chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: 5 hours after injection shivering began with extreme weakness and progressed in intensity over several hours during which fever (up to 101.7) and nausea  ensued and then muscle pains severe and unrelenting in hips bilateral with mild headache. After about 3 hours I took 300mg ibuprofen and was able to rest. The next morning and throughout the day I was exhausted. The next night I slept 12 hours. I usually sleep only 6-8 hours/night.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Condition aggravated, Nausea
Clinical narrative: Patient complained of nausea and mild chest pain.  Patient was assessed pt alert and oriented x 4.  Vital signs were taken and within limits. EMS was activated by security at site. At 1955 patient disclosed history of chest pain when nervous.  EMS arrived  2002, patient was assessed by EMS, patient reported feeling better and refused to go with EMS to hospital, prefer to go home. Patient left the site in no discomfort with roommate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Back pain, Confusional state, Decreased appetite, Dizziness
Clinical narrative: Since 081921:  Kidney pain. Lasted 8 days.  Jaw pain. Lasted 3 days.  Trouble swallowing. Lasted 4 days.  Bleeding ears. Lasted 1 day.  Nausea. Lasted 4 days.  No appetite. Lasted 7 days.  Vomiting. Lasted 2 days.  Migraines. Still occurring.  Dizziness. Still occurring.  Confusion. Lasted 8 days.  Memory loss. Lasted 8 days.  Brain zaps. Still occurring.  Acute lower back pain. Unable to stand/walk without assistance. Still occurring but getting better with medication use.  Unable to sleep due to pain. Lasted 4 days.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dysstasia, Ear haemorrhage, Electric shock sensation, Gait inability
Clinical narrative: Since 081921:  Kidney pain. Lasted 8 days.  Jaw pain. Lasted 3 days.  Trouble swallowing. Lasted 4 days.  Bleeding ears. Lasted 1 day.  Nausea. Lasted 4 days.  No appetite. Lasted 7 days.  Vomiting. Lasted 2 days.  Migraines. Still occurring.  Dizziness. Still occurring.  Confusion. Lasted 8 days.  Memory loss. Lasted 8 days.  Brain zaps. Still occurring.  Acute lower back pain. Unable to stand/walk without assistance. Still occurring but getting better with medication use.  Unable to sleep due to pain. Lasted 4 days.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Migraine, Nausea, Pain in jaw, Renal pain
Clinical narrative: Since 081921:  Kidney pain. Lasted 8 days.  Jaw pain. Lasted 3 days.  Trouble swallowing. Lasted 4 days.  Bleeding ears. Lasted 1 day.  Nausea. Lasted 4 days.  No appetite. Lasted 7 days.  Vomiting. Lasted 2 days.  Migraines. Still occurring.  Dizziness. Still occurring.  Confusion. Lasted 8 days.  Memory loss. Lasted 8 days.  Brain zaps. Still occurring.  Acute lower back pain. Unable to stand/walk without assistance. Still occurring but getting better with medication use.  Unable to sleep due to pain. Lasted 4 days.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Since 081921:  Kidney pain. Lasted 8 days.  Jaw pain. Lasted 3 days.  Trouble swallowing. Lasted 4 days.  Bleeding ears. Lasted 1 day.  Nausea. Lasted 4 days.  No appetite. Lasted 7 days.  Vomiting. Lasted 2 days.  Migraines. Still occurring.  Dizziness. Still occurring.  Confusion. Lasted 8 days.  Memory loss. Lasted 8 days.  Brain zaps. Still occurring.  Acute lower back pain. Unable to stand/walk without assistance. Still occurring but getting better with medication use.  Unable to sleep due to pain. Lasted 4 days.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypersensitivity, Malaise, Oropharyngeal pain
Clinical narrative: Episode of vomiting within 4 hours , headache , dizzy , sore throat , general not feeling well followed by urticaria at approximately 30 hrs , fever of 101.5 with Tylenol, Benadryl. Called PCP , within an hour seen at the local ED due to the allergic reaction, given IBU and Prendnisone at ED @ 10 pm , prescribed prendnisone for the following days.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Urticaria, Vomiting
Clinical narrative: Episode of vomiting within 4 hours , headache , dizzy , sore throat , general not feeling well followed by urticaria at approximately 30 hrs , fever of 101.5 with Tylenol, Benadryl. Called PCP , within an hour seen at the local ED due to the allergic reaction, given IBU and Prendnisone at ED @ 10 pm , prescribed prendnisone for the following days.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lacrimation increased, Nausea
