chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster, Post herpetic neuralgia
Clinical narrative: outbreak of herpes zoster; post herpetic neuralgia; vision loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for the routine health maintenance and for its intended purpose: the prevention of singles (herpes zoster).  Subsequently on an unknown date, the patient suffered and was treated for outbreak of herpes zoster, post herpetic neuralgia and vision loss. As a direct and proximate result of the patient's receipt of zoster vaccine live (ZOSTAVAX), the patient´s symptoms have resulted in physical limitations, mental and emotional distress not present prior to vaccination. Further as a tragic consequence, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   The outcome of herpes zoster, post herpetic neuralgia and vision loss was not recovered.   The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered all the events to be disabling.  Upon internal review, the event of visión loss was considered to be medically significant.
Sex: M
Vaccine: HPV9
Symptoms: Chemotherapy
Clinical narrative: chemotherapy; This spontaneous report was received from a medical assistant and refers to a 16-year-old male patient. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On unknown dates, the patient was vaccinated with two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route of administration, lot number and expiry date were not reported) for prophylaxis.  On an unknown date, shortly after receiving the 2 doses of the vaccine, the patient started chemotherapy. The reason for chemotherapy was not specified. The outcome of the event was not reported.  The relatedness between the event and the suspect vaccine was not provided.  Upon internal review, the event of chemotherapy was upgraded to be medically significant.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Immobile, Loss of consciousness, Pain
Clinical narrative: aches, light headed, immobility, lack of consciousness
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Immobile, Loss of consciousness, Pain
Clinical narrative: aches, light headed, immobility, lack of consciousness
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Mobility decreased, Rheumatoid arthritis
Clinical narrative: DIFFICULTY MOVING LEGS, DIFFICULTY WALKING.  STEROID TREATMENTS FOR SEVERAL MONTHS SINCE VACCINATION. SHE HAS SEEN SEVERAL DOCTORS AND HAVE BEEN LOOKING AT DIAGNOSIS OF RHEUMATOID ARTHRITIS.   SHE HAS BEEN WEANING OFF AND ENDED THERAPY 2 WEEKS AGO.  SHE IS NOW EXPERIENCING SAME SYMPTOMS AND IS NOW SEEKING OTHER TREATMENT FOR RHEUMATOID ARTHRITIS.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure increased, Muscle rigidity, Oxygen saturation decreased, Pallor, Syncope
Clinical narrative: syncope, pale skin, elevated blood pressure, rigid arms, non responsive x1 minute, low O2 sat.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: syncope, pale skin, elevated blood pressure, rigid arms, non responsive x1 minute, low O2 sat.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site swelling
Clinical narrative: Swollen thigh-Left
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Differential white blood cell count normal, Dizziness, Dyspnoea, Full blood count normal, Heart rate increased
Clinical narrative: Bexsero vaccine was given at our office at approximately 3:30 pm. The patient waited in our office for approximately 30 minutes before leaving our facility and on her way home. She started feeling body aches and pain about an hour and a half after leaving our facility. Tingling throughout her body, dizziness and shortness of breath also developed within a matter of minutes. After about 30 minutes she fainted and her mother brought her to hospital. At the hospital, oral pain killers were given along with 2 bags of IV fluids. She was monitored in the ER for 5 hours because of the increase in her pulse rate alongside with her dizziness. the patient was discharged and is still having pain in her arm.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Human chorionic gonadotropin normal, Metabolic function test normal, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Bexsero vaccine was given at our office at approximately 3:30 pm. The patient waited in our office for approximately 30 minutes before leaving our facility and on her way home. She started feeling body aches and pain about an hour and a half after leaving our facility. Tingling throughout her body, dizziness and shortness of breath also developed within a matter of minutes. After about 30 minutes she fainted and her mother brought her to hospital. At the hospital, oral pain killers were given along with 2 bags of IV fluids. She was monitored in the ER for 5 hours because of the increase in her pulse rate alongside with her dizziness. the patient was discharged and is still having pain in her arm.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: SARS-CoV-2 test negative, Syncope, Troponin I normal
