chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus generalised
Clinical narrative: Day after injection started itching all over. Started BENADRYL. Itching persisted and sought medical attention on 10/24/17. Started MEDROL DOSEPAK. Itching continues but decreased at this time.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Paraesthesia, Peripheral coldness, Pruritus
Clinical narrative: Within 7 minutes of injection employee complained of itching of left forearm and hand, stated she had a fine red rash and numbness, coldness and tingling in forearm. Numbness had gone to upper arm, deltoid area and not in hand or forearm. Also complained of vision being blurred. Symptoms were subsiding before leaving employee health office.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Vision blurred
Clinical narrative: Within 7 minutes of injection employee complained of itching of left forearm and hand, stated she had a fine red rash and numbness, coldness and tingling in forearm. Numbness had gone to upper arm, deltoid area and not in hand or forearm. Also complained of vision being blurred. Symptoms were subsiding before leaving employee health office.
Age: 48.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: I do not know if there was any adverse event that occurred. Instead of giving the vaccination subcutaneously, it was administered through the intramuscular route instead.
Age: 48.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: I do not know if there was any adverse event that occurred. Instead of giving the vaccination subcutaneously, it was administered through the intramuscular route instead.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Left arm....Pain, Swelling, Redness, stiffness, not able to lift arm. Fever Highest temperature 103F. Rigor. Visited Urgent Care on 10/24.2017 and was prescribed  D0XYCYCLINE HYCLATE 100 MG CAPSULE 1 every 12 hours.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Left arm....Pain, Swelling, Redness, stiffness, not able to lift arm. Fever Highest temperature 103F. Rigor. Visited Urgent Care on 10/24.2017 and was prescribed  D0XYCYCLINE HYCLATE 100 MG CAPSULE 1 every 12 hours.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Arthritis, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Case received vaccine on 10/12/17 (5:15pm) and stated the administration was very uncomfortable.  Within 24 hours, she was unable to raise her right arm above shoulder level without experiencing  severe, shooting, intermittent pain. Takes Advil twice a day for arthritis in her hands. Encouraged to contact health care provider as symptoms are not decreasing.
Age: 33.0
Sex: F
Vaccine: FLU4, HEP
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Reports soreness in right arm, with pain extending into right side of neck and right shoulder blade.   Initial soreness began within 24 hours of injection, extending pain began approx. 3 days later.  Received hepb at same time in L arm, no problems reported.
Age: 20.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 20 year old patient of unknown gender. On 08-SEP-2017, the patient was vaccinated with pediatric dose of VAQTA lot # N012324, 0.5 ml, intramuscularly for prophylaxis. The patient experienced no adverse event. The outcome of incorrect dose administered and no adverse event is unknown. The reporter considered incorrect dose administered and no adverse event to be not related to VAQTA.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from registered nurse concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 29-OCT-2013, the patient was vaccinated with the first dose of GARDASIL lot # J006236, expiration date 25-FEB-2016, for prophylaxis (dose and route of administration were not reported) and on 19-DEC-2013, received a second dose of GARDASIL lot # J006850, expiration date 31-MAR-2016, for prophylaxis (dose and route of administration were not reported). Subsequently, on 10-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot #L038503 expiration date 18-DEC-2017, intramuscularly, for prophylaxis (dose was not reported) and on 22-SEP-2017 received a second dose of GARDASIL 9 lot # N004799 expiration date 15-OCT-2019, intramuscularly, for prophylaxis (dose was not reported). No adverse effects were reported.
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a male patient of unknown age. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 11-SEP-2017, the patient was vaccinated with the first dose of ROTATEQ lot # M043836, expiration date 17-JUN-2018, orally, for prophylaxis (dose was not reported). On 02-OCT-2017, three weeks after the first dose was administered, the patient received a second dose of ROTATEQ lot # N005618 with expiration date 04-OCT-2018, orally (dose was not reported), also for prophylaxis.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 4 month old patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 11-OCT-2017, the patient was administered an expired dose of ROTATEQ oral liquid (lot number L008057, expiration date 01-DEC-2016) for prophylaxis. No adverse effects were reported.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Expired product administered, Injection site induration, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 68-year-old female patient. The patient did not have any pertinent medical history and any known drug reactions or allergies. On 09-OCT-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # L021367 expiration date 05-NOV-2016) (dose and anatomical location were not reported) for prophylaxis. Concomitant therapies included influenza virus vaccine (unspecified). On the same day, the patient experienced soreness and induration at the injection site. The outcome of the events was reported as recovering (symptoms have improved, but are still present). Causality assessment was not reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 15-OCT-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection, one shot (lot number: M005286; expiration date: 08-OCT-2017) for prophylaxis. The primary reporter denied any adverse effect with the patient.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report has been received from a physician concerning a male patient of unknown age. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The reporter stated that in another unspecified country on an unknown date, when the patient was one year of age, he was vaccinated with an unspecified monovalent dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis. Other suspect therapies included measles, mumps, rubella and varicella (oka-merck) virus vaccine live (manufacturer unknown). Information regarding doses, dose numbers, routes of administration, anatomical locations, lot numbers and expiration dates of the vaccines was not provided. On an unknown date, the patient developed mumps. At the time of reporting, the patient's outcome for mumps and the causal relationship between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (manufacturer unknown) were unknown.
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 67 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was inadvertently vaccinated with a first dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). There were no adverse symptoms reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from an 83-year-old male patient. The patient's medical history included varicella. No information regarding the patient's concurrent conditions, concomitant medications, drug reactions or allergies was provided. On an unknown date in the past, the patient was vaccinated with ZOSTAVAX (dose, frequency, route of administration, lot# and expiration date were not reported). On an unknown date, the patient stated that he did remember having an unspecified shingles outbreak. The outcome of shingles was reported as recovered. The relatedness between the event and ZOSTAVAX was unknown.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 58 year old male patient. Patients' medical history was not reported. Patient's current condition includes cholesterol condition. Concomitant therapies included EXCEDRIN and one or two maintenance medications. On 20-OCT-2017, the patient was vaccinated with ZOSTAVAX (lot # M033910, expiry date: 17-OCT-2017), 0.65 ml, once, subcutaneously to prevent shingles. The patient was vaccinated with ZOSTAVAX which was 3 days past its expiration date. The patient's laboratory data was unknown. The pharmacy staff contacted the patient last night (i.e. on 20-OCT-2017). The patient reported that he was not having any adverse experiences. The pharmacist reported that the pharmacy's district manager was notified. It was unknown if the prescribing doctor was notified. The pharmacist reported that the vaccine was stored appropriately.
Sex: F
Vaccine: VARZOS
Symptoms: Corneal scar, Decreased immune responsiveness, Herpes zoster, Keratitis, Ophthalmic herpes zoster
Clinical narrative: This initial spontaneous report was received on 23-OCT-2017 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 30-DEC-2015, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-OCT-2016, she was treated by a physician/MD at a medical group facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster and keratis (as reported) with cornea scarring, a damaging eye condition of zoster infections of the eye. The female patient has been prescribed tramadol (manufacturer not specified) and valacyclovir (VALTREX) for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Upon internal review, Keratis with cornea scarring, a damaging eye condition of zoster infections of the eye was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 23-OCT-2017 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 30-DEC-2015, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-OCT-2016, she was treated by a physician/MD at a medical group facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster and keratis (as reported) with cornea scarring, a damaging eye condition of zoster infections of the eye. The female patient has been prescribed tramadol (manufacturer not specified) and valacyclovir (VALTREX) for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Upon internal review, Keratis with cornea scarring, a damaging eye condition of zoster infections of the eye was determined to be medically significant. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 21-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M042170, expiry date: 22-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 5-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 23-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M042170, expiry date: 22-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 4-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 15-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M042170, expiry date: 22-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 04-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 22-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M042170, expiry date: 22-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 04-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 27-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M042170, expiry date: 22-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 04-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 28-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M042170, expiry date: 22-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 08-week-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 21-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M042170, expiry date: 22-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Age: 0.58
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 7-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 28-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ, orally, lot # M042170, expiry date: 22-JUN-2018, and RECOMBIVAX HB lot# N006321, expiry: 08-NOV-2019, both for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007014.
Age: 0.5
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 6-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 27-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ, orally, lot # M042170, expiry date: 22-JUN-2018, and RECOMBIVAX HB lot# N006321, expiry: 08-NOV-2019. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007014.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 22-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M042170, expiry date: 22-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 4-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 19-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M042170, expiry date: 22-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 04-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 11-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M042170, expiry date: 22-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 03-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 20-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M042170, expiry date: 22-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 11-week-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 20-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M042170, expiry date: 22-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 13 month old patient. On 06-SEP-2017, the patient vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002098: US-009507513-1709USA002186.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 13 month old patient. On 08-SEP-2017, the patient vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002098: US-009507513-1709USA002186.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 12 month old patient. On 11-SEP-2017, the patient vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # N008077, expiration date: 09-MAR-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002098: US-009507513-1709USA002186.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Limb mass, Localised infection
Clinical narrative: Patient called on 10/19/17 regarding her arm getting a lump and its getting bigger. She came in pharmacy and I looked at her arm and it does look infected. Advised her to go to a doctor and she called back later and said her doctor gave her some BENADRYL and antibiotics and that her doctor said the shot went into the fat tissue instead the muscle. She is okay overall.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Body temperature increased
Clinical narrative: Temp to 102 after imms.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Cellulitis, swelling, redness.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site rash
Clinical narrative: (L) thigh rash (raised) after Dtap administration.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Periarthritis
Clinical narrative: Frozen shoulder-arm pain.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: 10-26-17 Early morning started with high fever and very red and swollen arm where her flu was given. She also reacted last year but not as bad.
Age: 36.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Small area of erythema and induration on upper R deltoid.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, IPV, MNQ, TD
Symptoms: Syncope
Clinical narrative: The client fainted after the HPV vaccine. She remained seated in her chair and came to within a few seconds. She was monitored, given a granola bar, juice, and water and assisted to laying down. She remained laying down until her BP was 110/70 and pulse 80. At that point the last vaccination was given without complication and she remained laying down for around five more minutes and then slowly sat up until she felt ready to leave. The mother drove her home. The total recovery time was around thirty five minutes in all.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: Mother of patient reports hives at injection site and also at other areas of the body evening of immunization.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Within 30 minutes employee complained of wrist and lower arm hurting. There was not swelling or redness or itching. No treatment. Symptoms subsided.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Erythema, Herpes zoster, Pain
Clinical narrative: Shingles.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Shingles.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Feeling hot, Injection site pain, Pain, Pain in extremity
Clinical narrative: Very "hot" injection. I felt like I had been shot (as with a bullet). Typical pain and fever that follows a anthrax shot. Continued pain in the Left Upper/Mid shoulder, elbow, and hand. Pain still continues to this day. Pain is more prominent with exertion.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Pyrexia
Clinical narrative: Very "hot" injection. I felt like I had been shot (as with a bullet). Typical pain and fever that follows a anthrax shot. Continued pain in the Left Upper/Mid shoulder, elbow, and hand. Pain still continues to this day. Pain is more prominent with exertion.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site infection, Injection site scab
Clinical narrative: Patient developed small scab/infection near the injection site, approximate size of 3 cm x 2 cm which was noted weeks after administraiton.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: Intense arm pain, muscle/joint.
Age: 9.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was inadvertently given Tdap, MCV4 and HPV9 meant for her 11 year old sibling. Mom was immediately notified of the error. Child did not report any symptoms immediately after. Mom was instructed to call immediately if she noticed anything unusual.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9, VARCEL
Symptoms: Eye movement disorder, Oral discomfort
Clinical narrative: Patient was given vaccines and when he received last vaccine HPV patient felt his lips get tight and his arms went close to chest and eyes rolled back and patient was laid on exam table. Patient did awake to his name and was alert and oriented. Blood pressure was taken, and pulse ox was placed on pt. Patient was given crackers and juice.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Tenderness
Clinical narrative: It was really sore on Friday, which I know is normal, but then it turned really red and swollen. By Saturday it had gone down my arm almost to my wrist. It also itched a lot. It was sore to the touch also. Late Sunday it looked and felt better. I was going to call on Monday, but decided it was not necessary. By Tuesday every thing was back to normal, except the itching.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Feeling abnormal, Injection site pain, Malaise
Clinical narrative: Patient said something "did not feel right" as she was getting the shot...it hurt a lot and felt like a gamma globulin shot she had had years before. She could not get vaccinated in her right arm due to having breast cancer on that side. She started feeling bad that evening, gave it all day on 10/25/2017 and never felt better, then she came in this morning. She had fatigue, malaise but mentioned NOT having any fever. We called the dr's office who recommended she come in immediately, which she did.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Transplant patient received vaccine on 10/10/17 & developed all over body rash that resembled "mosquito bites" and was very itchy. Pt stated rash lasted approximately 2 weeks. Used "Aveeno" to help with itching.
Age: 20.0
Sex: M
Vaccine: FLU4, TD
Symptoms: Extra dose administered
Clinical narrative: FAMILY CALLED INTO CLINIC, VIS GIVEN AND WAS TOLD WHAT VACCINES THEY WOULD BE RECEIVING AND THAT IT WOULD BE THE LAST VACCINES REQUIRED BY IMMIGRATION, CLIENTS CALLED INTO ROOM AND VERIFIED ALLERGIES/HEALTH/LMP ETC PRIOR TO ADMINISTRATION OF VACCINES, CLIENTS FATHER HAD BANDAID TO ARM, WHEN WRITER ASKED REASON FOR BANDAID, CLIENT'S FATHER REPLIED "MY SON AND I RECEIVED A FLU VACCINE YESTERDAY FROM OUR JOB.  I SHOWED THE PAPER TO THE LADY OUT THERE", WRITE SPOKE WITH INTAKE WORKER WHO CONFIRMED WHAT CLIENTS FATHER PREVIOUSLY STATED BY SAYING, "YES THERE WAS 2 OF THEM AND I PUT THE FLU VACCINE ", AND SHE REQUESTED CLIENT ID NUMBERS AND STATED "I ENTERED THEM IN, BUT I DON'T KNOW WHY IT WAS NOT SAVED".  CLIENT DENIED ANY C/O DISCOMFORT, CALL MADE TO DR. AND INSTRUCTED TO EXPLAIN THE POSSIBLE S/E OF RECEIVING VACCINES IN INADVERTENLY 1 DAY APART, CLIENT EDUCATION PROVIDED VIA INTERPRETOR LINE, CLIENT VERBALIZIED UNDERSTANDING, COPY OF PAPERWORK COPIED AND PLACED IN CLIENTS FILE AS WELL AS VACCINE HX ENTERED INTO NCIR, SUPERVISOR MADE AWARE, WILL CONTINUE TO MONITOR.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Started with sore arm redness pain at injection site. Left arm numbness after injections and fever started 5 PM (undocumented) per patient report, vomiting occurred at 1:30 on 10/24/17. Symptoms resolved 10/25/17 midday. Rest and fluids by mouth for treatment. Report of illness by phone call and follow up by phone call.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: Started with sore arm redness pain at injection site. Left arm numbness after injections and fever started 5 PM (undocumented) per patient report, vomiting occurred at 1:30 on 10/24/17. Symptoms resolved 10/25/17 midday. Rest and fluids by mouth for treatment. Report of illness by phone call and follow up by phone call.
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Oropharyngeal pain, Throat tightness, Tremor
Clinical narrative: Throat pain - felt like it was closing. Chills, headache, shakes from chills. BENADRYL prescribed. Taken at 6:30 PM. Fell asleep at 9 PM and felt fine the next day.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Burning sensation, Injected limb mobility decreased, Pain
Clinical narrative: Extreme sore at 2 PM. Ibuprofen every 4 hours (3). Pain and burning from 4 PM to 8 AM, could not raise arm. Scale: 9. 8 AM to 11:30/12 noon scale: 7. Noon scale: 0. Then sore for 2 days.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Cellulitis, Chest X-ray normal, Chills, Culture urine negative
Clinical narrative: 72 year old male received influenza vaccine and 23-valent pneumococcal vaccine in the left arm on 10/10/17. Of note, pt has previously received both the influenza vaccine and 23-valent pneumococcal vaccine with no previous documented reaction. Pt called later that evening c/o redness, heat, and (3 inches across) swelling of injection site as well as minimal itching. Pt was instructed to apply cold compresses and take NSAIDs and hydroxyzine. On 10/12/17, pt reported he still felt weak and dizzy, swelling had improved but still warm. Pt presented to ER 10/12/17 c/o fever, chills, and body aches with temperature 102.1 and physical exam noted diffuse tenderness and erythema of left deltoid/proximal arm. Pt was diagnosed with fever and left arm cellulitis s/p vaccinations and discharged home on cotrimoxazole. Fever and Pruritus; Erythema; Cellulitis. Acetaminophen 1000 mg PRN, Sulfamethoxazole/trimethoprim 800/160 mg BID, hydroxyzine 50 mg PRN.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dizziness, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Injection site erythema
Clinical narrative: 72 year old male received influenza vaccine and 23-valent pneumococcal vaccine in the left arm on 10/10/17. Of note, pt has previously received both the influenza vaccine and 23-valent pneumococcal vaccine with no previous documented reaction. Pt called later that evening c/o redness, heat, and (3 inches across) swelling of injection site as well as minimal itching. Pt was instructed to apply cold compresses and take NSAIDs and hydroxyzine. On 10/12/17, pt reported he still felt weak and dizzy, swelling had improved but still warm. Pt presented to ER 10/12/17 c/o fever, chills, and body aches with temperature 102.1 and physical exam noted diffuse tenderness and erythema of left deltoid/proximal arm. Pt was diagnosed with fever and left arm cellulitis s/p vaccinations and discharged home on cotrimoxazole. Fever and Pruritus; Erythema; Cellulitis. Acetaminophen 1000 mg PRN, Sulfamethoxazole/trimethoprim 800/160 mg BID, hydroxyzine 50 mg PRN.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Pain
Clinical narrative: 72 year old male received influenza vaccine and 23-valent pneumococcal vaccine in the left arm on 10/10/17. Of note, pt has previously received both the influenza vaccine and 23-valent pneumococcal vaccine with no previous documented reaction. Pt called later that evening c/o redness, heat, and (3 inches across) swelling of injection site as well as minimal itching. Pt was instructed to apply cold compresses and take NSAIDs and hydroxyzine. On 10/12/17, pt reported he still felt weak and dizzy, swelling had improved but still warm. Pt presented to ER 10/12/17 c/o fever, chills, and body aches with temperature 102.1 and physical exam noted diffuse tenderness and erythema of left deltoid/proximal arm. Pt was diagnosed with fever and left arm cellulitis s/p vaccinations and discharged home on cotrimoxazole. Fever and Pruritus; Erythema; Cellulitis. Acetaminophen 1000 mg PRN, Sulfamethoxazole/trimethoprim 800/160 mg BID, hydroxyzine 50 mg PRN.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: 72 year old male received influenza vaccine and 23-valent pneumococcal vaccine in the left arm on 10/10/17. Of note, pt has previously received both the influenza vaccine and 23-valent pneumococcal vaccine with no previous documented reaction. Pt called later that evening c/o redness, heat, and (3 inches across) swelling of injection site as well as minimal itching. Pt was instructed to apply cold compresses and take NSAIDs and hydroxyzine. On 10/12/17, pt reported he still felt weak and dizzy, swelling had improved but still warm. Pt presented to ER 10/12/17 c/o fever, chills, and body aches with temperature 102.1 and physical exam noted diffuse tenderness and erythema of left deltoid/proximal arm. Pt was diagnosed with fever and left arm cellulitis s/p vaccinations and discharged home on cotrimoxazole. Fever and Pruritus; Erythema; Cellulitis. Acetaminophen 1000 mg PRN, Sulfamethoxazole/trimethoprim 800/160 mg BID, hydroxyzine 50 mg PRN.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: Burning, itching, red dots at injection site.
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Mobility decreased, Movement disorder, Neck pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a female patient who received FLUARIX QUADRIVALENT. On 13th October 2017, the patient received FLUARIX QUADRIVALENT. On 14th October 2017, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain. On 15th October 2017, the patient experienced movement disorder and neck pain. In October 2017, the outcome of the injection site pain, movement disorder and neck pain were recovered/resolved. It was unknown if the reporter considered the injection site pain, movement disorder and neck pain to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced difficulty turning her head, and pain up the side of her neck, on the side of the injection site.
Age: 0.83
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: Febrile seizure beginning approximately at 930 pm- temperature of 102.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Pt stated the day after that her arm was sore- I advised her that this was normal for a few days after given an intramuscular shot. I told pt to call be back to next day if it still hurt and I never heard from her. I told her to take MOTRIN to relieve soreness.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Musculoskeletal stiffness, Nuclear magnetic resonance imaging spinal abnormal, Pain in extremity, Paraesthesia
Clinical narrative: Patient received Tdap injection in clinic on 9/25/2017 in her right deltoid. She developed tingling in thumb and fingers of right hand. Also had shooting pain down her arm from elbow to hands, with noted stiffness. This all started 24-48 hours after receiving Tdap.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Facial paralysis, Headache, Hypoaesthesia
Clinical narrative: Bell's Palsy- treated with prednisone and acyclovir. Some residual still left. Numbness to right arm and leg. Severe headache.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Irritability, Pyrexia
Clinical narrative: Patient started running a fever about 1pm after she received the injections. Fever was 102.8 F rectally and required TYLENOL. Fever was 103.6 F that night at 11pm. Baby was very fussy and continued to run high fever for 3 days after immunizations.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Cold sweat, Crying, Eye movement disorder, Hypotonia, Irritability
Clinical narrative: Infant very irritable, with shrill cry around 4:45pm. At approximately 6pm, infant began vomiting excessively. Infant continued to vomit every 5-10 minutes. Infant became pale, lethargic, cool, clammy and limp. Eyes began to roll back into head. Infant taken to hospital. Abdominal ultrasound benign, ZOFRAN given for nausea. Infant stopped vomiting around 9pm and was able to breastfeed without vomiting.