chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Varicella post vaccine, Varicella virus test negative, Viral test negative
Clinical narrative: June 16 2020: 930 am Spoke with patient, right arm with oval redness about 1 and 1/2 inches. Slightly warm to the touch, painful. No fever. No blister/liquid. Using Neosporin ointment. No other over the counter meds. Started Fri, 6/12/20. Advised to follow up with MD if fever begins, or no improvement, advised not Usual occurrence after varicella immunization. He stated he had similar spot on his back a few years ago, had to be lancedX2. No culture done at that time. Also noticing a few red spots on his back and chest. June 17, 2020: 11 am Follow up phone call. Patient stated he began to have fever,101.4, around 4pm 7/16/20. Went to urgent care. Placed on Bactrim and Clindamycin. Area lanced. Told to go back for follow up 48 hrs. June 18, 2020: 1pm Phone conversation with Patient. Right arm less sore. Still fever 100, fatigue, sometimes headache. More spots all over body and in mouth. Will follow up w/urgent care physician. June 23, 2020 1215 Left message to call us back. June 25, 2020 Phone conversation with Patient. Had visit 6/19/20. Blood culture, Varicella Igg, Covid test done. Blood Culture neg for bacteria, non specific virus, Varicella negative, Covid negative per Patient. Said doctor thought it was Chicken Pox. Arm feeling better, no fever. Spots subsiding. July 9, 2020 2pm Drove wife to our office for immunizations. Spoke with Patient in parking lot as he was waiting in car with their children. Still has some discomfort if presses on site. Otherwise "back to normal." RN.
Age: 69.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Injection site warmth, Pain in extremity, Swelling
Clinical narrative: local swelling and inferior Pain, (R) Arm.  Site warm to touch.  No shortness of Breath or fever  No Prior Reactions to Vaccines  Steroid injection given in office  Steroids to start next day orally  Apply cold compress on site  ER for worsening symptoms
Age: 15.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Tremor
Clinical narrative: 5 minutes after Bexsero was given Pt. started with some dizziness, light headed, hands shaking. B.P. 115/74 HR: 106 @ 9:50. Pt. was given oral hydration. Pt. B.P. 100/67 HR: 109 @ 10:05  B.P. 109/62 HR: 92 @ 10:18 discharge stable B.P. 109/73 HR: 82
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Swollen tongue
Clinical narrative: Day one of second Shingrix shot same as first dose per patient (low energy & chills). On second day, felt tongue swollen. It resolved without medication
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Gait disturbance, Headache, Pain in extremity
Clinical narrative: SoRe ARm, IbupRofeN DizziNess 6:00 PM HeadAche, Chills 15 MiNutes In AM. No HeAdAche, Had VeRtigo, Trouble Walking Less Vertigo WAlking BetteR
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: SoRe ARm, IbupRofeN DizziNess 6:00 PM HeadAche, Chills 15 MiNutes In AM. No HeAdAche, Had VeRtigo, Trouble Walking Less Vertigo WAlking BetteR
Sex: M
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Erythema, Rash, Rash morbilliform, Skin lesion
Clinical narrative: the shape of measles in the arms; rash that affected the knees and legs, arms in the elbows and inside the arms.; lesions were red; lesions were red; developed from red to purple; This case was reported by a consumer via other manufacturer and described the occurrence of measles in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR 13) for prophylaxis.   Previously administered products included Prevnar 13 (initial dose received on 13th may 2019).   On 14th January 2020, the patient received the 1st dose of Shingrix and the 2nd dose of PREVNAR 13. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced measles (serious criteria GSK medically significant), rash, skin lesion, erythema and skin discoloration. On an unknown date, the outcome of the measles, rash, skin lesion, erythema and skin discoloration were unknown.   It was unknown if the reporter considered the measles, rash, skin lesion, erythema and skin discoloration to be related to Shingrix.  Additional information received as follows: The consumer called for information about if a second dose of Prevnar 13 could be appropriate to be administered on him. It was reported that he was administered initially at the age of 75 with an initial dose of Prevnar 13 on May 2019 and after that he was administered with a second dose of the vaccine on January 14 of 2020. The consumer reported that he think that the second vaccine would have been Pneumovax 23 instead of Prevnar 13 if needed. It was reported that the same day he was administered with the second dose of Prevnar 13 he was administered with the first dose of the Shingrix vaccine for Herpes Zoster. The consumer reported that after the administration of the vaccines he developed a rash that affected the knees and legs, arms in the elbows and inside the arms.  The lesions were red and with the shape of a pencil eraser in the knees and legs and the shape of measles in the arms. Somehow the patient still feel the lesions in the arms and they developed from red to purple until they slowly faded over between 3 to 4 months. On July 14 2020, the patient got the second dose of Shingrix. The consumer reported that the Physician authorized the second administration of Prevnar 13 after he requested to the pharmacy to verify the indication with the physician. It was unknown if the reporter considered the measles, rash, skin lesion, erythema and skin discoloration to be related to Prevnar 13.
Sex: M
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Erythema, Measles, Rash, Skin discolouration, Skin lesion
Clinical narrative: the shape of measles in the arms; rash that affected the knees and legs, arms in the elbows and inside the arms.; lesions were red; lesions were red; developed from red to purple; This case was reported by a consumer via other manufacturer and described the occurrence of measles in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR 13) for prophylaxis.   Previously administered products included Prevnar 13 (initial dose received on 13th may 2019).   On 14th January 2020, the patient received the 1st dose of Shingrix and the 2nd dose of PREVNAR 13. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced measles (serious criteria GSK medically significant), rash, skin lesion, erythema and skin discoloration. On an unknown date, the outcome of the measles, rash, skin lesion, erythema and skin discoloration were unknown.   It was unknown if the reporter considered the measles, rash, skin lesion, erythema and skin discoloration to be related to Shingrix.  Additional information received as follows: The consumer called for information about if a second dose of Prevnar 13 could be appropriate to be administered on him. It was reported that he was administered initially at the age of 75 with an initial dose of Prevnar 13 on May 2019 and after that he was administered with a second dose of the vaccine on January 14 of 2020. The consumer reported that he think that the second vaccine would have been Pneumovax 23 instead of Prevnar 13 if needed. It was reported that the same day he was administered with the second dose of Prevnar 13 he was administered with the first dose of the Shingrix vaccine for Herpes Zoster. The consumer reported that after the administration of the vaccines he developed a rash that affected the knees and legs, arms in the elbows and inside the arms.  The lesions were red and with the shape of a pencil eraser in the knees and legs and the shape of measles in the arms. Somehow the patient still feel the lesions in the arms and they developed from red to purple until they slowly faded over between 3 to 4 months. On July 14 2020, the patient got the second dose of Shingrix. The consumer reported that the Physician authorized the second administration of Prevnar 13 after he requested to the pharmacy to verify the indication with the physician. It was unknown if the reporter considered the measles, rash, skin lesion, erythema and skin discoloration to be related to Prevnar 13.
