chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Hypoaesthesia oral, Rash
Clinical narrative: The patient returned to the pharmacy two days after receiving the Shingrix vaccination with a shingle like rash from the back of the scalp , down the nech and onto the from of the chest. The patient was refered to her primary care physician, Dr.  When the patient reported that she was unable to be treated by her physician, the pharmacist reached out to the physician, who instructed the pharmacist to treat the patient because the pharmacy administered the vaccination, not the doctor.  Since that is outside of the scope of practice of a pharmacist, the patient was refered to urgent care, where she recieved a prescription of valacyclovir 1 gram to be taken 3 times a day for 7 days. As of 7/3/2020, she says she is feeling better and reports only occasional headache.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Muscle spasms, Nausea, Tension, Vomiting
Clinical narrative: PATIENT TENSED UP DURING THE SHOT, INDICATED IT WAS PAINFUL.  ABOUT 5 MIN LATER, HER BACK STARTED SPASMING FROM NECK TO HIP LEVEL, PATIENT BECAME NAUSEOUS AND VOMITED.  PATIENT WAS GIVEN COOL COMPRESSES AND STATED THAT SHE HAD JUST COME FROM HER PHYSICAL THERAPIST (WHOM WE CALLED AND  WHO INDICATED THAT PATIENTS THERAPY WAS MORE INTENSE THAN PREVIOUS SESSIONS)  PATIENT SAID SHE HAD NOT BEEN LIFTING QUITE RIGHT.   AFTER ABOUT 15 MINUTES THE NAUSEA AND SPASMS SUBSIDED, SHE FELT BETTER AND DECIDED TO GO HOME.SHE CALLED HER FAMILY MEMBER AND WAS GOING HOME TO NAP. AND MANAGEMENT HELPED HER OUT.  PATIENT DID NOT INDICATE ANY BREATHING PROBLEMS WHEN SPECIFICALLY ASKED. PATIENT APPEARS TO HAVE RECOVERED FROM INCIDENT WITHOUT FURTHER INTERVENTION.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, RV5, UNK, UNK
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever and hives. Fever is gone and hives have lessened but are still present
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Fatigue, Headache, Hyperacusis, Hypoaesthesia
Clinical narrative: Extreme fatigue, extreme headache, fever 100.8, arm and chest numbness, sensitivity to light and sounds, bruising along lower arm.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Photophobia, Pyrexia
Clinical narrative: Extreme fatigue, extreme headache, fever 100.8, arm and chest numbness, sensitivity to light and sounds, bruising along lower arm.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin reaction
Clinical narrative: Localized skin reaction. No s/sx of systemic reaction. Occurrence on 07/01/2020
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyskinesia, Loss of personal independence in daily activities, Paraesthesia
Clinical narrative: Patient states in evening her leg starts to vibrate and tingle that prevents her from going to the gym. Reaction started the evening of immunization.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: First vaccination no issues or SE reported. Second immunization was fine for first few days. About 5 days ago, patient reports that the site of injection became red, hot to the touch, hard to the touch, and itches. Patient reports no fever. Patient is out of town and does not want to see an md. Advised patient if became worse or did not improve to contact md.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pain, Swelling
Clinical narrative: Soreness, slight swelling, slight nausea, tired
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Acne, Chills, Dermatitis acneiform, Fatigue
Clinical narrative: Pain & redness at injection site - over 3 days.  Shivering and fever, muscle ache, and tiredness about 24 hours.  Upset stomach and headache about 3 days.   It was just annoying and unexpected.  It took a day out of my life to recover.  I didn't go to the doctor's. (Yes, it was better than getting the Shingles.) I believe for my first dose, I was achy and yucky for a day.  The 2nd dose was worse.  I think I had some pimple like spots after the first dose.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: Pain & redness at injection site - over 3 days.  Shivering and fever, muscle ache, and tiredness about 24 hours.  Upset stomach and headache about 3 days.   It was just annoying and unexpected.  It took a day out of my life to recover.  I didn't go to the doctor's. (Yes, it was better than getting the Shingles.) I believe for my first dose, I was achy and yucky for a day.  The 2nd dose was worse.  I think I had some pimple like spots after the first dose.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Pain & redness at injection site - over 3 days.  Shivering and fever, muscle ache, and tiredness about 24 hours.  Upset stomach and headache about 3 days.   It was just annoying and unexpected.  It took a day out of my life to recover.  I didn't go to the doctor's. (Yes, it was better than getting the Shingles.) I believe for my first dose, I was achy and yucky for a day.  The 2nd dose was worse.  I think I had some pimple like spots after the first dose.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Headache, Myalgia
Clinical narrative: Headache chills weakness heart palpitations muscle and joint pain
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: Headache chills weakness heart palpitations muscle and joint pain
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: For 8 days I have had a debilitating headache and chills that Motrin and aspirin get me a little relief and maybe 4 hour! I am on day 8!!!