Clinical narrative: Patient reported watery eye tearing, nauseated and numbness of lips at 4:40 pm.  patient viltals signs were taken within normal limits, ice pack, legs elevated and encouraged to drink water. Patient continuesly feeling nauseated. EMS activated by staff. Patient denies chest pain, shortness of breath as evidence by normal vital signs. Patient was able to answered questions when asked, ANOX3.  Patient denies difficulty swallowing nor swelling of throat or lips. EMS arrived, patient verbalized feeling better and wanting to go home. Patient refused to go with EMS. Patient was educated and reinforced the importance for further monitoring but patient strongly refused. Patient left building in stable condition and denies early symptoms.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fall, Fatigue, Full blood count normal
Clinical narrative: "Reports that immediately after receiving the J&J vaccination on 7/30/21, he felt  a fever and diarrhea 1-2 days but then this was followed by persistent lower  extremity weakness for approximately one week following, so much so that fell  twice with involuntary knee buckling at work the following Monday, Tuesday,  Wednesday (August 2,3,4) at truck stop location. Since then these symptoms have  resolved after 5+ days but now reporting continuous bilateral frontal headaches  lasting one minute and then returning.  Also reporting "no energy" and severe  fatigue and difficulty getting up in the morning even after 8-10 hours sleep."
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Immediate post-injection reaction, Metabolic function test normal, Muscular weakness, Pyrexia
Clinical narrative: "Reports that immediately after receiving the J&J vaccination on 7/30/21, he felt  a fever and diarrhea 1-2 days but then this was followed by persistent lower  extremity weakness for approximately one week following, so much so that fell  twice with involuntary knee buckling at work the following Monday, Tuesday,  Wednesday (August 2,3,4) at truck stop location. Since then these symptoms have  resolved after 5+ days but now reporting continuous bilateral frontal headaches  lasting one minute and then returning.  Also reporting "no energy" and severe  fatigue and difficulty getting up in the morning even after 8-10 hours sleep."
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Beginning to notice a lot of heart palpitations throughout day
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: Vaccine administrator did not properly dilute the Pfizer Vaccine. prior to injection  The full contents of the undiluted vial (6 Dose equivalent) was injected into the Patient  Patient was monitored and released after 15 minutes without incident or adverse event.  The patient was later contacted via telephone (Approximately 5:00 PM)  by the Facility Administrator.  The Administrator reported that at that time the patient was "Fine".  Note: The Administrator is assisting in translation.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Patient received undiluted pfizer
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Oral candidiasis, Tongue discolouration, Tongue discomfort, Tongue eruption
Clinical narrative: Oral thrush Bumps on the tongue  Very uncomfortable for me to eat and swallow  Burns a tad bit when I swallow  Tongue was very white in certain areas - Lasted for a few days before I got treated for it.  - Had to be treated for oral thrush twice.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: 207a21a
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Death, Gait inability, Peripheral swelling, Platelet count decreased
Clinical narrative: Swollen legs, could no longer walk, low platlet levels, needed a blood transfusion, cognitive decline, kidney failure, death
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Renal failure, Transfusion
Clinical narrative: Swollen legs, could no longer walk, low platlet levels, needed a blood transfusion, cognitive decline, kidney failure, death
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Nausea
