chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUR4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: pregnant patient received Flublok/ no adverse event; Initial information received on 13-Mar-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 36 years old pregnant female patient who was exposed to a dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The patient was exposed to vaccine at unknown gestation period. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient previous pregnancy details not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1905, expiry date: 21-May-2020, via unknown route in unknown administration site for prophylactic vaccination.  This was a case of Vaccine exposure during pregnancy. (Pharmacist stated that she was giving the vaccine today and only that vaccine, it was not confirmed if vaccine was given or not).  Prenatal test not reported.  At the time of report no adverse event reported.   Pregnancy outcome was unknown at the time of report.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was inadvertently administered two doses of Fluzone Quadrivalent on the same day/no AE; Initial information received on 12-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 years old female who was inadvertently administered two doses of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on the same day(Extra dose administered).  Medical history,concomitant therapy, treatment(s), vaccination(s) and family history were not provided.   On 12-Mar-2020, the patient received 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ279AA via intramuscular route at the left thigh for prophylactic vaccination. On same day she also received a dose  dose of the same vaccine  lot UJ279AA via intramuscular route at the right thigh for prophylactic vaccination.  It was of actual medication error case due to extra dose administer.  At the time of reporting, no adverse event was 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 and Module VI of the 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation concerning the patient of unknown age and gender. In 2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported), as prescribed and/or administered by a healthcare provider at Outpatient Clinic located for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by a physician for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received on 03-APR-2020 from a lawyer, regarding a case in litigation and refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for the long-term prevention of shingles and/or zoster-related conditions as prescribed and/or administered by a healthcare provider. Subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, on an unknown date, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was not reported. The reporter considered the shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain upper
Clinical narrative: it gave me an stomach ache; This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced stomach pain. On an unknown date, the outcome of the stomach pain was unknown.   The reporter considered the stomach pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 61 year or 62 years. The patient took first shot of Shingrix in October need to take second shot but had been really afraid to go because of the coved virus how long could they wait to get second shot, because it was coming up to six month. 1st dose of Shingrix gave patient an stomach ache.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: We both had a reaction to Shingrix; This case was reported by a consumer and described the occurrence of adverse drug reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th February 2020, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: This case was reported by the husband of the patient. The age at the vaccination was not reported. The reporter reported that they did not report this to her doctor. The reporter provided the name of his primary care physician who was most familiar with the event. The reporter reported that her spouse also had a reaction to the Shingrix. This case is linked to the case US2020032234, reported by the same reporter for himself.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm is very very sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   The reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient arm was very very sore from shingles vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Pain, Pyrexia, Rash
Clinical narrative: Mild rash; Hives; Mild fever; Increased levels of pain; Headache / Severe headaches; Severe dizziness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced fever, pain, headache, dizziness, rash and hives. On an unknown date, the outcome of the fever, pain, headache and dizziness were recovered/resolved and the outcome of the rash and hives were unknown.   It was unknown if the reporter considered the fever, pain, headache, dizziness, rash and hives to be related to Shingrix.  Additional details were provide as follows: After vaccination, the patient had I had a mild fever, increased levels of pain, headache and severe dizziness, which the patient considered just as extreme case of the possible documented reactions and side effects.  This lasted for 3 days before it subsided.  Until the vaccination, the patient had no health related issues and had lead a normal, healthy life.  Within 10 days, the patient developed a mild rash and hives which has persisted. The patient also had severe headaches since then. For tolerance to 2nd dose refer linked case US2020AMR059714 and US2020AMR059715, reported by the same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Mild rash; Hives; Mild fever; Increased levels of pain; Headache / Severe headaches; Severe dizziness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced fever, pain, headache, dizziness, rash and hives. On an unknown date, the outcome of the fever, pain, headache and dizziness were recovered/resolved and the outcome of the rash and hives were unknown.   It was unknown if the reporter considered the fever, pain, headache, dizziness, rash and hives to be related to Shingrix.  Additional details were provide as follows: After vaccination, the patient had I had a mild fever, increased levels of pain, headache and severe dizziness, which the patient considered just as extreme case of the possible documented reactions and side effects.  This lasted for 3 days before it subsided.  Until the vaccination, the patient had no health related issues and had lead a normal, healthy life.  Within 10 days, the patient developed a mild rash and hives which has persisted. The patient also had severe headaches since then. For tolerance to 2nd dose refer linked case US2020AMR059714 and US2020AMR059715, reported by the same reporter.
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: patients may have been administered improperly stored vaccines; This non-valid spontaneous report was received from a medical assistant and refers to an unspecified number of patient of unknown age and gender. The patients' pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On an unknown date, the patients may have been vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD) lot# S012468, expiration date; lot# S017245, expiration date 01-DEC-2020 and varicella virus vaccine live (oka/merck) (VARIVAX) lot# S015462, expiration date 20-MAY-2021 for prophylaxis (exact doses, routes of administration and anatomical locations were not reported for all vaccines). The vaccines experienced the temperature excursion of 40 degrees Fahrenheit for 2 hours and 30 minutes. Data logger was involved. There were no previous excursions reported. It was unknown if the diluent used to reconstitution of the vaccines was properly stored.  Follow-up information was received on 30-MAR-2020, a phone call request was made for administration dates and patient identifiers for those unspecified patients who were vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) or varicella virus vaccine live (oka/merck) (VARIVAX) which had undergone temperature excursion.  Follow-up information had been received from a healthcare professional on 06-APR-2020. This report refers to a currently 4 years old female patient (patient identifiers were missing in the previous report). The patient's concomitant therapy included diluent.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2004USA001910: US-009507513-2004USA002003: US-009507513-2004USA002008:
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: patients may have been administered improperly stored vaccines; This spontaneous report was received from a medical assistant, refers to 1 year old male patient. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. The patient's concomitant therapy included diluent.  On an unknown date, the patient may have been vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD) lot# S012468, expiration date; lot# S017245, expiration date 01-DEC-2020 and varicella virus vaccine live (oka/merck) (VARIVAX) lot# S015462, expiration date 20-MAY-2021 for prophylaxis (exact doses, routes of administration and anatomical locations were not reported for all vaccines) (product storage error). The vaccines experienced the temperature excursion of 40 degrees Fahrenheit for 2 hours and 30 minutes. Data logger was involved. There were no previous excursions reported. It was unknown if the diluent used to reconstitution of the vaccines was properly stored.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA010004: US-009507513-2004USA002003: US-009507513-2004USA002008:
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: patients may have been administered improperly stored vaccines; This spontaneous report was received from a medical assistant, refers to 2 year old female patient. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. The patient's concomitant medication included diluent.  On an unknown date, the patient may have been vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD) lot# S012468, expiration date; lot# S017245, expiration date 01-DEC-2020 and varicella virus vaccine live (oka/merck) (VARIVAX) lot# S015462, expiration date 20-MAY-2021 for prophylaxis (exact doses, routes of administration and anatomical locations were not reported for all vaccines) (product storage error). The vaccines experienced the temperature excursion of 40 degrees Fahrenheit for 2 hours and 30 minutes. Data logger was involved. There were no previous excursions reported. It was unknown if the diluent used to reconstitution of the vaccines was properly stored.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2004USA001910: US-009507513-1909USA010004: US-009507513-2004USA002008:
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: patients may have been administered improperly stored vaccines; This spontaneous report was received from a medical assistant, refers to a currently 4 year old female patient. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. The patient's concomitant medication included diluent.  On an unknown date, the patient may have been vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD) lot# S012468, expiration date; lot# S017245, expiration date 01-DEC-2020 and varicella virus vaccine live (oka/merck) (VARIVAX) lot# S015462, expiration date 20-MAY-2021 for prophylaxis (exact doses, routes of administration and anatomical locations were not reported for all vaccines) (product storage error). The vaccines experienced the temperature excursion of 40 degrees Fahrenheit for 2 hours and 30 minutes. Data logger was involved. There were no previous excursions reported. It was unknown if the diluent used to reconstitution of the vaccines was properly stored.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2004USA001910: US-009507513-2004USA002003: US-009507513-1909USA010004:
Sex: U
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: swelling where the Zoster vaccination was; redness  where the Zoster vaccination was; This case was reported by a consumer and described the occurrence of injection site swelling in a adult patient who received Herpes zoster (Zoster vaccine) for prophylaxis.   On an unknown date, the patient received Zoster vaccine at an unknown dose. On an unknown date, unknown after receiving Zoster vaccine, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were unknown.   It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Zoster vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient experienced redness and swelling where the Zoster vaccination was. The patient wanted to knowif he/she could put a cold compress on it.
Sex: U
Vaccine: UNK, VARZOS
Symptoms: Arthralgia, Condition aggravated, Fatigue, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; flare ups with pain in joints; Fatigue ; Shingles; This case was reported by a other health professional via other manufacturer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included tofacitinib citrate (Xeljanz Xr) for rheumatoid arthritis.   Concurrent medical conditions included rheumatoid arthritis and joint pain.   On an unknown date, the patient received Shingrix at an unknown dose. In August 2017, the patient started Xeljanz Xr (oral) 11 mg once daily (11 mg daily). In December 2019, unknown after receiving Shingrix, the patient experienced arthralgia aggravated and fatigue. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. Xeljanz Xr was continued with no change. On an unknown date, the outcome of the vaccination failure, arthralgia aggravated and fatigue were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, arthralgia aggravated and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Age at vaccination was not reported. However the patient was an adult at the time of vaccination. The patient reports some flare ups with pain in joints and fatigue since december, 2019 after start of therapy XELJANZ XR 8/2017. Reports shingles for 2 weeks in January or February 2020, after receiving Shingrix vaccination years ago. Agrees that generally it was been hard to cope with rheumatoid arthritis and sometimes feels discouraged, but not depressed, prior to and continuing unchanged since start of therapy. The case has been considered as suspected vaccination failure being full schedule was unknown. It was unknown if the reporter considered the shingles, arthralgia aggravated and fatigue to be related to Xeljanz Xr as well.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: The physician did note that this events was unlike he experienced using Shingrix previously; This case was reported by a physician via sales rep and described the occurrence of adverse drug reaction in a male patient who received Herpes zoster (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 adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The physician did note that this events (experienced by the patient) was unlike he experienced using Shingrix previously. Consented to follow up. This case is linked to the case US2020034226, reported by the same reporter for different patient.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Acarodermatitis, Biopsy skin normal, Blister, Blood test normal, Immediate post-injection reaction
Clinical narrative: Diagnosed it as a staph infection; Diagnosed it as scabies / Scaly scab-like form; Pain; still suffering with new blisters; scaly scabs; Extensive shingles-like reactions all over my body/ blister-like reaction/shingleslike blisters; This case was reported by a consumer via call center representative and described the occurrence of staphylococcal infection in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on 19th September 2019, refer case US2020AMR059707).   On 13th January 2020, the patient received the 2nd dose of Shingrix. On 13th January 2020, immediately after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the patient experienced staphylococcal infection (serious criteria GSK medically significant), scabies, pain, blister and skin scaly. On an unknown date, the outcome of the staphylococcal infection and pain were unknown and the outcome of the scabies, vesicular rash, blister and skin scaly were not recovered/not resolved.   It was unknown if the reporter considered the staphylococcal infection, scabies, vesicular rash, pain, blister and skin scaly to be related to Shingrix.  Additional details were provide as follows: This case was reported by patient herself. Right after vaccination, the patient had extensive shingles-like reactions all over my body and immediately met her primary care doctor. The primary care physician diagnosed it as a staph infection, prescribed antibiotics and also recommended her to follow up with a dermatologist.  There was no improvement to the patient's condition even after completing the antibiotic treatment.  As the pain and blister-like reaction all over my body was still persistent even after 10 days, the patient could met with a dermatologist who diagnosed it as scabies and prescribed medication for scabies.  After suffering for 2 more weeks, the patient could get an appointment with another dermatologist as the patient was suspicious and not convinced of the diagnosis of scabies. Also, the treatment prescribed for scabies did not work either. This time, the 2nd dermatologist did not have a diagnosis but prescribed a blood test for an auto-immune disorder.  The blood tests were completed, with a negative result and there was no indication of an auto-immune issue. The dermatologist also recommended a biopsy but the shingles like blisters which turn into a scaly scab-like form, persist even till the time of reporting, were small and had not lent themselves to biopsy.  The dermatologist also did mention that, they were noticing some strange reactions to Shingrix.  The patient wanted to know, that after many months of no clear diagnosis and still suffering with new blisters forming every few days and turning into scaly scabs. This case has been linked with case US2020AMR059715, reported by the same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash vesicular, Scab, Skin exfoliation, Staphylococcal infection
Clinical narrative: Diagnosed it as a staph infection; Diagnosed it as scabies / Scaly scab-like form; Pain; still suffering with new blisters; scaly scabs; Extensive shingles-like reactions all over my body/ blister-like reaction/shingleslike blisters; This case was reported by a consumer via call center representative and described the occurrence of staphylococcal infection in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on 19th September 2019, refer case US2020AMR059707).   On 13th January 2020, the patient received the 2nd dose of Shingrix. On 13th January 2020, immediately after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the patient experienced staphylococcal infection (serious criteria GSK medically significant), scabies, pain, blister and skin scaly. On an unknown date, the outcome of the staphylococcal infection and pain were unknown and the outcome of the scabies, vesicular rash, blister and skin scaly were not recovered/not resolved.   It was unknown if the reporter considered the staphylococcal infection, scabies, vesicular rash, pain, blister and skin scaly to be related to Shingrix.  Additional details were provide as follows: This case was reported by patient herself. Right after vaccination, the patient had extensive shingles-like reactions all over my body and immediately met her primary care doctor. The primary care physician diagnosed it as a staph infection, prescribed antibiotics and also recommended her to follow up with a dermatologist.  There was no improvement to the patient's condition even after completing the antibiotic treatment.  As the pain and blister-like reaction all over my body was still persistent even after 10 days, the patient could met with a dermatologist who diagnosed it as scabies and prescribed medication for scabies.  After suffering for 2 more weeks, the patient could get an appointment with another dermatologist as the patient was suspicious and not convinced of the diagnosis of scabies. Also, the treatment prescribed for scabies did not work either. This time, the 2nd dermatologist did not have a diagnosis but prescribed a blood test for an auto-immune disorder.  The blood tests were completed, with a negative result and there was no indication of an auto-immune issue. The dermatologist also recommended a biopsy but the shingles like blisters which turn into a scaly scab-like form, persist even till the time of reporting, were small and had not lent themselves to biopsy.  The dermatologist also did mention that, they were noticing some strange reactions to Shingrix.  The patient wanted to know, that after many months of no clear diagnosis and still suffering with new blisters forming every few days and turning into scaly scabs. This case has been linked with case US2020AMR059715, reported by the same reporter.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Aphthous ulcer, Asthenia, Condition aggravated, Headache, Hyperhidrosis
Clinical narrative: weakness/no energy; headache; canker sores in mouth; arm pain; fever; sweating; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included aphthous stomatitis.   On 20th February 2020, the patient received the 1st dose of Shingrix. On 20th February 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, fever and sweating. On 21st February 2020, the patient experienced weakness, headache and aphthous stomatitis. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the pain in arm, fever, sweating, weakness and headache were recovering/resolving and the outcome of the aphthous stomatitis was unknown.   It was unknown if the reporter considered the pain in arm, fever, sweating, weakness, headache and aphthous stomatitis to be related to Shingrix.  Additional details were provided as follows: The patient felt that her adverse experience was worse because she only weighs 90 pounds.  The patient took Advil the day after receiving her 1st dose of Shingrix and it initially helped to ease the pain, but the pain returned when the Advil wore off.  The patient had a sprained ring finger in November that had healed, but the pain had now returned. The patient did not have any known allergic reactions.  The patient has had canker sores in the past, but she now had recurrent sores in her mouth that were worse than normal. Did not consent to follow-up.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: weakness/no energy; headache; canker sores in mouth; arm pain; fever; sweating; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included aphthous stomatitis.   On 20th February 2020, the patient received the 1st dose of Shingrix. On 20th February 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, fever and sweating. On 21st February 2020, the patient experienced weakness, headache and aphthous stomatitis. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the pain in arm, fever, sweating, weakness and headache were recovering/resolving and the outcome of the aphthous stomatitis was unknown.   It was unknown if the reporter considered the pain in arm, fever, sweating, weakness, headache and aphthous stomatitis to be related to Shingrix.  Additional details were provided as follows: The patient felt that her adverse experience was worse because she only weighs 90 pounds.  The patient took Advil the day after receiving her 1st dose of Shingrix and it initially helped to ease the pain, but the pain returned when the Advil wore off.  The patient had a sprained ring finger in November that had healed, but the pain had now returned. The patient did not have any known allergic reactions.  The patient has had canker sores in the past, but she now had recurrent sores in her mouth that were worse than normal. Did not consent to follow-up.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Large, red bulge near the injection site about 2 inches; Large, red bulge near the injection site about 2 inches; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site erythema and injection site mass. On an unknown date, the outcome of the injection site erythema and injection site mass were unknown.   It was unknown if the reporter considered the injection site erythema and injection site mass to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of Bexsero and developed a large, red bulge near the injection site, about 2 inches. No other information was reported. The reporter consented to follow up. This case has been linked with US2020AMR039749, reported by same reporter.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Disturbance in attention, Fatigue, Feeling abnormal, Infectious mononucleosis, Laboratory test abnormal
Clinical narrative: had swelling right below the injection site; rash which was contiguous and extended to the hand and wrist of the injected arm; feeling tired; feeling fuzzy; could not concentrate; always felt like taking a nap; she was diagnosed with mononucleosis; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose in August 2019).   In November 2019, the patient received the 2nd dose of Shingrix. In February 2020, between 2 and 4 months after receiving Shingrix, the patient experienced mononucleosis. On an unknown date, the patient experienced local swelling, rash, tiredness, fuzzy, concentration impaired and sleepiness. On an unknown date, the outcome of the local swelling, rash, tiredness, fuzzy, concentration impaired and sleepiness were recovered/resolved and the outcome of the mononucleosis was recovering/resolving.   It was unknown if the reporter considered the local swelling, rash, tiredness, fuzzy, concentration impaired, sleepiness and mononucleosis to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of the vaccine,on the left arm in November 2019 and had swelling right below the injection site 1 week after receiving the injection with rash which was contiguous and extended to the hand and wrist of the injected arm. The patient stated that for about a month she was feeling tired, feeling fuzzy, could not concentrate and always felt like taking a nap. About 2 weeks ago, she was diagnosed with mononucleosis. All her lab values were normal, except for the early antigen level which was slightly elevated at 9. The reporter consented to follow up.      Lab Comments: On an unknown dates lab test were performed
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Somnolence, Swelling
Clinical narrative: had swelling right below the injection site; rash which was contiguous and extended to the hand and wrist of the injected arm; feeling tired; feeling fuzzy; could not concentrate; always felt like taking a nap; she was diagnosed with mononucleosis; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose in August 2019).   In November 2019, the patient received the 2nd dose of Shingrix. In February 2020, between 2 and 4 months after receiving Shingrix, the patient experienced mononucleosis. On an unknown date, the patient experienced local swelling, rash, tiredness, fuzzy, concentration impaired and sleepiness. On an unknown date, the outcome of the local swelling, rash, tiredness, fuzzy, concentration impaired and sleepiness were recovered/resolved and the outcome of the mononucleosis was recovering/resolving.   It was unknown if the reporter considered the local swelling, rash, tiredness, fuzzy, concentration impaired, sleepiness and mononucleosis to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of the vaccine,on the left arm in November 2019 and had swelling right below the injection site 1 week after receiving the injection with rash which was contiguous and extended to the hand and wrist of the injected arm. The patient stated that for about a month she was feeling tired, feeling fuzzy, could not concentrate and always felt like taking a nap. About 2 weeks ago, she was diagnosed with mononucleosis. All her lab values were normal, except for the early antigen level which was slightly elevated at 9. The reporter consented to follow up.      Lab Comments: On an unknown dates lab test were performed
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Purpura, Rash erythematous
Clinical narrative: Vaccine administered on 12/6/2019. On 12/8/2019, patient reports she developed a red raised rash on left arm to left wrist that spread to back and bottom. Rash was pruritic
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Antinuclear antibody positive, Costochondritis, Cytomegalovirus test positive, Fatigue, Headache
Clinical narrative: Chronic Headache; Persisting Fatigue; Myalgias; Costochondritis; Hypersomnolence - all sx began within 15 days of vaccine administration and have persistedover last 4+ months. Alternate etiology through extensive testing has yet to be identified. Patient did have Positive CMV titers less than 1 month after onset of symptoms. She also has a markedly positive ANA (1:640) with ongoing Rheumatology evaluation.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Hypersomnia, Myalgia, Vitamin B12 normal
Clinical narrative: Chronic Headache; Persisting Fatigue; Myalgias; Costochondritis; Hypersomnolence - all sx began within 15 days of vaccine administration and have persistedover last 4+ months. Alternate etiology through extensive testing has yet to be identified. Patient did have Positive CMV titers less than 1 month after onset of symptoms. She also has a markedly positive ANA (1:640) with ongoing Rheumatology evaluation.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 16 year old female patient was administered a dose of PROQUAD; This spontaneous report was received from a medical assistant referring to a 16-year-old female patient. The patient's concurrent conditions, pertinent medical history and drug reactions/allergies were not provided. Concomitant medication included sterile diluent (MK- 9395).  On 01-APR-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (PROQUAD)(rHA) (strength, and dose were not provided), lot #S027459, expiration date 02-MAR-2021, route of administration was defaulted to subcutaneous for prophylaxis (product administered to patient of inappropriate age). No additional adverse event (AE) information was provided.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Burning sensation, Dyspepsia, Headache, Injection site pain
Clinical narrative: burning back pain; burning back pain; sickness; experienced "sickness" headache; injection site pain; heart burn; This case was reported by a nurse via call center representative and described the occurrence of sickness in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 5th March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced sickness, headache, injection site pain, heartburn, burning sensation and back pain. On an unknown date, the outcome of the sickness, headache, injection site pain and heartburn were recovered/resolved and the outcome of the burning sensation and back pain were not recovered/not resolved.   It was unknown if the reporter considered the sickness, headache, injection site pain, heartburn, burning sensation and back pain to be related to Shingrix.  Additional details were reported as follows: On 4th December 2019, the patient received 1st dose. The patient received 2nd dose of Shingrix and experienced sickness, headache, injection site pain, heart burn and burning pain across back.  The healthcare professional (HCP) reported that all the symptoms went away after 1 day except the burning pain across back. No additional information provided. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: burning back pain; burning back pain; sickness; experienced "sickness" headache; injection site pain; heart burn; This case was reported by a nurse via call center representative and described the occurrence of sickness in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 5th March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced sickness, headache, injection site pain, heartburn, burning sensation and back pain. On an unknown date, the outcome of the sickness, headache, injection site pain and heartburn were recovered/resolved and the outcome of the burning sensation and back pain were not recovered/not resolved.   It was unknown if the reporter considered the sickness, headache, injection site pain, heartburn, burning sensation and back pain to be related to Shingrix.  Additional details were reported as follows: On 4th December 2019, the patient received 1st dose. The patient received 2nd dose of Shingrix and experienced sickness, headache, injection site pain, heart burn and burning pain across back.  The healthcare professional (HCP) reported that all the symptoms went away after 1 day except the burning pain across back. No additional information provided. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Bedridden, Chills, Fatigue, Feeling cold
Clinical narrative: he felt a little weak / The next day he felt very weak / By the 3rd day he still felt weak; he felt a little cold / By the 3rd day he still felt cold; he felt very tired\ fatigue; he started having hematuria with noticeable redness in his urine; have a lot of shivering\ chills; He spent most of the next couple days in bed due to fatigue and chills; This case was reported by a consumer via call center representative and described the occurrence of weakness in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hematuria and influenza (hematuria with influenza twice, at least once leading to hospitalization).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced weakness, cold, tiredness, hematuria, shivering and bedridden. On an unknown date, the outcome of the weakness, cold, tiredness and hematuria were recovered/resolved and the outcome of the shivering and bedridden were unknown.   It was unknown if the reporter considered the weakness, cold, tiredness, hematuria, shivering and bedridden to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix around late Jan or early Feb 2020 at 10 to 11 AM. The patient felt a little weak and cold on same night.  The next day he felt very weak and tired and had a lot of shivering.  He spent most of the next couple days in bed due to fatigue and chills.  By the 3rd day he still felt weak and cold, but it was tolerable.  That evening he started having hematuria with noticeable redness in his urine.  By the 5th day his symptoms had improved. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Haematuria
Clinical narrative: he felt a little weak / The next day he felt very weak / By the 3rd day he still felt weak; he felt a little cold / By the 3rd day he still felt cold; he felt very tired\ fatigue; he started having hematuria with noticeable redness in his urine; have a lot of shivering\ chills; He spent most of the next couple days in bed due to fatigue and chills; This case was reported by a consumer via call center representative and described the occurrence of weakness in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hematuria and influenza (hematuria with influenza twice, at least once leading to hospitalization).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced weakness, cold, tiredness, hematuria, shivering and bedridden. On an unknown date, the outcome of the weakness, cold, tiredness and hematuria were recovered/resolved and the outcome of the shivering and bedridden were unknown.   It was unknown if the reporter considered the weakness, cold, tiredness, hematuria, shivering and bedridden to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix around late Jan or early Feb 2020 at 10 to 11 AM. The patient felt a little weak and cold on same night.  The next day he felt very weak and tired and had a lot of shivering.  He spent most of the next couple days in bed due to fatigue and chills.  By the 3rd day he still felt weak and cold, but it was tolerable.  That evening he started having hematuria with noticeable redness in his urine.  By the 5th day his symptoms had improved. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Feeling hot, Swelling face, Tenderness
Clinical narrative: 1-31-2020 5 P 48 hours after receiving shingles (Rt) right cheek felt "newd" sore. (rt eye area (Rt) cheek swellon, "mild"numbness cheek to chin area, warm tender. Went to local urgent care Tx: Decadron 10 mg IM Rx: Medrol dose pack 4 mg tappery dose. Pt states reported to pharmacy thought they reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) as prescriber/administered by a pharmacist (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation), the patient was treated by a physician for shingles (herpes zoster); therefore, on an unknown date, she was hospitalized due to the event. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of herpes zoster was not recovered.  The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).