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Hyperhidrosis, Influenza like illness, Injection site erythema
Clinical narrative: On 7/2/20 Pt came in to let us know that she had a reaction to her shingrix vaccine.  7/1/20 : pt noticed hard lump, hot , red and itchy at site of injection. Pt states it hurt a bit. On tues/wed of the same week pt reported having flu like sx; aches, joint pain, chills and sweat. But pt reports feeling better 7/2/20  I calle dmd at 1130 am to inform md of situation. Left a message. At 225pm staff called back fr md office and I Faxed over the pts adverse rxn and asked md to follow up w pt. Will not re-challenge pt with second dose.  7/2/20 Pt states she is feeling  better but the redness at site of reaction is still present.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pruritus, Injection site warmth, Pain
Clinical narrative: On 7/2/20 Pt came in to let us know that she had a reaction to her shingrix vaccine.  7/1/20 : pt noticed hard lump, hot , red and itchy at site of injection. Pt states it hurt a bit. On tues/wed of the same week pt reported having flu like sx; aches, joint pain, chills and sweat. But pt reports feeling better 7/2/20  I calle dmd at 1130 am to inform md of situation. Left a message. At 225pm staff called back fr md office and I Faxed over the pts adverse rxn and asked md to follow up w pt. Will not re-challenge pt with second dose.  7/2/20 Pt states she is feeling  better but the redness at site of reaction is still present.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Myalgia
Clinical narrative: Muscle tenderness on 07/01/2020.  Right upper arm swelling, erythema covering approximately 2/3 of upper arm on 07/02/2020 Slight reduction in swelling and erythema on 07/03//2020 with onset of itching.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Nausea, Pain
Clinical narrative: violent nausea and vomiting for 36 hours; headache, body ache, incapacitating weakness (could not get out of bed for 36 hours) and poor speaking volume.. the 3rd day I could eat light meals and got exhausted when climbing a flight of stairs.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Speech disorder, Vomiting
Clinical narrative: violent nausea and vomiting for 36 hours; headache, body ache, incapacitating weakness (could not get out of bed for 36 hours) and poor speaking volume.. the 3rd day I could eat light meals and got exhausted when climbing a flight of stairs.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Injection site pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Pt called to report that he had a fever of 100F on Friday night and had symptoms of dizziness and chills and congestion throughout the day on Friday.  He also has some soreness at the injection site.  He said that he was feeling better today, but still had some congestion.  He said he took a walk for nearly an hour today with no issues.     He stated that he was given Shingrix on 7/1/20 in the afternoon and wondered whether the vaccination caused the symptoms.  Told him I was unsure and that it may be a good idea to get evaluated by his Dr.  He said his Dr was closed and that he was going to call urgent care for advice.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Nausea, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever Body Ache headache  Nausea
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Disturbance in attention, Fatigue, Headache
Clinical narrative: General fatigue - never experienced before with any other vaccines Headache, inability to concentrate Weakness
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Rash
Clinical narrative: Ongoing Blisters and rashes on arms accompanied with itching. Blisters tend to appear in pairs and rash spreads between the two. I am currently dealing with four individua outbreaks.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Injection site inflammation, Myalgia, Pyrexia
Clinical narrative: Fever, chills, muscle soreness, lack of energy, inflamed shot site.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Skin discolouration
Clinical narrative: Muscle soreness for 7 or 8 days. Light pink discoloration. Oval shaped about 1 inch wide and 3 inches long. Lasted about 4 days.
Age: 19.0
Sex: M
Vaccine: UNK
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Patient developed cellulitis after injection. The site is warm to touch with erythema. Patient stated " I received a meningococcal vaccine but I'm not sure which one"
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: Patient had red bumps all over body that she believes were hives. She went to a provider who did not know what could have caused it.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient awoke the next morning with some pain in the arm and redness near the injection site. Patient is unsure if she ?slept wrong?. Redness was still present when she came into the pharmacy three days later.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Injection site discolouration, Injection site reaction, Injection site warmth, Pyrexia, Rash erythematous
Clinical narrative: Started as a small red rash with a dark purple ring around the injection site the following morning.   At around 24 hours out, the rash began to spread around the thigh.  At 48+ hours out, almost the entire thigh is covered in a rash, hot to the touch, with a 99.9 fever.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Influenza like illness, Pain, Pyrexia
Clinical narrative: Pt reported flu like symptoms, fever, no vomiting, full body aches, loss of appetite.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Patient states left arm was still sore one week after injection, and today reports that arm soreness/pain still continues even after 6 months of administration.
