chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Sore left arm; muscular pain; fever; chills; Body aches/aches/pains; pain around injection site; weakness / made him feel weak; stiffness at injection site; starting to get a cold; tiredness; Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of nasopharyngitis (on an unknown date received vaccine and got a bad cold) and TDAP with an associated reaction of pain in extremity (on an unknown date received vaccine and experienced sore arm).   On 14th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 14th August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, muscle pain, fever, chills, general body pain, injection site pain, weakness, injection site movement impairment, cold, tiredness and influenza-like symptoms. On an unknown date, the outcome of the pain in arm, muscle pain, fever, general body pain, weakness, injection site movement impairment and tiredness were recovered/resolved and the outcome of the chills, injection site pain, cold and influenza-like symptoms were recovering/resolving.   It was unknown if the reporter considered the pain in arm, muscle pain, fever, chills, general body pain, injection site pain, weakness, injection site movement impairment, cold, tiredness and influenza-like symptoms to be related to Shingrix.  Additional details were received as follows: The patient experienced pain in arm, muscle pain, fever, chills, general body pain, injection site pain, weakness, injection site movement impairment, cold, tiredness and influenza-like symptoms. The patient did not consent to follow up. This case has been linked with case US2019AMR154515 and US2019150251, reported for same patient.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Myalgia, Pyrexia
Clinical narrative: Sore left arm; muscular pain; fever; chills; Body aches/aches/pains; pain around injection site; weakness / made him feel weak; stiffness at injection site; starting to get a cold; tiredness; Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of nasopharyngitis (on an unknown date received vaccine and got a bad cold) and TDAP with an associated reaction of pain in extremity (on an unknown date received vaccine and experienced sore arm).   On 14th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 14th August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, muscle pain, fever, chills, general body pain, injection site pain, weakness, injection site movement impairment, cold, tiredness and influenza-like symptoms. On an unknown date, the outcome of the pain in arm, muscle pain, fever, general body pain, weakness, injection site movement impairment and tiredness were recovered/resolved and the outcome of the chills, injection site pain, cold and influenza-like symptoms were recovering/resolving.   It was unknown if the reporter considered the pain in arm, muscle pain, fever, chills, general body pain, injection site pain, weakness, injection site movement impairment, cold, tiredness and influenza-like symptoms to be related to Shingrix.  Additional details were received as follows: The patient experienced pain in arm, muscle pain, fever, chills, general body pain, injection site pain, weakness, injection site movement impairment, cold, tiredness and influenza-like symptoms. The patient did not consent to follow up. This case has been linked with case US2019AMR154515 and US2019150251, reported for same patient.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Chills, Fatigue, Influenza like illness, Injection site movement impairment
Clinical narrative: Sore left arm; muscular pain; fever; chills; Body aches/aches/pains; pain around injection site; weakness / made him feel weak; stiffness at injection site; starting to get a cold; tiredness; Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of nasopharyngitis (on an unknown date received vaccine and got a bad cold) and TDAP with an associated reaction of pain in extremity (on an unknown date received vaccine and experienced sore arm).   On 14th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 14th August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, muscle pain, fever, chills, general body pain, injection site pain, weakness, injection site movement impairment, cold, tiredness and influenza-like symptoms. On an unknown date, the outcome of the pain in arm, muscle pain, fever, general body pain, weakness, injection site movement impairment and tiredness were recovered/resolved and the outcome of the chills, injection site pain, cold and influenza-like symptoms were recovering/resolving.   It was unknown if the reporter considered the pain in arm, muscle pain, fever, chills, general body pain, injection site pain, weakness, injection site movement impairment, cold, tiredness and influenza-like symptoms to be related to Shingrix.  Additional details were received as follows: The patient experienced pain in arm, muscle pain, fever, chills, general body pain, injection site pain, weakness, injection site movement impairment, cold, tiredness and influenza-like symptoms. The patient did not consent to follow up. This case has been linked with case US2019AMR154515 and US2019150251, reported for same patient.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Myalgia, Nasopharyngitis, Pain, Pain in extremity
Clinical narrative: Sore left arm; muscular pain; fever; chills; Body aches/aches/pains; pain around injection site; weakness / made him feel weak; stiffness at injection site; starting to get a cold; tiredness; Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of nasopharyngitis (on an unknown date received vaccine and got a bad cold) and TDAP with an associated reaction of pain in extremity (on an unknown date received vaccine and experienced sore arm).   On 14th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 14th August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, muscle pain, fever, chills, general body pain, injection site pain, weakness, injection site movement impairment, cold, tiredness and influenza-like symptoms. On an unknown date, the outcome of the pain in arm, muscle pain, fever, general body pain, weakness, injection site movement impairment and tiredness were recovered/resolved and the outcome of the chills, injection site pain, cold and influenza-like symptoms were recovering/resolving.   It was unknown if the reporter considered the pain in arm, muscle pain, fever, chills, general body pain, injection site pain, weakness, injection site movement impairment, cold, tiredness and influenza-like symptoms to be related to Shingrix.  Additional details were received as follows: The patient experienced pain in arm, muscle pain, fever, chills, general body pain, injection site pain, weakness, injection site movement impairment, cold, tiredness and influenza-like symptoms. The patient did not consent to follow up. This case has been linked with case US2019AMR154515 and US2019150251, reported for same patient.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Sore left arm; muscular pain; fever; chills; Body aches/aches/pains; pain around injection site; weakness / made him feel weak; stiffness at injection site; starting to get a cold; tiredness; Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of nasopharyngitis (on an unknown date received vaccine and got a bad cold) and TDAP with an associated reaction of pain in extremity (on an unknown date received vaccine and experienced sore arm).   On 14th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 14th August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, muscle pain, fever, chills, general body pain, injection site pain, weakness, injection site movement impairment, cold, tiredness and influenza-like symptoms. On an unknown date, the outcome of the pain in arm, muscle pain, fever, general body pain, weakness, injection site movement impairment and tiredness were recovered/resolved and the outcome of the chills, injection site pain, cold and influenza-like symptoms were recovering/resolving.   It was unknown if the reporter considered the pain in arm, muscle pain, fever, chills, general body pain, injection site pain, weakness, injection site movement impairment, cold, tiredness and influenza-like symptoms to be related to Shingrix.  Additional details were received as follows: The patient experienced pain in arm, muscle pain, fever, chills, general body pain, injection site pain, weakness, injection site movement impairment, cold, tiredness and influenza-like symptoms. The patient did not consent to follow up. This case has been linked with case US2019AMR154515 and US2019150251, reported for same patient.
Age: 15.0
Sex: F
Vaccine: MMR, MNQ, TDAP, VARCEL, MMR, MNQ, TDAP, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: 15 yo client in clinic on 8/19/19 for immunizations for school.  Client had the above listed vaccines due and administered. Client came into clinic 8/20/19 for pregnancy test which was positive.  EDC: 02/11/2020.  Parents  were advised of possible adverse reactions and possible complications with pregnancy.   Referred to OB/Gyn for  further evaluation.  Client has appointment with OB/Gyn on 8/30/19.
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Rash, Rash papular
Clinical narrative: intermittent appearance of erythematous papular rashes over the back of the neck/ shoulder, left arm and trunk in the last  6 weeks, first episode occurred 1 day after MMR,Pentacel ( L thigh), varicella (R thigh), significantly improved after antihistamine, total of 4 episodes.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Flare-up of shingles occur 5 days after vaccination.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Injection site paraesthesia, Middle insomnia, Screaming, Weight bearing difficulty
Clinical narrative: pain, tingling, refusal to bear weight on right leg causing him to wake up screaming  three nights in a row
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: after administration, on the same day, the patient began to experience excrutiating pain down her left arm; This spontaneous report was received from a nurse and refers to a 20-year-old, non-pregnant female patient. No information regarding her pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, exact dose, route of administration, lot # and expiration date were not reported) for health maintenance. There was not any problems following that administration. On 30-JUL-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly, lot # 1637641, expiration date 16-FEB-2022 (strength and exact dose were not reported) for health maintenance. On 30-JUL-2019, after administration, the patient began to experience excruciating pain down her left arm. The patient went to urgent care on an unspecified date and was given steroids as a treatment which helped for a couple of days. On 09-AUG-2019, the patient was still experiencing the same amount of the pain and was going to start another round of steroids on the same day. The outcome of the event was reported as not recovered. The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; the patinet was inadvertently administered one dose of expired VAQTA; Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent condition and concomitant therapy were not reported.     On 14-AUG-2019, the patient was inadvertently vaccinated with one dose of expired hepatitis a vaccine, inactivated (VAQTA) 50/1.0 U/ml (lot # R022983, expiration date: 09-AUG-2019) for prophylaxis (expired vaccine used). No adverse effects reported. No further information provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Post herpetic neuralgia, Rash, Rash vesicular