Clinical narrative: Bexsero vaccine was given at our office at approximately 3:30 pm. The patient waited in our office for approximately 30 minutes before leaving our facility and on her way home. She started feeling body aches and pain about an hour and a half after leaving our facility. Tingling throughout her body, dizziness and shortness of breath also developed within a matter of minutes. After about 30 minutes she fainted and her mother brought her to hospital. At the hospital, oral pain killers were given along with 2 bags of IV fluids. She was monitored in the ER for 5 hours because of the increase in her pulse rate alongside with her dizziness. the patient was discharged and is still having pain in her arm.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Feeling hot, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: After receiving Tdap yesterday, she noticed a small bump at injection site remainder of the day. She woke up this morning and noted more swelling/redness/warmth at injection site. Also noticed rash on hands and feet that is very itchy, hot. +loose stools. Similar reaction to flu/ppsv23 in past. She denies cough, SOB, tongue swelling but has noticed some tingling sensation around lips but no visible swelling. Denies fever. She took benadryl and ibuprofen this morning. Symptoms improving.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia oral, Rash, Rash pruritic
Clinical narrative: After receiving Tdap yesterday, she noticed a small bump at injection site remainder of the day. She woke up this morning and noted more swelling/redness/warmth at injection site. Also noticed rash on hands and feet that is very itchy, hot. +loose stools. Similar reaction to flu/ppsv23 in past. She denies cough, SOB, tongue swelling but has noticed some tingling sensation around lips but no visible swelling. Denies fever. She took benadryl and ibuprofen this morning. Symptoms improving.
Age: 43.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Fatigue, Pain, Pyrexia
Clinical narrative: I was administered the shingrix vaccine. Fever (temp got up to 101), body aches, tiredness, stomach pain. Symptoms are still current, currently resting and took 1000 mg Tylenol. Fever dropped to 99.8 within few hours of the 101 temp.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Feeling cold, Headache, Nausea
Clinical narrative: 11 hours after the vaccination I got sudden and uncontrollable shivers as if all of my bones were frozen and I was cold from the inside out and my body felt swollen all over but it wasn't. I kept adding more clothing and blankets and finally fell asleep for a couple of hours. Then more blankets. I was still cold in the morning but not uncontrollably. Then a headache hit and all I did all day (the day after the vaccination) was sleep and sip water. I felt slightly dizzy and nauseous that night but nothing significant and those symptoms went away by Wednesday morning. Wednesday and Thursday were periodic sluggishness and napping. Friday morning, 4 days since the vaccination I awoke feeling fine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Sluggishness, Somnolence, Swelling
Clinical narrative: 11 hours after the vaccination I got sudden and uncontrollable shivers as if all of my bones were frozen and I was cold from the inside out and my body felt swollen all over but it wasn't. I kept adding more clothing and blankets and finally fell asleep for a couple of hours. Then more blankets. I was still cold in the morning but not uncontrollably. Then a headache hit and all I did all day (the day after the vaccination) was sleep and sip water. I felt slightly dizzy and nauseous that night but nothing significant and those symptoms went away by Wednesday morning. Wednesday and Thursday were periodic sluggishness and napping. Friday morning, 4 days since the vaccination I awoke feeling fine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site induration, Injection site swelling
Clinical narrative: Symptoms included a hard bump with bruising at the injection site. Patient took Tylenol and applied ice packs which alleviated most symptoms, patient still has bruising.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Persistent arm and shoulder pain 10 days after injection
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Headache, Pain in extremity, Vomiting
Clinical narrative: Vomiting, Headache, Chills, pain in arm from injection
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse symptoms reported; inadvertently administered a dose of PROQUAD (Lot: S022912, Exp: 01/19/2021) via the intramuscular route rather than the recommended subcutaneous route; This spontaneous report has been received from a nurse referring to a patient with unknown age and gender. The concomitant therapy included sterile diluent (DILUENT MRK). Information about current condition, medical history, and drug reactions/allergies was not provided.   On 26-JUN-2020, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin(rHA)) (PROQUAD), lot# S022912, expiration date 19-JAN-2021 (strength, dose and frequency was not reported) as prophylaxis, inadvertently via the intramuscular route rather than the recommended subcutaneous route (incorrect route of product administration).  No adverse symptom was reported.
