chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: an unspecified patient received a dose of improperly stored PNEUMOVAX23; No adverse effect reported.; Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.       On an unknown date, the patient received a dose of improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S027047, expiration date 20-MAY-2021; dose, strength and route were unknown), which was exposed to an temperature excursions prior to being administered above 47 degrees Fahrenheit (48.13 degrees Fahrenheit) for 65 hours 30 minutes. There was no previous temperature excursion. The data logger was involved. No adverse effects were reported.   This is a non-valid case due to lack of patients' identifier.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Seizure
Clinical narrative: seizure; complaining of headaches; This spontaneous report was received from a consumer referring to her son, a 16-year-old male patient with Penicillin allergy. The patient had no concomitant medication and no pertinent medical history.    On 18-JUL-2019 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) (frequency: 3 doses, lot# reported as R032766; route of administration and expiration date were not reported) in the left arm for prophylaxis. On an unknown date in 2019 (reported as "a couple of days after 18-JUL-2019") the patient started complaining of headaches. On 29-OCT-2019, the patient was taken to the physician to seek medication attention for the headaches. On the same day, the patient administered the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot# reported as 1621929; dose, route of administration and expiration date were unknown). On 13-NOV-2019, the patient had a seizure. On the same day, the patient went to the emergency room at hospital. The patient was treated with anti-seizure medication levetiracetam(KEPPRA) and was admitted overnight. On 14-NOV-2019, the patient was discharged.   The reporter indicated the patient would not be receiving the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). There was no lab diagnostics/studies performed. The outcome of seizure and headaches was recovered. The causality assessment was not provided.   Upon interval review, seizure was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac failure, Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: heart failure exacerbation; COPD exacerbation; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. On or around 16-NOV-2017, the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(dose, route of administration, anatomical location, lot#, expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as "shortly after receiving zoster vaccine live(ZOSTAVAX)"), the patient suffered and was hospitalized with chronic obstructive pulmonary disease (COPD) exacerbation and heart failure exacerbation. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the zoster vaccine live(ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   COPD exacerbation and heart failure exacerbation were considered as disability. Upon internal review, heart failure exacerbation was determined to be medically significant.
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Adverse event
Clinical narrative: severe adverse events symptoms; It is unclear which brand name product the patient received; This spontaneous report was received from a consumer (patient's father) via social media regarding a patient of unknown age.     The patient's concomitant medications, pertinent medical history and drug reactions/allergies was not provided.      On an unknown date the patient was vaccinated with HPV vaccine (manufacturer unknown) (product origin unknown) for prophylaxis.  It was unclear which brand name product the patient received.  On an unknown date, the patient had experienced severe adverse events (symptoms).   The outcome of adverse event was unknown. Causality was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: area of the inflammation was about 3 inch by 5 inch; Site of the injection was raised and about 5 mm in diameter.; The inflammation was quite pink; This case was reported by a consumer via call center representative and described the occurrence of injection site inflammation in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included systemic lupus erythematosus.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site inflammation, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site inflammation, injection site swelling and injection site erythema were unknown.   It was unknown if the reporter considered the injection site inflammation, injection site swelling and injection site erythema to be related to Shingrix.   Additional details were provided as follows: The reporter was the patient's husband. The age at vaccination was not reported. The patient had lupus. The reporter described the reaction as, site of the injection was raised and about 5 mm in diameter. The area of the inflammation was about 3 inch by 5 inch and the inflammation was quite pink. Again, the reporter asked to send a photo of patient's reaction if anyone who would like to see it at any time. The patient's PA (physician assistant) recommended that, she should not get a 2nd shot. The reporter wondered how much protection could protect the patient. The reporter asked about the efficacy of receiving just one Shingrix vaccine injection instead of two shots to which the GlaxoSmithKline representative replied that, during clinical trials, evaluation of the efficacy of Shingrix started 1 month after the 2nd dose, therefore, the efficacy of the vaccine is unknown if the second dose is not received.