Sex: U
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; One improperly stored dose of VAQTA was administered to the patient; This spontaneous report was received from a medical assistant referring to an 18 year old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant medications were not reported.  On 23-APR-2020, the patient was vaccinated with in improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # S025993 with expiration date of 17-OCT-2020 (dose, route, and anatomical location were not provided), for prophylaxis. No adverse effects were reported.  The reporter stated that the vaccine experienced a temperature excursion of 68.58 F during 9 hours and 41 minutes. A previous excursion occurred with a temperature of 46.1 F during 7 minutes. No digital data logger was involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S025993; expirationdate: 17-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; Nurse called to report that on 22-JUN-2020 a patient received a dose of improperly stored PROQUAD; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, and previous drug reactions or allergies were not provided.  On 22-JUN-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) by subcutaneous route (PROQUAD) (dose, vaccination scheme, and anatomical site of vaccination were not provided) (lot number S031704 have been verified to be a valid, expiration date reported and validated as 06-APR-2021) as prophylaxis (product storage error). It was mentioned that the sterile diluent used was properly stored (lot number T001631 have been verified to be a valid, expiration date reported and validated as 11-JUN-2022).  The administered dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored in a temperature of -9 degrees Celsius (C) to 8 C (-8.3 C), for a time frame of 20 minutes. There was no previous temperature excursion. It was reported that a digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects were reported; patient received an expired dose of VAQTA; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 13-JUN-2020, patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) Injection, 0.5 milliliter, lot # S002507, expiration date 04-APR-2020, for prophylaxis (patient route of administration was not provided).   According to the reporter, the vaccine was properly stored, and no additional adverse effects were reported.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Confusional state, Pyrexia, Vomiting
Clinical narrative: confusion, vomiting and low grade fever; confusion, vomiting and low grade fever; confusion, vomiting and low grade fever; the emergency department physician stated that these symptoms might be related to the GARDASIL 9; This spontaneous report was received from a nurse prescriber via a company representative, referring to a 13-year-old female patient. The patient's pertinent medical history, concomitant therapies, and drug reactions or allergies were unknown by the reporter.  On 13-JUN-2019, the reporting nurse vaccinated the patient with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (formulation, concentration, vaccination scheme, frequency, route of administration, anatomical site of vaccination, lot number, and expiration date were not reported).       On 14-JUN-2019, the patient presented to the emergency department with confusion, vomiting and low grade fever (confusional state, vomiting and pyrexia). The reporter mentioned that the emergency department physician stated that these symptoms might have been related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (vaccination complication); however, the causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events above was not provided by the reporting nurse. It was unknown by the reporter if treatment was given to the patient or if laboratory diagnostics or studies were performed to the patient for these events.   At the time of reporting, the outcome of confusional state, vomiting, and pyrexia was unknown. It was reported that subsequent doses of therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) were not discontinued.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional adverse effect reported; A patient received improperly stored VARIVAX; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and historical drug were not provided. Concomitant therapies included sterile diluent(STERILE DILUENT).  On 16-JUN-2020, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) improperly stored for prophylaxis, lot number reported as R0277989, expiration date 01-OCT-2020. Strength, dose, frequency and route of administration were not provided.   The temperatures involved were: below -14 to -10 degrees celsius (-11.8 degrees Celsius) in a timeframe of 2 months. It was not reported a previous temperature excursion and a data logger was involved.   Lot number R0277989 is an invalid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX)
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care 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; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 20-MAR-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care 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; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 02-JAN-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care 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; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a male patient of unknown age. His medical history, concurrent conditions and concomitant medications were not provided. On or about 10-APR-2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not provided), as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to vaccination, he was treated by a physician for shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for those injuries; significant medical and related expenses as a result of those injuries, including but not limited to medical losses and costs include care 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; and will continue to suffer such losses, and damages in the future. The outcome for herpes zoster was unknown.
Age: 25.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms were reported.; The patient was administered a dose of improperly stored PROQUAD; The patient was to receive a dose of MMR II, however, the PROQUAD was being stored in the refrigerator and the wrong vaccine was inadvertently grabbed.; This spontaneous report was received from a registered nurse, referring to a 25-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 24-JUN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) a dose administered for prophylaxis (lot number S031705 which has been verified to be valid, expiration date reported and validated as 06-APR-2021) (strength, route of administration, vaccination scheme, frequency and anatomical site of injection were not reported) (product storage error). To reconstituted the vaccine properly stored sterile diluent was used. In addition, the nurse reported that, the patient was there to receive a dose of measles and mumps virus vaccine, live (M-M-R II), however, the measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) was stored in the refrigerator and the wrong vaccine was inadvertently grabbed (wrong product administered). The administered dose of the vaccine experienced a temperature excursion of -9 degrees Celsius (C) to 8 C (4 C), during a time frame of 1104 hours (also reported as "46 days"), as recorded by a data logger. There was no previous temperature excursion. No adverse symptoms were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA001420:
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: cerebrovascular accident; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (age not provided). Information about the patient's concurrent condition, concomitant medication or medical history was not provided.  Approximately, on 08-JAN-2016, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after, the patient suffered a cerebrovascular accident. As a direct and proximate result of her receipt of vaccination, the 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, and physical impairment and injury. At the time of the report, the patient had not recovered from the event, and the reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX) and disabling.  Upon internal review, the event of cerebrovascular accident was considered medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: painful blistering rash; painful blistering rash, which has recurred multiple times; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 11-AUG-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered from a painful blistering rash, which had recurred multiple times. As a result of these symptoms, the pt was seen and treated by medical providers. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt 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, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event of painful blistering rash was considered to be not recovered. The reporter determined the event to be related to zoster vaccine live (ZOSTAVAX). The event of painful blistering rash was considered to be disabling.
Sex: M
Vaccine: VARZOS
Symptoms: Retinal detachment
Clinical narrative: detached retina; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unknown age. No information regarding the pt's pertinent medical history, drug reactions or allergies, and concomitant medications was provided. On 08-SEP-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), for routine health maintenance and for the vaccine intended purpose: prevention of shingles (herpes zoster). On an unknown date, shortly after receiving the zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered from a detached retina. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the pt 's symptoms had resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of the zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Furthr, as a tragic consequence of thezoster vaccine live (ZOSTAVAX), the pt 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 the zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered as not recovered. The reporter assessed that the event was related to the zoster vaccine live (ZOSTAVAX).  The reporter considered the event of detached retina to be disabling. Upon internal review, the event of detached retina was considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Deafness, Herpes zoster
Clinical narrative: hearing loss; shingles; Information has been received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unknown age. No information was provided regarding the pt's medical history, concurrent conditions and concomitant medications. On 21-MAY-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, anatomical location and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt was diagnosed with shingles and suffered hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the pt's symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to physical limitations and seriousness of his condition. As a result of the vaccination, the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, he 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 the vaccination, the pt suffered and incurred damages, including medical expenses; the loss of accumulations and other economic and non-economic damages. The outcome of shingles and hearing loss was not recovered. The reporter considered shingles and hearing loss to be related to zoster vaccine live (ZOSTAVAX).   The events were considered to be disabling. Upon internal review, the event of hearing loss was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 27-JUL-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a healthcare provider at a community health center for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to inoculation with zoster vaccine live (ZOSTAVAX), the pt was treated by a healthcare provider at a community health center for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care 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; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received on from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 11-NOV-2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to inoculation with zoster vaccine live (ZOSTAVAX), the pt was treated by a physician for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care 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; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information regarding the pt's pertinent medical history, drug reactions or allergies, and concomitant medications was provided. On an unknown date in 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), as prescribed and/or administered by a healthcare provider at the physician's office, for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries; including but not limited to medical losses and costs include care 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; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered as not recovered. The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Blindness
Clinical narrative: vision loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unknown age. No information regarding the pt's pertinent medical history, drug reactions or allergies, and concomitant medications was provided. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), for routine health maintenance and for the vaccine intended purpose: prevention of shingles (herpes zoster). On an unknown date, shortly after receiving the zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered from vision loss. As a result of these symptoms, the pt was seen and treated by medical providers, and at the time of the report, the pt was still under their care. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of the zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the zoster vaccine live (ZOSTAVAX) use, the pt 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 the zoster vaccine live (ZOSTAVAX) use, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered as not recovered. The reporter assessed that the event was related to the zoster vaccine live (ZOSTAVAX).  The reporter considered the event of vision loss to be disabling. Upon internal review, the vision loss was considered to be medically significant.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; was administered a dose of improperly stored ROTATEQ; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were unknown not reported.       On 20-APR-2020, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, lot #, and expiration date were not reported) and on 22-APR-2020, the patient received the second dose of an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ)by oral route (lot # S005875 with an expiration date on 30-NOV-2020) for prophylaxis (strength and dose were not reported).  The dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) was exposed to a temperature excursion of below 36 Fahrenheit (°F) (34.8°F) for 25 minutes. There was a previous temperature excursion below 36°F (34.5°F) for 1 hour and 24 minutes which was detected by the data logger.   No additional adverse effect reported.
