chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: she administered a Menactra booster to a 17 year-old girl. She then realized that the vaccine was expired with no adverse event; Initial information was received on 23-Oct-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 17-year-old female patient who administered meningococcal a-c-y-w135 (d conj) vaccine [Menactra] by a nurse, she then realized that the vaccine was expired (expired product administered) on 23-Oct-2020 (formulation and strength was unknown) (lot number: U6179AA and expiry date: 29-Mar-2020) at 0.5 ml once via intramuscular route in the left arm for prophylactic vaccination.  Medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included influenza vaccine (Flu Shots).  This was an actual medication error case due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.  Disclaimer: 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 or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: mother told the medical assistant her daughter needed to get a Flu shot so the medical assistant administered another Fluzone Quad without looking at the chart with no adverse event; Initial information was received on 23-Oct-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 26-months-old female patient came in with the mother for a 3 year check up on 21-Oct-2020 and received the influenza quadrival a-b vaccine [Fluzone Quadrivalent] and a Hepatitis A vaccine (Concomitant medications). Then the mother brought the child back today and went to the outside drive up clinic and told the medical assistant her daughter needed to get a Flu shot so the medical assistant administered another influenza quadrival a-b vaccine without looking at the chart (extra dose administered). (formulation and strength were unknown) (lot number: UT7065MA and expiry date: 30-Jun-2021) at 0.5 ml twice via intramuscular route in the right thigh for prophylactic vaccination.  Medical history, past medical treatment, vaccination and family history were not provided.  This was an actual medication error case due to extra dose administered (latency 2 days).  At the time of reporting, no adverse event was reported.  Disclaimer: 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 or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 77.0
Sex: M
Vaccine: FLU3, FLU3, PNC13, PNC13, TDAP, TDAP, VARZOS, VARZOS
Symptoms: Headache, Injection site pain, Insomnia, Nausea, Pruritus
Clinical narrative: All body itching and rashes, pain on site exterior. Headache, some nausea. Unable to sleep.   Prescribed medications Zantac, benadryl extra strength(generic), cortisone cream.  Symptoms still continue less intense for rashes and itching after bowel movements specifically.
Age: 77.0
Sex: M
Vaccine: FLU3, FLU3, PNC13, PNC13, TDAP, TDAP, VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: All body itching and rashes, pain on site exterior. Headache, some nausea. Unable to sleep.   Prescribed medications Zantac, benadryl extra strength(generic), cortisone cream.  Symptoms still continue less intense for rashes and itching after bowel movements specifically.
Age: 46.0
Sex: M
Vaccine: FLUR4
Symptoms: Asthenia, Joint instability, Pain, Tendonitis
Clinical narrative: I seem to have an ongoing case of tendonitis in my right arm ever since I got the vaccine.  It doesn't hurt all the time, but when (for example) I pull out the pitcher of water out of the fridge or grab the bag of cereal out of the pantry, I experience mild pain in my right deltoid, and I don't have as much strength or stability as I used to have.