Clinical narrative: outbreaks of a painful blistering rash, along with nerve pain that remained after the rash subsided; outbreaks of a painful blistering rash, along with nerve pain that remained after the rash subsided along with nerve pain that remained after the rash subsided; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, the patient suffered severe outbreaks of a painful blistering rash, along with nerve pain that remained after the rash subsided along with nerve pain that remained after the rash subsided. As a result of these symptoms, the patient presented to a medical provider and she was diagnosed with Herpes Zoster and Postherpetic Neuralgia (dates un specified). Thereafter, the pt. had continued to suffer the effects of herpes zoster and post herpetic neuralgia. As a result, she had suffered and would continue -to suffer significant medical: expenses, pain and suffering, and other damages. The outcome of the events was considered not recovered/not resolved. The events were considered related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Injection site induration, Injection site mass
Clinical narrative: Right after the patient was administered her third dose of GARDASIL 9 she developed a 2 centimeter sized firm lump under the skin at the injection site.; The patient had received GARDASIL 9 on the following dosing schedule: 26-JUN-2018, 12-SEP-2018,03-JUL-2019.; This spontaneous report was received from a Nurse Practitioner via company representative, referring to a 22 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.      On 26-JUN-2018, the patient was vaccinated with her first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) via intramuscular (strength, dose, anatomical location, lot # and expiration date were unknown), and on 12-SEP-2018, the patient received her second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) via intramuscular (strength, dose, anatomical location, lot # and expiration date were unknown), and finally on 03-JUL-019, her third dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) via intramuscular (strength, dose, anatomical location, lot # and expiration date were unknown) all for protection from cancers. No adverse effects were reported after the first two doses, but the Nurse Practitioner reported that right after the patient was administered her third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), she developed a 2 centimeter sized firm lump under the skin at the injection site (injection site induration).   The Nurse Practitioner asked the patient to do a hard massage in the area of the lump, and put beat packs on it, and to get an ultrasound.   At the time of the report, the outcome of injection site induration was unknown. The nurse did not mention the causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination.
Age: 52.0
Sex: M
Vaccine: MMR
Symptoms: Mass, Rash, Rash morbilliform, Rib fracture, Road traffic accident
Clinical narrative: a couple of broken ribs; road rash; the patient had an accident on his bicycle; palpable, marble-sized lump on his buttocks; measles-like rash on bis arms and torso/bad another outbreak of about 6 spots of a measles-like rash, which are presently resolved; stressed physically and emotionally; This spontaneous report was received from a physician via a company representative referring to a 52-year-old male patient. Information about medical history, concurrent conditions and concomitant therapies was unknown.  The patient had negative titers to measles. Around approximately June or July of 2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route, lot # and expiration date were unknown) for prophylaxis. In June-July 2019 (following vaccination), the patient developed a palpable, marble-sized lump on his buttocks. Following that, the patient developed a measles-like rash on his arms and torso, which resolved in a few days.  After that the patient had an accident on his bicycle, which resulted in the patient experienced road rash and a couple of broken ribs. Following the bicycle accident, the patient then became stressed physically and emotionally, and had another outbreak of about 6 spots of a measles-like rash, which are presently resolved.  The outcome of broken ribs, road rash, accident on his bicycle, palpable marble-sized lump on his buttocks, and stressed physically and emotionally was reported as recovering/resolving. It was unknown if patient sought medical attention or not and if treatment was given for the events. Causality assessment was not provided. All the events were considered as significant disability or incapacity by the reporter.
Age: 52.0
Sex: M
Vaccine: MMR
Symptoms: Skin abrasion, Stress
Clinical narrative: a couple of broken ribs; road rash; the patient had an accident on his bicycle; palpable, marble-sized lump on his buttocks; measles-like rash on bis arms and torso/bad another outbreak of about 6 spots of a measles-like rash, which are presently resolved; stressed physically and emotionally; This spontaneous report was received from a physician via a company representative referring to a 52-year-old male patient. Information about medical history, concurrent conditions and concomitant therapies was unknown.  The patient had negative titers to measles. Around approximately June or July of 2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route, lot # and expiration date were unknown) for prophylaxis. In June-July 2019 (following vaccination), the patient developed a palpable, marble-sized lump on his buttocks. Following that, the patient developed a measles-like rash on his arms and torso, which resolved in a few days.  After that the patient had an accident on his bicycle, which resulted in the patient experienced road rash and a couple of broken ribs. Following the bicycle accident, the patient then became stressed physically and emotionally, and had another outbreak of about 6 spots of a measles-like rash, which are presently resolved.  The outcome of broken ribs, road rash, accident on his bicycle, palpable marble-sized lump on his buttocks, and stressed physically and emotionally was reported as recovering/resolving. It was unknown if patient sought medical attention or not and if treatment was given for the events. Causality assessment was not provided. All the events were considered as significant disability or incapacity by the reporter.
Age: 11.0
Sex: M
Vaccine: HPV9, PER
Symptoms: Loss of consciousness
Clinical narrative: passed out; This spontaneous report has been received from a medical assistant via a company representative referring to a healthy 11-year-old male patient. The patient's concurrent condition, medical history and concomitant therapy information was not provided.     On approximately 09-AUG-2019 (reported as about two weeks ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route, lot # and expiration date were not reported) as prevention of human papillomavirus vaccine (HPV). Other suspect therapy included unspecified pertussis vaccine and unspecified meningitis vaccine at the same visit (strength, dose, frequency, route, lot #, expiration date and indication were not reported).        On approximately 09-AUG-2019 (also reported as about two weeks ago), the patient experienced passed out for less than a minute. The outcome of passed out was reported as recovered. The patient did not seek any medical attention. No treatment was given to the patient. No lab diagnostics/studies were performed.  The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event passed out was determined to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: My daughter recently got the Gardasil 9 vaccine and boke out in rash after getting vaccine; This spontaneous report was received from a company representative referring to her daughter a patient of unknown age. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, lot/batch # and expiration date were not provided) for prophylaxis. The reporter stated that the patient broke out in a rash after getting the vaccine. The outcome of rash was unknown.        The causality assessment between rash and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: arm pain; decreased mobility of arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 52R7X, expiry date 10th October 2021) for prophylaxis.   On 25th July 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In July 2019, less than a week after receiving Shingrix, the patient experienced pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The pharmacist reported that, after vaccination over the weekend, the patient left the massage that, she continued to have pain in her left arm and still could not lift it past her shoulder. The reporter reported that, reviewed the post marketing data from prescribing information and offered the personal information. The reporter offered to be transferred to MIS, but declined.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Limb discomfort, Pyrexia
Clinical narrative: Woke with fever of 101.0 . Not C/O pain but is favoring arm. No redness.
Age: 28.0
Sex: M
Vaccine: TYP
Symptoms: Headache, Rash, Tenderness
Clinical narrative: Headache started at 1400 the same day as the vaccine. The next day a raised rash on left hand and right foot appeared as well as tenderness on right arm and right armpit
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Headache, Injection site pain, Myalgia
Clinical narrative: Shortness of breath, fever, shivering, muscle ache, headache, soreness at injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Shortness of breath, fever, shivering, muscle ache, headache, soreness at injection site.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Cold sweat, Pallor, Vision blurred
Clinical narrative: approximately 2-3 minutes after receiving the vaccine, patient became pale and complained of blurry vision.  His skin was also cool and moist.  Patient stated that he had not eaten lunch.  He was given a piece of candy and some water and cool compresses applied to head.  Within a few minutes, he was fully recovered.  He remained in the physician office for 30 minutes to monitor his condition.  No further symptoms exhibited.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain, Pruritus, Urticaria
Clinical narrative: The patient reports swelling and redness at and around the site of injection. It started shortly after the injection. The "welt" is about the size of her hand and is painful and itchy. She says it is less painful this morning than last night but is no smaller in size.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: she became dizzy and nauseous withing few minutes of vaccines and had few episodes of emesis. She felt better by lying down, cold compress on head and water and pedailyte popsicle She was able to walk after 15 minute without any recurrence of symptom
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Musculoskeletal stiffness, Pyrexia
Clinical narrative: dizzy,light headed, fever,feeling faint,stiff neck
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: Patient did not have an adverse reaction to the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Chest discomfort, Diarrhoea, Headache, Nausea
Clinical narrative: arm pain; joint pain; headaches; loose bowels; vomiting; chest discomfort; nausea; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain in arm, joint pain, headache, loose bowel, vomiting, chest discomfort and nausea. On an unknown date, the outcome of the pain in arm, joint pain, headache, loose bowel, vomiting, chest discomfort and nausea were unknown.   It was unknown if the reporter considered the pain in arm, joint pain, headache, loose bowel, vomiting, chest discomfort and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix and had pain in arm first few hours after injection. Followed by intensive joint pain and headache.  No history of headaches. After 12 hours loose bowels with uncontrolled vomiting for next 2 days. Minor chest discomfort. Better on 4th day with mild nausea. The patient was on brat diet.  The patient was little worried about possible reaction to 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Vomiting
Clinical narrative: arm pain; joint pain; headaches; loose bowels; vomiting; chest discomfort; nausea; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain in arm, joint pain, headache, loose bowel, vomiting, chest discomfort and nausea. On an unknown date, the outcome of the pain in arm, joint pain, headache, loose bowel, vomiting, chest discomfort and nausea were unknown.   It was unknown if the reporter considered the pain in arm, joint pain, headache, loose bowel, vomiting, chest discomfort and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix and had pain in arm first few hours after injection. Followed by intensive joint pain and headache.  No history of headaches. After 12 hours loose bowels with uncontrolled vomiting for next 2 days. Minor chest discomfort. Better on 4th day with mild nausea. The patient was on brat diet.  The patient was little worried about possible reaction to 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Injection site redness; Injection site pain; Injection site itching; Injection site warmth; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site pain, injection site itching and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site itching and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site itching and injection site warmth to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced skin redness, measuring 6 by 8 cm. at site of injection which was painful and itchy and warm to touch. With this reaction, the patient asked whether to  take the 2nd dose which would be on 12 October 2019.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: hot lump on arm at the injection site; red lump on arm at the injection site; lump on arm at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced injection site warmth, injection site erythema and injection site lump. On an unknown date, the outcome of the injection site warmth, injection site erythema and injection site lump were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, injection site erythema and injection site lump to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the dose of Shingrix in an unknown arm, one day before reporting date and had a hot, red lump at the injection site. The patient did not want to share any information for the event and would not answer further questions.
Age: 56.0
Sex: M
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 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient did not want to provide any additional information. The patient did not consent to follow up.
Sex: U
Vaccine: PNC13
Symptoms: Type IV hypersensitivity reaction
Clinical narrative: Delayed hypersensitivity; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced delayed hypersensitivity reaction to pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein). She was thinking it was related to the CRM protein. The outcome of the event was unknown.  Information on the batch number has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity, Tearfulness
Clinical narrative: Pt given PNEUMOCOCCAL POLYSACCHARIDE PPV23 into right arm in clinic on 8/21/19. Pt returned to clinic on 8/22/19 with site of injection/arm being red, swollen and hot from shoulder to elbow. Pt reports arm in very painful and is tearful. MD examined pt and prescribed doxycycline 100mg PO BID x 15 days to treat possible infection. Pt instructed patient to take acetaminophen for pain and to apply ice to site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Rash, Skin warm, Tenderness
Clinical narrative: Redness, warmth, mild tenderness, rash F/U with PCP Advil for pain & inflammation. Cold packs TID x next 24° then warm soaks. If redness worsens pt needs to be seen right away.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injection site rash, Localised oedema, Rash
Clinical narrative: Dizziness, headache, rash on inner left arm and neck, swelling/fluid accumulation on neck on the left side
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Dizziness, headache, rash on inner left arm and neck, swelling/fluid accumulation on neck on the left side
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site pruritus
Clinical narrative: Patient reported an arm that was extremely red that started the day after receiving the vaccine up to around 2 days ago (8/14/19-8/25/19). He also reported that the injection site is extremely itchy and has not subsided in itchiness.
Age: 61.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Erythema, Nausea, Pain in extremity, Swelling, Vomiting
Clinical narrative: Patient called 8/26/19 reporting of redness, swelling, and severe pain in left arm. She reports vomiting and feeling sick to her stomach. This has been ongoing for over a week and she still feels the symptoms as of 8/26/19. She said she felt some soreness in her right arm but that went away within a day or two. She visited 2 separate doctors which she mention did not help her. She was advised to help alleviate her symptoms Tylenol and icing to bring down the swelling and pain. She asked that someone call her to explain to her more about the vaccine and its side effects. A clinical pharmacist will be giving her a call to explain the possible side effects of the vaccines.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Nausea, Pain, Pyrexia
Clinical narrative: Nausea, some vomiting, fever <101.0, aches, chills, sweating
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Nausea, some vomiting, fever <101.0, aches, chills, sweating
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hyperhidrosis, Injection site erythema, Injection site mass, Injection site pain, Pain in extremity
Clinical narrative: Patient's left arm became sore and painful the day after the injection.  She came into clinic today 8/27/19 with a 3X1cm lump on left arm where she received the HPV and Menactra injections.   It is slightly pink.  It is only painful when she pushes on it or lays on it.  It is not warm to touch, does not show any signs of infection.   Mom said that she did get a bit sweaty a few days after the injection, but never took her temperature.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: scattered red areas, some itching (since resolved) no redness or bruising local to injection site, some pain in arm some areas pt indicated had no visible redness. pt stated it was "under the skin"
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: warm, itchy injection site which is bigger than the size of a quarter; warm, itchy injection site which is bigger than the size of a quarter; This spontaneous report as received from a pharmacist refers to a 25-year-old female patient with no drug reactions or allergies and with no medical history. It was reported that the patient was not pregnant.  On 27-JUL-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (indication reported as "vaccine") (lot number: R024144; expiration date: 23-AUG-2020) (dose was not reported) which was reconstituted in a sterile diluent (lot number: R032352; expiration date: 04-JUN-2021; dose, formulation and route of administration were not provided). Concomitant medication included measles virus vaccine live (enders-edmonston) (+) mumps virus vaccine live (jeryl lynn) (+) rubella virus vaccine live (wistar ra 27/3) (M-M-R II).  On the same day, the patient had warm, itchy injection site which was bigger than the size of a quarter. The concomitant measles virus vaccine live (enders-edmonston) (+) mumps virus vaccine live (jeryl lynn) (+) rubella virus vaccine live (wistar ra 27/3) (M-M-R II) was administered on the same date in an opposite arm and the patient had no reaction at that injection site. The patient did not seek medical attention. There was no treatment given for the events. No laboratory diagnostics or studies were performed. The outcome of the events was reported as not recovered.  The relatedness between both suspects and the events was unknown.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: no adverse effect; unknown amount of vaccine leaked out while administering the injection; a patient received less than full dose; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information on patient's pertinent medical history, concomitant medications, drug reaction or allergies was provided.      On 13-AUG-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R032766 has been verified to be a valid lot number, expiration date 31-AUG-2021 (dose and route of administration were not provided) for prophylaxis.   The nurse reported that the patient received less than a full dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) because an unknown amount of the vaccine leaked out while administering the injection. No adverse effects were reported. The outcome of syringe issue was unknown.  The relatedness between the syringe issue and the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site reaction, Night sweats, Rash erythematous
Clinical narrative: Night sweats; chills; red rash on arm; This case was reported by a physician via sales rep and described the occurrence of night sweat in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced night sweat, chills and red rash. On an unknown date, the outcome of the night sweat, chills and red rash were unknown.   It was unknown if the reporter considered the night sweat, chills and red rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had night sweats, chills, 3 days after injection, red rash on upper left arm. The reporter agreed to follow up.
Sex: M
Vaccine: FLUX
Symptoms: Nasopharyngitis
Clinical narrative: Had a cold; This case was reported by a consumer via call center representative and described the occurrence of cold in a 51-year-old male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced cold. On an unknown date, the outcome of the cold was recovered/resolved.   It was unknown if the reporter considered the cold to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced horrible cold after receiving vaccine. This case has been linked with cases US2019149365, reported by the same reporter.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Blister, Erythema, Injection site reaction, Injection site vesicles, Rash
Clinical narrative: Started the next day as a patch under left arm, same arm as injection.  No fever. No reaction to 1st vaccine.  Cheeks with red patches bilaterally, left inner upper arm with red patch with vesicles in middle, vesicles present to right ear, upper chest and neck (front and back) as well. Chest and neck with erythema patches. Scattered red papular lesions all over, varying size from pinpoint to dime sized..
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Rash erythematous, Rash papular, Skin lesion
Clinical narrative: Started the next day as a patch under left arm, same arm as injection.  No fever. No reaction to 1st vaccine.  Cheeks with red patches bilaterally, left inner upper arm with red patch with vesicles in middle, vesicles present to right ear, upper chest and neck (front and back) as well. Chest and neck with erythema patches. Scattered red papular lesions all over, varying size from pinpoint to dime sized..
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Blister, Neuralgia
Clinical narrative: 6 days after the vaccine I experienced sharp stabbing pains on right side under ribs followed closely by skin blisters in same area with severe nerve pain since that day. It's been more than a month now.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site papule
Clinical narrative: Reaction on Right Thigh.  2 mm diameter red papule on right thigh.  Non tender.  Documented on 8/26/2019 visit to primary care office by Dr.
Age: 9.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Amnesia, Disorientation, Fall, Head injury, Loss of consciousness
Clinical narrative: Approx 5 min after receiving the HPV vaccine (influenza vaccine was the first administered) , pt experienced a syncope episode. Was unresponsive for approx. 30 sec. Responded to sternal rub. Some memory loss that resolved approx. after 5 min. EMS called due to initial disorientation, patient urinated on self when lost consciousness, sustained head injury from fall. Vitals stable- BP 130/80, Pulse OX 98%, HR 60-80, 19-24 breaths/per min.
Age: 9.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Syncope, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: Approx 5 min after receiving the HPV vaccine (influenza vaccine was the first administered) , pt experienced a syncope episode. Was unresponsive for approx. 30 sec. Responded to sternal rub. Some memory loss that resolved approx. after 5 min. EMS called due to initial disorientation, patient urinated on self when lost consciousness, sustained head injury from fall. Vitals stable- BP 130/80, Pulse OX 98%, HR 60-80, 19-24 breaths/per min.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Night sweats, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Sweating in middle of night when it began, pain and tenderness and swelling in arm , severe swelling, could not raise arm It has started to improve today 8/27/19 when she notified us
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Gait disturbance, Pain
Clinical narrative: MOM STATES PT WAS C/O PAIN ON 08/26/19 AND WAS LIMPING. MOM GAVE IBUPROFEN FOR PAIN ON 08/26/19.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Inflammation, Injection site erythema
Clinical narrative: Patient reported back to the immunization center approx. an hour after vaccination with bilateral erythema below injection sites. Patient otherwise stable assessed by provider, monitored ibuprofen ordered for inflammation. Patient released with mother. Attempts to contact mother for follow up have been unsuccessful at this time. Mother given strict instructions of signs and symptoms, and when to seek emergency care if symptoms worsen.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect; the patient was inadvertently administered a dose of MMR II that was expired; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 23-JUL-2019, the patient was inadvertently vaccinated with the expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (lot number N019120, expiration date: 22-JUN-2019, albumin status: rha; dose and route of administration were not provided). No adverse effect was reported.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 4 weeks after the first dose, the patient was vaccinated with the second dose of Gardasil 9; No adverse effect; This spontaneous report was received from a medical assistant and refers to a 16 year old patient of unspecified gender.  The patient's concurrent conditions, medical history or concomitant therapies were not reported.  On an unspecified date, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) as prophylaxis (dose, frequency, anatomical location, route of administration, lot number and expiration date were not provided).  On an unspecified date, 4 weeks after the first dose, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9)  (dose, frequency, anatomical location, route of administration, lot number and expiration date were not provided).(Inappropriate schedule of product administration) No adverse effect was reported.