chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nerve injury, Peripheral swelling, Scar, Skin cancer, Surgery
Clinical narrative: Hard bump the size of an eraser came up right below my right shoulder. Red spots were partly around the bump. Biopsy revealed melanoma and red spots were pre-melanoma. Since diagnosed, I have had three surgeries in the same spot. Oct 2021 1st surgery, received COVID booster in Nov. 2021, melanoma came back in March 2022. May 10 surgery. June 14 surgery margins clear. I am receiving Immunotherapy every 3 weeks for one yr. Prior to Oct. 2021, I have never had a melanoma. My dermatologist thought the spot was a bug bite but being cautious, she biopsied it. When the pathology report came back "melanoma", my dermatologist said in all her 50 years of practice, she has never seen a melanoma look like mine. Highly unusual. I was referred to a melanoma specialist/surgeon. According to my pathology report, Dr said my melanoma was very unusual an very aggressive! This cancer came up on my back only about 3-4 weeks after my first covid shot. I had surgery in Oct. 2021 and margins were clear. I had a covid booster shot in Nov. of 2021 and Dec. dermatologist check up was good. When I went back in March, 2022, for my 3 mo. check up, the cancer was back "in the scar" of where my surgery was on my back. My health was perfect before I took the covid vaccination. I will never take another one. I now suffer from back pain caused by nerve damage from my first surgery.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: -left arm swelling, painful, joints hard to move, tingling fingers. -ibuprofen for pain, monitor at home, recheck prn
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pallor, Vomiting
Clinical narrative: After both vaccines given patient appeared pale and was vomiting when I entered room. Vomiting resolved after approximately 5-10 min. Vital signs normal. Patient was able to tolerate sprite and crackers. Monitored for 30 min and discharged home with mom.
Age: 11.0
Sex: F
Vaccine: COVID19, HPV4, MNQ, TDAP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 12 year old dose was given to a 11 year old child, No adverse effects noted.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Nervousness, Syncope
Clinical narrative: As per mother daughter with history of fainting at Dr. offices and dentist. Pt. nervous. Pt fainted and I and mother broke fall. Pt fainted less than a minute. As per pt ok and felt fine. Did not have breakfast.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Joint swelling, Pain
Clinical narrative: Received the second booster of the COVID-19 vaccine. This was my fourth shot, all of which were manufactured by Pfizer. Approximately twelve hours after receiving the injection, I began to experience debilitating body aches and a severe headache. My joints have begun to swell and it's extremely painful to walk. I have not had any side effects to this extend with any of the previous vaccinations I received for COVID.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: Several minor adverse reactions to first dose of Shingrix vaccine: Persistent redness and soreness at injection site lasting five days. Persistent muscle a joint soreness for several. Minor fever (99.6 deg.) lasting two days. Headache for one day.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Several minor adverse reactions to first dose of Shingrix vaccine: Persistent redness and soreness at injection site lasting five days. Persistent muscle a joint soreness for several. Minor fever (99.6 deg.) lasting two days. Headache for one day.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Anaphylactic shock, Blood test, Electrocardiogram
Clinical narrative: Multiple episodes of Anaphylaxis. One month after Moderna dose -Anaphylaxis. Exactly 6 months later - Anaphylaxis episode. Received booster January 2022 - Moderna Exactly one month later Anaphylaxis episode Exactly 6 months later - Anaphylaxis episode  Each time taken via ambulance in full Anaphylaxis shock. In 24 years before receiving any Moderna dosage never had an alergic reaction to any medicine, food, or other allergies
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Movement disorder, Neck pain, Pain, Pain in extremity, Skin mass