Clinical narrative: AT 10:52AM ON 08/31/2021, PATIENT RECEIVED FIRST PFIZER COVID VACCINE. AT  APPROXIMATELY 6:30 PM, PATIENT CALLED PHARMACY COMPLAINING THAT HE WAS HAVING A REACTION TO THE COVID VACCINE AND WAS EXPERIENCING NAUSEA AND A SENSATION THAT HIS LUNGS WERE "ON FIRE." HE STATED THAT THESE SYMPTOMS BEGAN AROUND 5:20PM AND WAS ONGOING.  UPON FURTHER QUESTIONING, PATIENT STATED THAT THE NAUSEA HAD BEGAN TO WAX AND WANE, BUT THAT NUMBNESS BEGAN TO DEVELOP IN HIS ARMS AND HANDS.  PATIENT STATED THAT HE HAD BEGAN ASHWAGANDHA RECENTLY WITHOUT INFORMING PCP OR PHARMACY.  UPON FURTHER QUESTIONING, PATIENT REVEALED THAT HE HAD 2 PRIOR MYOCARDIAL INFARCTIONS.  I STRONGLY RECOMMENDED THAT THE PATIENT GO TO THE ER AS I BELIEVED THESE WERE SYMPTOMS OF AN MI. PATIENT AGREED.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received Moderna vaccine outside of recommended age. Patient reported no adverse events.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram normal, Electrocardiogram ambulatory abnormal, Heart rate irregular, Ventricular extrasystoles
Clinical narrative: 4 weeks of constant PVCs, irregular heart rhythm every 2nd to 5th heart beat. I went to emergency, they gave me beta blockers which I took for 5 days but they did nothing. Symptoms stopped abruptly on their own. This began 2 weeks after the second shot.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Flank pain, Musculoskeletal chest pain, Musculoskeletal pain, Swelling
Clinical narrative: The evening of the day I had the shot ( in the morning), I had severe left rib and under the rib pain as well as pain on my left side and left lower back.  The pain was intermittent day and night from Aug 23 thru Aug 29 when it magically disappeared as quickly as it had come upon me. I had a video call Dr. Appt on 8/26 with a GP who thought it must be muscleoskeletal although I had no pother precipitating event besides the covid 19 shot.  I also saw a vascular doctor on 8/31 even though the pain was gone because there was also some swelling under the skin covering my rib which did not disappear and I wanted to make sure my situation was not related to my spleen issues
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood gases, Computerised tomogram, Death, Dyspnoea, Pneumonia
Clinical narrative: Difficulty breathing began approx 8 days post Vx, progressed to pneumonia after 10 days, deceased at 12 days
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, X-ray
Clinical narrative: Difficulty breathing began approx 8 days post Vx, progressed to pneumonia after 10 days, deceased at 12 days
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes underarm, right-side (the side I got the shot on).
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Asthenia, Inflammation, Influenza like illness
Clinical narrative: Felt everything like a flu, bust most painful is heart inflammation and weakness.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Flank pain, Injection site reaction, Musculoskeletal pain
Clinical narrative: On the 20th in the evening it had gradiated to extreme fatigue. The 26th I got pain in my right armpit. Over a few days, 3 or 4, it seemed to travel up my under arm. Then 8 days in, the 27th, I got an oval red itchy rash at injection site for about 3 days, then on the 29th and 30th, my bottom and the sides and small amount down the back of legs started hurting really bad. Felt like bruises sometimes and sometimes like hurting skin from flu, the skin seemed a bit swollen and made indentations easy from normal sleep patterns in blankets. Not sure what else might come next....
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash erythematous, Rash pruritic, Skin indentation, Skin swelling
Clinical narrative: On the 20th in the evening it had gradiated to extreme fatigue. The 26th I got pain in my right armpit. Over a few days, 3 or 4, it seemed to travel up my under arm. Then 8 days in, the 27th, I got an oval red itchy rash at injection site for about 3 days, then on the 29th and 30th, my bottom and the sides and small amount down the back of legs started hurting really bad. Felt like bruises sometimes and sometimes like hurting skin from flu, the skin seemed a bit swollen and made indentations easy from normal sleep patterns in blankets. Not sure what else might come next....
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Electromyogram, Guillain-Barre syndrome, Sensory loss
Clinical narrative: Guillain-Barré syndrome - left arm (vaccine given to right arm) Slight loss of sensitivity in left leg.  Occured around 2 weeks after vaccine.
