chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, muscle aches, fever, chills, shivering, fatigue.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Eczema, Pyrexia
Clinical narrative: Chronic Eczema on going  High fever for two days treated with Tylenol
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: Patient had body aches, felt ill for a couple days.  Then on 6/30 his right arm became reddened and warm to the touch from elbow to shoulder.  Injection site was swollen and he noted swollen axillary lymph nodes.  Contacted us on 7/10 and was advised to see his physician.  Was diagnosed with cellulitis and being treated with antibiotic.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Malaise, Pain
Clinical narrative: Patient had body aches, felt ill for a couple days.  Then on 6/30 his right arm became reddened and warm to the touch from elbow to shoulder.  Injection site was swollen and he noted swollen axillary lymph nodes.  Contacted us on 7/10 and was advised to see his physician.  Was diagnosed with cellulitis and being treated with antibiotic.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse reactions that staff is aware of. Pt just received vaccination too early.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic, Skin haemorrhage
Clinical narrative: Patient reports a red rash appearing around Sunday (7/7/19). The rash is itchy, slightly relieved by antihistamine (Benadryl).  When patient showed me his left arm, the lower portion just below the elbow was covered in a raised, papular rash which was oozing/bleeding from scratching.  He showed me his right arm which had very little bumps.  He said it also continues onto his left torso.  He said it has not gotten worse, but it has not improved.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Wound secretion
Clinical narrative: Patient reports a red rash appearing around Sunday (7/7/19). The rash is itchy, slightly relieved by antihistamine (Benadryl).  When patient showed me his left arm, the lower portion just below the elbow was covered in a raised, papular rash which was oozing/bleeding from scratching.  He showed me his right arm which had very little bumps.  He said it also continues onto his left torso.  He said it has not gotten worse, but it has not improved.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary mass
Clinical narrative: Patient complained of an "egg size" "jelly filed" protrusion in armpit of the arm immunized.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Mobility decreased, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Radiating soreness, on arm, back, up to shoulder and neck.   Patient has gone to urgent care and received anti-inflammatory and muscle relaxer. MD believes the severity of his reaction to be an anomaly.  This reaction has put limitations on his movements and plans and he came to me at work wanting to report this to the developer of the vaccine.   I counselled him and we discussed his symptoms and I agreed to report this for him.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Radiating soreness, on arm, back, up to shoulder and neck.   Patient has gone to urgent care and received anti-inflammatory and muscle relaxer. MD believes the severity of his reaction to be an anomaly.  This reaction has put limitations on his movements and plans and he came to me at work wanting to report this to the developer of the vaccine.   I counselled him and we discussed his symptoms and I agreed to report this for him.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Mother presented with female child for age 11 imms.  Child received HPV, Tdap, and MCV4.  Tolerated vaccinations well in nurse office, but when she was in the waiting room preparing to leave, it was reported that she experienced an episode of syncope, fell backwards, and hit the back of her head to the floor.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site rash, Pyrexia
Clinical narrative: Pain and large rash at injection site. Fever 100 F. Shivering
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Patient called up complaining of dizziness the following day
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Pain, Pyrexia, Tremor
Clinical narrative: Wife described reaction as having a fever, sweating, and achey about 12 hours after vaccination, then shakey legs in the morning after vaccination. The symptoms lasted about 12 hours, then was fine. Used no OTC medications to relieve symptoms.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test normal, Pain in extremity, Swelling
Clinical narrative: Patient had a swollen left toes after 2 days with unbearable pain. Pt went to ER and had all tests came negative. The swelling and pain went away next day.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Intense itching and red area larger than a quarter at injection site for 5 days.  Resolved after 5 days or so, but still slightly itchy more than 10 days later.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: Intense itching and red area larger than a quarter at injection site for 5 days.  Resolved after 5 days or so, but still slightly itchy more than 10 days later.
