chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On unknown dates in 2013, the patient received three separate doses of GARDASIL 9 injection (dose, lot number and expiration date were not reported). On 01-AUG-2018, the patient was inadvertently vaccinated with the fourth dose of GARDASIL 9 injection (dose, lot number and expiration date were not reported). No adverse effects were reported.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Affective disorder, Personality change
Clinical narrative: This spontaneous report was received from a nurse reporting from the doctor's office, via company representative, on behalf of the patient's mother, concerning a 24 year old female patient. The patient's historical condition, concurrent condition and concomitant therapy were unknown. On an unknown date, also reported as "years ago", at an unspecified age, the patient was vaccinated with GARDASIL  (strength, dose, route, frequency, lot# and expiration date were not reported) for prophylaxis. She received all 3 doses (unspecified dates). According to the patient's mother, the patient experienced a moody personality (not specified). On an unknown date in 2018, reported as "recently", the patient received the 1 dose of GARDASIL 9 (strength, dose, route, frequency, lot# and expiration date indication were not reported) for prophylaxis. On an unknown date in 2018, the patient's mother reported that she believed that her daughter experienced personality change after receiving GARDASIL 9, which she described as "moody". No hospitalization was required and no treatment was given for the events. It was unknown if the event presented a significant disability or incapacity, if laboratory diagnostics-studies were performed or if the patient sought for medical attention. The adverse event was not cancer and the patient did not overdosed. At the time of reporting, the outcome of personality change and moody was not recovered. Additionally, the causality assessment between GARDASIL 9 and the aforementioned event was not reported.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning multiple patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD, lot #N010865, expiration date 01-OCT-2018, albumin status of recombinant human albumin (rHA) (strength, dose, frequency and route of administration were not reported) and with improperly stored doses of VARIVAX, lot #M000997, expiration date 07-JAN-2018 (strength, dose, frequency and route of administration were not reported) for prophylaxis. The vaccines were reconstituted with a properly stored sterile diluent (lot # and expiration date were not reported). The temperature excursion was reported as 15 °F to 46 °F (23.4°F) for a time frame of 2 hours and 57 minutes. Previous temperature excursion was reported as 6 °F to 14 °F (13.4 °F) for 2 hours. Digital data logger was involved to capture the temperature excursions. No product quality complaint (PQC) was involved. Follow-up information was received on 24-JUL-2018. Additional information has been requested. This is non-valid report due to lack of patient identifiers. Follow-up information was received on 24-JUL-2018 from the medical assistant who provided patient identifiers for the reported event. The patient was a 12-month-old male who on 24-JAN-2018 was vaccinated with improperly stored dose of VARIVAX lot #M040137 with the expiration date of 28-SEP-2018. At the time of the excursion, the vaccine was deemed stable. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA012551: US-009507513-1807USA012552: US-009507513-1807USA012553: US-009507513-1807USA012554: US-009507513-1807USA012555: US-009507513-1712USA013102.
Age: 63.0
Sex: M
Vaccine: RAB
Symptoms: Myalgia, Neuropathy peripheral
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of neuropathy in a 63-year-old male patient who received RABAVERT (batch number 644011A, expiry date unknown) for prophylaxis. Concomitant products included RABAVERT, RABAVERT and RABAVERT. On 18th July 2018, the patient received the 4th dose of RABAVERT. In July 2018, less than a month after receiving RABAVERT, the patient experienced neuropathy (serious criteria GSK medically significant). On an unknown date, the patient experienced muscle pain. On an unknown date, the outcome of the neuropathy and muscle pain were unknown. It was unknown if the reporter considered the neuropathy and muscle pain to be related to RABAVERT. Additional information was reported as follows: The batch number for concomitant dose of RABAVERT was reported as 589011A. The patient was vaccinated with RABAVERT for a animal bite, where it was a squirrel bite. The reporter stated that, he received the first two doses of RABAVERT at an emergency room hospital at a different location, whereas the 3rd and the 4th dose were administered at a different location. The patient took the 1st and the 2nd dose, 3 days apart from each other. The patient was vaccinated with the 3rd and the 4th dose of RABAVERT a week apart from each other. On 18th July 2018, last Wednesday, prior to the date of reporting, the patient was vaccinated with the 4th dose of RABAVERT. One week prior to the date of vaccination of the 4th dose, the patient was vaccinated with the 3rd dose, 3 days prior to the date of vaccination for 3rd dose he had his 2nd dose and same for the 1st dose too. On the date of reporting, the patient called concerned about hearing of a recall of a rabies vaccine and was concerned if his product or any of its components were from recall. The patient did not provide the name of recalled product or company at the time of reporting, but however in the follow-up information the batch numbers were updated. The patient also noted during the conversation that he was having muscle pain and neuropathy which could also be rabies and was seeking if he needed other medication treatment if he had rabies. The patient was a lawyer, as stated by him; he received a call back from the Center for disease control and prevention (CDC) during the conversation and was unable to complete all questions. The patient was provided serial number (SR#) in order to call back again.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 66-year-old female patient who received SHINGRIX (batch number 49ST9, expiry date 4th July 2020) for prophylaxis. On 20th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced fever, headache and general body pain. On an unknown date, the outcome of the fever and general body pain were recovered/resolved and the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the fever, headache and general body pain to be related to SHINGRIX. Additional details were provided as follows: It was unsure of exactly when the symptoms began after vaccination. Vaccination was given on Friday and patient discussed the symptoms on Monday, saying all but headached resolved.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site hypoaesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site numbness in a 86-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 23rd July 2018) for prophylaxis. On 23rd July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 23rd July 2018, immediately after receiving SHINGRIX, the patient experienced injection site numbness. On 23rd July 2018, the outcome of the injection site numbness was recovered/resolved. It was unknown if the reporter considered the injection site numbness to be related to SHINGRIX. Additional information was received as follows: The pharmacist reported that right after the injection the patient experienced numbness that started at the injection site and went down her arm. After 5 minutes the numbness resolved. The patient did not feel any further symptoms and did not have any swelling.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site joint pain, Injection site pain, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 72-year-old male patient who received SHINGRIX for prophylaxis. On 29th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th May 2018, 1 days after receiving SHINGRIX, the patient experienced muscle pain, fatigue and injection site joint pain. On an unknown date, the outcome of the muscle pain, fatigue and injection site joint pain were recovered/resolved. It was unknown if the reporter considered the muscle pain, fatigue and injection site joint pain to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine on the left arm. The patient experienced the events the morning after getting the vaccination, his shoulder was sore at the injection site area and he felt tired. The events resolved within a day. The patient gave contact details of the physician.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site pain, Myalgia, Nausea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On 10th May 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, joint pain, muscle pain, nausea and chills. On an unknown date, the outcome of the injection site pain, joint pain, muscle pain, nausea and chills were recovered/resolved. It was unknown if the reporter considered the injection site pain, joint pain, muscle pain, nausea and chills to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. Around 10th May 2018, the patient received SHINGRIX. The patient experienced pain at the injection site, chills, nausea, muscle pain and joint pain.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site discomfort
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site discomfort in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site discomfort. On an unknown date, the outcome of the injection site discomfort was unknown. It was unknown if the reporter considered the injection site discomfort to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional reported that a lot of her patients had been complaining about feeling the vaccine going into the muscle when administering the vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a elderly female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, less than a month after receiving SHINGRIX, the patient experienced injection site warmth, injection site muscle pain and injection site induration. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site warmth, injection site muscle pain and injection site induration were recovered/resolved. It was unknown if the reporter considered the injection site warmth, injection site muscle pain and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination could be 71 years or 72 years. The patient was 72 years old at the time of reporting. The patient received SHINGRIX in the left deltoid. The patient experienced warmth, hardness and soreness of the muscle at injection site for about 2 days and that she was treated with Ibuprofen. The patient gave contact details of the physician. For tolerance to 2nd dose of SHINGRIX, refer case US2018GSK134425.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and feels awful. On an unknown date, the outcome of the fever and feels awful were unknown. It was unknown if the reporter considered the fever and feels awful to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The reporter called in for a friend who got the SHINGRIX vaccine and then experienced a fever and felt awful. The patient's healthcare provider's details were not available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash 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 rash. SHINGRIX was discontinued. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional reported that patient would not be getting 2nd dose of SHINGRIX due to a rash from the 1st dose. The healthcare professional did not want to provide any additional information.
Sex: U
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 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 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 reported as follows: The age group was not provided, but was selected adult as per the vaccine indication. The health care professional (HCP) reported that the patient received a dose of SHINGRIX and then the patient experienced active Shingles. No additional information was provided.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of erythema of extremities in a 54-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020) for prophylaxis. On 21st July 2018, the patient received SHINGRIX (intramuscular). On 22nd July 2018, 1 days after receiving SHINGRIX, the patient experienced erythema of extremities, raised rash and itchy upper limbs. On an unknown date, the outcome of the erythema of extremities and itchy upper limbs were not recovered/not resolved and the outcome of the raised rash was unknown. It was unknown if the reporter considered the erythema of extremities, raised rash and itchy upper limbs to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient experienced red, itchy, and raised areas on a large part of the arm. The adverse events were reported through social media. The redness and itching had continued to increase since then.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 54-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 20th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 20th July 2018, less than a day after receiving SHINGRIX, the patient experienced fever, general body pain and chills. On 22nd July 2018, the patient experienced itchy rash and erythematous rash. On an unknown date, the outcome of the fever, general body pain and chills were recovered/resolved and the outcome of the itchy rash and erythematous rash were not recovered/not resolved. It was unknown if the reporter considered the fever, general body pain, chills, itchy rash and erythematous rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the medical assistant on behalf of the patient. The patient received SHINGRIX on left deltoid. On the same day after receiving SHINGRIX, the patient experienced fever, chills and body aches. The caller stated that on Sunday, 2 days after receiving SHINGRIX, the patient noticed an itchy reddened rash on her left arm that was approximately 5 inches away from the injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Lymphadenopathy, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a female patient who received SHINGRIX for prophylaxis. On 23rd July 2018, the patient received the 1st dose of SHINGRIX. On 23rd July 2018, several hours after receiving SHINGRIX, the patient experienced chills, injection site pain and fever. On 24th July 2018, the patient experienced swollen glands. On an unknown date, the outcome of the chills, injection site pain and fever were recovered/resolved and the outcome of the swollen glands was not recovered/not resolved. It was unknown if the reporter considered the chills, injection site pain, swollen glands and fever to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. At 15:30, the patient received SHINGRIX on right arm. The night of the vaccination the patient presented with chills, fever and pain at injection site. The swollen gland was a little better but still swollen.
Age: 62.0
Sex: F
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 a 62-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date 31st October 2019) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 10th April 2018). On 21st July 2018, the patient received the 2nd dose of SHINGRIX. On 24th July 2018, 3 days 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: On 24th July 2018, the patient was diagnosed with shingles.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Headache, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 1st May 2018, the patient received the 1st dose of SHINGRIX. On 2nd May 2018, 1 days after receiving SHINGRIX, the patient experienced headache, appetite absent and fever. On an unknown date, the outcome of the headache, appetite absent and fever were recovered/resolved. It was unknown if the reporter considered the headache, appetite absent and fever to be related to SHINGRIX. Additional details were reported as follows: The next morning after receiving a dose of SHINGRIX, the patient experienced symptoms which resolved by the 3rd day of vaccination. This case was linked with case US2018GSK137751, reported by the same reporter for the same patient.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received SHINGRIX (batch number A4X57, expiry date 13th July 2020) for prophylaxis. On 17th April 2018, the patient received SHINGRIX (subcutaneous). In April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On 17th April 2018, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The health care professional (HCP) reported that, the patient received the SHINGRIX via subcutaneous route, which led to inappropriate route of vaccination.  The reporter also stated that, within 24 hours the patient experienced redness and swelling at the injection site. The onset of symptoms was within 24 hours and were resolved since then. No additional information was provided.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site mass, Injection site nodule, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 19th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 19th June 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain, injection site bruising, injection site erythema and injection site lump. On an unknown date, the outcome of the injection site pain, injection site bruising, injection site erythema and injection site lump were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site bruising, injection site erythema and injection site lump to be related to SHINGRIX. Additional details reported as follows: The patient immediately experienced pain, soreness, bruising, and a big red knot at the injection site after receiving SHINRIX. It resolved within 2 weeks. No additional information provided.
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Pain, Pain in extremity, Tenderness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020) for prophylaxis. On 28th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm, shoulder pain, neck pain and shooting pain. On an unknown date, the outcome of the pain in arm, shoulder pain, neck pain and shooting pain were recovering/resolving. It was unknown if the reporter considered the pain in arm, shoulder pain, neck pain and shooting pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. In 2018, the health care professional reported that the patient experienced tenderness of the arm with pain shooting to the should and neck and distally to the fingers. The health care professional also stated the adverse event described was similar to the pattern of shingles, however, it could be also been due to strenuous weight baring exercises the patient did earlier that same day. This case has been linked with US2018133481, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Limb mass, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of local swelling in a female patient who received SHINGRIX for prophylaxis. On 13th June 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced local swelling, extremities hot feeling of, pain in arm, erythema of extremities and swelling arm. On an unknown date, the outcome of the local swelling, extremities hot feeling of, pain in arm, erythema of extremities and swelling arm were recovered/resolved. It was unknown if the reporter considered the local swelling, extremities hot feeling of, pain in arm, erythema of extremities and swelling arm to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient who was a nurse. The age at vaccination was not reported. For about 1 week following SHINGRIX vaccination (timing unknown), the patient had a large lump which travelled down her arm with pain, redness, swelling, and heat, which had fully resolved. The GlaxoSmithKline account manager did not have lot number or expiry date for vaccine.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 87-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 2020) for prophylaxis. On 27th March 2018, the patient received SHINGRIX. In April 2018, 30 days after receiving SHINGRIX, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown. It was unknown if the reporter considered the shingles and pain to be related to SHINGRIX. Additional details reported as follows: The healthcare professional reported that after receiving the SHINGRIX the patient developed Shingles 1 month later. The patient had pain but no rash for 3 months. No additional information provided.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Hyperhidrosis, Influenza like illness, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 24th July 2018 12:00, the patient received the 1st dose of SHINGRIX. On 24th July 2018, several hours after receiving SHINGRIX, the patient experienced muscle pain, influenza-like symptoms and injection site warmth. On 25th July 2018, the patient experienced sweating, weakness, chills, fever and leg pain. On an unknown date, the outcome of the muscle pain, influenza-like symptoms and injection site warmth were recovering/resolving and the outcome of the sweating, weakness, chills, fever and leg pain were unknown. It was unknown if the reporter considered the muscle pain, influenza-like symptoms, sweating, weakness, chills, fever, injection site warmth and leg pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX around noon. Later that evening after vaccination, the patient experienced warmth and arm pain. She noted it was muscle pain. One day after vaccination, the patient experienced leg pain, weakness, fever, chills and sweating. On 25th July 2018, in the morning the patient experienced hurting in her legs and very weak. In the night of 25th July 2018, the patient experienced chills and a fever of 100 degree F. She slept well but awoke with sweats. The patient had plan to get the 2nd shot at this point, but was concerned if the symptoms would be worse. The patient was referred to her physician and the prescribing information was reviewed. The patient noted symptoms were not as bad as initially. The patient declined the healthcare professional (HCP) contact, as the HCP was not aware of her getting the vaccine.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 24th July 2018 12:00, the patient received the 1st dose of SHINGRIX. On 24th July 2018, several hours after receiving SHINGRIX, the patient experienced muscle pain, influenza-like symptoms and injection site warmth. On 25th July 2018, the patient experienced sweating, weakness, chills, fever and leg pain. On an unknown date, the outcome of the muscle pain, influenza-like symptoms and injection site warmth were recovering/resolving and the outcome of the sweating, weakness, chills, fever and leg pain were unknown. It was unknown if the reporter considered the muscle pain, influenza-like symptoms, sweating, weakness, chills, fever, injection site warmth and leg pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX around noon. Later that evening after vaccination, the patient experienced warmth and arm pain. She noted it was muscle pain. One day after vaccination, the patient experienced leg pain, weakness, fever, chills and sweating. On 25th July 2018, in the morning the patient experienced hurting in her legs and very weak. In the night of 25th July 2018, the patient experienced chills and a fever of 100 degree F. She slept well but awoke with sweats. The patient had plan to get the 2nd shot at this point, but was concerned if the symptoms would be worse. The patient was referred to her physician and the prescribing information was reviewed. The patient noted symptoms were not as bad as initially. The patient declined the healthcare professional (HCP) contact, as the HCP was not aware of her getting the vaccine.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Fatigue, Gait disturbance, Hypersomnia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of tiredness in a 16-year-old male patient who received BEXSERO (batch number 168101, expiry date 30th November 2018) for prophylaxis. On 11th July 2017, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 11th July 2017, less than a day after receiving BEXSERO, the patient experienced tiredness, chills, walking difficulty and hypersomnia. On an unknown date, the outcome of the tiredness, chills, walking difficulty and hypersomnia were recovered/resolved. It was unknown if the reporter considered the tiredness, chills, walking difficulty and hypersomnia to be related to BEXSERO. Additional details were reported as follows: The healthcare professional reported that the patient was tired, slept for about 5 hours, had a hard time walking for about 2 hours, and chills after receiving BEXSERO. The side effects resolved after about 8 hours.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a adult female patient who received SHINGRIX for prophylaxis. On 25th July 2018 15:00, the patient received SHINGRIX. On 25th July 2018 21:00, 6 hrs after receiving SHINGRIX, the patient experienced muscle pain, joint pain, chills and fever. On an unknown date, the outcome of the muscle pain, joint pain, chills and fever were unknown. It was unknown if the reporter considered the muscle pain, joint pain, chills and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At 9:00 pm in the evening, the patient started to experience muscle and joint pain around along with fever and chills. The patient's body temperature was registered at 102 degrees. The patient did not wish to provide additional information.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Myalgia, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 73-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 25th July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, muscle pain and activities of daily living impaired. The patient was treated with ADVIL. On an unknown date, the outcome of the general body pain, muscle pain and activities of daily living impaired were unknown. It was unknown if the reporter considered the general body pain, muscle pain and activities of daily living impaired to be related to SHINGRIX. Additional details were reported as follows: The healthcare professional reported that the patient experienced sudden onset of total body aches and muscle pain from head to legs, sufficient to cancel her planned day's activities. The patient self-medicated with ADVIL and reported no relief.
Sex: F
Vaccine: MENB
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 18-year-old female patient 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 pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the mobility decreased was recovered/resolved. It was unknown if the reporter considered the pain in arm and mobility decreased to be related to BEXSERO. Additional information was received as follows: The case was reported by medical assistant. At the time of reporting the patient was 18 years old. The age at vaccination was not reported. Medical Science Liaison was given speaker program and night before reporting date and was told that the patient had extreme arm pain and she was not able to lift it for a week. The question arose if the patient should receive the second dose. No additional information was known.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was not sure if SHINGRIX was related to the rash. The patient declined to provide any other information.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tinnitus aggravated in a 67-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. Concurrent medical conditions included tinnitus. On 26th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th July 2018, less than a day after receiving SHINGRIX, the patient experienced tinnitus aggravated. On an unknown date, the outcome of the tinnitus aggravated was not recovered/not resolved. It was unknown if the reporter considered the tinnitus aggravated to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in right arm. After receiving SHINGRIX vaccine, the patient experienced amplified tinnitus.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Hypotension, Malaise, Myalgia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received SHINGRIX. In June 2018, 1 day after receiving SHINGRIX, the patient experienced pain in arm, appetite absent, malaise, shivering, myalgia, fever and low blood pressure. On an unknown date, the outcome of the pain in arm, appetite absent, malaise, shivering, myalgia, fever and low blood pressure were recovering/resolving. It was unknown if the reporter considered the pain in arm, appetite absent, malaise, shivering, myalgia, fever and low blood pressure to be related to SHINGRIX. Additional details reported as follows: The patient experienced a sore arm, fever of 101 degrees F, loss of appetite, low blood pressure defined as 90 by 60 and unspecified myalgias. The events improved on day 3 after the injection. The patient was given the injection at an unknown pharmacy, but the medical office of the patient was the reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received SHINGRIX. In June 2018, 1 day after receiving SHINGRIX, the patient experienced pain in arm, appetite absent, malaise, shivering, myalgia, fever and low blood pressure. On an unknown date, the outcome of the pain in arm, appetite absent, malaise, shivering, myalgia, fever and low blood pressure were recovering/resolving. It was unknown if the reporter considered the pain in arm, appetite absent, malaise, shivering, myalgia, fever and low blood pressure to be related to SHINGRIX. Additional details reported as follows: The patient experienced a sore arm, fever of 101 degrees F, loss of appetite, low blood pressure defined as 90 by 60 and unspecified myalgias. The events improved on day 3 after the injection. The patient was given the injection at an unknown pharmacy, but the medical office of the patient was the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Migraine
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and migraine. On an unknown date, the outcome of the influenza-like symptoms and migraine were unknown. It was unknown if the reporter considered the influenza-like symptoms and migraine to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported, however, it could be 63 or 64 years. The patient did not provide exact dates. The patient did not provide any additional information.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of malaise in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 23rd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 mcg/mg. On 23rd April 2018, less than a day after receiving SHINGRIX, the patient experienced malaise, injection site pain and influenza-like symptoms. On an unknown date, the outcome of the malaise, injection site pain and influenza-like symptoms were unknown. It was unknown if the reporter considered the malaise, injection site pain and influenza-like symptoms to be related to SHINGRIX. Additional information was reported as follows: The patient stated that after vaccination with the dose of SHINGRIX, soreness in the upper arm where it was administered later in the same day. He also experienced a little malaise which he compared to the flu.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex, Immediate post-injection reaction, Skin lesion
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of herpes simplex in a 66-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date unknown) for prophylaxis. On 20th April 2018, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, immediately after receiving SHINGRIX, the patient experienced herpes simplex. The patient was treated with Valacyclovir. On an unknown date, the outcome of the herpes simplex was unknown. It was unknown if the reporter considered the herpes simplex to be related to SHINGRIX. Additional information was reported as follows: The patient received a dose of SHINGRIX and shortly after broke out with a herpes simplex lesion. The reporter did not directly speak to the patient. This information was heard through another pharmacist. She was unsure when the lesions appeared after the first injection. On 22nd July 2018, the patient was vaccinated with the 2nd dose of SHINGRIX (batch number: Z9RR4, expiry date: unknown), dose as 0.5 ml by intramuscular route. The reporter vaccinated the patient with the 2nd dose and had not been contacted about reoccurrence of the event again after the 2nd dose.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Headache, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of headache in a 65-year-old male patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 17th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 17th July 2018, several hours after receiving SHINGRIX, the patient experienced headache and discomfort. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the discomfort was unknown. It was unknown if the reporter considered the headache and discomfort to be related to SHINGRIX. Additional information was reported as follows: The reporter was a pharmacy student reporting that the patient received SHINGRIX at their pharmacy and within a couple of hours developed headache. The headache experienced by the patient had gotten worse progressively. The reporter stated that the patient started to limit the daily activities due to discomfort from the headache. The reporter also stated that, the patient had used over the counter medications as treatment and they had not helped out for headache.
Sex: M
Vaccine: VARZOS
Symptoms: Bone pain, Pain, Performance status decreased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, performance status decreased and bone pain. On an unknown date, the outcome of the general body pain, performance status decreased and bone pain were recovered/resolved. It was unknown if the reporter considered the general body pain, performance status decreased and bone pain to be related to SHINGRIX. Additional information was reported as follows: The exact age at vaccination was not provided. However, the patient was over 50 years old. After vaccination with SHINGRIX, the patient experienced systemic pain, inability to function and bone pain for a period of three days. The pharmacist did not have any other information at the time of reporting. The reporting pharmacist had not vaccinated the patient. No address was provided, as the reporting pharmacist she was not working at the time of reporting. This case was linked with case US2018GSK138588 (wife's case), reported by the same reporter.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest discomfort
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chest heaviness in a 68-year-old male patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 19th July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced chest heaviness. On an unknown date, the outcome of the chest heaviness was unknown. It was unknown if the reporter considered the chest heaviness to be related to SHINGRIX. Additional information was reported as follows: At an unknown time, the patient experienced heaviness in his chest after vaccination with SHINGRIX. The reporting pharmacy intern reported that the patient called the pharmacy on 20th July 2018 to report symptoms. At the reporting time, it was unknown if the symptoms had resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Contusion, Hypoaesthesia, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of numbness in fingers in a female patient who received SHINGRIX for prophylaxis. On 24th July 2018, the patient received SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced numbness in fingers, pain in arm, shivers, bruising of hand and fever. On an unknown date, the outcome of the numbness in fingers, pain in arm, shivers, bruising of hand and fever were unknown. It was unknown if the reporter considered the numbness in fingers, pain in arm, shivers, bruising of hand and fever to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient was vaccinated with SHINGRIX in the left deltoid. The patient experienced numbness of one finger on the left hand, small bruise on the palm of left hand and soreness of entire left arm.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Malaise, 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 elderly female patient who received SHINGRIX for prophylaxis. On 19th July 2018, the patient received SHINGRIX. On 19th July 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, fatigue, feeling unwell and dizziness. On an unknown date, the outcome of the pain in arm, fatigue, feeling unwell and dizziness were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, fatigue, feeling unwell and dizziness to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient was in her 70's when she reported for the adverse event experienced after vaccination. The patient experienced arm soreness, a generalized feeling of not feeling well and dizziness. The events were still unresolved till the 7th day post vaccination. The patient had denied permission to contact their physician. The reporter did not wish to participate in a safety report.