Age: 31.0
Sex: M
Vaccine: UNK
Symptoms: Miliaria, Skin lesion
Clinical narrative: Currently getting unknown skin lesions never seen before till today aside from heat rash as well.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Oropharyngeal pain, Swollen tongue, Tongue disorder
Clinical narrative: Bad, worst sore throat ever, swollen tongue, bumps all over tongue, fatigue, general muscle aches
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Sensitive skin
Clinical narrative: Skin was super-sensitive for a month, especially on the back of my head. I also randomly breakout.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Fatigue, Hypoaesthesia, Injection site pain
Clinical narrative: On day 1-3 Tingling and  pain in injection site.  On day 5 began hurting in all joints and numbness and overall fatigue  By day 7 Neuropathy was noted with vision disturbances (seeing quadruple and not able to focus.  Loss of balance and actually sprung right ankle.  All symptoms continue to worsen and compounded
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site paraesthesia, Ligament sprain, Metamorphopsia, Neuropathy peripheral
Clinical narrative: On day 1-3 Tingling and  pain in injection site.  On day 5 began hurting in all joints and numbness and overall fatigue  By day 7 Neuropathy was noted with vision disturbances (seeing quadruple and not able to focus.  Loss of balance and actually sprung right ankle.  All symptoms continue to worsen and compounded
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abnormal, Deep vein thrombosis, Haemothorax, Ultrasound Doppler
Clinical narrative: DVT to LUE, hemothorax x2
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Taste disorder
Clinical narrative: Loss of taste/limited taste spectrum after second injection. Negative tests for Covid prior to vaccine.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Accidental overdose, Death, Gastrooesophageal reflux disease, Interchange of vaccine products, Lymphoma
Clinical narrative: Wrong diagnosis Dr told us hiv barely detectable then said gallbladder then walked in ov stating well good news its not cancer . he told patient he had no choice but to get the covid vaccine even tho he didn't want or understand it at all he offered no info no time and threatened patient he would not prescribe his hiv pills unless he was vaccinated fully . patient had too much trust . Dr gave him two different types and he was scheduling athird patient side affects were ignored and told it was normal due to injection he soon after was hospitallzed having lymph nodes cancer and all the tests ran by Dr were not found abbott said well I never looked at imaging and we we re sure it is acid reflex . another doctor a specialist said he shpuld not have given him that type of vaccine with his medical jistory and allergies. Dr told us at hospital dont try goodbye because patient had only 6 months if that to live he walked put two weeks later we went to specialost who said he was wrong and didnt know why Dr said that but to cover his butt because of the wrong dying of covid vaccines. Patient died and the hospital staff said either vaccine caused this or overdose when shift change happened because he was given too many pain meds and three kinds . no one even knew je was in the room he was peed even tho they said he couldnt he had food on him all over and he was on liquod diet he was dirty no water no machines hooled up not even an IV help we need justice story gets more detailed I have pics and med rec this doctor wwas wrong abiut it all even vaccine .
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Victim of abuse
Clinical narrative: Wrong diagnosis Dr told us hiv barely detectable then said gallbladder then walked in ov stating well good news its not cancer . he told patient he had no choice but to get the covid vaccine even tho he didn't want or understand it at all he offered no info no time and threatened patient he would not prescribe his hiv pills unless he was vaccinated fully . patient had too much trust . Dr gave him two different types and he was scheduling athird patient side affects were ignored and told it was normal due to injection he soon after was hospitallzed having lymph nodes cancer and all the tests ran by Dr were not found abbott said well I never looked at imaging and we we re sure it is acid reflex . another doctor a specialist said he shpuld not have given him that type of vaccine with his medical jistory and allergies. Dr told us at hospital dont try goodbye because patient had only 6 months if that to live he walked put two weeks later we went to specialost who said he was wrong and didnt know why Dr said that but to cover his butt because of the wrong dying of covid vaccines. Patient died and the hospital staff said either vaccine caused this or overdose when shift change happened because he was given too many pain meds and three kinds . no one even knew je was in the room he was peed even tho they said he couldnt he had food on him all over and he was on liquod diet he was dirty no water no machines hooled up not even an IV help we need justice story gets more detailed I have pics and med rec this doctor wwas wrong abiut it all even vaccine .
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Pyrexia
Clinical narrative: Migraines, fever, muscle pain -otc pain meds, moderate relief
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additionall AEs reported; expired dose of PNEUMOVAX 23 was administered; This spontaneous report was received from a nurse prescriber concerning an unspecified patient of unknown age and gender. No information regarding patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 22-JUN-2021, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), expiration date reported as 10-JUN-2021 (lot number, dose, schedule, anatomical location, and route of administration were not reported) for prophylaxis. No additional adverse events (AEs) were reported.  This case was considered non-valid due to the lack of patient's identifiers.  Follow-up information was received from the nurse on 27-AUG-2021. The patient was a female patient of unknown age. It was stated that it was the only vaccine that the patient received that day and she had not received any vaccines in the four weeks prior. She also confirmed that no adverse events were reported.