Age: 65.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Injection site erythema, Pain in extremity, Peripheral swelling, Pyrexia, Vaccination site oedema
Clinical narrative: PT CAME INTO CLINIC 1 WEEK AFTER RECEIVING THE FLUAD AND PPSV23 VACCINES IN THE LEFT ARM.  PT HAD OBVIOUS EDEMA, TENDER TO THE TOUCH AND VERY WARM AROUND VACCINATION SITES.  IT WAS EVIDENT WHERE THE SHOTS WERE GIVEN (1 INCH APART) AS EACH VACCINE SITE WAS THE MOST RED, SWOLLEN AND TENDER. THE REDNESS SPREAD APROX 1 INCH AND A 1/2 TO 2 INCHES FROM THE SITE.   PT STATED THAT THE NIGHT OF THE VACCINATIONS HER ARM BEGAN TO SWELL AND THE FOLLOWING DAY SHE HAD A FEVER OVER 100 DEGREES F.   SHE STATED SHE TALKED TO A NURSE OF THE PHONE FROM THE CLINIC SUNDAY NIGHT (15TH NOV) AND THE NURSE QUESTIONED HER IF HER ARM WAS TWICE THE SIZE OF THE UNAFFECTED ARM,  SHE SAID NO, SO SHE DID NOT COME IN.   PT SAID SINCE THEN HER FEVER HAS REDUCED ALMOST BACK TO HER NORMAL TEMP.   PT'S ARM IS VISIBLY LESS SWOLLEN AS DESCRIBED FROM THE FIRST NIGHT BY PATIENT.   A SMALL KNOT WAS NOT FELT HOWEVER HER ENTIRE DELTOID HAD EDEMA.   PT WAS ADVISED TO CONTINUE MONITORING AND TAKING HER 500 MG TYLENOL, RUBBING THE VACCINATION SITE, ALTERNATING HEAT AND COLD PACKS,.  SHE WAS INSTRUCTED THAT IF IT CONSISTED PAST ONE MORE WEEK TO CONSULT HER DOCTOR.   PT STATED SHE DID NOT USUALLY RECIEVE MORE THAN ONE VACCINE AT A TIME AND USUALLY SPACED THEM OUT.   SHE ALSO RECEIVED THE SHINGRIX VACCINATION IN HER RIGHT DELTOID (UNAFFECTED OTHER THAN PRIOR SORENESS AFTER THE VACCINE)  IT WAS DISCUSSED THAT DUE TO HER RECIEVING THE SHINGRIX VACCINE 3 WEEKS PRIOR TO THE FLU AND PPSV23 VACCINES, HER IMMUNE SYSTEM COULD BE REACTING AND RECONGNIZING ALL THREE VACCINES, WHICH COULD HAVE OVERWHELMED HER SYSTEM.  PT WAS INFORMED TO BEGIN GETTING ONE VACCINE AT A TIME OR TO MAKE SURE ONLY ONE VACCINE WAS GIVEN IN EACH ARM.
Age: 65.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: PT CAME INTO CLINIC 1 WEEK AFTER RECEIVING THE FLUAD AND PPSV23 VACCINES IN THE LEFT ARM.  PT HAD OBVIOUS EDEMA, TENDER TO THE TOUCH AND VERY WARM AROUND VACCINATION SITES.  IT WAS EVIDENT WHERE THE SHOTS WERE GIVEN (1 INCH APART) AS EACH VACCINE SITE WAS THE MOST RED, SWOLLEN AND TENDER. THE REDNESS SPREAD APROX 1 INCH AND A 1/2 TO 2 INCHES FROM THE SITE.   PT STATED THAT THE NIGHT OF THE VACCINATIONS HER ARM BEGAN TO SWELL AND THE FOLLOWING DAY SHE HAD A FEVER OVER 100 DEGREES F.   SHE STATED SHE TALKED TO A NURSE OF THE PHONE FROM THE CLINIC SUNDAY NIGHT (15TH NOV) AND THE NURSE QUESTIONED HER IF HER ARM WAS TWICE THE SIZE OF THE UNAFFECTED ARM,  SHE SAID NO, SO SHE DID NOT COME IN.   PT SAID SINCE THEN HER FEVER HAS REDUCED ALMOST BACK TO HER NORMAL TEMP.   PT'S ARM IS VISIBLY LESS SWOLLEN AS DESCRIBED FROM THE FIRST NIGHT BY PATIENT.   A SMALL KNOT WAS NOT FELT HOWEVER HER ENTIRE DELTOID HAD EDEMA.   PT WAS ADVISED TO CONTINUE MONITORING AND TAKING HER 500 MG TYLENOL, RUBBING THE VACCINATION SITE, ALTERNATING HEAT AND COLD PACKS,.  SHE WAS INSTRUCTED THAT IF IT CONSISTED PAST ONE MORE WEEK TO CONSULT HER DOCTOR.   PT STATED SHE DID NOT USUALLY RECIEVE MORE THAN ONE VACCINE AT A TIME AND USUALLY SPACED THEM OUT.   SHE ALSO RECEIVED THE SHINGRIX VACCINATION IN HER RIGHT DELTOID (UNAFFECTED OTHER THAN PRIOR SORENESS AFTER THE VACCINE)  IT WAS DISCUSSED THAT DUE TO HER RECIEVING THE SHINGRIX VACCINE 3 WEEKS PRIOR TO THE FLU AND PPSV23 VACCINES, HER IMMUNE SYSTEM COULD BE REACTING AND RECONGNIZING ALL THREE VACCINES, WHICH COULD HAVE OVERWHELMED HER SYSTEM.  PT WAS INFORMED TO BEGIN GETTING ONE VACCINE AT A TIME OR TO MAKE SURE ONLY ONE VACCINE WAS GIVEN IN EACH ARM.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported red, swollen/painful deltoid which happened within 1-3 hours from having vaccination in clinic.  Urgent care sent her to ER  who then treated her with PO antibiotics and steroids.  Patient reports no further symptoms.
