chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Intercepted medication error, Intercepted product prescribing error, No adverse event
Clinical narrative: "70-year old woman was recommended by her dermatologist to receive GARDASIL 9. She is here now to be administered GARDASIL 9. She will not be administered GARDASIL 9; "70-year old woman was recommended by her dermatologist to receive GARDASIL 9. She is here now to be administered GARDASIL 9. She will not be administered GARDASIL 9; No additional adverse effect reported; "70-year old woman was recommended by her dermatologist to receive GARDASIL 9. She is here now to be administered GARDASIL 9. She will not be administered GARDASIL 9; This spontaneous report was received from a pharmacy technician refers to a 70 year old female patient. The patient's pertinent medical history, concomitant medication, drug reactions and allergies were not reported. On 20-MAY-2020, the patient was prescribed with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength and dose was not reported) of lot # R017624 with expiration date of 17-MAR-2021 via intramuscular route for prophylaxis by her dermatologist (product prescribing error). The patient went to get administered the vaccine but the reported stated that she would not be administered with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (circumstance or information capable of leading to medication error, no adverse event and product administered to patient of inappropriate age). No clarifying information provided. No additional adverse effect reported. The outcome of product prescribing error, circumstance or information capable of leading to medication error and product administered to patient of inappropriate age was considered as unknown. No product quality complaint (PQC) was involved with this report. 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: R017624; expirationdate: 17-MAR-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
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm soreness/under pain in arm; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th May 2020, the patient received the 2nd dose of Shingrix. In May 2020, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had arm soreness. The reporter consented to follow up. The reporter wanted to know was this normal. This case linked with US2020AMR082455, reported by same reporter.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: low grade temp / spouse developed a low grade fever (99.5F); This case was reported by a other health professional via call center representative and described the occurrence of fever in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th May 2020, the patient received the 2nd dose of Shingrix. On 14th May 2020, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The husband reported for her wife. The patient received Shingrix and had low grade temperature and temperature was recorded 99.5 degree F. The reporter wanted to know was that something we need to worry about as he read that was a common symptom. The reporter consented to follow up. This case linked with US2020AMR082449 and US2020082513, reported by same reporter.
Age: 79.0
Sex: F
Vaccine: FLUA3
Symptoms: Epistaxis
Clinical narrative: Severe nosebleed; This is a spontaneous case reported by other non health professional to agency reference number: SEQ19-01801) and initially received on 14-Aug-2019, concerning a 79-year-old, female patient.   The patient's medical history included occasionally, slightly elevated blood pressure.  On 13-Aug-2019, at 11:00 am, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, at a dose of 0.5 ml, route of administration, anatomical location, batch number and expiration date: not reported] for influenza prophylaxis.  On the same day, at 7:45 pm, approximately 9 hours after vaccination, the patient developed severe nosebleed. The patient put ice on her nose and later was advised by a nurse to pinch her nose.  Later that day, at 8:45 pm, the patient recovered from the event epistaxis'.  The reporter assessed the case as non-serious. The reporter's causality assessment was not reported, however, the patient's pharmacist advised her, that her nosebleed might be due to high blood pressure.  Company comment: A 79-year-old, female patient experienced epistaxis after receipt of Fluad (TIV). Chronology seems plausible. The patient's medical history included occasionally, slightly elevated blood pressure which, along with advanced age, may provide alternative aetiology for the event. With information provided, casual role is set as not related to the product.; Reporter's Comments: A 79-year-old, female patient experienced epistaxis after receipt of Fluad (TIV). Chronology seems plausible. The patient's medical history included occasionally, slightly elevated blood pressure which, along with advanced age, may provide alternative aetiology for the event. With information provided, casual role is set as not related to the product.
Age: 66.0
Sex: M
Vaccine: FLUA3, UNK
Symptoms: Arthralgia, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: The pain was radiating down his arm to his elbow; His arm was swelling on his bicep; This is a spontaneous case, reported by a pharmacist to agency (SEQ19-01900) and initially received on 20-Aug-2019, concerning a 66-year-old male patient.   The patient's medical history and concomitant medications were not reported.   On 19-Aug-2019, the patient was administered with Fluad (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59), anatomical location: arm, batch number: 260386, expiration date: 30-Apr-2020, (dose and route of administration were not reported) for an unknown indication. On the same day, the patient was administered with another vaccine Imovax (rabies vaccine), (dose, route of administration, batch number and expiration date were not reported) in the same arm for an unknown indication.   On the same day, later in the evening, around 11PM, the patient's arm was swelling on his biceps and the pain was radiating down his arm to his elbow.  On the next day, 20-Aug-2019, the swelling and pain were improving, but not completely resolved. The outcomes of the events were considered as recovering/resolving.   The reporter did not provide causality assessment to Fluad.  Company comment: The patient developed pain in extremity and peripheral swelling on the same day after vaccination with the suspect product Fluad (TIV). Chronology is plausible. No information regarding medical history or concomitant drugs was provided. Based on this information, causal relationship between the suspect product and both events is assessed as related.; Reporter's Comments: The patient developed pain in extremity and peripheral swelling on the same day after vaccination with the suspect product Fluad (TIV). Chronology is plausible. No information regarding medical history or concomitant drugs was provided. Based on this information, causal relationship between the suspect product and both events is assessed as related.
Sex: U
Vaccine: FLUC4
Symptoms: Influenza
Clinical narrative: Flu; This is a spontaneous case initially received from a physician (case ID: SEQ19-02028) on 26-Aug-2019, concerning a patient of unspecified age and gender.   The patient's concomitant medications included hydroxyzine pamoate (25 mg Capsule, 1-2 capsules, orally, every 4-6 hours as needed) for muscle spasm and Lyrica (pregabalin) (150 mg Capsule, 2 capsules in morning, 1 capsule in afternoon and 2 capsules at bedtime, orally, everyday) for unknown indication. The patient's drug allergies included Cymbalta (duloxetine), Depakote (divalproex) and gabapentin.  On an unspecified date, the patient was administered with Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, dose, route, batch number and expiration date: not reported] for unknown indication.   On an unspecified date, after vaccination, the patient developed flu from the vaccine.   At the time of reporting, the outcome of flu was not reported.  The reporter assessed the event as related to Flucelvax Quadrivalent.  Company comment: A patient of unspecified age and gender has experienced Influenza associated with Flucelvax QIV. Chronology needs more clarification. The patient's concomitant drug - pregabalin provides alternative aetiology for the event. With information provided, causality is assessed as not related to the product.; Reporter's Comments: A patient of unspecified age and gender has experienced Influenza associated with Flucelvax QIV. Chronology needs more clarification. The patient's concomitant drug - pregabalin provides alternative aetiology for the event. With information provided, causality is assessed as not related to the product.
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Pain on a scale of 1-10 rated 9.5; This is a spontaneous case initially received from consumer on 26-Aug-2019, concerning a female, 71-years-old patient.    The patient's medical history included opent heart surgery and heart valve replacement, multiple allergies including latex allergy, joint pain, muscle pain and walking with cane.   The patient's vaccine history included Afluria Trivalent for unknown indication. The patient's concomitant medication included Tylenol (paracetamol) for unknown indication. The patient reported taking ten drugs, but did not wish to list them all.  On an unspecified date in 2017, the patient was administered Afluria Quad [influenza vaccine, batch number, route of administration, anatomical location, expiry date: not provided] for influenza prophylaxis.   On an unspecified date, after vaccination, the patient experienced horrific side effects of pain on a scale of 1-10 she rated 9.5.   The outcome of the event pain was resolved.    The reported did not provide causality assessment.  This case is linked to 201904509, concerning the same patient.  Non-significant follow-up received from other non-health professional on 09-Oct-2019: Additional agency reference number 'SEQ19-02302' added. No changes in narrative.   Company Comment: The patient developed pain on unknown date after vaccination with the suspect product Afluria Quad (influenza vaccine). Chronology is plausible. Medical history of joint pain, muscle pain and advanced age (71) may have contributed to development of the event. Based on provided information, causal role of the suspect product cannot be totally excluded and is assessed as related.; Reporter's Comments: The patient developed pain on unknown date after vaccination with the suspect product Afluria Quad (influenza vaccine). Chronology is plausible. Medical history of joint pain, muscle pain and advanced age (71) may have contributed to development of the event. Based on provided information, causal role of the suspect product cannot be totally excluded and is assessed as related.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Extra dose administered
Clinical narrative: Patient was administered a 2nd dose of anthrax due to technician seeing date vaccine was administered (5/21/2020) was the current day of the other vaccines she was suppose to administer (5/21/2020). When verifying what vaccines were to be given she stated 3 vaccines Dated 5/21/2020, however anthrax was administered at another facility that morning.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; vaccinated wilh improperly stored VARIVAX; This spontaneous report was received from a physician referring to 10 unspecified patients of unknown age and gender. Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.    On 14-NOV-2019, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S019581, expiration date 25-JUN-2021, dosage detail, route, anatomical location and strength were not provided) for prophylaxis (product storage error). Administered doses of vaccine experienced temperature excursion from -50 degrees Celsius (C) to -15 C (-14.67C) for 3 hours. Total time in the range from 6 degrees Fahrenheit (F) to 14 degree F (-14 degree C to -10 degree C) (-14.4C) for 3 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.  The outcome of product storage error was considered as unknown. No product quality complaint (PQC) was involved with this report.     This is a non-valid case due to lack of patient identifier.  As of 19-MAY-2020, all telephone attempts trying to obtain additional information has been unsuccessful.  Follow up information has been received from the physician on 21-MAY-2020 refers to a 5 year old male patient. On 18-NOV-2019, the patient was vaccinated with one dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of the multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA007663: US-009507513-2005USA007664: US-009507513-2005USA007662: US-009507513-2005USA007661: US-009507513-2005USA007660: US-009507513-2005USA007665: US-009507513-2005USA007658: US-009507513-2005USA007659: US-009507513-2005USA007526:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE information provided; the patient was administered the second dose of GARDASIL 9 on 5/20/2020 which was over a year after the first dose; This spontaneous report was received from a nurse prescriber referring to a 14 years old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On an unknown date (reported as over a year ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, vaccine dosage detail, route of administration, lot# and expiration date were not reported) for prophylaxis. On 20-MAY-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, vaccine dosage detail, route of administration, lot# and expiration date were not reported) which was over a year after the first dose (inappropriate schedule of product administration). No additional adverse event information was provided (no adverse event).
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; vaccinated wilh improperly stored VARIVAX; This spontaneous report was received from a physician referring to a 5 year old female patient. Information about pertinent medical history, concomitant medications and drug reactions or allergies was not provided.    On 04-DEC-2019, the patient was vaccinated with improperly stored dose(1 dosage form) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S019581, expiration date 25-JUN-2021, route, anatomical location and strength were not provided) for prophylaxis (product storage error). No adverse effects were reported. Administered doses of vaccine experienced temperature excursion from -50 degrees Celsius (C) to -15 C (-14.67C) for 3 hours. Total time in the range from 6 degrees Fahrenheit (F) to 14 degree F (-14 degree C to -10 degree C) (-14.4C) for 3 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint (PQC) was involved with this report.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA006288:
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; vaccinated wilh improperly stored VARIVAX; This spontaneous report was received from a physician referring to a 4 year old female patient. Information about pertinent medical history, concomitant medications and drug reactions or allergies was not provided.    On 04-DEC-2019, the patient was vaccinated with improperly stored dose(1 dosage form) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S019581, expiration date 25-JUN-2021, route, anatomical location and strength were not provided) for prophylaxis (product storage error). No adverse effects were reported. Administered doses of vaccine experienced temperature excursion from -50 degrees Celsius (C) to -15 C (-14.67C) for 3 hours. Total time in the range from 6 degrees Fahrenheit (F) to 14 degree F (-14 degree C to -10 degree C) (-14.4C) for 3 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint (PQC) was involved with this report.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA006288:
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; vaccinated wilh improperly stored VARIVAX; This spontaneous report was received from a physician referring to a 4 year old male patient. Information about pertinent medical history, concomitant medications and drug reactions or allergies was not provided.    On 23-NOV-2019, the patient was vaccinated with improperly stored dose(1 dosage form) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S019581, expiration date 25-JUN-2021, route, anatomical location and strength were not provided) for prophylaxis (product storage error). No adverse effects were reported. Administered doses of vaccine experienced temperature excursion from -50 degrees Celsius (C) to -15 C (-14.67C) for 3 hours. Total time in the range from 6 degrees Fahrenheit (F) to 14 degree F (-14 degree C to -10 degree C) (-14.4C) for 3 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint (PQC) was involved with this report.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA006288:
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; vaccinated wilh improperly stored VARIVAX; This spontaneous report was received from a physician referring to a 4 year old female patient. Information about pertinent medical history, concomitant medications and drug reactions or allergies was not provided.    On 26-NOV-2019, the patient was vaccinated with improperly stored dose(1 dosage form) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S019581, expiration date 25-JUN-2021, route, anatomical location and strength were not provided) for prophylaxis (product storage error). No adverse effects were reported. Administered doses of vaccine experienced temperature excursion from -50 degrees Celsius (C) to -15 C (-14.67C) for 3 hours. Total time in the range from 6 degrees Fahrenheit (F) to 14 degree F (-14 degree C to -10 degree C) (-14.4C) for 3 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint (PQC) was involved with this report.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA006288:
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; vaccinated wilh improperly stored VARIVAX; This spontaneous report was received from a physician referring to a 4 year old male patient. Information about pertinent medical history, concomitant medications and drug reactions or allergies was not provided.    On 13-DEC-2019, the patient was vaccinated with improperly stored dose(1 dosage form) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S019581, expiration date 25-JUN-2021, route, anatomical location and strength were not provided) for prophylaxis (product storage error). No adverse effects were reported. Administered doses of vaccine experienced temperature excursion from -50 degrees Celsius (C) to -15 C (-14.67C) for 3 hours. Total time in the range from 6 degrees Fahrenheit (F) to 14 degree F (-14 degree C to -10 degree C) (-14.4C) for 3 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint (PQC) was involved with this report.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA006288:
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; vaccinated wilh improperly stored VARIVAX; This spontaneous report was received from a physician referring to a 2 year old male patient. Information about pertinent medical history, concomitant medications and drug reactions or allergies was not provided.    On 17-DEC-2019, the patient was vaccinated with improperly stored dose(1 dosage form) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S019581, expiration date 25-JUN-2021, route, anatomical location and strength were not provided) for prophylaxis (product storage error). No adverse effects were reported. Administered doses of vaccine experienced temperature excursion from -50 degrees Celsius (C) to -15 C (-14.67C) for 3 hours. Total time in the range from 6 degrees Fahrenheit (F) to 14 degree F (-14 degree C to -10 degree C) (-14.4C) for 3 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint (PQC) was involved with this report.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA006288:
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; vaccinated wilh improperly stored VARIVAX; This spontaneous report was received from a physician referring to a 12 months old female patient. Information about pertinent medical history, concomitant medications and drug reactions or allergies was not provided.    On 06-DEC-2019, the patient was vaccinated with improperly stored dose(1 dosage form) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S019581, expiration date 25-JUN-2021, route, anatomical location and strength were not provided) for prophylaxis (product storage error). No adverse effects were reported. Administered doses of vaccine experienced temperature excursion from -50 degrees Celsius (C) to -15 C (-14.67C) for 3 hours. Total time in the range from 6 degrees Fahrenheit (F) to 14 degree F (-14 degree C to -10 degree C) (-14.4C) for 3 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint (PQC) was involved with this report.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA006288:
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; vaccinated wilh improperly stored VARIVAX; This spontaneous report was received from a physician referring to a 12 months old female patient. Information about pertinent medical history, concomitant medications and drug reactions or allergies was not provided.    On 30-DEC-2019, the patient was vaccinated with improperly stored dose(1 dosage form) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S019581, expiration date 25-JUN-2021, route, anatomical location and strength were not provided) for prophylaxis (product storage error). No adverse effects were reported. Administered doses of vaccine experienced temperature excursion from -50 degrees Celsius (C) to -15 C (-14.67C) for 3 hours. Total time in the range from 6 degrees Fahrenheit (F) to 14 degree F (-14 degree C to -10 degree C) (-14.4C) for 3 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint (PQC) was involved with this report.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA006288:
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; vaccinated wilh improperly stored VARIVAX; This spontaneous report was received from a physician referring to a 5 year old male patient. Information about pertinent medical history, concomitant medications and drug reactions or allergies was not provided.    On 27-NOV-2019, the patient was vaccinated with improperly stored dose(1 dosage form) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S019581, expiration date 25-JUN-2021, route, anatomical location and strength were not provided) for prophylaxis (product storage error). No adverse effects were reported. Administered doses of vaccine experienced temperature excursion from -50 degrees Celsius (C) to -15 C (-14.67C) for 3 hours. Total time in the range from 6 degrees Fahrenheit (F) to 14 degree F (-14 degree C to -10 degree C) (-14.4C) for 3 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint (PQC) was involved with this report.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA006288:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Sciatic nerve injury
Clinical narrative: Strained her sciatica; This case was reported by a consumer via call center representative and described the occurrence of sciatic nerve injury in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On 26th April 2020, between 4 and 5 months after receiving Shingrix, the patient experienced sciatic nerve injury. On an unknown date, the outcome of the sciatic nerve injury was unknown.   It was unknown if the reporter considered the sciatic nerve injury to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had strained her sciatica. On 26th April 2020 she was working outside and strained her sciatica. For tolerances of 2nd dose, refer case US2020081792, reported by same reporter for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Nausea, Neuralgia, Sciatica, Vaccine positive rechallenge
Clinical narrative: Nausea; Pain / in the hip area; nerve pain; sciatica pain; This case was reported by a consumer via call center representative and described the occurrence of nausea in a female patient who received Herpes zoster (Shingrix) (batch number K9R97, expiry date 15th November 2021) for prophylaxis.   Previously administered products included shingrix with an associated reaction of sciatica (received 1st dose on 22nd November 2019, refer case US2020082540).   In March 2020, the patient received the 2nd dose of Shingrix. In May 2020, between 2 and 3 months after receiving Shingrix, the patient experienced sciatica and nerve pain. On an unknown date, the patient experienced nausea and pain in hip. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the nausea, sciatica, pain in hip and nerve pain were unknown.   It was unknown if the reporter considered the nausea, sciatica, pain in hip and nerve pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in March in left deltoid which resulted in nausea. The pain returned 1 week ago it was not as bad as before and was in the hip area and worse when she sits and stands. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the reporter for the her sister. The age at the vaccination was not reported. The patient received Shingrix and experienced arm pain.  No details about the patients was available at time of report. The reporter did not consent to follow up. This case linked with US2020AMR084981, US2020084176 and US2020AMR084982, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The case was reported by the reporter for the pharmacist. The patient received Shingrix and experienced arm pain.  No details about the patients was available at time of report. The reporter did not consent to follow up. This case linked with US2020AMR084981, US2020084176 and US2020AMR084982, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Crying, Gait inability, Insomnia, Magnetic resonance imaging spinal abnormal
Clinical narrative: cracked 2 teeth; crying; severe pain in her sciatic; could not sleep; could not walk; pain which felt like sandpaper scraping the nerve; This case was reported by a consumer via call center representative and described the occurrence of sciatica in a female patient who received Herpes zoster (Shingrix) (batch number D924E, expiry date unknown) for prophylaxis.   On 22nd November 2019, the patient received the 1st dose of Shingrix. On 25th November 2019, 3 days after receiving Shingrix and an unknown time after starting Cortison, the patient experienced chipped tooth. On an unknown date, the patient experienced sciatica, insomnia, unable to walk, nerve pain and crying. The patient was treated with cortisone acetate (Cortison), analgesic, nos (Painkiller) and antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the sciatica and nerve pain were recovered/resolved and the outcome of the insomnia, unable to walk, chipped tooth and crying were unknown.   It was unknown if the reporter considered the sciatica, insomnia, unable to walk, nerve pain, chipped tooth and crying to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in left deltoid and experienced severe pain in her sciatic area which shot all the way across the area and could not sleep or walk. The patient was crying from the pain which felt like sandpaper scraping the nerve and cracked 2 teeth and had to have 2 root canals.  The patient She saw her chiropractor and got 3 shots of cortisone which did not mitigate the pain. Her neurologist did an MRI ad X-ray which showed a cloudy area near her spine. Biopsy was done but since infection was not confirmed as a certain pathogen a high powered antibiotic was used. The pain finally went away. The patient was prescribed a potent painkiller which helped. The reporter did not consent to follow up. For tolerances of 2nd dose, refer case US2020AMR083177, reported by same reporter for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Sciatica, Spinal X-ray abnormal, Tooth fracture
Clinical narrative: cracked 2 teeth; crying; severe pain in her sciatic; could not sleep; could not walk; pain which felt like sandpaper scraping the nerve; This case was reported by a consumer via call center representative and described the occurrence of sciatica in a female patient who received Herpes zoster (Shingrix) (batch number D924E, expiry date unknown) for prophylaxis.   On 22nd November 2019, the patient received the 1st dose of Shingrix. On 25th November 2019, 3 days after receiving Shingrix and an unknown time after starting Cortison, the patient experienced chipped tooth. On an unknown date, the patient experienced sciatica, insomnia, unable to walk, nerve pain and crying. The patient was treated with cortisone acetate (Cortison), analgesic, nos (Painkiller) and antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the sciatica and nerve pain were recovered/resolved and the outcome of the insomnia, unable to walk, chipped tooth and crying were unknown.   It was unknown if the reporter considered the sciatica, insomnia, unable to walk, nerve pain, chipped tooth and crying to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in left deltoid and experienced severe pain in her sciatic area which shot all the way across the area and could not sleep or walk. The patient was crying from the pain which felt like sandpaper scraping the nerve and cracked 2 teeth and had to have 2 root canals.  The patient She saw her chiropractor and got 3 shots of cortisone which did not mitigate the pain. Her neurologist did an MRI ad X-ray which showed a cloudy area near her spine. Biopsy was done but since infection was not confirmed as a certain pathogen a high powered antibiotic was used. The pain finally went away. The patient was prescribed a potent painkiller which helped. The reporter did not consent to follow up. For tolerances of 2nd dose, refer case US2020AMR083177, reported by same reporter for the same patient.
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Pain on a scale of 1-10 rated a 4; This is a spontaneous case ates initially received from a other non-health professional on 26-Aug-2019, concerning a female, elderly patient.    The patient's medical history included open heart surgery and heart valve replacement that contained a plastic component, multiple allergies including latex allergy, joint pain, muscle pain and walking with cane.   The patient's past medications included Afluria Trivalent (influenza vaccine) and Afluria Quadrivalent (influenza vaccine).The patient's concomitant medication included Tylenol (paracetamol) for unknown indication. The patient reported taking ten drugs but did not wish to list them all.   On an unspecified date in 2018, the patient was administered Afluria [influenza vaccine, batch number, route of administration, anatomical location, expiry date: not provided] for influenza prophylaxis. The patient was unable to verify if this vaccine was Afluria trivalent or quadrivalent.   Within half hour after vaccination, the patient experienced pain. On a scale of 1-10, the patient rated a 4. The pain lasted 3-4 days and as reported, if the patient ate something which she should not, she got the same pain. The patient did not receive any treatment.   The reported did not provide causality assessment.   This case is linked to 201904505, concerning the same patient.  Non-significant follow-up received from other non-health professional on 09-Oct-2019: Additional agency reference number 'SEQ19-02302' added. No changes in narrative.   Company comment: The patient experienced pain, half an hour after vaccination with Afluria vaccine (not reported whether it was trivalent or quadrivalent). Chronology is plausible. Reportedly, the pain lasted 3-4 days and if the patient ate something which she should not, she got the same pain, which confounds causality. The patient's medical history of heart valve replacement, joint pain, muscle pain, advanced age and multiple concomitant drugs (not specified) also may have contributed to development of the event. More information regarding event details and concomitant medications is needed. Based on provided information, causal role of the suspect product cannot be totally excluded and is assessed as related.; Reporter's Comments: The patient experienced pain, half an hour after vaccination with Afluria vaccine (not reported whether it was trivalent or quadrivalent). Chronology is plausible. Reportedly, the pain lasted 3-4 days and if the patient ate something which she should not, she got the same pain, which confounds causality. The patient's medical history of heart valve replacement, joint pain, muscle pain, advanced age and multiple concomitant drugs (not specified) also may have contributed to development of the event. More information regarding event details and concomitant medications is needed. Based on provided information, causal role of the suspect product cannot be totally excluded and is assessed as related.
Age: 52.0
Sex: M
Vaccine: FLUC4
Symptoms: Body temperature fluctuation, Chills, Eye pain, Fatigue, Headache
Clinical narrative: Tenderness around the sockets of eyes; Aches and pains; Mild neuralgia; Fluctuating temperature that spiked as high as 101F; Fatigue; Chills; Small headache; This is a spontaneous case from reported by consumer to agency (ID number: SEQ19-03387) and initially retrieved on 27-Sep-2019, concerning a 52-year-old, male patient.  The patient's medical history included mild hypertension. The patient's concomitant medications included Aspirin (acetylsalicylic acid) for unknown indication. The patient had received flu vaccine shots for several years without reactions.  On 25-Sep-2019, the patient was administered Flucelvax QIV (Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5ml route of administration: intramuscular, anatomical location: deltoid, batch number: 261201, expiration date: Jun-2020) for influenza prophylaxis.  On 25-Sep-2019, the same day of vaccination, the patient developed adverse reaction to the Flucelvax. The patient developed aches and pains, a fluctuating temperature that spiked as high as 101F, and had tenderness around the sockets of eyes. Patient also experienced mild neuralgia and small headaches throughout the day, chills and fatigue.  On unspecified date, the patient started treatment with Aspirin 2-3 tablets every 4 hours. The patient reported that Aspirin only helps for a few hours, and than the high fever returned. The patient reached out to general practitioner (GP). GP suggested to the patient to go to and urgent care clinic, as he was worried about the headaches and intracranial bleeding. The patient advised GP he would wait until Sunday morning to see if he is better before going. GP indicated it was ok to wait until Sunday. Patient noted that the event were ongoing, usually started in the afternoon. The patient also reported, he hasn't had the fatigue he had for the last two days and no chills. Tenderness around the eye sockets continued.  The outcome of the events fatigue and chills was resolved, on an unspecified date.  The outcome of the event tenderness around the sockets of eyes, fluctuating temperature that spiked as high as 101F, mild neuralgia, small headaches, aches and pains was not resolved.  The reported did not provide seriousness but assessed this events as related to suspect drug.; Sender's Comments: A 52-year-old, male patient has experienced eye pain, pain, neuralgia, pyrexia, fatigue, chills and headache associated with Flucelvax QIV. Chronology seems suggestive. Reportedly, the patient had received flu vaccine shots for several years without reactions. Events suggest presence of flu like symptoms, although this event was not reported. Having in mind provided information, causality is assessed as possibly related to all events.
Age: 52.0
Sex: M
Vaccine: FLUC4
Symptoms: Influenza like illness, Neuralgia, Pain, Pyrexia
Clinical narrative: Tenderness around the sockets of eyes; Aches and pains; Mild neuralgia; Fluctuating temperature that spiked as high as 101F; Fatigue; Chills; Small headache; This is a spontaneous case from reported by consumer to agency (ID number: SEQ19-03387) and initially retrieved on 27-Sep-2019, concerning a 52-year-old, male patient.  The patient's medical history included mild hypertension. The patient's concomitant medications included Aspirin (acetylsalicylic acid) for unknown indication. The patient had received flu vaccine shots for several years without reactions.  On 25-Sep-2019, the patient was administered Flucelvax QIV (Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5ml route of administration: intramuscular, anatomical location: deltoid, batch number: 261201, expiration date: Jun-2020) for influenza prophylaxis.  On 25-Sep-2019, the same day of vaccination, the patient developed adverse reaction to the Flucelvax. The patient developed aches and pains, a fluctuating temperature that spiked as high as 101F, and had tenderness around the sockets of eyes. Patient also experienced mild neuralgia and small headaches throughout the day, chills and fatigue.  On unspecified date, the patient started treatment with Aspirin 2-3 tablets every 4 hours. The patient reported that Aspirin only helps for a few hours, and than the high fever returned. The patient reached out to general practitioner (GP). GP suggested to the patient to go to and urgent care clinic, as he was worried about the headaches and intracranial bleeding. The patient advised GP he would wait until Sunday morning to see if he is better before going. GP indicated it was ok to wait until Sunday. Patient noted that the event were ongoing, usually started in the afternoon. The patient also reported, he hasn't had the fatigue he had for the last two days and no chills. Tenderness around the eye sockets continued.  The outcome of the events fatigue and chills was resolved, on an unspecified date.  The outcome of the event tenderness around the sockets of eyes, fluctuating temperature that spiked as high as 101F, mild neuralgia, small headaches, aches and pains was not resolved.  The reported did not provide seriousness but assessed this events as related to suspect drug.; Sender's Comments: A 52-year-old, male patient has experienced eye pain, pain, neuralgia, pyrexia, fatigue, chills and headache associated with Flucelvax QIV. Chronology seems suggestive. Reportedly, the patient had received flu vaccine shots for several years without reactions. Events suggest presence of flu like symptoms, although this event was not reported. Having in mind provided information, causality is assessed as possibly related to all events.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperhidrosis, Myalgia, Pruritus, Rash, Scab
Clinical narrative: Rash that was like hives; Itching; Rash on neck, chest and back; Muscle aches/ muscle soreness; Woke up in sweats; This is a spontaneous case, initially received from other non-health professional via Agency (reference number: SEQ19-03632) on 01-Oct-2019, concerning a 46-year-old, female patient.   The patient's relevant medical history included seizures and migraine headaches. The patient's concomitant medications included seizure medication.  On 29-Sep-2019, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: right upper arm, batch number and expiration date: not reported] for influenza prophylaxis.  On the same day, a short while after vaccination, the patient experienced muscle aches.  On an unspecified date, the patient woke up in sweats.  On 30-Sep-2019, the patient experienced itching, rash on neck, chest and back.  On 01-Oct-2019, the patient stated that she continued to have muscle soreness, itching and rash that was like hives and became crusty.   The outcome for the events of muscle aches/ muscle soreness', itching', rash that was like hives' and rash on neck, chest and back' was not recovered, at the time of initial reporting.  The outcome for the event of night sweats' was not reported, at the time of initial reporting.  The reporter assessed the case as non serious but did not provide causality assessment to Afluria.; Sender's Comments: A 46-year-old female patient has experienced night sweats, myalgia, urticaria, pruritus and rash associated with Afluria Quadrivalent. Chronology seems plausible. The patient concomitant medications - seizure medications may have contributed in developing this events. Considering chronology, causality is assessed as possible for all events.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Rash that was like hives; Itching; Rash on neck, chest and back; Muscle aches/ muscle soreness; Woke up in sweats; This is a spontaneous case, initially received from other non-health professional via Agency (reference number: SEQ19-03632) on 01-Oct-2019, concerning a 46-year-old, female patient.   The patient's relevant medical history included seizures and migraine headaches. The patient's concomitant medications included seizure medication.  On 29-Sep-2019, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: right upper arm, batch number and expiration date: not reported] for influenza prophylaxis.  On the same day, a short while after vaccination, the patient experienced muscle aches.  On an unspecified date, the patient woke up in sweats.  On 30-Sep-2019, the patient experienced itching, rash on neck, chest and back.  On 01-Oct-2019, the patient stated that she continued to have muscle soreness, itching and rash that was like hives and became crusty.   The outcome for the events of muscle aches/ muscle soreness', itching', rash that was like hives' and rash on neck, chest and back' was not recovered, at the time of initial reporting.  The outcome for the event of night sweats' was not reported, at the time of initial reporting.  The reporter assessed the case as non serious but did not provide causality assessment to Afluria.; Sender's Comments: A 46-year-old female patient has experienced night sweats, myalgia, urticaria, pruritus and rash associated with Afluria Quadrivalent. Chronology seems plausible. The patient concomitant medications - seizure medications may have contributed in developing this events. Considering chronology, causality is assessed as possible for all events.