Age: 58.0
Sex: F
Vaccine: MMRV
Symptoms: Interchange of vaccine products, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: PROQUAD was administered to a 58 year old patient; MMRV was ordered and given by mistake; Patient was to recieve an MMR vaccine, MMRV was ordered and given by mistake; This spontaneous report was received from a nurse concerning a 58-year-old female patient. Information regarding the patient's current conditions, medical history and historical drug was not provided.   Concomitant vaccines administrated varicella zoster vaccine rge (CHO) (SHINGRIX)  On 28-JUL-2021, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliter subcutaneous route on the left arm, lot number T034612 expiration date 10-APR-2022 as prophylaxis.   However, it was reported that it was intented to be vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) by mistake.  No additional adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: No additional AE reported; a temperature excursion was administered to a patient; This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.    On 09-AUG-2021, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml; lot # T029522, expiration date reported as 13-MAR-2022, but upon internal validation established as 13-MAR-2023; strength, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The storage temperature was -4.8 Celsius degrees for 20 minutes. There was no previous temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) was reported. No data logger was involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T029522; expirationdate: 13-MAR-2023; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: she is one week behind on the second dose of GARDASIL 9.; The caller reported being one week behind due to the clinic not having the available supply for GARDASIL 9.; The caller reported being one week behind due to the clinic not having the available supply for GARDASIL 9.; No AE/PQC reported; This spontaneous report was received from a female patient concerning herself. No concurrent condition, medical history, or concomitant therapy was reported.  On an unknown date, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis. She was one week behind on the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) due to the clinic not having the available supply for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (product supply issue, circumstance or information capable of leading to medication error and inappropriate schedule of product administration). She refused to provide any additional information regarding the adverse event (AE) for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). No AE was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No other AE; temperature excursion on VARIVAX; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 12-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).  The following lot numbers were involved in the temperature excursion: U002398 (expiration date 22-JAN-2023), T041687 (expiration date 10-DEC-2022), T035399 (expiration date 16-OCT-2022), T028304 (expiration date 20-AUG-2022) and S036637 (expiration date 14-NOV-2021).  The vaccine was stored in a temperature of 7.3 degree Fahrenheit (°F) for 20 minutes. There was a previous temperature excursion reported (details not provided).  This is one of several reports received from the same reporter.
Age: 1.0
Sex: M
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient is not experiencing any side effects; Both PROQUAD and MMR-II administered on 19-AUG-2021; This spontaneous report was received from a medical assitant and refers to a 12 months and 15 days old male patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.   On 19-AUG-2021, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 ml and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 ml for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported). Laboratories were not performed and tretament was not given. At the reporting date, the patient was not experiencing any side effects.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored administered VARIVAX; No additional AE details provided; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with an improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot # S032356 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and establish as 14-OCT-2021) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were 9.6° Celsius (C) for 80 minutes respectively.  If a digital data logger was involved was not reported; varicella virus vaccine live (oka/merck) (VARIVAX) did not experience a previous temperature excursion.  No adverse event reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored administered PROQUAD vaccines; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 01-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), lot # T029103, expiration date 23-FEB-2022 for prophylaxis (dose, anatomical location and route of administration were not reported).  The vaccine was stored at the temperature that was reported as 9.6 degrees of Celsius for 80 minutes. There was no previous temperature excursion reported.  No additional adverse event reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, Product storage error
Clinical narrative: No additional AE details provided; Improperly stored PROQUAD administered vaccine; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 26-JUL-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose, route were not reported, lot # T029103, expiration date: 23-FEB-2022) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of 9.6 degree Celsius for a time frame of 80 minutes. There were no previous temperature excursions. No additional adverse event (AE) information was provided.