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Vision blurred
Clinical narrative: Patient reports blurred vision approximately 20-30 minutes after vaccine given. The visual disturbance progressed to severe headache.  Headache began approximately 40 minutes after injection.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pain
Clinical narrative: Patient said they have been experiencing radiating pain at injection site through the muscle and under the skin since the night they got the injection.  They also received the high dose flu shot on the same day in the same arm but the patient has had the flu shot before with no reaction.
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient called with concern of rash that started to appear on his back few days after receiving 3 vaccines on 10/14/2020:  Shingles vaccine(Right arm), Tdap+Fluclvx Quad (Left arm)  Patient also stated rashes are itchy and painful and he assumes its shingles infection. He did use Hydrocortisone cream and Tylenol for pain relief but haven't contacted his doctor yet.  Patient seemed upset about why would he get a shingles like rash/infection if he got a vaccine for Shingles and why wasn't he informed to watch out for any rash like side effect/reaction during vaccine administration? Upon further asking, patient also informed the pharmacist that he did some yard work/gardening few days after receiving the vaccine. Pharmacist advised patient to consult his doctor as reason of rash appears to be unclear.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injected limb mobility decreased, Neck pain, Pain
Clinical narrative: PATIENT CAME IN TODAY, COMPLAINING SHE IS BARELY ABLE TO MOVE HER RIGHT ARM WITHOUT SIGNIFICANT PAIN. SHE LIFTS ARM WITH LIMITATION, AND SLOWLY, BUT IT HURTS. JOINTS AT ELBOW HURT, NECK IS SORE, AND RIGHT SIDE OF TORSO IS SORE AS WELL. RECOMMENDED FOLLOWING UP WITH MD.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site pain, Injection site warmth, Migraine, Pyrexia
Clinical narrative: States at 1:30am after the vaccination, she woke up with a severe migrane, blurred vision to where she couldnt see, her body had heat wave with the shakes where the inside of her body felt overheated but her outer body was cold.  Her vision was so blurry so she laid back down and when she woke up she had fever of 101, her arm where ithe injection was is super tight, warm and hurts extremely bad so she went to the emergency room on 11/19/20 around 10. When getting the injection she states the nurse stuck her the first time and said she dont want to hurt her and removed that needle and got another needled and restuck her again
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor, Vision blurred
Clinical narrative: States at 1:30am after the vaccination, she woke up with a severe migrane, blurred vision to where she couldnt see, her body had heat wave with the shakes where the inside of her body felt overheated but her outer body was cold.  Her vision was so blurry so she laid back down and when she woke up she had fever of 101, her arm where ithe injection was is super tight, warm and hurts extremely bad so she went to the emergency room on 11/19/20 around 10. When getting the injection she states the nurse stuck her the first time and said she dont want to hurt her and removed that needle and got another needled and restuck her again
Age: 71.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Eye pain, Eye swelling, Lacrimation increased, Ocular hyperaemia, Ophthalmological examination
Clinical narrative: Woke up at 1 a. m with horrible pain in L eye; pain and watery. Pain was consistent, red and swollen. Patient took self pictures of eye. Conferred with opthamologist; 'squiggly line with circles and that it is shingles'. Opthamologist and PCM exchanged reports. Opthamologist states the site of injection is still visible; skin is discolored. No pain.  Left eye still bothers patient.  PCM advised not to have the second dose of the shingrex.
