chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Skin discolouration
Clinical narrative: rash on her arms and legs; Itchy rash; redness; Skin discoloration; This case was reported by a consumer via call center representative and described the occurrence of rash in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number X5XY4, expiry date 31st July 2019) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th October 2018). Concurrent medical conditions included systemic lupus erythematosus.   On 8th March 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced rash, itchy rash, red rash and skin discoloration. The patient was treated with methylprednisolone and topical steroid nos (Steroid Cream). On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the itchy rash, red rash and skin discoloration were unknown.   It was unknown if the reporter considered the rash, itchy rash, red rash and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The caller was a patient who received Shingrix and sometime after she experienced rash on her arms between elbow and wrists and legs around kneecap area up to middle thigh.   The caller reported that the rash was itchy and was red in color on her arms and more purple in color on her legs.   The caller notes that itchiness flares up when her skin gets overheated. The caller reports that she has used topical over the counter steroid cream that did not help and her doctor prescribed methylprednisolone oral tablet taper that did help with the itching but rash has not resolved. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: rash along her chest; burning sensation; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number F3D7H, expiry date 5th July 2021) for prophylaxis.   The patient's past medical history included shingles.   On 23rd May 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 8 days after receiving Shingrix, the patient experienced rash and burning sensation skin. On an unknown date, the outcome of the rash and burning sensation skin were not recovered/not resolved.   It was unknown if the reporter considered the rash and burning sensation skin to be related to Shingrix.  Additional case details were provided as follows: The patient received Shingrix in the left arm. Eight days after vaccination, she developed a rash along her chest. The patient stated that the rash was worsening and it burn but it did not burn as much as the last time she had shingles. The reporter consented to follow up and provided details.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Skin burning sensation
Clinical narrative: rash along her chest; burning sensation; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number F3D7H, expiry date 5th July 2021) for prophylaxis.   The patient's past medical history included shingles.   On 23rd May 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 8 days after receiving Shingrix, the patient experienced rash and burning sensation skin. On an unknown date, the outcome of the rash and burning sensation skin were not recovered/not resolved.   It was unknown if the reporter considered the rash and burning sensation skin to be related to Shingrix.  Additional case details were provided as follows: The patient received Shingrix in the left arm. Eight days after vaccination, she developed a rash along her chest. The patient stated that the rash was worsening and it burn but it did not burn as much as the last time she had shingles. The reporter consented to follow up and provided details.
Age: 47.0
Sex: M
Vaccine: TD, TD
Symptoms: Body temperature increased, Headache, Injection site pain, Injection site swelling, Nausea
Clinical narrative: PT received vaccine on 6/4/2019 at 1706 for wound to head.  He awake on 6/5/2019 not "feeling well".  He had low grade fever, swelling of his right arm into the chest, nausea, vomiting and dizziness.
Age: 47.0
Sex: M
Vaccine: TD, TD
Symptoms: Vomiting
Clinical narrative: PT received vaccine on 6/4/2019 at 1706 for wound to head.  He awake on 6/5/2019 not "feeling well".  He had low grade fever, swelling of his right arm into the chest, nausea, vomiting and dizziness.
Age: 47.0
Sex: M
Vaccine: TD, TD
Symptoms: Dizziness, Malaise, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: PT received vaccine on 6/4/2019 at 1706 for wound to head.  He awake on 6/5/2019 not "feeling well".  He had low grade fever, swelling of his right arm into the chest, nausea, vomiting and dizziness.
Age: 47.0
Sex: M
Vaccine: TD, TD
Symptoms: Swelling, Vomiting
Clinical narrative: PT received vaccine on 6/4/2019 at 1706 for wound to head.  He awake on 6/5/2019 not "feeling well".  He had low grade fever, swelling of his right arm into the chest, nausea, vomiting and dizziness.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: Vomiting once in afternoon. No treatment. First time the child has ever vomited.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Influenza like illness, Injection site pain, Pain
Clinical narrative: On the evening of the 12th around 5:30 or so i developed a really sever headache. After going to bed at 9:30 felt weak and achy still had the headache. Felt just like the flu. Got a night of restless sleep. Got up around 7:30 took 1 Aleve and very hot shower felt better 1 hour later. Shoulder still smarts at the injection site but that's to be expected. My wife had the same series of vaccinations with no side effects.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Poor quality sleep
Clinical narrative: On the evening of the 12th around 5:30 or so i developed a really sever headache. After going to bed at 9:30 felt weak and achy still had the headache. Felt just like the flu. Got a night of restless sleep. Got up around 7:30 took 1 Aleve and very hot shower felt better 1 hour later. Shoulder still smarts at the injection site but that's to be expected. My wife had the same series of vaccinations with no side effects.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: PT presented with severe bruising on left arm from the injection point to mid arm, wrapping partially around front of arm. Nurse evaluated arm.  No swelling, no harness.  Equal in size compared to right arm.  Bruising was yellowed, with some mild purple (more fresh) bruising on inner portion of arm.  Nurse asked patient if he was currently taking any "blood thinners" patient stated, "no", but on lated evaluation remembered he takes ASA 81mg. Patient c/o pain in left arm, but now only related to bruising.  Patient stated no other injury had occurred to arm. Nurse informed patient to return on Friday (2 days later) to ensure bruising was not worsening, or to report to ED if pain/bruising worsens.   Patient evaluated arm as well and concurred with nurse.  Patient in no immediate harm.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Peripheral swelling, Rash, Rash pruritic, Rash pustular
Clinical narrative: Patient states that he was given the incorrect Shingles vaccine. Pt was given Zostavax instead of Shingrix. (At our facility we do not have Shingirx) Pt states a few days after receiving his Shingles vaccine a pustular itchy rash started to form on his chest and right side. Pt states his right arm started to swell as well. Pt went to the ER room a few days later and was told that he had Shingles,
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong product administered
Clinical narrative: Patient states that he was given the incorrect Shingles vaccine. Pt was given Zostavax instead of Shingrix. (At our facility we do not have Shingirx) Pt states a few days after receiving his Shingles vaccine a pustular itchy rash started to form on his chest and right side. Pt states his right arm started to swell as well. Pt went to the ER room a few days later and was told that he had Shingles,
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Blood test, Injection site pain, Injection site reaction, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: Continuous muscle pain and weakness  in my upper left arm in the area where the shot was injected . Muscle pain when holding my arm out or up.  The pain is still here after 8 months. I have trouble doing everyday things like holding a door open,  putting on a shirt, waving hello, etc.
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Continuous muscle pain and weakness  in my upper left arm in the area where the shot was injected . Muscle pain when holding my arm out or up.  The pain is still here after 8 months. I have trouble doing everyday things like holding a door open,  putting on a shirt, waving hello, etc.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product use issue
Clinical narrative: received three doses of GARDASIL 9 while she was HPV positive; No adverse effects; Information has been received from a physician via a field representative referring to a female adolescent of unknown age. Information about medical history and concomitant medication was unknown.       On unknown dates the patient was vaccinated with three doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (intramuscular; strength, dose, frequency, lot# and expiration date were unspecified) for prophylaxis, while she was human papillomavirus(HPV) positive(product use issue). No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: low mumps titer; This spontaneous report has been received from a physician referring to an approximately 57 years old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live manufacturer unknown (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis.            The patient was serologically tested in recent past (week of 13-MAY-2019) based on recent measles outbreak circumstances. Titer results revealed low mumps titer and didn't show low measles titer. No treatment was given for the event. On an unspecified date in May 2019, the patient recovered from the event.  The causality between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live manufacturer unknown was not provided.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA008993: US-009507513-1906USA004734:
Sex: M
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: lowrubella titer; This spontaneous report has been received from a physician referring to an approximately 63 years old male patient. The patient's concurrent condition, medical history and concomitant therapy information was not provided.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live manufacturer unknown (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis.            The patient was serologically tested in recent past (week of 13-MAY-2019) based on recent measles outbreak circumstances. The titer results revealed low rubella titers and didn't show low measles titer. No treatment was given for the event. On an unspecified date in May 2019, the patient recovered from the event.  The causality between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live manufacturer unknown was not provided.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1905USA008985: US-009507513-1906USA004734:
Sex: U
Vaccine: HEP, HIBV, HPV9, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines were administered to an unspecified number of unspecified patients after being out of proper temperature range on unspecified dates; No adverse effects; This spontaneous report has been received from a nurse referring to an unspecified number of patients of unknown age and gender.      On unknown dates, these patients were vaccinated with an unspecified number of doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis after being out of proper temperature range (product storage error). The stored highest temperature reached 52.7 Fahrenheit (F) for 1 hour and 50 minutes and the data logger was involved. Vaccines had previously been exposed to out of range temperatures however this information was not available at the time of the report. No adverse effects reported.  This is a non-valid case due to no patient identifier.
Age: 1.0
Sex: F
Vaccine: FLUX, MMR
Symptoms: Mumps, Rubulavirus test positive, Swelling face
Clinical narrative: the patient broke out into mumps with swelling on the face; This spontaneous report concerns a 4 year old female patient, was received via medical records. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.      On 23-FEB-2016, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (rHA) (lot # L026551), subcutaneously on the left side, for prophylaxis (strength, dose and frequency were not provided). On the same date, the patient was vaccinated with the second dose of influenza virus vaccine (unspecified)(manufacturer unknown) intramuscular route of administration in the left thigh, for prophylaxis (Lot # 45387db with an expiration date in 30-SEP-2019) (strength, dose and frequency were not provided).      On 30-APR-2019, the patient broke out into mumps with swelling on the face (mumps). As a result, the patient was advised to go to the emergency room if the swelling progressed, and on 01-MAY-2019, the patient was taken to the hospital to the physician's office, where a blood test confirmed the development of mumps disease and subsequently on the same date, some additional laboratories were also performed as follows: Mumps abs, IgG-LC 244.0 (range and units not provided) and Mumps Antibodies, IgM-LC 1.37 (H) (range and units not provided). However, it was unknown if any treatment was given to the patient for the experienced event.         At the time of reporting, the outcome of mumps was reported as resolving.   The causal relationship between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), influenza virus vaccine (unspecified)(manufacturer unknown) and the reported mumps was not provided.        All available medical records will be provided upon request
Sex: M
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administration of vaccines at younger age than indicated age; VARIVAX may have also been given at the same time; no adverse effect; This spontaneous report was received from a nurse refers to a male patient of unknown age. Pertinent medical history and drug allergies were not reported. It was reported that on an unknown date, when the patient was 5 days old, he might have vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route, frequency unknown) (lot # 1314U, expiration date not reported, but upon internal validation established as 17-AUG-2009) for prophylaxis. On an unknown date, the patient might have also given varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route, frequency unknown) (lot # 0853U, expiration date not reported, but upon internal validation established as 25-MAY-2009) at same time (product administered to patient of inappropriate  age group and inappropriate schedule of product administration). No adverse effects were reported (no adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: about a year ago a young female patient fainted after receiving a GARDASIL 9 shot; This spontaneous report was received from a pharmacist referring to a young female patient of unknown age. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was unknown.  In approximately 2018 (reported as about a year ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. In approximately 2018 (reported as about a year ago), the patient fainted after receiving a hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) shot. The patient was not hospitalized. It was unknown if the patient sought medical attention, performed any lab diagnostics/studies or given any treatment. The pharmacist reported that the patient was fine at time of the report. The dechallenge was reported as yes. 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, faint was determined to be medically significant.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect reported; received an expired dose of VAQTA; Information has been received from a nurse referring to a 17 year old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided.  On 07-JUN-2019 the patient received  expired hepatitis a vaccine, inactivated (VAQTA) (1 dosage form, lot # R007388, expiration date 27-MAY-2019; strength and route were unknown) for prophylaxis (expired product administered). No adverse effect was reported.
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Dizziness, Inappropriate schedule of product administration
Clinical narrative: the patient was dizzy and weak and spent 3 weeks in bed/ continued feeling dizzy and weak for 3 months; the patient was dizzy and weak and spent 3 weeks in bed/ continued feeling dizzy and weak for 3 months; the patient received 1 or 2 doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 3 years ago; This spontaneous report has been received from a nurse prescriber concerning a 15 years old female patient. Information about medical history and concomitant therapies was unknown by the reporter. The patient had no drug reaction/allergies.  On an unknown date in June 2016 (reported as 3 years ago), the patient was vaccinated with 1 or 2 doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, frequency, route, lot number and expiration date were not reported) as pediatric vaccines for prophylaxis (Inappropriate schedule of product administration).         On an unknown date, the patient was dizzy and weak and spent 3 weeks in bed. Then the patient "returned to school but continued feeling dizzy and weak for 3 months". The reporter did not know if the patient received any treatment. On 07-JUN-2019, the reporter saw the patient for the first time. The outcome of the events was reported as recovered (date unknown).  The causality between the events and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 31-MAR-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event herpes zoster to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Hetpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 76 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event herpes zoster to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; Information has been received from a lawyer regarding a case in litigation concerning a currently 64-year-old female patient (pt). No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. On or about 26-AUG-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) injection (lot number, dose, vaccination site and route of administration were not provided) by a pharmacist for long-term prevention of shingles and zoster-related conditions. On an unknown date, the pt was treated at a physician's office for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) use: herpes zoster. The outcome of the event was unknown.    Additional information has been requested
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of currently 86 years old. No information was provided regarding medical history, concurrent conditions, concomitant medications, drug reactions or allergies.   On or about 15-JUN-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided) for the prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by a physician for Herpes zoster. The outcome of herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Age: 63.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; The patient was inadvertently administered an expired dose of PNEUMOVAX 23; This spontaneous report was received from a pharmacist referring to a 63 year old patient of an unknown gender. No information was provided regarding the patient's medical history, current conditions, concomitant medication, drug reactions and allergies.  On 10-JUN-2019, the patient was inadvertently administered an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) intramuscular with lot number N027624  and expiration date on 11-MAY-2019, for prophylaxis (dose, dose number, frequency and anatomical injection site were not reported). No adverse event were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Herpes Zoster; Post-herpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of currently 73 years old. No information was provided regarding medical history, concurrent conditions, concomitant medications, drug reactions or allergies.   On or about 24-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided) for the prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by a healthcare provider for Herpes zoster and post-herpetic neuralgia. The outcome of herpes zoster and post-herpetic neuralgia was not reported. The reporter considered both events to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects; a 4 year old patient was administered an expired dose of PROQUAD; This spontaneous report was received from a Licensed Practical concerning a 4 years old child patient of unknown race and gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 11-JUN-2019, the patient was vaccinated with an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) recombinant human albumin (rHA) lot number N035173 with expiration date on 09-JUN-2019 (dose, frequency and route of administration were not reported) for prophylaxis. No adverse effects were reported.  The outcome of expired product administered was unknown.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: patient received second dose in gardasil 9 series after it was determined she was pregnant; This spontaneous prospective pregnancy report was received from a nurse practitioner refers to a 24-year-old female (currently 25-year-old) patient. The patient had no medical history and concurrent conditions.  On 30-JAN-2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R023607, expiry: 06-MAY-2021, 0.5 milliliter, intramuscular for HPV prevention.  The patient became pregnant with Last Menstrual Period (LMP) of 06-MAR-2019 and Estimated Date of Delivery (EDD) of 11-DEC-2019.  After the patient was determined pregnant, on 06-JUN-2019, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R027577, expiry: 23-JUN-2021, 0.5 milliliter, intramuscular for HPV prevention (maternal exposure during pregnancy).  Concomitant therapies included prenatal vitamins.  The pregnancy outcome was outcome pending. The outcome of maternal exposure during pregnancy is unknown.  Product quality complaints was not involved.
Sex: U
Vaccine: SMALL
Symptoms: Chest pain, Local reaction, Myocarditis, Vaccination complication, Vaccination site vesicles
Clinical narrative: Myocarditis; Chest Pain; a local reaction or blister on the vaccine site; This spontaneous report was received on 31MAY2019 from a physician via medical inquiry. A patient with unknown demographics experienced myocarditis, chest pain and blister on the vaccination site following the administration of ACAM2000 (Smallpox (Vaccinia) vaccine, Live).  Seven days ago (24MAY2019) the patient received smallpox vaccine (lot, dose and route unknown). Patient was hospitalized for myocarditis and presented with chest pain, local reaction or blister on the vaccine site but no fever. Outcome at the time of report was unknown.  The reporting physician was not involved in the care of the patient and was consulted by a provider from another healthcare facility to determine whether the patient needs any isolation precautions from infection control standpoint. The reporting physician did not have any other patient details.  Medical History/ Allergies: Not reported  Concomitant medication: Not reported.  Company Medical Assessment:  The Company considers that the diagnosis of myocarditis was possible related to ACAM2000. Despite the information is limited, it is assumed that the diagnosis made at the hospital is correct. In primary vaccinees, the onset of myocarditis associated with chest pain is within 4-15 days after vaccination, the patient was vaccinated seven days prior. The vaccination site reaction appears to be a satellite lesion, which is also a common complication of vaccination. More information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Headache, Pain in extremity, Tremor
Clinical narrative: redness; arm pain; headache; mild tremor in hand; This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On 2nd June 2019, 2 days after receiving Shingrix, the patient experienced tremor of hands. On an unknown date, the patient experienced erythema, pain in arm and headache. On an unknown date, the outcome of the erythema, pain in arm, headache and tremor of hands were unknown.   It was unknown if the reporter considered the erythema, pain in arm, headache and tremor of hands 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 vaccine indication. The patient experienced headache, sore arm and redness but in the evening of reporting day the patient developed tremor in right hands
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: injection site pain; redness at injection site; swelling; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included MENACTRA for prophylaxis.   On an unknown date, the patient received Bexsero and MENACTRA. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to Bexsero.  Additional case details were provided as follows: The age at vaccination was not reported. The patient was given Bexsero and Menactra in same arm and pain, redness and swelling was reported after injection.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Rash; Tenderness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a adult patient who received Herpes zoster (Shingrix) (batch number MP42R, expiry date 20th May 2020) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site rash and injection site tenderness. On an unknown date, the outcome of the injection site rash and injection site tenderness were unknown.   It was unknown if the reporter considered the injection site rash and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The reporter stated that, the patient experienced rash around injection site, down her arm, and tenderness. The reporter declined to give patient information. This case has been linked with cases US2019102480, reported by the same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Mass
Clinical narrative: swelling on back of hand/lumps on back; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th May 2019, 1 days after receiving Shingrix, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was recovering/resolving.   It was unknown if the reporter considered the injection site swelling to be related to Shingrix.  Additional case details were provided as follows: The patient received 1st dose of Shingrix in left arm.   The next day, she experienced a lump on the back of her left hand about half the size of a golf ball.  It was the same arm as she received the injection.   The swelling had improved somewhat but was not completely resolved yet. The patient consented to follow up and provided her physician's details.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Pain; Loss of function; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 4X733, expiry date 8th March 2021) for prophylaxis.   On 18th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month 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 injection of Shingrix in an unknown arm 5 weeks ago from the date of reporting.  At the time of reporting, the patient's arm was sore. The patient complained of pain in the arm injected with loss of function. The patient was using their unaffected arm to move the affected arm.  The pharmacist stated that, the patient received other injections but did not specify name or type. No additional details were provided.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: left upper arm swelling; blister at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number KC9C4, expiry date 30th March 2020) for prophylaxis.   On 25th May 2019, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced swelling arm and injection site blisters. On an unknown date, the outcome of the swelling arm and injection site blisters were unknown.   It was unknown if the reporter considered the swelling arm and injection site blisters to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and experienced left upper arm swelling and blister at injection site.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: soreness left arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's wife. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: injection site Redness; injection site Swelling; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th May 2019, the patient received the 1st dose of Shingrix (intramuscular). In May 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovering/resolving.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The caller was medical assistant stated that the patient received Shingrix vaccine presented to the doctor office with redness and swelling at injection site.  The patient had another visit and the patient was doing much better on the arm. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th May 2019, the patient received the 1st dose of Shingrix. On 30th May 2019, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovering/resolving.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter did not consent to follow up. Limited information was provided.
Age: 0.33
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 month old had been given .5ml of Fluzone Quad; Upon second medical examination of the case during internal review, a significant correction was performed on 12-Jun-2019 to remove the classification "non-case".   Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 04 months old male patient who was given single 0.5ml of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on 15-Oct-2018 (lot number: UT6301MA, expiry date: 30-Jun-2019) via intramuscular route in the left thigh.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) for Immunisation and Rhodo virus vaccinations.  It was of actual medication error case due to inappropriate age at vaccine administration..  It was not reported if patient experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.  Addendum on 15-Oct-2018: Upon second medical examination of the case during internal review, a significant correction was performed on 12-Jun-2019 to remove the classification "non-case".
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: shipment of Menactra was too long in transit which was given to a patient/No AE; Initial information received on 05-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a unknown demographics patient who was given MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] which was too long in transit during shipment (lot number and expiry date not reported via unknown route in unknown administration site on an unknown date).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  They did not have Adverse Event patient information at this time.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Menactra was believed to be in shipment to long and administered with Menactra shipment that was still cold when it arrived; Initial information received on 05-Jun-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 18 years old female patient who was vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6346AA, expiry date: 30-Aug-2020) via intramuscular route in the left arm on 04-Jun-2019.  The patient's past vaccination(s) included MENACTRA on 03-JUN-2013. The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage it was reported that Menactra was believed to be in shipment to long. Before being told about this, the Menactra was administerd. It (Menactra shipment) was still cold when it arrived.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: the DTAP/IPV portion of the Pentacel injection was already injected because it is missing and the ActHIB powder portion remains; Initial information received on 05-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown demographic patient who was vaccinated with a dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ073AAA and Exp. Date 13-Jun-2020) via unknown route in unknown administration site on an unknown date.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate reconstitution technique as it was reported that the DTAP/IPV portion of the Pentacel injection was already injected because it is missing and the ActHIB powder portion remains.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: administered Adacel that were exposed to temperature excursions and not acceptable for use/no AE; Initial information received on 06-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA157616.  This case involves a 12 years old male patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and reported that administered Adacel that were exposed to temperature excursions and not acceptable for use/no AE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HUMAN PAPILLOMA VACCINE (HUMAN PAPILLOMA VACCINE); and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA).  On 28-May-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C5585AA and expiry date: 06-Mar-2019 via intramuscular route in the right deltoid.  It was a case of actual medication error due to incorrect product storage.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: IPV
Symptoms: Product dose omission
Clinical narrative: a 12 years old male patient received Ipol at ages 2 months, 4 months, and 6 months, however missed his 4-6 year dose; Initial information received on 06-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a male patient of an unknown age (patient was currently 12 years old), who missed the fourth dose of vaccine IPV (VERO) [IPOL].  The patient's past vaccination(s) included three doses of IPOL at ages 2 months, 4 months and 6 months.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was an actual medication error due to missed dose.  It was not reported if the patient experienced any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.