Age: 1.33
Sex: F
Vaccine: DTAP
Symptoms: Induration, Injection site swelling, Skin mass
Clinical narrative: Hard nodule under skin that started day after vaccine, minimal pain, no erythema, no drainage, mild swelling around site.  Home care of warm compresses, massage were recommended after evaluation in clinic
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Injection site pain, Muscular weakness
Clinical narrative: pt c/o of pain in right deltoid at site of HPV injection given on June 13, 2019. the pain started right after injection. she has pain that is sharp and constant, it is worsened by sleeping on the area and by lifting heavy things. today, the pain is slightly less than initial week. She sometimes has a feeling of weakness in the entire right arm. She has not tried ibuprofen or other pain relief measures.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: SWELLING AND REDNESS WELL BELOW THE INJECTION SITE
Age: 78.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Injection site haemorrhage, Peripheral swelling, Pruritus
Clinical narrative: no adverse event for the shingrix arm, but the pneumovax arm bled a little after the injection and an hour later, patient called and said arm swelled up and was itchy.  On day 2, patient said it's still red, but not swollen or itchy anymore
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, PPV
Symptoms: Decreased appetite, Irritability, Pyrexia, Rash generalised
Clinical narrative: She got a fever about 10 hours after the shot and had a 99-101.5 fever for 7 days straight and after that 7 days, she had a rash all over her body from her head to her private area. Did not show on her legs. She did not want to eat very much, was super fussy and clingy. I gave her an epsom salt bath for the past few days and it went away after a day 1/2. The entirety of the course has been about 12 days so far. She seems to be getting back to normal now, but I am still keeping a close eye out on her.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Child came to office with c/o pain & swelling of left shoulder/bicep pain. Area was tender, erythematous. Swollen 4" warm area, wrapping around upper left arm (deltoid) into posterior axilla. Consistent with cellulitis. Child had received 2 vaccines in this arm 2 days ago. Antibiotic was prescribed.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Dysstasia, Pain
Clinical narrative: About one hour after vaccine administration, patient felt like the entire right upper side of his body was dipped in gasoline and lit on fire. This is how he described the pain and burning sensation. For the next two days he had body aches, and he could not stand up straight on 07/03/19. As of 7/10/2019, all affects have resolved.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Nausea, Pain
Clinical narrative: Headaches, body aches, fever, chills, stomach cramps, nausea, local pain and rash. She came to see yesterday. I ordered Tylenol, Zofran, Zantac, benadryl and lidocaine patch. I think she will get better.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Headaches, body aches, fever, chills, stomach cramps, nausea, local pain and rash. She came to see yesterday. I ordered Tylenol, Zofran, Zantac, benadryl and lidocaine patch. I think she will get better.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: redness on (L) leg where vaccine given, @ 15 mm
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient came into Pharmacy on 7/10 stating having pain and redness in injection site. Stated injection site feels a little warm to touch but not hardening. Told patient expected soreness and redness for about 2 to 3 days after injection. Told patient to contact PCP if gets worse after three days and if not resolved by 7 days.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: redness on (L) leg where vaccine  given, 1.5 cm x 2 cm
Sex: F
Vaccine: PPV, VARZOS, FLUX, PPV
Symptoms: Arthralgia, Discomfort, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: diarrhea; This case was reported by a consumer via other and described the occurrence of diarrhea in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the diarrhea to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced diarrhea after receiving flu vaccine (unspecified manufacturer and date). No additional details were provided. The case was linked to case US2019AMR118888, reported by same reporter.
Sex: F
Vaccine: PPV, VARZOS, FLUX, PPV
Symptoms: Mobility decreased, Pain, Pain in extremity, Peripheral swelling, Sinus disorder
Clinical narrative: diarrhea; This case was reported by a consumer via other and described the occurrence of diarrhea in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the diarrhea to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced diarrhea after receiving flu vaccine (unspecified manufacturer and date). No additional details were provided. The case was linked to case US2019AMR118888, reported by same reporter.
Sex: F
Vaccine: PPV, VARZOS, FLUX, PPV
Symptoms: Tenderness, Toothache, X-ray dental abnormal
Clinical narrative: diarrhea; This case was reported by a consumer via other and described the occurrence of diarrhea in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the diarrhea to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced diarrhea after receiving flu vaccine (unspecified manufacturer and date). No additional details were provided. The case was linked to case US2019AMR118888, reported by same reporter.
Sex: F
Vaccine: PPV, VARZOS, FLUX, PPV
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: diarrhea; This case was reported by a consumer via other and described the occurrence of diarrhea in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the diarrhea to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced diarrhea after receiving flu vaccine (unspecified manufacturer and date). No additional details were provided. The case was linked to case US2019AMR118888, reported by same reporter.
