chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.42
Sex: M
Vaccine: VARCEL
Symptoms: Diarrhoea, Irritability, Pyrexia, Screaming, Sleep disorder
Clinical narrative: 6/10/2020 12:30 pm Sleep interruption (unusual), irritability 6:30 pm Diarrhea, irritability  6/11/2020 12:30 am Sleep interruption (unusual), screaming, diarrhea, fever of 101.4 degrees 1:00 am Vomiting, fever persists, irritability and screaming 2:30 am More vomiting, fever persists, irritability and screaming 3:30 am Fever decreased 100.0 degrees 4:30 am Fever remains 100.0 degrees 5:30 am Fever decreased to 99.5 degrees 6:30 am Fever increases to 103.4 degrees, irritability, Motrin administered 7:45 am Irritability 12:15 pm Fever of 101.1 degrees
Age: 1.42
Sex: M
Vaccine: VARCEL
Symptoms: Vomiting
Clinical narrative: 6/10/2020 12:30 pm Sleep interruption (unusual), irritability 6:30 pm Diarrhea, irritability  6/11/2020 12:30 am Sleep interruption (unusual), screaming, diarrhea, fever of 101.4 degrees 1:00 am Vomiting, fever persists, irritability and screaming 2:30 am More vomiting, fever persists, irritability and screaming 3:30 am Fever decreased 100.0 degrees 4:30 am Fever remains 100.0 degrees 5:30 am Fever decreased to 99.5 degrees 6:30 am Fever increases to 103.4 degrees, irritability, Motrin administered 7:45 am Irritability 12:15 pm Fever of 101.1 degrees
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Death
Clinical narrative: Patient passed away in May 2020. Experienced CIDP complications per office note. Daughter expressed that complications began after the patient received the flu shot in October 2019. Requested that report of adverse event was submitted.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Erythema, Pyrexia, Vomiting
Clinical narrative: Patient suffered a moderate to severe reaction. Symptoms: fever, repeated vomiting and still has a very large red spot on his arm almost an entire week later.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered a pediatric dose of VAQTA; No adverse symptoms reported.; Information has been received from a medical assistant reporting on an adult patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated inadvertently with a pediatric dose of hepatitis A vaccine, inactivated (VAQTA) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female 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 pain in arm. Rechallenge with Shingrix was negative. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced sore arm. The reporter consented to follow up. For tolerance of 2nd dose, refer case US2020093468.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020093468:Same patient
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: Side effects; This case was reported by a consumer and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The physician mentioned other patients who had other side effects and she did not see skin outbreak. The reporter gave authorization to contact physician. This case linked with US2020075690 and US2020075700, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020075690:same reporter US-GLAXOSMITHKLINE-US2020075700:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in jaw, Temporomandibular joint syndrome
Clinical narrative: tmj pain in my jaw; tmj pain in my jaw; This case was reported by a consumer and described the occurrence of temporomandibular joint disorder in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced temporomandibular joint disorder and jaw pain. On an unknown date, the outcome of the temporomandibular joint disorder and jaw pain were recovered/resolved.   It was unknown if the reporter considered the temporomandibular joint disorder and jaw pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, within 2 days, the patient began experiencing temporomandibular joint pain in his/her jaw, which had persisted over the next two weeks. The patient read that temporomandibular joint was one-way shingles might manifest so the patient was curious to know if the vaccine could have caused the pain to begin. The patient asked is this a side effect that had been reported before. The patient had seen both his/her dentist and doctor about the this and they believed the pain to be temporomandibular joint as well.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis contact, Diarrhoea, Herpes zoster, Influenza like illness, Nausea
Clinical narrative: Flu-like symptoms; Body aches; Minor aches in the arms; Nausea; Vomiting; Diarrhea; Rash; suspecting shingles; Suspected case of poison ivy; This case has been linked with wife's case US2020093437, reported by the same reporter. This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On 20th February 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 21st February 2020, 1 days after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced influenza-like symptoms, general body pain, pain in arm, nausea, vomiting, diarrhea, rash, shingles and poison ivy rash. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and prednisone. On 22nd February 2020, the outcome of the influenza-like symptoms, general body pain and pain in arm were recovered/resolved. On 23rd February 2020, the outcome of the nausea, vomiting, diarrhea, rash, shingles and poison ivy rash were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, general body pain, pain in arm, nausea, vomiting, diarrhea, rash, shingles and poison ivy rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. On 21st February 2020, the patient experienced flu-like symptoms, body aches, with minor aches in the arms, nausea, vomiting, and diarrhea, rash. On 22nd February 2020, the flu-like symptoms body aches, and minor arm aches subsided. On 23rd February 2020, the patient did not have any symptoms. The Nurse Practitioner prescribed valacyclovir 1 gm three times a day for one week due to suspecting shingles. The patient's doctor prescribed Prednisone after suspected case of poison ivy contracted during an outdoor camping trip. The patient, wanted the information regarding Shingrix Vaccine Interactions with other medications and whether he should still receive the 2nd dose of Shingrix since the nurse practitioner he saw because of the rash that developed, stated it was shingles. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020093437:same reporter(wife case)
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Rash, Vomiting
Clinical narrative: Flu-like symptoms; Body aches; Minor aches in the arms; Nausea; Vomiting; Diarrhea; Rash; suspecting shingles; Suspected case of poison ivy; This case has been linked with wife's case US2020093437, reported by the same reporter. This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On 20th February 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 21st February 2020, 1 days after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced influenza-like symptoms, general body pain, pain in arm, nausea, vomiting, diarrhea, rash, shingles and poison ivy rash. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and prednisone. On 22nd February 2020, the outcome of the influenza-like symptoms, general body pain and pain in arm were recovered/resolved. On 23rd February 2020, the outcome of the nausea, vomiting, diarrhea, rash, shingles and poison ivy rash were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, general body pain, pain in arm, nausea, vomiting, diarrhea, rash, shingles and poison ivy rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. On 21st February 2020, the patient experienced flu-like symptoms, body aches, with minor aches in the arms, nausea, vomiting, and diarrhea, rash. On 22nd February 2020, the flu-like symptoms body aches, and minor arm aches subsided. On 23rd February 2020, the patient did not have any symptoms. The Nurse Practitioner prescribed valacyclovir 1 gm three times a day for one week due to suspecting shingles. The patient's doctor prescribed Prednisone after suspected case of poison ivy contracted during an outdoor camping trip. The patient, wanted the information regarding Shingrix Vaccine Interactions with other medications and whether he should still receive the 2nd dose of Shingrix since the nurse practitioner he saw because of the rash that developed, stated it was shingles. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020093437:same reporter(wife case)
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Minor arm aches; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On 20th February 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 21st February 2020, 1 days after receiving Shingrix, the patient experienced pain in arm and tiredness. On 22nd February 2020, the outcome of the pain in arm and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain in arm and tiredness to be related to Shingrix.  Additional details were provided as follows: The reporter reported for his Wife. The patient experienced minor arm aches and tiredness one day after receiving the Shingrix injection. The arm aches and tiredness lasted one day. The reporter consented to follow up. This case has been linked with wife's case   US2020093436, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020093436:same reporter
Sex: U
Vaccine: TDAP
Symptoms: Incorrect route of product administration, Injection site swelling, Peripheral swelling, Skin mass
Clinical narrative: Pocket, which became swollen and raised; Pocket, which became swollen and raised; Given slightly below the deltoid; Injected more into the subcutaneous region; Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. Additional event(s) included intramuscular formulation administered by other route on 29th May 2020, hand swelling and skin nodule. The outcome of vaccine administered at inappropriate site was unknown. The outcome(s) of the additional event(s) included hand swelling (unknown), skin nodule (unknown) and intramuscular formulation administered by other route (unknown).     Other possible cause(s) of the hand swelling included Diphtheria toxoid 2 IU, Tetanus toxoid 20 IU, Pertussis toxoid 8 ug, Filamentous Haemagglutinin 8 ug, Pertactin 2.5 ug. Other possible cause(s) of the skin nodule included Diphtheria toxoid 2 IU, Tetanus toxoid 20 IU, Pertussis toxoid 8 ug, Filamentous Haemagglutinin 8 ug, Pertactin 2.5 ug.   Pharmacist states that Boostrix was administered to a patient who had a very large arm, and it was given slightly below the deltoid region. He also states that it was injected more into the subcutaneous region rather than intramuscular due to this and developed a pocket, which became swollen and raised. He is inquiring if the needs to be repeated? Did not consent to follow-up. Call Notes:HCP declined to leave patient demographics and does not wish to be contacted about this case.  Additional details were provided as follows:  The age at vaccination was not reported. The Boostrix vaccine was administered to the patient who had a very large arm, and it was given slightly below the deltoid region, which led to vaccine administered at inappropriate site and intramuscular formulation administered by other route. The reporter also stated that it was injected more into the subcutaneous region rather than intramuscular due to this and developed a pocket, which became swollen and raised.  The pharmacist asked if the needs to be repeated. The reporter did consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 87-year-old female 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 patient asked to reporter, if a patient had first dose of shingrix however developed shingles prior to the second dose what was the recommendation regarding second dose. HCP did not have vaccine details (lot number or expiry date of administration).  He or she also stopped responding when asked if they could be contacted regarding the report. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: developed Tinnitus; This case was reported by a physician via call center representative and described the occurrence of tinnitus in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number K9R97, expiry date unknown) 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 tinnitus. On an unknown date, the outcome of the tinnitus was unknown.   It was unknown if the reporter considered the tinnitus to be related to Shingrix  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and developed Tinnitus.  The reporter consented to follow up. .
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Malaise, Pruritus, Rash papular
Clinical narrative: have Hair Loss / hair falling out; Itchy scalp bumps; Not feeling well /  did not feel well; Itchy scalp bumps; This case was reported by a consumer via call center representative and described the occurrence of hair loss in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Revlimid. Concurrent medical conditions included multiple myeloma and amyloidosis.   On 3rd March 2020, the patient received the 1st dose of Shingrix (intramuscular). On 17th March 2020, 14 days after receiving Shingrix, the patient experienced hair loss, papular rash, malaise and pruritus. On an unknown date, the outcome of the hair loss and malaise were resolved with sequelae and the outcome of the papular rash and pruritus were recovering/resolving.   The reporter considered the hair loss, papular rash, malaise and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient reported adverse reaction she believed to Shingrix injection and wanted to know if these were common for individuals receiving Shingrix. The patient's hairs were falling out when she brushed it, itchy bumps on scalp, and not feeling well.  The reporter consented to follow up.
Age: 12.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 12 year old had been given the vaccine Daptacel when it should have Adacel/No AE; 12 year old had been given the vaccine Daptacel when it should have Adacel/No AE; Initial information was received on 03-Jun-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 12 year old male patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Wrong product administered and Product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included a dose of MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation.  On 03-Jun-2020, the patient received a 0.5 mL dose of (frequency: once) suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5643CA, expiry date- 17-Jul-2021) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  Medical assistance stated a 12 year old had been given the vaccine Daptacel when it should have been Adacel. MA wants to know is there a different amount of Pertussis amount compared to Adacel to Daptacel.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: TTOX
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; Initial information was received on 03-Jun-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves child female patient (currently patient is 67-years-old) who experienced allergic reaction (hypersensitivity), while she received vaccine TETANUS TOXOID.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect TETANUS TOXOID (produced by unknown manufacturer) (lot number not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious allergic reaction (hypersensitivity) on an unknown latency following the administration of TETANUS TOXOID.  Reporter stated that the patient had an allergic reaction before to an old tetanus vaccine when she was child and reporter did not know the name of the previous tetanus vaccine the patient received. Reporter wanted to ask if the Adacel contains horse blood extract and wanted to know if the Adacel has the same ingredient like old toxoid Tetanus.  Details of laboratory data was not reported.  Final diagnosis was allergic reaction.   It was not reported if the patient received a corrective treatment.  The outcome was unknown for the event of allergic reaction.  There will be no information available on the batch number for this case.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: an outdated Ipol was given to the patient/no AE; Initial information was received on 05-Jun-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 5 years old male patient who was vaccinated with an outdated IPV (VERO) [IPOL] (batch number P1A46 and expiry date 03-MAY-2020) via unknown route in unknown administration site on an unknown date for prophylactic vaccination(expired product administered).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was of actual medication error case due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 31.0
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: consumer received Imogam/Imovax on 25-May-2020 and received second dose on 04-Jun-2020, no AE.; Initial information received on 08-Jun-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 31 years old male patient who was vaccinated with first and second dose of suspect RABIES VACCINE [IMOVAX RABIES] (lot number and other dosing details were not reported) via unknown route in unknown administration site on 25-May-2020  and 04-Jun-2020 respectively as prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate schedule of vaccine administration.  The pharmacist had reported that the consumer had a delayed dose on the second injection of suspect imovax rabies. it was informed that the patient had begun on day zero on 25-May-2020 and had a second dose on 04-Jun-2020, also pharmacist informed that the patient has been behaving erratically described as making trips to the emergency room for other things (unspecified) and not telling the staff that he was there for his follow up Imovax Rabies doses.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expired on 29-May-2020 and administered on 01 and 08 June with no adverse event; Initial information regarding this unsolicited valid non-serious case recieved on 08-Jun-2020 from a non-health care professional (Office staff).  