chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint stiffness, Lymph node pain, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Fever, severe fatigue, pain and swelling at injection site, joint pain and stiffness , muscle pain, abdominal pain, swollen and painful lymph nodes
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives, two weeks after second shot. Now using Zyrtec and sometimes hydrocortisone, which cures it for 2-3 days at a time
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Cardioversion, Coronary arterial stent insertion, Coronary artery occlusion, Intensive care
Clinical narrative: Pfizer COVID shot 1st dose on 8/23.  Acute MI and VF arrest on 8/24 - defibrillated x2.  Drug eluding stent x1 to left anterior descending artery that was 99% occluded.  Patient awake, alert, but forgetful.  Currently resting in Cardiac ICU at local Hospital.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment, Ventricular fibrillation
Clinical narrative: Pfizer COVID shot 1st dose on 8/23.  Acute MI and VF arrest on 8/24 - defibrillated x2.  Drug eluding stent x1 to left anterior descending artery that was 99% occluded.  Patient awake, alert, but forgetful.  Currently resting in Cardiac ICU at local Hospital.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore arm, fever (100.2 at 4am following day).
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Anger, Illness, Insomnia, Pyrexia
Clinical narrative: fever; had trouble sleeping; did not feel well; really grumpy; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), INSOMNIA (had trouble sleeping), ILLNESS (did not feel well) and ANGER (really grumpy) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from 20-Oct-2020 to 27-Oct-2020. Concurrent medical conditions included Diabetes and Hypertension.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced PYREXIA (fever), INSOMNIA (had trouble sleeping), ILLNESS (did not feel well) and ANGER (really grumpy). At the time of the report, PYREXIA (fever), INSOMNIA (had trouble sleeping), ILLNESS (did not feel well) and ANGER (really grumpy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included Tylenol. No concomitant medications were provided by reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Pain, Tachycardia
Clinical narrative: onset of severe dizziness with rapid heartbeat and pain; extreme dizziness/onset of severe dizziness; rapid heart beat/onset of severe dizziness with rapid heartbeat; headaches daily/daily headaches since receiving the vaccine.; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extreme dizziness/onset of severe dizziness), TACHYCARDIA (rapid heart beat/onset of severe dizziness with rapid heartbeat), HEADACHE (headaches daily/daily headaches since receiving the vaccine.), FATIGUE (fatigue) and PAIN (onset of severe dizziness with rapid heartbeat and pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergies to Doxycycline, Nubaine, Codeine, Shellfish, Eggs, Milk, Soy, Beans, Salmon.), Asthma (Has gotten worse, albuterol is too strong, less in control) since 05-May-2008 and Hypertension since 18-Apr-2014. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) from 18-Jul-2020 to an unknown date for Allergy, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, AMITRIPTYLINE for Depression and Anxiety, LISINOPRIL, SPIRONOLACTONE, DICLOFENAC and SALBUTAMOL SULFATE (PROAIR HFA) from 05-May-2008 to an unknown date for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced DIZZINESS (extreme dizziness/onset of severe dizziness), TACHYCARDIA (rapid heart beat/onset of severe dizziness with rapid heartbeat) and HEADACHE (headaches daily/daily headaches since receiving the vaccine.). On an unknown date, the patient experienced FATIGUE (fatigue). an unknown date, the patient experienced PAIN (onset of severe dizziness with rapid heartbeat and pain). The patient was treated with ALBUTEROL SULFATE for Asthma, at a dose of unknown and MEFENAMIC ACID (ADVIL [MEFENAMIC ACID]) for Headache, at an unspecified dose and frequency. On 02-Mar-2021, DIZZINESS (extreme dizziness/onset of severe dizziness) and TACHYCARDIA (rapid heart beat/onset of severe dizziness with rapid heartbeat) had resolved. At the time of the report, HEADACHE (headaches daily/daily headaches since receiving the vaccine.) and FATIGUE (fatigue) had resolved with sequelae and PAIN (onset of severe dizziness with rapid heartbeat and pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 15-Aug-2021: Follow up received. Updated Reporter details, Updated Patient's demographics and other relevant histories, Updated Suspect Product 1st dose start date, Updated and added Concomitant medications and treatment medications, Updated Vaccine facility information, Added Adverse events (Fatigue and Pain), Updated Adverse Events start and stop date, duration, outcome.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: little itchy; rash on neck, bend of arms, across middle of back, hip area; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (little itchy) and RASH (rash on neck, bend of arms, across middle of back, hip area) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, CHLORTHALIDONE, DILTIAZEM, SERTRALINE, LOSARTAN and CLONAZEPAM for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (little itchy) and RASH (rash on neck, bend of arms, across middle of back, hip area). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (little itchy) and RASH (rash on neck, bend of arms, across middle of back, hip area) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Bruise; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruise) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Prinzmetal angina since 2004. Concomitant products included EZETIMIBE (ZETIA), PRAVASTATIN, ACETYLSALICYLIC ACID (ASPIRINE), METOPROLOL, OMEPRAZOLE, LOSARTAN and TRAZODONE for an unknown indication.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced CONTUSION (Bruise). At the time of the report, CONTUSION (Bruise) had resolved.            No treatment medications were provided.  The patient felt a knot which was like a pencil eraser under her skin. It was obviously a knot in a vein. A bruise began to spread.  A month later patient got second vaccine, but didn't go to the doctor for that one.   This case was linked to MOD-2021-021685 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Patient suffered Celulitis with the second dose; This is a spontaneous report from a contactable pharmacist. A 61-year-old female patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 04Aug2021 at 13:30 (Batch/Lot Number: FA7484) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been been tested for COVID-19. The patient suffered celulitis with the second dose on 04Aug2021 at 13:30. Therapeutic measures were taken as a result of patient suffered celulitis with the second dose. Outcome of the event was recovered. The patient received first dose of BNT162B2 on an unspecified date.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event "Cellulitis" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: my left shoulder and arm started hurting; My left shoulder and arm started hurting; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: ER8734), at the age of 40 years old, in left arm on 10Apr2021 at 11:00 at single dose for COVID-19 immunisation. The patient was not pregnant at time of vaccination. The patient had no known allergies. Medical history included asthma and high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccine in four weeks of vaccination. Concomitant medications included amlodipine (strength: 5 mg) at 5 mg; montelukast sodium (MONTELUCAST, strength: 10 mg) at 10 mg. The patient previously received the first dose of BNT162B2 (lot number: EP6915), at the age of 40 years old, in left arm on 20Mar2021 at 11:00 at single dose for COVID-19 immunisation. The patient experienced left shoulder and arm started hurting on 17May2021. It was not a constant pain. The pain start worst on 06Jun2021. The pain was constant. The events resulted in doctor or other healthcare professional office/clinic visit. The patient had been tested for COVID-19 post vaccination. The patient underwent lab tests and procedures which included COVID PCR test: negative (Nasal swab) on 29Apr2021, COVID PCR test: negative (Nasal swab) on 06May2021. Therapeutic measures were taken as a result of left shoulder and arm started hurting and included treatment with prednisone 20mg twice a day for five days. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Skin disorder, Urticaria
Clinical narrative: body is full of bumps; eyes get swelled up; hives; This is a spontaneous report from a contactable consumer (patient). A 53-years-old male patient received bnt162b2 (Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in arm left on 16Apr2021 16:00 (at the age of 53-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. Since the day he received first dose of Pfizer's vaccine, his body was full of bumps and eyes get swelled up, before this he did not have any type of allergy, now wake up every day full of hives on 16Apr2021. The event required to emergency room visit. Treatment was not received for events. The outcome of events was unknown.  The batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Dizziness; Bone hurt; Nausea; Fever; Tiredness that wont go away; Nagging Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), BONE PAIN (Bone hurt), NAUSEA (Nausea), PYREXIA (Fever) and FATIGUE (Tiredness that wont go away) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy (medicines: Penicillin), Sulfonamide allergy (medicines: sulfadrug), Food allergy (Food: Horse radish), Fruit allergy (Food: apricots), Vertigo (Not just a few second to maybe two minutes it continues on all day and night.), Atopic dermatitis since 2017 and Hypercholesterolemia since 2013. Concomitant products included ROSUVASTATIN, EZETIMIBE and LORATADINE for an unknown indication.    On 06-Aug-2021 at 2:55 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced HEADACHE (Nagging Headache). On 07-Aug-2021, the patient experienced DIZZINESS (Dizziness), BONE PAIN (Bone hurt), NAUSEA (Nausea), PYREXIA (Fever) and FATIGUE (Tiredness that wont go away). At the time of the report, DIZZINESS (Dizziness), BONE PAIN (Bone hurt), NAUSEA (Nausea), PYREXIA (Fever), FATIGUE (Tiredness that wont go away) and HEADACHE (Nagging Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Patient medical relevant history added, concomitant drugs added,event was added.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Dizziness; Bone hurt; Nausea; Fever; Tiredness that wont go away; Nagging Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), BONE PAIN (Bone hurt), NAUSEA (Nausea), PYREXIA (Fever) and FATIGUE (Tiredness that wont go away) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy (medicines: Penicillin), Sulfonamide allergy (medicines: sulfadrug), Food allergy (Food: Horse radish), Fruit allergy (Food: apricots), Vertigo (Not just a few second to maybe two minutes it continues on all day and night.), Atopic dermatitis since 2017 and Hypercholesterolemia since 2013. Concomitant products included ROSUVASTATIN, EZETIMIBE and LORATADINE for an unknown indication.    