chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Injection site pain
Clinical narrative: Soreness at the injection site; Pimple which is located two inches away from the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and acne.   On 24th March 2020, the patient received the 1st dose of Shingrix (intramuscular). On 24th March 2020, 2 hrs after receiving Shingrix, the patient experienced injection site pain and pimples. On an unknown date, the outcome of the injection site pain and pimples were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and pimples to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right deltoid. The patient experienced soreness at the injection site after his first dose of Shingrix. The patient also reported a pimple which was located two inches away from the injection site towards the back of the deltoid. The permission to follow up was denied. This case had been linked to the case US2020AMR053734, reported by same reporter. The outcome of the events were reported as not recovered/ not resolved in the Database however in source document, it was mentioned as recovering/resolving.
Age: 83.0
Sex: U
Vaccine: VARZOS
Symptoms: Arthropod bite, Herpes virus infection, Muscular weakness, Neuropathy peripheral, Rash
Clinical narrative: neuropathy in right leg; weakness in right leg; spot on his right leg / herpetic lesion the size is 3cm x 2 cm.; mosquito like bite; spot on his right leg; This case was reported by a consumer via call center representative and described the occurrence of peripheral neuropathy in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on an unknown date).   In December 2019, the patient received the 2nd dose of Shingrix (intramuscular). In December 2019, less than a month after receiving Shingrix, the patient experienced peripheral neuropathy (serious criteria GSK medically significant), lower extremities weakness of, herpetiform lesion, mosquito bite and rash. On an unknown date, the outcome of the peripheral neuropathy, lower extremities weakness of, herpetiform lesion, mosquito bite and rash were unknown.   It was unknown if the reporter considered the peripheral neuropathy, lower extremities weakness of, herpetiform lesion, mosquito bite and rash to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself. In December 2019, the patient received a dose of Shingrix on the left deltoid. In December 2019, the patient was beginning neuropathy and weakness in his right leg . The patient saw a neurologist in February 2020.  The patient had a spot on his right leg that initially looked like a mosquito bite but got worse. At the time of reporting, it was a herpetic lesion the size was 3cm by 2 cm. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Herpes zoster
Clinical narrative: Shingles; all of the side effects listed on your site but severe; This case was reported by a nurse via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (has had shingles 7 times).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles and adverse drug reaction. On an unknown date, the outcome of the shingles and adverse drug reaction were recovered/resolved.   It was unknown if the reporter considered the shingles and adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. Nurse reported the symptoms that the patient had after the first dose was all of the side effects listed on GlaxoSmithKline site but severe. The reporter stated it was worse than the flu but only for about 48 hours. The reporter was trying to decide when to give her the second dose. Nurse ended the chat before additional information could be obtained.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity, Swelling
Clinical narrative: Arm pain and swelling; swelling; feeling of Malaise; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in an elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Nucala with an associated reaction of pain (for tolerance, refer case US2020AMR057319). Concurrent medical conditions included asthma.   On 15th November 2019, the patient received Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm, swelling and malaise. On an unknown date, the outcome of the pain in arm and malaise were recovered/resolved and the outcome of the swelling was unknown.   It was unknown if the reporter considered the pain in arm, swelling and malaise to be related to Shingrix.  Additional details were provided as follows: The age at event onset was not reported but it could be 64 years or 65 years. The patient experienced arm pain and swelling and a feeling of malaise. The patient consented to follow up.
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: her arm swelled up; This is a spontaneous report based on the information received by Pfizer from Merck National Service Center (Mfr. Control No.#: 01514538). A contactable consumer (patient's daughter) reported for a female patient that:  To Whom It May Concern:  The Merck National Service Center has received information regarding an adverse experience report for the product listed below. Since this product is manufactured by your company, I am forwarding all available data we have received for this report of an adverse experience to you for your processing and follow-up investigation.  Description: The daughter of the patient stated "My mother received Prevnar 13 in 2010, I think, and her arm swelled up." Many fields marked refused to answer as the caller disconnected the line and an outbound call to them was unsuccessful. Full patient and health care provider demographics refused. No AE/PQC.  Physician Information: First Name: Refused to answer Last Name: Refused to answer Type: Physician Country:   Product: Product: Prevnar Product Circular #: # Lot Number: Refused to answer Expiration Date: Refused to answer Dose/Frequency: Refused to answer  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise, Pain, Pyrexia
Clinical narrative: Dull headache, body ache, low grade fever, malaise for 36 hours,  12 hours after vaccine administered
Age: 0.5
Sex: F
Vaccine: HPV9, UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient has not shown any symptoms as of yet; Gardasil 9 was accidentally give to a 6 month old.; Gardasil 9 was accidentally give to a 6 month old.; This spontaneous report was received from a medical assistant and refers to a 6-month-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. The case concerns 1 patient and 1 combination product. On 26-MAR-2020, the patient received accidentally a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # S008154, expiration date 20-NOV-2021 (exact dose and injection site; route of administration was reported as injectable) for prophylaxis (indication was also reported as accidental exposure). The patient had not shown any symptoms as of report time, but was also no longer at the facility. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S008154; expirationdate: 20-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: Others tell me second (expletive) they got had more side effects; This case was reported by a nurse via call center representative and described the occurrence of adverse drug reaction in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was recovered/resolved.   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 applicable for this report. The patients experienced side effects after 1st dose. Nurse stated others told second (expletive) they got had more side effects.  Consented to follow up via mail. No further details provided at the time of this chat interaction. This case is linked to the case US2020056774, reported for the 2nd dose. This case is linked to the case US2020056770, reported by the same reporter.
Sex: M
Vaccine: TDAP
Symptoms: Blood immunoglobulin G increased, Condition aggravated, Hypersensitivity
Clinical narrative: Elevated IG antibodies; lactose allergy / when IG antibodies become elevated, the exposure to dairy products for the patient can get worse; This case was reported by a consumer via call center representative and described the occurrence of immunoglobulin g increased in a child male patient who received DTPa (DTPa vaccine) for prophylaxis.   Concurrent medical conditions included lactose intolerance.   On an unknown date, the patient received DTPa vaccine (intramuscular). On an unknown date, unknown after receiving DTPa vaccine, the patient experienced immunoglobulin g increased and allergy aggravated. On an unknown date, the outcome of the immunoglobulin g increased and Allergy aggravated were not recovered/not resolved.   It was unknown if the reporter considered the immunoglobulin g increased and allergic reaction to be related to DTPa vaccine.  Additional details were provided as follows: The age at the vaccination was not reported. Mother of patient reported that her son has a lactose allergy and that he had a TDAP vaccine in 2016. She did not recall what the name of the vaccine. She said that after that, her son had elevated IG antibodies. She said that when IG antibodies become elevated, the exposure to dairy products for the patient could get worse, as has happened with her son.      Lab Comments: Lab test done on an unknown date
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Rash, Swelling
Clinical narrative: Rash; red knot and hot; red knot; red knot; This case was reported by a pharmacist via call center representative and described the occurrence of rash in an unspecified number of patients who received Herpes zoster (Shingrix) (batch number NB9D3, expiry date 16th April 2022) for prophylaxis.   On an unknown date, the patients received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patients experienced rash, feeling hot, local swelling and erythema. On an unknown date, the outcome of the rash, feeling hot, local swelling and erythema were unknown.   It was unknown if the reporter considered the rash, feeling hot, local swelling and erythema to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not applicable for this report. Several patients from a nursing home who experienced after the second dose of Shingrix a rash, did not know exactly how many, if they were female or male, but provided with a vaccine data of one that was administered. The health care professional described symptoms as big red knot and hot. The reporter consented to follow up. No patients data was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: Others tell me second (expletive) they got had more side effects; This case was reported by a nurse via call center representative and described the occurrence of adverse drug reaction in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. 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 applicable for this report. Nurse stated others told second (expletive) they got had more side effects.  Consented to follow up via mail. No further details provided at the time of this chat interaction. This case is linked to the case US2020AMR057294, reported for the 1st dose. This case is linked to the case US2020056770, reported by the same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bronchiectasis, Condition aggravated, Incomplete course of vaccination, Pneumonia, Pseudomonas infection
Clinical narrative: 'pseudomonas infection; first dose of the Shingrix vaccine on 08/06/2019. She has not received the second dose; fever; Condition aggrevated; bronchiectasis flare up; pneumonia; This case was reported by a consumer via call center representative and described the occurrence of bronchiectasis in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included bronchioectasis.   On 8th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In January 2020, between 6 and 8 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pneumonia (serious criteria GSK medically significant) and fever. In February 2020, the patient experienced bronchiectasis (serious criteria GSK medically significant) and condition aggravated. On an unknown date, the patient experienced pseudomonas infection (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the bronchiectasis, pneumonia and condition aggravated were recovered/resolved and the outcome of the pseudomonas infection was not recovered/not resolved and the outcome of the fever and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the bronchiectasis, pneumonia, pseudomonas infection, condition aggravated and fever to be related to Shingrix.  Additional details were provide as follows: This case was reported by patient herself. The patient had a pre-existing diagnosis of bronchiectasis. In early January 2020, the patient had diagnosis of pneumonia for two weeks and in February 2020 for 6 weeks she had a flare-up of bronchiectasis. In January and February of 2020, the patient had fever. The patient was still undergoing treatment of the pseudomonas infection and the patient stated as other infection, which patient did not want to disclose. Customer states had fever in January and February of 2020. Till the time of reporting, the did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: 'pseudomonas infection; first dose of the Shingrix vaccine on 08/06/2019. She has not received the second dose; fever; Condition aggrevated; bronchiectasis flare up; pneumonia; This case was reported by a consumer via call center representative and described the occurrence of bronchiectasis in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included bronchioectasis.   On 8th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In January 2020, between 6 and 8 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pneumonia (serious criteria GSK medically significant) and fever. In February 2020, the patient experienced bronchiectasis (serious criteria GSK medically significant) and condition aggravated. On an unknown date, the patient experienced pseudomonas infection (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the bronchiectasis, pneumonia and condition aggravated were recovered/resolved and the outcome of the pseudomonas infection was not recovered/not resolved and the outcome of the fever and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the bronchiectasis, pneumonia, pseudomonas infection, condition aggravated and fever to be related to Shingrix.  Additional details were provide as follows: This case was reported by patient herself. The patient had a pre-existing diagnosis of bronchiectasis. In early January 2020, the patient had diagnosis of pneumonia for two weeks and in February 2020 for 6 weeks she had a flare-up of bronchiectasis. In January and February of 2020, the patient had fever. The patient was still undergoing treatment of the pseudomonas infection and the patient stated as other infection, which patient did not want to disclose. Customer states had fever in January and February of 2020. Till the time of reporting, the did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm hurt; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and since then her arm hurts. No further information was provided.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Syncope
Clinical narrative: Syncope, lower extremities elevated, provided with moist compress, vital signs remained stable. Monitored for 30 minutes, patient alert and oriented. Patient reported that he had not eaten prior to vaccines.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Malaise
Clinical narrative: have a headache; am feeling tired; general malaise; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (1st dose received on an unknown date, refer case US2020AMR047463).   In February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced headache, tiredness and malaise. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, tiredness and malaise were unknown.   It was unknown if the reporter considered the headache, tiredness and malaise to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient had vaccine about a month before the time of reporting and felt tired, had a headache and general malaise. Someone told the patient that this could be long lasting side effects of the Shingles vaccine. The patient wanted to know if that was possible. This case had been linked with case US2020AMR047463, reported for same patient.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Adverse event
Clinical narrative: have a headache; am feeling tired; general malaise; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (1st dose received on an unknown date, refer case US2020AMR047463).   In February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced headache, tiredness and malaise. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, tiredness and malaise were unknown.   It was unknown if the reporter considered the headache, tiredness and malaise to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient had vaccine about a month before the time of reporting and felt tired, had a headache and general malaise. Someone told the patient that this could be long lasting side effects of the Shingles vaccine. The patient wanted to know if that was possible. This case had been linked with case US2020AMR047463, reported for same patient.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Malaise
Clinical narrative: someone told me that people have symptoms for months following the vaccine; This case was reported by a consumer via call center representative and described the occurrence of adverse event in an unspecified number of patients 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 event. On an unknown date, the outcome of the adverse event was recovered/resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not aaplicable for this report. It was stated that people had symptoms for months following the vaccine. This case had been linked with case US2020AMR047463 and US2020AMR047412, reported by same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Adverse event
Clinical narrative: someone told me that people have symptoms for months following the vaccine; This case was reported by a consumer via call center representative and described the occurrence of adverse event in an unspecified number of patients 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 event. On an unknown date, the outcome of the adverse event was recovered/resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not aaplicable for this report. It was stated that people had symptoms for months following the vaccine. This case had been linked with case US2020AMR047463 and US2020AMR047412, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: flu like symptoms; low grade fever; body aches; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of 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 influenza-like symptoms, fever and general body pain. On an unknown date, the outcome of the influenza-like symptoms, fever and general body pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms, fever and general body pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. 1 out of 6 people may get flu like symptoms of low grade fever and body aches. This case had been linked to US2020030262, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: low grade fever; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a 57-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 1 day after receiving Shingrix, the patient experienced low grade fever. On an unknown date, the outcome of the low grade fever was unknown.   It was unknown if the reporter considered the low grade fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced low grade fever after vaccination. The patient asked can develop a fever the day after the shingrix shot if did not have it the first night.
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Hot flush, Injection site pain, Injection site swelling, Nausea, Pyrexia
Clinical narrative: slight nausea; sore; Swollen location where shot was given; fever; feels like a never ending hot flash with no sweat; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 50-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd March 2020, the patient received the 1st dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced nausea, injection site pain, injection site swelling, fever and hot flashes. On an unknown date, the outcome of the nausea, injection site pain, injection site swelling, fever and hot flashes were unknown.   It was unknown if the reporter considered the nausea, injection site pain, injection site swelling, fever and hot flashes to be related to Shingrix.  Additional case details were reported as follows: The patient experienced nausea, injection site pain, injection site swelling, fever and hot flashes after vaccination. The patient felt like a never ending hot flash with no sweat. The patient asked how long do these last, will they eventually just quit. The patient asked events could last 3 days up to 30, it just depends on the person.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Nausea, Vomiting
Clinical narrative: nausea; Puked once; Blisters; This case was reported by a consumer via call center representative and described the occurrence of nausea in an unspecified number of patients 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 nausea, vomiting and blister. On an unknown date, the outcome of the nausea, vomiting and blister were unknown.   It was unknown if the reporter considered the nausea, vomiting and blister to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that the unspecified number of patients experienced nausea, vomiting and blister after vaccination. This case has been linked with case US2020053253, reported for same reporter.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Influenza, Nasopharyngitis
Clinical narrative: flu/cold; flu/cold; This case was reported by a consumer via call center representative and described the occurrence of influenza in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd October 2019, the patient received the 1st dose of Shingrix. On 24th October 2019, 1 days after receiving Shingrix, the patient experienced influenza and cold. On an unknown date, the outcome of the influenza and cold were unknown.   It was unknown if the reporter considered the influenza and cold to be related to Shingrix.  Additional case details were reported as follows: The patient got a terrible flu and cold after vaccination. The patient was due for the 2nd dose but very concerned about reduced immunity for fighting Coronavirus.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Malaise
Clinical narrative: I felt terrible; headache; chills; weakness; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a day after receiving Shingrix, the patient experienced malaise, headache, chills and asthenia. On an unknown date, the outcome of the malaise, headache, chills and asthenia were not recovered/not resolved.   It was unknown if the reporter considered the malaise, headache, chills and asthenia to be related to Shingrix.  Additional information was provided as follows: The patient received second dose of Shingrix two days before the time of reporting. The patient felt terrible the first night with headache and chills and weakness.
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular, Rash pruritic, Varicella
Clinical narrative: Could this be a diminished outbreak of chickenpox/Has anyone else reported breakthrough chickenpox; small itchy bumps on my torso /  had noticed several of these these small itchy bumps; small itchy bumps on my torso / had noticed several of these these small itchy bumps; This case was reported by a consumer and described the occurrence of chickenpox in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th March 2020, the patient received the 1st dose of Shingrix. On 23rd March 2020, 19 days after receiving Shingrix, the patient experienced chickenpox, itchy rash and papular rash. On an unknown date, the outcome of the chickenpox, itchy rash and papular rash were unknown.   It was unknown if the reporter considered the chickenpox, itchy rash and papular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On about 23rd March 2020 (specific date not recalled), the patient noticed small itchy bumps on torso.  Since 23rd March 2020, the patient had noticed several more of these small itchy bumps. The itching was well-controlled by anti-itch cream. There were less than 50 of those spots.  The patient asked if this could be a diminished outbreak of chickenpox. The patient also asked if anyone else had reported breakthrough chickenpox.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation
Clinical narrative: Neck inflammation; This case was reported by a pharmacist via call center representative and described the occurrence of inflammation in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced inflammation. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the inflammation was unknown.   The reporter considered the inflammation to be unrelated to Shingrix.  Additional case details were reported as follows: The reporter stated that the patient experienced neck inflammation after vaccination. The patient steroid injection after the first dose of Shingrix because a neck inflammation. The patient was going to receive the second dose of Shingrix. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Cellulitis at the injection site; Redness at injection site; The injection site that extended over 7 to 8 inches up and down the arm with pain; Flu Like Symptoms; Chills; Fever; Restlessness; Malaise; Itching all over the body; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number ZR979, expiry date 28th March 2022) for prophylaxis.   The patient's past medical history included shingles (has shingles in 2000 and 3 months before reporting date). Previously administered products included tetanus vaccine (received on an unknown date), Chickenpx vaccine (received on an unknown date), Measles vaccine (received on an unknown date) and vaccine (childhood vaccine on an unknown date).   On 1st March 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st March 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, chills, fever, restlessness, malaise and generalized pruritus. On 2nd March 2020, the patient experienced injection site cellulitis, injection site erythema and injection site pain. On an unknown date, the outcome of the influenza-like symptoms, chills, fever, restlessness, malaise and generalized pruritus were recovered/resolved and the outcome of the injection site cellulitis, injection site erythema and injection site pain were recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, chills, fever, restlessness, malaise, generalized pruritus, injection site cellulitis, injection site erythema and injection site pain to be related to Shingrix.  Additional case details were reported as follows: The patient received her first dose of Shingrix vaccine and experienced flu like symptoms, chills, fever, restlessness, malaise and itching all over the body for 24 hours post vaccination. The patient also experienced cellulitis, redness at the injection site that extended over 7 to 8 inches up and down the arm with pain.  Pain and cellulitis have decreased and the redness has decreased down to 2 cm at the spot of injection. The patient consented to follow up. This case is 1 out of 2 cases reported by the same reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pruritus, Pyrexia, Restlessness
Clinical narrative: Cellulitis at the injection site; Redness at injection site; The injection site that extended over 7 to 8 inches up and down the arm with pain; Flu Like Symptoms; Chills; Fever; Restlessness; Malaise; Itching all over the body; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number ZR979, expiry date 28th March 2022) for prophylaxis.   The patient's past medical history included shingles (has shingles in 2000 and 3 months before reporting date). Previously administered products included tetanus vaccine (received on an unknown date), Chickenpx vaccine (received on an unknown date), Measles vaccine (received on an unknown date) and vaccine (childhood vaccine on an unknown date).   On 1st March 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st March 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, chills, fever, restlessness, malaise and generalized pruritus. On 2nd March 2020, the patient experienced injection site cellulitis, injection site erythema and injection site pain. On an unknown date, the outcome of the influenza-like symptoms, chills, fever, restlessness, malaise and generalized pruritus were recovered/resolved and the outcome of the injection site cellulitis, injection site erythema and injection site pain were recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, chills, fever, restlessness, malaise, generalized pruritus, injection site cellulitis, injection site erythema and injection site pain to be related to Shingrix.  Additional case details were reported as follows: The patient received her first dose of Shingrix vaccine and experienced flu like symptoms, chills, fever, restlessness, malaise and itching all over the body for 24 hours post vaccination. The patient also experienced cellulitis, redness at the injection site that extended over 7 to 8 inches up and down the arm with pain.  Pain and cellulitis have decreased and the redness has decreased down to 2 cm at the spot of injection. The patient consented to follow up. This case is 1 out of 2 cases reported by the same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: Sore Arm; Lousy feeling; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm and feeling bad. On an unknown date, the outcome of the pain in arm and feeling bad were recovered/resolved.   It was unknown if the reporter considered the pain in arm and feeling bad to be related to Shingrix.  Additional case details were reported as follows: The case was reported by patient's sister. The reporter stated that the patient experienced sore arm that lasted for 3 days, and lousy feeling that lasted for 24 hours. No further details were provided. This case is 1 out of 2 cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever; Nausea; Headache; Chills; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fever, nausea, headache and chills. On an unknown date, the outcome of the fever, nausea, headache and chills were resolved with sequelae.   It was unknown if the reporter considered the fever, nausea, headache and chills to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient after receiving the second dose of Shingrix, experienced fever, nausea, headache, chills, the next day the vaccine was administered and events lasted for about 8hrs. The patient consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: headache; chills; fatigue; low grade fever; This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced headache, chills, fatigue and low grade fever. On an unknown date, the outcome of the headache, chills, fatigue and low grade fever were not recovered/not resolved.   It was unknown if the reporter considered the headache, chills, fatigue and low grade fever to be related to Shingrix.  Additional case details were reported as follows: The patient stated that after receiving 1st dose experienced headache, chills, fatigue and low grade fever. The patient received the 2nd dose in February 2020. The patient had been to her regular physician and had also been seen by a rheumatologist and blood work had come back normal. The patient consented to follow up.      Lab Comments: on an unknown date blood test was done
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Shingles after the first dose of Shingrix; He received the first dose 4 years ago; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 4 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient needed to ask many questions about Shingrix. He received the first dose 4 years ago and now was developing Shingles. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient was transferred to the Patient Assistant department. The reporter mentioned he did not want to spend any more money until he get the information he needs.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: redness and swelling at the injection site; redness and swelling at the injection site; Pain in arm; unable to lift his arm above his head; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th March 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 26th March 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, pain in arm and injected limb mobility decreased. On 31st March 2020, the outcome of the injection site erythema, injection site swelling, pain in arm and injected limb mobility decreased were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, pain in arm and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: No Lot number or expiry details were known. The patient received Shingirx in the left deltoid last Wednesday (from the date of reporting). The reporter reported caused redness and swelling at the injection site.  It also caused pain in his arm and he was unable to lift his arm above his head.  He wanted to know if the second dose was the same as the first. The reporter declined to provide his medical doctor information.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Diarrhoea, Papule, Rash erythematous, Rash pruritic
Clinical narrative: Mother states that on Sunday the child developed an itchy rash that started on face and has spread to the torso. The rash are pinpoint red papules on face, torso, arms and legs; no papules on hands or feet. Child also started to have diarrhea, along with the rash.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Pain
Clinical narrative: flushed face mostly on the cheeks  x 1 day   sunburn-like pain on cheeks x 4-5 days
Age: 19.0
Sex: M
Vaccine: YF
Symptoms: Discomfort, Periorbital swelling, Vulvovaginal swelling
Clinical narrative: R periorbital swelling, labial swelling, little to no respiratory discomfort reported.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Lip discolouration, Loss of consciousness, Pyrexia, Vomiting
Clinical narrative: Mother described: Purple lips but breathing, Vomiting, Fever, Loss of Consciousness, No Jerking or twitching reported
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Pneumonia, Sepsis, Wheezing
Clinical narrative: Pneumonia; Sepsis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 13-MAY-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for routine adult health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), she suffered shortness of breath and wheezing.  Therefore, the patient was hospitalized and diagnosed with pneumonia and sepsis due to pneumonia and shortness of breath. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), patient's symptoms had resulted in physical limitation not present prior to using zoster vaccine live (ZOSTAVAX). At the time of this report, the outcome of sepsis and pneumonia was unknown. The reporter assessed that the events were related to zoster vaccine live (ZOSTAVAX).  Upon internal review, pneumonia and sepsis were considered to be medically significant events.  Reporter considered pneumonia and sepsis to be disabling events.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Malaise, Pain
Clinical narrative: made us both sick; we had weakness; we had chills; we had body aches; This case was reported by a consumer and described the occurrence of sickness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (for tolerance of 1st dose refer case US2020AMR044287).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness, weakness, chills and general body pain. On an unknown date, the outcome of the sickness, weakness, chills and general body pain were unknown.   It was unknown if the reporter considered the sickness, weakness, chills and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The patient received Shingrix and had weakness, chills, body aches and sickness. This is 1 of the 4 linked cases reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Bedridden, Chills, Decreased appetite, Hyperhidrosis
Clinical narrative: made us both sick; we had weakness; we had chills; we had body aches; This case was reported by a consumer and described the occurrence of sickness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (for tolerance of 1st dose refer case US2020AMR044287).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness, weakness, chills and general body pain. On an unknown date, the outcome of the sickness, weakness, chills and general body pain were unknown.   It was unknown if the reporter considered the sickness, weakness, chills and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The patient received Shingrix and had weakness, chills, body aches and sickness. This is 1 of the 4 linked cases reported by the same reporter.