Age: 71.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pupil dilation procedure, Visual impairment
Clinical narrative: Woke up at 1 a. m with horrible pain in L eye; pain and watery. Pain was consistent, red and swollen. Patient took self pictures of eye. Conferred with opthamologist; 'squiggly line with circles and that it is shingles'. Opthamologist and PCM exchanged reports. Opthamologist states the site of injection is still visible; skin is discolored. No pain.  Left eye still bothers patient.  PCM advised not to have the second dose of the shingrex.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: LYOPHILIZED POWDER WAS RECONSTITUTED WITH STERILE WATER
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Headache, Lethargy
Clinical narrative: PATIENT EXPERIENCED MORE NAUSEA, HEADACHES, EXTREME LETHARGY,
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administration ofMMR II.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 13-OCT-2020, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, route of administration and anatomical site of vaccination were not reported, lot# S007813, expiration date was 14-MAR-2021) for prophylaxis.  Other suspect therapies included sterile diluent (STERILE DILUENT). The administered dose of vaccine experienced improperly stored vaccine administration and the temperature excursion of 62 Fahrenheit (F) for 2 hours (product storage error), as recorded by data logger. No previous temperature excursion was reported. The outcome of product storage error was unknown.; Sender's Comments:  US-009507513-2010USA009775: US-009507513-2010USA010221: US-009507513-2010USA010255:
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, Product storage error
Clinical narrative: patient was given RECOMBIVAX HB that was recalled; Improperly stored vaccine administered; This spontaneous report was received from a nurse referring to a 9-week-old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was not provided.  On 23-OCT-2020, the patient was vaccinated with a recalled and improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (0.5 milliliter, route of administration was unknown, lot # T007984 which has been verified to valid, expiration date reported and validated as 01-NOV-2022) for prophylaxis.         The outcome of recalled product administered and product storage error was unknown.
Sex: U
Vaccine: HIBV, HPV4, HPV9, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored PEDVAX HIB, GARDASIL, GARDASIL 9 and MMR II; No additional AE/PQCS reported.; This spontaneous non-valid report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of: - haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # T000883, expiration date 28-MAY-2022 (dose and route of administration were not reported), administered doses of vaccines experienced the temperature excursion of below 36 (35.2) degrees Fahrenheit for 14 minutes; - quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (lot number, expiration date, dose and route of administration were not reported), administered doses of vaccines experienced the temperature excursion of below 36 (35.2) degrees Fahrenheit for 14 minutes; - hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot # 1637648, expiration date 19-JUN-2022 (dose and route of administration were not reported), administered doses of vaccines experienced the temperature excursion of below 36 (35.2) degrees Fahrenheit for 14 minutes; - measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot # S015428, expiration date 20-MAY-2021, albumin status recombinant Human albumin (rHA) (dose and route of administration were not reported), administered doses of vaccines experienced the temperature excursion of minus 58 and plus 46 (35.2) degrees Fahrenheit for 14 minutes. There was no adverse effect reported. Data logger was involved. There were no previous excursions reported. This case is non-valid due to non of patients' identifier provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637648; expirationdate: 19-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9
Symptoms: Syringe issue, Underdose
Clinical narrative: no additional AE; administered dose of GARDASIL was incomplete / there was still liquid in the syringe after administrating the vaccine; This spontaneous report was received from a registered nurse referring to a patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.  On 09-DEC-2019 and 15-JUL-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1 an 2 respectively (dose, route and site of administration, lot number and expiration date were not reported).  On 06-OCT-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) pre-filled syringe, 0.5ml, dose 3 for prophylaxis  (route and site of administration, lot number and expiration date were not reported).  The nurse stated the patient did not receive the full dose, she noticed there was still liquid in the syringe after administrating the vaccine to the patient, so it was incomplete (underdose).  The patient experienced no adverse event.    The outcome of underdose was unknown.   The nurse inquired the validity of the administered dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF);   deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Paraesthesia, Rash
Clinical narrative: Felt tingling in my left breast, armpit, and left arm; I start to get a rash; This case was reported by a consumer via interactive digital media and described the occurrence of tingling of extremity in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2020, the patient received the 1st dose of Shingrix. In November 2020, 2 days after receiving Shingrix, the patient experienced tingling of extremity and rash. On an unknown date, the outcome of the tingling of extremity and rash were unknown.   It was unknown if the reporter considered the tingling of extremity and rash 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 captured as adult as per vaccine indication.  After receiving 1st dose of Shingrix, the patient experienced tingling in my left breast, armpit and left arm.. The patient got shot on Monday the following Friday patient start to get a rash that by Saturday. The reporter did not consent to follow up.
Age: 60.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Chills
Clinical narrative: chills; This case was reported by a consumer via call center representative and described the occurrence of chills in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus.   In October 2020, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2020-2021 season (intramuscular). On an unknown date, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced chills. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the chills to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: Four weeks before the date of reporting, the patient received 1st dose of Shingrix intramuscularly in the left arm and a flu shot intramuscularly in the right arm. The Patient reported on the same day after receiving the vaccines, he had chills that lasted about 20 hours and then resolved. The Patient reported he took Tylenol for the chills. The Patient did not have lot number or expiration date information for these vaccines. The Patient gave consent to follow up with HCP. For tolerance in 2nd dose of Shingrix, refer case US2020AMR225450; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR225450:same reporter.
Sex: M
Vaccine: DTAP
Symptoms: Pertussis, Vaccination failure
Clinical narrative: We are all Dtaped. Aka vaccinated/Suspected vaccination failure; Whooped; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received DTPa (DTaP vaccine) for prophylaxis.   On an unknown date, the patient received DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown.   It was unknown if the reporter considered the vaccination failure and whooping cough to be related to DTaP vaccine.  Additional details were provided as follows: The age at vaccination was not reported. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming whopping cough were not provided. The patient received Dtap and had whopping cough. No further information was provided. This case linked with US2020AMR227439, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR227439:reporter's case
Sex: U
Vaccine: TDAP
Symptoms: Allergy to vaccine, Attention deficit hyperactivity disorder, Generalised tonic-clonic seizure, Seizure
Clinical narrative: Epilepsy; Seizures; ADHD; Allergic to the Pertussis portion; This case was reported by a consumer via interactive digital media and described the occurrence of grand mal epilepsy in a infant patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of DTPa vaccine. On an unknown date, less than a year after receiving DTPa vaccine, the patient experienced grand mal epilepsy (serious criteria GSK medically significant), seizure (serious criteria GSK medically significant), attention deficit hyperactivity disorder and drug allergy. On an unknown date, the outcome of the grand mal epilepsy, seizure, attention deficit hyperactivity disorder and drug allergy were unknown.   It was unknown if the reporter considered the grand mal epilepsy, seizure, attention deficit hyperactivity disorder and drug allergy to be related to DTPa vaccine.  Additional details were reported as follows:  The age at vaccination was not reported. The patient stated that he/she received vaccine 3 time at 1st year of life. The patient was allergic to the Pertussis portion and still received vaccine which led to documented hypersensitivity to administered product.  The patient experienced epilepsy with grand mal seizure, Attention deficit hyperactivity disorder. The patient stated that he/he heard Tdap was much safer than the DPT shot from old time. The patient still willing to do what he/she must for his/her  children though. For tolerance of 2nd and 3rd dose refer case US2020AMR228496 and US2020AMR228497 respectively.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR228496:2nd Dose US-GLAXOSMITHKLINE-US2020AMR228497:3rd dose
Sex: U
Vaccine: TDAP
Symptoms: Allergy to vaccine, Attention deficit hyperactivity disorder, Epilepsy, Generalised tonic-clonic seizure, Near death experience
Clinical narrative: Nearly died the last time; Epilepsy; Grand mal seizure; ADHD; Allergic to the Pertussis portion; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a infant patient who received DTPa (DTPa vaccine) for prophylaxis.   Previously administered products included DTPa vaccine (1st dose received on an unknown date) and DTPa vaccine (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of DTPa vaccine. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening), epilepsy (serious criteria GSK medically significant), grand mal seizure (serious criteria GSK medically significant), attention deficit hyperactivity disorder and allergy. On an unknown date, the outcome of the near death experience, epilepsy, grand mal seizure, attention deficit hyperactivity disorder and allergy were unknown.   It was unknown if the reporter considered the near death experience, epilepsy, grand mal seizure, attention deficit hyperactivity disorder and allergy to be related to DTPa vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had 3 vaccine in 1st year of life. At time of 3rd dose the patient as nearly died. The patient had epilepsy, grand mal seizures, Attention deficit hyperactivity disorder and other which was the patient not discuss. The patient was allergic to pertussis portion and had ADHD, seizures. The patient was not dead.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR228374:3rd dose
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Injection site haemorrhage
Clinical narrative: vaccination went into the skin and started bleeding a little bit; patient was not sure if he received the complete dose; This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 to 3 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site hemorrhage and inappropriate dose of vaccine administered. On an unknown date, the outcome of the injection site hemorrhage was recovered/resolved and the outcome of the inappropriate dose of vaccine administered was unknown.   It was unknown if the reporter considered the injection site hemorrhage to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient received 2nd dose of Shingrix and the vaccination went into the skin and started bleeding a little bit. The patient had a band it on it and it kind of blood through the band it and then stopped (as reported), so patient was not sure if he received the complete dose, which led to inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Pyrexia
Clinical narrative: lack of energy; had a fever; This case was reported by a consumer via call center representative and described the occurrence of asthenia in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 10th November 2020, 1 days after receiving Shingrix, the patient experienced asthenia and fever. On an unknown date, the outcome of the asthenia was recovering/resolving and the outcome of the fever was unknown.   It was unknown if the reporter considered the asthenia and fever to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient and reported he received the second dose of Shingrix vaccine and next day morning The patient had a fever and lack of energy.  The patient reported he still has a lack of energy currently but feels a little bit better. The patient did not have lot number or expiration date information to provide. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Illness, Malaise, Muscle tightness, Nausea
Clinical narrative: over her waist, down the back of her legs, inside her left arm; rash with spots which were dime and nickel size and some small spots; sore; muscles felt super tight; felt really sick; headache; fever; shaking like crazy with her bed shaking.; nausea; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included adalimumab (Humira).   On 2nd October 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd October 2020, 1 days after receiving Shingrix, the patient experienced pain and muscle tightness. On 5th October 2020, the patient experienced rash and spot-like rash. In October 2020, the patient experienced sickness, headache, fever, tremor and nausea. On an unknown date, the outcome of the sickness, headache, fever, tremor, nausea, pain and muscle tightness were recovered/resolved and the outcome of the rash and spot-like rash were not recovered/not resolved.   It was unknown if the reporter considered the sickness, headache, fever, tremor, nausea, pain and muscle tightness to be related to Shingrix. The reporter considered the rash and spot-like rash to be possibly related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with Shingrix and 3 days after vaccination patient had broke out in a rash with spots which were dime and nickel size and some small spots as well.  The rash was all over her waist, down the back of her legs, inside her left arm. The patient was visited a dermatologist and they could not determine the cause of the rash.   They biopsied the rash and it came back inconclusive but it may be a possible reaction to a medication. The patient was also taking Humira. The patient felt really sick the night after receiving the vaccination with a headache, fever, nausea and she was shaking like crazy with her bed shaking and more she tried to stop the shaking the worse it got. The patient was sore the next day and her muscles felt super tight. Till the time of reporting rash was unresolved while other symptoms were resolved. The patient stated that she experienced all the side effects listed for the Shingrix vaccine. The reporter consent to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rash, Rash macular, Tremor
Clinical narrative: over her waist, down the back of her legs, inside her left arm; rash with spots which were dime and nickel size and some small spots; sore; muscles felt super tight; felt really sick; headache; fever; shaking like crazy with her bed shaking.; nausea; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included adalimumab (Humira).   On 2nd October 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd October 2020, 1 days after receiving Shingrix, the patient experienced pain and muscle tightness. On 5th October 2020, the patient experienced rash and spot-like rash. In October 2020, the patient experienced sickness, headache, fever, tremor and nausea. On an unknown date, the outcome of the sickness, headache, fever, tremor, nausea, pain and muscle tightness were recovered/resolved and the outcome of the rash and spot-like rash were not recovered/not resolved.   It was unknown if the reporter considered the sickness, headache, fever, tremor, nausea, pain and muscle tightness to be related to Shingrix. The reporter considered the rash and spot-like rash to be possibly related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with Shingrix and 3 days after vaccination patient had broke out in a rash with spots which were dime and nickel size and some small spots as well.  The rash was all over her waist, down the back of her legs, inside her left arm. The patient was visited a dermatologist and they could not determine the cause of the rash.   They biopsied the rash and it came back inconclusive but it may be a possible reaction to a medication. The patient was also taking Humira. The patient felt really sick the night after receiving the vaccination with a headache, fever, nausea and she was shaking like crazy with her bed shaking and more she tried to stop the shaking the worse it got. The patient was sore the next day and her muscles felt super tight. Till the time of reporting rash was unresolved while other symptoms were resolved. The patient stated that she experienced all the side effects listed for the Shingrix vaccine. The reporter consent to follow up.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got terribly sick; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves patient (unknown demographics) who got terribly sick (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got terribly sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Bronchitis, Cough, Pneumonia
Clinical narrative: pneumonia; bronchitis; wracking cough; Initial information received on 11-Nov-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional via social media.  This case involves patient (unknown demographics) who experienced pneumonia, bronchitis and wracking cough (cough), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious event pneumonia unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  On an unknown date, the patient developed non-serious events bronchitis and wracking cough (cough) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for all events.  Information on batch number was requested.; Sender's Comments: This poorly documented social media case concerns a patient (unknown demographics) who suffered from pneumonia, bronchitis and cough after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset was unknown. Moreover, patient's medical condition at the time of vaccination, lab tests ruling out predisposing etiologies were not reported. Based upon the reported information and considering the infectious nature of the event, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Paraplegia
Clinical narrative: paralyzed from  mid back down; Initial information was received on 11-Nov-2020 regarding an unsolicited valid serious social media  case from the non-health care professional   This case involves a female patient of unknown age who paralyzed from her mid back down (paraplegia), after she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient paralyzed from her mid back down (paraplegia), (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  Information on batch number requested.; Sender's Comments: This poorly documented social media case concerns an patient of unknown demographic who had paraplegia after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Also, the patient's medical condition at the time of vaccination, concomitant therapy and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 12-Nov-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional (patient) via social media.  This case involves a male patient (age unspecified) who had flu (influenza), while he received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date (1957-1961), the patient received a dose of suspect INFLUENZA VACCINE (which contained live virus) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date (in following year), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (second flu shot) (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (1957-1961), the patient developed a serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event. This was the first time when patient had flu.  On an unknown date (in following year), the patient developed a serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  He never took flu shot again until years later when he learned that they were using dead virus. That was the only time when he had flu twice.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  The information on lot number was requested for this case.; Sender's Comments: This case concerns a male patient who had influenza twice after vaccination with INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLU3
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea, Injection site erythema, Injection site inflammation
Clinical narrative: COPD was not well controlled and during that time last year when she got the Fluzone HD vaccine they were increasing her COPD medications; the patient experienced shortness of breath; slight pain, redness and a rash at sight of the injection; slight pain, redness and a rash at sight of the injection; slight pain, redness and a rash at sight of the injection; slight pain, redness and a rash at sight of the injection; Initial information regarding this unsolicited valid non-serious case via Agency (reference number: 00294722) received from a physician and transmitted to Sanofi 30-Sep-2020.  This case involved a 71 years old female patient for whom chronic obstructive pulmonary disease (COPD) was not well controlled and during that time last year when she got the INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] vaccine they were increasing her copd medications and the patient experienced shortness of breath (dyspnoea), slight pain, redness and a rash at sight of the injection (vaccination site rash and vaccination site inflammation associated with vaccination site inflammation pain and vaccination site erythema).  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.  Concurrent condition included COPD.   On an unknown date in the last year (as reported), the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UJ236AA, expiry date not reported) via intramuscular route in the left deltoid for prophylactic vaccination. The patient was also administered with Pneumococcal vaccine.  On an unknown date, the patient developed non-serious shortness of breath (dyspnoea), slight pain, redness and a rash at sight of the injection (vaccination site rash and vaccination site inflammation associated with vaccination site inflammation pain and vaccination site erythema) unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.   This patient had pre-existing COPD. Her COPD was not well controlled and during that time last year, unknown latency, following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE COPD medications were increased (condition aggravated).  Relevant laboratory test was not reported.  Final diagnosis was slight pain, redness and a rash at sight of the injection, the patient experienced shortness of breath and copd was not well controlled and during that time last year when she got the fluzone hd vaccine they were increasing her copd medications.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site rash
Clinical narrative: COPD was not well controlled and during that time last year when she got the Fluzone HD vaccine they were increasing her COPD medications; the patient experienced shortness of breath; slight pain, redness and a rash at sight of the injection; slight pain, redness and a rash at sight of the injection; slight pain, redness and a rash at sight of the injection; slight pain, redness and a rash at sight of the injection; Initial information regarding this unsolicited valid non-serious case via Agency (reference number: 00294722) received from a physician and transmitted to Sanofi 30-Sep-2020.  This case involved a 71 years old female patient for whom chronic obstructive pulmonary disease (COPD) was not well controlled and during that time last year when she got the INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] vaccine they were increasing her copd medications and the patient experienced shortness of breath (dyspnoea), slight pain, redness and a rash at sight of the injection (vaccination site rash and vaccination site inflammation associated with vaccination site inflammation pain and vaccination site erythema).  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.  Concurrent condition included COPD.   On an unknown date in the last year (as reported), the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UJ236AA, expiry date not reported) via intramuscular route in the left deltoid for prophylactic vaccination. The patient was also administered with Pneumococcal vaccine.  On an unknown date, the patient developed non-serious shortness of breath (dyspnoea), slight pain, redness and a rash at sight of the injection (vaccination site rash and vaccination site inflammation associated with vaccination site inflammation pain and vaccination site erythema) unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.   This patient had pre-existing COPD. Her COPD was not well controlled and during that time last year, unknown latency, following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE COPD medications were increased (condition aggravated).  Relevant laboratory test was not reported.  Final diagnosis was slight pain, redness and a rash at sight of the injection, the patient experienced shortness of breath and copd was not well controlled and during that time last year when she got the fluzone hd vaccine they were increasing her copd medications.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.