On 06-Aug-2021 at 2:55 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced HEADACHE (Nagging Headache). On 07-Aug-2021, the patient experienced DIZZINESS (Dizziness), BONE PAIN (Bone hurt), NAUSEA (Nausea), PYREXIA (Fever) and FATIGUE (Tiredness that wont go away). At the time of the report, DIZZINESS (Dizziness), BONE PAIN (Bone hurt), NAUSEA (Nausea), PYREXIA (Fever), FATIGUE (Tiredness that wont go away) and HEADACHE (Nagging Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Patient medical relevant history added, concomitant drugs added,event was added.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cardiac stress test, Chest pain, Echocardiogram, Electrocardiogram
Clinical narrative: Chest and arm pain Abnormal heart rate Hypertensive Crisis/High Blood Pressure
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate abnormal, Hypertension, Hypertensive crisis, Pain in extremity, Urine analysis
Clinical narrative: Chest and arm pain Abnormal heart rate Hypertensive Crisis/High Blood Pressure
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Computerised tomogram abdomen, Computerised tomogram pelvis, Sciatica, Urine analysis
Clinical narrative: left sided low back pain with sciatica; pain resolves and recurs spontaneously.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypomenorrhoea, Intermenstrual bleeding
Clinical narrative: I usually have extremely heavy periods that typically last 5-6 days. Heavy from day 1 through to 3 and less so for days 4-6.   Since I had my first dose of the vaccine I was a little shocked to see I only had spotting has a period.   The second month I noticed similar with a very light period only lasting a day or so. A dramatic change to what I have been used to my entire life.   Of course I'm not complaining, I'm much happier with lighter periods and less opportunity for embarrassment. But simply wish to report.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Skin burning sensation
Clinical narrative: Pin-like pains all over body Burning under skin all over body Small pains all over body
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Lymphadenopathy
Clinical narrative: Headache, pain at injection site same/next day after injection  Muscle pain, joint pain, swollen lymph nodes, fatigue one week after injection
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE/ PQC reported at this time; HCP called in to report a temperature excursion; This spontaneous report was received from a medical assistant referring to a 12 months old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 26-JUL-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # T030944, expiration date 09-MAR-2022 (dose number, dose and route of administration were not reported) for prophylaxis.  The vaccine was stored improperly in the temperature between 14 degrees Fahrenheit (F) and 46 degrees Fahrenheit (26.6 F) for the time frame of 3 hours and 20 minutes. There was no previous temperature excursion. Digital Data Logger was not involved. No adverse event was reported.; Sender's Comments:  US-009507513-2107USA008190: US-009507513-2107USA008378:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; VARlVAX expired on 22 JUL 2021 and was administered on 27 JUL 2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.   On 27-JUL-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S022757, expiration date 22-JUL-2021, (exact dose and route of administration were not provided) for prophylaxis. No additional adverse event was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA008314:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Customer calls and reports a temperature excursion. She reports that some of the vaccines were administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 27-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), lot # T023918, expiration date 09-JAN-2022 for prophylaxis (dose, anatomical location and route of administration were not reported).  Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 8.3 degrees of Fahrenheit for 9 minutes. There was no previous temperature excursion reported.  No additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000657: US-009507513-2108USA000658:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Customer calls and reports a temperature excursion. She reports that some of the vaccines were administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 27-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), lot # T019423, expiration date 02-DEC-2021 for prophylaxis (dose, anatomical location and route of administration were not reported).  Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 8.3 degrees of Fahrenheit for 9 minutes. There was no previous temperature excursion reported.  No additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000620: US-009507513-2108USA000658:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Customer calls and reports a temperature excursion. She reports that some of the vaccines were administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 29-JUL-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T021826, expiration date 25-JUN-2022 for prophylaxis (dose, anatomical location and route of administration were not reported).       Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 8.3 degrees of Fahrenheit for 9 minutes. There was no previous temperature excursion reported.  No additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000657: US-009507513-2108USA000620:
Sex: M
Vaccine: MMR, MMRV
Symptoms: Inappropriate schedule of product administration, Ocular hyperaemia, Periorbital swelling
Clinical narrative: received PROQUAD and MMR II at the same time on 7/30/2021 and developed red puffy eyes on 8/3/2021; received PROQUAD and MMR II at the same time on 7/30/2021 and developed red puffy eyes on 8/3/2021; received PROQUAD and MMR II at the same time on 7/30/2021; This spontaneous report has been received from a researcher referring to her friend's son, a 1-year-old male patient.  The patient's pertinent medical history, concomitant therapies, previous drug reactions, or allergies were not reported.     On 30-JUL-2021, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) as prophylaxis (doses, routes of administration, vaccination scheme frequencies, anatomical locations, lot numbers and expiration dates were not reported) (inappropriate schedule of product administration).  On 03-AUG-2021, the patient developed red puffy eyes (periorbital swelling and ocular hyperaemia) that recovered on the same day. It was unknown if the patient sought medical attention, received treatment, or if any lab diagnostics or studies were performed.  The causality assessment between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) and the mentioned events was not reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: no adverse event; two vaccines were administered to a 5 month old in error.; This spontaneous report was received from a licensed nurse practitioner and refers to a 5-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 12-AUG-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA 1 dose lot # S037497, expiration date 20-NOV-2021 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. On the same day, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot# S031496, expiration date 07-OCT-2021 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. The reporter stated that the vaccines were administered to the patient in error. The reporter did not report if error occurred due to labeling or actual products involved. No adverse event was reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported by any of the patients; a temperature excursion that occurred on 8/11/2021 / VARlVAX lot: T037643 has been administered to (3) patients; This spontaneous report was received from a nurse and refers to a 12-month-old patient. No information regarding the patient's medical history, drug allergies/reactions or concomitant therapies was provided.  On 11-AUG-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), dose reported as 1 (unit not provided), lot # T037643, expiration date 06-NOV-2022 (route of administration was not provided) for prophylaxis. No adverse symptoms were reported. Administered dose of vaccine experienced the temperature excursion of 8 Fahrenheit degrees for 2 hours and 15 minutes. There were no previous excursions reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA003810: US-009507513-2108USA003979:
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: other zoster related injuries; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 01-MAY-2010, the pt was administered zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions, by a physician. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by the physician and other healthcare providers for shingles and other zoster related injuries. At the time of the report, the outcome of the events of shingles and other zoster-related injuries was unknown. The reporter considered both events to be related to zoster vaccine live (ZOSTAVAX).
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster related injuries; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 24-MAY-2017, the pt was administered zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions, by a healthcare provider. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician and other healthcare providers for shingles and other zoster related injuries. At the time of the report, the outcome of the events of shingles and other zoster-related injuries was unknown. The reporter considered both events to be related to zoster vaccine live (ZOSTAVAX).
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse experience; Improperly stored vaccine administered; This spontaneous report as received from a nurse refers to a 4-year-old male patient. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 16-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot number: U009261, expiration date: 19-SEP-2022; dose and route of administration not provided). The vaccine was stored in temperature 38 degrees Fahrenheit for 67 hours 30 minutes and 0 seconds. There was no previous temperature excursion.  No adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster related injuries; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about unknown date (reported as 40953), the pt was administered zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions, by a healthcare provider. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician, nurse practitioner and other healthcare providers for shingles and other zoster related injuries. At the time of the report, the outcome of the events of shingles and other zoster-related injuries was unknown. The reporter considered both events to be related to zoster vaccine live (ZOSTAVAX).
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE PQC reported; temperature excursion PROQUAD were administered to 5 patients; This spontaneous report has been received from a physician assistant concerning to a 4-years-old child patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 11-AUG-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (route of administration, dose number and dose were not provided) (lot#: T034613, expiration date: 10-APR-2022) (product storage error) as prophylaxis. The total temperature excursion was above -15 degree Celsius (-5 degree Celsius) for a total time frame of 15 minutes. There were no previous temperature excursions. No additional adverse events were reported.  This case is one of six cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA004895: US-009507513-2108USA004894: US-009507513-2108USA004893: US-009507513-2108USA004896: US-009507513-2108USA004892:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE PQC reported; temperature excursion PROQUAD were administered to 5 patients; This spontaneous report has been received from a physician assistant concerning to a 4-years-old child patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 11-AUG-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (route of administration, dose number and dose were not provided) (lot#: T034613, expiration date: 10-APR-2022) (product storage error) as prophylaxis. The total temperature excursion was above -15 degree Celsius (-5 degree Celsius) for a total time frame of 15 minutes. There were no previous temperature excursions. No additional adverse events were reported.  This case is one of six cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA004895: US-009507513-2108USA004894: US-009507513-2108USA004878: US-009507513-2108USA004896: US-009507513-2108USA004892:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE PQC reported; temperature excursion PROQUAD were administered to 5 patients; This spontaneous report has been received from a physician assistant concerning to a 4-years-old child patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 11-AUG-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD (route of administration, dose number and dose were not provided) (lot#: T034613, expiration date: 10-APR-2022) (product storage error) as prophylaxis. The total temperature excursion was above -15 degree Celsius (-5 degree Celsius) for a total time frame of 15 minutes. There were no previous temperature excursions. No additional adverse events were reported.  This case is one of six cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA004895: US-009507513-2108USA004894: US-009507513-2108USA004893: US-009507513-2108USA004878: US-009507513-2108USA004892:
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Deafness, Herpes zoster, Ill-defined disorder
Clinical narrative: hearing loss; shingles; other zoster related injuries; Information has been received from a lawyer referring to a currently 66 years old patient of unknown gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. In or about November 2016 (at 61 years old), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) by a healthcare provider at a pharmacyfor the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by healthcare providers and a doctor at healthcare facilities for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: shingles, hearing loss and other zoster related injuries(Ill-defined disorder). The outcome of these events was unknown.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Herpes zoster, Ill-defined disorder
Clinical narrative: congestive heart failure; other zoster related injuries; shingles; Information has been received from a lawyer and an elderly patient of unknown gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 01-MAY-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions in a pharmacy. Subsequent to the inoculation (date not reported), the patient was treated by a physician at a healthcare facility for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: congestive heart failure, shingles, and other zoster related injuries. The outcome of the events were unknown. The causality assessment was considered as related by the lawyer.  Upon internal review, congestive heart failure was determined to be medically significant.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Bell's palsy, Ill-defined disorder
Clinical narrative: Bell's Palsy; other zoster related injuries; other zoster related injuries; Information has been received from a lawyer regarding a case in litigation referring to an elderly patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. In or about April 2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) by a healthcare provider at a clinic for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: Bell's Palsy and other zoster related injuries. The outcome of the events was unknown.   Upon internal review, Bell's Palsy was determined to be medically significant.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: ther zoster related injuries; Herpes Zoster; Information has been received from a lawyer regarding a case in litigation referring to an elderly patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 01-APR-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) by a physician at a clinic for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by the physician and other healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster and other zoster related injuries. The outcome of the events was unknown.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Blindness
Clinical narrative: vision loss; other zoster related injuries; Information has been received regarding a case in litigation from a lawyer and refers to a currently 71-years-old patient of unknown gender.  No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 01-JAN-2015, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (dose, route, lot # and expiration date was not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequent (unspecified date), the patient was treated by a physician and other healthcare providers at a healthcare facility for the following injuries resulting from Plaintiff's zoster vaccine live (ZOSTAVAX) use: vision loss and other zoster related injuries. At the reporting time, the outcome of the events was unknown. Both events were related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event vision loss was considered to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Blood pressure decreased, Dysphonia, Hypersensitivity, Pallor, Pruritus
Clinical narrative: she experienced allergic reactions after receiving PNEUMOVAX:She developed hives, itching, drop in blood pressure and her voice was hoarse; This spontaneous report as received from a 66-year-old female patient concerning herself with allergic reaction to penicillin, gabapentin and other unspecified medications. Patient's historical conditions include allergic reactions.  Concomitant therapies included metoprolol, potassium, torasemide, acetylsalicylic acid (BABY ASPIRIN), vitamins nos and omeprazole. On 09-AUG-2021, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  On the same date, the patient developed hives, itching, drop in blood pressure and her voice was hoarse (Allergy to vaccine). When the blood pressure was measured, it was 90/50 (units not provided) and her face was pale like a "ghost". She had to get epinephrine (EPI-PEN) injection and take diphenhydramine (BENADRYL) to treat her allergic reaction. Her blood pressure was low for few more days but now she felt better. The patient sought medical attention by speaking with the physician.The outcome of allergy to vaccine  was reported as recovering.     The reporter considered allergy to vaccine to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).    The event of allergy to vaccine  was considered to be life threatening by the reporter.
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: she experienced allergic reactions after receiving PNEUMOVAX:She developed hives, itching, drop in blood pressure and her voice was hoarse; This spontaneous report as received from a 66-year-old female patient concerning herself with allergic reaction to penicillin, gabapentin and other unspecified medications. Patient's historical conditions include allergic reactions.  Concomitant therapies included metoprolol, potassium, torasemide, acetylsalicylic acid (BABY ASPIRIN), vitamins nos and omeprazole. On 09-AUG-2021, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  On the same date, the patient developed hives, itching, drop in blood pressure and her voice was hoarse (Allergy to vaccine). When the blood pressure was measured, it was 90/50 (units not provided) and her face was pale like a "ghost". She had to get epinephrine (EPI-PEN) injection and take diphenhydramine (BENADRYL) to treat her allergic reaction. Her blood pressure was low for few more days but now she felt better. The patient sought medical attention by speaking with the physician.The outcome of allergy to vaccine  was reported as recovering.     The reporter considered allergy to vaccine to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).    The event of allergy to vaccine  was considered to be life threatening by the reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; PROQUAD that underwent a temperature excursion was administered; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender, identified as NS.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 17-AUG-2021, the patient was vaccinated with an incorrect measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) storage, lot # T010288 with expiration date on 20-SEP-2021, for prophylaxis (dose and route of administration were not provided). The vaccine underwent a temperature excursion of 14°F to 46°F (15.2F) for 4 hours 40 minutes and 0 seconds. There was not previous temperature excursion. No additional adverse effect reported.; Sender's Comments:  US-009507513-2108USA006345:
Sex: U
Vaccine: SMALL
Symptoms: Rash
Clinical narrative: Rash; On 10AUG2021 a spontaneous report was received from the immunoglobulin program:  On 07AUG2021 an adult male of (age unknown) received a booster dose of ACAM2000 (smallpox vaccine, live) as part of the immunoglobulin program.  He reported that he had experienced two unspecified reactions since the administration of smallpox vaccine. He reported that the event had placed him "in the hospital last night".  His face and head were noted to not be affected by the rash. It was noted that the male had since been discharged and a diagnosis was unknown.  The donor reported he has had two reactions since administration. No further medical history or concomitant medications are known.  Company comment:  The picture shows generalized rash consistent with an allergic reaction. The information received Is limited and there is no indication that the patient was admitted to the hospital or what the second event was. The rash doesn't seem to be enough reason for admission to the hospital, therefore, the company considers that the rash was an allergic reaction, not serious and possible related to ACAM2000. More information will be sought.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; got shingles again; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles shot, the patient got shingles. After that, the patient got new shot of two. The patient stated that, hope he/she would not get them again. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; have shingles now. Got my vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the shingle vaccine and still got shingles. The patient wished that he/ she had of got vaccine sooner. The patient advised all to get the vaccine and stated that shingles was no joke. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.