Clinical narrative: growth inside my mouth on the left side; neck and fingers hurt; arm hurts constantly,arm hurt,in the muscle,arm hurt after third dose; It's in the muscle, between the shoulder blade and elbow,hurts like a son of a gun; neck and fingers hurt; This spontaneous case was reported by a patient and describes the occurrence of ORAL DISORDER (growth inside my mouth on the left side), NECK PAIN (neck and fingers hurt), PAIN IN EXTREMITY (arm hurts constantly,arm hurt,in the muscle,arm hurt after third dose), MYALGIA (It's in the muscle, between the shoulder blade and elbow,hurts like a son of a gun) and PAIN IN EXTREMITY (neck and fingers hurt) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L21B, 037T521A and 027C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codin), Penicillin allergy, Contrast media allergy, COPD (Start date: 8 years ago), Blood pressure and High cholesterol.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ORAL DISORDER (growth inside my mouth on the left side), NECK PAIN (neck and fingers hurt), PAIN IN EXTREMITY (arm hurts constantly,arm hurt,in the muscle,arm hurt after third dose), MYALGIA (It's in the muscle, between the shoulder blade and elbow,hurts like a son of a gun) and PAIN IN EXTREMITY (neck and fingers hurt). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ORAL DISORDER (growth inside my mouth on the left side), NECK PAIN (neck and fingers hurt) and PAIN IN EXTREMITY (neck and fingers hurt) outcome was unknown and PAIN IN EXTREMITY (arm hurts constantly,arm hurt,in the muscle,arm hurt after third dose) and MYALGIA (It's in the muscle, between the shoulder blade and elbow,hurts like a son of a gun) had not resolved.            Concomitant medications include COPD medicine, blood pressure medicine, high cholesterol medicine. Patient mentioned that this is all happening on the left side. It has been hurting for close to two years. Patient was treated with Steroids for the growth inside the mouth on the left side. The patient's arm hurt became worst after third dose. The patient was not sure about the fourth shot.   This case was linked to MOD-2022-615975, MOD-2022-607760 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Wound
Clinical narrative: growth inside my mouth on the left side; neck and fingers hurt; arm hurts constantly,arm hurt,in the muscle,arm hurt after third dose; It's in the muscle, between the shoulder blade and elbow,hurts like a son of a gun; neck and fingers hurt; This spontaneous case was reported by a patient and describes the occurrence of ORAL DISORDER (growth inside my mouth on the left side), NECK PAIN (neck and fingers hurt), PAIN IN EXTREMITY (arm hurts constantly,arm hurt,in the muscle,arm hurt after third dose), MYALGIA (It's in the muscle, between the shoulder blade and elbow,hurts like a son of a gun) and PAIN IN EXTREMITY (neck and fingers hurt) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L21B, 037T521A and 027C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codin), Penicillin allergy, Contrast media allergy, COPD (Start date: 8 years ago), Blood pressure and High cholesterol.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ORAL DISORDER (growth inside my mouth on the left side), NECK PAIN (neck and fingers hurt), PAIN IN EXTREMITY (arm hurts constantly,arm hurt,in the muscle,arm hurt after third dose), MYALGIA (It's in the muscle, between the shoulder blade and elbow,hurts like a son of a gun) and PAIN IN EXTREMITY (neck and fingers hurt). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ORAL DISORDER (growth inside my mouth on the left side), NECK PAIN (neck and fingers hurt) and PAIN IN EXTREMITY (neck and fingers hurt) outcome was unknown and PAIN IN EXTREMITY (arm hurts constantly,arm hurt,in the muscle,arm hurt after third dose) and MYALGIA (It's in the muscle, between the shoulder blade and elbow,hurts like a son of a gun) had not resolved.            Concomitant medications include COPD medicine, blood pressure medicine, high cholesterol medicine. Patient mentioned that this is all happening on the left side. It has been hurting for close to two years. Patient was treated with Steroids for the growth inside the mouth on the left side. The patient's arm hurt became worst after third dose. The patient was not sure about the fourth shot.   This case was linked to MOD-2022-615975, MOD-2022-607760 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Neck pain, Oral disorder, Pain in extremity
