test positive, Culture urine negative, Differential white blood cell count normal, Electroencephalogram normal
Clinical narrative: Opsoclonus - Irregular eye movements and fussiness.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, RV1, DTAPHEPBIP, RV1
Symptoms: Eye movement disorder, Full blood count normal, Irritability, Magnetic resonance imaging head normal, Magnetic resonance imaging normal
Clinical narrative: Opsoclonus - Irregular eye movements and fussiness.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, RV1, DTAPHEPBIP, RV1
Symptoms: Metabolic function test normal, Opsoclonus myoclonus, Renal mass, Ultrasound abdomen abnormal, Viral test positive
Clinical narrative: Opsoclonus - Irregular eye movements and fussiness.
Age: 65.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Injected limb mobility decreased, Pain in extremity, Product administered at inappropriate site
Clinical narrative: No Help   from    Dr sore right arm so bad can't move Hand the first day. Arm still sore 1 week later
Age: 65.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: No Help   from    Dr sore right arm so bad can't move Hand the first day. Arm still sore 1 week later
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Nasal congestion, SARS-CoV-2 test
Clinical narrative: the patient tested positive for Covid 19; the patient tested positive for Covid 19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 90-year-old female patient received BNT162b2 (BNT162B2), on 02May2022 as dose 4 (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) 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 08May2022, outcome "unknown" and all described as "the patient tested positive for Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Positive, notes: the patient tested positive for Covid 19.  Clinical course: On 03May2022 the patient developed tiredness, headache and congestion. On 08May2022, the patient tested positive for Covid 19. Her tiredness has resolved, the headache and congestion are ongoing. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid 19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: the patient tested positive for Covid 19; the patient tested positive for Covid 19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 90-year-old female patient received BNT162b2 (BNT162B2), on 02May2022 as dose 4 (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) 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 08May2022, outcome "unknown" and all described as "the patient tested positive for Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Positive, notes: the patient tested positive for Covid 19.  Clinical course: On 03May2022 the patient developed tiredness, headache and congestion. On 08May2022, the patient tested positive for Covid 19. Her tiredness has resolved, the headache and congestion are ongoing. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid 19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache
Clinical narrative: the patient tested positive for Covid 19; the patient tested positive for Covid 19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 90-year-old female patient received BNT162b2 (BNT162B2), on 02May2022 as dose 4 (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) 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 08May2022, outcome "unknown" and all described as "the patient tested positive for Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Positive, notes: the patient tested positive for Covid 19.  Clinical course: On 03May2022 the patient developed tiredness, headache and congestion. On 08May2022, the patient tested positive for Covid 19. Her tiredness has resolved, the headache and congestion are ongoing. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid 19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: parathyroidectomy; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 76 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "knees replacements" (unspecified if ongoing), notes: caller had 2 knees replacements. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, NDC number: Unknown, Lot number: EN5318, Expiration date: Unknown, Dose and route: Unknown dose, was an injection in arm.), administration date: 08Feb2021, for Covid-19 Immunization; BNT162b2 (DOSE 2, NDC number: Unknown, Lot number: EN6202, Expiration date: Unknown, Dose and route: Unknown dose, was an injection in arm.), administration date: 01Mar2022, for Covid-19 Immunization. The following information was reported: PARATHYROIDECTOMY (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Positive, notes: Tested positive for Covid Sunday, 08May2022.  Clinical Course: The Pfizer Medical Information Team. Reporter was calling about Paxlovid and mentioned she had just completed day 2 of the Paxlovid treatment and mentioned that she experienced diarrhea. Caller mentioned that after about 4 to 5 hours the side effect, which is the diarrhea, tapers off. Caller had a question regarding if Pfizer has some information on the interval for a patient to get the Pfizer COVID-19 vaccine booster shot once the patient had completed the 5 day Paxlovid treatment, was scheduled to get the 2nd booster dose and then tested positive for Covid. Person giving the vaccine was saying how careful he had to be about how long the vaccine had to be in and out of the refrigerator or freezer and stuff. Medical Conditions: Only other thing different with reporter health was that in Jan2022, after getting all of these vaccines caller had a parathyroidectomy and during the previous year, after the 1st and 2nd doses of the vaccine, reporter had 2 knees replacements.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully 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: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Parathyroidectomy, SARS-CoV-2 test
Clinical narrative: parathyroidectomy; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 76 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "knees replacements" (unspecified if ongoing), notes: caller had 2 knees replacements. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, NDC number: Unknown, Lot number: EN5318, Expiration date: Unknown, Dose and route: Unknown dose, was an injection in arm.), administration date: 08Feb2021, for Covid-19 Immunization; BNT162b2 (DOSE 2, NDC number: Unknown, Lot number: EN6202, Expiration date: Unknown, Dose and route: Unknown dose, was an injection in arm.), administration date: 01Mar2022, for Covid-19 Immunization. The following information was reported: PARATHYROIDECTOMY (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Positive, notes: Tested positive for Covid Sunday, 08May2022.  Clinical Course: The Pfizer Medical Information Team. Reporter was calling about Paxlovid and mentioned she had just completed day 2 of the Paxlovid treatment and mentioned that she experienced diarrhea. Caller mentioned that after about 4 to 5 hours the side effect, which is the diarrhea, tapers off. Caller had a question regarding if Pfizer has some information on the interval for a patient to get the Pfizer COVID-19 vaccine booster shot once the patient had completed the 5 day Paxlovid treatment, was scheduled to get the 2nd booster dose and then tested positive for Covid. Person giving the vaccine was saying how careful he had to be about how long the vaccine had to be in and out of the refrigerator or freezer and stuff. Medical Conditions: Only other thing different with reporter health was that in Jan2022, after getting all of these vaccines caller had a parathyroidectomy and during the previous year, after the 1st and 2nd doses of the vaccine, reporter had 2 knees replacements.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood culture positive, Blood test normal, Chills, Computerised tomogram abnormal, Diabetic ketoacidosis
Clinical narrative: First experienced intermittent discomfort/pain in the right lower back (now known to be related to kidney) weeks before second dose of vaccine.  Second dose of Pfizer Covid19 vaccine was administered 5/4/21. Within 7 hours I had fever and chills and assumed it was normal side effects. Symptoms continued for several days. 3 days after vaccine dose, felt my heart racing and shortness of breath, with increasing kidney pain. Went to urgent care on 5/10/21. They identified tachycardia and very high blood pressure compared to my normal BP. They said a blood clot was possible and directed me to go to the emergency room immediately. Went to the emergency room on 5/10/21. They diagnosed a renal infarct and diabetic keto acidosis without coma. They took blood cultures but I don?t believe the results were in immediately. They intended to transfer me to another hospital with the appropriate specialists and an expected opening in ICU. I was transferred by ambulance to alternate Hospital late on 5/10/21 or in the very early morning hours of 5/11/21. While hospitalized, blood cultures were positive for MRSA. Doctors indicated the infection must have come from a wound or skin opening, but I had no wounds or signs of infections in/on skin. Root cause could not be identified by Infectious Disease. Doctors were unable to determine if the renal infarct was caused by a blood clot or the infection. Clot was not present at the time the renal infarct was diagnosed by CT. Remained hospitalized until discharge on 5/18/21. After hospitalization, endocrinologist suggested that I have infection-induced diabetes because I responded very well to treatment and my A1C dropped to 5.6 at 6 months post-hospitalization. A1c was over 12 upon hospitalization. I drank plenty of fluids before and after the vaccine dose, but was unable to eat normally due to what I perceived to be standard vaccine flu-like side effects.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Eating disorder, Echocardiogram, Glycosylated haemoglobin increased, Hypertension
Clinical narrative: First experienced intermittent discomfort/pain in the right lower back (now known to be related to kidney) weeks before second dose of vaccine.  Second dose of Pfizer Covid19 vaccine was administered 5/4/21. Within 7 hours I had fever and chills and assumed it was normal side effects. Symptoms continued for several days. 3 days after vaccine dose, felt my heart racing and shortness of breath, with increasing kidney pain. Went to urgent care on 5/10/21. They identified tachycardia and very high blood pressure compared to my normal BP. They said a blood clot was possible and directed me to go to the emergency room immediately. Went to the emergency room on 5/10/21. They diagnosed a renal infarct and diabetic keto acidosis without coma. They took blood cultures but I don?t believe the results were in immediately. They intended to transfer me to another hospital with the appropriate specialists and an expected opening in ICU. I was transferred by ambulance to alternate Hospital late on 5/10/21 or in the very early morning hours of 5/11/21. While hospitalized, blood cultures were positive for MRSA. Doctors indicated the infection must have come from a wound or skin opening, but I had no wounds or signs of infections in/on skin. Root cause could not be identified by Infectious Disease. Doctors were unable to determine if the renal infarct was caused by a blood clot or the infection. Clot was not present at the time the renal infarct was diagnosed by CT. Remained hospitalized until discharge on 5/18/21. After hospitalization, endocrinologist suggested that I have infection-induced diabetes because I responded very well to treatment and my A1C dropped to 5.6 at 6 months post-hospitalization. A1c was over 12 upon hospitalization. I drank plenty of fluids before and after the vaccine dose, but was unable to eat normally due to what I perceived to be standard vaccine flu-like side effects.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Intensive care, Palpitations, Pyrexia, Renal infarct
Clinical narrative: First experienced intermittent discomfort/pain in the right lower back (now known to be related to kidney) weeks before second dose of vaccine.  Second dose of Pfizer Covid19 vaccine was administered 5/4/21. Within 7 hours I had fever and chills and assumed it was normal side effects. Symptoms continued for several days. 3 days after vaccine dose, felt my heart racing and shortness of breath, with increasing kidney pain. Went to urgent care on 5/10/21. They identified tachycardia and very high blood pressure compared to my normal BP. They said a blood clot was possible and directed me to go to the emergency room immediately. Went to the emergency room on 5/10/21. They diagnosed a renal infarct and diabetic keto acidosis without coma. They took blood cultures but I don?t believe the results were in immediately. They intended to transfer me to another hospital with the appropriate specialists and an expected opening in ICU. I was transferred by ambulance to alternate Hospital late on 5/10/21 or in the very early morning hours of 5/11/21. While hospitalized, blood cultures were positive for MRSA. Doctors indicated the infection must have come from a wound or skin opening, but I had no wounds or signs of infections in/on skin. Root cause could not be identified by Infectious Disease. Doctors were unable to determine if the renal infarct was caused by a blood clot or the infection. Clot was not present at the time the renal infarct was diagnosed by CT. Remained hospitalized until discharge on 5/18/21. After hospitalization, endocrinologist suggested that I have infection-induced diabetes because I responded very well to treatment and my A1C dropped to 5.6 at 6 months post-hospitalization. A1c was over 12 upon hospitalization. I drank plenty of fluids before and after the vaccine dose, but was unable to eat normally due to what I perceived to be standard vaccine flu-like side effects.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain, Sepsis, Staphylococcal infection, Staphylococcus test positive, Tachycardia
Clinical narrative: First experienced intermittent discomfort/pain in the right lower back (now known to be related to kidney) weeks before second dose of vaccine.  Second dose of Pfizer Covid19 vaccine was administered 5/4/21. Within 7 hours I had fever and chills and assumed it was normal side effects. Symptoms continued for several days. 3 days after vaccine dose, felt my heart racing and shortness of breath, with increasing kidney pain. Went to urgent care on 5/10/21. They identified tachycardia and very high blood pressure compared to my normal BP. They said a blood clot was possible and directed me to go to the emergency room immediately. Went to the emergency room on 5/10/21. They diagnosed a renal infarct and diabetic keto acidosis without coma. They took blood cultures but I don?t believe the results were in immediately. They intended to transfer me to another hospital with the appropriate specialists and an expected opening in ICU. I was transferred by ambulance to alternate Hospital late on 5/10/21 or in the very early morning hours of 5/11/21. While hospitalized, blood cultures were positive for MRSA. Doctors indicated the infection must have come from a wound or skin opening, but I had no wounds or signs of infections in/on skin. Root cause could not be identified by Infectious Disease. Doctors were unable to determine if the renal infarct was caused by a blood clot or the infection. Clot was not present at the time the renal infarct was diagnosed by CT. Remained hospitalized until discharge on 5/18/21. After hospitalization, endocrinologist suggested that I have infection-induced diabetes because I responded very well to treatment and my A1C dropped to 5.6 at 6 months post-hospitalization. A1c was over 12 upon hospitalization. I drank plenty of fluids before and after the vaccine dose, but was unable to eat normally due to what I perceived to be standard vaccine flu-like side effects.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Type 2 diabetes mellitus
Clinical narrative: First experienced intermittent discomfort/pain in the right lower back (now known to be related to kidney) weeks before second dose of vaccine.  Second dose of Pfizer Covid19 vaccine was administered 5/4/21. Within 7 hours I had fever and chills and assumed it was normal side effects. Symptoms continued for several days. 3 days after vaccine dose, felt my heart racing and shortness of breath, with increasing kidney pain. Went to urgent care on 5/10/21. They identified tachycardia and very high blood pressure compared to my normal BP. They said a blood clot was possible and directed me to go to the emergency room immediately. Went to the emergency room on 5/10/21. They diagnosed a renal infarct and diabetic keto acidosis without coma. They took blood cultures but I don?t believe the results were in immediately. They intended to transfer me to another hospital with the appropriate specialists and an expected opening in ICU. I was transferred by ambulance to alternate Hospital late on 5/10/21 or in the very early morning hours of 5/11/21. While hospitalized, blood cultures were positive for MRSA. Doctors indicated the infection must have come from a wound or skin opening, but I had no wounds or signs of infections in/on skin. Root cause could not be identified by Infectious Disease. Doctors were unable to determine if the renal infarct was caused by a blood clot or the infection. Clot was not present at the time the renal infarct was diagnosed by CT. Remained hospitalized until discharge on 5/18/21. After hospitalization, endocrinologist suggested that I have infection-induced diabetes because I responded very well to treatment and my A1C dropped to 5.6 at 6 months post-hospitalization. A1c was over 12 upon hospitalization. I drank plenty of fluids before and after the vaccine dose, but was unable to eat normally due to what I perceived to be standard vaccine flu-like side effects.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Blood test, Computerised tomogram abdomen, Diarrhoea
Clinical narrative: Pain in shoulder up my neck immediately. Upset stomach, increased diarrhea,  headache,  body aches,  vomiting, fatigue, heart palpitations  started immediately. Contacted doctors office and visited ER. Referred to cardiologist and revisit gastroenteritis. Multiple blood and bowel tests. Doctor refuses to believe its an adverse reaction. Taking Imodium, Ibuprofen changed diet.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Headache, Immediate post-injection reaction, Immunisation reaction
Clinical narrative: Pain in shoulder up my neck immediately. Upset stomach, increased diarrhea,  headache,  body aches,  vomiting, fatigue, heart palpitations  started immediately. Contacted doctors office and visited ER. Referred to cardiologist and revisit gastroenteritis. Multiple blood and bowel tests. Doctor refuses to believe its an adverse reaction. Taking Imodium, Ibuprofen changed diet.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Neck pain, Pain, Palpitations, Stool analysis
Clinical narrative: Pain in shoulder up my neck immediately. Upset stomach, increased diarrhea,  headache,  body aches,  vomiting, fatigue, heart palpitations  started immediately. Contacted doctors office and visited ER. Referred to cardiologist and revisit gastroenteritis. Multiple blood and bowel tests. Doctor refuses to believe its an adverse reaction. Taking Imodium, Ibuprofen changed diet.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, Vomiting, X-ray
Clinical narrative: Pain in shoulder up my neck immediately. Upset stomach, increased diarrhea,  headache,  body aches,  vomiting, fatigue, heart palpitations  started immediately. Contacted doctors office and visited ER. Referred to cardiologist and revisit gastroenteritis. Multiple blood and bowel tests. Doctor refuses to believe its an adverse reaction. Taking Imodium, Ibuprofen changed diet.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, Cerebral infarction, Red blood cell sedimentation rate increased, Thrombocytopenia
Clinical narrative: corona radiata stroke
Sex: M
Vaccine: 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) (Physician). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Apr2022, outcome "unknown", COVID-19 (medically significant) with onset Apr2022, outcome "recovered" (Apr2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Negative; (Apr2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: It was reported that after taking the entire 5 day regimen of Paxlovid patient became asymptomatic and negative to nasopharyngeal testing. At day 12 patient began having fever and cough. Retested positive to nasopharyngeal testing. Patient's entire family also got infected, because patient had stopped isolating at day 10. They became symptomatic on day 15. Adverse event start date and stop date reported as Apr2022. It was also reported that patient recovered from the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events covid 19 and drug ineffective and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events; Expired dose of GARDASIL 9 was administered to female patient.; This spontaneous report was received from an office manager and refers to a female patient of unknown age. There was no information regarding the patient's medical history, concurrent conditions or concomitant therapies provided.  On 20-APR-2022, the patient was vaccinated with an expired dose of HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, expiration date: 08-APR-2022 (exact dose, route of administration, anatomical location and lot # were not provided) for prophylaxis (expired product administered). No additional adverse events reported (no adverse event).