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Patient who received their first dose of GARDASIL 9 a couple of years ago. The patient did not receive any additional doses after first dose; No other Adverse Events; This spontaneous report was received from a customer concerning a patient of currently 35-year-old. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.       On an unknown date (couple of years ago/unable to specify date of administration), 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) (dose, frequency, route, lot#, and the expiration date were not reported) for prophylaxis.       The patient did not receive any additional doses after the 1st dose. Confirmed with customer no other AE occurred (inappropriate schedule of product administration and no adverse event).
Sex: M
Vaccine: VARCEL
Symptoms: Disseminated varicella zoster virus infection, Illness, Varicella virus test negative
Clinical narrative: Disseminated VZV; Patient is quite ill; This spontaneous report was received from a physician, and refers to a 33 year old male patient. The patient's concurrent conditions included seronegative inflammatory arthritis, and his concomitant medications included methotrexate, etanercept (ENBREL), and prednisone (all given for the concurrent condition). The patient had no prior history of primary varicella.  On an unknown date (reported as one month prior), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, route, anatomical location, lot #, and expiration date were not provided) as his serologies were negative for varicella.  On an unknown date, the patient experienced disseminated varicella zoster virus (VZV) and was quite ill (illness). Subsequently, on an unknown date, the patient was admitted to hospital because of the events.  The outcome of the events was unknown.  The reporter's causality assessment between the events and the suspect vaccine was not provided.  Upon internal review, disseminated varicella zoster virus (VZV) was determined to be a medically significant event.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; Inappropriate schedule of vaccine administered; This spontaneous report was received from an adult female patient, concerning to herself via medical record from a case in litigation for zoster vaccine live (ZOSTAVAX) (Marrs# 1902USA002572). The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.     On 09-MAR-2017, the patient was vaccinated with pneumococcal polysaccharide PPV23 (manufacturer unknown) (dose, route of administration, anatomical site, vaccination scheme, lot number, and expiration date were not provided). It was reported that other doses of pneumonia (manufacturer unknown) (dose, route of administration, anatomical site, vaccination scheme, lot number, and expiration date were not provided) were administered on approximately 2019 and 2020, she did no recall that exact date (inappropriate schedule of product administration).  This is one of two reports received from the same patient. ; Sender's Comments:  US-009507513-1902USA002572:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, Product storage error
Clinical narrative: No other AE; temperature excursion on VARIVAX; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 12-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).  The following lot numbers were involved in the temperature excursion: U002398 (expiration date 22-JAN-2023), T041687 (expiration date 10-DEC-2022), T035399 (expiration date 16-OCT-2022), T028304 (expiration date 20-AUG-2022) and S036637 (expiration date 14-NOV-2021).  The vaccine was stored in a temperature of 7.3 degree Fahrenheit (°F) for 20 minutes. There was a previous temperature excursion reported (details not provided).  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; An expired dose of M-M-R-II was administered to the patient; This spontaneous report was received from a physician concerning a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.      On 19-AUG-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 milliliter, for prophylaxis (lot number S025155, has been determined to be valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported and establish as 13-AUG-2021) (strength, route of administration and anatomical location were not provided).   No adverse event reported.
Age: 33.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No other AEs reported; Patient received VARIVAX less than 28 days after MMRII; This spontaneous report was received from a nurse concerning a 33 year old patient. Information regarding the patient's  medical history, concurrent conditions and concomitant medications was not reported.   On 18-AUG-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot number T013727 was determined to be valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported and establish as 21-APR-2022) (strength, dose, route of administration and anatomical location were not provided).  On 25-AUG-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (inappropriate schedule of product administration) for prophylaxis (lot number U002399 was determined to be valid for varicella virus vaccine live (oka/merck), expiration date reported and establish as 22-JAN-2023) (strength, dose, route of administration and anatomical location were not provided).  No adverse event reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; PROQUAD was administered on 08/24/2021 following a temperature excursion.; This spontaneous report was received from an office manager and refers to a patient of unspecified age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 24-AUG-2021, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella, and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (concentration, dose, vaccination scheme frequency, route, and anatomical site of administration were not reported; lot number U009260 was verified to be a valid lot number with an expiration date reported and established as 19-SEP-2022) for prophylaxis. It was reported that the administered vaccine experienced a temperature excursion of minus (-)10.7 degrees Celsius (°C) for a time frame of192 hours (product storage error). If there was any previous temperature excursion this information was not reported. No additional adverse event was provided.  This is one of two reports reported by the same reporter. Sender's Comments: US-009507513-2108USA007542.
Age: 0.92
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; the patient was accidentally administered VARIVAX instead of VAXELIS; 11 month old patient was accidentally administered VARIVAX; This spontaneous report was received from a consumer via representative and refers to an 11-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 23-AUG-2021, the patient was accidently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter (formulation, route of administration, lot#, expiry date were not reported) for prophylaxis instead of intended diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS). It was reported that there was no further adverse event.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Administration following an excursion event; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 24-AUG-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella, and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human albumin) (PROQUAD) lot #T031825 was confirmed to be valid, expiration date 16-MAR-2022, for prophylaxis (dose, route, and site of administration were not reported). The administered dose was exposed to the temperature of -10.7 degrees Celsius for 192 hours. No additional adverse event was provided.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report has been received from a lawyer and the patient, via a Plaintiff from a case in litigation for ZOSTAVAX (MARRS # 2105USA000853), concerning a currently 67-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  In October 2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) for prophylaxis and with influenza vaccine (FLU) (doses, routes, anatomical location, lot # and expiration dates were not reported).  On an unknown date, the patient experienced sore arm. At the reporting time, the outcome of sore arm was unknown.     The reporter considered sore arm to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) and influenza vaccine (FLU).; Sender's Comments:  US-009507513-2105USA000853:
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Feeling hot, Injected limb mobility decreased, Pain in extremity
Clinical narrative: red under where it was injected; felt warm; elbow pain; hurt down to my elbow; Still hurts to left my arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  In August 2021, the patient received the 1st dose of Shingles vaccine. In August 2021, several hours after receiving Shingles vaccine, the patient experienced pain in arm, injected limb mobility decreased and pain in elbow. On 20th August 2021, the patient experienced erythema of extremities and feeling of warmth. On an unknown date, the outcome of the pain in arm, injected limb mobility decreased and pain in elbow were not recovered/not resolved and the outcome of the erythema of extremities and feeling of warmth were recovering/resolving.   It was unknown if the reporter considered the pain in arm, injected limb mobility decreased, erythema of extremities, feeling of warmth and pain in elbow to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingles vaccine and hurt bad down elbow a few hours later, and still hurts to lift patient arm. it's red under where it was injected felt warm last night less today. The patient stated that he/she didn't expect that. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Off label use
Clinical narrative: gave me an injection at the time I had the shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of off label use in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The doctor gave an injection at the time patient had the shingles, which led to off label use. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: that vaccine hurts; This case was reported by a consumer via  interactive digital media and described the occurrence of pain 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 pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient stated that vaccine hurt. The patient further specified that the patient's tetanus shot didn't hurt at all, for reference but if shingles was worse and the patient heard it was, then the patient regret nothing. No contact details were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: 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, 1 day 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 details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient received Shingles vaccine and experienced sickness. For tolerance of 2nd dose of Shingles vaccine, refer case US2021AMR178221, reported by the same reporter. This case has been linked to US2021AMR178143, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178143:comment response case US-GLAXOSMITHKLINE-US2021AMR178221:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Vaccine positive rechallenge
Clinical narrative: sick; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (1st dose received on an unknown date, refer case US2021AMR178217).   On 20th August 2021, the patient received the 2nd dose of Shingles vaccine. On 21st August 2021, 1 days after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On 22nd August 2021, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient just got second shot on Friday. The patient was sick the next day after first so the patient expected to be sick 21st August 2021 as well and sure enough the patient was. The patient reported that on the day of reporting all was well. This case has been linked to US2021AMR178143, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178143:comment response case US-GLAXOSMITHKLINE-US2021AMR178217:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: broke out with chicken pox; This case was reported by a consumer via  interactive digital media and described the occurrence of chickenpox in a male 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, less than a week after receiving Shingles vaccine, the patient experienced chickenpox. On an unknown date, the outcome of the chickenpox was unknown.   It was unknown if the reporter considered the chickenpox to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingles vaccine he broke out with chicken pox. The follow-up would not possible as no contact details were available. For tolerance of 2nd dose of Shingles vaccine, refer link case US2021AMR178363.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178363:Same reporter