chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: given a pediatric dose of VAQTA instead of the intended adult dose; No adverse effects; This spontaneous report was received from a nurse regarding an adult patient of unknown age and gender. Information on patient's medical history, concurrent conditions and concomitant therapies was not provided. On an unknown date unspecified patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) strength 50 dose/frequency (dosage form) (dose, frequency were not reported, lot # R034339, expiration date  23-NOV-2019) via unknown route for prophylaxis. On an unknown date the patient was given a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) instead of the intended adult dose (incorrect dose administered). No adverse effects were reported (no adverse event). There was no involvement of product quality complaint (PQC).
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling
Clinical narrative: patient experienced "swelling" at injection site after receiving second dose; This spontaneous report was received from a medical assistant regarding a currently 40-year-old, non-pregnant female patient. The information about the patient's concomitant medication was unknown by the reporter. It was reported she did not have pertinent medical history or drug reactions/allergies.   On 03-JUL-2019, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot 1602284 number and expiration date 26-SEP-2021) intramuscularly for HPV prevention (prophylaxis). Subsequently, on an unspecified date in July 2019 (also reported as: adverse event (AE) onset unknown), the patient experienced "swelling" at the injection site. It was unknown by the reporter if treatment was given for the adverse event, however, it was reported that the patient did not seek medication attention and there were no laboratory diagnostics or studies performed.   At the time of reporting, the outcome of the injection site swelling was unknown. The reporter did not provide a causality assessment between the event occurrence and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Seizure, Syncope
Clinical narrative: the patient had a seizure by the front door of the office and collapsed; This spontaneous report has been received from a physician via a field representative referring to a 18 year old female patient. Information about concomitant medication and drug reactions/allergies was unknown. The patient had no pertinent medical history.  On approximately 17-JUN-2019 (reported as 3 weeks ago from yesterday), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) (dose detail, anatomical location, route of administration, batch/lot # and expiration date were not reported) for prophylaxis.  On the same day, the patient waited for 15 minutes after administration. As the patient was going to leave the physician office, the patient had a seizure by the front door of the office and collapsed. The paramedics came and the patient possibly had cardiopulmonary resuscitation (CPR) to prevent serious criteria.   The outcome of the event was reported as recovered in 2019.  No causality assessment was provided.     Upon internal review, the event of a seizure by the front door of the office and collapsed was considered to be medically significant.
Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects reported; she was administered GARDASIL (unspecified lot and expiration) "15 years ago" at the age of "35" which at the time was outside of the indicated age range for GARDASIL; Information has been received from a 35 years old female physician referring to herself. There was no information about the patient's concurrent conditions, concomitant therapies, medical history drug reactions/allergies provided.  On an unknown date in 2004 (reported as 15 years ago), the patient was administered quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis, which was outside of the indicated age range (Inappropriate age at vaccine administration). No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects reported.; one dose of MMR II (lot number R018526, expiration date 10/04/2020) was inadvertently given by the intramuscular route, instead of subcutaneous on 7/08/2019; Information has been received from a pharmacist referring to a 22 years old patient of unknown gender. Information about concurrent condition, concomitant medication, drug reactions/allergies and medical history was not provided.  The reporter reported that one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R018526, expiration date was 04-OCT-2020, intramuscular; strength and dose were not reported) for prophylaxis was inadvertently given by the intramuscular route, instead of subcutaneous (Incorrect route of product administration) on 08-JUL-2019. No adverse effects was reported. No PQC.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: on 7/8/2019, patient received one dose of ROTATEQ (N030995) that expired on 6/17/2019; No adverse effects; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided.     On 08-JUL-2019, the patient was vaccinated with one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose and frequency were not reported) lot # N030995, expiration date: 17-JUN-2019, orally for prophylaxis (expired vaccine used). There were no temperature excursions reported. There were no adverse effects reported.
Sex: F
Vaccine: MMR
Symptoms: Culture urine positive
Clinical narrative: Patient was prescribed an unspecified dose of cefprozil for 10 days due to a positive urine culture; This spontaneous report was received from the patient's mother and refers to her 8 year old daughter. The patient's concurrent conditions included allergic reaction after previous use of sulfamethoxazole, trimethoprim (BACTRIM). Her medical history and concomitant medications were not reported. On 03-JUL-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route, lot #, expiration date and frequency were not reported) for prophylaxis.   On an unspecified date in July 2019, the patient had an unspecified positive result from a culture urine and, as consequence, she had to be treated with cefprozil (dose, route and frequency were not reported) during 10 days.  At the reporting time, the outcome of culture urine positive was not reported. The reporter did not provide a causality assessment between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).
Age: 1.0
Sex: F
Vaccine: MMRV, UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; a female 1 year old received properly stored PROQUAD and properly stored VARIVAX on the same day; Information has been received from a medical assistant referring to a 1 year old female patient. Information about concurrent condition, concomitant medication and medical history was not provided.    On 09-JUL-2019, the patient received properly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot# S002501, expiration date 23-JUL-2020, in the right thigh; strength, dose and route were unknown) and properly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (expiration date 23-JAN-2021, in the left thigh; strength, dose, route and lot # were unknown) for prophylaxis on the same day (overdose). Both measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (Oka/Merck) (VARIVAX) were reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (lot# R012275, expiration 28-JAN-2021; the same lot was used for both vaccines). No adverse effects was reported.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: the patient was two weeks pregnant when she received her final shot of the 3 dose of GARDASIL; This spontaneous retrospective pregnancy report was received from an approximately 24 years old female patient referring to herself. The patients' concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.      On an unknown date in January 2010, the patient was vaccinated with her final shot of the third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, frequency, route, lot# and expiration date were not reported) for prophylaxis. The patient reported she was two weeks pregnant when she received the vaccine (maternal exposure during pregnancy).
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on chest; This case was reported by a consumer via call center representative and described the occurrence of rash in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. In June 2019, 7 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. About 3 weeks ago, the patient received 1st shot of Shingrix..  About a week or so after receiving the shot, the patient experienced rash on chest. At first, the patient thought it was a bunch of bug bites, but have not been out since and it was spreading.  The patient asked could it be a reaction to the shot.
Sex: U
Vaccine: UNK, VARZOS
Symptoms: Back pain, Blister, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; Blistering; intense pain in right lower back area; This case was reported by a physician via other manufacturer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included tofacitinib citrate (Xeljanz Xr) for an unknown indication.   Previously administered products included Methotrexate with an associated reaction of hepatic enzyme increased (The form, route, and dose used by the patient was not specified).   On an unknown date, the patient received Shingrix and Xeljanz Xr 11 mg at an unknown frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister and back pain. The action taken with Xeljanz Xr was unknown (Dechallenge was unknown). Rechallenge with Xeljanz Xr was unknown. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, blister and back pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister and back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per the vaccine indication. The patient had the shingles again, till the date of reporting and had blistering and intense back pain in right lower back area which had happened numerous times. The patient had Shingrix vaccine and has and had at least 3 outbreaks even since then. The reporter stated that the patient stopped her Xeljanz when the shingles breaks out. As per current medication, the patient was prescribed Xeljanz XR 11 mg one tablet daily. All quotations in that verbatim entered as they appear in the reporter's documentation. It was unknown if the reporter considered the shingles, blister and back pain to be related to Xeljanz Xr. No additional information provided. FBallentine LVN It was unknown if the reporter considered the vaccination failure, shingles, blister and back pain to be related to Shingrix. This case was considered as suspected vaccination failure, as the time to onset, details of primary immunization and laboratory confirmation for Shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: extreme swelling around injection site; redness around injection site; pain around injection site; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult 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 week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site pain. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient reported and adverse event with Shingrix and was looking to receive the 2nd dose when due but the patient want to try to determine if there was potential risk to the patient in receiving the 2nd dose. The patient had redness, extreme swelling, and pain around the injection site. The reporter saw the site about 6 days after the administration and the site was still red and mildly swollen in about a 5 inch x 4 inch area of the bicep area of the arm where the injection was given.
Age: 46.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Patient was given a pediatric dose of Hep A.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient was given a pediatric Hep B thinking that 2 pediatric doses would equal an adult dose.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient was given a pediatric Hep B dose.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient was given a pediatric dose of Hep B.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient was given a pediatric dose of Hep B.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Gave Hep A pediatric dose.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction noted this is notification the patient was given an extra varivax in the form of proquad
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Patient was given Pediatric dose of Hep A
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hyperhidrosis, Myalgia
Clinical narrative: Chills; Sweating; Muscle aches; Fatigue; Possible start of Migraine
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient called this clinic after hours , stated was in extreme pain was unable to move her arm well, no redness or swelling noted per patient, patient stated she went to the ER , they gave her Tordal injection for the pain, patient was not admitted, was released home, this morning this nurse called patient when message was received , was given the information above, informed patient she needs to follow up today in clinic to be seen
Age: 50.0
Sex: F
Vaccine: MMRV
Symptoms: Underdose
Clinical narrative: Patient was given pediatric dose of MMRV.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Gave Kinrix instead of Pediarix.
Age: 0.25
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Gave Kinrix, instead the appropriate dose Pediarix.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Patient was given Kinrix instead of Pediarix
Age: 0.75
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Patient was given Kinrix instead of Pediarix.
Age: 0.17
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Patient was given Kinrix instead of Pediarix
Age: 0.25
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Patient was given Kinrix instead of Pediarix
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Asthenia, Back pain, Chest X-ray, Chest discomfort
Clinical narrative: Begain scratchy throat day after vaccine, followed by cough, wheezing, hoarseness, tightness in throat and chest with some mucus, occasional headache, occasional nausea, shortness of breath, tired/weak, painful areas (about the size of my fingertip) across chest, abdomin, sides, back, shoulders, arm, neck, cheek under rt. eye, shooting pain across chest and down front of thighs upon coughing spasms.  Upon this date, I still have hoarseness, cough, some wheezing, although most painful areas have subsided.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Cough, Dysphonia, Dyspnoea, Facial pain
Clinical narrative: Begain scratchy throat day after vaccine, followed by cough, wheezing, hoarseness, tightness in throat and chest with some mucus, occasional headache, occasional nausea, shortness of breath, tired/weak, painful areas (about the size of my fingertip) across chest, abdomin, sides, back, shoulders, arm, neck, cheek under rt. eye, shooting pain across chest and down front of thighs upon coughing spasms.  Upon this date, I still have hoarseness, cough, some wheezing, although most painful areas have subsided.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Flank pain, Headache, Musculoskeletal pain, Nausea
Clinical narrative: Begain scratchy throat day after vaccine, followed by cough, wheezing, hoarseness, tightness in throat and chest with some mucus, occasional headache, occasional nausea, shortness of breath, tired/weak, painful areas (about the size of my fingertip) across chest, abdomin, sides, back, shoulders, arm, neck, cheek under rt. eye, shooting pain across chest and down front of thighs upon coughing spasms.  Upon this date, I still have hoarseness, cough, some wheezing, although most painful areas have subsided.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Pain in extremity, Secretion discharge, Throat irritation
Clinical narrative: Begain scratchy throat day after vaccine, followed by cough, wheezing, hoarseness, tightness in throat and chest with some mucus, occasional headache, occasional nausea, shortness of breath, tired/weak, painful areas (about the size of my fingertip) across chest, abdomin, sides, back, shoulders, arm, neck, cheek under rt. eye, shooting pain across chest and down front of thighs upon coughing spasms.  Upon this date, I still have hoarseness, cough, some wheezing, although most painful areas have subsided.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat tightness, Wheezing
Clinical narrative: Begain scratchy throat day after vaccine, followed by cough, wheezing, hoarseness, tightness in throat and chest with some mucus, occasional headache, occasional nausea, shortness of breath, tired/weak, painful areas (about the size of my fingertip) across chest, abdomin, sides, back, shoulders, arm, neck, cheek under rt. eye, shooting pain across chest and down front of thighs upon coughing spasms.  Upon this date, I still have hoarseness, cough, some wheezing, although most painful areas have subsided.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Patient was given Kinrix instead of Pediarix
Age: 0.75
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: PT Kinrix instead of Pediarix
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Patient reports developing fever on 7/13. She took 2 doses of Tylenol bid. Rash also developed on right arm on 7/13 and not spreading.  I advised patient to ice the area of it is bothersome.
Age: 36.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Death
Clinical narrative: Patient died 7/11/2019
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Patient was given a Kinrix instead of Pediarix
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave MMRV which is not indicated for under 4 years.
Age: 1.92
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave MMRV proquad to PT which is not indicated for under 4 years old.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave Patient MMRV Proquad, which isn't indicated for under the age of 4.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave Patient MMRV Proquad, which is not indicated for under 4 years old.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Full blood count abnormal, Induration, Inflammation, Injection site vesicles
Clinical narrative: Redness, inflammation,  area hard and hot to the touch. Water vesicles on the right arm. Administration Cleocin 200 mg every 8 hours Famotidine 10 mg every 12 hours Solumedrol 10 mg Iv .45 Dx
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Laboratory test abnormal, Skin warm
Clinical narrative: Redness, inflammation,  area hard and hot to the touch. Water vesicles on the right arm. Administration Cleocin 200 mg every 8 hours Famotidine 10 mg every 12 hours Solumedrol 10 mg Iv .45 Dx
Age: 37.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: DONOR STATED AFTER RECEIVING RABIES VACCINE ON 06/27/19 SHE HAD MILD SYMPTOMS DUE TO VACCINE THE DAY AFTER . SYPMTOMS INCLUDED NAUSEA W/ VOMITIMG NAD DIZZINESS. DONOR DIDNOT SEEK MEDICAL ATTENTION , STATED SHE RECOVERED NATURALLY. DONOR ONLY ADVISED STAFF OF EVENT TODAY WHILE TALKING TO STAFF.
Age: 37.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: DONOR STATED AFTER RECEIVING RABIES VACCINE ON 06/27/19 SHE HAD MILD SYMPTOMS DUE TO VACCINE THE DAY AFTER . SYPMTOMS INCLUDED NAUSEA W/ VOMITIMG AND DIZZINESS. DONOR DIDNOT SEEK MEDICAL ATTENTION , STATED SHE RECOVERED NATURALLY. DONOR ONLY ADVISED STAFF OF EVENT TODAY WHILE TALKING TO STAFF.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given MMRV which is not indicated for under 4 years old.
Age: 1.25
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given MMRV proquad which is not indicated for under 4 years old.
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave MMRV Proquad, which is not indicated for under 4 years old.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave MMRV Proquad, which is not indicated for under 4 years old.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given MMRV Proquad, which is not indicated for under 4 years old.
Age: 1.75
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Was given MMRV Proquad, which is not indicated for under 4 years old.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles outbreak; Incomplete course of vaccination; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine but did not have the specific date. The patient has an outbreak of shingles that started about a week or 10 days ago. She has not seen a physician to get a formal diagnosis yet. The patient would like to have her 2nd dose of Shingrix at the time of reporting but did not know if she could still have it, which led to incomplete course of vaccination. Did not collect reporter's phone number.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: Aches/ Pain; Fever; Rash; This case was reported by a physician via sales rep and described the occurrence of pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain, fever and rash. On an unknown date, the outcome of the pain, fever and rash were recovered/resolved.   It was unknown if the reporter considered the pain, fever and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The field representative reported the doctor mentioned a colleague of the doctor's received unknown dose of Shingrix vaccine at an unknown time, but experienced aches, pain, fever, and rash for approximately 4 to 5 days. The reporter did not give consent to follow up. The doctor who reported adverse event to field representative did not want to be contacted.
Sex: M
Vaccine: MENB
Symptoms: Full blood count normal, Pyrexia
Clinical narrative: Pretty high fever; This is a spontaneous report from a contactable nurse (patient's parent) through a Pfizer sales representative. A male patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA, Lot number and expiration date were not reported), with route of administration and therapy date, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had a pretty high fever "about 10 hours" after vaccine administration. The patient underwent laboratory tests and procedures which included normal complete blood count (CBC) and physical examination. The outcome of the event, 'pretty high fever', was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 1.17
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: given MMRV Proquad which is not indicated for under 4 years old.
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave MMRV Proquad, which is not indicated for under 4 years old.
Age: 4.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Gave Hep B adult dose to Pediatric patient
Age: 52.0
Sex: F
Vaccine: DTAP
Symptoms: Underdose
Clinical narrative: Gave pediatric dose of DTaP
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: Given Bexsero, which is for another age group.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: Given Bexsero, which is not indicated for her age group.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave Menveo, which is not indicated for this Patients age group.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site mass, Injection site swelling, Pain, Ultrasound scan
Clinical narrative: Patient has had a mass of varying size under the injection site that causes him pain. Within 24 hourse of the vaccine his leg that received the DTaP vaccine was extremely swollen ( especially in the thigh area) After the swelling reduced he had a mass approximately the size of a small Brussels sprout. His parents understood that this occurs in ~1/500 cases and that it should resolve in ~2 weeks. A month after the vaccine patient still had a mass the size of a large pea and they brought him to the Medical Unit for an Ultrasound. They were advised that the mass should dissipate but it has not over three months post vaccination.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: Given Bexsero, which is indicated for another age group.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Swelling
Clinical narrative: Swollen red rash about 2 inches in diameter.  Was not hot and did not itch.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: Gave Bexsero, which is not indicated for this age group.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: Gave Bexsero, which is not indicated for this Patients age group.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: Given Bexsero, which is not indicated for this age group.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: Given a Bexsero which is not for this age group.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: Gave Bexsero, which is not for this age group.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Decreased appetite, Fatigue, Feeling abnormal, Headache
Clinical narrative: Headache, joint pain, arm pain at shot location, fatigue, no appetite, aching. 2 days in and feel better but arm very sore and still not feeling normal
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Headache, joint pain, arm pain at shot location, fatigue, no appetite, aching. 2 days in and feel better but arm very sore and still not feeling normal
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: Patient was given Bexsero which is not for his age group.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: Given Bexsero which is not indicated for this age group.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: Given Bexsero which is not indicated for this age group.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: Given Bexsero which is indicated for a different age group.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Inflammation, Nodule
Clinical narrative: Patient returned to office 17 days later with a red, inflamed nodule on her left nodule that she claimed started on 6/26/19.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Immediately after administration pt stated she "felt dizzy" then proceeded to pass out. Pt laid flat: 0 injury; Dr. informed and spoke with pt and family
Sex: U
Vaccine: VARZOS
Symptoms: Antinuclear antibody positive, Herpes simplex, Herpes simplex test positive
Clinical narrative: Herpes simplex 1 & 2; Anti Nuclear Antibodies; This case was reported by a consumer via call center representative and described the occurrence of herpes simplex in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 19th October 2018).   On 7th February 2019, the patient received the 2nd dose of Shingrix. In June 2019, less than a year after receiving Shingrix, the patient experienced herpes simplex and antinuclear antibody positive. On an unknown date, the outcome of the herpes simplex and antinuclear antibody positive were unknown.   It was unknown if the reporter considered the herpes simplex and antinuclear antibody positive to be related to Shingrix.  Additional details were provided as follows: The age group of the patient was not reported, but selected as an adult as per vaccine indication. The patient had done blood test last week from the date of reporting with positive result for anti nuclear antibodies and herpes simplex 1 and 2. The patient asked, if Shingrix causing a positive for these types of blood tests.      Lab Comments: IN 2019, the patient underwent blood tests for Anti Nuclear Antibodies and Herpes Simplex 1 & 2 and was positive for all tests.
Sex: F
Vaccine: MNQ
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema
Clinical narrative: swollen arm; red arm; This case was reported by a physician via sales rep and described the occurrence of extensive swelling of vaccinated limb in a female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo at an unknown dose. On an unknown date, unknown after receiving Menveo, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that they had a female patient that experienced a large, red, swollen arm the size of a hand. The physician reported that injection site reactions were seen more with Menveo then other vaccines given at this age visit. The reporter did not agreed to follow up. The case has been linked to the case US2019AMR122565, reported by same reporter.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle Pain; This case was reported by a other health professional via call center representative and described the occurrence of myalgia upper extremities in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 99D9F, expiry date 14th April 2020) for prophylaxis.   On 8th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 8th May 2019, less than a day after receiving Shingrix, the patient experienced myalgia upper extremities. On an unknown date, the outcome of the myalgia upper extremities was not recovered/not resolved.   It was unknown if the reporter considered the myalgia upper extremities to be related to Shingrix.  Additional details were provided as follows: The pharmacist intern reported that the patient received Shingrix in left arm and experienced muscle pain in arm described as achy that started day of vaccination and has gotten worse on pain scale. The intern inquiries if it was common for pain to last beyond 30 days. There is discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Application site rash, Blood thyroid stimulating hormone decreased, Bone pain, Diarrhoea, Erythema
Clinical narrative: It's been lousy; Rash that's formed at the application site; Welt like rash; Loose bowels; Fever; Felt flu-like; Fatigue/I feel fatigue/Fatigue was reported as worsened; Bones ached; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A 75-year-old female patient started to receive pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration in the left arm on 02Jul2019 15:15 at single dose to prevent pneumonia in a doctor's office. Medical history included low thyroid diagnosed 25 years ago and it was ongoing. History of previous immunization and family history relevant to the adverse events was reported as none. There were no concomitant medications. The patient had a pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) pneumonia shot on Tuesday 02Jul2019. Twenty four hours later on 03Jul2019, she had a fever but had no adverse reaction in her arm. Patient reported that she never took her temperature, but she knew she had a fever. Then she felt flu-like: her bones ached and everything. She also felt fatigued on 03Jul2019. Reported that she was very healthy and works out 6 out of 7 days a week. Patient also had loose bowels on 04Jul2019. On 05Jul2019, she asked her husband to scratch her back, and her husband saw this rash on her hip on her left side, it was like a welt about 4.5-5 inches long and 1.5 inches wide. The welts stick out and are bright pink. Reported that she had never had anything like that, and she wished they told her or she never would have gotten it. She washed the rash with soap and water, and thought if this was MRSA it would be awful. She has to go back to a doctor to see about her rash that had formed at the application site. So she had side effect from pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) vaccine from the injection. Further reported that vaccine had been lousy on her and she felt fatigue and everything. The events did not require a visit to emergency room and no investigational assessment done. Patient recovered from fever on 03Jul2019, was recovering from flu-like, not recovered from fatigue, loose bowels, and welt like rash. Outcome of the other events was unknown.  Information on the batch number has been requested.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Influenza like illness, Pruritus, Pyrexia, Urticaria
Clinical narrative: It's been lousy; Rash that's formed at the application site; Welt like rash; Loose bowels; Fever; Felt flu-like; Fatigue/I feel fatigue/Fatigue was reported as worsened; Bones ached; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A 75-year-old female patient started to receive pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration in the left arm on 02Jul2019 15:15 at single dose to prevent pneumonia in a doctor's office. Medical history included low thyroid diagnosed 25 years ago and it was ongoing. History of previous immunization and family history relevant to the adverse events was reported as none. There were no concomitant medications. The patient had a pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) pneumonia shot on Tuesday 02Jul2019. Twenty four hours later on 03Jul2019, she had a fever but had no adverse reaction in her arm. Patient reported that she never took her temperature, but she knew she had a fever. Then she felt flu-like: her bones ached and everything. She also felt fatigued on 03Jul2019. Reported that she was very healthy and works out 6 out of 7 days a week. Patient also had loose bowels on 04Jul2019. On 05Jul2019, she asked her husband to scratch her back, and her husband saw this rash on her hip on her left side, it was like a welt about 4.5-5 inches long and 1.5 inches wide. The welts stick out and are bright pink. Reported that she had never had anything like that, and she wished they told her or she never would have gotten it. She washed the rash with soap and water, and thought if this was MRSA it would be awful. She has to go back to a doctor to see about her rash that had formed at the application site. So she had side effect from pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) vaccine from the injection. Further reported that vaccine had been lousy on her and she felt fatigue and everything. The events did not require a visit to emergency room and no investigational assessment done. Patient recovered from fever on 03Jul2019, was recovering from flu-like, not recovered from fatigue, loose bowels, and welt like rash. Outcome of the other events was unknown.  Information on the batch number has been requested.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: Given a Bexsero which is for a different age group.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Full blood count normal, Headache, Loss of personal independence in daily activities
Clinical narrative: Patient states receiving the first dose of her shingrix vaccine on 6/28/2019 with symptoms starting on 6/30/2019.  Patient states that initially she had symptoms of nausea, vomiting, diarrhea, muscle pain, fatigue, and headaches that were severe and limited her ability to preform normal daily activities.  Reports that she still has some symptoms 2 weeks later but has been getting better.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Metabolic function test normal, Myalgia, Nausea, Vomiting
Clinical narrative: Patient states receiving the first dose of her shingrix vaccine on 6/28/2019 with symptoms starting on 6/30/2019.  Patient states that initially she had symptoms of nausea, vomiting, diarrhea, muscle pain, fatigue, and headaches that were severe and limited her ability to preform normal daily activities.  Reports that she still has some symptoms 2 weeks later but has been getting better.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis, Gait disturbance, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: My son was given the Prevnar 13 vaccine on 6/25/19. When I picked him up from school that day he was limping. The vaccine was administered in his left thigh. The next day his left thigh was nearly double in size and was red, hot, swollen and hard.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site warmth
Clinical narrative: My son was given the Prevnar 13 vaccine on 6/25/19. When I picked him up from school that day he was limping. The vaccine was administered in his left thigh. The next day his left thigh was nearly double in size and was red, hot, swollen and hard.
Age: 38.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Erythema, Muscle swelling, Pain, Rash macular
Clinical narrative: Saturday 7/13/19 woke up at 5am with an intense amount of pain and took ibuprofen which helped Swelling in deltoid at that point Sunday 7/14/19 noticed more swollen on tricep and red and splotchy  Was told to ice and take benadryl  Less splotchy today, but more all over red and now hot   Provider treating for cellulitis after examination
Age: 38.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Skin warm, Swelling
Clinical narrative: Saturday 7/13/19 woke up at 5am with an intense amount of pain and took ibuprofen which helped Swelling in deltoid at that point Sunday 7/14/19 noticed more swollen on tricep and red and splotchy  Was told to ice and take benadryl  Less splotchy today, but more all over red and now hot   Provider treating for cellulitis after examination
Age: 50.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site reaction, Nausea
Clinical narrative: Light headedness, Nausea, Fever of 100.5 Fahrenheit, Redness/Pain at injection site, and Welts at injection site.
Age: 50.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: Light headedness, Nausea, Fever of 100.5 Fahrenheit, Redness/Pain at injection site, and Welts at injection site.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Asthenia, Confusional state, Headache, Hyperhidrosis, Hypoaesthesia oral
Clinical narrative: Patient called to discuss symptoms she experienced last night after having received both meningitis vaccines. She went to a concert the same evening after receiving both vaccines. Patient reported  experiencing nausea w/o vomiting, vertigo, sweats, HA and confusion while at the concert.  Patient's mother stated patient had sudden onset of headache, sweats, difficulty speaking, generalized weakness, vomiting, numbness around mouth, cramping in hands while at concert. Symptoms began resolving once patient was removed from the concert. Patient had not consumed any new medications to mother's knowledge. She had Menactra and Trumenba in the office earlier in the day.    Per mother, Patient has returned to normal at this time - Reported at 5:22 pm the day after receiving vaccines and going to concert.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Muscle spasms, Nausea, Speech disorder, Vertigo, Vomiting
Clinical narrative: Patient called to discuss symptoms she experienced last night after having received both meningitis vaccines. She went to a concert the same evening after receiving both vaccines. Patient reported  experiencing nausea w/o vomiting, vertigo, sweats, HA and confusion while at the concert.  Patient's mother stated patient had sudden onset of headache, sweats, difficulty speaking, generalized weakness, vomiting, numbness around mouth, cramping in hands while at concert. Symptoms began resolving once patient was removed from the concert. Patient had not consumed any new medications to mother's knowledge. She had Menactra and Trumenba in the office earlier in the day.    Per mother, Patient has returned to normal at this time - Reported at 5:22 pm the day after receiving vaccines and going to concert.
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Antibody test negative
Clinical narrative: Patient who was administered a 2-dose series of V ARIV AX "as a child" had titers drawn "recently" which were negative for immunity to varicella.; This spontaneous report was received from a healthcare professional (Medical assistant) via office manager refers to a female patient of around 20 years old. The patient's concurrent conditions, medical history and concomitant medications were not provided. The patient had allergy with many foods. On an unknown date, the patient was vaccinated with 2-dose series of varicella virus vaccine live (oka/merck)(VARIVAX) as child for immunity of varicella (prophylaxis) (strength, dose, lot number, expiry date unspecified). Other suspect therapies included sterile diluent (STERILE DILUENT)(strength, dose, lot number, expiry date unspecified). On an unknown date in 2019 (reported as recently), the patient had titers down recently which were negative for immunity to varicella (antibody test negative). As a result, patient was administered a third dose of varicella virus vaccine live (VARIVAX) on an unknown date in 2019 (reported as recently). No additional information provided. There was no treatment given for AE. There was no intervention to previous serious criteria. No cancer was diagnosed. No overdose. No PQC involved. The outcome of antibody test negative was unknown. Reporter's causality was not provided.