Sex: U
Vaccine: HEPA, UNK
Symptoms: Expired product administered
Clinical narrative: No additional adverse effects were reported in the patient.; Nurse reports that a patient received an expired dose of VAQTA; This spontaneous report was received from a Registered Nurse, referring to a patient of unknown age and gender.The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 14-JUL-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) syringe (also reported as "vial 50" conflicting information) 1 ml (strength, route, frequency,and anatomical location were unknown) with lot # S001832, and expiration date 12-MAY-2020 for prophylaxis. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S001832; expirationdate: 12-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 1.33
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Product storage error
Clinical narrative: the day after his daughters arm was red at the injection site; there was an issue with their freezer and it was supposed to hold the vaccine that was given frozen but instead it was liquid and they still had given it to her; it was supposed to hold the vaccine that was given frozen but instead it was liquid and they still had given it to her; This spontaneous report was received from a consumer, referring to his daughter a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were unknown by the reporter.  In May 2020, the patient at the age of 16 months old, was vaccinated with a dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection, administered on an unspecified arm, as prophylaxis (dosage, vaccination scheme, route of administration, lot number and expiration date were unknown by the reporter).  On an unspecified day in May 2020 (also reported as "the day after"), the patient's arm was red at the injection site (injection site erythema). The father stated that, it had been like that for a month now. It was unknown by the reporter if the patient sought medical attention, if laboratory diagnostic studies were performed or if treatment was given for the adverse event.   On an unspecified date in July 2020 (also reported as "2 months later"), the father received a call from the office where the patient had gotten the vaccine. They informed him that, there was an issue with their freezer, it was supposed to hold the given vaccine frozen, but instead it was liquid, and still it was administered to his daughter (product storage error and product physical consistency issue). In addition, the father wanted to know if this could be a major problem for the child.   The outcome of the event injection site erythema was not reported. The causal relationship between the aforementioned event and therapy with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD), was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Neuralgia, Rash, Rash vesicular
Clinical narrative: nerve pain; recurring painful blistering rash; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70-year-old patient (pt) of unknown gender. No information regarding the pt's pertinent medical history, drug reactions or allergies, and concomitant medications was provided. On or about 03-OCT-2013, the pt was inoculated by a nurse with zoster vaccine live (ZOSTAVAX) (dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), at a family practice, for the long-term prevention of shingles and zoster-related conditions. On an unknown date, reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) use: recurring painful blistering rash and nerve pain. The pt claimed damages as a result of injury to themselves, loss of services and economic loss. The outcomes of the events were not provided. The reporter assessed that the events were related to the zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: patient may have improperly stored GARDASIL 9 administered; This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 11-MAY-2020, the patient may have been administered an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R030453 (expiration date: 23-JUL-2021) for prophylaxis (additional dosage regimen information was not reported).  It was mentioned that the vaccines were found out of the refrigerator on 13-MAY-2020. 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: R030453; expirationdate: 23-JUL-2021; 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 suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2007USA008888:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse event; A dose of varivax undergone temperature excursions; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.    On 21-JUL-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live)Oka/Merck)(VARIVAX) (dose, frequency, lot number, expiration date and route were not provided) for prophylaxis.    The vaccine underwent a temperature excursion (exact temperature not reported). It was unknown if the vaccine had previous temperature excursion. The excursion was called by a digital data logger. The physician reported that the patient did not experience any adverse event.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Impaired work ability, Injected limb mobility decreased, Injection site pain
Clinical narrative: Arm was sore at the injection site, as the day worn on it became extremely painful to the point where I couldn't lift my arm.  During the night I woke up shivering and my entire body ached.  I could hardly sleep.  I could not go to work the day after the injection.  I felt aching and tired through the afternoon and my arm still ached.  By evening I felt much better. The following day I was able to return to work and normal activities with still a bit of pain in my arm
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain, Pain in extremity
Clinical narrative: Arm was sore at the injection site, as the day worn on it became extremely painful to the point where I couldn't lift my arm.  During the night I woke up shivering and my entire body ached.  I could hardly sleep.  I could not go to work the day after the injection.  I felt aching and tired through the afternoon and my arm still ached.  By evening I felt much better. The following day I was able to return to work and normal activities with still a bit of pain in my arm
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injected limb mobility decreased, Myalgia
Clinical narrative: Three hours after injection, severe pain in entire right arm with little mobility lasting 6 hours.  Also experienced extreme whole body muscle aches and chills lasting approx. 18 hours after injection.  Extreme tiredness lasting 24 hours after injection.  Onset of moderate headache 20 hours after injection lasting 6 hours.  Took Ibuprofen for headache.  Mild nausea throughout.  All symptoms were gone 36 hours after injection.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity
Clinical narrative: Three hours after injection, severe pain in entire right arm with little mobility lasting 6 hours.  Also experienced extreme whole body muscle aches and chills lasting approx. 18 hours after injection.  Extreme tiredness lasting 24 hours after injection.  Onset of moderate headache 20 hours after injection lasting 6 hours.  Took Ibuprofen for headache.  Mild nausea throughout.  All symptoms were gone 36 hours after injection.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Injection site erythema, Muscle mass, Pyrexia, Skin mass, Tenderness
Clinical narrative: low grade fever of 100-101F. Localized redness/erythema to injection site tissue. Small muscle/skin mass approximately 2cm in diameter. Tender to touch.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Pt. developed fever of 103 F for 3 days, fever reducing medication bought it down to 101 F, general body aches and malaise.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Eyelid disorder, Muscle twitching, Seizure like phenomena
Clinical narrative: seizure like activity / the patient's eyes fluttered and his hands twitched; This spontaneous report was received from a registered nurse via a company representative and refers to an 11 year old male patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.      On 17-JUL-2020, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot# and expiration date were not reported) for human papillomavirus (HPV) prophylaxis; with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (dose, route of administration, lot# and expiration date were not reported) and with meningococcal acyw conj vaccine (crm197)(MENVEO) (dose, route of administration, lot# and expiration date were not reported). On the same day, after vaccines administration, the patient experienced seizure like activity. It was reported that "the patient's eyes fluttered and his hands twitched". The patient was in the office when the seizure like activity occurred. No treatment was given for the event and no laboratory diagnostics was performed. The outcome of seizure was not reported. The relatedness between the event and suspect vaccines was not provided.      Upon internal review, the event of seizure was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: feeling tired; headache; upset stomach; hard to take full breath in; dizziness; heart beating fast/HR 78; slight temp; This case was reported by a nurse via sales rep and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) (batch number 4ME42, expiry date 14th November 2021) for prophylaxis.   On 18th June 2020, the patient received the 1st dose of Shingrix. On 19th June 2020, 1 days after receiving Shingrix, the patient experienced tiredness, headache, upset stomach, difficulty breathing, dizziness, heartbeats increased and slight temperature. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the tiredness, headache, upset stomach, difficulty breathing, dizziness, heartbeats increased and slight temperature were unknown.   It was unknown if the reporter considered the tiredness, headache, upset stomach, difficulty breathing, dizziness, heartbeats increased and slight temperature to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experinced tired, headache, upset stomach, hard to take full breath in, dizziness, heart beating fast, slight temprature. The patient was able to talk without difficulty. It was reported requesting 2nd dose of Shingrix be cancelled. This case is one of the 3 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR135190:Same reporter US-GLAXOSMITHKLINE-US2020AMR135291:same reporter US-GLAXOSMITHKLINE-US2020AMR137983:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: feeling tired; headache; upset stomach; hard to take full breath in; dizziness; heart beating fast/HR 78; slight temp; This case was reported by a nurse via sales rep and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) (batch number 4ME42, expiry date 14th November 2021) for prophylaxis.   On 18th June 2020, the patient received the 1st dose of Shingrix. On 19th June 2020, 1 days after receiving Shingrix, the patient experienced tiredness, headache, upset stomach, difficulty breathing, dizziness, heartbeats increased and slight temperature. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the tiredness, headache, upset stomach, difficulty breathing, dizziness, heartbeats increased and slight temperature were unknown.   