chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Herpes zoster, Pain, Pruritus, Scar
Clinical narrative: shingles across his head and face/diagnosed with herpes zoster; Information has been received from a lawyer referring to a patient of unknown age and gender. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 02-FEB-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the patient suffered severe, painful and debilitating shingles across his head and face. The patient was diagnosed with herpes zoster and underwent extensive medical treatment. The patient has permanent scarring on his head and occasional itching above his eyes to this day. These injuries and medical treatment were caused by zoster vaccine live (ZOSTAVAX). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event herpes zoster was not recovered and causal relationship was assessed as related.   The lawyer considered the event herpes zoster to be disability.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; product storage error; This spontaneous report as received from a other health professional refers to a patient of unknown age.    On 21-MAY-2020 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S031702 for prophylaxis.    Concomitant therapies included sterile diluent(STERILE DILUENT).   On 21-MAY-2020, 1 day after onset of therapy the patient experienced product storage error.  On an unknown date the patient experienced no adverse event.    The outcome of product storage error and no adverse event is unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Dose of Shingrix more than a year ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received more than a years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, the patient received 1st dose more than a years ago, and now wanted to receiv 2nd dose. Till the time of reporting, the patient did not receive 2nd dose, which led to  incomplete course of vaccination. No further information provided. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: nausea; fever; This case was reported by a consumer via call center representative and described the occurrence of nausea in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea and fever. On an unknown date, the outcome of the nausea and fever were unknown.   It was unknown if the reporter considered the nausea and fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient no side effects with 1st dose of Shingrix After receiving the 2nd dose of Shingrix the patient experiecced fever over 100 degrees F and nausea.  The call was hung up, could not get all details such as dates. The reporter consented to follow up.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Cyst
Clinical narrative: swelling of cyst behind right ear; swelling of cyst; This case was reported by a consumer via call center representative and described the occurrence of cyst in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cyst (cyst behind right ear).   On 18th May 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 28th May 2020, 10 days after receiving Shingrix, the patient experienced cyst and condition aggravated. On an unknown date, the outcome of the cyst was not recovered/not resolved and the outcome of the condition aggravated was unknown.   It was unknown if the reporter considered the cyst and condition aggravated to be related to Shingrix.  Additional case details were reported as follows: The patient reported had a longtime cyst behind her right ear and after the 2nd dose of Shingrix the patient had experienced swelling of cyst behind right ear. The patient planned to follow-up with her physician on an unknown date.  The reporter consented to follow up.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: tiredness; body aches; chills; fever; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th May 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 19th May 2020, 1 days after receiving Shingrix, the patient experienced tiredness, general body pain, chills and fever. On 20th May 2020, the outcome of the tiredness, general body pain, chills and fever were recovered/resolved.   It was unknown if the reporter considered the tiredness, general body pain, chills and fever to be related to Shingrix.  Additional case details were reported as follows: The patient reported that he experienced fever, chills, body aches, and tiredness after the 2nd dose of  Shingrix. The reporter follow up was consented by the wife of the patient. This case was linked with case US2020091005 reported by the same reporter
Age: 19.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood glucose normal, Limb discomfort, Nausea, Paraesthesia oral
Clinical narrative: 19 y/o patient, first time receiving flu vaccine. Right after shot was administered (3 minutes), patient experienced heavy tongue, forcibly closed eye and heavy arm. Then, 5 minutes after the patient experienced nausea.  Benadryl 25mg tablet was given to the patient. Patient was relatively stable while waiting for medical assistance.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: sharp mid-back pain from neck to mid-thoracic back, aching, stiffness
Age: 57.0
Sex: M
Vaccine: UNK
Symptoms: Magnetic resonance imaging abnormal, Mobility decreased, Musculoskeletal pain, Osteoarthritis, Pain in extremity
Clinical narrative: Shoulder pain post AVA notes that this started at same time had anthrax shot, notes they injected him rather high and feels that triggered it. Difficulty with putting on jacket and other motions involving overhead movements   Symptoms: PAIN IN LEFT ARM(M79602).
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Wrong product administered
Clinical narrative: patient was given the wrong vaccine, it was checked by one nurse, and didn't catch that it was the Proquad just saw the MMR , vaccines were switched around in the freezer and there fore was given the wrong one
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse effects reported; a patient was administred an improperly stored dose of VARIVAX; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On 11-MAY-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S010297, expiration date: 03-APR-2020 (strength, dosing schedule and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature: 7 Fahrenheit degrees for 5 hours and 4 minutes. Previous temperature excursion was: 11 Fahrenheit degrees for 3 hours and 31 minutes, as recorded by digital data logger. No additional adverse event reported.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Influenza like illness, Paraesthesia, Vomiting
Clinical narrative: she broke out with the blisters on her left side of face by eye, goes up to her crown of her head on the left side.; area turned red; tingle on the left side of her face, forehead and scalp; flu like symptoms; vomiting; This case was reported by a nurse via sales rep and described the occurrence of tingling in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number EG3A3, expiry date 12th October 2021) for prophylaxis.   On 20th May 2020, the patient received Shingrix. In May 2020, less than a week after receiving Shingrix, the patient experienced vomiting and influenza-like symptoms. On 21st May 2020, the patient experienced tingling. On 22nd May 2020, the patient experienced erythema. On 23rd May 2020, the patient experienced blister. On an unknown date, the outcome of the tingling, erythema, blister and influenza-like symptoms were unknown and the outcome of the vomiting was recovered/resolved.   It was unknown if the reporter considered the tingling, erythema, blister, vomiting and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm and started to had a tingle on the left side of her face, forehead and scalp and the area turned red.  The patient broke out with the blisters on her left side of face by eye, goes up to her crown of her head on the left side and had been vomiting a for two days and has flu like symptoms after the injection.
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: pain in the injected arm that radiated all the way down to the fingers; Numbness/that radiated all the way down to the fingers/and got progressively worse with numbness; tingling/and got progressively worse with numbness and tingling.; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2020, the patient received the 1st dose of Shingrix. In May 2020, 3 days after receiving Shingrix, the patient experienced pain in arm, numbness and tingling. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the numbness and tingling were unknown.   It was unknown if the reporter considered the pain in arm, numbness and tingling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and on approximately day 3 after Vaccine was given the patient called and reported pain in the injected arm that radiated all the way down to the fingers and got progressively worse with numbness and tingling.  The pain in arm was so bad he made an emergency room visit.  The reporter spoke with patient at the time of reporting and arm was much better.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Left arm soreness; Uncomfortable; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd March 2020, the patient received the 1st dose of Shingrix. On 3rd March 2020, couple of hours after receiving Shingrix, the patient experienced pain in arm and arm discomfort. On an unknown date, the outcome of the pain in arm and arm discomfort were recovered/resolved.   It was unknown if the reporter considered the pain in arm and arm discomfort to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and experienced left arm soreness within a couple of hours after receiving the injection. It was uncomfortable more than an average vaccination and it took about 4-5 days to resolve.   The reporter consented to follow up. For tolerances of 2nd dose, refer case US2020090247, reported by same reporter for the same patient.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever; Chills; Headaches; This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th May 2020, the patient received the 2nd dose of Shingrix. In May 2020, less than 2 weeks after receiving Shingrix, the patient experienced fever, chills and headache. On an unknown date, the outcome of the fever, chills and headache were unknown.   It was unknown if the reporter considered the fever, chills and headache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had a fever, chills and headaches.  The reporter did not wish to provide HCP or full mailing address and did not have lot number. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a nurse via call center representative and described the occurrence of suspected vaccination failure in a adult 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. The reporter asked if after the Shingrix shot within days, someone was having a shingles outbreak, were they able to start on Valtrex or would this effect replication of the vaccine. Specialist attempted to clarify, but the reporter ended the chat without confirming whether this was a hypothetical inquiry, or if there was a patient involved. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided.
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration, Injection site erythema
Clinical narrative: administered Boostrix subcutaneously; redness around the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number XF3RY, expiry date 4th February 2022) for prophylaxis.   On 22nd May 2020, the patient received Boostrix (subcutaneous). In May 2020, less than a week after receiving Boostrix, the patient experienced injection site erythema. On 22nd May 2020, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site erythema to be related to Boostrix.  Additional case details were reported as follows: The age at vaccination was not reported. The nurse administered Boostrix in right arm by subcutaneous route to the patient, which led to intramuscular formulation administered by other route.  The patient was experiencing redness around the injection site and it was being monitored by a physician. No other details were provided.
Age: 21.0
Sex: M
Vaccine: RAB
Symptoms: Anxiety, Auditory disorder, Dizziness, Fatigue, Feeling hot
Clinical narrative: Signs/Symptoms: anxiety; auditory disturbance; cold extremities; dizziness; facial pallor; fatigue; feeling of warmth; lightheadedness; hypotensive LOC; restlessness. Description:  After receiving the Rabies vaccine, donor stated he felt dizzy and lost consciousness for more than 60 seconds.  Donor's legs were elevated and he was fanned.  Vitals were taken every 5-15 minutes and were in normal range.  Donor was given water, a protein bar, and PowerAde.  Donor stated he had been nervous about receiving the shot.  Donor left the center in good condition.
Age: 21.0
Sex: M
Vaccine: RAB
Symptoms: Hypotension, Loss of consciousness, Pallor, Peripheral coldness, Restlessness
Clinical narrative: Signs/Symptoms: anxiety; auditory disturbance; cold extremities; dizziness; facial pallor; fatigue; feeling of warmth; lightheadedness; hypotensive LOC; restlessness. Description:  After receiving the Rabies vaccine, donor stated he felt dizzy and lost consciousness for more than 60 seconds.  Donor's legs were elevated and he was fanned.  Vitals were taken every 5-15 minutes and were in normal range.  Donor was given water, a protein bar, and PowerAde.  Donor stated he had been nervous about receiving the shot.  Donor left the center in good condition.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PT CALLED AND COMPLAINED OF REDNESS AND SWELLING AT INJECTION SITE
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Ageusia
Clinical narrative: Patient says she lost her sense of taste.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Gait disturbance, Injection site erythema, Injection site swelling, Lethargy, Swelling face
Clinical narrative: redness and swelling at both injection sites. later patient went to ED for evaluation and at that point patient was lethargic, dragging left leg, hives, and facial swelling
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: redness and swelling at both injection sites. later patient went to ED for evaluation and at that point patient was lethargic, dragging left leg, hives, and facial swelling
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; patient was inadvertently administered an expired dose of VARIVAX; This spontaneous report was received from a registered nurse referring to a 15-month-old patient of unknown gender. The patient's pertinent medical history, historical drug, current conditions, concomitant medication and drug reactions or allergies were not reported.     On 20-MAY-2020, the patient was inadvertently vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot number R011807, which was verified to be a valid one, and expiration date on 23-APR-2020 (strength, dose, vaccination scheme, anatomical location and route of administration were not provided), as prophylaxis (expired product administered); which was reconstituted with a sterile diluent (MERCK STERILE DILUENT). No adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blister, Eye pain, Glaucoma, Herpes zoster
Clinical narrative: Herpes zoster with ophthalmic complications; Uncontrolled glaucoma in both eyes; Optic nerve damage; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 20-SEP-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dosage and route of administration were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX) the patient suffered severe, painful and debilitating shingles across her forehead and eye area. These blisters and rashes caused permanent scarring above the patient's eyebrows. The patient developed increased preassure resulting in extrema pain, water and redness in both eyeballs. The patient suffered decreased vision. She was formally diagnosed with herpes zoster with ophthalmic complications, uncontrolled glaucoma in both eyes and optic nerve damage. The patient underwent extensive treatment as a result of her singles diagnosis and eye complications, including surgical trabeculotomies on both eyes in order to lower the intraocular pressure associated with glaucoma. All of these injuries were caused by zoster vaccine live (ZOSTAVAX). It was also specified that the patient suffered serious, progressive, permanent, and incurable disfiguring injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life and physical impairment.  Upon internal Review, ophthalmic herpes zoster, optic nerve injury and glaucoma were considered medically significant. The events were considered to be disabling due to the severe, permanent and incurable injuries.
Sex: F
Vaccine: VARZOS
Symptoms: Lacrimation increased, Ocular discomfort, Ocular hyperaemia, Ophthalmic herpes zoster, Optic nerve injury
Clinical narrative: Herpes zoster with ophthalmic complications; Uncontrolled glaucoma in both eyes; Optic nerve damage; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 20-SEP-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dosage and route of administration were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX) the patient suffered severe, painful and debilitating shingles across her forehead and eye area. These blisters and rashes caused permanent scarring above the patient's eyebrows. The patient developed increased preassure resulting in extrema pain, water and redness in both eyeballs. The patient suffered decreased vision. She was formally diagnosed with herpes zoster with ophthalmic complications, uncontrolled glaucoma in both eyes and optic nerve damage. The patient underwent extensive treatment as a result of her singles diagnosis and eye complications, including surgical trabeculotomies on both eyes in order to lower the intraocular pressure associated with glaucoma. All of these injuries were caused by zoster vaccine live (ZOSTAVAX). It was also specified that the patient suffered serious, progressive, permanent, and incurable disfiguring injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life and physical impairment.  Upon internal Review, ophthalmic herpes zoster, optic nerve injury and glaucoma were considered medically significant. The events were considered to be disabling due to the severe, permanent and incurable injuries.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Scar, Trabeculectomy, Visual impairment
Clinical narrative: Herpes zoster with ophthalmic complications; Uncontrolled glaucoma in both eyes; Optic nerve damage; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 20-SEP-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dosage and route of administration were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX) the patient suffered severe, painful and debilitating shingles across her forehead and eye area. These blisters and rashes caused permanent scarring above the patient's eyebrows. The patient developed increased preassure resulting in extrema pain, water and redness in both eyeballs. The patient suffered decreased vision. She was formally diagnosed with herpes zoster with ophthalmic complications, uncontrolled glaucoma in both eyes and optic nerve damage. The patient underwent extensive treatment as a result of her singles diagnosis and eye complications, including surgical trabeculotomies on both eyes in order to lower the intraocular pressure associated with glaucoma. All of these injuries were caused by zoster vaccine live (ZOSTAVAX). It was also specified that the patient suffered serious, progressive, permanent, and incurable disfiguring injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life and physical impairment.  Upon internal Review, ophthalmic herpes zoster, optic nerve injury and glaucoma were considered medically significant. The events were considered to be disabling due to the severe, permanent and incurable injuries.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was inadvertently administered an expired dose of Vaqta; This spontaneous report was received from a nurse concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 02-JUN-2020, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, inactivated (VAQTA), (dose, route and frequency not reported. Lot No. S021094 was reported and has been verified to be a valid lot number for Hepatitis A Vaccine, inactivated (VAQTA), expiration date reported and validated as 18-MAY-2020) for prophylaxis. No temperature excursion was reported. No additional adverse event information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Infection, Ulcer
Clinical narrative: seemed infected; gave a red sore; gave a red sore; This case was reported by a consumer via interactive digital media and described the occurrence of infection in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   In February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced infection, localized erythema and ulcer. On an unknown date, the outcome of the infection, localized erythema and ulcer were not recovered/not resolved.   It was unknown if the reporter considered the infection, localized erythema and ulcer to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient had red sore that had not gone away and seemed infected.
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis
Clinical narrative: woke up with my gown totally soaking wet; This case was reported by a consumer and described the occurrence of sweating in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th May 2020, the patient received the 2nd dose of Shingrix. On 31st May 2020, 1 days after receiving Shingrix, the patient experienced sweating. On an unknown date, the outcome of the sweating was unknown.   It was unknown if the reporter considered the sweating to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and her gown totally soaking wet. Never happened to patient before. The reporter asked could this be a side effect if receive second shot.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: diluent that was used for the dose had expired, no AE; Initial information received on 27-May-2020 regarding an unsolicited valid non-serious case from the nurse.  This case involves an 6 months old male patient, who received 0.5 ml second dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ033AA, expiry date: 07-Oct-2020) via unknown route in the right thigh for prophylactic vaccination on 21-May-2020. It was reported that the diluent that was used for the dose was expired (lot: U6205AA and expiry 22-Apr-2020).  Medical history, medical treatment, vaccination, family history were not provided.   Concomitant medication included IPOL, Rotavirus vaccine and Prevenar 13 vaccine.  It was a case of an actual medication error due to expired product administered.  At the time of report 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 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.
Age: 65.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was inadvertently administered an expired dose of the Tenivac, no adverse event; Initial information was received on 27-May-2020 regarding an unsolicited valid non-serious case from a nurse  This case involves a 65 year old female patient who was inadvertently administered an expired dose of the DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (Expired product administered)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 27-May-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U5854AB, expiry date 25-Jan-2020, single dose vial) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  At the time of report, 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.
Sex: U
Vaccine: MNQ
Symptoms: Adverse event
Clinical narrative: adverse event; Initial information received on 28-May-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a patient with unknown demographics who experienced adverse event (adverse event), while patient received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment, vaccination and family history were not provided. List of concomitant medication not reported.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious adverse event (adverse event) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Details of laboratory data not reported.  Final diagnosis was adverse event.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown for adverse event.  There will be no information available on the batch number for this case.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Decreased appetite, Diarrhoea, Pruritus, Pyrexia, Rash
Clinical narrative: 2 days fever, resolved  4 days rash, persists and increasing Also low appetite, mild pruritus, mild diarrhea days 1 2 3 4 5  1-4 BM/day mushy scratching -50% intake Rash is not morbilliform, but is very pink and clustered on trunk and body creased (neck, behind ears, axilla and inguinal) > limbs. Rapid strep test (nucleic acid) negative for G.A.S. Rash appearance scarletinkform or atopic dermalike, but more intense. No limb/digit desquamation, no oral/peri-oral lesions, no conjunctival injections, no peripheral edema or pain.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Rash erythematous, Streptococcus test negative
Clinical narrative: 2 days fever, resolved  4 days rash, persists and increasing Also low appetite, mild pruritus, mild diarrhea days 1 2 3 4 5  1-4 BM/day mushy scratching -50% intake Rash is not morbilliform, but is very pink and clustered on trunk and body creased (neck, behind ears, axilla and inguinal) > limbs. Rapid strep test (nucleic acid) negative for G.A.S. Rash appearance scarletinkform or atopic dermalike, but more intense. No limb/digit desquamation, no oral/peri-oral lesions, no conjunctival injections, no peripheral edema or pain.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms
Clinical narrative: EXTREME MUSCLE CRAMPS
Age: 4.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Erythema, Feeling cold, Hypotonia, Lethargy, Nausea
Clinical narrative: Grandma came back to peds floor with patient stating that he went limp, vomiting, and was lethargic in the elevator after his WCC. He did receive vaccines and has a history of allergic reaction to vaccines but per grandma it was not to the ones that he received today.  Upon entering the room the writer noted that the patient was lethargic but would follow commands. His skin was cool and he was pale. RN stayed with patient in the room.  Dr. was pulled from a room to assess patient. At that time it was noted that his skin was bright red and he was starting to itch. He was gagging as if he was nauseated. No breathing difficulty noted.  22mg benadryl given per providers request at 1415.   Epi pen junior administered per providers request at 1420. Patient tolerated well.  Mom and Patient placed in wheelchair and patient was brought down to ED where father was waiting for him.  On the wheelchair ride down patient was talkative and skin was less red. He was no longer itching.  Transferred care to ED staff.    Was also given Decadron 10 milligrams orally and Zyrtec 2.5 milligrams in the ER according to documentation
Age: 4.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Pallor, Pruritus, Retching, Vomiting
Clinical narrative: Grandma came back to peds floor with patient stating that he went limp, vomiting, and was lethargic in the elevator after his WCC. He did receive vaccines and has a history of allergic reaction to vaccines but per grandma it was not to the ones that he received today.  Upon entering the room the writer noted that the patient was lethargic but would follow commands. His skin was cool and he was pale. RN stayed with patient in the room.  Dr. was pulled from a room to assess patient. At that time it was noted that his skin was bright red and he was starting to itch. He was gagging as if he was nauseated. No breathing difficulty noted.  22mg benadryl given per providers request at 1415.   Epi pen junior administered per providers request at 1420. Patient tolerated well.  Mom and Patient placed in wheelchair and patient was brought down to ED where father was waiting for him.  On the wheelchair ride down patient was talkative and skin was less red. He was no longer itching.  Transferred care to ED staff.    Was also given Decadron 10 milligrams orally and Zyrtec 2.5 milligrams in the ER according to documentation
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Blood creatine phosphokinase, Full blood count, Metabolic function test, Radiculitis brachial
Clinical narrative: brachial neiritis
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: injection given on 5/27/2020. Pt developed erythema and swelling the following day at the injection site. The swelling & erythema have spread down the posterior aspect of the left arm by the time she was the office again on 5/29/2020. Pt given doxycycline for cellulitis. Instructed to elevate arm for swelling & wrap w/ace bandage.
Age: 15.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse effects reported; Received 4 doses of GARDASIL9.; fisrt dose on 04-MAY-2018, the second dose on 09-NOV-2018, the third dose on 07-AUG-2019 and the fourth dose on 05-MAY-2020; This spontaneous report was received from a registered nurse (also reported as a nurse) referring to an approximately 16 years old male patient. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On 04-MAY-2018, the patient received his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# N026812 with expiration date 22-JUN-2020, dose detail and route were not reported) for prophylaxis.  On 09-NOV-2018 the patient received his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # N035955 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 09-OCT-2020, dose detail and route were not reported) for prophylaxis.  On 07-AUG-2019, the patient received his third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1602284 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 26-SEP-2021, dose detail and route were not reported) for prophylaxis (inappropriate schedule of product administration, onset date was on 04-MAY-2019).   On 05-MAY-2020, the patient received his fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # S004578 with expiration date 29-SEP-2021, dose detail and route were not reported) for prophylaxis (extra dose administered). No additional adverse effects were reported.   combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Feeling abnormal
Clinical narrative: feeling lousy; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Hepatitis A vaccine for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on unknown date).   On 26th May 2020, the patient received the 2nd dose of Shingles vaccine and Hepatitis A vaccine. On 27th May 2020, 1 days after receiving Shingles vaccine and Hepatitis A vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine and Hepatitis A vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received shingles shot and hepatitis A vacine on same day anf felt lousy. No other information was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Malaise
Clinical narrative: Flu-like symptoms; Sick; Felt like he was going to die; Not been able to take the second dose; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms, sickness and feeling lifeless. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the sickness and feeling lifeless were unknown.   It was unknown if the reporter considered the influenza-like symptoms, sickness and feeling lifeless to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received his 1st Shingrix shot and he became sick with flu- ike symptoms and  felt like he was going to die. The reporter did not consent to follow up. This case has been linked with US2020089530, reported by same reporter.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Per the patient's father, on 6/2/20 she woke up with swelling and redness at the site on her right upper arm. He has been treating it with ice packs and Tylenol. He states her arm is much better today. She presents with some mild redness and mild swelling at the injection site that is slightly warm to the touch. Temp: 97.5. She does not complain of pain.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Irritability, Pyrexia
Clinical narrative: Pt received DTaP-Hib-IPV, PCV13 yesterday.  She developed a fever yesterday evening.  She woke up in the night with a temp of 102-103 with temporal thermometer After giving tylenol, temp is consistently around 101F.  Mom just gave tylenol and will recheck temp in an hour.  Eating and drinking fine.  She is a bit fussy.  No vomiting or diarrhea. Mom says the injection site looks fine, no redness or swelling.
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody negative, Arthralgia, C-reactive protein normal, Chills
Clinical narrative: In PM of day of vaccination (Wed) dev hives, flushing and warmth on face, neck and chest. Confluent on face, blotchy on chest. The following day flu like sx, chills, some swelling of arm, that pm dev fever 103 and arthralgia SI joints, hands, feet and ankles. Fri seen tx with Hydroxyzine, Tylenol, ranitidine, and Allegra. 18 may pain persisted given prednisone. Slight relief. Pain persists and currently(Aug 20) given another course of Steroids and undergoing Rheum eval. Diagnosed with seroneg RA.  2 yrs later, joint pain remains, controlled with Humara, and steroids for flares.   Symptoms: FEVER, UNSPECIFIED(R509), PAIN IN UNSPECIFIED JOINT(M2550), URTICARIA, UNSPECIFIED(L509).
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Clostridium test positive, Feeling hot, Flushing, HLA-B*27 assay, Influenza like illness
Clinical narrative: In PM of day of vaccination (Wed) dev hives, flushing and warmth on face, neck and chest. Confluent on face, blotchy on chest. The following day flu like sx, chills, some swelling of arm, that pm dev fever 103 and arthralgia SI joints, hands, feet and ankles. Fri seen tx with Hydroxyzine, Tylenol, ranitidine, and Allegra. 18 may pain persisted given prednisone. Slight relief. Pain persists and currently(Aug 20) given another course of Steroids and undergoing Rheum eval. Diagnosed with seroneg RA.  2 yrs later, joint pain remains, controlled with Humara, and steroids for flares.   Symptoms: FEVER, UNSPECIFIED(R509), PAIN IN UNSPECIFIED JOINT(M2550), URTICARIA, UNSPECIFIED(L509).
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Parvovirus B19 test negative, Peripheral swelling, Pyrexia, Rash macular, Red blood cell sedimentation rate increased
Clinical narrative: In PM of day of vaccination (Wed) dev hives, flushing and warmth on face, neck and chest. Confluent on face, blotchy on chest. The following day flu like sx, chills, some swelling of arm, that pm dev fever 103 and arthralgia SI joints, hands, feet and ankles. Fri seen tx with Hydroxyzine, Tylenol, ranitidine, and Allegra. 18 may pain persisted given prednisone. Slight relief. Pain persists and currently(Aug 20) given another course of Steroids and undergoing Rheum eval. Diagnosed with seroneg RA.  2 yrs later, joint pain remains, controlled with Humara, and steroids for flares.   Symptoms: FEVER, UNSPECIFIED(R509), PAIN IN UNSPECIFIED JOINT(M2550), URTICARIA, UNSPECIFIED(L509).
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Rheumatoid arthritis, Rheumatoid factor negative, Urticaria
Clinical narrative: In PM of day of vaccination (Wed) dev hives, flushing and warmth on face, neck and chest. Confluent on face, blotchy on chest. The following day flu like sx, chills, some swelling of arm, that pm dev fever 103 and arthralgia SI joints, hands, feet and ankles. Fri seen tx with Hydroxyzine, Tylenol, ranitidine, and Allegra. 18 may pain persisted given prednisone. Slight relief. Pain persists and currently(Aug 20) given another course of Steroids and undergoing Rheum eval. Diagnosed with seroneg RA.  2 yrs later, joint pain remains, controlled with Humara, and steroids for flares.   Symptoms: FEVER, UNSPECIFIED(R509), PAIN IN UNSPECIFIED JOINT(M2550), URTICARIA, UNSPECIFIED(L509).
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Pain, Pyrexia
Clinical narrative: fever of 101.2, which started approximately 24 hours after vaccine associated with pain and redness to injection site. He also reported body aches.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Borrelia test negative, Facial paralysis, Polymerase chain reaction
Clinical narrative: Right sided facial nerve palsy that presented 13 days after vaccine (first signs on 5/31/20; vaccine given on 5/18/20).
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Auditory disorder, Dizziness, Hyperhidrosis, Hypotension
Clinical narrative: Hypotension s/s post tetanus immunization. S/S included: auditory disturbance, lightheadedness, dizziness, pale skin, sweating, visual disturbance, and weakness. Donor received 500 ml procedural saline, oral fluids, and monitored vitals. After discussion, donor stated she hadn't ate enough prior to that day's donation and immunization.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Pallor, Visual impairment
Clinical narrative: Hypotension s/s post tetanus immunization. S/S included: auditory disturbance, lightheadedness, dizziness, pale skin, sweating, visual disturbance, and weakness. Donor received 500 ml procedural saline, oral fluids, and monitored vitals. After discussion, donor stated she hadn't ate enough prior to that day's donation and immunization.