chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a Registered Nurse referring to a 4 years old female patient. The patient did not have any pre-existing physician-diagnosed allergy, birth defects, medical conditions or illness at time of vaccination. On 20-SEP-2018, the patient was vaccinated with M-M-R II lot # R011217, expiration date: 15-OCT-2019, subcutaneously (SC) in the left thigh (LT); she was also vaccinated that day with influenza virus vaccine (unspecified) lot # UJ012AD (expiration date not provided), intramuscular (IM) in the right thigh (RT); and diphtheria toxoid (+) pertussis acellular 1-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (DTAP-IPV) lot # C5497AA (expiration date not provided), IM RT both manufactured by Sanofi. All the vaccines were administered for prophylaxis and purchased with private funds. The administered doses of the vaccines experienced a freezer temperature excursion (not specified) (product storage error) as recorded from a digital data logger which occurred at the time of storage in clinical practice. None adverse effects were reported. (conflicting information reported that the patient received an unspecified treatment for the "none" experience). This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1809USA010598: US-009507513-1901USA002765: US-009507513-1901USA002758: US-009507513-1901USA002759: US-009507513-1901USA002760: US-009507513-1901USA002761: US-009507513-1901USA002762: US-009507513-1901USA002763: US-009507513-1901USA002764: US-009507513-1901USA002755: US-009507513-1901USA002754: US-009507513-1901USA002753: US-009507513-1901USA002757:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 08-JAN-2019, the patient was vaccinated with an expired dose of VAQTA (lot # N028743 and expiration date 23-NOV-2018) (strength, dose and frequency were not reported), intramuscularly for prophylaxis. No known adverse effects.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: Information has been received from a 71 years old female patient referring to herself with low blood pressure. The patient was allergic to a few unspecified antibiotics. The patient's concomitant medication included blood pressure medicine. On 15-JAN-2019 the patient was vaccinated with PNEUMOVAX 23 (route reported as "1 shot", lot # and expiration date unknown) for prevention of pneumococcal disease. On the same day within an hour of receiving her PNEUMOVAX 23 injection the patient experienced severe pain and her arm swelled up (south of the injection site) and doubled in size of her arm. The patient reported that she was unable to lift her arm. The patient had blood work and the result was not provided. The patient also reported that she spoke with her physician who recommended that ice be applied at the swelling location and the swelling was still present, but it had gotten better. The outcome of the events was recovering. Causality was not reported.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided. In October 2018, the patient was vaccinated with a dose of VARIVAX (strength, dose detail, lot # and expiration date were not reported), subcutaneously for prophylaxis during her first month of pregnancy (the patient was pregnant with last menstrual period (LMP) approximately in September 2018) (exposure during pregnancy). The pregnancy outcome was pending. No adverse effects were reported. The outcome of exposure during pregnancy was unknown.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 28-NOV-2018, the patient was administered improperly stored GARDASIL 9 for prophylaxis lot #1586751 and expiration date 16-FEB-2021 (strength, dose, frequency and route of administration were not reported). No adverse effects were reported. The lowest temperature of excursion was below 36°F / 2°C (34.9°F) for 28 minutes including below 32°F for 15 minutes. There was no previous temperature excursion. There was no digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-09507513-1901USA007858.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 28-NOV-2018, the patient was administered impoperly stored LIQUID PEDVAXHIB for prophylaxis lot #R005118 and expiration date 28-NOV-2020 (strength, dose, frequency and route of administration were not reported).  No adverse effects were reported.  The lowest temperature of excursion was below 36°F / 2°C (34.9°F) for 28 minutes including below 32°F for 15 minutes. There was no previous temperature excursion. There was no digital data logger involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-09507513-1901USA007858:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 28-NOV-2018, the patient was administered impoperly stored LIQUID PEDVAXHIB for prophylaxis lot #R005118 and expiration date 28-NOV-2020 (strength, dose, frequency and route of administration were not reported). No adverse effects were reported. The lowest temperature of excursion was below 36°F / 2°C (34.9°F) for 28 minutes including below 32°F for 15 minutes. There was no previous temperature excursion. There was no digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-09507513-1901USA007858.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 28-NOV-2018, the patient was administered improperly stored LIQUID PEDVAXHIB for prophylaxis lot #R005118 and expiration date 28-NOV-2020 (strength, dose, frequency and route of administration were not reported). No adverse effects were reported. The lowest temperature of excursion was below 36 degrees F / 2 degrees C (34.9 degrees F) for 28 minutes including below 32 degrees F for 15 minutes. There was no previous temperature excursion. There was no digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-09507513-1901USA007858.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 28-NOV-2018, the patient was administered impoperly stored ROTATEQ for prophylaxis lot #R013289 and expiration date 03-OCT-2019 and lot #N030152 and expiration date 01-SEP-2019 (strength, dose, frequency and route of administration were not reported). No adverse effects were reported. The lowest temperature of excursion was below 36°F / 2°C (34.9°F) for 28 minutes including below 32°F for 15 minutes. There was no previous temperature excursion. There was no digital data logger involved. This is one of several reports received from the same reporter.; Sender's Comments: US-09507513-1901USA007858:
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a 69 year old male patient, and his wife. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 15-JAN-2010, the male patient was administered the ZOSTAVAX by a healthcare provider at a health department (lot number, dosage and route of administration not provided). On or about 20-JUL-2010, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Shingles. The patient claims damages as a result of the ZOSTAVAX including: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Splenomegaly, White blood cell count increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of splenomegaly in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 30 days after receiving SHINGRIX, the patient experienced splenomegaly and white blood cell count increased. On an unknown date, the outcome of the splenomegaly and white blood cell count increased were recovering/resolving. It was unknown if the reporter considered the splenomegaly and white blood cell count increased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. About a month after vaccination, the patient experienced splenomegaly and elevated white blood cell (WBC). It was slowly resolving. The patient seen a different provider at another clinic. The reporter would need to get her consent and hoped her provider reported this probable adverse reaction. The reporter asked if splenomegaly was the adverse reaction. The reporter declined to provide demographics and any other information. Lab Comments: on an unknown date, White blood cell count was done.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity, Tenderness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 67-year-old male patient who received 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 pain in arm and influenza-like symptoms. The patient was treated with Pain Reliever (Nos). On an unknown date, the outcome of the pain in arm and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient reported very sore arm and had flu like symptoms for 2 to 3 days. After the 2 days his arm was less tender. It was reported that the patient started to feel better after the 2 to 3 days. The nurse spoke directly to patient and physician was informed. The nurse reported to patient with suggestion of use of pain reliever. The nurse agreed for follow up contact.
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Myalgia, Pain in extremity, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (1st dose received on the 30th August 2018, refer case for 1st dose US2019003458). On 17th January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced muscle pain, fever, pain in arm and nocturnal awakening. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the muscle pain, fever, pain in arm and nocturnal awakening were recovered/resolved. It was unknown if the reporter considered the muscle pain, fever, pain in arm and nocturnal awakening to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received a 2nd dose of SHINGRIX in the late afternoon. On Friday night, the patient experienced muscles became achy and the patient had a low-grade fever along with a sore arm, which woke her up. The adverse events were mild compared to those when the patient had after a 1st dose. On Saturday, the patient was fine but the cycle repeated on Sunday night. On Monday all symptoms were resolved.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse reaction in a patient who received 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 adverse reaction. On an unknown date, the outcome of the adverse reaction was recovered/resolved. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had been in contact with healthcare provider who had prescribed treatment. For tolerance to the 2nd dose of SHINGRIX, refer case US2019GSK011461.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Impaired work ability, Influenza like illness, Injected limb mobility decreased, Peripheral swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling arm in a patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of adverse event (Please refer the 1st dose case US2019GSK011459). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced swelling arm, erythema of extremities, skin discoloration, influenza-like symptoms and injected limb mobility decreased. On an unknown date, the outcome of the swelling arm, erythema of extremities, skin discoloration, influenza-like symptoms and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the swelling arm, erythema of extremities, skin discoloration, influenza-like symptoms and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced the reactions were more severe after the 2nd dose. The patient experienced arm swell, turn red, and discolor, and experienced flu-like symptoms which necessitated a loss of a day of work. The patient also could not lift my arm up past a certain point. It was three days later and still experiencing these reactions. The patient had been in contact with my healthcare provider who had prescribed treatment. This case has been linked with case US2019GSK011459, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling arm in a patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of adverse event (Please refer the 1st dose case US2019GSK011459). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced swelling arm, erythema of extremities, skin discoloration, influenza-like symptoms and injected limb mobility decreased. On an unknown date, the outcome of the swelling arm, erythema of extremities, skin discoloration, influenza-like symptoms and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the swelling arm, erythema of extremities, skin discoloration, influenza-like symptoms and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced the reactions were more severe after the 2nd dose. The patient experienced arm swell, turn red, and discolor, and experienced flu-like symptoms which necessitated a loss of a day of work. The patient also could not lift my arm up past a certain point. It was three days later and still experiencing these reactions. The patient had been in contact with my healthcare provider who had prescribed treatment. This case has been linked with case US2019GSK011459, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. In January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced fever, injection site pain, fatigue and muscle pain. On an unknown date, the outcome of the fever, injection site pain, fatigue and muscle pain were not recovered/not resolved. It was unknown if the reporter considered the fever, injection site pain, fatigue and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 30th October 2018, the patient received 1st dose of SHINGRIX. Six days after receiving 2nd dose of SHINGRIX it was reported that, the patient experienced low grade fever (body temperature was 99 to 100 degree F), site pain, fatigue and muscle aches. The patient stated that, site pain was expected and was not the issue, but asked how long should they be concerned about the fever, fatigue and muscle aches.
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. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient asked would taking ibuprofen for the SHINGRIX arm ache diminish its effectiveness.
Sex: U
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fainting in a patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, immediately after receiving BEXSERO, the patient experienced fainting (serious criteria GSK medically significant). On an unknown date, the outcome of the fainting was unknown. It was unknown if the reporter considered the fainting to be related to BEXSERO. Additional details were received as follows: The age at vaccination was not reported. The patient fainted shortly after vaccination with BEXSERO. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in an unspecified number of patients who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional information was provided as follows: The age at vaccination was not applicable for this report. The injection site pain lasted a week. The reporter gave consent to follow up. This case linked with case US2019GSK011434, reported by same reporter.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 11th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema and injection site pain. On 18th October 2018, the outcome of the injection site swelling, injection site erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The pharmacist was the patient. The patient received SHINGRIX on left deltoid. The pharmacist reported that his injection site reactions went from his deltoid down towards his elbow. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Inappropriate schedule of product administration, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (On 22nd June 2018, received 1st dose intramuscularly in left arm). On 15th January 2019, the patient received SHINGRIX (intramuscular) .5 ml. In January 2019, less than a week after receiving SHINGRIX, the patient experienced joint pain and muscle pain. On 15th January 2019, the patient experienced drug dose administration interval too long. The patient was treated with prednisone. On an unknown date, the outcome of the joint pain, muscle pain and drug dose administration interval too long were unknown. It was unknown if the reporter considered the joint pain and muscle pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The patient received 2nd dose late than recommended time frame, which led to lengthening of vaccination schedule. She experienced muscle pain and joint pain with the second dose of the vaccine. She stated that it felt like her muscles were on fire. On 17th January 2019, she saw her physician assistant due to the pain she was experiencing. She was then prescribed Prednisone to be taken for 5 days. The patient also wanted to know how effective the vaccine would be since she received the second dose after the recommended time frame. Consent to follow up was given. No further details were provided. Referred the patient to the healthcare professional and provided phone number to medical information for the healthcare professional to call.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fibromyalgia, Injection site pain, Insomnia, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of possible fibromyalgia in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 3rd July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In July 2018, 14 days after receiving SHINGRIX, the patient experienced fibromyalgia, injection site pain, muscle pain, joint pain and difficulty sleeping. On an unknown date, the outcome of the fibromyalgia, muscle pain, joint pain and difficulty sleeping were unknown and the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the fibromyalgia, injection site pain, muscle pain, joint pain and difficulty sleeping to be related to SHINGRIX. Additional details were reported as follows: The patient stated she had a reaction to the SHINGRIX vaccine received on left arm. The patient experienced pain at the injection site which lasted for about a week. About 2 weeks after receiving the vaccine the patient experienced muscle pain and joint pain on both sides of the body which was worse at night. Due to the pain the patient was not able to sleep at night. The patient thought she might had fibromyalgia but she had not been diagnosed with it. Since her symptoms were similar to what fibromyalgia could cause. The reporter consented to follow up. No further details were provided. The patient did not have her doctor's information but she would call back to provided that information. The patient did not have her physician's information but she would call back to provided that information.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a adult female 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 injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of SHINGRIX in left arm a little over 1 month before the date of reporting. The patient developed a rash at the injection site. The rash lasted for approximately 1 week, then went away. The reporter did not consent to follow-up.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Flu vaccine. Additional details were reported as follows: The age at vaccination was not reported. The reporter unable to provide patient's demographics, batch number, expiry date and other details. The patient had an allergic reaction to a previous dose of the flu vaccine but it was unknown which vaccine received. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received 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 erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After vaccination, the patient experienced a half dollar sized amount of redness around the injection site for weeks.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 10th December 2018, the patient received the 1st dose of SHINGRIX. In December 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, headache, shivering, fever and general body pain. On an unknown date, the outcome of the fatigue, headache, shivering, fever and general body pain were recovered/resolved. It was unknown if the reporter considered the fatigue, headache, shivering, fever and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter received SHINGRIX vaccine on left arm sometime in the afternoon. The patient reported that within 12 to 14 hours she began to experience fatigue, headache, shivering, fever and general body aches. All symptoms resolved within 12 hours. The reporter consented to follow up. The reporter gave permission for her physician to be contacted. The reporter was unable to provide additional information.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in an elderly male patient who received 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 shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 79 or 80 years old. The reporter did not have batch number of SHINGRIX at the time of call. The patient experienced mild case of shingles after receiving a dose of SHINGRIX. The reporter consented to follow up.
Age: 54.0
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site pain, Myalgia
Clinical narrative: Next morning experienced pain at injection site. In addition, body muscle and joint aches and pain. Headache.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report received from a registered nurse refers to a 12 months old male patient with no illness at time of vaccination. The patient did not have any pre-existing physician-diagnosed allergy, birth defects, medical conditions or illness at time of vaccination. His concomitant therapies and historical vaccines were not reported. On 14-SEP-2018, the patient was vaccinated with an improperly stored first dose of M-M-R II, subcutaneously (SC) in the right thigh, lot # N025899 (expiration date: 19-SEP-2019); with an improperly stored first dose of VARIVAX, SC, in the left thigh lot # N035940 (expiration date: 18-DEC-2019); with an improperly stored first dose of VAQTA intramuscularly (IM) in the right thigh, lot # R006210 (expiration date: 22-APR-2019) and with an improperly stored fourth dose of PREVNAR IM, in the left thigh, lot # T94429 (expiration date not reported). All the vaccines were administered for prophylaxis and purchased with public funds. The administered doses of the vaccines experienced a freezer temperature excursion (not specified) (product storage error) which occurred at the time of storage in clinical practice. No adverse effect was reported  (conflicting information reported that the patient received an unspecified treatment for the "none" experience). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA010598; US-009507513-1901USA002753; US-009507513-1901USA002754; US-009507513-1901USA002755; US-009507513-1901USA002756; US-009507513-1901USA002757; US-009507513-1901USA002758; US-009507513-1901USA002759; US-009507513-1901USA002760; US-009507513-1901USA002762; US-009507513-1901USA002763; US-009507513-1901USA002764; US-009507513-1901USA002765.
Sex: M
Vaccine: VARZOS
Symptoms: Corneal epithelium defect, Keratitis, Ophthalmic herpes zoster, Rash, Rash generalised
Clinical narrative: Information has been received on 23-JAN-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 23-JUL-2012, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster.) Shortly after receiving the ZOSTAVAX, the patient suffered widespread rash throughout his body and continues to suffer from this constant and painful rash. The patient also suffered blurry vision, corneal epithelial defects and epithelial keratitis and was ultimately diagnosed with herpes zoster ophthalmicus. As a direct and proximate result of ZOSTAVAX the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has suffered and incurred damages, including medical expenses, loss of accumulations and other economic and non-economic damages. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including but not limited to the patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages. Herpes zoster ophthalmicus and widespread rash throughout his body and continues to suffer from this constant and painful rash were considered to be disabling. Upon internal review, herpes zoster ophthalmicus was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: Information has been received on 23-JAN-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 23-JUL-2012, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster.) Shortly after receiving the ZOSTAVAX, the patient suffered widespread rash throughout his body and continues to suffer from this constant and painful rash. The patient also suffered blurry vision, corneal epithelial defects and epithelial keratitis and was ultimately diagnosed with herpes zoster ophthalmicus. As a direct and proximate result of ZOSTAVAX the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has suffered and incurred damages, including medical expenses, loss of accumulations and other economic and non-economic damages. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including but not limited to the patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages. Herpes zoster ophthalmicus and widespread rash throughout his body and continues to suffer from this constant and painful rash were considered to be disabling. Upon internal review, herpes zoster ophthalmicus was considered to be medically significant. Additional information has been requested.
Age: 1.58
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Lacrimation increased
Clinical narrative: Area around injection site with redness, swelling and warmth noted day after injection that got larger throughout the day. Saw in office 1/30/19 and mom stated the redness and swelling was down. In office today 1/30, no warmth, mild erythema approximately 8 cm with induration directly around injection site. Patient was also noted to have clear runny nose and watery eyes the day after the injection.
Age: 1.58
Sex: F
Vaccine: DTAP
Symptoms: Rhinorrhoea
Clinical narrative: Area around injection site with redness, swelling and warmth noted day after injection that got larger throughout the day. Saw in office 1/30/19 and mom stated the redness and swelling was down. In office today 1/30, no warmth, mild erythema approximately 8 cm with induration directly around injection site. Patient was also noted to have clear runny nose and watery eyes the day after the injection.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Swelling face
Clinical narrative: Face swelling, weak.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blindness, Dizziness, Fall, Nausea, Pallor
Clinical narrative: After administration of MENACTRO and BEXSERO, the patient had a pale complexion, felt dizzy and slid out of the chair she was sitting in. This author caught the patient before she fell on the floor and was able to put her back into a sitting position. The patient then lost vision in both eyes, but was breathing and able to answer commands. This author held the patient for about 5 minutes, until she was able to sit up by herself. A medical assistant did retrieve some water for the patient and provider was notified. The Provider came in and patient was able to answer her commands, however then experienced nausea and vomiting. Ice pack was applied to back of neck and patient put her head between her legs for an additional 5 minutes. Medical staff then moved her to the exam table where she was able to tell this author she could see again and could recall some events that had just transpired. Patient did stay on exam table for an additional 15 minutes, was examiner by provider and was able to ambulate out of office without difficulty, with her mother accompanying her.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Vomiting
Clinical narrative: After administration of MENACTRO and BEXSERO, the patient had a pale complexion, felt dizzy and slid out of the chair she was sitting in. This author caught the patient before she fell on the floor and was able to put her back into a sitting position. The patient then lost vision in both eyes, but was breathing and able to answer commands. This author held the patient for about 5 minutes, until she was able to sit up by herself. A medical assistant did retrieve some water for the patient and provider was notified. The Provider came in and patient was able to answer her commands, however then experienced nausea and vomiting. Ice pack was applied to back of neck and patient put her head between her legs for an additional 5 minutes. Medical staff then moved her to the exam table where she was able to tell this author she could see again and could recall some events that had just transpired. Patient did stay on exam table for an additional 15 minutes, was examiner by provider and was able to ambulate out of office without difficulty, with her mother accompanying her.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Erythema, Feeling cold, Peripheral swelling, Skin warm
Clinical narrative: Pt reported via email - on 28 Jan "I had the shot at 9 AM and at 4 PM I had cold chills and slight shakiness. I had to lie down. By morning (29 Jan) the arm was swollen and hot to the touch. I put ice on it. By noon I had a red mark going down the inside of the arm and across to the elbow where the swelling was. Late afternoon it had disappeared. It is much better today (30 Jan). Still slightly swollen but the heat is gone and almost back to normal."
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Tremor
Clinical narrative: Pt reported via email - on 28 Jan "I had the shot at 9 AM and at 4 PM I had cold chills and slight shakiness. I had to lie down. By morning (29 Jan) the arm was swollen and hot to the touch. I put ice on it. By noon I had a red mark going down the inside of the arm and across to the elbow where the swelling was. Late afternoon it had disappeared. It is much better today (30 Jan). Still slightly swollen but the heat is gone and almost back to normal."
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Erythema, Peripheral swelling, Skin warm, Tremor
Clinical narrative: Pt reported via email - on 28 Jan "I had the shot at 9 AM and at 4 PM I had cold chills and slight shakiness. I had to lie down. By morning (29 Jan) the arm was swollen and hot to the touch. I put ice on it. By noon I had a red mark going down the inside of the arm and across to the elbow where the swelling was. Late afternoon it had disappeared. It is much better today (30 Jan). Still slightly swollen but the heat is gone and almost back to normal."
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: Flu-like symptoms of achiness, severe back pain, chills and sweating, head pounding. The following day a red rash appeared on front trunk of body.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash erythematous
Clinical narrative: Flu-like symptoms of achiness, severe back pain, chills and sweating, head pounding. The following day a red rash appeared on front trunk of body.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Diarrhoea, Rash, Vomiting
Clinical narrative: Symptoms began with a rash on his face, back, and abdomen. And developed into vomiting and diarrhea which is ongoing. If symptoms persist or continue to worsen we will seek medical attention for dehydration.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 8 year old patient was given the adult dose. Patient's parents were immediately notified and warn of possible systemic/localized adverse effects. Parents denied any adverse effects. Parents informed no additional Hep A immunization needed since this was patient's second Hep A dose.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Dysphagia, Dyspnoea, Pruritus, Swollen tongue, Throat tightness
Clinical narrative: Hives and itchiness on arms, swollen tongue, tightness in throat, trouble breathing and swallowing all within 30 to 45 minutes of receiving vaccine. Took 50 mg of BENADRYL which reduced symptoms. Received a steroid shot to further reduce the skin reaction.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Hives and itchiness on arms, swollen tongue, tightness in throat, trouble breathing and swallowing all within 30 to 45 minutes of receiving vaccine. Took 50 mg of BENADRYL which reduced symptoms. Received a steroid shot to further reduce the skin reaction.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a physician via field representative and refers to a female patient of unknown age. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. In approximately 2018 (alse reported as "within the last year"), the patient was vaccinated with GARDASIL 9, intramuscularly (dose, lot# and expiration date were not reported) for prophylaxis. The physician reported that a patient received a dose of GARDASIL 9 and developed dizziness afterwards. The outcome of dizziness was unknown. The relatedness between the event and GARDASIL 9 was not reported.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site swelling, Pain
Clinical narrative: Chills, soreness at injection site, swelling at injection site, achiness.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pain
Clinical narrative: Flu like symptoms 12 hours after 1st and 2nd vaccination. Terrible body aches, headache.
Age: 27.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Erythema, Injection site bruising, Local reaction, Skin irritation, Swelling
Clinical narrative: PT HAD NO LOCAL REACTION AT THE TYPHOID INJECTION SITE. PT HAD A LARGE LOCAL REACTION WITH SLIGHT BRUISING AROUND THE INJECTION SITE OF ANTHRAX. PT HAS REDNESS SWELLING AND MINOR IRRITATION BELOW THE SITE ONTO THE BACK OF HIS ARM. PT RECEIVED THE VACCINES ON JAN 28TH AROUND 1300 AND BEGAN TO FEEL THE REACTION WORSENING AROUND 1900 ON 29 JAN.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Laboratory test normal, Muscular weakness
Clinical narrative: Patient complains of left arm weakness since after receiving SHINGRIX first dose vaccine at Pharmacy 9/2018.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hyperhidrosis, Pain
Clinical narrative: 2 days after vaccination patient experiencing chills and sweats without fever, diffuse pain. No trouble at injection site, no respiratory symptoms. Reported to pharmacy today; directed patient to reach out to primary care doctor, waiting to hear back from them.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Chills, Heart rate increased, Hyperhidrosis, Hypotension
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fainting in a 60-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of fatigue (1st dose received on 26th October 2018, refer case: US2019GSK016718). On 22nd January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 23rd January 2019, 1 days after receiving SHINGRIX, the patient experienced fainting (serious criteria GSK medically significant), feeling unwell, chills, low blood pressure, pulse rapid and sweating. On an unknown date, the outcome of the fainting was recovered/resolved and the outcome of the feeling unwell, chills, low blood pressure, pulse rapid and sweating were recovering/resolving. It was unknown if the reporter considered the fainting, feeling unwell, chills, low blood pressure, pulse rapid and sweating to be related to SHINGRIX. Additional details were received as follows: The case was reported by the patient's husband. At the time of reporting, in the morning patient woke up with not feeling good and she presented with chills as well.  The patient got up and tried to do some stuff, but she ended up fainting 3 times. The patient's blood pressure was very low, which was showed to be 20 points lower than normal range. The patient's pulse was up and sweaty. The patient was laying down helped and went back to sleep. At the time of reporting, the patient was not awake again and was feeling better.