It was unknown if the reporter considered the tiredness, headache, upset stomach, difficulty breathing, dizziness, heartbeats increased and slight temperature to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experinced tired, headache, upset stomach, hard to take full breath in, dizziness, heart beating fast, slight temprature. The patient was able to talk without difficulty. It was reported requesting 2nd dose of Shingrix be cancelled. This case is one of the 3 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR135190:Same reporter US-GLAXOSMITHKLINE-US2020AMR135291:same reporter US-GLAXOSMITHKLINE-US2020AMR137983:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: headache; fever; body aches; fatigue; redness in my arm; This case was reported by a consumer via call center representative and described the occurrence of headache in a 62-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 headache, fever, general body pain, fatigue and erythema of extremities. On an unknown date, the outcome of the headache, fever, general body pain, fatigue and erythema of extremities were not recovered/not resolved.   It was unknown if the reporter considered the headache, fever, general body pain, fatigue and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experianced fever, body aches, headache, fatigue and redness on her arm. The patient had very mild symptoms on 1st dose and lasted 2 and half days. The patient wanted to know was this normal to last so long.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: How long do the side effects from the Shingrix normally last?; This case was reported by a consumer via interactive digital media 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 not recovered/not resolved.   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 captured as adult as per the vaccine indication. After receiving Shingrix, the patient experienced side effects. The patient was asking, how long did the side effects from the Shingrix normally lasted.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Stress, Tension
Clinical narrative: she was stressed; Scarring post outbreak; Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (2 prior episodes pre-Shingrix).   On 12th February 2020, the patient received the 1st dose of Shingrix. On 18th April 2020, 66 days after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced shingles. On an unknown date, the patient experienced stress and feeling tense. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the stress and feeling tense were unknown.   It was unknown if the reporter considered the shingles, stress and feeling tense to be related to Shingrix.  Additional details were provided as follows: After receiving 1st dose of Shingrix, the patient developed an outbreak of Shingles and received Valtrex. The outbreak was reported to be resolved at the time of reporting. The patient thought it was a bug bite at the onset of the episode, she was stressed and this outbreak scarred her more than the past episodes. The reporter was consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling hot, Nausea, Pain in extremity
Clinical narrative: nausea; sore arm; chills; exhausted; feeling hot; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 15th January 2020).   On 15th July 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 15th July 2020, 8 hrs after receiving Shingrix, the patient experienced pain in arm, chills, exhaustion and feeling hot. On 16th July 2020, the patient experienced nausea. On an unknown date, the outcome of the nausea, pain in arm, chills, exhaustion and feeling hot were unknown.   It was unknown if the reporter considered the nausea, pain in arm, chills, exhaustion and feeling hot to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix on 15th January 2020, and reported no adverse events.  After receiving the 2nd dose of Shingrix the patient the patient experienced sore arm, feeling hot, feeling exhausted, has chills, and 1 day after vaccination the patient experienced nausea. The reporter did not consent to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Oxygen saturation decreased
Clinical narrative: Fever; Body Aches; Extreme fatigue; Myalgia; Shivering; Facial swelling; Tachycardia; Headache; Low Oxygen level; This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 13th July 2020, the patient received the 2nd dose of Shingrix. In July 2020, 12 hrs after receiving Shingrix, the patient experienced fever (serious criteria hospitalization), general body pain (serious criteria hospitalization), fatigue (serious criteria hospitalization), myalgia (serious criteria hospitalization), shivering (serious criteria hospitalization), facial swelling (serious criteria hospitalization), tachycardia (serious criteria hospitalization), headache (serious criteria hospitalization) and oxygen saturation decreased (serious criteria hospitalization). On an unknown date, the outcome of the fever was unknown and the outcome of the general body pain, fatigue, myalgia, shivering, facial swelling, tachycardia and oxygen saturation decreased were recovered/resolved and the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the fever, general body pain, fatigue, myalgia, shivering, facial swelling, tachycardia, headache and oxygen saturation decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. After receiving Shingrix, the patient experienced fever, body aches, myalgia, extreme fatigue, shivering, facial swelling, tachycardia and headache. The patient was hospitalized on 18th July 2020.  The patient had low oxygen levels.  The patient was released from hospital on 19th July 2020.  Till the time of reporting, the patient had headache and did not know if the patient still had fever.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020136675:same reporter
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Swelling face, Tachycardia
Clinical narrative: Fever; Body Aches; Extreme fatigue; Myalgia; Shivering; Facial swelling; Tachycardia; Headache; Low Oxygen level; This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 13th July 2020, the patient received the 2nd dose of Shingrix. In July 2020, 12 hrs after receiving Shingrix, the patient experienced fever (serious criteria hospitalization), general body pain (serious criteria hospitalization), fatigue (serious criteria hospitalization), myalgia (serious criteria hospitalization), shivering (serious criteria hospitalization), facial swelling (serious criteria hospitalization), tachycardia (serious criteria hospitalization), headache (serious criteria hospitalization) and oxygen saturation decreased (serious criteria hospitalization). On an unknown date, the outcome of the fever was unknown and the outcome of the general body pain, fatigue, myalgia, shivering, facial swelling, tachycardia and oxygen saturation decreased were recovered/resolved and the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the fever, general body pain, fatigue, myalgia, shivering, facial swelling, tachycardia, headache and oxygen saturation decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. After receiving Shingrix, the patient experienced fever, body aches, myalgia, extreme fatigue, shivering, facial swelling, tachycardia and headache. The patient was hospitalized on 18th July 2020.  The patient had low oxygen levels.  The patient was released from hospital on 19th July 2020.  Till the time of reporting, the patient had headache and did not know if the patient still had fever.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020136675:same reporter
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pruritus, Urticaria
Clinical narrative: Mother reports started  itching over weekend.  Started getting welts on Tuesday.  Noting on arms and legs.  Under arms and outer thighs are worst.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: On 7/18, he had redness and swelling, warm to touch around injection site. 7/19 increased in size, arm painful and stiff neck.  Warmth and erythema increased to 3x5in. Did not increase in size after Zyrtec. 7/20, redness and swelling almost all gone, injection site still firm and warm. c/o left side neck pain with movement 7/19-7/20, mostly hurting when moving and turning to left. Some nausea, no vomiting.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Nausea, Neck pain, Pain, Pain in extremity
Clinical narrative: On 7/18, he had redness and swelling, warm to touch around injection site. 7/19 increased in size, arm painful and stiff neck.  Warmth and erythema increased to 3x5in. Did not increase in size after Zyrtec. 7/20, redness and swelling almost all gone, injection site still firm and warm. c/o left side neck pain with movement 7/19-7/20, mostly hurting when moving and turning to left. Some nausea, no vomiting.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Erythema 4 cm in diameter on left thigh, warm to touch with minimal swelling. Treating empirically with cephalexin for possible Staph infection.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Gait inability, Injection site erythema, Injection site movement impairment, Injection site swelling, Pyrexia
Clinical narrative: right thigh swelled really badly, turned really red, fever of 101.1 ,vomiting, and couldn't walk and couldn't put any pressure on the right leg. Still can't walk and is super swollen on 7/24/2020.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Ultrasound scan, Vomiting, Weight bearing difficulty, X-ray
Clinical narrative: right thigh swelled really badly, turned really red, fever of 101.1 ,vomiting, and couldn't walk and couldn't put any pressure on the right leg. Still can't walk and is super swollen on 7/24/2020.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Inappropriate schedule of product administration, Nausea, Pallor
Clinical narrative: Patient was given one vaccine Today. She was given Gardasil 9 Her second Dose. First Dose she Received 1 year ago on 7-22-2019 and reports No Adverse effects at that time. Patient Reports being very nervous about getting A shot today, Became Dizzy and Nauseous After Receiving the Vaccine. She was very pale in color. Given A Sprite, cheese and crackers and A cold pack to Apply
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Erythema, Fatigue, Myalgia, Pain
Clinical narrative: Soreness, swelling, redness, tiredness, chills, muscle pain in arm...still sore 2 days later
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Swelling
Clinical narrative: Soreness, swelling, redness, tiredness, chills, muscle pain in arm...still sore 2 days later
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Dermatitis acneiform, Pyrexia, Rash
Clinical narrative: about 9 days after vaccine, patient had a mild fever (99-100 degrees); this resolved itself within 48 hours and never was above 100.5 . About 10 days after the vaccine, patient developed a very mild rash - he had about 10 pimple looking blemishes across his body. This resolved itself within 48 hours - the bumps looked like pimples or clogged pores - he had one on his cheek and then 9-ish across his body (stomach, butt, arms)
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis developed to right arm where received Menveo injection. Treated with cephalexin.
Sex: U
Vaccine: VARZOS
Symptoms: Facial paralysis, Herpes zoster
Clinical narrative: Bell's palsy; shingles; Information has been received from a lawyer and the consumer regarding a case in litigation referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. In or around 19-MAY-2011, pt was inoculated with zoster vaccine live (ZOSTAVAX) by unknown route, for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, on an unknown date, pt suffered shingles and Bell's palsy. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms had resulted in physical limitations not present prior to using the vaccine. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition, severe and permanent personal injuries, also suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, loss of enjoyment of life, physical impairment and injury. At reporting time, pt was not recovered from shingles and Bell's palsy and the events were considered to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review the event Facial paralysis was determined to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient received a total of 2 shots since the first visti/the patient case back to the office and brought her medical records which showed two prior injectiosn of Gardasil 9; No additional AE reported; This spontaneous report as received from a nurse via company representative, concerning to female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date (discrepant information reported as on 20-JUL-2020 and also reported as date unknown), the patient was vaccinated with an extra dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (frequency, route, lot number and expiration date were not provided) for prophylaxis with no adverse event. The reporter stated that the patient came approximately in 2019 (reported as about a year ago), and did not have her records of whether the patient had been previously had hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or not; the nurse went ahead and began the series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The patient received a total of 2 shots since the first visit on an unknown date. The patient came back to the office and brought her medical records which showed two prior injections of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash, Rash pruritic, Rash vesicular
Clinical narrative: rash that looks like shingles; rash; painful; itching on his back; This case was reported by a physician via call center representative and described the occurrence of vesicular rash in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received Shingrix. In July 2020, less than 3 weeks after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced vesicular rash, itchy rash, painful rash and pruritus. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vesicular rash, itchy rash, painful rash and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vesicular rash, itchy rash, painful rash and pruritus to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not repoted. The patient received Shingrix about 2.5 weeks ago. Several days ago the patient started having itching on his back. More recently the areas that were itching started becoming painful. The patient looked at his back and saw that there was a rash that looks like shingles.  The patient had started taking Valtrex.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: rash that looks like shingles; rash; painful; itching on his back; This case was reported by a physician via call center representative and described the occurrence of vesicular rash in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received Shingrix. In July 2020, less than 3 weeks after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced vesicular rash, itchy rash, painful rash and pruritus. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vesicular rash, itchy rash, painful rash and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vesicular rash, itchy rash, painful rash and pruritus to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not repoted. The patient received Shingrix about 2.5 weeks ago. Several days ago the patient started having itching on his back. More recently the areas that were itching started becoming painful. The patient looked at his back and saw that there was a rash that looks like shingles.  The patient had started taking Valtrex.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash, Rash pruritic, Rash vesicular
Clinical narrative: episode of Shingles; Pain; outbreak; This case was reported by a physician via call center representative and described the occurrence of shingles in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th June 2020, the patient received the 1st dose of Shingrix. In July 2020, 2 weeks after receiving Shingrix, the patient experienced shingles, pain and skin breakout. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles, pain and skin breakout were unknown.   It was unknown if the reporter considered the shingles, pain and skin breakout to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The physician reported that he developed an episode of Shingles 2 weeks after receiving the 1st dose of Shingrix.  The patient stated he had pain as a symptom and was on Valtrex for the outbreak.  The reporter consent to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: episode of Shingles; Pain; outbreak; This case was reported by a physician via call center representative and described the occurrence of shingles in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th June 2020, the patient received the 1st dose of Shingrix. In July 2020, 2 weeks after receiving Shingrix, the patient experienced shingles, pain and skin breakout. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles, pain and skin breakout were unknown.   It was unknown if the reporter considered the shingles, pain and skin breakout to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The physician reported that he developed an episode of Shingles 2 weeks after receiving the 1st dose of Shingrix.  The patient stated he had pain as a symptom and was on Valtrex for the outbreak.  The reporter consent to follow up.