This case involves a patient of unknown demographics who was vaccinated with expired vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].   Medical history and concomitant medication were not reported.   On 01-Jun-2020 and 08-Jun-2020, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Lot number not reported, Expiration date- 29-May-2020) via unknown route in unknown administration site.   It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: PNC, PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional adverse event; Wrong vaccine administered; This spontaneous report as received from a registered nurse refers to a 14 month old female patient (also reported as 2 year old patient). Patient's medical history, concurrent conditions and concomitant therapies were not provided.     On 23-AUG-2019, the patient was inadvertently vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) prefilled vial, lot # S002640 expiration date: 29-SEP-2020, (dose and route of administration were not provided) for prophylaxis instead of pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR). There was no additional adverse event.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; On 01-JUN-2020 a patient was administered an improperly stored dose of MMR II.; This spontaneous report was received from an administrator refering to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions/allergies were not reported.  On 01-JUN-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) (lot number S014430, which has been verified to be valid, expiration date reported and validated as 09-MAY-2021) (vaccination scheme, anatomical injection site, and route of administration were not reported) for prophylaxis (product storage error). No additional adverse effects reported.  The administered vaccine was exposed to an unknown temperature excursion for 20 hours. No data logger involved. There were no previous excursions reported.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Gastrointestinal infection, Nerve injury, Tinnitus
Clinical narrative: effected their "cranial nerve VII"; balance was affected; Gastrointestinal issues; Tinnitis; This case was reported by a consumer via call center representative and described the occurrence of nerve injury in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included irritable bowel syndrome and shingles (28 days prior to the 1st dose).   On 27th March 2020, the patient received Shingrix (intramuscular). On 27th March 2020, 8 hrs after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the patient experienced nerve injury, balance difficulty and gastrointestinal infection nos. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the nerve injury, balance difficulty and gastrointestinal infection nos were unknown and the outcome of the tinnitus was not recovered/not resolved.   It was unknown if the reporter considered the nerve injury, tinnitus, balance difficulty and gastrointestinal infection nos to be related to Shingrix.  Additional details were provided as follows: The patient had Shingles 28 days prior to their 1st dose of Shingrix. Less than a week after receiving the vaccine the patient experienced effect in cranial nerve VII and caused tinnitus. And the tinnitus was present 80 percent of the time and had not recovered from it.  The patient had irritable bowel syndrome that not sure if the dose did or did not affect the gastrointestinal due to the medical condition. The reporter stated that their balance was affected slightly but only noticeable when they did yoga.  The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, chills, headache, fatigue, muscle aches
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Burning sensation, Cough, Gait disturbance, Hypertension, Hypoaesthesia
Clinical narrative: Burn feeling, hurt in the left arm and the body. The patient referred to feel numbness and heaviness in both legs and present difficult to walk, hypertension and dry cough.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Limb discomfort, Pain, Pain in extremity
Clinical narrative: Burn feeling, hurt in the left arm and the body. The patient referred to feel numbness and heaviness in both legs and present difficult to walk, hypertension and dry cough.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Mobility decreased, Pain, Pyrexia
Clinical narrative: The evening after the injection, she had fever of 103, body aches, her arm at the injection site was red and swollen, she was unable to get out of bed for 48 hours.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Rash papular
Clinical narrative: Noted small erythematous papule on volar aspect of R proximal wrist day after vaccine, which subsequently developed into vesicle and burned. Resolved within one week.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Discomfort, Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: Pain the in right arm centered around the injection site.  The problem of pain is chronic and worse when down.  Hurts every morning and then lessens during the day.  Still sore and takes effort to overcome stiffness and mild pain to raise the right arm.  We have no done anything because of the current covid-19 crisis.  Discomfort is bearable but persistent and does not seem to be lessening.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Swelling face, Swollen tongue
