chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a other health professional via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Influenza vaccine Quadrivalent unspecified season for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at the vaccination was not reported. The reporter reported that she worked in a nursing home for years and every time they gave flu shots to the patients, they all got the flu. Then they had to give another medication to counter act it for 3 months. The reporter worked the Alzheimer's unit and that made them really lively it was awful. So the reporter never got the flu shots except for some dumb reason the swine flu shot her 3 son's and herself and they all had bad ear infections that winter. The reporter blamed it on that shot. Her sons were supposed to get a 2nd one but they banned them so they still say they got the flu from that. The reporter reported that anyone could get flu.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nasopharyngitis, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 59-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (experienced after receiving 1st dose, refer case US2018GSK226605). On 12th December 2018, the patient received the 2nd dose of SHINGRIX. In December 2018, less than a week after receiving SHINGRIX, the patient experienced tiredness, cold and shivers. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the tiredness, cold and shivers were unknown. It was unknown if the reporter considered the tiredness, cold and shivers to be related to SHINGRIX. Additional details were provided as follows: A day before reporting the patient received 2nd dose of SHINGRIX. The patient felt more of the tiredness, a little cold might be less severe than the 1st dose and little bit shivery more than last time. The patient did not felt fever after 2nd dose. The patient did not feel as bad overall. The patient asked was the ingredients in dose 1 and dose 2 were the same.
Sex: F
Vaccine: FLUX
Symptoms: Adverse event, Arthritis, X-ray abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination not reported. The patient had tendency to have reactions to vaccines and always had a weird reaction to the flu vaccine. She did not provide any further details regarding that. The patient did not consent to follow-up. This case was linked with US2018225911, reported for the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema 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, unknown after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site swelling and injection site cellulitis. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling and injection site cellulitis were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling and injection site cellulitis to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. After vaccination, the patient experienced injection site reactions consistent with cellulitis, such as pain, redness and swelling. The reporter was not certain that this case confirmed with cellulitis, but the patient did voluntarily seek treatment from a physician. The pharmacist reported the all events to VAERs. The call center representative advised to reporter, called to GlaxoSmithKline if had any future events. This is one of the 13 cases reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema 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, unknown after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site swelling and injection site cellulitis. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling and injection site cellulitis were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling and injection site cellulitis to be related to SHINGRIX.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. After vaccination, the patient experienced injection site reactions consistent with cellulitis, such as pain, redness and swelling. The reporter was not certain that this case confirmed with cellulitis, but the events were resolved spontaneously. The pharmacist reported the all events to VAERs. The call center representative advised to reporter, called to GlaxoSmithKline if had any future events. This is one of the 13 cases reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Chills, Headache, Injection site erythema
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. The patient's past medical history included shingles (in 2015). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 days after receiving SHINGRIX, the patient experienced headache, nausea, chills, fever, stomach pain, joint pain, muscle pain, injection site pain and injection site erythema. On an unknown date, the outcome of the headache, nausea, chills, fever, stomach pain, joint pain, muscle pain, injection site pain and injection site erythema were recovered/resolved.  It was unknown if the reporter considered the headache, nausea, chills, fever, stomach pain, joint pain, muscle pain, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 58 or 59 years old. The patient did not have the date when she had the 1st SHINGRIX vaccine with her at the time of the reporting. However, the patient had the injection at night and the next day after the 1st dose of SHINGRIX, she experienced headache, nausea, chills, fever, stomach pain, joint pain, muscle aches, injection site pain, red at the injection site and muscle pain at the injection site. The symptoms went away within a week. The injection site pain did last for a longer time, that took a very long time to go away. The patient did not consent to be followed up. For tolerance to next dose, refer case US2018226724.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Nausea, 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. The patient's past medical history included shingles (in 2015). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 days after receiving SHINGRIX, the patient experienced headache, nausea, chills, fever, stomach pain, joint pain, muscle pain, injection site pain and injection site erythema. On an unknown date, the outcome of the headache, nausea, chills, fever, stomach pain, joint pain, muscle pain, injection site pain and injection site erythema were recovered/resolved.  It was unknown if the reporter considered the headache, nausea, chills, fever, stomach pain, joint pain, muscle pain, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 58 or 59 years old. The patient did not have the date when she had the 1st SHINGRIX vaccine with her at the time of the reporting. However, the patient had the injection at night and the next day after the 1st dose of SHINGRIX, she experienced headache, nausea, chills, fever, stomach pain, joint pain, muscle aches, injection site pain, red at the injection site and muscle pain at the injection site. The symptoms went away within a week. The injection site pain did last for a longer time, that took a very long time to go away. The patient did not consent to be followed up. For tolerance to next dose, refer case US2018226724.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes virus infection, Oral herpes
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of herpes virus infection in a 71-year-old female patient who received SHINGRIX for prophylaxis.  Concurrent medical conditions included herpes virus infection (history of herpes since childhood).  On 27th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced herpes virus infection, condition aggravated and cold sore mouth. On an unknown date, the outcome of the herpes virus infection, condition aggravated and cold sore mouth were unknown. It was unknown if the reporter considered the herpes virus infection, condition aggravated and cold sore mouth to be related to SHINGRIX. Additional details were provided as follows: The patient stated that, since getting SHINGRIX she had more problems with herpes outbreaks compared to before getting the SHINGRIX vaccine. The patient had a cold sore on her mouth about 3 weeks before the date of reporting and it took longer than usual to resolve even with medication. The reporter gave consent to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination, Malaise, Surgery
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received TWINRIX for prophylaxis. Concomitant products included TWINRIX. In May 2017, the patient received the 2nd dose of TWINRIX. On an unknown date, unknown after receiving TWINRIX and TWINRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to TWINRIX. Additional information received as follows: The age at vaccination was not reported. In May 2017, the patient received the first 2 doses of TWINRIX and she got sick and had surgery (unspecified) and never got the third shot of the TWINRIX. She wondered if she should get it at the time of reporting. No further information to provide.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Herpes zoster, Pyrexia, Rash macular
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of fever in a 81-year-old female patient who received SHINGRIX (batch number 273BZ, expiry date unknown) for prophylaxis. Previously administered products included ZOSTAVAX vaccine and SHINGRIX (1st dose received on 25th July 2018 (batch number 7X3EJ)). On 10th December 2018, the patient received the 2nd dose of SHINGRIX. On 10th December 2018, less than a day after receiving SHINGRIX, the patient experienced fever, chills and headache. On 12th December 2018, the patient experienced generalized macular rash and shingles. On an unknown date, the outcome of the fever, chills and headache were recovered/resolved and the outcome of the generalized macular rash and shingles were unknown. It was unknown if the reporter considered the fever, chills, headache, generalized macular rash and shingles to be related to SHINGRIX.   Additional details were reported as follows: Office manager mentioned to sales representative the day of treporting that one of her patients experienced side effects with Shingrix. The patient received 2 doses of Shingrix. After the 2nd dose and within 24 hours the patient experienced fever, chills and headache. It lasted about 24 hours. Two days after the second dose the patient noticed spots and a rash on her body.  The patient saw a dermatologist and was diagnosed with shingles.  Emergency room visit required. Initial reporter only had one address on file.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 10th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In December 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm and itchy rash. On an unknown date, the outcome of the pain in arm and itchy rash were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. After receiving SHINGRIX later that evening the patient experienced that her legs were itchy and in the middle of the night, she noticed an itchy rash that started on her legs and the rash spread to her arms and torso.  The patient stated that her left arm was sore as well after receiving the SHINGRIX. The patient did not consent to follow-up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised, Rash macular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 73-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On 8th November 2018, the patient received the 1st dose of SHINGRIX. In November 2018, less than a month after receiving SHINGRIX, the patient experienced generalized pruritus and erythromacular rash. On an unknown date, the outcome of the generalized pruritus and erythromacular rash were not recovered/not resolved. It was unknown if the reporter considered the generalized pruritus and erythromacular rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the spouse of the patient. The patient had a history of shingles but he was not suspicious of shingles. About 2 weeks ago, he started having itching all over his body and about a week ago he started noticing strange little red dots that itch all over his body.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 61-year-old male patient who received SHINGRIX for prophylaxis. On 30th July 2018, the patient received the 1st dose of SHINGRIX. On 31st July 2018, 1 days after receiving SHINGRIX, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was recovered/resolved. It was unknown if the reporter considered the itchy rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported but it could be 60 or 61 year. The patient received SHINGRIX vaccine on left arm. The next day after receiving SHINGRIX, the patient reported that he developed a rash that was itchy, but not painful, in the left arm where he received the injection. The rash was intermittent for the next 3 weeks, and then resolved. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Blister, Chills, Eye irritation
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. The patient's past medical history included shingles (in 2015). Previously administered products included SHINGRIX with an associated reaction of headache (1st dose received on an unknown date, refer case US2018GSK231619). On 10th December 2018, the patient received the 2nd dose of SHINGRIX. On 11th December 2018, 1 days after receiving SHINGRIX, the patient experienced headache, nausea, chills, fever, stomach pain, joint pain, muscle pain, injection site pain and injection site erythema. On 13th December 2018, the patient experienced blister, eye pruritus, burning in eyes, facial neuralgia, nasal burning, swollen mouth and toothache. The patient was treated with valaciclovir hydrochloride (Valacyclovir). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the headache, blister, eye pruritus, burning in eyes, facial neuralgia, nasal burning and toothache were not recovered/not resolved and the outcome of the nausea, chills, joint pain, muscle pain, injection site pain and injection site erythema were unknown and the outcome of the fever and stomach pain were recovered/resolved and the outcome of the swollen mouth was not recovered/not resolved. It was unknown if the reporter considered the headache, nausea, chills, fever, stomach pain, joint pain, muscle pain, injection site pain, injection site erythema, blister, eye pruritus, burning in eyes, facial neuralgia, nasal burning, swollen mouth and toothache to be related to SHINGRIX. Additional details were provided as follows: The next day of having the SHINGRIX vaccine, the patient experienced headache, nausea, chills, fever, stomach pain, joint pain, muscle aches, injection site pain, red at the injection site and muscle pain at the injection site. So far, the stomach pain was gone and the patient thought that the fever was gone. The headache was worse.  But all other side effects were getting better. In addition, a day before the date of reporting the patient started experiencing blisters. She explained that she had blisters under her nose, nasal cavities on both sides, bottom of nose, all over her upper lips, all over lower lips and left corner of mouth down to each side. The patient's eyes were itching terribly and burning. Her left eye was especially itching a lot. She was also having nerve pain on her face on her forehead and on each cheek. Her nose felt like burning. She was having muscle pain all over her body. The inside of her mouth was swollen and her teeth ache when she ate. The patient had not visited her physician. She called her pharmacist and her pharmacist called her physician and she had a prescription for valacyclovir filled. The patient did not consent to be followed up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pruritus, Facial neuralgia, Headache, Injection site erythema, Injection site pain
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. The patient's past medical history included shingles (in 2015). Previously administered products included SHINGRIX with an associated reaction of headache (1st dose received on an unknown date, refer case US2018GSK231619). On 10th December 2018, the patient received the 2nd dose of SHINGRIX. On 11th December 2018, 1 days after receiving SHINGRIX, the patient experienced headache, nausea, chills, fever, stomach pain, joint pain, muscle pain, injection site pain and injection site erythema. On 13th December 2018, the patient experienced blister, eye pruritus, burning in eyes, facial neuralgia, nasal burning, swollen mouth and toothache. The patient was treated with valaciclovir hydrochloride (Valacyclovir). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the headache, blister, eye pruritus, burning in eyes, facial neuralgia, nasal burning and toothache were not recovered/not resolved and the outcome of the nausea, chills, joint pain, muscle pain, injection site pain and injection site erythema were unknown and the outcome of the fever and stomach pain were recovered/resolved and the outcome of the swollen mouth was not recovered/not resolved. It was unknown if the reporter considered the headache, nausea, chills, fever, stomach pain, joint pain, muscle pain, injection site pain, injection site erythema, blister, eye pruritus, burning in eyes, facial neuralgia, nasal burning, swollen mouth and toothache to be related to SHINGRIX. Additional details were provided as follows: The next day of having the SHINGRIX vaccine, the patient experienced headache, nausea, chills, fever, stomach pain, joint pain, muscle aches, injection site pain, red at the injection site and muscle pain at the injection site. So far, the stomach pain was gone and the patient thought that the fever was gone. The headache was worse.  But all other side effects were getting better. In addition, a day before the date of reporting the patient started experiencing blisters. She explained that she had blisters under her nose, nasal cavities on both sides, bottom of nose, all over her upper lips, all over lower lips and left corner of mouth down to each side. The patient's eyes were itching terribly and burning. Her left eye was especially itching a lot. She was also having nerve pain on her face on her forehead and on each cheek. Her nose felt like burning. She was having muscle pain all over her body. The inside of her mouth was swollen and her teeth ache when she ate. The patient had not visited her physician. She called her pharmacist and her pharmacist called her physician and she had a prescription for valacyclovir filled. The patient did not consent to be followed up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Mouth swelling, Myalgia, Nasal discomfort, Nausea, 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. The patient's past medical history included shingles (in 2015). Previously administered products included SHINGRIX with an associated reaction of headache (1st dose received on an unknown date, refer case US2018GSK231619). On 10th December 2018, the patient received the 2nd dose of SHINGRIX. On 11th December 2018, 1 days after receiving SHINGRIX, the patient experienced headache, nausea, chills, fever, stomach pain, joint pain, muscle pain, injection site pain and injection site erythema. On 13th December 2018, the patient experienced blister, eye pruritus, burning in eyes, facial neuralgia, nasal burning, swollen mouth and toothache. The patient was treated with valaciclovir hydrochloride (Valacyclovir). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the headache, blister, eye pruritus, burning in eyes, facial neuralgia, nasal burning and toothache were not recovered/not resolved and the outcome of the nausea, chills, joint pain, muscle pain, injection site pain and injection site erythema were unknown and the outcome of the fever and stomach pain were recovered/resolved and the outcome of the swollen mouth was not recovered/not resolved. It was unknown if the reporter considered the headache, nausea, chills, fever, stomach pain, joint pain, muscle pain, injection site pain, injection site erythema, blister, eye pruritus, burning in eyes, facial neuralgia, nasal burning, swollen mouth and toothache to be related to SHINGRIX. Additional details were provided as follows: The next day of having the SHINGRIX vaccine, the patient experienced headache, nausea, chills, fever, stomach pain, joint pain, muscle aches, injection site pain, red at the injection site and muscle pain at the injection site. So far, the stomach pain was gone and the patient thought that the fever was gone. The headache was worse.  But all other side effects were getting better. In addition, a day before the date of reporting the patient started experiencing blisters. She explained that she had blisters under her nose, nasal cavities on both sides, bottom of nose, all over her upper lips, all over lower lips and left corner of mouth down to each side. The patient's eyes were itching terribly and burning. Her left eye was especially itching a lot. She was also having nerve pain on her face on her forehead and on each cheek. Her nose felt like burning. She was having muscle pain all over her body. The inside of her mouth was swollen and her teeth ache when she ate. The patient had not visited her physician. She called her pharmacist and her pharmacist called her physician and she had a prescription for valacyclovir filled. The patient did not consent to be followed up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Toothache, Vaccine positive rechallenge
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. The patient's past medical history included shingles (in 2015). Previously administered products included SHINGRIX with an associated reaction of headache (1st dose received on an unknown date, refer case US2018GSK231619). On 10th December 2018, the patient received the 2nd dose of SHINGRIX. On 11th December 2018, 1 days after receiving SHINGRIX, the patient experienced headache, nausea, chills, fever, stomach pain, joint pain, muscle pain, injection site pain and injection site erythema. On 13th December 2018, the patient experienced blister, eye pruritus, burning in eyes, facial neuralgia, nasal burning, swollen mouth and toothache. The patient was treated with valaciclovir hydrochloride (Valacyclovir). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the headache, blister, eye pruritus, burning in eyes, facial neuralgia, nasal burning and toothache were not recovered/not resolved and the outcome of the nausea, chills, joint pain, muscle pain, injection site pain and injection site erythema were unknown and the outcome of the fever and stomach pain were recovered/resolved and the outcome of the swollen mouth was not recovered/not resolved. It was unknown if the reporter considered the headache, nausea, chills, fever, stomach pain, joint pain, muscle pain, injection site pain, injection site erythema, blister, eye pruritus, burning in eyes, facial neuralgia, nasal burning, swollen mouth and toothache to be related to SHINGRIX. Additional details were provided as follows: The next day of having the SHINGRIX vaccine, the patient experienced headache, nausea, chills, fever, stomach pain, joint pain, muscle aches, injection site pain, red at the injection site and muscle pain at the injection site. So far, the stomach pain was gone and the patient thought that the fever was gone. The headache was worse.  But all other side effects were getting better. In addition, a day before the date of reporting the patient started experiencing blisters. She explained that she had blisters under her nose, nasal cavities on both sides, bottom of nose, all over her upper lips, all over lower lips and left corner of mouth down to each side. The patient's eyes were itching terribly and burning. Her left eye was especially itching a lot. She was also having nerve pain on her face on her forehead and on each cheek. Her nose felt like burning. She was having muscle pain all over her body. The inside of her mouth was swollen and her teeth ache when she ate. The patient had not visited her physician. She called her pharmacist and her pharmacist called her physician and she had a prescription for valacyclovir filled. The patient did not consent to be followed up.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-DEC-2018 the patient was vaccinated with a pediatric dose of VAQTA lot # N023953, expiration date: 05-NOV-2018, intramuscular, for prophylaxis (dose, frequency were not reported), instead of an adult dosage. Additionally the nurse reported that the VAQTA was discovered to be expired. No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a healthcare worker regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 07-DEC-2018, the patient was vaccinated with improperly stored VARIVAX injection, lot number R009821 with expiration date in 03-APR-2020 which were reconstituted with properly stored sterile diluent (MRK) for prophylaxis (dose, strength and anatomical location not reported). The VARIVAX was stored at a temperature range of -9 degrees Celsius (°C) to 8 °C (2.8C) for the time frame of 37 hours. There was no previous temperature excursion and the call was because of a data logger. No adverse effects reported. This was one of several reports received from the same reporter. Sender's Comments: US-009507513-1812USA010605: US-009507513-1812USA010604: US-009507513-1812USA008007: US-009507513-1812USA010603.
Sex: F
Vaccine: DTAPIPVHIB, HEP, HIBV, PNC, RV5
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Initial information received on 14-Dec-2018 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a two- months old female patient who was vaccinated with a 0.5 ml first dose of PENTACEL (lot number: PENTACEL- Dtap-IPV (Lot: C5426AA and expiry date: 04-Oct-2019); ACThib- Powder (Lot: UI907AA and expiry date: 26-Oct-2019) via intramuscular route in the left thigh on an 13 Dec 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE), ROTATEQ and PREVNAR for immunisation. It was a case of actual medication error due to inappropriate reconstitution technique as dose of PENTACEL that was mixed with a component from ACTHIB.. No adverse symptoms were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Initial information received on 13-Dec-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a nine-months old female patient who was vaccinated with third dose of PENTACEL with liquid part DTaP-IPV only and not the powder part lot number not reported via unknown route of and anatomical site of administration on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error case due to inappropriate reconstitution technique as patient was only given DTap-IPV. Patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Headache, Insomnia, Malaise, Nasal congestion
Clinical narrative: Initial information received on 13-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case is linked to case 2018SA390652 (patient's husband). This case involves a 67-years old female patient who experienced strong cough with mucus, stuffy nose, at night couldn't sleep, headaches, chest pain and sick with a cold, while she received vaccine FLUZONE HIGH DOSE. The patient's past vaccination(s) included INFLUENZA VACCINE (Reporter stated that they always have flu vaccine and never experienced any reactions). The patient's past medical history, medical treatment(s) and family history were not provided. On an unknown date in September 2018, the patient received a single dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ000AB via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious strong cough with mucus (productive cough), stuffy nose (nasal congestion), couldn't sleep (sleep disorder), headaches (headache), chest pain and sick with a cold (malaise) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that the patient got really sick after a day, strong cough with mucus comes from the chest, with chest pain, stuffy nose, at night couldn't sleep along with headaches. (Other relevant tests included No lab data.) Final diagnosis was sick after a day, chest pain, headaches, at night couldn't sleep, stuffy nose and strong cough with mucus. The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) to help alleviate their symptoms. The patient outcome was reported as Unknown for all the events. List of documents held by sender- none.
Sex: F
Vaccine: FLU3
Symptoms: Nasopharyngitis, Productive cough
Clinical narrative: Initial information received on 13-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case is linked to case 2018SA390652 (patient's husband). This case involves a 67-years old female patient who experienced strong cough with mucus, stuffy nose, at night couldn't sleep, headaches, chest pain and sick with a cold, while she received vaccine FLUZONE HIGH DOSE. The patient's past vaccination(s) included INFLUENZA VACCINE (Reporter stated that they always have flu vaccine and never experienced any reactions). The patient's past medical history, medical treatment(s) and family history were not provided. On an unknown date in September 2018, the patient received a single dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ000AB via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious strong cough with mucus (productive cough), stuffy nose (nasal congestion), couldn't sleep (sleep disorder), headaches (headache), chest pain and sick with a cold (malaise) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that the patient got really sick after a day, strong cough with mucus comes from the chest, with chest pain, stuffy nose, at night couldn't sleep along with headaches. (Other relevant tests included No lab data.) Final diagnosis was sick after a day, chest pain, headaches, at night couldn't sleep, stuffy nose and strong cough with mucus. The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) to help alleviate their symptoms. The patient outcome was reported as Unknown for all the events. List of documents held by sender- none.
Sex: F
Vaccine: FLU4
Symptoms: Cardiac disorder, Limb discomfort, Mobility decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Initial information received on 17-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 62 years old female patient who experienced stiffness in her thumbs when, sharp pain in her hand/ her feet are bothering, heart problem and mobility and pain issues, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included Arthritis. The patient's past vaccination(s) included flu vaccine with reports having flu shots in previous years with no problems. The patient's past medical treatment(s) and family history were not provided. In October 2017, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious stiffness in her thumbs, heart problem, sharp pain in her hand/ her feet are bothering and mobility and pain issues 24-hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported that the patient had a sharp pain in her hand and that is "too coincidental", her feet are bothering and there is a stiffness in her thumbs when she does too many things with her hands periodically. She also reports multiple mobility and pain issues, a heart problem, calling EMS, taking prednisone. (Other relevant tests included on unknown date in Jan 2017 she was positive for rheumatoid factor.) Final diagnosis was mobility and pain issues, heart problem, sharp pain in her hand/ her feet are bothering and stiffness in her thumbs when. The patient was treated with PREDNISONE. The patient outcome is reported as Unknown for sharp pain in her hand/ her feet are bothering, as Unknown for stiffness in her thumbs when, as Unknown for heart problem and as Unknown for mobility and pain issues. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Initial information received on 17-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 62 years old female patient who experienced stiffness in her thumbs when, sharp pain in her hand/ her feet are bothering, heart problem and mobility and pain issues, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included Arthritis. The patient's past vaccination(s) included flu vaccine with reports having flu shots in previous years with no problems. The patient's past medical treatment(s) and family history were not provided. In October 2017, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious stiffness in her thumbs, heart problem, sharp pain in her hand/ her feet are bothering and mobility and pain issues 24-hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported that the patient had a sharp pain in her hand and that is "too coincidental", her feet are bothering and there is a stiffness in her thumbs when she does too many things with her hands periodically. She also reports multiple mobility and pain issues, a heart problem, calling EMS, taking prednisone. (Other relevant tests included on unknown date in Jan 2017 she was positive for rheumatoid factor.) Final diagnosis was mobility and pain issues, heart problem, sharp pain in her hand/ her feet are bothering and stiffness in her thumbs when. The patient was treated with PREDNISONE. The patient outcome is reported as Unknown for sharp pain in her hand/ her feet are bothering, as Unknown for stiffness in her thumbs when, as Unknown for heart problem and as Unknown for mobility and pain issues. List of documents held by sender: none.
Sex: M
Vaccine: DTAP
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Initial information received on 17-Dec-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves Infant male patient who experienced shortness of breath and hives, while he received vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. The patient's past medical history, medical treatments, vaccinations and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS (lot number and Expiry date unknown) via unknown route in unknown administration site. The patient developed a non-serious shortness of breath and hives (Unknown latency) following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. (Other relevant tests included No lab data.) Final diagnosis was hives and shortness of breath. It was not reported if the patient received a corrective treatment. The event outcome was reported as Unknown. List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Headache, Insomnia, Malaise, Nasal congestion
Clinical narrative: Initial information received on 13-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer. This case is linked to case 2018SA389639 same reporter. This case involves a 74 years old male patient who experienced stuffy nose, strong cough with mucus, chest pain, headaches and got sick after a day of vaccination, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history included Diabetes mellitus and Hypertension. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Notes: Patient had vascular surgery. In end of September 2018, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ000AB via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious stuffy nose, strong cough with mucus, chest pain, headaches and strong cough with mucus, with chest pain, stuffy nose, at night couldn't sleep- it comes from the chest and got sick after a day of vaccination following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included no lab data.) Final diagnosis was got sick after a day of vaccination, headaches, chest pain, strong cough with mucus and stuffy nose. The patient was treated with TYLENOL for Product used for unknown indication and NYQUIL for Product used for unknown indication. The outcome of the event was not reported. Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Productive cough
Clinical narrative: Initial information received on 13-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer. This case is linked to case 2018SA389639 same reporter. This case involves a 74 years old male patient who experienced stuffy nose, strong cough with mucus, chest pain, headaches and got sick after a day of vaccination, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history included Diabetes mellitus and Hypertension. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Notes: Patient had vascular surgery. In end of September 2018, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ000AB via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious stuffy nose, strong cough with mucus, chest pain, headaches and strong cough with mucus, with chest pain, stuffy nose, at night couldn't sleep- it comes from the chest and got sick after a day of vaccination following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included no lab data.) Final diagnosis was got sick after a day of vaccination, headaches, chest pain, strong cough with mucus and stuffy nose. The patient was treated with TYLENOL for Product used for unknown indication and NYQUIL for Product used for unknown indication. The outcome of the event was not reported. Documents held by sender: none.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, FLU4, IPV, RVX
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 17-Dec-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a five months old female patient who was vaccinated with a 0.25 ml first dose of vaccine FLUZONE QUADRIVALENT (lot UT626KA and Exp. Date 30 Jun 2019) via unknown route in the left thigh on 03-Oct-2018 when she was 5 months old. The patient's medical history not reported and concomitant medications included PENTACEL; POLIO VACCINE INACT (IPV); and ROTAVIRUS VACCINE via oral route for Immunization on 03-Oct-2018. It was an actual medication error case due to inappropriate age at vaccine administration. No any adverse event experienced by patient. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: Abdominal discomfort, Malaise, Nausea
Clinical narrative: Initial information received on 14-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves an unknown age female patient who felt really sick; similar to gastrointestinal abdominal pain, discomfort and nauseous, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect FLUBLOK QIV lot QFAA1829, expiry date via unknown route in unknown administration site. On an unknown date, the patient felt really sick; similar to gastrointestinal abdominal pain and discomfort and nauseous (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Other relevant tests included no lab data. Final diagnosis was nauseous and felt really sick; similar to gastrointestinal abdominal pain and discomfort. It was not reported if the patient received a corrective treatment. The Event outcome was not reported. List of documents held by sender: none.