Clinical narrative: growth inside my mouth on the left side; neck and fingers hurt; arm hurts constantly,arm hurt,in the muscle,arm hurt after third dose; It's in the muscle, between the shoulder blade and elbow,hurts like a son of a gun; neck and fingers hurt; This spontaneous case was reported by a patient and describes the occurrence of ORAL DISORDER (growth inside my mouth on the left side), NECK PAIN (neck and fingers hurt), PAIN IN EXTREMITY (arm hurts constantly,arm hurt,in the muscle,arm hurt after third dose), MYALGIA (It's in the muscle, between the shoulder blade and elbow,hurts like a son of a gun) and PAIN IN EXTREMITY (neck and fingers hurt) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L21B, 037T521A and 027C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codin), Penicillin allergy, Contrast media allergy, COPD (Start date: 8 years ago), Blood pressure and High cholesterol.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ORAL DISORDER (growth inside my mouth on the left side), NECK PAIN (neck and fingers hurt), PAIN IN EXTREMITY (arm hurts constantly,arm hurt,in the muscle,arm hurt after third dose), MYALGIA (It's in the muscle, between the shoulder blade and elbow,hurts like a son of a gun) and PAIN IN EXTREMITY (neck and fingers hurt). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ORAL DISORDER (growth inside my mouth on the left side), NECK PAIN (neck and fingers hurt) and PAIN IN EXTREMITY (neck and fingers hurt) outcome was unknown and PAIN IN EXTREMITY (arm hurts constantly,arm hurt,in the muscle,arm hurt after third dose) and MYALGIA (It's in the muscle, between the shoulder blade and elbow,hurts like a son of a gun) had not resolved.            Concomitant medications include COPD medicine, blood pressure medicine, high cholesterol medicine. Patient mentioned that this is all happening on the left side. It has been hurting for close to two years. Patient was treated with Steroids for the growth inside the mouth on the left side. The patient's arm hurt became worst after third dose. The patient was not sure about the fourth shot.   This case was linked to MOD-2022-615975, MOD-2022-607760 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: growth inside my mouth on the left side; neck and fingers hurt; arm hurts constantly,arm hurt,in the muscle,arm hurt after third dose; It's in the muscle, between the shoulder blade and elbow,hurts like a son of a gun; neck and fingers hurt; This spontaneous case was reported by a patient and describes the occurrence of ORAL DISORDER (growth inside my mouth on the left side), NECK PAIN (neck and fingers hurt), PAIN IN EXTREMITY (arm hurts constantly,arm hurt,in the muscle,arm hurt after third dose), MYALGIA (It's in the muscle, between the shoulder blade and elbow,hurts like a son of a gun) and PAIN IN EXTREMITY (neck and fingers hurt) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L21B, 037T521A and 027C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codin), Penicillin allergy, Contrast media allergy, COPD (Start date: 8 years ago), Blood pressure and High cholesterol.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ORAL DISORDER (growth inside my mouth on the left side), NECK PAIN (neck and fingers hurt), PAIN IN EXTREMITY (arm hurts constantly,arm hurt,in the muscle,arm hurt after third dose), MYALGIA (It's in the muscle, between the shoulder blade and elbow,hurts like a son of a gun) and PAIN IN EXTREMITY (neck and fingers hurt). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ORAL DISORDER (growth inside my mouth on the left side), NECK PAIN (neck and fingers hurt) and PAIN IN EXTREMITY (neck and fingers hurt) outcome was unknown and PAIN IN EXTREMITY (arm hurts constantly,arm hurt,in the muscle,arm hurt after third dose) and MYALGIA (It's in the muscle, between the shoulder blade and elbow,hurts like a son of a gun) had not resolved.            Concomitant medications include COPD medicine, blood pressure medicine, high cholesterol medicine. Patient mentioned that this is all happening on the left side. It has been hurting for close to two years. Patient was treated with Steroids for the growth inside the mouth on the left side. The patient's arm hurt became worst after third dose. The patient was not sure about the fourth shot.   This case was linked to MOD-2022-615975, MOD-2022-607760 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: COVID vaccine breakthrough case
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: SUSPECTED COVID-19 INFECTION; EARS PLUGGED; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 68 year old female of unspecified race. The patient's height, and weight were not reported. The patient's concurrent conditions included: hashimotos, hypertension, aging, nickel allergy, and adhesives allergy, and other pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin were not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered 1 in total to the right arm on 09-MAR-2021 14:00 for covid-19 prophylaxis. Age at time of vaccination 66 years old.  The patient additionally received non-company suspect vaccine included: tozinameran (Pfizer biontech covid-19 vaccine) (Dose number in series 2) (form of admin, route of admin, were not reported, batch number: FD0809 expiry: UNKNOWN,) dose was not reported, administered to the right arm on 11-NOV-2021 13:00 for covid-19 prophylaxis.   The patient additionally received non-company suspect vaccine included: tozinameran (Pfizer biontech covid-19 vaccine) (Dose number in series 3) (form of admin, route of admin were not reported, batch number: FK9895 expiry: UNKNOWN,) dose was not reported, administered to the left arm on 15-APR-2022 15:00 for covid-19 prophylaxis. Concomitant medications included carvedilol, levothyroxine, rivaroxaban, and rosuvastatin calcium. The patient received non-company co-suspect drug Paxlovid (form of administration, route of administration, batch number, and expiry were not reported) dose was not reported, administered from 19-JUN-2022 to 23-JUN-2022 for treatment of COVID-19. On 24-JUL-2022, 17:00 the patient experienced nasal congestion, unproductive cough, some shortness of breath (was coded as suspected covid-19 infection) and ears plugged (Dose number in series 3). Treatment medications (dates unspecified) included: guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran (Pfizer biontech covid-19 vaccine), tozinameran (Pfizer biontech covid-19 vaccine) was not applicable and with Paxlovid was drug discontinued. The patient was recovering from suspected covid-19 infection, and ears plugged. This report was non-serious.          .
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ear discomfort, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; EARS PLUGGED; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 68 year old female of unspecified race. The patient's height, and weight were not reported. The patient's concurrent conditions included: hashimotos, hypertension, aging, nickel allergy, and adhesives allergy, and other pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin were not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered 1 in total to the right arm on 09-MAR-2021 14:00 for covid-19 prophylaxis. Age at time of vaccination 66 years old.  The patient additionally received non-company suspect vaccine included: tozinameran (Pfizer biontech covid-19 vaccine) (Dose number in series 2) (form of admin, route of admin, were not reported, batch number: FD0809 expiry: UNKNOWN,) dose was not reported, administered to the right arm on 11-NOV-2021 13:00 for covid-19 prophylaxis.   The patient additionally received non-company suspect vaccine included: tozinameran (Pfizer biontech covid-19 vaccine) (Dose number in series 3) (form of admin, route of admin were not reported, batch number: FK9895 expiry: UNKNOWN,) dose was not reported, administered to the left arm on 15-APR-2022 15:00 for covid-19 prophylaxis. Concomitant medications included carvedilol, levothyroxine, rivaroxaban, and rosuvastatin calcium. The patient received non-company co-suspect drug Paxlovid (form of administration, route of administration, batch number, and expiry were not reported) dose was not reported, administered from 19-JUN-2022 to 23-JUN-2022 for treatment of COVID-19. On 24-JUL-2022, 17:00 the patient experienced nasal congestion, unproductive cough, some shortness of breath (was coded as suspected covid-19 infection) and ears plugged (Dose number in series 3). Treatment medications (dates unspecified) included: guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran (Pfizer biontech covid-19 vaccine), tozinameran (Pfizer biontech covid-19 vaccine) was not applicable and with Paxlovid was drug discontinued. The patient was recovering from suspected covid-19 infection, and ears plugged. This report was non-serious.          .
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arteriospasm coronary, Cardiac stress test, Chest pain, Computerised tomogram thorax, Electrocardiogram abnormal
Clinical narrative: I developed chest pain within a week of vacation.  I thought it was acid reflux. Pain worsened. Went to er multiple times. Had elevated heart enzymes, abnormal ekg . Started having severe cardiac Vaso spasms admitted to hospital. Many test and many medications later we are sure my myocarditis was caused by vaccine booster
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging heart, Myocardial necrosis marker increased, Myocarditis
Clinical narrative: I developed chest pain within a week of vacation.  I thought it was acid reflux. Pain worsened. Went to er multiple times. Had elevated heart enzymes, abnormal ekg . Started having severe cardiac Vaso spasms admitted to hospital. Many test and many medications later we are sure my myocarditis was caused by vaccine booster
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Laboratory test normal, Menstruation irregular, Thrombosis
Clinical narrative: Continue to bleed in between periods as well as blood clots, irregular periods as well. Ever since received 2nd dose of Covid vaccine on 7/27/2021 I have been experiencing issues with my periods. Over a year now & doesn?t go back to normal prior to receiving vaccine. I have had all tests done with gynecologist and they can?t find anything that would be causing this to occur.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: Grand mal seizures started 3 weeks after vaccination.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2020 as dose 1, single (Lot number: EL1284), in left arm, on 20Jan2021 as dose 2, single (Lot number: EL9261) and on 22Dec2021 at 12:00 as dose 3 (booster), single (Lot number: FE3594) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Test negative for antigen at day 7; (08Jan2021) Positive, notes: Treatment of COVID-19; (29Jul2022) Positive, notes: test positive today 29Jul. Therapeutic measures were taken as a result of vaccination failure, covid-19 and was treated with Paxlovid from 15Jul2022 to 20Jul2022.  Clinical Information: Rebound 10 days after initial dose. Test negative for antigen at day 7; test positive on 29Jul. Symptoms runny nose.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: administration of vaccines during temperature excursion; This spontaneous report has been received from a nurse regarding a 1-year-old female patient. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies was provided.  On 14-JUL-2022, the patient was vaccinated with the first dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) subcutaneous injection 0.5 ml for prophylaxis (strength, vaccination scheme frequency, anatomical location, route, lot number and expiration date were not reported) during temperature excursion (product storage error). Temperature and period of time of the temperature excursion were not provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA005211: US-009507513-2207USA005319: US-009507513-2207USA005196:
Age: 11.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported.; an adult dose of VAQTA was administered to an 11 year old pediatric patient; This spontaneous report was received from a nurse practitioner (N.P.), concerning a 11-year-old patient of unknown gender. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not provided.  On 17-JUL-2022, an adult dose of hepatitis A vaccine, inactivated (VAQTA) 50U/1.0ml prefilled syringe intramuscular injection, lot number U022161, expiration date reported as 14-JAN-2022, was administered to the pediatric patient as directed to prevent hepatitis A infection (product administered to patient of inappropriate age). Lot number U022161, is an invalid lot number for hepatitis A vaccine, inactivated (VAQTA). Lot number U022161 does not match any Company product as confirmed by Lot Verification team, (strength, dose, route of administration, and anatomical location were not provided).   No additional adverse event was reported.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: a patient who is 23 years old received two doses of GARDASIL at 18 years old in 2015; No additional AEs; This spontaneous report was received from a medical assistant referring to a currently 23-year-old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies was not reported.   In 2015 (also reported as at 18 years old), the patient was vaccinated with the two doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (frequency, lot #, expiry date were unknown; does, strength, anatomical location, and route of administration were not provided) for prophylaxis (inappropriate schedule of product administration). No additional adverse event (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; MMRII with a labeled expiry of 5/29/2022 was administered; This spontaneous report was received from an office manager via employee, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies, and concomitant therapies were not reported.  On 13-JUN-2022, the patient was vaccinated with one dose (quality: 1) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: rHA) subcutaneous injection, 0.5 milliliter, lot #T018669, expiration date: 29-MAY-2022 (strength, route of administration and anatomical location were not provided) administered for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).  This is the one of six reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA006816: US-009507513-2207USA007188: US-009507513-2207USA007041: US-009507513-2207USA007043: US-009507513-2207USA007052:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: multiple outbreaks of herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender.  No information was provided regarding concomitant medications, concurrent conditions or medical history.   On an unknown date, the patient was inoculated with a dose of zoster vaccine live (ZOSTAVAX) vaccine (dose, anatomical location, lot number, expiration date  and administration route were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified, the patient experienced multiple outbreaks of herpes zoster. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct result of the vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also sustained severe and permanent personal injuries. The outcome of the event was not recovered, and the causality assessment was reported as related.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Caller is a nurse practitioner calling to report multiple temperature excursions for GARDASIL 9.; This spontaneous report was received from a nurse practitioner, referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-JUN-2022, the patient was vaccinated with an improper storage HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), 0.5 ml (valid lot #T036444, expiration date: 09-APR-2023) (strength, anatomical location and route of administration were not provided) for prophylaxis. No additional adverse events were reported.  This is one of several reports received from the same reporter (captured in the following cases: MARRS#2207USA007332, MARRS#2207USA007630, MARRS#2207USA007632, MARRS#2207USA007383, MARRS#2207USA007612, MARRS#2207USA007323 and MARRS#2207USA007382). ; Sender's Comments:  US-009507513-2207USA007332: US-009507513-2207USA007630: US-009507513-2207USA007632: US-009507513-2207USA007383: US-009507513-2207USA007612: US-009507513-2207USA007323: US-009507513-2207USA007382:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: multiple temperature excursions for PEDVAXHIB; No additional AE reported; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Their pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.  On 05-APR-2022, the patient received a dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) 0.5 milliliter (ml), administered as prophylaxis (dose regimen and route of administration was not reported). Lot# U014483 has been verified to be valid Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB), expiration date was provided and verified to be on 15-SEP-2023.  The nurse reported that there were multiple temperature excursions for Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB), and the vaccine had been administered to the patient (product storage error). A temperature excursion evaluation had not been performed at the time of the call.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Caller is a nurse practitioner calling to report multiple temperature excursions for GARDASIL 9.; This spontaneous report was received from a nurse practitioner, referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-MAY-2022, the patient was vaccinated with an improperly storage HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), 0.5 ml (valid lot #T036444, expiration date: 09-APR-2023) (strength, anatomical location and route of administration were not provided) for prophylaxis. No additional adverse events were reported.  This is one of several reports received from the same reporter (captured in the following cases: MARRS#2207USA007332, MARRS#2207USA007630, MARRS#2207USA007632, MARRS#2207USA007365, MARRS#2207USA007612, MARRS#2207USA007323 and MARRS#2207USA007382). ; Sender's Comments:  US-009507513-2207USA007365: US-009507513-2207USA007332: US-009507513-2207USA007630: US-009507513-2207USA007632: US-009507513-2207USA007612: US-009507513-2207USA007323: US-009507513-2207USA007382:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; vaccine was administered following multiple temperature excursions; This spontaneous report has been received from an office manager referring a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and previous drug allergies or reactions were not provided. Concomitant medication included sterile diluent (MERCK STERILE DILUENT).   On 08-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) at a dose of 0.5 ml once, lot number W006583, expiration date: 23-AUG-2023 (strength, route of administration, and anatomical location were not reported) as prophylaxis following a temperature excursion (product storage error). Excursions occurred before patient's administration included: on 11-MAY-2022 a temperature of 5.7 Fahrenheit degrees (F) for 7 minutes; on 27-MAY-2022 a temperature of 5.7 F for 5 minutes; on 06-JUN-2022 a temperature of 5.9 F for 6 minutes. There was no temperature excursions prior to 11-MAY-2022. The patient had no adverse effect or other symptoms as a result of the vaccine administration (no adverse event).  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2207USA007928:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: shingles since the vaccine/Suspected Vaccination Failure; internal shingles; extreme pain; This case was reported by a consumer via interactive digital media and described the occurrence of 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), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 26-Jul-2022 Reporter's comment: The case was received from the patient via nteractive digital media. The patient have had internal shingles since the vaccine and in extreme pain went to a cardiologist, wanted to put the patient on narcotics. The patient did not want that no one believes the patient, he/she need help where should he/she go and did not do that. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the Singles and had the shot/Suspected vaccination failure; I had the Singles; This case was reported by a consumer via interactive digital media and described the occurrence of 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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 26-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shot and had the shingles. The patient stated that thank you for the shot it would had been a lot worse. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I still have flareups 2 and 3 times a year/Suspected vaccination failure; I still have flareups 2 and 3 times a year; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had deal with shingles on and off since the patient was 30). Previously administered products included Shingles vaccine  (received original Shingles vaccine on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). 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 Shingrix and Shingrix.     Linked case(s) involving the same patient:  US2022AMR112219   Additional Information: GSK receipt date: 26-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had deal with shingles on and off since the patient was 30.  The patient was 70 years old. The patient have had the original shingle vaccine and the 2 part of Shingrix and still have had flare-ups 2 and 3 times a year. The patient takes 500 mg Valtrex every day. The case was linked with case US2022AMR112219, reported by same reporter for himself/herself. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As per reported narrative, the patient had received the original shingles vaccine but it was unknown whether it was of GSK or Non-GSK, in worst approach it was captured as historical product as shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Suspected vaccination failure/I got my shingles and I've had shingles for over 10 years now; I've had shingles for over 10 years now; Red swollen itchy painful mark on my arm; Red swollen itchy painful mark on my arm; Red swollen itchy painful mark on my arm; Red swollen itchy painful mark on my arm; This case was reported by a consumer via interactive digital media and described the occurrence of 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), shingles, swelling arm, pruritus, pain in arm and erythema. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the swelling arm, pruritus, pain in arm and erythema were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, swelling arm, pruritus, pain in arm and erythema to be related to Shingles vaccine.     Additional Information: GSK receipt date: 27-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got his/her shingles shot and got a huge red swollen itchy and painful mark on his/her arm that lasted a whole month. The patient have had shingles for over 10 years now that comes and goes and it was very debilitating. The patient was due again and was hesitant.  The patient stated that thank goodness have had his/her acyclovir.  Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: Suspected vaccination failure/I got my shingles and I've had shingles for over 10 years now; I've had shingles for over 10 years now; Red swollen itchy painful mark on my arm; Red swollen itchy painful mark on my arm; Red swollen itchy painful mark on my arm; Red swollen itchy painful mark on my arm; This case was reported by a consumer via interactive digital media and described the occurrence of 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), shingles, swelling arm, pruritus, pain in arm and erythema. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the swelling arm, pruritus, pain in arm and erythema were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, swelling arm, pruritus, pain in arm and erythema to be related to Shingles vaccine.     Additional Information: GSK receipt date: 27-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got his/her shingles shot and got a huge red swollen itchy and painful mark on his/her arm that lasted a whole month. The patient have had shingles for over 10 years now that comes and goes and it was very debilitating. The patient was due again and was hesitant.  The patient stated that thank goodness have had his/her acyclovir.  Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got two shots and still got them/Suspected Vaccination Failure; still got them a few times; so painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 27-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had got two shots and still got them a few times and was so painful. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingrix vaccine, broke out with shingles; broke out with shingles, still suffering; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID 19 VACCINE) for prophylaxis.   On an unknown date, the patient received Shingrix and COVID 19 VACCINE. On an unknown date, unknown after receiving Shingrix, 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 Shingrix.     Additional Information: GSK Receipt Date: 27-Jul-2022 Reporter's Comments: The reporter was patient's relative reported via interactive digital media The reporter's sister had the shingrix vaccine and thought she was protected.  The patient had three weeks after getting Covid booster she broke out with shingles and still suffering with it.  The reporter's daughter also got shingles after getting Covid shot. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Diplegia, Guillain-Barre syndrome, Immunisation reaction
Clinical narrative: Guillain-Barre Syndrome/vaccine induced acute inflammatory demyelinating polyradiculoneuropathy (AIDP); This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th December 2020, the patient received Shingrix. On 24th December 2020, 9 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.   GSK Receipt Date: 28 Jul 2022 Reporter's Comments Plaintiff being administered the Shingrix on 15 Dec 2020.On or about 24 Dec 2020, Plaintiff started experiencing signs and symptoms of Guillain-Barre Syndrome including ascending motor paralysis in his legs and arms.On or about 7 Jan 2021, Plaintiff was diagnosed with vaccine induced acute inflammatory demyelinating polyradiculoneuropathy (AIDP), otherwise known as Guillain-Barre Syndrome.