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional adverse event filled; The customer reported that after he administered the MMR II, he retracted the needle, and 2-3 drops of M-M-R II "went into the air"; This spontaneous report was received from a physician, who was also the patient's husband and refers to a 37-year-old non-pregnant female patient. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 21-APR-2022, the patient was vaccinated with a dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. The reporter stated that after the administration, he retracted the needle and 2-3 drops of the vaccine "went into the air" (incorrect dose administered). There was a treatment given for the event. The reporter was was very worried about the possible exposure of the live virus in the air, especially because they had an infant in the home and the possible lack of effect for the patient since her titers were "undetectable" (the reporter did not specify which titers he was referring to). The reporter was also unable to confirm if the patient had ever received measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) or any other unspecified vaccine in the past. There was no additional adverse event reported.  This is one of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA007608:
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE information provided; VAQTA LOT T036739 that expired on 4/22/2022 was administered to a 22 year-old female patient today; This spontaneous report was received from a nurse prescriber and refers to a 22-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 26-APR-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 1 ml, 50 units, lot # T036739 (route of administration was not provided) for prophylaxis, which expired on 22-APR-2022 (expired product administered). There was no temperature excursion. No additional adverse event information provided.  Lot number T036739 was assessed to be valid for V251 formulation vial.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse eventswere reported; Nurse is reporting that an expired ROTATEQ was given; This spontaneous report was received from a nurse, regarding a patient of unknown age and gender. Information regarding the patient's historical conditions, past drugs reactions or allergies, concurrent conditions or concomitant therapies was not provided.  On 26-APR-2022, the patient was vaccinated with one expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (Lot number reported as T034513, expiration date reported as 13-APR-2022) administered for prophylaxis (strength, exact dose, and route of administration were not provided) (expired product administered). No additional adverse events reported.
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event, Product quality issue, Wrong product administered
Clinical narrative: Patient who was previously scheduled to be administered VARIVAX, MMRII was inadvertently, concomitantly administered PROQUAD with the intended VARIVAX; Patient who was previously scheduled to be administered VARIVAX, MMRII was inadvertently, concomitantly administered PROQUAD with the intended VARIVAX; No additional AE reported; This spontaneous report was received from a nurse via a company representative referring to a child patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not provided.  The patient was previously scheduled to be administered varicella virus vaccine live (Oka/Merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). However, on an unknown date, an unspecified nurse inadvertently vaccinated the patient with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) with the intended varicella virus vaccine live (Oka/Merck) (VARIVAX) concomitantly for prophylaxis (strength, dose, route, lot number and expiration date were not reported) (wrong product administered, accidental overdose). The reporter was unable to confirm if the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) prior to or at the reporting time. The reporter was unable to further clarify these statements at the reporting time. No additional adverse event (AE) or product quality complaint (PQC) was reported.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Interchange of vaccine products, No adverse event, Product storage error, Wrong product administered
Clinical narrative: Temperature 14°F up to 46°F (-10°C up to 8°C) 40 F for 120 hours / Time frame 120 hours; No additional AE; patient administered PROQUAD instead of MMRII.; patient administered PROQUAD instead of MMRII.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 25-APR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot #W004694 has been verified to be a valid lot, expiration date 08-AUG-2023, (strength, dose, route of administration and anatomical location were not provided) administered for prophylaxis, instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered) (interchange of vaccine product). No additional adverse event were reported (no adverse event). For measles, mumps, rubella and varicella (oka-merck) virus vaccine live  (recombinant human albumin) (PROQUAD) temperature excursion was from 14 to 46 Fahrenheit (also reported as -10 centigrade up to 8 centigrade), in addition the temperature was measured as 40 F for 120 hours (product storage error).; Sender's Comments:  US-009507513-2204USA009535:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE info; Nurse calling for TE evaluation of refrigerated products mentions vaccines were administered to 4 patients. See AE cases 02157107, 02157111, and 02157116 for additional patients.  Names of vaccines involved (including lot/exp) MMR II; T033814; 10/5/2; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-APR-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA))(M-M-R II) (valid lot #T033814, expiration date: 05-OCT-2022) (strength, dose and route of administration were not provided) for prophylaxis. The vaccine underwent a temperature excursion at 58.5 Fahrenheit degrees (F) for 4 hours and 2 minutes. No previous temperature excursion occurred. There was no adverse event reported.  This is one of several reports received from the same reporter (captured in MARRS# 2205USA000274, MARRS# 2205USA000427 and MARRS# 2205USA000454).; Sender's Comments:  US-009507513-2205USA000274: US-009507513-2205USA000427: US-009507513-2205USA000454: US-009507513-2205USA000427:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines stored outside of recommended range were administered to patients; No additional AE details; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drugs reactions or allergies and concomitant medications was provided.  On an unknown date, the patient received a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, lot # U039258 for prophylaxis, expiration date 09-JUN-2023 (strength, dose, frequency, route of administration were not reported) for prophylaxis. Other suspect therapies included sterile diluent, solution for injection/infusion (strength, dose, frequency, route of administration, indication, lot # and expiration date were not reported). Administered dose of vaccine was exposed to a temperature excursion of 7.9 degrees Fahrenheit (reported as "6 F up to 14 F (7.9F)") for 4 hours 8 minutes. There were no previous excursions reported. No additional adverse event details (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA001043:02158519 US-009507513-2205USA001061:02158514 US-009507513-2205USA001205:02158509 US-009507513-2205USA001272:02158506 US-009507513-2205USA001202:02158490 US-009507513-2205USA001271:02158523
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Underdose
Clinical narrative: No other issues or concerns noted; only half the dose being given; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 03-MAY-2022, the patient was vaccinated with half of the dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) subcutaneous injection, lot #W004030 (lot number W004030 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)), expiration date: 02-AUG-2023 (anatomical location and route of administration were not provided) for prophylaxis (Underdose). The reported inquired if the patient needed to be readministered with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD). No other issues or concerns were noted (No adverse event).
Age: 0.17
Sex: U
Vaccine: HEPA, HIBV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE reported; Caller is a nurse calling to report a medication error for PEDVAXHIB. Caller reports that the patient was inadvertently administered a dose of PEDVAXHIB. Caller reports that the patient was scheduled to receive a dose of VARIVAX, M-M-R II, and HAVRIX; This spontaneous report was received from a nurse and refers to a 12-month-old patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On unknown dates in 2021, at the age of 2 and 4 months, the patient received the first and the second doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On 04-MAY-2022, at the age of 12 months, the patient was inadvertently vaccinated only with the third dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 ml, lot #U014992, expiration date: 29-OCT-2023, (strength, anatomical location, and route of administration were not provided) administered for prophylaxis instead of scheduled doses of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, (strength, dose description, lot #, expiry date, anatomical location, and route of administration were not provided), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, (strength, dose description, lot #, expiry date, anatomical location, and route of administration were not provided), and hepatitis A vaccine inact (HAVRIX) (strength, dose description, lot #, expiry date, anatomical location, and route of administration were not provided) (wrong product administered). No additional adverse events (AE) was reported (No adverse event).
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No adverse event
Clinical narrative: Patient received Hepatitis B Vaccine as a child but they did not have hepatitis B antibodies when tested around age 9-10.; Currectly currently 16-17 years of age and antibody test was again negative; This spontaneous report was received from a physician via a company representative, referring to a child patient of unknown exact age and gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.     On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant)(manufacturer unknown) for prophylaxis (dose, route of administration, lot number, and expiration date were not reported).        Physician stated that their patient received hepatitis b vaccine (recombinant)(manufacturer unknown) as a child but they did not have hepatitis B antibodies on an unknown date, when tested around age 9-10 (hepatitis b surface antibody negative). Then, on an unknown date, patient was given a second series of 3 hepatitis b vaccine (recombinant)(manufacturer unknown) immunizations and the patient did have hepatitis B antibodies when they were checked around 1 year after second series. However, on an unknown date, the patient was currently 16-17 years of age and antibody test was again negative (hepatitis b surface antibody negative). It was unknown if the patient received treatment for the events. No additional adverse events.  At the reporting time, the outcome of both occurrences of hepatitis b surface antibody negative was unknown. The causality assessment between hepatitis b vaccine (recombinant)(manufacturer unknown) and the event was not reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; expired dose of MMR II was administered; This spontaneous report was received from a registered nurse concerning a patient of unknown gender and age. The patient's medical history, concurrent condition, concomitant therapy and drug reactions or allergies were not provided.  On 06-MAY-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) 0.5ml (strength, route of administered not provided) lot # T013724, expiry date: 21-APR-2022 for prophylaxis (Expired product administered). No temperature excursion on the product. No additional adverse event reported (No adverse event).
Age: 35.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; dose of VAQTA with a labeled expiration of 3/28/2022 was administered to a patient on 5/6/2022; This spontaneous report has been received from  a vaccine administrator/coordinator, and refers to a 35 year old male patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.    On 06-MAY-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 1.0 mL, lot # T034003 with expiration date of 28-MAR-2022 (expired product administered) for prophylaxis (strength, route, frequency, and anatomical location were not provided). No temperature excursion involved. No additional information provided. No adverse event reported.