chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Decreased appetite, Disturbance in attention, Dizziness, Feeling abnormal
Clinical narrative: - "COVID arm", extremely painful, couldn't touch or move, rash - Nausea, almost vomited - Random muscle pains (legs, shoulders, back, arms) - Shaking jaw - Hot flashes for several next days - Weird dreams mixed with reality all night, couldn't sleep well - Feeling dizzy, like floating on the clouds, and world spinning - Hard to concentrate and think - Stomachache  - Painful pulsation in the whole arm, shaking  - Something (most likely lymph node) in the right armpit swollen and painful - Tinnitus (long noise in the right ear) - Weird feeling of circulation in the head during the night after. Felt like some liquid is moving  - ADHD and anxiety got worse - Tears when sleeping (constant crying), wanted to pee a lot that night after - Also weird circulation in the stomach in two days, like some hot liquid was moving there  - Cough, runny nose - Pain in the sides of the neck, like lymph nodes - Pimples on the chest - No appetit
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Immunisation reaction, Insomnia, Movement disorder, Myalgia
Clinical narrative: - "COVID arm", extremely painful, couldn't touch or move, rash - Nausea, almost vomited - Random muscle pains (legs, shoulders, back, arms) - Shaking jaw - Hot flashes for several next days - Weird dreams mixed with reality all night, couldn't sleep well - Feeling dizzy, like floating on the clouds, and world spinning - Hard to concentrate and think - Stomachache  - Painful pulsation in the whole arm, shaking  - Something (most likely lymph node) in the right armpit swollen and painful - Tinnitus (long noise in the right ear) - Weird feeling of circulation in the head during the night after. Felt like some liquid is moving  - ADHD and anxiety got worse - Tears when sleeping (constant crying), wanted to pee a lot that night after - Also weird circulation in the stomach in two days, like some hot liquid was moving there  - Cough, runny nose - Pain in the sides of the neck, like lymph nodes - Pimples on the chest - No appetit
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pain, Pain in extremity, Pollakiuria
Clinical narrative: - "COVID arm", extremely painful, couldn't touch or move, rash - Nausea, almost vomited - Random muscle pains (legs, shoulders, back, arms) - Shaking jaw - Hot flashes for several next days - Weird dreams mixed with reality all night, couldn't sleep well - Feeling dizzy, like floating on the clouds, and world spinning - Hard to concentrate and think - Stomachache  - Painful pulsation in the whole arm, shaking  - Something (most likely lymph node) in the right armpit swollen and painful - Tinnitus (long noise in the right ear) - Weird feeling of circulation in the head during the night after. Felt like some liquid is moving  - ADHD and anxiety got worse - Tears when sleeping (constant crying), wanted to pee a lot that night after - Also weird circulation in the stomach in two days, like some hot liquid was moving there  - Cough, runny nose - Pain in the sides of the neck, like lymph nodes - Pimples on the chest - No appetit
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rhinorrhoea, Sensory disturbance, Swelling, Tenderness
Clinical narrative: - "COVID arm", extremely painful, couldn't touch or move, rash - Nausea, almost vomited - Random muscle pains (legs, shoulders, back, arms) - Shaking jaw - Hot flashes for several next days - Weird dreams mixed with reality all night, couldn't sleep well - Feeling dizzy, like floating on the clouds, and world spinning - Hard to concentrate and think - Stomachache  - Painful pulsation in the whole arm, shaking  - Something (most likely lymph node) in the right armpit swollen and painful - Tinnitus (long noise in the right ear) - Weird feeling of circulation in the head during the night after. Felt like some liquid is moving  - ADHD and anxiety got worse - Tears when sleeping (constant crying), wanted to pee a lot that night after - Also weird circulation in the stomach in two days, like some hot liquid was moving there  - Cough, runny nose - Pain in the sides of the neck, like lymph nodes - Pimples on the chest - No appetit
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Thinking abnormal, Tinnitus, Tremor, Trismus, Vertigo
Clinical narrative: - "COVID arm", extremely painful, couldn't touch or move, rash - Nausea, almost vomited - Random muscle pains (legs, shoulders, back, arms) - Shaking jaw - Hot flashes for several next days - Weird dreams mixed with reality all night, couldn't sleep well - Feeling dizzy, like floating on the clouds, and world spinning - Hard to concentrate and think - Stomachache  - Painful pulsation in the whole arm, shaking  - Something (most likely lymph node) in the right armpit swollen and painful - Tinnitus (long noise in the right ear) - Weird feeling of circulation in the head during the night after. Felt like some liquid is moving  - ADHD and anxiety got worse - Tears when sleeping (constant crying), wanted to pee a lot that night after - Also weird circulation in the stomach in two days, like some hot liquid was moving there  - Cough, runny nose - Pain in the sides of the neck, like lymph nodes - Pimples on the chest - No appetit
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Severe Dizziness
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Client presented to the vaccination site on 11/14/2021, accompanied by his parent for his first dose Pfizer COVID vaccine. Today, the client received the first dose Pfizer COVID vaccine for 5 through 11 years of age (Lot# FK5618 exp: 01.19.22) at 1303) noted the client was 13 years old after administration of the Pfizer COVID vaccine for 5 through 11 years of age. With  translating, provided education stating the client received the incorrect formulation of the Pfizer COVID vaccine. educated client on possible adverse reactions and when to seek medical care. The client denied any chronic conditions, current medications, or known allergies. verbally consulted with Clinical Project Coordinator requesting for guidance on how to proceed. While the client was at the observation area, Clinical Project Coordinator, received a recommendation from the doctor via text. The doctor recommended against repeat vaccination today but stated in 21 days the client may receive a dose of COVID vaccine Pfizer for 12 years of age and older at the parent's request. talked to the client's father at the EMT station. provided education regarding administration of the incorrect formulation of the Pfizer COVID vaccine and the recommendation from the doctor stating the client may receive a Pfizer COVID vaccine for 12 years of age and older in 21 days. provided education again to the client's father regarding possible adverse reactions, and when to seek medical care. The client did not report any symptoms during the 30-minute observation period. The client left the vaccination site at 1333 ambulating unassisted with a steady gait with his parent.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram abnormal, Pain, Sleep disorder
Clinical narrative: PATIENT HAD CHEST DISCOMFORT AND PAIN NIGHT OF THE VACCINE. HE WAS UNABLE TO SLEEP DUE TO DIFFICULTY BREATHING. THE NEXT MORNING, HE WENT TO THE CARDIOLOGIST, AND AFTER AN EKG. DUE TO ALARMING RESULTS, PATIENT WAS ADVISED TO CHECK INTO AN ER.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Acupuncture, Ageusia, Anosmia, Axillary mass, Breast mass
Clinical narrative: Covid 19 positive in January 2021 (sick for 2 weeks). After my second Covid vaccine, fatigue, coughing, muscle aches, loss of smell, lost a little bit of taste but not as bad as smell. I had an extreme sinus infection for 10 days. Two months later I got flu shot and tetanus shot and I got mammogram and I had a lump under my arm/breast. I have been going to acupuncturists for relief of symptoms for about 3 weeks. Slowly getting better but it's taking several weeks/months.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Lymphadenopathy, Mammogram
Clinical narrative: Covid 19 positive in January 2021 (sick for 2 weeks). After my second Covid vaccine, fatigue, coughing, muscle aches, loss of smell, lost a little bit of taste but not as bad as smell. I had an extreme sinus infection for 10 days. Two months later I got flu shot and tetanus shot and I got mammogram and I had a lump under my arm/breast. I have been going to acupuncturists for relief of symptoms for about 3 weeks. Slowly getting better but it's taking several weeks/months.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Sinusitis, Ultrasound scan
Clinical narrative: Covid 19 positive in January 2021 (sick for 2 weeks). After my second Covid vaccine, fatigue, coughing, muscle aches, loss of smell, lost a little bit of taste but not as bad as smell. I had an extreme sinus infection for 10 days. Two months later I got flu shot and tetanus shot and I got mammogram and I had a lump under my arm/breast. I have been going to acupuncturists for relief of symptoms for about 3 weeks. Slowly getting better but it's taking several weeks/months.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Laboratory test
Clinical narrative: started the day following vaccination with a cherry red under the nose  to top of the upper lip that grew larger, was not painful, did not itch.  then approx 4th day after the vaccine face started discoloring both sides of the cheeks and the chin specifically; another cherry red spot developed on the bottom right lip.  Saw PCP who prescribed AV cream to be applied to these areas which did help. Also has had some similar discoloration on right arm and on her chest.  Scheduled to see dermatologist in August 2022 ( reports she has already been going to see Dr. for other skin issues in the past)
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hepatectomy, SARS-CoV-2 test positive
Clinical narrative: 11/10/21 presents "as transfer from another HCF" for "for IR consultation and intervention for suspected hepatic adenoma with hemorrhage". PMH "asthma, obesity, anxiety/depression, and sleep apnea".
