chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MENB
Symptoms: Meningococcal infection, Polymerase chain reaction, Vaccination failure
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a adolescent patient who received BEXSERO for prophylaxis. Co-suspect products included BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO and the 2nd dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO and 1 year after receiving BEXSERO and BEXSERO, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningococcal infection (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and meningococcal infection were unknown. It was unknown if the reporter considered the vaccination failure and meningococcal infection to be related to BEXSERO and BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient was with no known underlying conditions. The patient developed meningococcal disease 1 year following completion of primary series. The isolate was not tested but on route to CDC. This case was 1 of 4 case reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Autopsy, Death, Fall
Clinical narrative: This case was reported in a literature article and described the occurrence of fall in a 86-year-old female subject who received Hz/su + AS01B for prophylaxis. On an unknown date, 6 hrs after receiving Hz/su + AS01B, the subject developed fall. Serious criteria included death. The outcome of fall was fatal. The reported cause of death was fall. An autopsy was performed. The investigator considered that there was a reasonable possibility that the fall may have been caused by Hz/su + AS01B. Additional information was provided. This case was reported in a literature article and described the occurrence of fall in an 86-year-female who was vaccinated with SHINGRIX (GlaxoSmithKline) for prophylaxis. The patient was a part of a Centre for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) began safety monitoring of recombinant zoster vaccine (RZV; Shingrix), in the Vaccine Adverse Event Reporting System (VAERS) for the period between 20 October 2017 and 30 June 2018. No information on patient's family or medical history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received SHINGRIX (administration route and site unspecified; dosages unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, between 6 hours and 6 weeks, the patient died due to a fall. Autopsy was performed on unspecified date (results not available). [In this study, according to autopsy reports, death certificates, or medical records, the median decedent age was 65 years (range = 61-86 years), and the interval from vaccination to death ranged from 6 hours to 6 weeks]. This case has been considered serious due to death. The authors commented, "CDC and FDA will continue to closely monitor the safety of RZV. Whereas the initial safety data for RZV are reassuring, the vaccine is still in the early uptake period. Understanding of the safety of RZV will advance as use increases and additional data become available from VAERS and from near real-time sequential monitoring in CDC's Vaccine Safety Datalink."; Reported Cause(s) of Death: fall.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoacusis, Multiple allergies, Nerve injury, Sinusitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old male patient who received SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles, hard of hearing, nerve damage, multiple allergies and sinusitis. On an unknown date, the outcome of the shingles, hard of hearing, nerve damage and multiple allergies were not recovered/not resolved and the outcome of the sinusitis was unknown. It was unknown if the reporter considered the shingles, hard of hearing, nerve damage, multiple allergies and sinusitis to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on the left arm down below the shoulder. After vaccination, the patient had shingles in the middle of his spine and he experienced trouble with the nerves in both legs. The patient also experienced damaged hearing which also started from last year and it was getting worse and varies from day to day. The patient also getting allergies including sinus in his head, which started later a receiving the SHINGRIX dose. The patient failed to get the 2nd dose of SHINGRIX in August or September 2018. The patient had an appointment with surgical on 6th March 2019 to did a hearing test. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Nausea, 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 (batch number K2ZY4, expiry date 13th April 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date and had zero reaction). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced fever, injection site pain, nausea, headache and tiredness. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the injection site pain and nausea were unknown and the outcome of the headache and tiredness were not recovered/not resolved. It was unknown if the reporter considered the fever, injection site pain, nausea, headache and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. On Friday, the patient received a dose of SHINGRIX. On Saturday, the patient had a fever of 100 degrees F, which was sub-norm and it was an increased by 3 degrees. Less than year after vaccination, the patient experienced injection site pain, a little nausea, throbbing headache, very tired and the patient was slept most of the day. Then the fever went down and his stomach was great, but the patient still had a headache and kind of tiredness. These was persisted for about 7 days. The patient wanted to know, how long it looked for most patients that call in. The patient declined to provide any patient identifiers or complete full safety report. Lab Comments: On an unknown date, the fever was 100 degree C and it was increased by 3 100 degree C.
Sex: U
Vaccine: VARZOS
Symptoms: Somnolence
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 (batch number K2ZY4, expiry date 13th April 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date and had zero reaction). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced fever, injection site pain, nausea, headache and tiredness. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the injection site pain and nausea were unknown and the outcome of the headache and tiredness were not recovered/not resolved. It was unknown if the reporter considered the fever, injection site pain, nausea, headache and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. On Friday, the patient received a dose of SHINGRIX. On Saturday, the patient had a fever of 100 degrees F, which was sub-norm and it was an increased by 3 degrees. Less than year after vaccination, the patient experienced injection site pain, a little nausea, throbbing headache, very tired and the patient was slept most of the day. Then the fever went down and his stomach was great, but the patient still had a headache and kind of tiredness. These was persisted for about 7 days. The patient wanted to know, how long it looked for most patients that call in. The patient declined to provide any patient identifiers or complete full safety report. Lab Comments: On an unknown date, the fever was 100 degree C and it was increased by 3 100 degree C.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 67-year-old female patient who received SHINGRIX (batch number 455KD, expiry date 4th May 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date and did not have a reaction to it). On 5th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In February 2019, less than a week after receiving SHINGRIX, the patient experienced injection site rash and injection site nodule. On an unknown date, the outcome of the injection site rash and injection site nodule were not recovered/not resolved. It was unknown if the reporter considered the injection site rash and injection site nodule to be related to SHINGRIX.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Abnormal dreams, Chills, Fatigue, Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 56-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (on an unknown date received the 1st dose). On 6th February 2019 16:00, the patient received the 2nd dose of SHINGRIX (intramuscular). On 6th February 2019 21:00, 5 hrs after receiving SHINGRIX, the patient experienced tiredness. In February 2019, the patient experienced fever, chills, general body pain, muscle pain and bizarre dreams. On an unknown date, the outcome of the tiredness, fever, chills, general body pain, muscle pain and bizarre dreams were recovering/resolving. It was unknown if the reporter considered the tiredness, fever, chills, general body pain, muscle pain and bizarre dreams to be related to SHINGRIX. Additional details were provided as follows: The patient received vaccine on left arm. After vaccination at around 9:00 or 10:00 pm the patient felt very tired. On 7th February 2019, the patient woke up at night at around 1:00 am or 2:00 am, 9 hours after receiving SHINGRIX, the patient experienced fever, chills, body aches, and muscles pains. He could not get warm and experienced weird nightmares. On the day of reporting the patient felt better but was not fully recovered. The reporter had no consent to follow up and would not be providing any additional information.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 56-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (on an unknown date received the 1st dose). On 6th February 2019 16:00, the patient received the 2nd dose of SHINGRIX (intramuscular). On 6th February 2019 21:00, 5 hrs after receiving SHINGRIX, the patient experienced tiredness. In February 2019, the patient experienced fever, chills, general body pain, muscle pain and bizarre dreams. On an unknown date, the outcome of the tiredness, fever, chills, general body pain, muscle pain and bizarre dreams were recovering/resolving. It was unknown if the reporter considered the tiredness, fever, chills, general body pain, muscle pain and bizarre dreams to be related to SHINGRIX. Additional details were provided as follows: The patient received vaccine on left arm. After vaccination at around 9:00 or 10:00 pm the patient felt very tired. On 7th February 2019, the patient woke up at night at around 1:00 am or 2:00 am, 9 hours after receiving SHINGRIX, the patient experienced fever, chills, body aches, and muscles pains. He could not get warm and experienced weird nightmares. On the day of reporting the patient felt better but was not fully recovered. The reporter had no consent to follow up and would not be providing any additional information.
Sex: U
Vaccine: DTAP
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of anaphylaxis in a adult patient who received DTaP vaccine for prophylaxis. On an unknown date, the patient received DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylaxis was unknown. It was unknown if the reporter considered the anaphylaxis to be related to DTaP vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a reaction to a previous DTaP vaccine. The patient described the reaction as a severe anaphylactic reaction. No additional details were available. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dysgeusia, Headache, Influenza like illness, Injection site pain
Clinical narrative: Pain and blotchy redness around injection site, progressing to muscle aches and pains involving shoulder and pelvic girdle and Achilles tendon, headache, flu like symptoms, and taste perversion. Low-grade fever and chills. Self treated with OTC ibuprofen every six hours.  Symptoms gradually resolved over the course of 02/13/2019.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Myalgia, Pyrexia, Rash macular
Clinical narrative: Pain and blotchy redness around injection site, progressing to muscle aches and pains involving shoulder and pelvic girdle and Achilles tendon, headache, flu like symptoms, and taste perversion. Low-grade fever and chills. Self treated with OTC ibuprofen every six hours.  Symptoms gradually resolved over the course of 02/13/2019.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Abdominal pain, Faeces discoloured, Melaena
Clinical narrative: Patient experienced severe abdominal pain and black tarry stools.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Balance disorder, Chest X-ray, Eye pain, Headache, Laboratory test
Clinical narrative: Patient started experiencing headaches, scalp tenderness, eye pain, blurred vision, and loss of balance approximately 3 days after getting flu shot. Patient was seen here in office on 2/14/19 and then in emergency room on 2/15/19. Neurology and hematology referrals given. Multiple labs were done in emergency room on 2/15/19 to check for meningitis as well as other illnesses. Most of these labs are still pending.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging brain, Pain of skin, Vision blurred
Clinical narrative: Patient started experiencing headaches, scalp tenderness, eye pain, blurred vision, and loss of balance approximately 3 days after getting flu shot. Patient was seen here in office on 2/14/19 and then in emergency room on 2/15/19. Neurology and hematology referrals given. Multiple labs were done in emergency room on 2/15/19 to check for meningitis as well as other illnesses. Most of these labs are still pending.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Do to an oversight, Patient received Hep B immunization to (R) Thigh approximately 2 weeks after first Hep B immunization. No adverse signs/symptoms. Physician notified along with patient's family.
Age: 52.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Injection site swelling
Clinical narrative: Gave pt Hep B vaccine in right deltoid and the SHINGRIX in the left deltoid. I noticed some swelling in her right deltoid, no redness or shortness of breath. I then called the provider in the room.
Age: 24.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 24-year-old male patient. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications was reported. On 07-JAN-2019, the patient was vaccinated with VARIVAX subcutaneously, (lot # R019235, expiration date: 04-JUL-2020), (exact dose and injection site were not provided), for prevention of varicella. On 07-JAN-2019, the patient began experiencing redness, warmth, itching, and mild pain at the injection site. On unknown date, the patient sought medical attention via visit in physician's office. The patient received treatment which included an unspecified anti-histamine and an unspecified anti-inflammatory medication. The outcome of the events was reported as recovered on unknown date in January 2019 (reported as a few days after vaccination). The relatedness between the events and the suspect vaccine was not provided. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1902USA004146:US-009507513-1902USA006028.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old male patient who received SHINGRIX for prophylaxis. On 7th February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced injection site pain, fever and feeling unwell. On an unknown date, the outcome of the injection site pain, fever and feeling unwell were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, fever and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain at shot site, fever of 100.4 degree F and not feeling well. The reporter stated he only wanted to know that how long the effects might last.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site swelling in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received 4 month before 2nd shot). On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than an hour after receiving SHINGRIX, the patient experienced injection site swelling, pruritus, burn, erythema and pain. The patient was treated with ZYRTEC. On an unknown date, the outcome of the injection site swelling, pruritus, burn and erythema were unknown and the outcome of the pain was recovered/resolved. The reporter considered the injection site swelling, pruritus, burn, erythema and pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The side effects including swelling at injection site within 10 to 15 mins, on fire, itched, burned, bright red. The patient started ZYRTEC immediately after shot. The patient experienced Intense pain less than week after vaccination. Intense pain subsided within 2 days, full week before totally pain free. The second dose received 4 months initial shot. The patient and health care professional certain adverse event directly related to receiving shot. The reporter did not agreed to follow up with GlaxoSmithKline.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Back pain, Chills, Discomfort, Feeling abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 76-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Previously administered products included ZOSTAVAX(received on an unknown date) and SHINGRIX an associated reaction of pain (flu like symptoms, fever, chills and just felt lousy experienced after received 1st dose of SHINGRIX in July 2018, refer case US2019023816). On 5th February 2019, the patient received the 2nd dose of SHINGRIX. On 5th February 2019, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too long. In February 2019, the patient experienced shingles, pain, influenza-like symptoms, fever, chills, feeling bad, discomfort, back pain and abdominal pain. Rechallenge with SHINGRIX was positive. In February 2019, the outcome of the pain, influenza-like symptoms, fever, chills, feeling bad and discomfort were recovered/resolved. On an unknown date, the outcome of the shingles, back pain, abdominal pain and drug dose administration interval too long were unknown. It was unknown if the reporter considered the shingles, pain, influenza-like symptoms, fever, chills, feeling bad, discomfort, back pain and abdominal pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's wife. Less than a week after receiving SHINGRIX, the patient experienced aches, flu like symptoms, fever, chills, pain and just felt lousy for about 24 hours but were worse as compared to the 1st dose. The patient also had a case of shingles started. The reporter stated that the patient had a pain around his back-right side at the kidney level and a dot in the front of his abdomen at that area.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Influenza like illness, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 76-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Previously administered products included ZOSTAVAX(received on an unknown date) and SHINGRIX an associated reaction of pain (flu like symptoms, fever, chills and just felt lousy experienced after received 1st dose of SHINGRIX in July 2018, refer case US2019023816). On 5th February 2019, the patient received the 2nd dose of SHINGRIX. On 5th February 2019, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too long. In February 2019, the patient experienced shingles, pain, influenza-like symptoms, fever, chills, feeling bad, discomfort, back pain and abdominal pain. Rechallenge with SHINGRIX was positive. In February 2019, the outcome of the pain, influenza-like symptoms, fever, chills, feeling bad and discomfort were recovered/resolved. On an unknown date, the outcome of the shingles, back pain, abdominal pain and drug dose administration interval too long were unknown. It was unknown if the reporter considered the shingles, pain, influenza-like symptoms, fever, chills, feeling bad, discomfort, back pain and abdominal pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's wife. Less than a week after receiving SHINGRIX, the patient experienced aches, flu like symptoms, fever, chills, pain and just felt lousy for about 24 hours but were worse as compared to the 1st dose. The patient also had a case of shingles started. The reporter stated that the patient had a pain around his back-right side at the kidney level and a dot in the front of his abdomen at that area.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 76-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Previously administered products included ZOSTAVAX(received on an unknown date) and SHINGRIX an associated reaction of pain (flu like symptoms, fever, chills and just felt lousy experienced after received 1st dose of SHINGRIX in July 2018, refer case US2019023816). On 5th February 2019, the patient received the 2nd dose of SHINGRIX. On 5th February 2019, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too long. In February 2019, the patient experienced shingles, pain, influenza-like symptoms, fever, chills, feeling bad, discomfort, back pain and abdominal pain. Rechallenge with SHINGRIX was positive. In February 2019, the outcome of the pain, influenza-like symptoms, fever, chills, feeling bad and discomfort were recovered/resolved. On an unknown date, the outcome of the shingles, back pain, abdominal pain and drug dose administration interval too long were unknown. It was unknown if the reporter considered the shingles, pain, influenza-like symptoms, fever, chills, feeling bad, discomfort, back pain and abdominal pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's wife. Less than a week after receiving SHINGRIX, the patient experienced aches, flu like symptoms, fever, chills, pain and just felt lousy for about 24 hours but were worse as compared to the 1st dose. The patient also had a case of shingles started. The reporter stated that the patient had a pain around his back-right side at the kidney level and a dot in the front of his abdomen at that area.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Feeling abnormal, Influenza like illness, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a elderly male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Previously administered products included ZOSTAVAX (received on an unknown date). In July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 µg. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, influenza-like symptoms, fever, chills, feeling bad and discomfort. On an unknown date, the outcome of the pain, influenza-like symptoms, fever, chills, feeling bad and discomfort were recovered/resolved. It was unknown if the reporter considered the pain, influenza-like symptoms, fever, chills, feeling bad and discomfort to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's wife. The age at vaccination was not reported but it could be 75 or 76 years. The patient experienced aches, flu like symptoms, fever, chills, pain and just felt lousy for about 24 hours. For tolerance to the 2nd dose of SHINGRIX, refer case US2019GSK028966.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a elderly male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Previously administered products included ZOSTAVAX (received on an unknown date). In July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 µg. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, influenza-like symptoms, fever, chills, feeling bad and discomfort. On an unknown date, the outcome of the pain, influenza-like symptoms, fever, chills, feeling bad and discomfort were recovered/resolved. It was unknown if the reporter considered the pain, influenza-like symptoms, fever, chills, feeling bad and discomfort to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's wife. The age at vaccination was not reported but it could be 75 or 76 years. The patient experienced aches, flu like symptoms, fever, chills, pain and just felt lousy for about 24 hours. For tolerance to the 2nd dose of SHINGRIX, refer case US2019GSK028966.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 76-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On 7th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 8th February 2019, 1 days after receiving SHINGRIX, the patient experienced general body pain, injection site pain and upset stomach. On an unknown date, the outcome of the general body pain, injection site pain and upset stomach were unknown. It was unknown if the reporter considered the general body pain, injection site pain and upset stomach to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the husband of the patient. On the morning of 8th February 2019, around 10 am, the patient started to experience upset stomach, pain at the injection site and body aches. The reporter did not give consent for follow up. Patient was present in the background during the call. No further details were provided.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of migraine in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 31st January 2019, the patient received the 1st dose of SHINGRIX. On 7th February 2019, 7 days after receiving SHINGRIX, the patient experienced migraine. On an unknown date, the outcome of the migraine was unknown. It was unknown if the reporter considered the migraine to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had no history of migraine. SHINGRIX dose was given in a retail pharmacy. Lot number was not available. The patient developed a severe migraine and needed to be seen in an emergency department. The reporter gave consent to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of migraine in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 1st February 2019, the patient received SHINGRIX (intramuscular). On 8th February 2019, 7 days after receiving SHINGRIX, the patient experienced migraine. On 8th February 2019, the outcome of the migraine was recovered/resolved. It was unknown if the reporter considered the migraine to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient received SHINGRIX vaccine in left deltoid and developed migraine 7 days later. Emergency room visit required. The event resolved now. The reporter did not consent to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of shingles in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 4th February 2019, the patient received SHINGRIX. On 6th February 2019, 2 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: Nurse Practitioner on the line stated that the patient went to her pharmacy to receive SHINGRIX on Monday and then on Wednesday started to have shingles. The reporter had two other providers confirm the patient's shingles as well. The reporter not gave the product, she believes it was given at a pharmacy. She did not have that information to provide. Also, cannot confirm placement of product, but she would assume they administered the product as recommended. The reporter did not have lot number or expiration date to provide.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Injection site pain, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 80-year-old male patient who received SHINGRIX for prophylaxis. On 15th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th January 2019, less than a day after receiving SHINGRIX, the patient experienced headache, myalgia, shivering, stomach pain, injection site pain and fever. On an unknown date, the outcome of the headache, myalgia, shivering, stomach pain, injection site pain and fever were recovered/resolved.  It was unknown if the reporter considered the headache, myalgia, shivering, stomach pain, injection site pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient experienced myalgia, headache, shivering, light fever, bad stomachache and stomach cramps. The symptoms lasted through the night before resolving. The patient also had soreness at the injection site for a couple days. The reporter consented to follow up.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 80-year-old male patient who received SHINGRIX for prophylaxis. On 15th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th January 2019, less than a day after receiving SHINGRIX, the patient experienced headache, myalgia, shivering, stomach pain, injection site pain and fever. On an unknown date, the outcome of the headache, myalgia, shivering, stomach pain, injection site pain and fever were recovered/resolved.  It was unknown if the reporter considered the headache, myalgia, shivering, stomach pain, injection site pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient experienced myalgia, headache, shivering, light fever, bad stomachache and stomach cramps. The symptoms lasted through the night before resolving. The patient also had soreness at the injection site for a couple days. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Pain in extremity, Paraesthesia, Rash macular
Clinical narrative: Evening of day 1 chills, day 2 sore painful arm, day 5 hot tingling face advancing down to calves became blotchy with hives lasted about less than 1 hour.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Evening of day 1 chills, day 2 sore painful arm, day 5 hot tingling face advancing down to calves became blotchy with hives lasted about less than 1 hour.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Nausea, Pain, Pain in extremity, Palpitations
Clinical narrative: AFTERNOON AND EVENING HAD SORE ARM AND BODY ACHES. AT 2AM WAS WOKE UP WITH HEART RACING AND NAUSEA AND ACHES. TOOK ADVIL AND WENT BACK TO SLEEP. AT NOON ON SATURDAY HAD PAIN AROUND TORSO. MONDAY MORNING ONLY HAS REDNESS AROUND INJECTION SITE.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Pain in extremity, Pallor
Clinical narrative: Patient stated that she went to church the next morning and became faint, and pale white. She got dizzy and left church early. Complained of left arm pain for 3-4 days.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site, blistered.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Contusion, Cough, Erythema, Headache
Clinical narrative: The injection site immediately became sore. Within 24 hours a bruise developed with several red streaks. This has lasted 14 days, but the severity has decreased. Also within 24 hours of injection, I developed a severe headache, body aches and chills. The headache and body aches have persisted for 14 days, but are now subsiding. I developed a severe cough 4 days after the injection, which currently persists.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: The injection site immediately became sore. Within 24 hours a bruise developed with several red streaks. This has lasted 14 days, but the severity has decreased. Also within 24 hours of injection, I developed a severe headache, body aches and chills. The headache and body aches have persisted for 14 days, but are now subsiding. I developed a severe cough 4 days after the injection, which currently persists.
Age: 1.67
Sex: M
Vaccine: HIBV
Symptoms: Rash
Clinical narrative: Rash on face, got progressively worse for several days and is now getting better. Still present, using aquifer without much change.
Age: 52.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Decreased appetite, Disturbance in attention, Fatigue, Feeding disorder, Headache
Clinical narrative: Starting around 9:15 - 9:45 am, started with tiredness which eventually became extreme, then skin sensitivity, followed by all over muscle ache (not just injection site), headache, nausea, total loss of appetite, trouble concentrating/thinking. Unable to drive, work or eat, difficult to move around/go up & down stairs. I mostly slept. I would have gone to my primary care doctor, but I couldn't really process information well enough to call the office, nor could I have safely driven there. I may or may not have taken ibuprofen at 10:15 (opened the drawer where I keep it, got distracted, then couldn't remember if I took it or not). Took ibuprofen again around 4 or 5 pm, and symptoms slowly started to improve around 8 pm  Mostly better the next day - able to function around the house, drive, etc, tired easily and rash/pain at/near injection site. Pretty much all better 2 days later.
Age: 52.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Hypersomnia, Impaired driving ability, Impaired work ability, Injection site pain, Injection site rash
Clinical narrative: Starting around 9:15 - 9:45 am, started with tiredness which eventually became extreme, then skin sensitivity, followed by all over muscle ache (not just injection site), headache, nausea, total loss of appetite, trouble concentrating/thinking. Unable to drive, work or eat, difficult to move around/go up & down stairs. I mostly slept. I would have gone to my primary care doctor, but I couldn't really process information well enough to call the office, nor could I have safely driven there. I may or may not have taken ibuprofen at 10:15 (opened the drawer where I keep it, got distracted, then couldn't remember if I took it or not). Took ibuprofen again around 4 or 5 pm, and symptoms slowly started to improve around 8 pm  Mostly better the next day - able to function around the house, drive, etc, tired easily and rash/pain at/near injection site. Pretty much all better 2 days later.
Age: 52.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Mental impairment, Mobility decreased, Myalgia, Nausea, Sensitive skin
Clinical narrative: Starting around 9:15 - 9:45 am, started with tiredness which eventually became extreme, then skin sensitivity, followed by all over muscle ache (not just injection site), headache, nausea, total loss of appetite, trouble concentrating/thinking. Unable to drive, work or eat, difficult to move around/go up & down stairs. I mostly slept. I would have gone to my primary care doctor, but I couldn't really process information well enough to call the office, nor could I have safely driven there. I may or may not have taken ibuprofen at 10:15 (opened the drawer where I keep it, got distracted, then couldn't remember if I took it or not). Took ibuprofen again around 4 or 5 pm, and symptoms slowly started to improve around 8 pm  Mostly better the next day - able to function around the house, drive, etc, tired easily and rash/pain at/near injection site. Pretty much all better 2 days later.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant referring to a patient of unknown age and unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date in 2010 and 2015, the patient was separately vaccinated with a dose of GARDASIL 9 (strength, dose, lot # and expiration date were not reported) intramuscularly for prophylaxis (inappropriate schedule of product administration). No adverse effects were reported in the patient.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 12-JUN-2018, the patient was vaccinated with a first dose of GARDASIL 9 injection, lot number: N028092, expiration date: 28-MAY-2020. On 28-AUG-2018, she was vaccinated with a second dose of GARDASIL 9 injection, lot number: R011628, expiration date: 11-DEC-2020. On 08-NOV-2018, she was vaccinated with a third dose of GARDASIL 9 injection, lot number: R017133, expiration date: 29-APR-2021. All the doses were administered intramuscularly (dose was not reported) for prophylaxis. No adverse effect was reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, drug reactions and allergies and concomitant medications were not reported. On 13-FEB-2019, the patient was vaccinated with PNEUMOVAX 23 via unspecified route (strength, dose, site of administration were not reported) lot # R018135, expiry date 15-JUN-2020, for prophylaxis. The suspected vaccine was stored in temperature above 47 degrees Fahrenheit (F) / (9 degrees Celsius) for 1 hour and 30 minutes. The highest temperature was 55 F. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 13-FEB-2019, the patient was vaccinated with an expired dose of PNEUMOVAX 23 first dose, intramuscularly in the left deltoid, lot # N019348 with expiration date 08-FEB-2019, for prophylaxis. It was confirmed that no adverse effects were reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a health care worker referring to a patient of an unknown age and an unknown gender. Information about pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medication was not reported. On unknown date, the patient was vaccinated with an unknown vaccine, which was improperly stored at 1.9 degree Celsius for 3 hours and 12minutes, for prophylaxis. These improperly stored vaccines included VARIVAX lot# R017946 with expiration date 24-JUN-2020, lot# N031939 with expiration date 13-NOV-2019 (dose detail, route were not reported) and PROQUAD lot# R0202675 with expiration date 15-JAN-2020, lot# R024015 with expiration date 19-FEB-2020, lot# R023500 with expiration date 13-FEB-2020 (dose detail, route were not reported). There was no previous temperature excursion. The call was because of a data logger involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1902USA006359.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of injection site pain in a 84-year-old female patient who received SHINGRIX for prophylaxis. On 8th November 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient indicated soreness of arm at the injection site. No other side effects besides the soreness at the injection site.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received SHINGRIX (batch number 3Z53C, expiry date 13th March 2021) for prophylaxis. On 12th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: At the time of reporting, the patient was experiencing sore arm after getting a dose of SHINGRIX. Advised pharmacist to refer the patient to Healthcare professional. No further details were provided.
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 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 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 at vaccination was not reported. The pharmacist was asked to provide information for the report questions, but she stated that she did not have all the details. All that was documented was what she said. The reporter did not consent to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of blurred vision in a 53-year-old female patient who received SHINGRIX (batch number G72ZD, expiry date 24th November 2020) for prophylaxis. On 7th February 2019, the patient received SHINGRIX (intramuscular). In February 2019, less than a week after receiving SHINGRIX, the patient experienced blurred vision. On an unknown date, the outcome of the blurred vision was unknown. It was unknown if the reporter considered the blurred vision to be related to SHINGRIX. Additional details were provided as follows: After receiving the SHINGRIX dose, the patient had blurred vision. The reporter gave consent for follow up.