chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Diarrhoea, Fatigue, Muscular weakness, Nausea, Pain
Clinical narrative: Information has been received from a consumer via a company employee, referring to her 17 year old daughter. Information of concomitant therapy, pertinent medical history and current condition was unknown. On 11-AUG-2018, the patient was administered her first dose of GARDASIL 9 (strength, frequency, route, lot# and expiration date unknown) for prophylaxis(reported as vaccination) at an unspecified medical walk in clinic. On August 2018, 24-36 hours post vaccination, the patient experienced aches, pain, muscle weakness, fatigue, diarrhea and nausea lasting until 13-AUG-2018(reported as yesterday and today). The outcome of the events was unknown. The causality assessment between the events and GARDASIL 9 was not provided.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 4 month old male patient. The patient's medical history and concomitant therapy were not reported. At the time of the vaccination, the patient had an upper respiratory tract infection. On 06-AUG-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # N030176, expiry date: 17-JUN-2019; dosing details unknown) orally for prophylaxis in a public health clinic/hospital using public funds (Incorrect product storage). Other suspect therapies administered on the same day included PREVNAR 13 (lot # T94424) in the right thigh and PENTACEL (lot #C5461AA) in the left thigh. The patient was previously administered with 1 dose of the vaccines. No prescription drug treatment was required for the experience. The patient did not receive any reverse reactions to the vaccine. The vaccine was stored at a temperature of 0 Celsius (C) degree to 1 C degree for 41 hours, below 0 C degree (-0.01) for 27 hours and between 9 C degree to 25 C degree (16.4 C) for 12 hours 30 minutes. Previous temperature excursion were 0 C degree to 1 C degree for 27 hours. Data logger was involved. No adverse effect reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1808USA003706.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 17-year-old male patient. The patient's concurrent conditions pertinent, medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date in July 2017, the patient was vaccinated with the first dose of VAQTA (dose, route of administration, #lot and expiration date were unspecified). On an unknown date in February 2018, the patient was vaccinated with the second dose of VAQTA (dose, route of administration, #lot and expiration date were unspecified). The pharmacist reported that the second dose was given only 5 and half months after the first dose. No adverse effect was reported.
Sex: M
Vaccine: HPV9
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: This spontaneous report was received from a physician refers to a 14 year old male patient. Information on the patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dosing details, batch/lot number unspecified) for prophylaxis. On 17-AUG-2018 the patient had fever and flu like symptoms. The patient was under observation for thirty to sixty minutes in the office. Outcome of pyrexia and influenza like illness was unknown. Causality assessment was not reported. No product quality complaint involved.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report has been received from a physician and a medical student, and refers to a 17 months old patient. No information was provided regarding the patient's concomitant medications, pertinent medical history, drug reaction or allergies. On an unknown date, the patient was vaccinated with VARIVAX lot number: N025935 and expiration date: 19-SEP-2019 for prophylaxis (route of administration was not provided), which was diluted with sterile diluent (MERCK STERILE DILUENT) lot number 00006430900. On 17-AUG-2018 (reported as "4 days ago"), the patient developed shingles, for which he was hospitalized on an unspecified date in August 2018. The physician was requesting PCR testing. At the time of reporting, it was unknown if the patient had recovered from the event. The causal relationship between shingles and the suspect therapies was not provided.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with improperly stored M-M-R II (lot # N023024, expiration date: 23-AUG-2019, dose and route of administration were not provided) for prophylaxis. Administered vaccine experienced multiple temperature excursion between 47 to 77 degrees Fahrenheit (55.5 degrees Fahrenheit) for 1 hour and 20 minutes. There was previous temperature excursion between 47 to 77 degrees Fahrenheit (51.9 degrees Fahrenheit) for 4 hours and 24 minutes. Digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: HEP, HEPA, HIBV, RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report has been received from a physician referring to an unspecified number of patients of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient were vaccinated with improperly stored doses of ROTATEQ lot # R012957 with expiration date of 11-JUN-2019 (indication, strength, dose, and frequency were not provided). For prophylaxis. Other suspect therapies included LIQUID PEDVAXHIB, VAQTA and RECOMBIVAX HB. The vaccines were exposed to a temperature range between 32 degree F to 35 degree F (32.5 degree F), during a time frame of 4 hours, which was called by a data logger. No previous temperature excursions were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with  improperly stored VARIVAX (which had a lot # of N021317 and an expiration date of 07-AUG-2019 also reported with this expiration date 07-FEB-2019; however, dosage number, route of administration, anatomical site were not reported), for prophylaxis. That was reconstituted with properly stored sterile diluent.  Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursions: 15 F degrees to 46 F degrees (38.1 F degrees) for 59 minutes on unknown date. Reportedly, there had been no previous temperature excursions and no data logger. Furthermore, no product quality complaint was involved.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant, referring to a 71 year old female patient. Information about medical history, concurrent condition and concomitant therapy was unknown. On 23-AUG-2018, the patient was vaccinated with PNEUMOVAX 23 (0.5ml given once, lot# M039060, expiration date: 22-MAY-2018; strength unknown) intramuscularly for prophylaxis (expired product administered). The PNEUMOVAX 23 had been stored appropriately, no temperature excursions. No adverse effects reported.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via company representative concerning a 65 year old male patient. Information on the patient's concomitant medications, pertinent medical history and drug reactions or allergies was unknown. On 26-AUG-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis at a pharmacy (dosing details, lot#, expiry date not reported). It was unknown by the reporter if the patient had received PNEUMOVAX 23 previously. On an unknown date in August 2018, the patient experienced redness and swelling at the injection site (vaccination site swelling and vaccination site erythema). On 27-AUG-2018, the patient went to the pharmacy due to the events. The patient was not given treatment for his symptoms; however, the pharmacist advised the patient to start taking TYLENOL for the symptoms. The pharmacist also advised the patient that if the symptoms continue or worsen, to seek medical attention with a physician. No product quality was involved. Outcome of vaccination site swelling and vaccination site erythema was unknown. The reporter's causality assessment was not provided.
Sex: F
Vaccine: HPVX
Symptoms: Anal cancer, Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a female patient of unknown age via a company representative, regarding herself. Information on the patient's pertinent medical history, concurrent condition, concomitant medication and drug allergies/reactions were unknown by the reporter. On an unspecified date, the patient received the Human papillomavirus (HPV) vaccine (lot number, dose, frequency and route was not provided) for prophylaxis, after the age of 50. It was reported that it was unknown if the patient was administered with GARDASIL 9 (unidentified Merck HPV vaccine) or GARDASIL (unidentified Merck HPV vaccine). It was reported that the patient was an anal cancer survivor, however it was unknown if the patient was diagnosed with "anal cancer" before or after administration (anal cancer). The outcome of the event anal cancer was unknown. The causality assessment for the event of anal cancer was not provided. This report was not associated with a product quality complaint. Upon internal review, the event of anal cancer was determined to be medically significant.
Age: 13.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a 13 years old female patient. Information about the patient's pertinent medical history, previous drug reactions, allergies and concomitant medications was not provided. The medical assistant reported that, on 28-AUG-2018, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose number, frequency, route of administration and anatomical location of vaccination were not provided; lot number R000692, expiration date 09-SEP-2019). No adverse effects were reported. Further information was not provided.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions and concomitant medications. On 29-AUG-2018, the patient was inadvertently vaccinated with an expired dose of VAQTA, intramuscular, lot # M039055 (expiration date: 22-JUL-2018), for prophylaxis (strength, dose and frequency, were not reported). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On 27-AUG-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis, lot # R002056 and expiration date 22-JAN-2020 (dose, strength, and route of administration were unknown). No adverse effects were reported. The reporter stated that the vaccine was stored at a temperature of -14 degree C to -10 degree C for 30 minutes and -9 degree C to 8 degree C for 2 hours. Digital data logger was involved.
Sex: F
Vaccine: HPV4
Symptoms: Poor quality drug administered
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with GARDASIL (lot#, expiration date, strength, dosing details and route of administration were not reported) for prophylaxis. On an unknown date, the patient felt she received defective product (poor quality drug administered and product quality issue) and asked if company knew the lot number of the GARDASIL she had received. The outcome of product quality issue was unknown. Causality assessment was not provided by the reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-AUG-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ, lot # R003114, expiration date 27-SEP-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 74 degrees Fahrenheit for 72 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA003367.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis.  Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain and product supply issue. On an unknown date, the outcome of the pain and product supply issue were unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The healthcare professional did not have a specific patient and was making a general comment about the SHINGRIX stating her patients had mentioned that the vaccine was painful and did not want to restart the series if the vaccine did not come in time for their 2nd dose. The healthcare professional reported that they were having a hard time getting SHINGRIX ordered.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Injection site pain, Migraine, Neck pain, Product label confusion
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of migraine in a adult female patient who received SHINGRIX for prophylaxis.  Co-suspect products included SHINGRIX for prophylaxis. Concurrent medical conditions included migraine headache. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml and the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, not applicable after receiving SHINGRIX and less than a year after receiving SHINGRIX, the patient experienced migraine, injection site pain, neck pain, product leaflet instructions confusion and product leaflet instructions confusion. On an unknown date, the outcome of the migraine, injection site pain, neck pain, product leaflet instructions confusion and product leaflet instructions confusion were unknown. It was unknown if the reporter considered the migraine, injection site pain and neck pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The health care professional (HCP) did not have vaccine information. The health care professional (HCP) reported that, their patient received a dose of SHINGRIX at local pharmacy. The reporter was unsure if the patient received correct vaccine or not. Because the patient told reporter that, it was stored incorrectly and administered by intramuscular route. The reporter confused about correct storage of SHINGRIX, thought it was supposed to be frozen and vaccinated subcutaneously like ZOSTAVAX vaccine. The patient had a migraine, neck pain, and injection site soreness with 2nd dose of SHINGRIX. The SHINGRIX vaccine was not administered at reporter's location. The reporter was confused regarding SHINGRIX vaccination and storage information. The reporter did not have further information regarding adverse event.
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of migraine in a adult female patient who received SHINGRIX for prophylaxis.  Co-suspect products included SHINGRIX for prophylaxis. Concurrent medical conditions included migraine headache. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml and the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, not applicable after receiving SHINGRIX and less than a year after receiving SHINGRIX, the patient experienced migraine, injection site pain, neck pain, product leaflet instructions confusion and product leaflet instructions confusion. On an unknown date, the outcome of the migraine, injection site pain, neck pain, product leaflet instructions confusion and product leaflet instructions confusion were unknown. It was unknown if the reporter considered the migraine, injection site pain and neck pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The health care professional (HCP) did not have vaccine information. The health care professional (HCP) reported that, their patient received a dose of SHINGRIX at local pharmacy. The reporter was unsure if the patient received correct vaccine or not. Because the patient told reporter that, it was stored incorrectly and administered by intramuscular route. The reporter confused about correct storage of SHINGRIX, thought it was supposed to be frozen and vaccinated subcutaneously like ZOSTAVAX vaccine. The patient had a migraine, neck pain, and injection site soreness with 2nd dose of SHINGRIX. The SHINGRIX vaccine was not administered at reporter's location. The reporter was confused regarding SHINGRIX vaccination and storage information. The reporter did not have further information regarding adverse event.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of general malaise in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 20th August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a day after receiving SHINGRIX, the patient experienced general malaise and fever. On an unknown date, the outcome of the general malaise and fever were unknown. It was unknown if the reporter considered the general malaise and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX a day prior to reporting date, and overnight experienced general malaise and a possible low grade fever. The reporter did not have access to lot number or expiration date.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Influenza like illness, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 65-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included carcinoma brain. On 25th June 2018, the patient received the 1st dose of SHINGRIX 1 ml. On an unknown date, several days after receiving SHINGRIX, the patient experienced pain, influenza-like symptoms, fever and overdose. On an unknown date, the outcome of the pain, influenza-like symptoms, fever and overdose were unknown. It was unknown if the reporter considered the pain, influenza-like symptoms and fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's wife. After receiving SHINGRIX, the patient developed aches, low grade fever and flu like symptoms. Also the  patient received 1.0 ml dose of SHINGRIX, instead of 0.5 ml, which led to overdose. This case has been linked with case US2018151969 (wife's case), reported by same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 19th August 2018, the patient received SHINGRIX. On 19th August 2018, less than a day after receiving SHINGRIX, the patient experienced chills, pain, nausea, fatigue, fever and headache. On 20th August 2018, the patient experienced feeling bad. On an unknown date, the outcome of the chills, nausea, fever and headache were recovered/resolved and the outcome of the pain and fatigue were not recovered/not resolved and the outcome of the feeling bad was unknown. It was unknown if the reporter considered the chills, pain, nausea, fatigue, fever, headache and feeling bad to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The evening of vaccination she had severe headache. She had a little bit of nausea and had been feeling fatigued and achy. On 20th August 2018, 1 day after vaccination the patient felt bad, but felt a little better Tuesday morning. By 6 PM Tuesday, 21st August 2018, she had to take Tylenol again because the headache and fever had come back. On 22nd August 2018, this morning, she was feeling better except that she still feels tired and achy. This experience had felt like the worst case of flu that she has had.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 19th August 2018, the patient received SHINGRIX. On 19th August 2018, less than a day after receiving SHINGRIX, the patient experienced chills, pain, nausea, fatigue, fever and headache. On 20th August 2018, the patient experienced feeling bad. On an unknown date, the outcome of the chills, nausea, fever and headache were recovered/resolved and the outcome of the pain and fatigue were not recovered/not resolved and the outcome of the feeling bad was unknown. It was unknown if the reporter considered the chills, pain, nausea, fatigue, fever, headache and feeling bad to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The evening of vaccination she had severe headache. She had a little bit of nausea and had been feeling fatigued and achy. On 20th August 2018, 1 day after vaccination the patient felt bad, but felt a little better Tuesday morning. By 6 PM Tuesday, 21st August 2018, she had to take Tylenol again because the headache and fever had come back. On 22nd August 2018, this morning, she was feeling better except that she still feels tired and achy. This experience had felt like the worst case of flu that she has had.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. 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 vaccination was not reported. The caller stated that he received a dose of SHINGRIX vaccine 2 months before the time of reporting. The patient had pain in the left arm (injected arm) that lasted a month. The patient stated that it was not a big deal but was surprised that it lasted that long. The patient did mention it to his doctor. The patient had given permission to contact the physician. This case has been linked with case US2018152725, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Inappropriate schedule of drug administration, Injection site pain, Insurance issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 22nd August 2018, immediately after receiving SHINGIRX, the patient experienced injection site pain and drug dose administration interval too long. On an unknown date, the outcome of the injection site pain and drug dose administration interval too long were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient got the 2nd dose late which led to lengthening of vaccination. The caller requested reimbursement for vaccine explained that the shot was very painful. The patient was upset and did not want to speak to the product team. The caller gave permission for someone to call her and ask questions in regards to side effects at a later date or time. The patient got a SHINGRIX shot late because the manufacturer did not provide the shot. The reporter ended up having to pay full price for the shot because our insurance did not cover it. The patient planned for the insurance to cover it, and it covered the 1st one but would not cover the 2nd one.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 61-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date unknown) for prophylaxis. On 16th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced fever, rash, injection site pain and pain in arm. The patient was treated with paracetamol (Tylenol). In August 2018, the outcome of the fever and injection site pain were recovered/resolved. On an unknown date, the outcome of the rash was recovering/resolving and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the fever, rash, injection site pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, the patient experienced fever for 3 days, pain at injection site lasting several days and also had a rash on their torso. The patient took Tylenol for the pain in her arm and that helped to resolve the pain. The rash had also dissipated at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported adverse event during click to chat forum. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The HCP reported that the patient experienced a severe systemic reaction after receiving initial dose of SHINGRIX. No further details were available at the time of reporting.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included breast cancer, cataract extraction, chemotherapy and axillary lymphadenectomy (of right arm). Previously administered products included ZOSTAVAX (received on an unknown date). Concurrent medical conditions included neuropathy peripheral (severe neuropathy of hands and feet). In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to SHINGRIX. Additional information was received as follows: The patient was a breast cancer survivor. She could only receive vaccines on the left side, on her arm since she has had lymph node removed from the right arm. She was on chemotherapy regimen while she underwent treatment for breast cancer. She inquired about optic ischemic neuropathy and its instance with SHINGRIX vaccine, since she had severe neuropathy in her hands and feet. The patient received SHINGRIX on the left arm. The patient stated she experienced redness, and raised skin at the injection site which lasted for about total of one week. The patient had denied permission to contact their physician. The patient was provided information in regards to optic ischemic neuropathy from the prescribing information. No further details were provided.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site rash, Injection site warmth, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 69-year-old female patient who received SHINGRIX (batch number G933B, expiry date 22nd November 2020) and (batch number 4F7K7, expiry date 5th December 2020) for prophylaxis. On 20th August 2018, the patient received SHINGRIX .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site rash, painful rash, raised rash, erythematous rash, injection site warmth and chills. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site rash, painful rash, raised rash, erythematous rash, injection site warmth and chills were not recovered/not resolved.  The reporter considered the injection site rash, painful rash, raised rash, erythematous rash, injection site warmth and chills to be almost certainly related to SHINGRIX. Additional details were provided as follows: The SHINGRIX adjuvant batch number was corrected from 457K7 to 4F7K7, as per sales data sheet. On 22nd August 2018, at morning, the patient called the healthcare professional and reported the following; After receiving SHINGRIX, the patient experienced rash at the injection site that was tender, red, warm to touch and raised-the size of 2.5-3.5 inches.  The patient took ibuprofen for chills as well. The symptoms were not resolved.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 69-year-old female patient who received SHINGRIX (batch number G933B, expiry date 22nd November 2020) and (batch number 4F7K7, expiry date 5th December 2020) for prophylaxis. On 20th August 2018, the patient received SHINGRIX .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site rash, painful rash, raised rash, erythematous rash, injection site warmth and chills. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site rash, painful rash, raised rash, erythematous rash, injection site warmth and chills were not recovered/not resolved.  The reporter considered the injection site rash, painful rash, raised rash, erythematous rash, injection site warmth and chills to be almost certainly related to SHINGRIX. Additional details were provided as follows: The SHINGRIX adjuvant batch number was corrected from 457K7 to 4F7K7, as per sales data sheet. On 22nd August 2018, at morning, the patient called the healthcare professional and reported the following; After receiving SHINGRIX, the patient experienced rash at the injection site that was tender, red, warm to touch and raised-the size of 2.5-3.5 inches.  The patient took ibuprofen for chills as well. The symptoms were not resolved.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 82-year-old female patient who received SHINGRIX for prophylaxis. On 28th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 28th July 2018, immediately after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the patient experienced injection site pain. The patient was treated with TYLENOL. In August 2018, the outcome of the injection site erythema was recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in the left arm and immediately after receiving the injection, she had redness at the injection site. The patient stated that the redness went away after 1 week. The Patient was experiencing pain at the injection site and stated that she felt the pain whenever she lifted her arm or reached for something. The patient was not sure when the pain started. The patient stated that she had been taking TYLENOL for the pain.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 20th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 21st August 2018, the patient experienced injection site erythema, feeling unwell, fever, injection site warmth and injection site swelling. SHINGRIX was continued with no change. On an unknown date, the outcome of the injection site erythema, feeling unwell, fever, injection site pain, injection site warmth and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, feeling unwell, fever, injection site pain, injection site warmth and injection site swelling to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient stated that on the same day that she received the injection, she experienced soreness at the injection site. On 21st August 2018, 1 day after vaccination, the patient experienced injection site erythema, feeling unwell, fever, injection site warmth and injection site swelling. The patient stated that the day before reporting, she noticed redness at the injection site that is raised and feels hot to the touch. The patient stated that she was not feeling well and she was running a slight fever. The patient stated that her not feeling well and the fever started afternoon on the prior day before the reporting date. The patient had not been to see her doctor, however, she had a nurse at the school check it out and also reported this to the pharmacy.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 20th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 21st August 2018, the patient experienced injection site erythema, feeling unwell, fever, injection site warmth and injection site swelling. SHINGRIX was continued with no change. On an unknown date, the outcome of the injection site erythema, feeling unwell, fever, injection site pain, injection site warmth and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, feeling unwell, fever, injection site pain, injection site warmth and injection site swelling to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient stated that on the same day that she received the injection, she experienced soreness at the injection site. On 21st August 2018, 1 day after vaccination, the patient experienced injection site erythema, feeling unwell, fever, injection site warmth and injection site swelling. The patient stated that the day before reporting, she noticed redness at the injection site that is raised and feels hot to the touch. The patient stated that she was not feeling well and she was running a slight fever. The patient stated that her not feeling well and the fever started afternoon on the prior day before the reporting date. The patient had not been to see her doctor, however, she had a nurse at the school check it out and also reported this to the pharmacy.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness, Product administered at inappropriate site
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of limbs stiffness in a 60-year-old female patient who received SHINGRIX (batch number M224F, expiry date 8th February 2021) for prophylaxis. On 1st August 2018, the patient received SHINGRIX. On 1st August 2018, immediately after receiving SHINGRIX, the patient experienced limbs stiffness, shoulder pain, injected limb mobility decreased and wrong route of administration. The patient was treated with ibuprofen and medication unknown (Ice Pack (Nos)). On 15th August 2018, the outcome of the limbs stiffness was recovered/resolved. On 16th August 2018, the outcome of the shoulder pain was recovered/resolved. On an unknown date, the outcome of the injected limb mobility decreased and wrong route of administration were unknown. It was unknown if the reporter considered the limbs stiffness, shoulder pain and injected limb mobility decreased to be related to SHINGRIX. Additional information was received as follows: The patient experienced significant pain after injection, and difficulty in moving her arm. This required evaluation in urgent care. The patient received SHINGRIX approximately 2 inches above the recommended site in the deltoid, which led to wrong route of administration. The healthcare professional uncertain where the vaccine was actually administered. If it reached the muscle, in the joint, tendon.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity, Pruritus, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 20th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, 18 hrs after receiving SHINGRIX, the patient experienced pruritus. On 20th August 2018, the patient experienced pain in arm and influenza like illness. The patient was treated with paracetamol (Tylenol) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the pruritus and pain in arm were not recovered/not resolved and the outcome of the influenza like illness was unknown. It was unknown if the reporter considered the pruritus, pain in arm and influenza like illness to be related to SHINGRIX. Additional details were provided as follows: In the morning, around 10:30 AM, the patient received SHINGRIX on left arm. Less than a day after receiving SHINGRIX, the patient arm hurt the first day and then got bad and her arm was still sore to the touch. Less than a week after receiving SHINGRIX, the patient felt like flu and received Tylenol. Around 6:00 pm on Tuesday, the patient experienced itching. Two days later, the patient had an incredible itch on the palms of her hands and the soles of her feet. The patient was still taking Benadryl and the itching had not resolved. This is 1 of the 4 linked cases reported by the same reporter.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Limb discomfort, Mobility decreased, Muscle spasms, Neck pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included paraplegia (Patient is a paraplegic and has neurological issues). On 20th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, several hours after receiving SHINGRIX, the patient experienced leg cramps, headache, neck pain and leg discomfort. On 20th August 2018, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, leg cramps, headache, neck pain and leg discomfort were recovered/resolved. It was unknown if the reporter considered the pain in arm, leg cramps, headache, neck pain and leg discomfort to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. In the morning around 10:30 AM, the patient received SHINGRIX on right arm. Six hours after receiving SHINGRIX, the patient experienced arm pain and moved into neck and head pain with a bad headache. Then (several hours after vaccination) the patient experienced spasms in both legs and he could not straighten out his legs which lasted 8 hours. All of his side effects had since resolved. This is 1 of the 4 linked cases reported by the same reporter.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included paraplegia (Patient is a paraplegic and has neurological issues). On 20th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, several hours after receiving SHINGRIX, the patient experienced leg cramps, headache, neck pain and leg discomfort. On 20th August 2018, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, leg cramps, headache, neck pain and leg discomfort were recovered/resolved. It was unknown if the reporter considered the pain in arm, leg cramps, headache, neck pain and leg discomfort to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. In the morning around 10:30 AM, the patient received SHINGRIX on right arm. Six hours after receiving SHINGRIX, the patient experienced arm pain and moved into neck and head pain with a bad headache. Then (several hours after vaccination) the patient experienced spasms in both legs and he could not straighten out his legs which lasted 8 hours. All of his side effects had since resolved. This is 1 of the 4 linked cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included paraplegia (Patient is a paraplegic and has neurological issues). On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year 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 vaccination was not reported. The reporter spoke to a friend who received SHINGRIX vaccine and her arm killed her. The patient had denied permission to contact their physician. No additional details were available. This case is 1 of the 4 linked cases reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itchy upper limbs in a adult male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included paraplegia (Patient is a paraplegic and has neurological issues). On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced itchy upper limbs. On an unknown date, the outcome of the itchy upper limbs was unknown. It was unknown if the reporter considered the itchy upper limbs to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter spoke to a friend whose husband received SHINGRIX vaccine. The patient experienced itching on his arms after receiving the vaccination. No additional details were available. The patient had denied permission to contact their physician. This case is 1 of the 4 linked cases reported by the same reporter.