Sex: F
Vaccine: HPV9
Symptoms: Guillain-Barre syndrome, Mental status changes
Clinical narrative: Guillain-Barre syndrome; change in mental status; This spontaneous report as received from a consumer refers to an unspecified female patient of unknown age.  the patient's concurrent conditions, medical history and concomitant therapies were unknown.       On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route, lot and dosage information were unknown) for prophylaxis.  On an unknown date the patient developed Guillain-Barre síndrome  and change in mental status.   The outcome of Guillain--Barre syndrome and mental status changes was unknown.  The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was also unknown.  The reporter stated that there should be more research performed in the  population for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).    Upon internal review Guillain--Barre syndrome was considered to be a medically significant event.   This is one of three cases from the same reporter (2007USA000339 and 2007USA000340). The patient's sisters experienced the same adverse events after vaccination.; Sender's Comments:  US-009507513-2007USA000339: US-009507513-2007USA000340:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No other adverse effects; inadvertently given one dose each of VARIVAX and PROQUAD; This spontaneous report was received from a registered licensed practical nurse concerning a patient of an unknown age and gender. The patient's concurrent conditions and medical history were not provided. The patient's concomitant therapies included sterile diluent.     On an unspecified date, the patient patient was inadvertently given one dose each of   varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot# R018932 expiration date 02-JUL-2020) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot# S012533 expiration date 20-OCT-2020) both for prophylaxis during the same office visit (strength, dose and route were not provided). No other adverse effects were reported in the patient.
Age: 72.0
Sex: U
Vaccine: HEPA, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms reported; the patient was inadvertently administered an expired dose of VAQTA; This spontaneous report was received from a pharmacist referring to a 72 year old patient of unknown gender. Information regarding the patient's concurrent conditions, pertinent medical history and concomitant medications was not provided.      On 30-JUN-2020, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe, strength, route of administration and anatomical location were not reported (Lot # S001832, expiration date 12-MAY-2020) for prophylaxis.   No adverse symptoms were reported. Product quality complaint was not involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S001832; expirationdate: 12-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: HPV9
Symptoms: Guillain-Barre syndrome, Mental status changes
Clinical narrative: Guillain-Barre syndrome; change in mental status; This spontaneous report as received from a consumer refers to an unspecified female patient of unknown age.  the patient's concurrent conditions, medical history and concomitant therapies were unknown.       On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route, lot and dosage information were unknown) for prophylaxis.  On an unknown date the patient developed Guillain-Barre síndrome  and change in mental status.   The outcome of Guillain--Barre syndrome and mental status changes was unknown.  The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was also unknown.  The reporter stated that there should be more research performed in the population for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).    Upon internal review Guillain--Barre syndrome was considered to be a medically significant event.   This is one of three cases from the same reporter. The patient's sisters experienced the same adverse events after vaccination.; Sender's Comments:  US-009507513-2007USA000244:Original Case : 2007USA000244 US-009507513-2007USA000340:Original Case : 2007USA000244
Sex: F
Vaccine: HPV9
Symptoms: Guillain-Barre syndrome, Mental status changes
Clinical narrative: Guillain-Barre syndrome; change in mental status; This spontaneous report as received from a consumer refers to an unspecified female patient of unknown age.  the patient's concurrent conditions, medical history and concomitant therapies were unknown.       On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route, lot and dosage information were unknown) for prophylaxis.  On an unknown date the patient developed Guillain-Barre síndrome  and change in mental status.   The outcome of Guillain--Barre syndrome and mental status changes was unknown.  The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was also unknown.  The reporter stated that there should be more research performed in the population for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).    Upon internal review Guillain--Barre syndrome was considered to be a medically significant event.   This is one of three cases from the same reporter (2007USA000339 and 2007USA000244). The patient's sisters experienced the same adverse events after vaccination.; Sender's Comments:  US-009507513-2007USA000339: US-009507513-2007USA000244: