chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple unspecified patients may have been administered improperly stored VARIVAX that was reconstitiued with properly stored sterile water diluent; no adverse events; This non valid spontaneous report was received from a nurse practitioner referring to multiple patients of unknown age or gender.  The patients' concurrent conditions, medical history or concomitant therapies were not reported.   On unknown dates, the patients were vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S005079, expiration date on 19-FEB-2021; lot # N030571, expiration date on 31-OC-2019 and lot # R008393, expiration date on 20-MAR-2020 for prophylaxis (doses, routes or frequencies were not provided). The temperature or time frame range from 6°F to 14 °F (12.5 °F) for 21 hours, the nurse stated that other recent temperature excusions occurred as well, but did not have additional information at the reporting time. There was no previous temperature excursions. There was involved a data logger issue. No adverse events were present. The vaccine was reconstituted with properly stored sterile water diluent lo# R003740, expiration date on 23-SEP-2020.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effect; 53-old female received one dose of gardasil 9; This spontaneous report as received from a pharmacist refers to a 53 year old female patient.    On 2019 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis.       On 2019 the patient experienced product administered to patient of inappropriate age.  On an unknown date the patient experienced no adverse event.    The outcome of product administered to patient of inappropriate age and no adverse event is unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; patient received a dose of a vaccine following temperature excursion; This spontaneous report was received from a physician refers to a patient of unknown demographics.    The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 04-SEP-2019, the patient was vaccinated with improperly stored (also reported as "following a temperature excursion") varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dosage information, route of administration and anatomical locations were unknown) of lot # S005077 and expiry date of 19-FEB-2021 for prophylaxis (product storage error). No adverse effects reported. It was reported that the vaccine was exposed to a temperature of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (-9 degree Celsius to 8 degree Celsius) (45F) for a time frame of 1 hour 30 minutes. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu Like Symptoms; This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th July 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional information received were as follows: The patient experienced flu like symptoms that lasted for 2 weeks. No further details were provided.  The pharmacy tech was reporting adverse event for two patients. Thsi case has been linked with US2019158355, reported by the same reporter.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Immediate post-injection reaction, Influenza like illness, Injection site erythema
Clinical narrative: Flu like symptoms; Injection Site Pain; Injection Site Swelling; Red Circle at the Injection Site; Area was hot as fire and swollen; Hurt muscles; shivering; headache; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Zostavax.   On 27th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th August 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, injection site pain, injection site swelling, injection site erythema, injection site warmth, muscle pain, shivering and headache. On an unknown date, the outcome of the influenza-like symptoms, injection site pain, injection site swelling, injection site erythema, injection site warmth, muscle pain, shivering and headache were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, injection site pain, injection site swelling, injection site erythema, injection site warmth, muscle pain, shivering and headache to be related to Shingrix.  Additional details were provided as follows: The patient had the Zostavax vaccine many years ago and he got shingles later. The patient received Shingrix in his left arm at physician's office. The patient immediately experienced pain, swelling and a red circle at the injection site. The area was hot as fire and swollen. He also reported about hurt muscles, flu like symptoms, shivering and headache. The patient stated, these side effects were worse than when he had shingles previously. The experience was so painful that he would not be getting the 2nd dose of Shingrix. All of his reactions continued and were unchanged. The patient consented to follow up and provided his physician's address. This case has been linked to US2019158373, reported by the same reporter.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Flu like symptoms; Injection Site Pain; Injection Site Swelling; Red Circle at the Injection Site; Area was hot as fire and swollen; Hurt muscles; shivering; headache; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Zostavax.   On 27th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th August 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, injection site pain, injection site swelling, injection site erythema, injection site warmth, muscle pain, shivering and headache. On an unknown date, the outcome of the influenza-like symptoms, injection site pain, injection site swelling, injection site erythema, injection site warmth, muscle pain, shivering and headache were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, injection site pain, injection site swelling, injection site erythema, injection site warmth, muscle pain, shivering and headache to be related to Shingrix.  Additional details were provided as follows: The patient had the Zostavax vaccine many years ago and he got shingles later. The patient received Shingrix in his left arm at physician's office. The patient immediately experienced pain, swelling and a red circle at the injection site. The area was hot as fire and swollen. He also reported about hurt muscles, flu like symptoms, shivering and headache. The patient stated, these side effects were worse than when he had shingles previously. The experience was so painful that he would not be getting the 2nd dose of Shingrix. All of his reactions continued and were unchanged. The patient consented to follow up and provided his physician's address. This case has been linked to US2019158373, reported by the same reporter.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: Body aches; Tired/ exhaustion; This case was reported by a consumer and described the occurrence of general body pain in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date, refer case US2019AMR157415).   On 27th August 2019, the patient received the 2nd dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced general body pain and tiredness. On an unknown date, the outcome of the general body pain and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the general body pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient experienced body aches and so tired. The patient asked how long it would last.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a physician via sales rep and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 30 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. Approximately, a month post first dose, the patient experienced shingles.
Sex: F
Vaccine: FLUX
Symptoms: Erythema
Clinical narrative: Redness on her arm near the injection site; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 74-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was recovered/resolved.   It was unknown if the reporter considered the erythema of extremities to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced redness on her arm near the injection site. This case is linked to the case US2019158360, reported by the same reporter.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th June 2019, the patient received the 1st dose of Shingrix. On 28th June 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 1st July 2019, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. The patient experienced sore arm which resolved within 3 days. For tolerance to 2nd dose, refer linked case US2019158370.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Paraesthesia
Clinical narrative: Full body paresthesia; This case was reported by a physician via sales rep and described the occurrence of paresthesia generalized in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced paresthesia generalized. Shingrix was discontinued. On an unknown date, the outcome of the paresthesia generalized was recovered/resolved.   It was unknown if the reporter considered the paresthesia generalized to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported but it could be 79 years or 80 years. Approximately 4 months before the date of reporting, in 2019, the patient received Shingrix. The patient experienced full body paresthesia which lasted about 2 days. The patient was fully recovered but refused to receive 2nd dose. The reporter denied for follow up contact.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site mass
Clinical narrative: Firm lump at the site of injection; This case was reported by a physician via sales rep and described the occurrence of injection site lump in a 17-year-old 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, 30 days after receiving Bexsero, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was recovered/resolved.   It was unknown if the reporter considered the injection site lump to be related to Bexsero.  Additional details were reported as follows: The patient experienced a residual firm lump at the site of injection post 1 month. At 2 months, no lump. No pain associated with lump at the 1 month post injection. Patient received 2nd dose 2 months post 1st injection. No side effects after 2nd injection.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Synovitis
Clinical narrative: synovitis in his first metatarsal of his left hand; inappropriate schedule of vaccine; This case was reported by a physician via sales rep and described the occurrence of synovitis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of synovitis (received 1st dose on 19th April 2018, refer case US2018GSK169735).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced synovitis and drug dose administration interval too long. On an unknown date, the outcome of the synovitis and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the synovitis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional has self report of synovitis in his first metatarsal of his left hand after receiving his 2nd dose of Shingrix. He had it evaluated by a rheumatologist and it did not appear to the rheumatoid arthritis. He had a similar adverse event after 1st dose however it happened on his right hand. That was previously reported. His 2nd dose occurred 1 year and 2 months after his 1st dose.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Pain in the muscle in arm; This case was reported by a consumer and described the occurrence of muscle pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced muscle pain. The patient was treated with ibuprofen and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. About 3 months ago, the patient received Shingrix. At the time of reporting, the patient still had pain in the muscle in my arm. The patient asked what could she do and should she still receive the 2nd vaccination. The patient had already iced, ibuprofen, massages and moved it.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles outbreak; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (since puberty).   On an unknown date, the patient received the 1st dose of Shingrix. In February 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and less than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient suffers from shingles since puberty. The patient received 1st Shingrix vaccine in 2018. The patient received 2nd Shingrix vaccine in February 2019. After that the patient had shingles outbreak on leg. This case was considered as suspected vaccination failure since the details regarding completion of time to onset and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Eye infection, Eye irritation, Foreign body sensation in eyes, Ocular hyperaemia, Ophthalmic herpes zoster
Clinical narrative: extremely irritated left eye (red); eye infection; left eye with possibly herpes zoster; irritation in left eye; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in May 2019, but had no problems).   On 26th August 2019, the patient received the 2nd dose of Shingrix. On 28th August 2019, 2 days after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), eye irritation and eye infection. On 29th August 2019, the patient experienced eye red. The patient was treated with artificial tears nos (Artificial Tears) and antivirals nos (Anti-Viral Medicine (Nos)). On an unknown date, the outcome of the ophthalmic herpes zoster, eye irritation, eye red and eye infection were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster, eye irritation, eye red and eye infection to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient started having irritation in left eye, which the patient believed was a foreign body. The patient was tried flushing with artificial tears to no avail. Three days after vaccination, the patient woke up with an extremely irritated left eye and the eye was red. On 30th August 2019, the patient went to the eye physician who diagnosed the patient's left eye with possibly herpes zoster and was treating for an eye infection to be followed by some anti-virals based on the patient's response. The patient read the Shingrix literature and understand it did not contain a virus only proteins to mimic an immune response. The patient asked that, was there any reported side effects of eye infections was bacterial or viral with the administration of Shingrix.
Sex: U
Vaccine: FLUX
Symptoms: Pneumonia
Clinical narrative: pneumonia; This case was reported by a consumer via interactive digital media and described the occurrence of pneumonia in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pneumonia (serious criteria GSK medically significant). Flu vaccine was discontinued. On an unknown date, the outcome of the pneumonia was unknown.   It was unknown if the reporter considered the pneumonia to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The Flu shot give pneumonia to the patient 5 years in row. The patient never took it again and never had the flu. This case has been linked with case US2019AMR153058, reported by the same reporter.
Sex: F
Vaccine: TDAP
Symptoms: Adverse reaction
Clinical narrative: Bad reaction; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a child female patient who received DTPa (DTPa vaccine) for an unknown indication.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to DTPa vaccine.  Additional details were provided as follows: The reporter was the patient's mother. The age at vaccination was not reported. The patient's mother reported that, the patient previously had bad reaction to the immunization, but did not stated to which vaccine, patient had a bad reaction. The reporter was trying to find out if the Whooping cough vaccine was available as an individual vaccine. The reporter needed to get updates on dtap and meningococcal vaccine. No additional information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash in a few different areas of body; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was recovered/resolved.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional information received were as follows: The caller was a pharmacist and was calling on behalf of his friend that was the patient. The age at vaccination was not reported. The patient received Shingrix shot at pharmacy a little bit more than two months ago. The patient experienced rash in a few different areas of her body. The patient had recovered from the rash. It took a few days to clear up. This case has been linked with US2019157515, reported by the same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site haematoma, Injection site induration, Injection site nodule
Clinical narrative: Hematoma; Bluish Bruise hard and has a nodule; Bluish Bruise hard and has a nodule; Bluish Bruise hard and has a nodule; This case was reported by a pharmacist via call center representative and described the occurrence of injection site hematoma in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 3LL4P, expiry date 19th October 2021) for prophylaxis.   On 26th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2019, less than a week after receiving Shingrix, the patient experienced injection site hematoma, injection site bruising, injection site induration and injection site nodule. On an unknown date, the outcome of the injection site hematoma, injection site bruising, injection site induration and injection site nodule were not recovered/not resolved.   It was unknown if the reporter considered the injection site hematoma, injection site bruising, injection site induration and injection site nodule to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left deltoid. The pharmacist reported that her patient who was a nurse presented to her pharmacy a day before the reporting date with a hematoma on the upper arm of injection.  The hematoma described as a bluish bruise, hard and had a nodule. The pharmacist would call back at a more convenient time to report other Shingrix adverse events.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on her entire torso; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 26th August 2020) for prophylaxis.   On 26th August 2019, the patient received the 1st dose of Shingrix .5 ml. In August 2019, less than a week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: Patient experienced rash on her entire torso. No further details were provided.  The case has been linked with case US2019158353, reported by same reporter.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Skin exfoliation
Clinical narrative: Redness at injection site; Tenderness at injection site; Peeling skin; Painful / Hurt like crazy; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd June 2019, the patient received the 1st dose of Shingrix. In June 2019, 3 days after receiving Shingrix, the patient experienced injection site erythema, injection site tenderness, skin peeling and pain. On an unknown date, the outcome of the injection site erythema, injection site tenderness, skin peeling and pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site tenderness, skin peeling and pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist stated that the patient received Shingrix about three days later she had redness and tenderness at the site, which pharmacist states looked normal. Then about 7 days after the injection the patient experienced skin peeling at the site, which was painful and hurt like crazy. The pharmacist stated that the symptoms were resolved. The reporter consented to follow up. The pharmacist grants permission to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure increased, Chills, Headache, Heart rate increased, Injection site pain
Clinical narrative: Injection site soreness; Body aches; chills; nausea; Slight increase in blood pressure; increase in pulse rate; headache; Feeling of being unwell; Heart is pounding; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 28th June 2019, refer linked case US2019AMR158858).   On 28th August 2019, the patient received the 2nd dose of Shingrix. On 28th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, general body pain, chills, nausea, increased blood pressure, pulse rate increased, headache, feeling unwell and heart pounding. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the general body pain, chills and nausea were not recovered/not resolved and the outcome of the increased blood pressure, pulse rate increased, headache, feeling unwell and heart pounding were unknown.   It was unknown if the reporter considered the injection site pain, general body pain, chills, nausea, increased blood pressure, pulse rate increased, headache, feeling unwell and heart pounding to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. The patient experienced a feeling of being unwell which includes body aches, chills, nausea and headache. The patient stated that her heart was pounding with a slight increase in blood pressure and also reported increase in pulse rate.  The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Nausea, Pain, Palpitations
Clinical narrative: Injection site soreness; Body aches; chills; nausea; Slight increase in blood pressure; increase in pulse rate; headache; Feeling of being unwell; Heart is pounding; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 28th June 2019, refer linked case US2019AMR158858).   On 28th August 2019, the patient received the 2nd dose of Shingrix. On 28th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, general body pain, chills, nausea, increased blood pressure, pulse rate increased, headache, feeling unwell and heart pounding. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the general body pain, chills and nausea were not recovered/not resolved and the outcome of the increased blood pressure, pulse rate increased, headache, feeling unwell and heart pounding were unknown.   It was unknown if the reporter considered the injection site pain, general body pain, chills, nausea, increased blood pressure, pulse rate increased, headache, feeling unwell and heart pounding to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. The patient experienced a feeling of being unwell which includes body aches, chills, nausea and headache. The patient stated that her heart was pounding with a slight increase in blood pressure and also reported increase in pulse rate.  The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Heart rate increased, Myalgia, Nausea
Clinical narrative: Injection site soreness; Body aches; chills; nausea; Slight increase in blood pressure; increase in pulse rate; headache; Feeling of being unwell; Heart is pounding; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 28th June 2019, refer linked case US2019AMR158858).   On 28th August 2019, the patient received the 2nd dose of Shingrix. On 28th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, general body pain, chills, nausea, increased blood pressure, pulse rate increased, headache, feeling unwell and heart pounding. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the general body pain, chills and nausea were not recovered/not resolved and the outcome of the increased blood pressure, pulse rate increased, headache, feeling unwell and heart pounding were unknown.   It was unknown if the reporter considered the injection site pain, general body pain, chills, nausea, increased blood pressure, pulse rate increased, headache, feeling unwell and heart pounding to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. The patient experienced a feeling of being unwell which includes body aches, chills, nausea and headache. The patient stated that her heart was pounding with a slight increase in blood pressure and also reported increase in pulse rate.  The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Palpitations, Tremor
Clinical narrative: Injection site soreness; Body aches; chills; nausea; Slight increase in blood pressure; increase in pulse rate; headache; Feeling of being unwell; Heart is pounding; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 28th June 2019, refer linked case US2019AMR158858).   On 28th August 2019, the patient received the 2nd dose of Shingrix. On 28th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, general body pain, chills, nausea, increased blood pressure, pulse rate increased, headache, feeling unwell and heart pounding. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the general body pain, chills and nausea were not recovered/not resolved and the outcome of the increased blood pressure, pulse rate increased, headache, feeling unwell and heart pounding were unknown.   It was unknown if the reporter considered the injection site pain, general body pain, chills, nausea, increased blood pressure, pulse rate increased, headache, feeling unwell and heart pounding to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. The patient experienced a feeling of being unwell which includes body aches, chills, nausea and headache. The patient stated that her heart was pounding with a slight increase in blood pressure and also reported increase in pulse rate.  The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Injection Site Pain; Injection Site Swelling; Red circle at the injection site; Area was hot as fire; hurt muscles; flu like symptoms; shivering; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th August 2019, immediately after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema, injection site warmth, muscle pain, influenza-like symptoms, shivering and headache. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, injection site warmth, muscle pain, influenza-like symptoms, shivering and headache were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, injection site warmth, muscle pain, influenza-like symptoms, shivering and headache to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm in her physician's office. The patient experienced pain, swelling and a red circle at the injection site. Less than a day after receiving Shingrix, the area was hot as fire and swollen. Less than a day after receiving Shingrix, the patient experienced hurt muscles, flu like symptoms, shivering and a headache. The patient's reactions continue to be unchanged. The reporter consented to follow up. This case has been linked with US2019158372, reported by the same reporter.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Injection Site Pain; Injection Site Swelling; Red circle at the injection site; Area was hot as fire; hurt muscles; flu like symptoms; shivering; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th August 2019, immediately after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema, injection site warmth, muscle pain, influenza-like symptoms, shivering and headache. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, injection site warmth, muscle pain, influenza-like symptoms, shivering and headache were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, injection site warmth, muscle pain, influenza-like symptoms, shivering and headache to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm in her physician's office. The patient experienced pain, swelling and a red circle at the injection site. Less than a day after receiving Shingrix, the area was hot as fire and swollen. Less than a day after receiving Shingrix, the patient experienced hurt muscles, flu like symptoms, shivering and a headache. The patient's reactions continue to be unchanged. The reporter consented to follow up. This case has been linked with US2019158372, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Rash; Blisters (fluid filled); This case was reported by a other health professional via call center representative and described the occurrence of rash in a 87-year-old female patient who received Herpes zoster (Shingrix) (batch number JC55P, expiry date 20th April 2021) for prophylaxis.   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 rash and blistery rash. On an unknown date, the outcome of the rash and blistery rash were unknown.   It was unknown if the reporter considered the rash and blistery rash to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The pharmacy intern called to report that the patient experienced rash within a few hours after receiving first dose of Shingrix. Within 7 days after receiving Shingrix, the patient experienced developed blisters (fluid filled). The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site indentation, Injection site pain
Clinical narrative: pain at injection site / feels like a bee sting; indentation in skin at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 4LH35, expiry date 11th September 2021) for prophylaxis.   On 16th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2019, 35 days after receiving Shingrix, the patient experienced injection site pain and injection site indentation. On an unknown date, the outcome of the injection site pain and injection site indentation were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injection site indentation to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on the right deltoid. Approximately 1 week before the date of reporting, the patient developed pain at the injection site that he stated felt like a bee sting.  The patient also experienced an indentation at the injection site. The caller did not provide any additional information.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Antibody test negative, Hepatitis B antibody, Therapy non-responder
Clinical narrative: non therapy-responder; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 57-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On an unknown date, less than a year after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine.  Additional information received were as follows: The age at vaccination was not reported. The healthcare professional reported that the patient received the 3 dose series of Hepatitis B vaccine this past year. The doctor said that the patient had no antibodies against Hepatitis B vaccine, which led the patient to be therapy non-responder. The reporter consented to follow up.      Lab Comments: Lab test done on an unknown date
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Soreness when arm is raised/Pain at site and area when arm is raised; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number GZ29L, expiry date 23rd May 2021) for prophylaxis.   On 31st July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The pharmacist asked if any information available as the patient experienced soreness and pain at the site and area when patient raises arm. The patient has to support arm.  The reporter had consented to follow up.
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Hepatitis A, Incomplete course of vaccination
Clinical narrative: Heptatis Ainfection; Incomplete course of vaccination; This case was reported by a consumer via call center representative and described the occurrence of hepatitis a in a adult female patient who received HAV (Havrix adult) for prophylaxis.   Co-suspect products included HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received the 1st dose of Havrix adult and the 2nd dose of Havrix adult. On an unknown date, several years after receiving Havrix adult and not applicable after receiving Havrix adult, the patient experienced hepatitis a and incomplete course of vaccination. On an unknown date, the outcome of the hepatitis a and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the hepatitis a to be related to Havrix adult.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine years ago and experienced hepatitis a. Till the time of reporting the patient not receive the booster dose which led to incomplete course of vaccination. The patient stated that the health department told her to just get the booster vaccination, but the CDC told her to get the Havrix series again.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Shingrix. On 28th August 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The report was notifed by friend of family via text, stated that he received Shingrix he had flu like symptoms.  No other details were shared by the friend. The reporter stated that she received a text last evening from the friend.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Swelling
Clinical narrative: Flu-like symptoms; Swelling; Malaise; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms, swelling and malaise. On an unknown date, the outcome of the influenza-like symptoms, swelling and malaise were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, swelling and malaise to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not applicable for this report. The number of patient's have reported having general flu-like symptoms, malaise, swelling, after receiving a dose of Shingrix. The symptoms had resolved. The reporter did not consent to followup. No specific patient or vaccine details available.
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: itchy rash; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2018, the patient received the 2nd dose of Shingrix (intramuscular). In January 2019, between 1 and 2 months after receiving Shingrix, the patient experienced itchy rash. The patient was treated with dermatologicals nos (Calamine Lotion). 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 information received were as follows: The age at vaccination was not reported. In mid December 2018, the patient received Shingrix. In late January 2019, the patient experienced experienced itchy rash around the inside and back of his knees that resolved after a few days and using Calamine lotion. The patient reported that the rash would occur every 2 to 3 weeks between January 2019 and May 2019, but had not recurred since May 2019. The reporter consented to follow up.