Clinical narrative: Patient woke up in the morning and around 9am had a swollen upper lip. This progressed to a swollen face and a swollen tongue. Patient self administered 50mg of diphenhydramine. She did not have trouble swallowing or breathing.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Full blood count, Metabolic function test, Nausea, Pain in extremity
Clinical narrative: Fever, arm pain, jaw pain, nausea, mild SOB, possible diarrhea
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in jaw, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever, arm pain, jaw pain, nausea, mild SOB, possible diarrhea
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: 2:00 pm very very tired, slept 45 min., 9 pm headache, very tired, muscle aches, fever 100.2, chilled, arm at shot site hurt,  hardly slept all night because muscles all over my body hurt, elbow joints hurt,  6:30 am 100 temp, still tired, rested, 10:30 am 99.3 temp. feeling less tired 3:30 pm 98.6 temp and felt much better.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Myalgia, Pyrexia
Clinical narrative: 2:00 pm very very tired, slept 45 min., 9 pm headache, very tired, muscle aches, fever 100.2, chilled, arm at shot site hurt,  hardly slept all night because muscles all over my body hurt, elbow joints hurt,  6:30 am 100 temp, still tired, rested, 10:30 am 99.3 temp. feeling less tired 3:30 pm 98.6 temp and felt much better.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Angiotensin converting enzyme, Anti-ganglioside antibody negative, Areflexia, Asthenia, Blood creatine phosphokinase normal
Clinical narrative: 36 y.o.  female with history of insomnia, presenting with progressive weakness.  She was initially seen on 6/5 with 3 days of leg heaviness and difficulty lifting arms.  Exam at that time showed minimal weakness in left shoulder/wrist as well as mild hip flexor weakness bilaterally and right knee flexor weakness with diffuse hyperreflexia and Hoffman's.  MRI of neuroaxis was recommended but patient left AMA.  She represented the following day with significant progression of weakness, inability to walk and inability to lift arms antigravity.  At that point, she had loss of reflexes in lower extremities.  She subsequently developed respiratory failure requiring intubation.   .  She was started on IVIG for presumed GBS.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: CSF glucose normal, CSF protein increased, CSF red blood cell count positive, CSF white blood cell count negative, Cytology normal
Clinical narrative: 36 y.o.  female with history of insomnia, presenting with progressive weakness.  She was initially seen on 6/5 with 3 days of leg heaviness and difficulty lifting arms.  Exam at that time showed minimal weakness in left shoulder/wrist as well as mild hip flexor weakness bilaterally and right knee flexor weakness with diffuse hyperreflexia and Hoffman's.  MRI of neuroaxis was recommended but patient left AMA.  She represented the following day with significant progression of weakness, inability to walk and inability to lift arms antigravity.  At that point, she had loss of reflexes in lower extremities.  She subsequently developed respiratory failure requiring intubation.   .  She was started on IVIG for presumed GBS.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Endotracheal intubation, Gait inability, Guillain-Barre syndrome, HIV test negative, Hoffmann's sign
Clinical narrative: 36 y.o.  female with history of insomnia, presenting with progressive weakness.  She was initially seen on 6/5 with 3 days of leg heaviness and difficulty lifting arms.  Exam at that time showed minimal weakness in left shoulder/wrist as well as mild hip flexor weakness bilaterally and right knee flexor weakness with diffuse hyperreflexia and Hoffman's.  MRI of neuroaxis was recommended but patient left AMA.  She represented the following day with significant progression of weakness, inability to walk and inability to lift arms antigravity.  At that point, she had loss of reflexes in lower extremities.  She subsequently developed respiratory failure requiring intubation.   .  She was started on IVIG for presumed GBS.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperreflexia, Immunoglobulin therapy, Immunophenotyping, Influenza A virus test negative, Influenza B virus test
Clinical narrative: 36 y.o.  female with history of insomnia, presenting with progressive weakness.  She was initially seen on 6/5 with 3 days of leg heaviness and difficulty lifting arms.  Exam at that time showed minimal weakness in left shoulder/wrist as well as mild hip flexor weakness bilaterally and right knee flexor weakness with diffuse hyperreflexia and Hoffman's.  MRI of neuroaxis was recommended but patient left AMA.  She represented the following day with significant progression of weakness, inability to walk and inability to lift arms antigravity.  At that point, she had loss of reflexes in lower extremities.  She subsequently developed respiratory failure requiring intubation.   .  She was started on IVIG for presumed GBS.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza virus test negative, Injected limb mobility decreased, Limb discomfort, Magnetic resonance imaging brain abnormal, Magnetic resonance imaging spinal abnormal