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Hepatic adenoma, Hepatic haemorrhage, SARS-CoV-2 test positive
Clinical narrative: 11/10/21 presents "as transfer from another HCF" for "for IR consultation and intervention for suspected hepatic adenoma with hemorrhage". PMH "asthma, obesity, anxiety/depression, and sleep apnea".
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chapped lips, Conjunctivitis, Coronary artery dilatation, Immunoglobulin therapy, Inflammatory marker increased
Clinical narrative: Vaccine 2/17/2022, developed MISC 3/3/2022
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Kawasaki's disease, Multisystem inflammatory syndrome in children, Oral disorder, Pyrexia, Rash
Clinical narrative: Vaccine 2/17/2022, developed MISC 3/3/2022
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood fibrinogen increased, Brain natriuretic peptide increased, C-reactive protein increased, Coronary artery dilatation, Echocardiogram abnormal
Clinical narrative: Vaccine 2/17/2022, developed MISC 3/3/2022
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer, Multisystem inflammatory syndrome in children, Red blood cell sedimentation rate increased, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test positive
Clinical narrative: Vaccine 2/17/2022, developed MISC 3/3/2022
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Serum ferritin normal, Troponin
Clinical narrative: Vaccine 2/17/2022, developed MISC 3/3/2022
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Dysgraphia, Grip strength decreased, Hypoaesthesia, Limb discomfort
Clinical narrative: The day following second dose of Moderna -  started experiencing inability to grip, numbness, dryness and swelling as well as soreness and tingling.  Specifically reports both hands feeling like she has a "boxing mitt" on each hand but there is nothing there. Also not able to write with right hand without feeling like her hands are numb and misses some writing.     PCP prescribed AV cream and instructed her to stay out of water.  Scheduled to see dermatologist in August 2022.  Dr. is her dermatologist.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Paraesthesia, Swelling
Clinical narrative: The day following second dose of Moderna -  started experiencing inability to grip, numbness, dryness and swelling as well as soreness and tingling.  Specifically reports both hands feeling like she has a "boxing mitt" on each hand but there is nothing there. Also not able to write with right hand without feeling like her hands are numb and misses some writing.     PCP prescribed AV cream and instructed her to stay out of water.  Scheduled to see dermatologist in August 2022.  Dr. is her dermatologist.
Age: 61.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Laboratory test, Pain in extremity
Clinical narrative: patient stated she had pain in arm after vaccine given that continued with swelling, sweating and hard to move arm.  She went to ER and dr believed immunization given too high into the joint.
Age: 61.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Hyperhidrosis, Joint range of motion decreased, Pain in extremity, Product administered at inappropriate site, Swelling
Clinical narrative: patient stated she had pain in arm after vaccine given that continued with swelling, sweating and hard to move arm.  She went to ER and dr believed immunization given too high into the joint.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Costochondritis, Dyspnoea
Clinical narrative: Hyperinflated lungs typical with COPD; Hyperinflated lungs typical with COPD; Breathing at times I feel like I need to take a breath; Fever; chills; Some chest pains/pain in chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Some chest pains/pain in chest), LUNG HYPERINFLATION (Hyperinflated lungs typical with COPD), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Hyperinflated lungs typical with COPD), DYSPNOEA (Breathing at times I feel like I need to take a breath) and PYREXIA (Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 025B21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Non-smoker.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST PAIN (Some chest pains/pain in chest). On an unknown date, the patient experienced LUNG HYPERINFLATION (Hyperinflated lungs typical with COPD), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Hyperinflated lungs typical with COPD), DYSPNOEA (Breathing at times I feel like I need to take a breath), PYREXIA (Fever) and CHILLS (chills). In March 2022, CHEST PAIN (Some chest pains/pain in chest) had resolved. At the time of the report, LUNG HYPERINFLATION (Hyperinflated lungs typical with COPD), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Hyperinflated lungs typical with COPD), DYSPNOEA (Breathing at times I feel like I need to take a breath), PYREXIA (Fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal Normal and (showed) hyperinflated lungs typical with copd (showed) hyperinflated lungs typical with COPD. On an unknown date, Echocardiogram: normal Normal. On an unknown date, Electrocardiogram: normal Normal. On an unknown date, SARS-CoV-2 antibody test: negative Negative.         No concomitant medication information was provided.  The patient stated that 3 weeks later after vaccination with booster, patient developed pain in chest that continued for several weeks and she went to primary care provider. Patient stated that primary care provider thought she had COVID and treated her with antibiotic and steroids.  Patient was wondering if any of events were a side effect of the vaccine and was worried about getting (2nd booster).   This case was linked to MOD-2022-546365, MOD-2022-546366 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Follow up contains no new information.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: late administration of dose 2. Was given after month 2 from original dose given; This spontaneous report was received from a medical assistant on behalf of a health care professional concerning to a 26-year-old patient. The patient's concurrent conditions, medical history, concomitant medications, and previous drugs reactions or allergies were not provided.   On an unknown date, the patient was vaccinated with the first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, formulation, dose, route of administration, anatomical site of injection, lot number and expiration date were not reported).  On an unknown date, the patient received a late administration of second dose. It was given after month 2 from original dose given (inappropriate schedule of product administration).
Age: 50.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Caller reports that a patient was administered the first dose of GARDASIL 9 at the age of 50 years old; No additional AE reported; This spontaneous report has been received from a nurse prescriber via a company representative, referring to a 50 years old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not reported.   On an unknown date, the patient was administered the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route, lot number and expiration were unknown) for prophylaxis at the age of 50 years old (Product administered to patient of inappropriate age). No additional adverse event (AE) reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event, Product preparation issue
Clinical narrative: No additional AE information; MMRII that had been reconstituted with expired diluent had been inadvertently administered to a patient.; MMRII that had been reconstituted with expired diluent had been inadvertently administered to a patient; This spontaneous report was received from a consumer referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  A dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency, route, lot number and expiration date were not provided) which had been reconstituted with expired sterile diluent (STERILE DILUENT) (lot# S025290, expiration date 20-MAR-2022) was inadvertently administered to the patient on 30-MAR-2022 for prophylaxis (expired product administered, product preparation issue). The vaccine was not expired and did not experience any temperature excursions. The diluent did not experience any temperature excursions. There was no additional adverse event or product quality complaint.
Age: 0.58
Sex: U
Vaccine: VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No other issues or concerns noted; Customer called to report that a 7 month old patient had been administered VARIVAX a few month early.  No PQC.  No other issues or concerns noted.; This spontaneous report has been received from a health professional and refers to a 7-month-old infant patient.  The patient's medical history, concurrent conditions, drug allergies or reactions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (strength, dose description, route of administration, lot number and expiry date were not provided) a few months earlier (product administered to patient of inappropriate age). No other issues or concerns noted.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Discomfort, Incorrect dose administered
Clinical narrative: the patient "squirmed."; Due to this movement "a little drop did not go in."; This spontaneous report was received from a healthcare professional referring to a 15-molth-old patient of unspecified gender. The patient's medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported.   On an unspecified date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, vaccine scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) as prophylaxis. It was reported that the patient "squirmed" (discomfort). Due to this movement, a "little drop did not go in" (incorrect dose administered). The patient's physician requested information regarding revaccination.   The outcome of discomfort was unknown. The causal relationship between varicella virus vaccine live (Oka/Merck) (VARIVAX) and the event was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No AE; VARIVAX LOT T010314, expiration date 3/24/2022 was accidentally administered to a patient on April 11, 2022.; This spontaneous report was received from an office manager on behalf of health care office, referring to a patient of unspecified age and gender. The patient's medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported.  On 11-APR-2022, the patient was accidentally vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliters, as prophylaxis (route of administration, vaccine scheme, and anatomical site of vaccination were not reported; lot number T010314 has been verified to be valid, expiration date reported and established as 24-MAR-2022) (expired product administered).   It was reported that the product was stored appropriately, and it did not have any temperature excursions. No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no adverse event; VARIVAX experienced temperature excursion and was administered; This spontaneous report as received from a vaccine coordinator refers to a patient of unknown age and gender. On 08-APR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Lot # U015685 exp date 18-MAY-2023) (dose and route not reported). Concomitant therapies included sterile diluent. The temperature of excursion was -13.86 °C for a time frame of 4 hours. There was no previous temperature excursion.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE details; VARIVAX and PROQUAD were inadvertently concomitantly administered to a 12 month old patient; This spontaneous report was received from a nurse referring to a 12-month-old male patient. The patient's medical history, concurrent conditions, and previous drug reactions or allergies were unknown by the reporter. Concomitant therapies included sterile diluent.   On 01-APR-2022, the patient was inadvertently concomitantly administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rha) (PROQUAD) 0.5 milliliters (mL) subcutaneously (lot number U029149 has been verified to be valid, expiration date reported and established as 16-MAR-2023), and varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliters (mL), once (route of administration was not reported; lot number U020240 has been verified to be valid, expiration date reported and established as 28-JUN-2023) (inappropriate schedule of product administration). Both vaccines were administered as prophylaxis.   No additional adverse event reported (no adverse event).
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Overdose
Clinical narrative: a dose of PROQUAD was administered with VARIVAX for 8 different patients; This spontaneous report was received from a pharmacy technician and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 30-MAR-2022, the patient received varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, lot #U024221, expiration date: 04-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided); and  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 1 dose, lot #U028179, expiration date: 08-MAR-2023, administered for prophylaxis (strength, and route of administration were not provided) (overdose). It is unknown if any product confusion occurred, that may have contributed to the error. No further information provided. No product quality complaints.  This is one of eight reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA004906:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse events reported; an improperly stored dose of VARIVAX was administered to a patient; This spontaneous report was received from pharmacist and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 05-APR-2022, an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, lot #T012551, expiration date: 10-APR-2022 (strength and route of administration were not provided) was administered to the patient for prophylaxis. The vaccine was exposed to temperature of 46 Fahrenheit for 144 hours. No previous temperature excursion was reported. No further information provided. No other adverse events reported. No product quality complaint.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: The customer reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a medical assistant concerning to an unknown age and gender patient. The patient's concurrent conditions, medical history, drugs reactions or allergies and concomitant medications were not provided.  On 10-MAY-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) administered for prophylaxis, (strength, dose, frequency, route of administration and anatomical injection site were not provided; lot number U028184 with an expiration date on 08-MAR-2023, was verified to be valid lot numbers) (product storage error).  Administered dose of the suspect vaccine experienced a temperature excursion of -12.7 degrees Celsius (C) for 3 hours. The previous temperature excursion was -12.3 degrees C for 4 hours.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: had been stored outside of recommended storage range; No additional AE details; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history provided. Concomitant therapies included sterile diluent(MERCK STERILE DILUENT).    On an unknown date, the patient was vaccinated with an improperly stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA (recombinant Human albumin), lot # U029147, expiration date 16-MAR-2023) for prophylaxis (dose, route and site of administration were not reported).   The administered dose of the vaccine experienced a temperature excursion of -58 Degree Fahrenheit to 5 Degree Fahrenheit with average of -7 Degree Fahrenheit for 2 hours and below -59 Degree Fahrenheit with average of -65.2 Degree Fahrenheit for 46 hours. Pharmacist would like to know when the patient could be re-vaccinated. No additional adverse event detail.  This is one case of some cases from same reporter.; Sender's Comments:  US-009507513-2204USA006370: US-009507513-2204USA006442:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: PROQUAD that had been stored outside of recommended storage range; No additional AE details; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history provided. Concomitant therapies included sterile diluent(MERCK STERILE DILUENT).    On an unknown date, the patient was vaccinated with an improperly stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA (recombinant Human albumin), lot # U029147, expiration date 16-MAR-2023) for prophylaxis (dose, route and site of administration were not reported).   The administered dose of the vaccine experienced a temperature excursion of -58 Degree Fahrenheit to 5 Degree Fahrenheit with average of -7 Degree Fahrenheit for 2 hours and below -59 Degree Fahrenheit with average of -65.2 Degree Fahrenheit for 46 hours. Pharmacist would like to know when the patient could be re-vaccinated. No additional adverse event detail.  This is one case of some cases from same reporter.; Sender's Comments:  US-009507513-2204USA006370: US-009507513-2204USA006442: US-009507513-2204USA006506:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD was administered after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 25-AUG-2021, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #U028184, expiration date: 08-MAR-2023, administered for prophylaxis (strength, and route of administration were not provided). The vaccine was exposed to temperature of -14 Celsius for 7 hours. No previous temperature excursion was reported. No PQC was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513- 2204USA006070:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 14-APR-2022, the patient received rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #1742464, expiration date: 20-SEP-2022, administered orally for prophylaxis. The vaccine was exposed to temperature of 47.8 Fahrenheit for 45 minutes. No previous temperature excursion was reported. No other information provided.  No additional AEs or PQC reported.
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: she experienced a slight rash a couple days after the administration of PNEUMOVAX 23.; This spontaneous report was received from a retired pharmacist referring to herself, a female patient of unspecified age. The patient's medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported.  On an unspecified date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, vaccine scheme, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis.   On an unspecified date (reported as "many years ago"), a couple of days after the administration of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), the patient experienced a slight (mild) rash.   The outcome of rash (mild) was unknown. The reporter stated that she was not sure if the event was a result of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information; Office manager responsible for storage and handling of vaccines reported patient administered MMRII and VARIVAX that experienced supported temperature excursion.; This spontaneous report was received from an office manager referring to a patient of unspecified age and gender. The patient's pertinent medical history, concomitant therapies, concurrent conditions and previous drug reactions or allergies were not reported.   On 13-APR-2022, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rha) (M-M-R II) 0.5 milliliters (mL), once (lot number  T027937 has been verified to be valid, expiration date reported and established as 18-AUG-2022 ) and one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliters (mL), once (lot number U019904  has been verified to be valid, expiration date reported and established as 24-JUN-2023) (routes of administration, anatomical sites of vaccination, and vaccine schemes were not reported). Both vaccines were administered as prophylaxis.   It was reported that the vaccines were exposed to supported temperature excursion before being administered. No additional adverse event was reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA007198: US-009507513-2204USA007134:
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: arm was red; arm was swollen; Hard at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th April 2022, the patient received the 1st dose of Shingrix. On 13th April 2022, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site induration. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site induration were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site induration to be related to Shingrix.     Linked case(s) involving the same patient:  US2021133158   Additional Information: GSK Receipt Date: 15-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine in left arm and on next day his arm was red, swollen and hard at injection site. Referred to HCP (Health Care Professional). Adverse event filed in past with different product. This case has been linked with case US2021133158, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021133158:Same patient
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Mild case of shingles, bothering me; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced mild case of Shingles. The patient stated that the shingles was bothering him/her. The patient asked that could he/she get his 2nd vaccination now as he/she was experiencing the virus. Additional supportive information: The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: I fit so sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and felt so sick. The patient stated that the doctor wouldn't give him/her the second shot. Additional supportive information: The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Really tired but planned to lay low; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-APR-2022 Reporter's comment: This case was reported by patient via interactive digital media. The patient received second dose of Shingles vaccine and patient was really tired, but patient planned to lay low. Additional Supportive Information: This case is linked with case US2022AMR066730 reported by same reporter. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR066730:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Some people I know had flu like symptoms; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in an unspecified number of patients 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-APR-2022 Reporter's comment: This case was reported by consumer via interactive digital media. The patients received doses of Shingles vaccine and had flu like symptoms. Additional Supportive Information: This case is linked with case US2022AMR066728 reported by same reporter. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR066728:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: mild case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 18-Apr-2022 Reporter's comment: The case was received by the patient via Shingrix. The patient stated that you (GSK) and your people never got back with him/her the other day after they texted and chatting over a half an hour about his/her concerned in receiving the second vaccine. The patient was now actually experiencing a mild case of shingles. Additional Supportive Information: Follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose in Feb-2020, 2nd dose in Apr-2022; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in February 2020).   In April 2022, the patient received the 2nd dose of Shingrix. In April 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient reported that he/she took the first dose of Shingrix and the second dose in April 2022 and enquired if he/she need a third dose. Additional Supportive Information: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not received the 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 28th September 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 19-APR-2022 Reporter's Comments: The case was reported by patient. The patient received the 1st dose of SHIGNRIX but had not received the 2nd dose as she was not aware she had to have the 2nd dose month 2 to 6. The reporter inquired if she would need to restart the vaccine schedule and what was the efficacy of SHINGRIX. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose which led to incomplete course of vaccination.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: expired dose was given; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number Z3YL4, expiry date 4th April 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th April 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 15th April 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-APR-2022 Reporter's Comments: An expired dose of pediarix  was given to the patient. The reporter consented to follow up. Additional Supportive Information:  The patient received vaccine after it's expiry date, which led to expired vaccine used. This is one of three cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066910:Same reporter US-GLAXOSMITHKLINE-US2022066911:Same reporter
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: expired dose was given; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number Z3YL4, expiry date 4th April 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th April 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 15th April 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-APR-2022 Reporter's Comments: An expired dose of pediarix  was given to the patient. The reporter consented to follow up. Additional Supportive Information:  The patient received vaccine after it's expiry date, which led to expired vaccine used. This is one of three cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066909:Same reporter US-GLAXOSMITHKLINE-US2022066911:Same reporter