Sex: U
Vaccine: PPV, UNK
Symptoms: Expired product administered
Clinical narrative: expired dose of PNEUMOVAX 23; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant therapies were not reported.   On 26-JUN-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection (lot # R022232, expiry date 16-APR-2020, 1 dose; route of administration and anatomical location not provided) for prophylaxis. The vaccine was properly stored. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: R022232; expirationdate: 16-APR-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; inadvertently administered an expired dose of VARIVAX; This spontaneous report was received from a pharmacist and refers to a 41-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 14-JUL-2020, the patient was inadvertently administered an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # N031937, expiration date 13-NOV-2019 (strength, dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (lot# S016521, expiration date 09-APR-2022). No adverse effects were reported. No additional information provided.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: the patient experienced no symptoms; first dose ofGARDASIL 9 on 10/30/2018 and a second dose ofGARDASIL 9 on 1/18/2019; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 30-OCT-2018, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (strength, lot# and expiration date were not provided) for prophylaxis. On 18-JAN-2019, the patient received second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, lot# and expiration date were not provided) for prophylaxis. The patient experienced no symptoms. No further information provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; the patient received an improperly stored dose of PROQUAD on 7/15/2020; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 15-JUL-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S030206, expiration date reported as 24-MAR-2021, but upon internal validation established as 25-MAR-2021 (exact dose, dose number, vaccination site and route of administration were not provided) for prophylaxis. Other suspect therapies included sterile diluent.  Administered doses of vaccine was exposed to the temperature excursion of 10.3 degrees Fahrenheit for 46 minutes. There was previous temperature excursion, 52.1 degrees Fahrenheit for 3 hours. Digital Data Logger was involved. No adverse symptoms were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects were reported; patient received improperly stored M-M-R II on 6/29/2020, after prior excursion on 6/25/2020; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided.   On 29-JUN-2020, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status: recombinant Human albumin (rHA)) lot # R030812, expiration date 24-OCT-2020 for prophylaxis (exact dose, dose #, route of administration were not provided). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) lot # S038150, expiration date 07-AUG-2022. On 25-JUN-2020, the temperature excursion was above 47 degrees Fahrenheit (F) (46.6 F) for 6 minutes. There was no previous excursions reported. The digital data logger was involved.  On 19-JUL-2020, the next temperature excursions were: above 47 degrees F (56.8 F) for 2 hours and 37 minutes and below 36 degrees F (33.1 F) for 12 minutes. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: redness at the injection site; warmth at the injection site; swelling at the injection site; throbbing pain in that area; This case was reported by a other health professional via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd June 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site erythema, injection site warmth, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site swelling and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site swelling and injection site pain to be related to Shingrix.  Additional details were reported as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix and experienced the typical side effects of redness, warmth, and swelling at the vaccination site this lasted about 5 days.  The patient experienced deep throbbing pain in that area.  It was not constant but more still b.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Musculoskeletal pain, Pain in extremity
Clinical narrative: large reddened and sore area on shoulder and upper arm/shoulder redness; sore area on shoulder and upper arm; sore area on shoulder and upper arm; This case was reported by a other health professional via sales rep and described the occurrence of localized erythema in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date 19th July 2021) for prophylaxis.   On 17th April 2019, the patient received the 2nd dose of Shingrix .5 ml. On 17th April 2019, less than a day after receiving Shingrix, the patient experienced localized erythema, pain in arm and shoulder pain. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the localized erythema was recovered/resolved and the outcome of the pain in arm and shoulder pain were unknown.   It was unknown if the reporter considered the localized erythema, pain in arm and shoulder pain to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and had large reddened and sore area on shoulder and upper arm, later in the afternoon and came into clinic the next day of reporting and was put on antibiotics.  The redness was resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: myalgia; fever; This case was reported by a nurse and described the occurrence of myalgia in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myalgia and fever. On an unknown date, the outcome of the myalgia and fever were recovered/resolved.   It was unknown if the reporter considered the myalgia and fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experienced significant myalgia for 4 days and fever for 1 day.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR135104:same reporter US-GLAXOSMITHKLINE-US2020AMR135190:same reporter US-GLAXOSMITHKLINE-US2020AMR135291:same reporter US-GLAXOSMITHKLINE-US2020AMR135486:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: soreness at injection site; redness at injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) (batch number 557ZA, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The case was reported by the nurse for another co worker. The age at vaccination was not reported. The nurse reported that patient received a Shingrix vaccination.  The patient experienced redness and soreness at injection site. The reporter consented to follow up. This case has been linked with the case US2020138148 and US2020138149, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020138148:same reporter US-GLAXOSMITHKLINE-US2020138149:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm soreness occurred after dose 1; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 67-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, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported however patient could be 65 or 66 years at time of vaccination. The patient experienced arm sorenss after 1st dose which was recovered. The reporter consented to follow up. This case is linked to case US2020AMR137938, reported by same reporter for same patient (2nd dose).; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR137938:same reporter
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Headache, Herpes zoster, Nausea, Pain
Clinical narrative: social problem; blisters; round circle on her back; circle got bigger and painful; circle got bigger and bigger and it was itchy and painful; shingles; nausea; headache; fever; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in mid January 2020 and had no problems).   On 27th June 2020, the patient received the 2nd dose of Shingrix. On 27th June 2020, 6 hrs after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced nausea, headache and fever. On 7th July 2020, the patient experienced shingles, rash, pain and pruritus. On 16th July 2020, the patient experienced blister. On an unknown date, the patient experienced social problem. The patient was treated with valaciclovir hydrochloride (Valtrex). On 28th June 2020, the outcome of the nausea, headache and fever were recovered/resolved. On an unknown date, the outcome of the shingles, pruritus, blister and social problem were unknown and the outcome of the rash and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, pruritus and blister to be related to Shingrix. The reporter considered the nausea, headache, fever, rash and pain to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix around noon and by 6:00, she had a fever of 102 degrees, a headache and was nauseous.   19 days after the patient had blistered. By the time she woke the morning and all symptoms had resolved.   The patient noticed a round circle on her back and sent a picture to her doctor who advised her to keep an eye on it and report if anything further developed.   The circle got bigger and bigger and it was itchy and painful.   The patient again sent a picture to her doctor who said it was shingles and prescribed Valtrex.   She took her 1st dose of Valtrex at 5:00pm and the area was blistered and did not hurt. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Rash, Social problem
Clinical narrative: social problem; blisters; round circle on her back; circle got bigger and painful; circle got bigger and bigger and it was itchy and painful; shingles; nausea; headache; fever; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in mid January 2020 and had no problems).   On 27th June 2020, the patient received the 2nd dose of Shingrix. On 27th June 2020, 6 hrs after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced nausea, headache and fever. On 7th July 2020, the patient experienced shingles, rash, pain and pruritus. On 16th July 2020, the patient experienced blister. On an unknown date, the patient experienced social problem. The patient was treated with valaciclovir hydrochloride (Valtrex). On 28th June 2020, the outcome of the nausea, headache and fever were recovered/resolved. On an unknown date, the outcome of the shingles, pruritus, blister and social problem were unknown and the outcome of the rash and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, pruritus and blister to be related to Shingrix. The reporter considered the nausea, headache, fever, rash and pain to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix around noon and by 6:00, she had a fever of 102 degrees, a headache and was nauseous.   19 days after the patient had blistered. By the time she woke the morning and all symptoms had resolved.   The patient noticed a round circle on her back and sent a picture to her doctor who advised her to keep an eye on it and report if anything further developed.   The circle got bigger and bigger and it was itchy and painful.   The patient again sent a picture to her doctor who said it was shingles and prescribed Valtrex.   She took her 1st dose of Valtrex at 5:00pm and the area was blistered and did not hurt. The reporter consented to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Circumstance or information capable of leading to medication error, Inappropriate schedule of product administration, Influenza like illness, Injection site pain
Clinical narrative: Left shoulder hurt really badly; Felt sluggish; Felt feverish; Had no energy; Like he had the flu; drug dose administration intervell; Circumstance or information capable of leading to medication error; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 13th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 13th July 2020, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shoulder pain, sluggishness, fever, loss of energy and influenza-like symptoms. On an unknown date, the patient experienced drug dose administration interval too short and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the shoulder pain, sluggishness and fever were recovered/resolved and the outcome of the loss of energy, influenza-like symptoms, drug dose administration interval too short and circumstance or information capable of leading to medication error were unknown.   It was unknown if the reporter considered the shoulder pain, sluggishness, fever, loss of energy and influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: On 13th July 2020, the patient received 1st dose of Shingrix in left deltoid. After receiving the 1st Shingrix vaccine, his left shoulder hurt really badly, he felt sluggish, had no energy, and felt feverish like he had the flu. Customer reports that he is just getting back on his feet and started feeling better three days after Shingrix dose.  The health care professional scheduled the 2nd dose on 17th August 2020, which was less than two months after first dose the patient was not yet received, which led ted shortening of schedule and circumstance or information capable of leading to medication error. The reporter stated he read the package insert and wants to know if that scheduled date is appropriate. Informed customer that second Shingrix dose should be administered 2 to 6 months after the first dose and not sooner. The reporter did not consent to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Pyrexia, Sluggishness
Clinical narrative: Left shoulder hurt really badly; Felt sluggish; Felt feverish; Had no energy; Like he had the flu; drug dose administration intervell; Circumstance or information capable of leading to medication error; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 13th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 13th July 2020, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shoulder pain, sluggishness, fever, loss of energy and influenza-like symptoms. On an unknown date, the patient experienced drug dose administration interval too short and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the shoulder pain, sluggishness and fever were recovered/resolved and the outcome of the loss of energy, influenza-like symptoms, drug dose administration interval too short and circumstance or information capable of leading to medication error were unknown.   It was unknown if the reporter considered the shoulder pain, sluggishness, fever, loss of energy and influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: On 13th July 2020, the patient received 1st dose of Shingrix in left deltoid. After receiving the 1st Shingrix vaccine, his left shoulder hurt really badly, he felt sluggish, had no energy, and felt feverish like he had the flu. Customer reports that he is just getting back on his feet and started feeling better three days after Shingrix dose.  The health care professional scheduled the 2nd dose on 17th August 2020, which was less than two months after first dose the patient was not yet received, which led ted shortening of schedule and circumstance or information capable of leading to medication error. The reporter stated he read the package insert and wants to know if that scheduled date is appropriate. Informed customer that second Shingrix dose should be administered 2 to 6 months after the first dose and not sooner. The reporter did not consent to follow up.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Lymphadenopathy, Subcutaneous abscess
Clinical narrative: Swollen lymph node; Could be an abscess; This case was reported by a nurse via call center representative and described the occurrence of axillary lymph nodes enlarged in a 22-year-old female patient who received HBV (Engerix B) for prophylaxis.   On 8th July 2020, the patient received the 2nd dose of Engerix B. On 8th July 2020, less than a day after receiving Engerix B, the patient experienced axillary lymph nodes enlarged and axillary abscess. On an unknown date, the outcome of the axillary lymph nodes enlarged and axillary abscess were unknown.   It was unknown if the reporter considered the axillary lymph nodes enlarged and axillary abscess to be related to Engerix B.  Additional information was provided as follows: The patient developed a swollen lymph node to the left axilla. The health care professional stated that there was no redness and that it could be an abscess. No ultrasound had been performed The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever; Body Ache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th July 2020, the patient received the 2nd dose of Shingrix. In July 2020, 12 hrs after receiving Shingrix, the patient experienced fever and general body pain. On an unknown date, the outcome of the fever and general body pain were recovered/resolved.   It was unknown if the reporter considered the fever and general body pain to be related to Shingrix.  Additional case details were reported as follows: The patient received her 2nd dose of Shingrix Vaccine in upper left arm the patient reported fever and body aches 12 hours after she received vaccine.  The patient reported that symptoms resolved 24 hours after the injection. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020136679:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: High Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had fever. The reporter asked was it normal to have high fever after the 2nd dose of Shingrix Vaccine. The reporter did not provide demographics or any additional information. The reporter did not consent to follow up. The reporter denied demographics.  The reporter provided name but did not confirm spelling and declined to offer any additional information.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Fatigue, Pain, Pyrexia
Clinical narrative: The patient mistakenly received a third dose of Shingrix over a year later since the second dose. The patient reported typical post-vaccination symptoms associated with this vaccine (i.e. fatigue, aches, mild fever). Patient requested and was provided with available safety data from the manufacturer (GSK) regarding patients receiving a third dose.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Dizziness, Fatigue, Injection site erythema
Clinical narrative: The shot was administered on Monday 7/20/2020.  The Patient (my 82 year old mother) had redness, swelling and pain at the injection site for several days.  She reported having body aches and joint paint throughout the entire body.  There has been no fever.    Since the day the shot was given (Monday) she reported feeling extremely tired,  weak and faint and dizzy.  Could not participate in her daily chair yoga class on Zoom, nor carry on normal household chores and activities, because of feeling dizzy and generally ill.  I am happy to report that as of mid-Morning on Friday she seemed a little more perky and less 'out of sorts'  .  On Friday 7/24/2020 she reported feeling better, although still tired.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Loss of personal independence in daily activities, Malaise, Pain
Clinical narrative: The shot was administered on Monday 7/20/2020.  The Patient (my 82 year old mother) had redness, swelling and pain at the injection site for several days.  She reported having body aches and joint paint throughout the entire body.  There has been no fever.    Since the day the shot was given (Monday) she reported feeling extremely tired,  weak and faint and dizzy.  Could not participate in her daily chair yoga class on Zoom, nor carry on normal household chores and activities, because of feeling dizzy and generally ill.  I am happy to report that as of mid-Morning on Friday she seemed a little more perky and less 'out of sorts'  .  On Friday 7/24/2020 she reported feeling better, although still tired.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Vomiting
Clinical narrative: Vomiting/ Tired
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, IPV, MMR, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted after having the MCV4 vaccine administered (2nd of 6 vaccines administered).  Patient stated that she had not eaten anything in the last two hours and was very nervous about the number of vaccines that she was going to receive.  Patient was sitting on exam bed when receiving the vaccines so she was assisted by staff to lie down on the bed with her legs elevated to improve blood circulation.  Patient was administered oxygen via mask and all vitals were within normal levels (BP 110/67; pulse 58; resp 14; Oxygen 99%).  Patient and guardian agreed to complete administration of pending vaccines.  I contacted guardian at 2:48PM to check on patient and was advised that she was feeling well with no adverse effects from the incident.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Nodule
Clinical narrative: 3 CM NODULE LEFT ARM
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea, Pain, Pain in extremity
Clinical narrative: Chills, body aches, fever, fatigue, nausea sore arm Tylenol, Ibuprofen, fluids, rest. Lasting 2 days, slight improvement day 2
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills, body aches, fever, fatigue, nausea sore arm Tylenol, Ibuprofen, fluids, rest. Lasting 2 days, slight improvement day 2
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Mass, Neck pain, Spinal pain
Clinical narrative: PATIENT REPORTS STARTING 7/22/2020   1 RED BLISTERY PAINFUL SPOT ON NECK AND 2 SEPARATE RED PAINFUL LUMPS/ SPOTS ON SPINE  THAT ARE NOT BLISTERY       PHARMACY AND PATIENT TRYING TO REACH PRIMARY MD
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pruritus, Swelling
Clinical narrative: Looks like an allergic reaction; swelling and itching
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Rash
Clinical narrative: Patient developed a rash all over her stomach approximately 24 hours after the injection. She also developed a rash and redness at injection site which was expected. For her rash on her stomach, she took a Benadryl for 2 days and the rash subsided after about 3 days. Patient has experienced this kind of allergic reaction from other medications.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Body aches, headache, fatigue, chills.  Still present 24-hours after onset.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Patient developed large red, warm to the touch area on deltoid requiring steroids
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Back pain, Chills, Eye pain, Headache, Neck pain
Clinical narrative: Started with a bump behind my left ear on the mastoid bone in the morning on Sunday 7/5 (This finally went away around 7/15.  7/8 I woke up with extreme upper back/neck pain on my right side that began getting better on 7/11 but did not fully recover until around 7/15 that was accompanied by a headache mostly concentrated at the back of my head that lasted the duration of all other symptoms. On 7/9 around 1am I woke up with a fever that reached 100.1 (my normal temp ranges 96.8-97.2) with chills, body aches and a continuing headache and upper back/neck pain. This temperature stayed around 99.2 until 7/11 when it returned to normal. 7/11 I woke up with extensive pain in my right eye only when looking around. I got tested for COVID-19 after a phone appointment with a doctor. 7/13 I woke up with a warm to the touch body rash (very heavily concentrated on my neck where it severely itched and was extremely painful) that was everywhere except for my legs and the outside of my arms.  This rash resolved to minor itching the next day 7/14 and a reduced rash and was nearly gone by 7/15.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Pyrexia, Rash, Rash pruritic, SARS-CoV-2 test negative
Clinical narrative: Started with a bump behind my left ear on the mastoid bone in the morning on Sunday 7/5 (This finally went away around 7/15.  7/8 I woke up with extreme upper back/neck pain on my right side that began getting better on 7/11 but did not fully recover until around 7/15 that was accompanied by a headache mostly concentrated at the back of my head that lasted the duration of all other symptoms. On 7/9 around 1am I woke up with a fever that reached 100.1 (my normal temp ranges 96.8-97.2) with chills, body aches and a continuing headache and upper back/neck pain. This temperature stayed around 99.2 until 7/11 when it returned to normal. 7/11 I woke up with extensive pain in my right eye only when looking around. I got tested for COVID-19 after a phone appointment with a doctor. 7/13 I woke up with a warm to the touch body rash (very heavily concentrated on my neck where it severely itched and was extremely painful) that was everywhere except for my legs and the outside of my arms.  This rash resolved to minor itching the next day 7/14 and a reduced rash and was nearly gone by 7/15.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Skin warm, Swelling
Clinical narrative: Started with a bump behind my left ear on the mastoid bone in the morning on Sunday 7/5 (This finally went away around 7/15.  7/8 I woke up with extreme upper back/neck pain on my right side that began getting better on 7/11 but did not fully recover until around 7/15 that was accompanied by a headache mostly concentrated at the back of my head that lasted the duration of all other symptoms. On 7/9 around 1am I woke up with a fever that reached 100.1 (my normal temp ranges 96.8-97.2) with chills, body aches and a continuing headache and upper back/neck pain. This temperature stayed around 99.2 until 7/11 when it returned to normal. 7/11 I woke up with extensive pain in my right eye only when looking around. I got tested for COVID-19 after a phone appointment with a doctor. 7/13 I woke up with a warm to the touch body rash (very heavily concentrated on my neck where it severely itched and was extremely painful) that was everywhere except for my legs and the outside of my arms.  This rash resolved to minor itching the next day 7/14 and a reduced rash and was nearly gone by 7/15.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Headache, Injection site erythema, Injection site nodule, Injection site rash, Injection site reaction
Clinical narrative: Large swollen knot on left thigh at MMR injection site.  Initially noticed the afternoon of the injection about 2:30 PM. Area is warm to the touch and red welt that gradually spread over the evening and through the next day. Child complained of a headache and had a low grade fever the evening of the injection. Still complaining of headache the following day.  Small rash on thighs and groin area appeared the morning after the injection was given.  Phone call to pediatric clinic  placed on 24 July at 3:00 PM to notify of the reaction. I was advised to watch the area for further spreading of irritation and to monitor for fever. Due to the COVID19 outbreak  it was not suggested that we return to the clinic unless the reaction became worse.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Injection site warmth, Pyrexia, Rash, Urticaria
Clinical narrative: Large swollen knot on left thigh at MMR injection site.  Initially noticed the afternoon of the injection about 2:30 PM. Area is warm to the touch and red welt that gradually spread over the evening and through the next day. Child complained of a headache and had a low grade fever the evening of the injection. Still complaining of headache the following day.  Small rash on thighs and groin area appeared the morning after the injection was given.  Phone call to pediatric clinic  placed on 24 July at 3:00 PM to notify of the reaction. I was advised to watch the area for further spreading of irritation and to monitor for fever. Due to the COVID19 outbreak  it was not suggested that we return to the clinic unless the reaction became worse.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site reaction, Myalgia
Clinical narrative: muscle soreness at injection site: 4 days muscle soreness, whole body: 4 days extreme fatigue, tiredness: 4 days
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Agitation, Chills, Injection site pain, Injection site reaction, Pyrexia
Clinical narrative: red rash at injection site,  pain at injection sight, fever of 100.8 degrees, chills, restlessness, agitation.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Restlessness
Clinical narrative: red rash at injection site,  pain at injection sight, fever of 100.8 degrees, chills, restlessness, agitation.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: swelling in (R) deltoid with reddness & heat to the touch. No treatment needed Started Thursday morning, mother states  already looks better today.
Age: 22.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Lymphadenopathy
Clinical narrative: pt started getting swollen lymph nodes starting three days after she received the vaccines, she went to clinic.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Erythema, Skin warm
Clinical narrative: Shingrix was given on 5/20/20 in (L) left Deltoid IM. on 5/21/20 patient called and told RN she has a red circle on the arm, its hot to the touch and big, patient states "her stomach is also feels sick with some cramping pains". On 5/22/20 patient talked with RN again the area is larger in size measure 4 x 4" still red and Hot the touch. Ice & Hot pack were applied
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Hypophagia, Injection site pain, Swelling
Clinical narrative: (R) deltoid was sore + neck area is swollen. pt was not eating or drinking. Applied ice + Tylenol given. 7/24/20 Doctor called pts mom pt doing better, visible swelling per pts mom on side injections given. No difficulty swallowing or breathing.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Pruritus
Clinical narrative: Itchy calves and arms
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Paraesthesia
Clinical narrative: Patient started experiencing tingling in his left arm. Sensation was going down to his fingers. Per Dr. patient has equal strength and moving hand appropriately. Sensation continued for 25 mins. Sensation was worse with utilization of the arm. No rash. No shortness of breath. No other sypmtoms. Triage nurse (RN) spoke with mom on 07/24/2020 who reported that the patient's symptoms resolved. Patient is active and alert. Denies tingling is present in the left arm.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Pain, Somnolence
Clinical narrative: Started with nausea about 2-3pm and body aches proceeded throughout the evening. Took a Benedryl and melatonin to help sleep. Woke up next day feeling worse body aches and slept most of the day. No medication given. Reporting on day 2 at time of reporting still having major aches and pains throughout entire body.