chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: rash around the injection site; This case was reported by a consumer via call center representative and described the occurrence of rash in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 27th January 2020, 3 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: On monday, the patient noticed a rash around the injection site. The patient consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pyrexia, Rash pruritic
Clinical narrative: forearm hives; itchy body rash of "pustules, vesicles, that look like tiny chicken pox"; itchy body rash of "pustules, vesicles, that look like tiny chicken pox"; itchy body rash of "pustules, vesicles, that look like tiny chicken pox"; Flu like symptoms; headache; chills; fever; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (for tolerance of 1st dose refer case US2020018229).   On 22nd January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 23rd January 2020, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms (serious criteria clinically significant/intervention required), headache (serious criteria clinically significant/intervention required), chills (serious criteria clinically significant/intervention required) and fever (serious criteria clinically significant/intervention required). On 24th January 2020, the patient experienced hives (serious criteria clinically significant/intervention required), vesiculopustular rash (serious criteria clinically significant/intervention required), varicella-like rash (serious criteria clinically significant/intervention required) and itchy rash (serious criteria clinically significant/intervention required). The patient was treated with benadryl (nos) (Benadryl). On 25th January 2020, the outcome of the influenza-like symptoms, headache, chills, fever and hives were recovered/resolved. On an unknown date, the outcome of the vesiculopustular rash, varicella-like rash and itchy rash were recovering/resolving.   Additional details were provided as follows: The age at vaccination was not reported. The patient developed flu like symptoms of fever, chills and a headache which lasted for 2 days and resolved. The patient developed hives on her right forearm and a full body itch rash of pustules and vesicles that look like tiny chicken pox. The patient's rash had improved, but still remained. The patient stated that she had been to see her physician about this rash and had treated it with benadryl. Emergency room visit was required. The reporter consented to follow up.  It was unknown if the reporter considered the influenza-like symptoms, headache, chills, fever, hives, vesiculopustular rash, varicella-like rash and itchy rash to be related to Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Rash pustular, Rash vesicular, Urticaria
Clinical narrative: forearm hives; itchy body rash of "pustules, vesicles, that look like tiny chicken pox"; itchy body rash of "pustules, vesicles, that look like tiny chicken pox"; itchy body rash of "pustules, vesicles, that look like tiny chicken pox"; Flu like symptoms; headache; chills; fever; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (for tolerance of 1st dose refer case US2020018229).   On 22nd January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 23rd January 2020, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms (serious criteria clinically significant/intervention required), headache (serious criteria clinically significant/intervention required), chills (serious criteria clinically significant/intervention required) and fever (serious criteria clinically significant/intervention required). On 24th January 2020, the patient experienced hives (serious criteria clinically significant/intervention required), vesiculopustular rash (serious criteria clinically significant/intervention required), varicella-like rash (serious criteria clinically significant/intervention required) and itchy rash (serious criteria clinically significant/intervention required). The patient was treated with benadryl (nos) (Benadryl). On 25th January 2020, the outcome of the influenza-like symptoms, headache, chills, fever and hives were recovered/resolved. On an unknown date, the outcome of the vesiculopustular rash, varicella-like rash and itchy rash were recovering/resolving.   Additional details were provided as follows: The age at vaccination was not reported. The patient developed flu like symptoms of fever, chills and a headache which lasted for 2 days and resolved. The patient developed hives on her right forearm and a full body itch rash of pustules and vesicles that look like tiny chicken pox. The patient's rash had improved, but still remained. The patient stated that she had been to see her physician about this rash and had treated it with benadryl. Emergency room visit was required. The reporter consented to follow up.  It was unknown if the reporter considered the influenza-like symptoms, headache, chills, fever, hives, vesiculopustular rash, varicella-like rash and itchy rash to be related to Shingrix.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: swelling/inflammation extending from deltoid muscle (injection site) to upper trapezius muscle.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: Chronic Muscle pain and chronic tiredness
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Malaise
Clinical narrative: Rigors, general malaise.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient developed a rash on the arm where the injection occurred.  The rash wasn't directly around the injection site, but on the front portion of the biceps muscle.  The patient's wife noticed the rash two days after the vaccine.  The rash wasn't blistered and it didn't itch or hurt the patient.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Nerve compression, Pain in extremity
Clinical narrative: The patient experienced arm soreness as well as stating she had pinched a nerve from this vaccine.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse symptoms reported.; an expired dose of PROQUAD (ROl 1216, 10/15/2019) was administered to a patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided. On 29-JAN-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (exact dose, frequency and route of administration were not reported) lot # R011216 and expiration date: 15-OCT-2019, for prophylaxis. The vaccine was reconstituted with sterile diluent. No additional adverse symptoms reported.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: varicella type rash over her right eyebrow going up her scalp on right side; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. In or around 19-OCT-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), she suffered varicella type rash over her right eyebrow going up her scalp on right side (rash vesicular). As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccination, the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the patient had not recovered from the rash vesicular. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Ear infection, Influenza virus test negative, Injection site discolouration, Injection site induration, Measles
Clinical narrative: right thigh induration and discoloration; macular, papular rash on the torso, face, extremities, palms, and soles of feet; the patient had fever of 101.2 F; right thigh induration; Koplik's spots in the mouth; left ear infection; This spontaneous report as received from a nurse refers to a 12 month old female patient. The concomitant medications included hepatitis a virus vaccine inactivated (HAVRIX) and pneumococcal 13v conj vaccine (crm197) (PREVNAR 13). None pertinent medical history, drug reactions and allergies were provided.  On 10-JAN-2020, the patient was vaccinated with dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), subcutaneously, lot # S013711, expiration date 11-JAN-2020 (exact dose not reported) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT) (dose, route of administration, indication, lot# and expiration date were not reported). On 11-JAN-2020, the patient had fever of 38.44 degrees of Celsius (101.2 degrees F), right thigh induration and discoloration, Koplik's spots in the mouth, macular, papular rash on the torso, face, extremities, palms, and soles of feet. It was reported that the treatment was given for adverse event. On 22-JAN-2020, the patient was prescribed diphenhydramine hydrochloride (BENADRYL) and cefdinir for left ear infection. Lot Check requested, reporter requested response as quickly as possible. The flu test was performed on an unknown date and the result was negative. It was reported that the patient sought medical attention and the intervention to prevent serious criteria was needed. The nurse also reported that there was no cancer nor overdose event. The nurse informed that the cases were likely mild case of measles and would most likely not result in any samples being submitted to the Varicella Zoster Virus Identification Program (VZVIP). The outcome of pyrexia was reported as recovered/resolved on 23-JAN-2020. The outcome of right thigh induration and discoloration, Koplik's spots in the mouth, macular, papular rash on the torso, face, extremities, palms, and soles of feet was unknown.  The causality assessment between the events and the suspect therapies was not provided.  Upon internal review, the events of fever, right thigh induration and discoloration, Koplik's spots in the mouth, macular, papular rash on the torso, face, extremities, palms, and soles of feet was determined to be medically significant.  This is one of five cases received from the same reporter.; Sender's Comments:  US-009507513-2002USA001548: US-009507513-2002USA001496: US-009507513-2002USA001425: US-009507513-2002USA001134:
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Measles post vaccine, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: right thigh induration and discoloration; macular, papular rash on the torso, face, extremities, palms, and soles of feet; the patient had fever of 101.2 F; right thigh induration; Koplik's spots in the mouth; left ear infection; This spontaneous report as received from a nurse refers to a 12 month old female patient. The concomitant medications included hepatitis a virus vaccine inactivated (HAVRIX) and pneumococcal 13v conj vaccine (crm197) (PREVNAR 13). None pertinent medical history, drug reactions and allergies were provided.  On 10-JAN-2020, the patient was vaccinated with dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), subcutaneously, lot # S013711, expiration date 11-JAN-2020 (exact dose not reported) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT) (dose, route of administration, indication, lot# and expiration date were not reported). On 11-JAN-2020, the patient had fever of 38.44 degrees of Celsius (101.2 degrees F), right thigh induration and discoloration, Koplik's spots in the mouth, macular, papular rash on the torso, face, extremities, palms, and soles of feet. It was reported that the treatment was given for adverse event. On 22-JAN-2020, the patient was prescribed diphenhydramine hydrochloride (BENADRYL) and cefdinir for left ear infection. Lot Check requested, reporter requested response as quickly as possible. The flu test was performed on an unknown date and the result was negative. It was reported that the patient sought medical attention and the intervention to prevent serious criteria was needed. The nurse also reported that there was no cancer nor overdose event. The nurse informed that the cases were likely mild case of measles and would most likely not result in any samples being submitted to the Varicella Zoster Virus Identification Program (VZVIP). The outcome of pyrexia was reported as recovered/resolved on 23-JAN-2020. The outcome of right thigh induration and discoloration, Koplik's spots in the mouth, macular, papular rash on the torso, face, extremities, palms, and soles of feet was unknown.  The causality assessment between the events and the suspect therapies was not provided.  Upon internal review, the events of fever, right thigh induration and discoloration, Koplik's spots in the mouth, macular, papular rash on the torso, face, extremities, palms, and soles of feet was determined to be medically significant.  This is one of five cases received from the same reporter.; Sender's Comments:  US-009507513-2002USA001548: US-009507513-2002USA001496: US-009507513-2002USA001425: US-009507513-2002USA001134:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, Wrong product administered
Clinical narrative: Inadvertently received a dose of proquad that had expired; Inadvertently received a dose of proquad that had expired; This spontaneous report was received from medical assistant refers to an 8-year-old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy of the patient included sterile diluent (MERCK STERILE DILUENT). On 03-FEB-2020, the patient was inadvertently vaccinated with third dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) with lot# R020814 and expiry date 16-JAN-2020 (strength, dose, route were not reported) for prophylaxis (wrong product administered and expired product administered). No symptoms was reported. The reporter stated that the patient received first two doses of the vaccines at unspecified times from country. No product quality complaint was reported. The outcome of wrong product administered and expired product administered was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling cold, Pain in extremity
Clinical narrative: arm really hurts; freezing; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced pain in arm and feeling cold. On an unknown date, the outcome of the pain in arm and feeling cold were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and feeling cold to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. Post vaccination the patient's arm really hurted and he was freezing. The reporter inquired how long will the events would last.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: chills; aches; headache; fever; This case was reported by a consumer via call center representative and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on an unknown date, did not had side effects).   On 28th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced chills, pain, headache and fever. On an unknown date, the outcome of the chills, pain, headache and fever were not recovered/not resolved.   It was unknown if the reporter considered the chills, pain, headache and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not provided. The age group was not reported but was selected as adult as per vaccine indication.  After second shot the patient experienced chills, aches, headache and fever. The reporter asked how long the events last.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: itchy red spots; Red spots; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than 2 weeks after receiving Shingrix, the patient experienced itchy rash and red spotty rash. On an unknown date, the outcome of the itchy rash and red spotty rash were unknown.   It was unknown if the reporter considered the itchy rash and red spotty rash to be related to Shingrix.  Additional details were provided as follows: The pateint received shingrix shot about 2 weeks ago and experienced  itchy red spots in a wide base across her back from waist up to bra band.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: had a reaction to Shingrix; This case was reported by a other health professional via interactive digital media and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient had a reaction to Shingrix. The follow up was not required.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling cold, Pain in extremity
Clinical narrative: arm really hurts; he's freezing; This case was reported by a other health professional via interactive digital media and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced pain in arm and feeling cold. On an unknown date, the outcome of the pain in arm and feeling cold were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and feeling cold to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter was patient's wife. The patient got the first dose of Shingrix on day before reporting.  The patient's arm really hurts and he was freezing. The reporter enquired how long would this event last. The follow up was not required.
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Hypoaesthesia, Injection site pain, Muscle spasticity, Pain
Clinical narrative: Diagnosis from ER was muscle spacicity; pain radiating from injection site to back; pain radiating from injection site to back, suspected brachial plexus; forearm numbness; This case was reported by a physician via sales rep and described the occurrence of muscle spasticity in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number CF9K4, expiry date unknown) for prophylaxis.   On 9th July 2019, the patient received the 1st dose of Shingrix .5 ml. In July 2019, less than a week after receiving Shingrix, the patient experienced muscle spasticity, injection site pain, back pain and numbness of upper extremities. On an unknown date, the outcome of the muscle spasticity, injection site pain and back pain were recovered/resolved and the outcome of the numbness of upper extremities was not recovered/not resolved.   The reporter considered the muscle spasticity, injection site pain, back pain and numbness of upper extremities to be possibly related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the had forearm numbness after vaccination. The patient had pain radiating from injection site to back, suspected brachial plexus. The patient did seek medical help from emergency room for muscle spacicity.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Product preparation issue, Product storage error
Clinical narrative: my right arm still hurts; bottle was freeze dried; all of it didn't dissolve; Inappropriate dose of vaccine administered; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain, product storage error, inappropriate reconstitution technique and inappropriate dose of vaccine administered. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the product storage error, inappropriate reconstitution technique and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received a dose of Shingrix in right arm. The patient still hurts over one year later at the injection site and on day of reporting patient moving throughout his or her arm making it week had this ever happened to anyone before. The patient did notice that the pharmacist was shaking the bottle and patient asked him why he did that, then he said because it was freeze dried, which led to product storage error. The pharmacist had to add liquid or something, the patient was wondering if might be all of it did not dissolve when it was injected into patient's arm and could that have caused the problems, which led to reconstitution technique and inappropriate dose of vaccine administered. The patient thought something's not right in his or her arm and did not even know what kind of physician would know what to do. The patient mentioned it to regular doctor and they just shrugged like they never heard of it before this was not normal. The patient enquired what should he or she do in this situation. The requesting consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Injected limb mobility decreased, Injection site pain, Poor quality sleep, Pyrexia
Clinical narrative: injection site hurts; coming down with the flu / feel like you are coming down with flu; slight fever; you do not want to move that muscle; restless night of sleep; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced injection site pain, influenza-like symptoms, fever, injected limb mobility decreased and sleep restless. The patient was treated with ibuprofen, benadryl (nos) (Benadryl) and paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain, influenza-like symptoms, fever, injected limb mobility decreased and sleep restless were recovered/resolved.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms, fever, injected limb mobility decreased and sleep restless to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient got the vaccine in night at 6:30 p.m.  It was very restless night of sleep. The bourbon or rum did not help. The patient probably should have taken Benadryl. The patient requested to take shortly before or after the injection Tylenol or ibuprofen and continue every 4 to 6 hours for 24 hours. The patient would felt coming down with the flu and might have slight fever. The injection site hurts, then move that muscle a lot, even though you were not going to move it. The follow up was not required. This is 1 of the 3 linked cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: my first shot hurts; had flu like symptoms for a couple of days; low grade fever; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, influenza-like symptoms and fever. On an unknown date, the outcome of the injection site pain and fever were unknown and the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms and fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The first short of vaccine hurt's the patient and had flu like symptoms for a couple of days plus a low grade fever. The follow up was not required. This is 1 of the 3 linked cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: injection site for second dose was defiinitely more sore; had flu like symtoms for 24 hours; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms and injection site pain. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms and injection site pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The injection site for 2nd dose was definitely more sore and had flu like symptoms for 24 hours. The localized pain at the injection site was much worse (could have been the shooter). But the flu like symptoms were not as bad. The follow up was not required. This is 1 of the 3 linked cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Malaise
Clinical narrative: inflamed arm; quite sick; This case was reported by a nurse via sales rep and described the occurrence of inflammation localized 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 inflammation localized and sickness. On an unknown date, the outcome of the inflammation localized and sickness were unknown.   It was unknown if the reporter considered the inflammation localized and sickness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient after vaccination had really inflamed arm and was quite sick.
Sex: U
Vaccine: VARZOS
Symptoms: Gait inability, Headache
Clinical narrative: the side effect of headaches / severe headaches; crippling; This case was reported by a consumer and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. In February 2020, less than 2 months after receiving Shingles vaccine, the patient experienced headache and unable to walk. On an unknown date, the outcome of the headache and unable to walk were unknown.   It was unknown if the reporter considered the headache and unable to walk to be related to Shingles vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received the first injection of the shingles vaccine and on day of reporting patient experiencing severe headaches. It has been about six weeks till reporting and it was crippling the patient. The patient enquired how long does this side effect last or was there a treatment to counter react this side effect. The requesting consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Myasthenia gravis crisis
Clinical narrative: it put him into a Myasthenia gravis crisis; This case was reported by a nurse via call center representative and described the occurrence of myasthenia gravis crisis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myasthenia gravis crisis (serious criteria GSK medically significant). On an unknown date, the outcome of the myasthenia gravis crisis was unknown.   It was unknown if the reporter considered the myasthenia gravis crisis to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced myasthenia gravis crisis. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: experienced vomiting after 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of vomiting in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included gluten intolerance.   On 18th January 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown.   It was unknown if the reporter considered the vomiting to be related to Shingrix.  Additional details were provided as follows: The patient experienced vomiting after 1st dose of Shingrix. The reporter asked if gluten present in Shingrix, as patient had gluten intolerance. The healthcare professional (HCP) unable to provide full details of vaccine. The reporter asked howto proceed over 6 months for 2nd dose of Shingrix. The reporter Did not consent to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Loss of personal independence in daily activities, Pain, Rash papular, Tenderness
Clinical narrative: Erythema; Raised rash; Soreness; Tenderness; unable to workout; This case was reported by a physician via call center representative and described the occurrence of erythema in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number GH455, expiry date 29th January 2022) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced erythema, raised rash, pain, tenderness and activities of daily living impaired. The patient was treated with methylprednisolone (Medrol) and antiinflammatory/antirheumatic products (Anti Inflammatory Drug (Nos)). On an unknown date, the outcome of the erythema, raised rash, tenderness and activities of daily living impaired were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the erythema, raised rash, pain, tenderness and activities of daily living impaired to be related to Shingrix.  Additional case details were reported as follows: The patient was unable to workout. The patent had Medrol pack on another anti inflammatory. The reporter consented to follow up. This case has been linked with case US2020015854, reported by same reporter.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Blister, Diarrhoea, Flatulence, Gastric disorder
Clinical narrative: pain in her right shoulder; blisters on the inside of her nose; Mucous stools; loose stool/Mucous diarrhoea mucous coming out; gas; stomach cramping; nausea; bad stomach problem; rash on the back of her right shoulder; headache; This case was reported by a consumer via call center representative and described the occurrence of gastric disorder in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a day after receiving Shingrix, the patient experienced headache. On 20th January 2020, the patient experienced gastric disorder and itchy rash. On 21st January 2020, the patient experienced loose stools, gas, stomach cramps, nausea, blister and mucus stools. On 27th January 2020, the patient experienced shoulder pain. The patient was treated with loperamide hydrochloride (Imodium) and nutritional supplement (Probiotic). On an unknown date, the outcome of the gastric disorder, loose stools, gas, stomach cramps, nausea, shoulder pain, blister and mucus stools were unknown and the outcome of the headache and itchy rash were recovered/resolved.   It was unknown if the reporter considered the gastric disorder, headache, itchy rash, loose stools, gas, stomach cramps, nausea, shoulder pain, blister and mucus stools to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and caused a bad stomach problem. She reported that she had a headache with an itch and rash on the back of her right shoulder which has since resolved. The patient had loose stools, gas and stomach cramping with mucous coming out. She experienced little blisters on the inside of her nose. She had nausea with diarrhea and she tried the BRAT diet and a probiotic and nothing worked. She also experienced pain in her right shoulder. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Mucous stools, Musculoskeletal pain, Nausea, Rash pruritic
Clinical narrative: pain in her right shoulder; blisters on the inside of her nose; Mucous stools; loose stool/Mucous diarrhoea mucous coming out; gas; stomach cramping; nausea; bad stomach problem; rash on the back of her right shoulder; headache; This case was reported by a consumer via call center representative and described the occurrence of gastric disorder in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a day after receiving Shingrix, the patient experienced headache. On 20th January 2020, the patient experienced gastric disorder and itchy rash. On 21st January 2020, the patient experienced loose stools, gas, stomach cramps, nausea, blister and mucus stools. On 27th January 2020, the patient experienced shoulder pain. The patient was treated with loperamide hydrochloride (Imodium) and nutritional supplement (Probiotic). On an unknown date, the outcome of the gastric disorder, loose stools, gas, stomach cramps, nausea, shoulder pain, blister and mucus stools were unknown and the outcome of the headache and itchy rash were recovered/resolved.   It was unknown if the reporter considered the gastric disorder, headache, itchy rash, loose stools, gas, stomach cramps, nausea, shoulder pain, blister and mucus stools to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and caused a bad stomach problem. She reported that she had a headache with an itch and rash on the back of her right shoulder which has since resolved. The patient had loose stools, gas and stomach cramping with mucous coming out. She experienced little blisters on the inside of her nose. She had nausea with diarrhea and she tried the BRAT diet and a probiotic and nothing worked. She also experienced pain in her right shoulder. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Headache, Injection site pain, Pain
Clinical narrative: Slight soreness of the injected left arm; headache; Feeling hot; Terrible whole body pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain, headache, feeling hot and general body pain. On an unknown date, the outcome of the injection site pain, headache, feeling hot and general body pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, headache, feeling hot and general body pain to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix vaccine in left deltoid and experienced soreness of the injected left arm and headache. Both injection site pain and headache were resolved . The headache lasted only a few days. The patient stated that about 1 to 2 months after receiving the vaccine, one night she woke up feeling hot with terrible whole body pain which resolved in about 10 minutes. The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: FLU4, UNK, VARZOS
Symptoms: Injection site vesicles, Pain in extremity, Rash
Clinical narrative: Left arm hurt / arm was sore; Spots that look like a burn; Blisters present at the injection site on the left arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 7L27G, expiry date 27th February 2022) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 5MM97, expiry date 30th June 2020) for prophylaxis and DIPHTHERIA TOXOID + TETANUS TOXOID (TD ADSORBED) for prophylaxis.   On 27th January 2020, the patient received Shingrix, Fluarix Quadrivalent 2019-2020 season and TD ADSORBED. On 28th January 2020, 1 days after receiving Shingrix, Fluarix Quadrivalent 2019-2020 season and TD ADSORBED, the patient experienced pain in arm, rash and injection site blisters. The patient was treated with prednisone. On an unknown date, the outcome of the pain in arm, rash and injection site blisters were unknown.   It was unknown if the reporter considered the pain in arm, rash and injection site blisters to be related to Shingrix and Fluarix Quadrivalent 2019-2020 season.  Additional details were received as follows: The reporter stated that the patient left arm hurt and there were spots that look like a burn and had blisters present at the injection site on the left arm. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Peripheral swelling, Ultrasound scan abnormal
Clinical narrative: enlarged lymph nodes; Swelling in his left arm; This case was reported by a other health professional via call center representative and described the occurrence of enlargement of lymph nodes in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2020, the patient received the 2nd dose of Shingrix .5 ml. On 17th January 2020, 4 days after receiving Shingrix, the patient experienced enlargement of lymph nodes and swelling arm. On an unknown date, the outcome of the enlargement of lymph nodes and swelling arm were recovering/resolving.   It was unknown if the reporter considered the enlargement of lymph nodes and swelling arm to be related to Shingrix.  Additional details were received as follows: The reporter stated that the patient received a second dose of the vaccine and experienced swelling in his left arm. The reporter stated that an ultrasound showed 2 enlarged lymph nodes. The patient returned on the day of reporting and the swelling had reduced. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: TDAP, UNK, VARZOS
Symptoms: Bedridden, Chills, Ear pain, Headache, Injection site pain
Clinical narrative: Could not get out of bed; pain all over his body, torso is hurting and the pain is constant with intermittent stabbing pains; headache; shivering; Ear pain; Thigh pain; Not feel well; pain at all three sights; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis and DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On 10th January 2020, the patient received the 1st dose of Shingrix (intramuscular), Influenza vaccine Quadrivalent 2019-2020 season (intramuscular) and Tdap Vaccine (intramuscular). On 11th January 2020, 1 days after receiving Shingrix, Influenza vaccine Quadrivalent 2019-2020 season and Tdap Vaccine, the patient experienced injection site pain. On 19th January 2020, the patient experienced feeling unwell, general body pain, headache, shivering, ear pain and pain in thigh. On 20th January 2020, the patient experienced bedridden. The patient was treated with antihistamine, muscle relaxants (Muscle Relaxant) and ketorolac trometamol (Toradol). On an unknown date, the outcome of the injection site pain, headache and shivering were recovering/resolving and the outcome of the feeling unwell and bedridden were unknown and the outcome of the general body pain, ear pain and pain in thigh were not recovered/not resolved.   Additional details were received as follows: The case was reported by patient's wife. The reporter stated that the patient after the day of vaccinations experienced pain at all three sights. The patient started to not feel well and by January 20 he could not get out of bed. The pain was bearable so he got up to eat then went back to bed and had pain all over his body. The patient torso was hurting and the pain was constant with intermittent stabbing pains. The patient had pain behind his left ear and inside his left thigh. The patient also suffered from headaches, a few times with shivering but has not had any fever. The patient had been to his family doctor, the Urgent Care and the emergency room where he was for several hours. The reporter consented to follow up. It was unknown if the reporter considered the injection site pain, feeling unwell, bedridden, general body pain, headache, shivering, ear pain and pain in thigh to be related to Shingrix, Influenza vaccine Quadrivalent 2019-2020 season and Tdap Vaccine.
Age: 66.0
Sex: M
Vaccine: TDAP, UNK, VARZOS
Symptoms: Malaise, Pain, Pain in extremity
Clinical narrative: Could not get out of bed; pain all over his body, torso is hurting and the pain is constant with intermittent stabbing pains; headache; shivering; Ear pain; Thigh pain; Not feel well; pain at all three sights; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis and DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On 10th January 2020, the patient received the 1st dose of Shingrix (intramuscular), Influenza vaccine Quadrivalent 2019-2020 season (intramuscular) and Tdap Vaccine (intramuscular). On 11th January 2020, 1 days after receiving Shingrix, Influenza vaccine Quadrivalent 2019-2020 season and Tdap Vaccine, the patient experienced injection site pain. On 19th January 2020, the patient experienced feeling unwell, general body pain, headache, shivering, ear pain and pain in thigh. On 20th January 2020, the patient experienced bedridden. The patient was treated with antihistamine, muscle relaxants (Muscle Relaxant) and ketorolac trometamol (Toradol). On an unknown date, the outcome of the injection site pain, headache and shivering were recovering/resolving and the outcome of the feeling unwell and bedridden were unknown and the outcome of the general body pain, ear pain and pain in thigh were not recovered/not resolved.   Additional details were received as follows: The case was reported by patient's wife. The reporter stated that the patient after the day of vaccinations experienced pain at all three sights. The patient started to not feel well and by January 20 he could not get out of bed. The pain was bearable so he got up to eat then went back to bed and had pain all over his body. The patient torso was hurting and the pain was constant with intermittent stabbing pains. The patient had pain behind his left ear and inside his left thigh. The patient also suffered from headaches, a few times with shivering but has not had any fever. The patient had been to his family doctor, the Urgent Care and the emergency room where he was for several hours. The reporter consented to follow up. It was unknown if the reporter considered the injection site pain, feeling unwell, bedridden, general body pain, headache, shivering, ear pain and pain in thigh to be related to Shingrix, Influenza vaccine Quadrivalent 2019-2020 season and Tdap Vaccine.