Sex: U
Vaccine: RAB
Symptoms: Confusional state, Hallucination
Clinical narrative: hallucinations; extreme confusion; This case was reported by a other health professional via call center representative and described the occurrence of hallucination in a patient who received Rabies NVS (Rabies Vaccine (Potential Marburg)) for prophylaxis.   Co-suspect products included immunoglobulin human anti-rabies (Rabies Immunoglobulin) for product used for unknown indication.   On an unknown date, the patient received Rabies Vaccine (Potential Marburg) at an unknown dose and Rabies Immunoglobulin at an unknown dose and frequency. On an unknown date, unknown after receiving Rabies Vaccine (Potential Marburg), the patient experienced hallucination (serious criteria GSK medically significant) and confusion. The action taken with Rabies Vaccine (Potential Marburg) was unknown. The action taken with Rabies Immunoglobulin was unknown. On an unknown date, the outcome of the hallucination and confusion were unknown.   It was unknown if the reporter considered the hallucination and confusion to be related to Rabies Vaccine (Potential Marburg).  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced extreme confusion and hallucinations. The reporter consented to follow up. It was unknown if the reporter considered the hallucination and confusion to be related to Rabies immunoglobulin.
Sex: M
Vaccine: MENB
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever(approx. 101); chills; fatigue; body aches; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 18 years old male received meningococcal group b rlp2086 (TRUMENBA) on an unknown date, at single dose, for immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced fever (approx. 101), chills, fatigue and body aches. Events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain, Abdominal tenderness, C-reactive protein increased, Chills, Cold sweat
Clinical narrative: Severe systemic inflammatory response syndrome starting within 24 hours of vaccine dose characterized by fever, malaise, abdominal pain, chills, "cold sweats" with nausea and vomiting. NOTE: Patient had never received Heplisav-B before (was vaccine naive to this).
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Fibrin D dimer increased, Hyperhidrosis, Lymphocyte count decreased, Malaise, Nausea
Clinical narrative: Severe systemic inflammatory response syndrome starting within 24 hours of vaccine dose characterized by fever, malaise, abdominal pain, chills, "cold sweats" with nausea and vomiting. NOTE: Patient had never received Heplisav-B before (was vaccine naive to this).
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia, SARS-CoV-2 test negative, Systemic inflammatory response syndrome, Vomiting, White blood cell count decreased
Clinical narrative: Severe systemic inflammatory response syndrome starting within 24 hours of vaccine dose characterized by fever, malaise, abdominal pain, chills, "cold sweats" with nausea and vomiting. NOTE: Patient had never received Heplisav-B before (was vaccine naive to this).
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: fever for 2 days and generalized rash
Age: 52.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: SIRVA
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: Large red area with significant soreness
Age: 16.0
Sex: U
Vaccine: MENB, MNQ
Symptoms: Immediate post-injection reaction, Pallor, Presyncope, Tonic clonic movements, Unresponsive to stimuli
Clinical narrative: He received MenactRa in left arm and seemed ok. Immediately after Receiving bexsero in Right arm, he turned pale and became unresponsive, followed by tonic-clonic jerks of arms + legs he was laid down on table - Episode lasted ^10 seconds. He recovered after about 30 minutes - vital signs consistent with probable vasovagal reaction. Similar events have occured to other Family members. Don't think it was due to vaccine but due to injection itself.