Clinical narrative: 36 y.o.  female with history of insomnia, presenting with progressive weakness.  She was initially seen on 6/5 with 3 days of leg heaviness and difficulty lifting arms.  Exam at that time showed minimal weakness in left shoulder/wrist as well as mild hip flexor weakness bilaterally and right knee flexor weakness with diffuse hyperreflexia and Hoffman's.  MRI of neuroaxis was recommended but patient left AMA.  She represented the following day with significant progression of weakness, inability to walk and inability to lift arms antigravity.  At that point, she had loss of reflexes in lower extremities.  She subsequently developed respiratory failure requiring intubation.   .  She was started on IVIG for presumed GBS.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Red blood cell sedimentation rate normal, Respiratory failure, SARS-CoV-2 test negative, Scan with contrast abnormal
Clinical narrative: 36 y.o.  female with history of insomnia, presenting with progressive weakness.  She was initially seen on 6/5 with 3 days of leg heaviness and difficulty lifting arms.  Exam at that time showed minimal weakness in left shoulder/wrist as well as mild hip flexor weakness bilaterally and right knee flexor weakness with diffuse hyperreflexia and Hoffman's.  MRI of neuroaxis was recommended but patient left AMA.  She represented the following day with significant progression of weakness, inability to walk and inability to lift arms antigravity.  At that point, she had loss of reflexes in lower extremities.  She subsequently developed respiratory failure requiring intubation.   .  She was started on IVIG for presumed GBS.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Streptococcus test negative, Treponema test negative
Clinical narrative: 36 y.o.  female with history of insomnia, presenting with progressive weakness.  She was initially seen on 6/5 with 3 days of leg heaviness and difficulty lifting arms.  Exam at that time showed minimal weakness in left shoulder/wrist as well as mild hip flexor weakness bilaterally and right knee flexor weakness with diffuse hyperreflexia and Hoffman's.  MRI of neuroaxis was recommended but patient left AMA.  She represented the following day with significant progression of weakness, inability to walk and inability to lift arms antigravity.  At that point, she had loss of reflexes in lower extremities.  She subsequently developed respiratory failure requiring intubation.   .  She was started on IVIG for presumed GBS.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Muscle spasms, Tremor
Clinical narrative: Per mom that Patient had 2 episodes of "leg spasms" on 6/9/20. She states she was otherwise doing well and for first occurrence was eating and smiling when she noticed that her left leg was shaking. Denies any jerking or rhythmic movements. Mom had her hand there and felt it shaking but did not try to stop it. This lasted approximately 5 seconds and resolved. Then 2 hours later she had a similar episode where again she was smiling throughout. Per mom she remained engaged and alert throughout both episodes and is otherwise acting normally. Denies any fevers, chills, swelling or redness at injection site.  She otherwise has been doing well since vaccines on 6/4/20.  offered office visit to evaluate, mom declined as she felt Patient was doing better and would call back if sx recurred.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Formication, Paraesthesia
Clinical narrative: Tingling/parathesis and a feeling of "crawling" within his right ear and near his temporal area. He also notices electrical impulses near his nostrils and eyes.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: Woke up with chills, fever~100 degrees, aches, just feeling sick. Symptoms gone by late afternoon on same day.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Pt said she felt dizzy and light-headed after getting her 2nd Shingrix shot. The store manager, service center attendant and I had her sit down for several minutes after she said she started feeling light-headed to prevent her from falling. We got her a granola bar and some orange juice. Once she had some food in her system, she said she started feeling better. She also complained of it feeling as though was difficult to breath with her mask on. She said she thought this was just because her mask. She was talking okay and did not appear visibly short of breath. She said that the dizziness and breathing issue wasn't a problem anymore and said she felt okay to go home. I called to check in on her when she got home, and she said she was doing okay. I recommended that if the difficulty in breathing she had mentioned got worse or did not go away, she should go to the ER. I also called her PCP, and they said they would follow up with her today.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red rash covering whole bicep of left arm.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient called to say that she went to md because her up arm was red and warm from the shot. This did not happen with the previous dose. MD prescribed Medrol dose pak and recommended benadryl
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Urticaria