Age: 18.0
Sex: U
Vaccine: MENB
Symptoms: Malaise, Pyrexia
Clinical narrative: Malaise; Fever; This case was reported by a nurse via sales rep and described the occurrence of malaise in a 18-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced malaise and fever. The patient was treated with ibuprofen. On an unknown date, the outcome of the malaise and fever were unknown.   The reporter considered the malaise and fever to be related to Bexsero.  Additional information was received as follows: The patient experienced malaise and fever when vaccinated with Bexsero. The reporter felt symptoms related to vaccine. The patient took ibuprofen for symptoms. This was 1 out of 2 cases reported by same reporter. The reporter did not agreed to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Left arm is still hurts & in pain; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and left arm was still hurts and in pain. The patient talked to doctor a week after shot and told her about the soreness and pain. It was decided to let some time go by to see if the issue resolved itself. To date this issue has not been resolved.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram, Dizziness, Dyspnoea, Electrocardiogram, Investigation normal
Clinical narrative: Passed out; vomit; nauseous / Nausea worse; dizzy; shortness of breath; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fish allergy.   On 20th November 2019, the patient received Shingrix. In November 2019, 10 hrs after receiving Shingrix, the patient experienced nausea, dizziness and shortness of breath. On 21st November 2019, the patient experienced passed out (serious criteria GSK medically significant) and vomiting. On an unknown date, the outcome of the passed out, shortness of breath and vomiting were unknown and the outcome of the nausea and dizziness were recovered/resolved.   It was unknown if the reporter considered the passed out, nausea, dizziness, shortness of breath and vomiting to be related to Shingrix.  Additional case details were reported as follows: The patient was excellent in health and very allergic to shell fish. The patient received vaccine at about 3:00 pm. About 10 hours later, patient felt nauseous, dizzy and experienced shortness of breath. The next morning, 1 day after vaccination patient became much more nauseous and dizzy. The patient passed out and his wife had to call 911. The nausea got worse and patient began to vomit (not food but both dry heaves and green bile). The hospital performed various tests (ekg, ct scans, xrays, etc). The patient did not have a heart attack, a stoke, and that his lungs, brain and blood pressure were normal.  After follow up with doctor a week later also found no abnormalities. The nausea went away but the dizziness persisted for a few days and was gone now. The patient asked whether it was possible that what he experienced was a severe side effect. The reporter requesting consent to follow up.      Lab Comments: on an unknown date lab test was performed.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of consciousness, Nausea, Vomiting, X-ray
Clinical narrative: Passed out; vomit; nauseous / Nausea worse; dizzy; shortness of breath; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fish allergy.   On 20th November 2019, the patient received Shingrix. In November 2019, 10 hrs after receiving Shingrix, the patient experienced nausea, dizziness and shortness of breath. On 21st November 2019, the patient experienced passed out (serious criteria GSK medically significant) and vomiting. On an unknown date, the outcome of the passed out, shortness of breath and vomiting were unknown and the outcome of the nausea and dizziness were recovered/resolved.   It was unknown if the reporter considered the passed out, nausea, dizziness, shortness of breath and vomiting to be related to Shingrix.  Additional case details were reported as follows: The patient was excellent in health and very allergic to shell fish. The patient received vaccine at about 3:00 pm. About 10 hours later, patient felt nauseous, dizzy and experienced shortness of breath. The next morning, 1 day after vaccination patient became much more nauseous and dizzy. The patient passed out and his wife had to call 911. The nausea got worse and patient began to vomit (not food but both dry heaves and green bile). The hospital performed various tests (ekg, ct scans, xrays, etc). The patient did not have a heart attack, a stoke, and that his lungs, brain and blood pressure were normal.  After follow up with doctor a week later also found no abnormalities. The nausea went away but the dizziness persisted for a few days and was gone now. The patient asked whether it was possible that what he experienced was a severe side effect. The reporter requesting consent to follow up.      Lab Comments: on an unknown date lab test was performed.
Sex: F
Vaccine: VARZOS
Symptoms: Glaucoma
Clinical narrative: Glaucoma; This case was reported by a physician via sales rep and described the occurrence of glaucoma in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced glaucoma (serious criteria GSK medically significant). On an unknown date, the outcome of the glaucoma was unknown.   The reporter considered the glaucoma to be probably related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was diagnosed with glaucoma soon after the injection. The patient wanted it reported to the company fearing there could be a relationship with the vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia, Anaemia, Blood iron decreased, Diarrhoea, Dizziness
Clinical narrative: low iron; incontinence; memory loss; dizziness; felt sick/thinks she might have passed out; anemia; headache; vomiting; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of anemia in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 16th August 2019, 1 days after receiving Shingrix, the patient experienced anemia, headache, vomiting, diarrhea, dizziness and feeling unwell. On 18th August 2019, the patient experienced memory loss. On 19th August 2019, the patient experienced incontinence. In September 2019, the patient experienced iron decreased. On an unknown date, the outcome of the anemia, memory loss and iron decreased were unknown and the outcome of the headache, vomiting, diarrhea, incontinence and dizziness were recovered/resolved and the outcome of the feeling unwell was recovering/resolving.   It was unknown if the reporter considered the anemia, headache, vomiting, diarrhea, memory loss, incontinence, dizziness, iron decreased and feeling unwell to be related to Shingrix.  Additional case details were reported as follows: The patient felt sick with headache, dizziness, vomiting and diarrhea.  On 18th August 2019, 3 days after receiving Shingrix, the patient was very sick and did not remember that evening at all.  Four days after receiving Shingrix, when the patient woke up around 3 to 4 am, her nightgown was soaked in urine and she thought she might have passed out. In September 2019, the patient had her routine physical with her doctor and standard blood tests showed her iron levels were down to 10 ng.   The patient was diagnosed with anemia.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise, Urinary incontinence, Vomiting
Clinical narrative: low iron; incontinence; memory loss; dizziness; felt sick/thinks she might have passed out; anemia; headache; vomiting; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of anemia in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 16th August 2019, 1 days after receiving Shingrix, the patient experienced anemia, headache, vomiting, diarrhea, dizziness and feeling unwell. On 18th August 2019, the patient experienced memory loss. On 19th August 2019, the patient experienced incontinence. In September 2019, the patient experienced iron decreased. On an unknown date, the outcome of the anemia, memory loss and iron decreased were unknown and the outcome of the headache, vomiting, diarrhea, incontinence and dizziness were recovered/resolved and the outcome of the feeling unwell was recovering/resolving.   It was unknown if the reporter considered the anemia, headache, vomiting, diarrhea, memory loss, incontinence, dizziness, iron decreased and feeling unwell to be related to Shingrix.  Additional case details were reported as follows: The patient felt sick with headache, dizziness, vomiting and diarrhea.  On 18th August 2019, 3 days after receiving Shingrix, the patient was very sick and did not remember that evening at all.  Four days after receiving Shingrix, when the patient woke up around 3 to 4 am, her nightgown was soaked in urine and she thought she might have passed out. In September 2019, the patient had her routine physical with her doctor and standard blood tests showed her iron levels were down to 10 ng.   The patient was diagnosed with anemia.
Age: 42.0
Sex: F
Vaccine: VARZOS
Symptoms: Off label use, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Off label use; A 42 year old reported that received the first dose of Shingrix; Right arm was pretty sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 42-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On 26th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 26th June 2019, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced pain in arm and off label use. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the inappropriate age at vaccine administration and off label use were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was received as follows: A 42 year old female received the first dose of Shingrix, which led to inappropriate age at vaccine administration. The pharmacy was refusing the patient to provide the second dose because of her age due to state law. The patient had a prescription from her physician due to her recurrent case of shingles.  She also reported that her right arm was pretty sore for two to three days after the vaccination and then it resolved. The reporter did not consent to follow up.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site
Clinical narrative: aches and pain in his left arm; can't lift arm; received the vaccine closer to the top of his shoulder; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hernia repair (on 28th October 2019, had hernia operation) and knee operation (had knee operation). Previously administered products included Shingrix (1st dose received on 3rd June 2019 midway between elbow and shoulder in left arm and had no reaction or side effects). Concurrent medical conditions included knee arthritis (had knee arthritis).   On 25th November 2019, the patient received the 2nd dose of Shingrix. On 25th November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injected limb mobility decreased and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received 2nd dose of Shingrix in the lefarm. on 3rd June 2019, the patient received 1st dose of Shingrix midway between elbow and shoulder in the left arm and had no reaction or side effects.  The patient reported that, couple of hours after 2nd dose of vaccination, had aches and pain in his left arm  where received the vaccine and couldn't lift the arm. The patrient stated that, 2nd dose of Shingrix was received closer to the top of his shoulder, which led to vaccine administered at inappropriate site. The reporter was asked, if the 2nd dose of Shingrix was given properly because of the side effects experienced. The reporter consented to follow up.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number 47JA3, expiry date 12th May 2020) for prophylaxis.   On 3rd June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 5 months after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The pharmacist on the line with a patient who developed a mild case of shingles recently.  The reporter consented to follow up. The Caller stated the patient's physician just called him, so he assumes it started within the last couple or few days. It was ongoing and the patient was being prescribed acyclovir.
Age: 90.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: fatigue; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 90-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th November 2019, the patient received Shingrix. On 25th November 2019, immediately after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right arm. The patient received the vaccine late afternoon and felt fatigued shortly after on day of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a physician via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that the patient developed a case of Shingles after receiving Shingrix.  The reporter did not consent to follow up.  Collected from chat and provider did not feel it was a vaccination failure and declined to provide additional.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Mobility decreased, Musculoskeletal pain, Pain, Paraesthesia, Pyrexia
Clinical narrative: - pt states she got her 2nd dose of bexero 2 d ago.  At the time of the shot she got some tingling down her arm that resolved and then shoulder started hurting that night and is not getting better.  Hurts to move the shoulder/arm.  No help with tylenol or motrin.  Ice and heat help some but only while actually being on her skin.  No known fever at home, did have low grade here.  No other sx.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Neck pain, Pain, Pain in extremity, Pneumonia
Clinical narrative: PT HAD SORE/ARM FOR A FEW DAYS FOLLOWING INJECTION. FEW DAYS LATER, HE SPIKED A FEVER AND DR ADVISED HIM TO GO TO ER. PT WAS DIAGNOSED WITH PNEUMONIA. SINCE THE INJECTION, PT STILL HAS PAIN AT INJECTION SITE AND SHOOTING PAIN FROM ARM TO SHOULDER TO NECK WHEN RAISING ARM (LIKE WHEN EATING)
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: PT HAD SORE/ARM FOR A FEW DAYS FOLLOWING INJECTION. FEW DAYS LATER, HE SPIKED A FEVER AND DR ADVISED HIM TO GO TO ER. PT WAS DIAGNOSED WITH PNEUMONIA. SINCE THE INJECTION, PT STILL HAS PAIN AT INJECTION SITE AND SHOOTING PAIN FROM ARM TO SHOULDER TO NECK WHEN RAISING ARM (LIKE WHEN EATING)
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Fatigue, Impaired work ability, Mobility decreased, Oropharyngeal pain
Clinical narrative: Sore throat, extremely sore arm (first day could barely lift arm), 102 degree temp one time only spike but 101 consistently till morning of next day before returning to normal plus body body aches and sinus drainage.  Morning of day 3 (today, 12/5/2019), arm remains sore but has improved, no fever, ongoing sinus drainage and fatigue. Since injection 3 days  ago unable to perform duties as pilot.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Paranasal sinus hypersecretion
Clinical narrative: Sore throat, extremely sore arm (first day could barely lift arm), 102 degree temp one time only spike but 101 consistently till morning of next day before returning to normal plus body body aches and sinus drainage.  Morning of day 3 (today, 12/5/2019), arm remains sore but has improved, no fever, ongoing sinus drainage and fatigue. Since injection 3 days  ago unable to perform duties as pilot.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles rash onhis left waist; Rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. In September 2019, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient after vaccination broke out with singles. The patient stated that probably was coming down with them. The patient asked whether to get quadravalent flue shot and 2nd dose of Shingrix. The patient really do not like adverse reactions. The patient consented to follow up.   Follow up information was received from the pharmacist on 14th November 2019: The reporter followed up with Medical Information on 14thNovember 2019 and stated the shingles rash was located on his left waist and his physician prescribed Valcyclovir and a Medrol dose pack, which he has completed. In September 2019, 3 days after receiving Shingrix, the patient experienced rash.  On an unknown date, the outcome of the rash were unknown.  It was unknown if the reporter considered the rash to be related to Shingrix. No further details provided at the time of reporting.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The batch number was not reported. The patient received Shingrix and had shingles. The reporter consented to follow up. No additional information was provided.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain in extremity
Clinical narrative: arm pain--suggested patient go to MD office, no follow-up from patient.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: administered a dose of proquad intramuscularly instead of subcutaneously; No adverse effect; This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 14-NOV-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), of one dosage form (lot S012531 exp.date : 31-OCT-2020) via intramuscularly instead of subcutaneously (incorrect route of product administration) for prophylaxis. No adverse events were reported. No product quality compliant was reported. The outcome of incorrect route of product administration and no adverse event was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; the patient was administered improperly stored PROQUAD; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. The patient's pertinent medical history and drug reactions/allergies were not reported.  On 19-MAR-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose and route were unknown, lot# R020678, expiration date 15-JAN-2020) for prophylaxis, which was reported as improperly stored (temperature (32.57 degrees Fahrenheit) 15 degrees Fahrenheit to 46 degrees Fahrenheit, time frame was 22 hours) (product storage error). There was no previous temperature excursion. Data logger was involved. No additional adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; patient was inadvertently administered a dose Varivax, that was improperly stored; This spontaneous report was received from a Research Coordinator concerning a patient of unknown age and gender. Concomitant therapies included sterile diluent. The patient's pertinent medical history, concurrent conditions and drug allergies or reactions were not reported.    On 19-NOV-2019, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number 2005084 and expiration date 19-FEB-2021) for prophylaxis (dosage schedule, route, and anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion of -13.8 °C degrees Celsius for 51 minutes, as recorded by a data logger. No previous temperature excursion was reported. There was no adverse effect reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles or herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. Patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not provided) in 2016, as prescribed and/or administered by physician at a Health Center for the long-term prevention of herpes zoster or shingles. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by the physician at the Health Center, for shingles or herpes zoster (onset date not provided). As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; significant medical and related expenses as a result of these injuries, including but not limited to costs for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages. The outcome of the event was unknown. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Dyspnoea, Herpes zoster, Pain, Rash
Clinical narrative: permanent scarring; balance and breathing problems; balance and breathing problems; a rash and painful shingles on her neck and face; Information has been received from a lawyer concerning a case in litigation and refers to a female patient of an unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. On 28-JUN-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), in November 2017, the patient suffered a rash and painful shingles on her neck and face that resulted in permanent scarring as well as balance and breathing problems. These conditions resulted in prolonged medical treatment. As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered severe injuries and disfigurement not present prior to using the product, which were directly caused by the zoster vaccine live (ZOSTAVAX) vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and has suffered economic losses due to her inability to work. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and disfiguring personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of rash and painful shingles on her neck and face that resulted in permanent scarring, balance and breathing problems were considered to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Scar
Clinical narrative: permanent scarring; balance and breathing problems; balance and breathing problems; a rash and painful shingles on her neck and face; Information has been received from a lawyer concerning a case in litigation and refers to a female patient of an unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. On 28-JUN-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), in November 2017, the patient suffered a rash and painful shingles on her neck and face that resulted in permanent scarring as well as balance and breathing problems. These conditions resulted in prolonged medical treatment. As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered severe injuries and disfigurement not present prior to using the product, which were directly caused by the zoster vaccine live (ZOSTAVAX) vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and has suffered economic losses due to her inability to work. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and disfiguring personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of rash and painful shingles on her neck and face that resulted in permanent scarring, balance and breathing problems were considered to be disabling.
Sex: M
Vaccine: RV5
Symptoms: Choking, Oral administration complication
Clinical narrative: an unspecified patient "was choking" after receiving a dose of ROTATEQ on an unspecified date "about 2 months ago".; This spontaneous report was received from a physician, referring to a 2-months-old male patient. The patient had no concurrent conditions, concomitant medications, and previously drug reactions or allergies. The patient's medical history included a premature birth (reported as preemie) and myocele.   On an unspecified date in October 2019, reported as "about 2 months ago", the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orallly, as prophylaxis (strength, formulation, dose number, dose, frequency, lot number and expiration date were unknown by the reporter).  It was reported that, after the vaccination with rotavirus vaccine live, oral pentavalent (ROTATEQ), the patient started choking, however, it was reported that the patient recovered during the same office visit. There was no treatment given to the patient per the event, no laboratories or exams were performed to the patient, also it was reported that the event was not related to cancer or overdose, and that the patient did not seek medical attention.  At the time of this report, the causality assessment between the event choking and the vaccination with rotavirus vaccine live, oral pentavalent (ROTATEQ) was not provided.   Upon internal review, the event choking was considered to be medically significant.
Sex: F
Vaccine: FLUX
Symptoms: Gingival swelling, Glossodynia, Lip pain, Pain in extremity
Clinical narrative: Pain in arm; Pain in lips; Pain in tongue; Gums swelling; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm, lip pain, tongue pain and gum swelling. On an unknown date, the outcome of the pain in arm, lip pain, tongue pain and gum swelling were unknown.   It was unknown if the reporter considered the pain in arm, lip pain, tongue pain and gum swelling to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Flu shot with unspecified dose and experienced pain in arm, pain in lips, pain in tongue and gums swelling.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Muscle pain / General muscle soreness; Fever; This case was reported by a pharmacist via call center representative and described the occurrence of myalgia in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 9DE73, expiry date 6th December 2021) for prophylaxis.   On 1st November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, less than a month after receiving Shingrix, the patient experienced myalgia and fever. On an unknown date, the outcome of the myalgia and fever were not recovered/not resolved.   It was unknown if the reporter considered the myalgia and fever to be related to Shingrix.  Additional details were provided as follows: The patient experienced muscle pain, fever and general muscle soreness.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Joint swelling, Limb discomfort, Muscular weakness, Musculoskeletal pain
Clinical narrative: hand weakness; arm pain; neck pain; shoulder pain; hand discomfort; swollen fingers; swollen joints/swollen knuckles; painful joints; This case was reported by a nurse via call center representative and described the occurrence of limb discomfort in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included drug allergy (experienced reaction in the past,prior to receiving Shingrix where she could not control her body heat.).   On 10th December 2018, the patient received the 1st dose of Shingrix. On 10th December 2018, less than a day after receiving Shingrix, the patient experienced hands weakness of. In December 2018, the patient experienced limb discomfort, swelling of fingers, swollen joints, joint pain, pain in arm, neck pain and shoulder pain. On an unknown date, the outcome of the limb discomfort, swelling of fingers, swollen joints, joint pain, pain in arm, neck pain and shoulder pain were recovered/resolved and the outcome of the hands weakness of was not recovered/not resolved.   It was unknown if the reporter considered the limb discomfort, swelling of fingers, swollen joints, joint pain, hands weakness of, pain in arm, neck pain and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on her left deltoid.  It was reported that, within a couple of days of receiving Shingrix, the patient experienced discomfort left hand, fingers became swollen, joints were swollen, painful joints.  Right away, after receiving Shingrix, the patient also experienced weakness in left hand to the point that she could not make fist. The pain radiated to her arm, left neck and left shoulder. She spoke with her physician and they opted not to give her the the second dose of Shingrix.  At the time of reporting, it was almost a year left discomfort and knuckles on her left hand had not gone down yet but they were still swollen. The patient was prescribed prednisone and steroid cream and she did not use either one. The reporter consented to follow up. The outcome reported for all AES in the structured field is "recovering" instead of "not resolved" (outcome uploaded in database).
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: hand weakness; arm pain; neck pain; shoulder pain; hand discomfort; swollen fingers; swollen joints/swollen knuckles; painful joints; This case was reported by a nurse via call center representative and described the occurrence of limb discomfort in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included drug allergy (experienced reaction in the past,prior to receiving Shingrix where she could not control her body heat.).   On 10th December 2018, the patient received the 1st dose of Shingrix. On 10th December 2018, less than a day after receiving Shingrix, the patient experienced hands weakness of. In December 2018, the patient experienced limb discomfort, swelling of fingers, swollen joints, joint pain, pain in arm, neck pain and shoulder pain. On an unknown date, the outcome of the limb discomfort, swelling of fingers, swollen joints, joint pain, pain in arm, neck pain and shoulder pain were recovered/resolved and the outcome of the hands weakness of was not recovered/not resolved.   It was unknown if the reporter considered the limb discomfort, swelling of fingers, swollen joints, joint pain, hands weakness of, pain in arm, neck pain and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on her left deltoid.  It was reported that, within a couple of days of receiving Shingrix, the patient experienced discomfort left hand, fingers became swollen, joints were swollen, painful joints.  Right away, after receiving Shingrix, the patient also experienced weakness in left hand to the point that she could not make fist. The pain radiated to her arm, left neck and left shoulder. She spoke with her physician and they opted not to give her the the second dose of Shingrix.  At the time of reporting, it was almost a year left discomfort and knuckles on her left hand had not gone down yet but they were still swollen. The patient was prescribed prednisone and steroid cream and she did not use either one. The reporter consented to follow up. The outcome reported for all AES in the structured field is "recovering" instead of "not resolved" (outcome uploaded in database).
Sex: U
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: wants to know how long does the pain in the arm should last for a pateint that 2 years after the vaccination still has pain.; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unspecified date in 2017 at single dose for immunisation .  The patient medical history and concomitant medications were not reported.  It was reported that 2 years after the vaccination, patient still had pain in the arm. The pharmacist wanted to know how long did the pain in the arm should last for this patient that 2 years after the vaccination still has pain. Outcome of the event was not recovered. Information on the batch number has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: pain and weakness of left upper arm; normal passive ROM, but is unable to actively raise her arm past 15 degrees
Age: 54.0
Sex: F
Vaccine: FLUC4, PPV, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site warmth, Nausea
Clinical narrative: 11/22 nauseated  11/23  dime sized red area lower bicep left arm  11/24  50 cent size red area lower bicep left arm "warm to touch" , normal ROJM  r/t PCP for f/u   11/25  PCP  dx cellulitis  rx antibiotics  not over vaccination site did not feel it was related    12/05  PCP permission for Health Department to revaccinate for Shingrix and Twinrix