Sex: F
Vaccine: PPV, VARZOS, FLUX, PPV
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This case was reported by a consumer via other and described the occurrence of diarrhea in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the diarrhea to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced diarrhea after receiving flu vaccine (unspecified manufacturer and date). No additional details were provided. The case was linked to case US2019AMR118888, reported by same reporter.
Sex: F
Vaccine: PPV, VARZOS, FLUX, PPV
Symptoms: Back pain, Injected limb mobility decreased, Injection site erythema, Injection site pain, Insomnia
Clinical narrative: diarrhea; This case was reported by a consumer via other and described the occurrence of diarrhea in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the diarrhea to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced diarrhea after receiving flu vaccine (unspecified manufacturer and date). No additional details were provided. The case was linked to case US2019AMR118888, reported by same reporter.
Sex: F
Vaccine: PPV, VARZOS, FLUX, PPV
Symptoms: Myalgia, Nerve conduction studies normal, Pain, Pain in extremity, Paraesthesia
Clinical narrative: diarrhea; This case was reported by a consumer via other and described the occurrence of diarrhea in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the diarrhea to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced diarrhea after receiving flu vaccine (unspecified manufacturer and date). No additional details were provided. The case was linked to case US2019AMR118888, reported by same reporter.
Sex: F
Vaccine: PPV, VARZOS, FLUX, PPV
Symptoms: Periarthritis, Peripheral swelling, Tooth disorder, X-ray dental normal
Clinical narrative: diarrhea; This case was reported by a consumer via other and described the occurrence of diarrhea in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the diarrhea to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced diarrhea after receiving flu vaccine (unspecified manufacturer and date). No additional details were provided. The case was linked to case US2019AMR118888, reported by same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Lip blister, Oral mucosal blistering, Pruritus, Swelling
Clinical narrative: broke out; blisters; whelps; Itching both hands; This case was reported by a pharmacist via call center representative and described the occurrence of skin breakout in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 3L794, expiry date 21st September 2021) for prophylaxis.   The patient's past medical history included shingles. Concomitant products included Herpes zoster (Shingrix).   On 28th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 30th June 2019, 2 days after receiving Shingrix, the patient experienced skin breakout, lip blister, welts and pruritus. On an unknown date, the outcome of the skin breakout, lip blister, welts and pruritus were unknown.   It was unknown if the reporter considered the skin breakout, lip blister, welts and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient experienced breaking out with blisters on her lips, whleps on her upper legs and her hands itching after 2nd dose of Shingrix.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: broke out; blisters; whelps; Itching both hands; This case was reported by a pharmacist via call center representative and described the occurrence of skin breakout in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 3L794, expiry date 21st September 2021) for prophylaxis.   The patient's past medical history included shingles. Concomitant products included Herpes zoster (Shingrix).   On 28th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 30th June 2019, 2 days after receiving Shingrix, the patient experienced skin breakout, lip blister, welts and pruritus. On an unknown date, the outcome of the skin breakout, lip blister, welts and pruritus were unknown.   It was unknown if the reporter considered the skin breakout, lip blister, welts and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient experienced breaking out with blisters on her lips, whleps on her upper legs and her hands itching after 2nd dose of Shingrix.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Lip blister, Pruritus, Rash, Urticaria
Clinical narrative: broke out; blisters; whelps; Itching both hands; This case was reported by a pharmacist via call center representative and described the occurrence of skin breakout in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 3L794, expiry date 21st September 2021) for prophylaxis.   The patient's past medical history included shingles. Concomitant products included Herpes zoster (Shingrix).   On 28th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 30th June 2019, 2 days after receiving Shingrix, the patient experienced skin breakout, lip blister, welts and pruritus. On an unknown date, the outcome of the skin breakout, lip blister, welts and pruritus were unknown.   It was unknown if the reporter considered the skin breakout, lip blister, welts and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient experienced breaking out with blisters on her lips, whleps on her upper legs and her hands itching after 2nd dose of Shingrix.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Myalgia, Pain, Pregnancy
Clinical narrative: Moderate pain near injection site, radiates down arm and also into shoulder/neck. Muscle aches in same areas lasting 3 days now. Short term low grade fever and headache. Pregnancy uncomplicated. Estimated date of delivery is 8/28/19.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Moderate pain near injection site, radiates down arm and also into shoulder/neck. Muscle aches in same areas lasting 3 days now. Short term low grade fever and headache. Pregnancy uncomplicated. Estimated date of delivery is 8/28/19.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Soreness and swelling started at the injection site after 5 hours.  Fever started after 10 hours.  Fever peaked at 101.9 degF at 15 hours.  Fever down to 99.7 after 24 hours.  No drugs were taken to lower fever.  First dose only produced some injection site swelling. and was taken 3 months before this 2nd dose.  Didn't expect a high fever on second dose.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 64 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On unspecified date in April 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for the event. The outcome of herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: IIIrd nerve paralysis
Clinical narrative: Ocularmotor nerve palsy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 55 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced ocularmotor nerve palsy. On an unspecified date, the patient was treated by a physician for the event. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV, UNK, VARCEL
Symptoms: Injection site erythema, Rash, Rash erythematous
Clinical narrative: red raised bumps on her ankles, wrists and elbows; patient received a dose of VARIVAX and a dose of PROQUAD during the same office visit; localized redness at her right lateral thigh; This spontaneous report was received from a registered nurse and refers to a 1-year-old female patient. No details regarding the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were provided. On 19-JUN-2019, the patient received a dose of varicella virus vaccine live (oka/merck)(VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (exact dose, strength, route and site of administration, lot # and expiration date were not reported for any), both as 1 year old vaccinations. Varicella virus vaccine live (oka/merck)(VARIVAX) was reconstituted with sterile diluent (STERILE DILUENT MRK) (dose, lot # and expiration date were not reported). On an unknown date in June 2019, the patient developed localized redness at her right lateral thigh. On unspecified dates, the patient took an unspecified number of doses of diphenhydramine hydrochloride (BENADRYL). On 21-JUN-2019, the patient developed red raised bumps on her ankles, wrists and elbows. The patient would be seeing a physician on an unspecified date. The outcome of the events was reported as not recovered/not resolved.  The causality assessment between the suspect products and the events was not provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 20-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R027157, expiry date 14-JUL-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000929: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000927: US-009507513-1907USA000862: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000928: US-009507513-1907USA000936: US-009507513-1907USA000923: US-009507513-1907USA000938: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-0095075131-907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000925: US-009507513-1907USA000882: US-009507513-1907USA000924: US-009507513-1907USA000937:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 24-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R027157, expiry date 14-JUL-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000929: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000927: US-009507513-1907USA000930: US-009507513-1907USA000862: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000928: US-009507513-1907USA000936: US-009507513-1907USA000923: US-009507513-1907USA000938: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000882: US-009507513-1907USA000925: US-009507513-1907USA000924: US-009507513-1907USA000937:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On  07-MAY-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sex: M
Vaccine: HEP, HEPA, MMR, MMRV, VARCEL
Symptoms: Blood test, Hepatitis A antibody negative, Hepatitis B antibody negative, Measles antibody negative, Mumps antibody test negative
Clinical narrative: negative measles, mumps, varicella, hepatitis A and hepatitis B titers; negative measles, mumps, varicella, hepatitis A and hepatitis B titers; negative measles, mumps, varicella, hepatitis A and hepatitis B titers; negative measles, mumps, varicella, hepatitis A and hepatitis B titers; negative measles, mumps, varicella, hepatitis A and hepatitis B titers; the patient was vaccinated with PROQUAD on 6/20/2019; subsequently developed T cell acute lymphoblastic leukaemia; Information has been received from a registered nurse referring to a currently 25 years old male patient. The patient's concurrent conditions included avascular necrosis of bilateral hips. Besides, the patient was allergic to oxycodone and had seasonal allergies. He did not have any concomitant medications. His historical conditions were not provided.  On an unknown date when he was a child, the patient was vaccinated with an unspecified number of doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II); varicella virus vaccine live (oka/merck )(VARIVAX); hepatitis a vaccine (manufacturer unknown) and hepatitis b vaccine (manufacturer unknown), all of them administered as prophylaxis (dose, route of administration, anatomical injection site, lot number and expiration date were unknown by reporter).  In May 2015, the patient developed T cell acute lymphoblastic leukemia. On 20-JUN-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) as prophylaxis (dose, dose number, anatomical injection site, lot number and expiration date were not provided; route of administration was unknown by reporter) (product administered to patient of inappropriate age). On an unknown date, the patient had negative measles, mumps, varicella, hepatitis A and hepatitis B titers (measles antibody negative, mumps antibody test negative, varicella virus test negative, hepatitis A antibody negative and hepatitis B antibody negative, respectively). No adverse symptoms were reported in regards to the patient receiving measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). The patient sought for medical attention in a office visit, but it was unknown by reporter if he received any treatment for the event. It was reported that a blood work was performed, but the results were not provided.  At the time of the report, the patient had not recovered from the events. The causality assessment between all the suspect vaccines and T-cell type acute leukaemia, measles antibody negative, mumps antibody test negative, varicella virus test negative, hepatitis A antibody negative and hepatitis B antibody negative was not reported.  Upon internal review, t-cell type acute leukaemia was determined to be medically significant.
Sex: M
Vaccine: HEP, HEPA, MMR, MMRV, VARCEL
Symptoms: Product administered to patient of inappropriate age, T-cell type acute leukaemia, Varicella virus test negative
Clinical narrative: negative measles, mumps, varicella, hepatitis A and hepatitis B titers; negative measles, mumps, varicella, hepatitis A and hepatitis B titers; negative measles, mumps, varicella, hepatitis A and hepatitis B titers; negative measles, mumps, varicella, hepatitis A and hepatitis B titers; negative measles, mumps, varicella, hepatitis A and hepatitis B titers; the patient was vaccinated with PROQUAD on 6/20/2019; subsequently developed T cell acute lymphoblastic leukaemia; Information has been received from a registered nurse referring to a currently 25 years old male patient. The patient's concurrent conditions included avascular necrosis of bilateral hips. Besides, the patient was allergic to oxycodone and had seasonal allergies. He did not have any concomitant medications. His historical conditions were not provided.  On an unknown date when he was a child, the patient was vaccinated with an unspecified number of doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II); varicella virus vaccine live (oka/merck )(VARIVAX); hepatitis a vaccine (manufacturer unknown) and hepatitis b vaccine (manufacturer unknown), all of them administered as prophylaxis (dose, route of administration, anatomical injection site, lot number and expiration date were unknown by reporter).  In May 2015, the patient developed T cell acute lymphoblastic leukemia. On 20-JUN-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) as prophylaxis (dose, dose number, anatomical injection site, lot number and expiration date were not provided; route of administration was unknown by reporter) (product administered to patient of inappropriate age). On an unknown date, the patient had negative measles, mumps, varicella, hepatitis A and hepatitis B titers (measles antibody negative, mumps antibody test negative, varicella virus test negative, hepatitis A antibody negative and hepatitis B antibody negative, respectively). No adverse symptoms were reported in regards to the patient receiving measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). The patient sought for medical attention in a office visit, but it was unknown by reporter if he received any treatment for the event. It was reported that a blood work was performed, but the results were not provided.  At the time of the report, the patient had not recovered from the events. The causality assessment between all the suspect vaccines and T-cell type acute leukaemia, measles antibody negative, mumps antibody test negative, varicella virus test negative, hepatitis A antibody negative and hepatitis B antibody negative was not reported.  Upon internal review, t-cell type acute leukaemia was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 65 year old female patient (pt). No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 03-NOV-2015, pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not provided) by a pharmacist for the long-term prevention of shingles and zoster-related conditions. Pt was prescribed the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider. On an unknown date, pt suffered the following injury resulting from zoster vaccine live (ZOSTAVAX) use: Herpes Zoster. Pt was treated by a physician. The outcome of the event was unknown. The reporter considered the event to be related with the suspect therapy.
Age: 0.17
Sex: U
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: an unspecified two month old patient may have been inadvertently administered a dose of GARDASIL 9; This spontaneous report was received from a registered nurse. It was mentioned that on an unspecified date, a 2-months unidentified patient of an unknown gender might had been inadvertently vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dosage schedule, route of administration, lot number and expiration date were not provided) (product administered to patient of inappropriate age).
Age: 57.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Anxiety, Inappropriate schedule of product administration, Nervousness
Clinical narrative: I received my second Varivax dose less than 28 days after the initial vaccination; worried; nervous; This spontaneous report as received from a 57 year old female patient referring to herself. The patient's concurrent conditions, medical history and concomitant medications were not provided.     On 24-APR-2019, she was vaccinated with her first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and on 09-JUN-2019, the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) for vaccination (before travel) (strength, dose, route, frequency, lot# and expiration date were not provided for both vaccines).  On 07-JUL-2019, she called in, and was nervous and worried about having received the varicella virus vaccine live (Oka/Merck) (VARIVAX) initial vaccination and second vaccination less that 4 weeks apart. She was worried and nervous that she also was receiving the second Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) vaccination less than 1 month after her initial varicella virus vaccine live (Oka/Merck) (VARIVAX) vaccination; and that the vaccinations she received on 05-JUL-2019 would not be effective and she would need to be re-vaccinated (inappropriate schedule of product administration). She stated she was feeling fine after receiving both varicella virus vaccine live (Oka/Merck) (VARIVAX) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) on 05-JUL-2019, but was just nervous and worried there would be a problem since she received the vaccinations outside of the recommended dosing schedule. She had already consulted the pharmacy who administered the vaccinations on 05-JUN-2019 (conflicting information, other vaccinations dates provided), regarding her concern and was informed by the pharmacy she would be fine. Despite the pharmacy telling her she would be fine, she was still nervous and worried about the situation. No laboratory data was provided. As of 07-JUL-2019, it was unknown if she would continue varicella virus vaccine live (Oka/Merck) (VARIVAX) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) and the outcome of the early vaccination was unknown. She continued to be worried and nervous.   The  causal relationship between the events and the varicella virus vaccine live (Oka/Merck) (VARIVAX) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) vaccines was not provided.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects were reported in the patient; a 15 month old patient received a dose of MMR II on 7/5/2019 at his 15 month check up. It was later discovered that the patient had aslo received a dose of MMR II at the 12 month checkup; This spontaneous report was received from a medical assistant referring to a 15 month old male patient. No information was provided regarding the patient's medical history, current conditions, concomitant medications, drug reactions and allergies.  On 05-JUL-2019, the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously for prophylaxis (dose, route of administration, anatomical injection site, lot number and expiration date were not reported) at his 15 month checkup. Then it was later discovered that the patient also received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) at the 12 month visit as well in approximately April 2019 (inappropriate schedule of product administration). No adverse effects were reported in the patient.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; Product storage error; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  Since an unknown date, the following lot# of varicella virus vaccine live (Oka/Merck) (VARIVAX) were improperly stored between 15 degrees Fahrenheit and 46 degrees Fahrenheit (mainly at 39.7 degrees Fahrenheit) for 2 hours and 20 minutes. Lot# R034391 (expiration date: 27-NOV-2020), lot# S005082 (has been verified to be a valid lot number for varicella virus vaccine live (Oka/Merck), expiration date reported as 28-FEB-2021, but upon internal validation established as 19-FEB-2021) and lot# S000132 (expiration date: 02-JAN-2021). On 03-JUL-2019, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, frequency and route not reported) for prophylaxis. The nurse was not sure with which of the improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot numbers was administered to the patient. No previous temperature of excursion was reported. A digital data logger was involved. No adverse effects were reported.; Sender's Comments:  US-009507513-1907USA004327: US-009507513-1907USA004329: US-009507513-1907USA004328:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; Product storage error; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  Since an unknown date, the following lot# of varicella virus vaccine live (Oka/Merck) (VARIVAX) were improperly stored between 15 degrees Fahrenheit and 46 degrees Fahrenheit (mainly at 39.7 degrees Fahrenheit) for 2 hours and 20 minutes. Lot# R034391 (expiration date: 27-NOV-2020), lot# S005082 (has been verified to be a valid lot number for varicella virus vaccine live (Oka/Merck), expiration date reported as 28-FEB-2021, but upon internal validation established as 19-FEB-2021) and lot# S000132 (expiration date: 02-JAN-2021). On 03-JUL-2019, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, frequency and route not reported) for prophylaxis. The nurse was not sure with which of the improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot numbers was administered to the patient. No previous temperature of excursion was reported. A digital data logger was involved. No adverse effects were reported.; Sender's Comments:  US-009507513-1907USA004242: US-009507513-1907USA004328: US-009507513-1907USA004329: