chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm, Urticaria
Clinical narrative: arm swelling; arm red; arm hot; welt; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling arm, erythema of extremities, skin warm and welts. On an unknown date, the outcome of the swelling arm, erythema of extremities, skin warm and welts were unknown.   It was unknown if the reporter considered the swelling arm, erythema of extremities, skin warm and welts to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The caller stated that 3 other people she spoke with had the same reaction as her. Following Shingrix the patients arm was swollen, red and very hot. The welt was 6 to 7 inches long. The caller did not provide any additional information, though she still wants to be reimbursed for the vaccine. This case has been linked to US2019AMR068938, US2019AMR068949, US2019AMR068953 reported by same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Sore arm; headache; temperature; body aches; tired; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th April 2019, the patient received Shingrix. On 18th April 2019, 1 days after receiving Shingrix, the patient experienced pain in arm, headache, fever, general body pain, tiredness and diarrhea. On an unknown date, the outcome of the pain in arm, headache, fever, general body pain, tiredness and diarrhea were unknown.   It was unknown if the reporter considered the pain in arm, headache, fever, general body pain, tiredness and diarrhea to be related to Shingrix.  Additional details were provided as follows: The reporter had his Shingrix vaccine one day before reporting. On the day of reporting the patient had the side effects sore arm, headache, temperature, body aches, tired, mild diarrhea. The reporter asked how long would these side effects last.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Sore arm; headache; temperature; body aches; tired; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th April 2019, the patient received Shingrix. On 18th April 2019, 1 days after receiving Shingrix, the patient experienced pain in arm, headache, fever, general body pain, tiredness and diarrhea. On an unknown date, the outcome of the pain in arm, headache, fever, general body pain, tiredness and diarrhea were unknown.   It was unknown if the reporter considered the pain in arm, headache, fever, general body pain, tiredness and diarrhea to be related to Shingrix.  Additional details were provided as follows: The reporter had his Shingrix vaccine one day before reporting. On the day of reporting the patient had the side effects sore arm, headache, temperature, body aches, tired, mild diarrhea. The reporter asked how long would these side effects last.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly 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 fever. The patient was treated with ibuprofen. On an unknown date, the outcome of the fever was recovered/resolved.   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 event lasted for 24 hours, incapacitating. The patient gave consent to contact the physician. For tolerance after 2nd dose refer case US2019GSK080332.
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Influenza, Influenza like illness, Musculoskeletal chest pain
Clinical narrative: Suspected vaccination failure; Flu; Rib cage hurts; Body aches; Drained; Sinus pain; Head pain; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 67-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, rib pain, general body pain, sinus pain, headache and exhaustion. On an unknown date, the outcome of the vaccination failure, influenza, rib pain, general body pain and exhaustion were unknown and the outcome of the sinus pain and headache were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, influenza, rib pain, general body pain, sinus pain, headache and exhaustion to be related to Influenza vaccine Quadrivalent 2018-2019 season.  Additional details were provided as follows as follows: The age at vaccination was not reported. The patient received unknown flu vaccine in 2018. On 4th March 2019, the patient went to emergrncy room because of rib cage pain, the patient also had body ache, sinus pain and excrutiating pain in head. The patient was daignosed with flu like symptoms in emergency room. It took 2 weeks to resolve all the symptoms and patient felt drained during this 2 weeks. The reporter did not consent to follow-up. This case is linked to case US2019073161, reported due to same patient.
Sex: F
Vaccine: UNK
Symptoms: Pain, Sinus pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Flu; Rib cage hurts; Body aches; Drained; Sinus pain; Head pain; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 67-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, rib pain, general body pain, sinus pain, headache and exhaustion. On an unknown date, the outcome of the vaccination failure, influenza, rib pain, general body pain and exhaustion were unknown and the outcome of the sinus pain and headache were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, influenza, rib pain, general body pain, sinus pain, headache and exhaustion to be related to Influenza vaccine Quadrivalent 2018-2019 season.  Additional details were provided as follows as follows: The age at vaccination was not reported. The patient received unknown flu vaccine in 2018. On 4th March 2019, the patient went to emergrncy room because of rib cage pain, the patient also had body ache, sinus pain and excrutiating pain in head. The patient was daignosed with flu like symptoms in emergency room. It took 2 weeks to resolve all the symptoms and patient felt drained during this 2 weeks. The reporter did not consent to follow-up. This case is linked to case US2019073161, reported due to same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Influenza like illness, Loss of personal independence in daily activities, Nausea
Clinical narrative: activity of daily leaving impaired; fever; shivering; diarrhea; flu like symptoms; nausea; This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on an unknown date, refer case US2019AMR078143).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, shivering, diarrhea, influenza-like symptoms, nausea and activities of daily living impaired. The patient was treated with ibuprofen. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, shivering, diarrhea, influenza-like symptoms and nausea were recovered/resolved and the outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the fever, shivering, diarrhea, influenza-like symptoms, nausea and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced fever shivering nausea and diarrhea, just like the flu.  The event lasted for 24 hours, incapacitating. The patient gave consent to contact the safety physician.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: activity of daily leaving impaired; fever; shivering; diarrhea; flu like symptoms; nausea; This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on an unknown date, refer case US2019AMR078143).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, shivering, diarrhea, influenza-like symptoms, nausea and activities of daily living impaired. The patient was treated with ibuprofen. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, shivering, diarrhea, influenza-like symptoms and nausea were recovered/resolved and the outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the fever, shivering, diarrhea, influenza-like symptoms, nausea and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced fever shivering nausea and diarrhea, just like the flu.  The event lasted for 24 hours, incapacitating. The patient gave consent to contact the safety physician.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Vaccine positive rechallenge
Clinical narrative: Sick; This case was reported by a other health professional via sales rep and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (received 1st dose on unknown date, refer case US2019AMR068777).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness 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 it was selected as adult as per the vaccine indication. The patient received 2nd dose of Shingrix and was sick.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Pain
Clinical narrative: Pain; Headache; Dizziness; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th April 2019, the patient received the 1st dose of Shingrix. In April 2019, less than a week after receiving Shingrix, the patient experienced pain, headache and dizziness. On an unknown date, the outcome of the pain, headache and dizziness were recovering/resolving.   It was unknown if the reporter considered the pain, headache and dizziness to be related to Shingrix.  Additional details were provided as follows: The pharmacist was the reporter and the patient. The reporter could not provide lot number or expiration date of Shingrix. The patient received 1st dose of Shingrix in left deltoid. The patient experienced pain, headache, and dizziness following dose 1 of Shingrix. The headache and dizziness started approximately 5 hours after receiving dose 1 of Shingrix. The pain was mild and dull. The headache, dizziness, and pain had improved since they started, but were not fully resolved. The reporter could not provide complete address or phone number for Pharmacy, where he received the vaccine.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness; Swelling; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 4257F, expiry date 11th September 2021) for prophylaxis.   On 15th April 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In April 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient was experiencing redness and swelling at the injection site in size of 2 inches in diameter. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: dizziness; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included zostavax vaccination. Concurrent medical conditions included fibromyalgia.   On 1st March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 1st March 2019, immediately after receiving Shingrix, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was recovered/resolved.   It was unknown if the reporter considered the dizziness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced dizziness right after the dose. Did not consent to follow-up.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Mother stated the Patient developed Right arm swelling, redness, and itching (started small and progressed) at the injection site on Friday (05/03/2019). Patient also developed warmth "spiked a fever", temp unknown and the Patient did not feel well (went to bed early). Mother applied OTC topical solutions to the Right arm to help with symptoms. Symptoms elevated by Monday (05/06/2019).
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: Mother stated the Patient developed Right arm swelling, redness, and itching (started small and progressed) at the injection site on Friday (05/03/2019). Patient also developed warmth "spiked a fever", temp unknown and the Patient did not feel well (went to bed early). Mother applied OTC topical solutions to the Right arm to help with symptoms. Symptoms elevated by Monday (05/06/2019).
Age: 0.08
Sex: M
Vaccine: PNC13
Symptoms: Crying, Life support
Clinical narrative: SIDS- we caught it in time to bring his pulse back but he is on complete life support. After the baby had been given the shot the babies crying increased and he used to crawl his knees towards his stomach..which I thought was coming from gas pains but later learnt that this may have been side effects.
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: Irritability, Language disorder, Lethargy
Clinical narrative: Lethargy, extreme irritability within 2 hours of immunization- lasted for 2 days. Regression of language for 3 weeks
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth, Limb discomfort
Clinical narrative: Pt. noted on 5/7/19, left arm "heaviness", warmth and pink elevated bump at the vaccine injection site while getting dressed the following day after vaccine administered. Pt. denied any itching or vesicular rash at injection site. Denies any fevers or chills, pain or tenderness. On exam a 5x 6cm oval wheal noted to left posterior upper arm where injection given on 5/6/19, warm to touch. No lymphadenopathy, no fevers, chills, streaking, drainage. VSS. Pt. given cold ice packs, OTC Hydrocortisone cream to site and area outlined to monitor. Pt. has follow up scheduled for 5/10/19.
Age: 9.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Redness, warmth + swelling beyond injection site. Pain + fever not responsive to Tylenol and Ibuprofen. Required an antibiotic
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: 4/26/19 Patient called stating arm sore. 4/27/19 Patient spoke with pharmacist stating seemed to be getting better, and would follow up with us if still an issue. 5/7/19 Patient stated still soreness in Right Deltoid at injection site and on range of motion moving arm upward to head at side of body.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Hemiparesis, Injection site pain
Clinical narrative: When I was injected w/Flu Vacc. it burned like Acid. I told the Person giving it to me, it hurt then and it has not stopped hurting since, my Left side is weak and I have trouble keeping anything on that side
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Injection site haemorrhage, Injection site inflammation
Clinical narrative: Erythema and inflammation at side of injection. Treated with cold packs, NSAIDs, and antihistamine. No systemic symptoms.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Hypophagia, Malaise, Pyrexia
Clinical narrative: Patient started with headache the night of vaccine and took Tylenol.   By 3am patient woke up with shakes, chills, fever, and did not feel well.  Patient ate very little and drank many fluids that day. In the morning of 5/6 patient noticed rash all over the body: back of body from hairline to buttocks--full back, back of upper arms, under breast and under belly line to private area--nothing on legs or feet or hands. Patient went to walk in clinic and prescribed Hydroxyzine HCL 25 mg, every 6 hours. Today patient is doing much better. Almost 75% of rash is gone; it is just pale rash now.  Patient's appetite is also back to normal.   Doctor's fax: 703.239.0442
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash generalised, Tremor
Clinical narrative: Patient started with headache the night of vaccine and took Tylenol.   By 3am patient woke up with shakes, chills, fever, and did not feel well.  Patient ate very little and drank many fluids that day. In the morning of 5/6 patient noticed rash all over the body: back of body from hairline to buttocks--full back, back of upper arms, under breast and under belly line to private area--nothing on legs or feet or hands. Patient went to walk in clinic and prescribed Hydroxyzine HCL 25 mg, every 6 hours. Today patient is doing much better. Almost 75% of rash is gone; it is just pale rash now.  Patient's appetite is also back to normal.   Doctor's fax: 703.239.0442
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site rash, Pyrexia, Rash, Tremor
Clinical narrative: Patient started with headache the night of vaccine and took Tylenol.   By 3am patient woke up with shakes, chills, fever, and did not feel well.  Patient ate very little and drank many fluids that day. In the morning of 5/6 patient noticed rash all over the body: back of body from hairline to buttocks--full back, back of upper arms, under breast and under belly line to private area--nothing on legs or feet or hands. Patient went to walk in clinic and prescribed Hydroxyzine HCL 25 mg, every 6 hours. Today patient is doing much better. Almost 75% of rash is gone; it is just pale rash now.  Patient's appetite is also back to normal.   Doctor's fax: 703.239.0442
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Hypophagia, Malaise, Pyrexia
Clinical narrative: shake, shivering, feverish (98.8), rash did not show till monday but did not itch, rash on whole back and neck and the back of upper arms on both sides, under your breast..and went to see doctor at 1130 am on monday 05/06 and was given hydroxyzine 25mg 1tab every 6hrs..the rash is getting better almost gone
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash generalised, Tremor
Clinical narrative: shake, shivering, feverish (98.8), rash did not show till monday but did not itch, rash on whole back and neck and the back of upper arms on both sides, under your breast..and went to see doctor at 1130 am on monday 05/06 and was given hydroxyzine 25mg 1tab every 6hrs..the rash is getting better almost gone
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site rash, Pyrexia, Rash, Tremor
Clinical narrative: shake, shivering, feverish (98.8), rash did not show till monday but did not itch, rash on whole back and neck and the back of upper arms on both sides, under your breast..and went to see doctor at 1130 am on monday 05/06 and was given hydroxyzine 25mg 1tab every 6hrs..the rash is getting better almost gone
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Cartilage injury, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging abnormal, Periarthritis
Clinical narrative: Left Shoulder Pain with limited mobility
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Rotator cuff syndrome
Clinical narrative: Left Shoulder Pain with limited mobility
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Enema administration, Faeces discoloured, Intussusception, Irritability, Melaena
Clinical narrative: Intussusception - 1 day of projectile vomiting, back arching, fussiness and black tarry stool.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Opisthotonus, Ultrasound abdomen abnormal, Ultrasound scan abnormal, Vomiting projectile
Clinical narrative: Intussusception - 1 day of projectile vomiting, back arching, fussiness and black tarry stool.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Blood test normal, Decreased appetite, Food refusal, Influenza virus test negative, Lacrimation increased
Clinical narrative: Started with watery eyes and runny nose. Face started to rash and swell. Appetite and fluids decreased to nothing.  fever spiked in the night. Rash spread throughout the body by next morning and temperature rose. Continues to refuse food and beverages. Brought to ER. Did blood work strep test influenza test. All labs normal and all tests negative. Child is continuing with poor appetite. Still has rash on day 3 and still low grade temp.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Rash generalised, Rhinorrhoea, Streptococcus test negative
Clinical narrative: Started with watery eyes and runny nose. Face started to rash and swell. Appetite and fluids decreased to nothing.  fever spiked in the night. Rash spread throughout the body by next morning and temperature rose. Continues to refuse food and beverages. Brought to ER. Did blood work strep test influenza test. All labs normal and all tests negative. Child is continuing with poor appetite. Still has rash on day 3 and still low grade temp.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Swelling face
Clinical narrative: Started with watery eyes and runny nose. Face started to rash and swell. Appetite and fluids decreased to nothing.  fever spiked in the night. Rash spread throughout the body by next morning and temperature rose. Continues to refuse food and beverages. Brought to ER. Did blood work strep test influenza test. All labs normal and all tests negative. Child is continuing with poor appetite. Still has rash on day 3 and still low grade temp.
Age: 12.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site pain, Pyrexia, Vomiting
Clinical narrative: Fever 101.8 Day of vaccine x 24 hr Vomiting x 1 Redness/tender @ sight of  PCV/Hib
Age: 43.0
Sex: F
Vaccine: HPV9
Symptoms: Induration, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: experiencing induration 6 inchs long on her arm  for about a week; swelling, hardness and pain at the injection site; swelling, hardness and pain at the injection site; This spontaneous report was received from a nurse practitioner via company representative refers to a 43-year-old female patient. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medications were not reported. On 28-MAR-2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dosing details, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date in March 2019, the patient reported that for the past one week she had experienced induration 6 inches long on her arm. On an unknown date in 2019, she also had swelling, hardness and pain at the injection site. The symptoms lasted an extra week beyond 05-APR-2019. The outcome of vaccination site induration, vaccination site pain and vaccination site swelling was unknown. Reporters causality assessment was not reported. There was no product quality complaint associated with this report.
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   01-MAR-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above 1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Pruritus, Urticaria
Clinical narrative: hives and itching; hives and itching; This spontaneous report was received from a physician via company representative regarding a 11-year-old female child patient. Information on patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-MAY-2019 the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) via unknown route for prophylaxis (also reported as for prevention of HPV: Human papilloma virus), strength, dose, frequency, lot # and expiration date were not reported.On 03-MAY-2019, the mother of the patient called the physician's office to report that her child (patient) had developed hives and itching (urticaria and pruritus) on 02-MAY-2019. It was not specified if events had occurred at injection site or elsewhere on the body. Patient had not recovered from the events urticaria and pruritis. Causality assessment was not reported. There was no involvement of product quality issue (PQC).   This is one of the two reports received from the same source.
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: Pruritus, Urticaria
Clinical narrative: hives and itching; hives and itching; This spontaneous report was received from a physician via company representative regarding a 9-year-old male child patient. Information on patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-MAY-2019 the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) via unknown route for prophylaxis (also reported as for prevention of HPV: Human papilloma virus), strength, dose, frequency, lot # and expiration date were not reported.On 03-MAY-2019, the mother of the patient called the physician's office to report that her child (patient) had developed hives and itching (urticaria and pruritus) on 02-MAY-2019. It was not specified if events had occurred at injection site or elsewhere on the body. Patient had not recovered from the events urticaria and pruritis. Causality assessment was not reported. There was no involvement of product quality issue (PQC).   This is one of the two reports received from the same source.
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 25-FEB-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above 1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 28-FEB-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above 1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Age: 75.0
Sex: F
Vaccine: PNC, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient got the pneumovax vaccine first and then received the prevnar 13 vacccine; This spontaneous report as received from a physician (primary care) via Pfizer (#2019195978) refers to a currently 82 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-NOV-2012 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) dose 1 for prophylaxis, then later on 21-JUN-2016, she received a pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR) for prophylaxis (inappropriate schedule of product administration).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Urticaria
Clinical narrative: hive-like patches on her arm, neck, and wrist; sore arm; This case was reported by a consumer 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 26th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 26th April 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 28th April 2019, the patient experienced hives. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the pain in arm and hives were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and hives to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient reported that she had hive-like patches on her arm, neck, and wrist 2 days after vaccination with Shingrix into the left arm.  The events were alleviated by Benadryl, but were present at time of reporting.  The patient also experienced a sore arm, which was present at time of reporting. The patient did not consent to follow up. The patient's pharmacy did not provide the lot number of Shingrix.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Feeling cold, Pain in extremity
Clinical narrative: shivering; cold; soreness; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th April 2019, the patient received Shingrix (intramuscular). On 1st May 2019, 1 days after receiving Shingrix, the patient experienced shivering, cold, pain in arm and upset stomach. On an unknown date, the outcome of the shivering, cold, pain in arm and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the shivering, cold, pain in arm and upset stomach to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix on an unknown arm the day before reporting in the evening.  At the reporting date, she felt very cold and was shivering.  The patient also had minor soreness in her arm and a bit of an upset stomach. The reporter did not give consent to follow up.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to pt <4yrs of age. No problems reported after receiving vaccination
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site bruising, Injection site discolouration, Myalgia, Pyrexia
Clinical narrative: Flu-like symptoms (fever, muscle aches) beginning ~6 hours after vaccination.... and black/blue bruise around injection site (developing 24 hours later and still somewhat apparent (faint dark-coloring on skin) about 2 weeks later.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Rash, Rash erythematous
Clinical narrative: 5-10 minutes after vaccination pt developed an erythematous rash in patches over mid to upper back some raised spots 1mm. No facial swelling, fever, wheeze or cough. Pt kept in observation for > 1hr where frequent 10-15 minute reassessments were made. The rash increased but not in any other areas. No meds were given rash began to fade and pt was released to go home.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Rash
Clinical narrative: 5-10 minutes after vaccination pt developed an erythematous rash in patches over mid to upper back some raised spots 1mm. No facial swelling, fever, wheeze or cough. Pt kept in observation for > 1hr where frequent 10-15 minute reassessments were made. The rash increased but not in any other areas. No meds were given rash began to fade and pt was released to go home.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pain, Skin disorder
Clinical narrative: patient reported muscle soreness and a formation of a dimple, then pain radiating
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site mass
Clinical narrative: large lump on L thigh where he had received vaccines on 5/3/19. No redness or bruising. Not painful
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes virus infection, Pruritus
Clinical narrative: On 4-4-19 patient woke up to redness on left palm and severe itching which eventually spread to his right palm. Initially the Dr. put him on Keflex 500mg which did nothing. The patient completed two rounds of 5 day Prednisone 20 mg which helped but did not completely take it away. The patient went to a dermatologist on 5-8-19 and was diagnosed with a herpes type infection and put on a 10 day taper of prednisone.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: Patient called store later and complained of severe sore shoulder with intense pain
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered <4yrs of age. No adverse effects or sxs reported
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Rash, Rash erythematous
Clinical narrative: Both lower arms and hands presented with red spots (approximately 5). Left hand became red and swollen for about 1 day.  Spots still present at time of report (7 days later)
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Patient stated she had no reaction to first shot received. However with second dose she had redness and swelling at injection site, soreness of arm, flu-like symptoms, stomach pain and upset, and panic attack. I confirmed with patient that there were no anaphylactic symptoms, no shortness of breath, trouble breathing, throat closure, rash, dizziness. she confirmed did not experience any of those side effects just ones mentioned. She is feeling slightly better still has stomach upset and some soreness in arm.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Panic attack
Clinical narrative: Patient stated she had no reaction to first shot received. However with second dose she had redness and swelling at injection site, soreness of arm, flu-like symptoms, stomach pain and upset, and panic attack. I confirmed with patient that there were no anaphylactic symptoms, no shortness of breath, trouble breathing, throat closure, rash, dizziness. she confirmed did not experience any of those side effects just ones mentioned. She is feeling slightly better still has stomach upset and some soreness in arm.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Injection occurred on 3/21/19 and patient had Shingles 4/2/19 (right T10 dermatome)
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Herpes zoster, Pruritus, Scab, Swelling
Clinical narrative: 4/30/19 Patient had itching on back of right thigh, noticed 3-4 raised areas. On 5/1/19 patient noticed 12-15 more raised areas on right thigh and had Temperature of 101 degrees F. On 5/2/19 Supervisor and Employee Health RN notified and at that time patient told RN that both of her children had similar reactions following varicella vaccination. On 5/2/19 patient was sent to an Occupational Health facility for evaluation and treatment. Diagnosed with shingles, no confirmatory testing done. Valtrex prescribed. On 5/4/19 patient reported itching and swelling resolved and crusting noted.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Incomplete course of vaccination, Influenza like illness, Vomiting
Clinical narrative: Extreme flu-like symptoms, head-ache and vomiting. Dr advised pt not to get second dose in series due to severe reaction. Pt requested VAERS to be filled out
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: CSF glucose normal, CSF protein increased, CSF red blood cell count, CSF white blood cell count negative, Demyelinating polyneuropathy
Clinical narrative: Patient began to neurological symptoms 3/12/2018 which gradually progressed and was diagnosed with Guillan Barre Syndrome. She was admitted to hospital 3/23/2019 and plasmapheresis initiated.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Hyporeflexia, Muscular weakness, Neurological symptom
Clinical narrative: Patient began to neurological symptoms 3/12/2018 which gradually progressed and was diagnosed with Guillan Barre Syndrome. She was admitted to hospital 3/23/2019 and plasmapheresis initiated.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging spinal normal, Pain in extremity, Paraesthesia, Peripheral sensory neuropathy, Plasmapheresis
Clinical narrative: Patient began to neurological symptoms 3/12/2018 which gradually progressed and was diagnosed with Guillan Barre Syndrome. She was admitted to hospital 3/23/2019 and plasmapheresis initiated.
Age: 50.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Erythema, Local reaction, Pain in extremity, Peripheral swelling
Clinical narrative: patient developed redness, swelling, pain on right arm only about 11 PM on 4/18/19.  (Of note, on 1/30/14, she had Prevnar, Menactra and Hib and had no reaction. On  3/31/14, she had  Pneumovax  and Menactra at a local MD's office, administered in same arm,  and she had a considerable local reaction to the  vaccines  with an ensuing  possible strep infection resulting in a hospital admission/IV antibiotics.  This was not seen by this writer, but well described by patient .)
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired dose of HEPLISAV-B given to a patient; Initial Report Received on 23-Apr-2019   A pharmacist reported that his pharmacy sent an expired vial of Heplisav-B (hepatitis B vaccine) for hepatitis B immunization to a nursing facility and the nursing facility administered the medication to 55-year-old patient (gender and race not provided).  Relevant medical history included seizure disorder, depression, and history of deep vein thrombosis (DVT) in right lower leg. The patient had no known allergies.   Concomitant medications were not provided.   On 23-Apr-2019, a pharmacist reported that his pharmacy sent an expired vial of Heplisav-B (lot #1032912, expiration date 19-Mar-2019, NDC #43528000205) to a nursing facility on 11-Apr-2019. The nursing facility administered the medication to a patient. The pharmacist provided the patient's physician information. The pharmacist reported the information on behalf of the nursing facility to find out if there was an extended shelf-life for the product or what should be done since it (the vaccine) was given. The pharmacist gave permission to be contacted back via email or phone. No additional information was provided.   At the time of the report, there have been no adverse reactions reported to the expired dose of medication.   The reporter did not provide a seriousness assessment for the event.   Company comment:  The company assessed the event of expired product administered as non-serious. The event of expired product administered is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of expired product administered as non-serious. The event of expired product administered is unlisted per HEPLISAV-B USPI.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site rash, Rash
Clinical narrative: Broke out in rash on right thigh the following day, rash on arms and back
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain
Clinical narrative: Headache, fatigue, pain at injection site.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Cow's milk intolerance, Eyelid rash, Gluten sensitivity, Injection site reaction, Irritability
Clinical narrative: Some symptoms she had at the time were: very fussy, high fever (104), bad skin rash, whelp where shot was given. Gave Childrens TYLENOL as suggested by doctors office, but she's had issues ever since then.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Pain, Pyrexia, Rash, Urticaria
Clinical narrative: Some symptoms she had at the time were: very fussy, high fever (104), bad skin rash, whelp where shot was given. Gave Childrens TYLENOL as suggested by doctors office, but she's had issues ever since then.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Scab, Skin lesion, Varicella
Clinical narrative: Patient stated he broke out in "chicken pox", 19 days after having the Shingrix vaccine.  Had fluid filled blisters that popped and became crusted over.  lesions were very itchy.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Pain
Clinical narrative: On the day of the administration of the 1st dose of Shingrix, adverse events were reported as feeling like "hit by fright train", extremely exhausted at night, joint hurts, and extreme body aches. The next day of the administration, the symptoms got better
Age: 78.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Computerised tomogram head normal, Skin laceration, Suture insertion, Syncope
Clinical narrative: Patient states she "fainted" while standing in her kitchen.  was seen by MD, total of  3 stitches on the back of her head and CT scan of the head done. Vaccine received on May 2nd at around 2:20. Episode occurred  On May 3rd after she woke up at 2:45am.
Age: 78.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Computerised tomogram head normal, Head injury, Suture insertion, Syncope
Clinical narrative: Patient states she "fainted" while standing in her kitchen.  was seen by MD, total of  3 stitches on the back of her head and CT scan of the head done. Vaccine received on May 2nd at around 2:20. Episode occurred  On May 3rd after she woke up at 2:45am.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: Pt was 28 weeks pregnant and was known to be GBS positive with no other relevant medical history. EDD 07/01/2019. Pt was given a possible ineffective vaccine due to a temperature excursion of -0.2 degrees Celsius for estimated less than a minute, but was under the recommended 2 degrees Celsius for an estimated 12 minutes. The excursion was noted on 04/09/2019 et per manufacturers review was notified ok to use vaccine, later identified per email from manufacturer a miscommunication may have been noted. Manufacturer recontacted and was noted to have been a miscommunication as interpreted as 0.2 degrees Celsius vs actual -0.2 degrees Celsius and was then noted to not give and discard any/all of the in stock lot number 97NL3, which had then been notified patient already received vaccine. No adverse outcome noted at this time, patient was notified and offered revaccination due to possibly receiving ineffective vaccine and patient declined at 04/24/2019 visit.