Clinical narrative: painful arm for 1 day; hives, itchy, whole body itchy
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Hypoaesthesia
Clinical narrative: Headache + numbness in leg Administered by LPN
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Dyspnoea, Nausea, Paraesthesia
Clinical narrative: Pt complained about being nauseas, light headedness, difficult to breath & tingling sensation in left arm. mimicking signs of a syncope. pt was made to lie down for 1/2 hr with legs up & pt returned to feeling well & normal. pt was also observed for another 15 min sitting upright & was cognitive & alert. pt was followed later in the day via phone to see how she is doing. pt stated she is alert, cognitive & normal with no signs of any discomfort or adverse reactions. pt has been advised to check with her pcp too.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HEP, HIBV, PNC
Symptoms: Body temperature increased, Dermatitis diaper, Rash
Clinical narrative: Developed rash to body 1 day ago on 6/10/20, started on abdomen and spread to feet. Temp 100.6 today. Rash on bottoms of feet and diaper area.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC13
Symptoms: Acarodermatitis, Rash
Clinical narrative: Mom stated that after 2-4 weeks of 12 mths vaccines child develop a rash all over body mom visted ER at Hospital and was Dx with scabies no medication was given.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patients did not experience any symptoms; patients were vaccinated with improperly stored varivax between 11/15/2019 and 11/25/2019; This spontaneous report was received from a medical assistant concerning seven unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. The patients' concomitant therapy included sterile diluent(STERILE DILUENT).   On unknown date in November 2019, (reported as a date between 15-NOV-2019 and 25-NOV-2019), seven unspecified patients were vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S021927, expiration date: 15-JUL-2021; lot # S006647, expiration date: 05-MAR-2021 and lot # S004119, expiration date: 11-FEB-2021) for prophylaxis (strength, anatomical location, dose and route of administration were not reported) (product storage error). The outcome of the event was unknown. Patients' did not experience any symptoms. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This case has been considered as non-valid due to lack of patient' identifiers.  Lot number S006647 is an invalid lot number for varicella virus vaccine live (oka/merck).  As of 26-MAY-2020, all telephone attempts trying to obtain additional information has been unsuccessful.  Follow up information has been received from another medical assistant on 28-MAY-2020.  The medical assistant stated that, the physician preferred to have in writing of the request for patient identifiers and dates of administration of the varicella virus vaccine live (oka/merck) (VARIVAX) that had undergone temperature excursion.  Follow up information has been received from the medical assistant on 10-JUN-2020 refers to a patient of 4 year old male patient. On 15-NOV-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) of lot# S004119, expiration date reported as 11-FEB-2021.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-2006USA004158:
Sex: U
Vaccine: HEPA, UNK
Symptoms: No adverse event, Underdose
Clinical narrative: no additional adverse effects; an adult patient was administered a pediatric dose of VAQTA; This initial spontaneous report as received from a nurse refers to an adult patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. This case concerns 1 patient and 1 combination product.   On 12-MAY-2020, the adult patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not reported) (lot # S032056, expiration date: 09-NOV-2020) (exact dose, route of administration and anatomical location were not reported) for prophylaxis. No additional adverse effects were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S032056; expirationdate: 09-NOV-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: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; on 2/4/2020 a patient was administered an improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a 18-year-old patient of unknown gender. The patient's pertinent medical history, historical drug, concurrent conditions, and drug reactions or allergies were not provided.      On 04-FEB-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot number S006018, which has been verified to be valid, expiration date reported and validated as 27-FEB-2021 (strength, dosage schedule, vaccination scheme, anatomical location and route of administration were not provided), for prophylaxis (product storage error); the vaccine was reconstitued with a properly stored sterile diluent (MERCK STERILE DILUENT). Additionaly, it was stated that the vaccine was exposed to a temperature between 15 degrees Fahrenheit (F) to 46 degrees F (36.86 F) for a time frame of 9 hours and 49 minutes. Furthermore, there was a previous temperature excursion reported at a temperature of 15 degrees F to 46 degrees F (19.13 F) for a time frame of 1 hour and 30 minutes. There was no digital data logger involved. No additional adverse events were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA002222: