chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Sensitive skin
Clinical narrative: migraine/headache; migraine/headache; chills; myalgia; arthralgia; sensitive skin; flank pain; This case was reported by a physician via call center representative and described the occurrence of migraine headache 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, unknown after receiving Shingrix, the patient experienced migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain. On an unknown date, the outcome of the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain were unknown.   It was unknown if the reporter considered the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter believed that the adverse events were much more severe after 2nd dose compared with the 1st dose. No additional demographic information of patient was provided. The reporter consent to follow up. This is 1 of 11 cases, reported by the same reporter, for tolerance of 2nd dose, refer case US2019AMR208414.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Flank pain, Headache, Migraine
Clinical narrative: migraine/headache; migraine/headache; chills; myalgia; arthralgia; sensitive skin; flank pain; This case was reported by a physician via call center representative and described the occurrence of migraine headache 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, unknown after receiving Shingrix, the patient experienced migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain. On an unknown date, the outcome of the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain were unknown.   It was unknown if the reporter considered the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter believed that the adverse events were much more severe after 2nd dose compared with the 1st dose. No additional demographic information of patient was provided. The reporter consent to follow up. This is 1 of 11 cases, reported by the same reporter, for tolerance of 2nd dose, refer case US2019AMR208415.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Sensitive skin
Clinical narrative: migraine/headache; migraine/headache; chills; myalgia; arthralgia; sensitive skin; flank pain; This case was reported by a physician via call center representative and described the occurrence of migraine headache 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, unknown after receiving Shingrix, the patient experienced migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain. On an unknown date, the outcome of the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain were unknown.   It was unknown if the reporter considered the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter believed that the adverse events were much more severe after 2nd dose compared with the 1st dose. No additional demographic information of patient was provided. The reporter consent to follow up. This is 1 of 11 cases, reported by the same reporter, for tolerance of 2nd dose, refer case US2019AMR208415.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Flank pain, Headache, Migraine
Clinical narrative: migraine/headache; migraine/headache; chills; myalgia; arthralgia; sensitive skin; flank pain; This case was reported by a physician via call center representative and described the occurrence of migraine headache 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, unknown after receiving Shingrix, the patient experienced migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain. On an unknown date, the outcome of the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain were unknown.   It was unknown if the reporter considered the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter believed that the adverse events were much more severe after 2nd dose compared with the 1st dose. No additional demographic information of patient was provided. The reporter consent to follow up. This is 1 of 11 cases, reported by the same reporter, for tolerance of 2nd dose, refer case US2019AMR208416.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Sensitive skin
Clinical narrative: migraine/headache; migraine/headache; chills; myalgia; arthralgia; sensitive skin; flank pain; This case was reported by a physician via call center representative and described the occurrence of migraine headache 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, unknown after receiving Shingrix, the patient experienced migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain. On an unknown date, the outcome of the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain were unknown.   It was unknown if the reporter considered the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter believed that the adverse events were much more severe after 2nd dose compared with the 1st dose. No additional demographic information of patient was provided. The reporter consent to follow up. This is 1 of 11 cases, reported by the same reporter, for tolerance of 2nd dose, refer case US2019AMR208416.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Flank pain, Headache, Migraine
Clinical narrative: migraine/headache; migraine/headache; chills; myalgia; arthralgia; sensitive skin; flank pain; This case was reported by a physician via call center representative and described the occurrence of migraine headache 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, unknown after receiving Shingrix, the patient experienced migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain. On an unknown date, the outcome of the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain were unknown.   It was unknown if the reporter considered the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter believed that the adverse events were much more severe after 2nd dose compared with the 1st dose. No additional demographic information of patient was provided. The reporter consent to follow up. This is 1 of 11 cases, reported by the same reporter, for tolerance of 2nd dose, refer case US2019AMR208417.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Sensitive skin
Clinical narrative: migraine/headache; migraine/headache; chills; myalgia; arthralgia; sensitive skin; flank pain; This case was reported by a physician via call center representative and described the occurrence of migraine headache 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, unknown after receiving Shingrix, the patient experienced migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain. On an unknown date, the outcome of the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain were unknown.   It was unknown if the reporter considered the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter believed that the adverse events were much more severe after 2nd dose compared with the 1st dose. No additional demographic information of patient was provided. The reporter consent to follow up. This is 1 of 11 cases, reported by the same reporter, for tolerance of 2nd dose, refer case US2019AMR208417.
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Insomnia
Clinical narrative: Sleeplessness; This case was reported by a other health professional via call center representative and described the occurrence of sleeplessness in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Concurrent medical conditions included type i diabetes mellitus.   On 10th November 2019, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On 10th November 2019, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced sleeplessness. On an unknown date, the outcome of the sleeplessness was unknown.   It was unknown if the reporter considered the sleeplessness to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient experienced sleeplessness after vaccination with Shingrix and unspecified flu vaccine. The healthcare professional who reached out to Medical Information via chat function declined to provide any contact information and wishes to remain anonymous. The brand of flu vaccine was known, healthcare professional provided that it is the flu vaccine for patients over 65. No further details were provided. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: injection site pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient 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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The reporter stated that the patient experienced severe pain in his arm after vaccination. Additional information was not provided. The reporter did not consent to follow up.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Pain in extremity, Peripheral swelling
Clinical narrative: sore arm; Swelled like golf ball; Red arm; Flu achy symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2019, the patient received the 1st dose of Shingrix. On 9th November 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and swelling arm. In November 2019, the patient experienced influenza-like symptoms and erythema of extremities. The patient was treated with cetirizine (Claritin (Cetirizine)). On an unknown date, the outcome of the influenza-like symptoms, pain in arm, swelling arm and erythema of extremities were unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain in arm, swelling arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient noticed their arm was sore and swollen on the same day of vaccination. The symptoms worsened Swelling was like a golf ball and there was redness, so patient took Claritin. The patient also experienced some flu achy symptoms. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Injection site pain
Clinical narrative: stomach cramps; tenderness at injection site; This case was reported by a consumer via call center representative and described the occurrence of stomach cramps 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, less than a day after receiving Shingrix, the patient experienced stomach cramps and injection site tenderness. On an unknown date, the outcome of the stomach cramps and injection site tenderness were unknown.   It was unknown if the reporter considered the stomach cramps and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she had the first dose of Shingrix and experienced tenderness at the injection site and stomach cramps the same day of the injection. The patient did not want to share any more information and provided case number for follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Rash erythematous, Skin warm
Clinical narrative: pain /achy; shivering; tired; hot; rash; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles 30 years ago). Concomitant products included Herpes zoster (Shingrix).   On 8th November 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 8th November 2019, less than a day after receiving Shingrix, the patient experienced pain, shivering and tiredness. In November 2019, the patient experienced red rash and skin warm. Rechallenge with Shingrix was positive. On 9th November 2019, the outcome of the pain, shivering and tiredness were recovered/resolved. On an unknown date, the outcome of the red rash and skin warm were unknown.   It was unknown if the reporter considered the red rash, pain, shivering, tiredness and skin warm to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in the early September 2019 in left arm and had similar side effects. The patient received dose of Shingrix in the left arm around 5 pm. In the middle of night of vaccination day, the patient had pain, shivering, tiredness and achiness and then resolved in the following day. On 10th November 2019, the patient took band aid off from arm and noticed a 3 inch red rash on left arm that was two inches below the injection site. The patient reported smaller areas of a rash beside them that was hot to the touch. The reporter consented to follow up. This is 1 of the 2 cases reported by the same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: pain /achy; shivering; tired; hot; rash; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles 30 years ago). Concomitant products included Herpes zoster (Shingrix).   On 8th November 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 8th November 2019, less than a day after receiving Shingrix, the patient experienced pain, shivering and tiredness. In November 2019, the patient experienced red rash and skin warm. Rechallenge with Shingrix was positive. On 9th November 2019, the outcome of the pain, shivering and tiredness were recovered/resolved. On an unknown date, the outcome of the red rash and skin warm were unknown.   It was unknown if the reporter considered the red rash, pain, shivering, tiredness and skin warm to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in the early September 2019 in left arm and had similar side effects. The patient received dose of Shingrix in the left arm around 5 pm. In the middle of night of vaccination day, the patient had pain, shivering, tiredness and achiness and then resolved in the following day. On 10th November 2019, the patient took band aid off from arm and noticed a 3 inch red rash on left arm that was two inches below the injection site. The patient reported smaller areas of a rash beside them that was hot to the touch. The reporter consented to follow up. This is 1 of the 2 cases reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Tinnitus
Clinical narrative: ringing in ears; soreness; This case was reported by a consumer via call center representative and described the occurrence of ringing in ears in a male patient 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 ringing in ears and pain. On an unknown date, the outcome of the ringing in ears was not recovered/not resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the ringing in ears and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix and was experiencing ringing in ears and soreness. The patient refused to provide any additional details. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise
Clinical narrative: flu like symptoms; feeling sick; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose year ago from time of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms and feeling unwell. On an unknown date, the outcome of the influenza-like symptoms was resolved with sequelae and the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The case was reported by the reporter for her cousin was around 70 years old. The age at vaccination was not reported. The patient felt sick like she had the flu after the 2nd dose. This is 1 of the 3 cases reported by same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Inappropriate schedule of vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female 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, 183 days 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 case details were reported as follows: The patient had shingles 6 months after the first dose. The reporter stated a patient was due for the second dose of vaccine, which led to incomplete course of vaccination.  The specialist neglected to obtain additional information and no further details were provided by reporter on the call. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative 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, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A patient developed shingles following 1st dose of Shingrix vaccine. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Influenza like illness
Clinical narrative: flu like symptoms; dizziness; tiredness; headache; muscle aches; joint aches; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, dizziness, tiredness, headache, muscle pain and joint pain. In November 2019, the outcome of the influenza-like symptoms, dizziness, tiredness, headache, muscle pain and joint pain were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, dizziness, tiredness, headache, muscle pain and joint pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of Shingrix vaccine and had experienced flu like symptoms, dizziness, tiredness, headache, muscle aches and joint aches. The patient states that the symptoms resolved sometime between 6th November 2019 and 7th November 2019. The reporter denied consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: flu like symptoms; dizziness; tiredness; headache; muscle aches; joint aches; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, dizziness, tiredness, headache, muscle pain and joint pain. In November 2019, the outcome of the influenza-like symptoms, dizziness, tiredness, headache, muscle pain and joint pain were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, dizziness, tiredness, headache, muscle pain and joint pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of Shingrix vaccine and had experienced flu like symptoms, dizziness, tiredness, headache, muscle aches and joint aches. The patient states that the symptoms resolved sometime between 6th November 2019 and 7th November 2019. The reporter denied consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: aching; tiredness; This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced pain and tiredness. On an unknown date, the outcome of the pain and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain and tiredness to be related to Shingrix.  Additional details were provided as follows: This case was reported by the reporter for his wife. The age at vaccination was not reported. The reporter reported that his wife received the 1st dose of Shingrix and the 2nd dose in August 2019. The reporter stated that after getting the vaccine, she experienced aching and tiredness. The reporter refused to provide any further information about his wife. This case has been linked with US2019206662, having same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Bad reaction; Contraindicated drug administered; Documented hypersensitivity to administered product; This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sucrose intolerance.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction, contraindicated drug administered and documented hypersensitivity to administered product. On an unknown date, the outcome of the adverse reaction, contraindicated drug administered and documented hypersensitivity to administered product were unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The student pharmacist reported that a patient with a sucrose allergy had a pretty bad reaction to Shingrix. The reporter was consented to follow up. The reporter had no further details. The patient identifiers or any further details regarding vaccine unknown where the event occured.
Sex: U
Vaccine: FLUX
Symptoms: Adverse reaction, Contraindication to vaccination, Documented hypersensitivity to administered product
Clinical narrative: adverse reaction; Reaction; Contraindicated drug administered; This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Concurrent medical conditions included egg allergy (patient had an egg allergy or some other type of vaccine in the past).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse reaction, documented hypersensitivity to administered product and contraindicated drug administered. On an unknown date, the outcome of the adverse reaction, documented hypersensitivity to administered product and contraindicated drug administered were unknown.   It was unknown if the reporter considered the adverse reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient with an egg allergy had a reaction to a flu vaccine or some other type of vaccine in the past.  The reporter did not consent to follow up.  The caller has no further information regarding reaction or involved vaccine. Declined to provide patient identifiers.  The reporter stated the testing was done after the patient had the reaction and it was determined it was due to the egg content in the unknown vaccine.
Sex: M
Vaccine: UNK
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting; Fever; This case was reported by a other health professional via call center representative and described the occurrence of vomiting in a male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 24PP4, expiry date 30th June 2020) for prophylaxis.   In October 2019, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced vomiting and fever. On an unknown date, the outcome of the vomiting and fever were unknown.   It was unknown if the reporter considered the vomiting and fever to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant stated that, the patient received dose of Flulaval quadrivalent season 2019-2020 either on 18th October 2019, or within the week afterwards. The patient experienced events either the day of vaccination, or the day after vaccination. The reporter consented to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting; Fever; This case was reported by a other health professional via call center representative and described the occurrence of vomiting in a female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 24PP4, expiry date 30th June 2020) for prophylaxis.   In October 2019, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced vomiting and fever. On an unknown date, the outcome of the vomiting and fever were unknown.   It was unknown if the reporter considered the vomiting and fever to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The medical assiatant stated that, the patient received dose of Flulaval quadrivalent 2019-2020 season either on 18th October 2019, or within the week afterwards. The patient experienced vomiting and fever either the day of vaccination, or the day after vaccination. The reporter consented to follow up. This case has been linked with case US2019207544, reported by same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: Sore; Swollen; Achy; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th November 2019, the patient received the 1st dose of Shingrix. On 12th November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling and pain. On an unknown date, the outcome of the injection site pain, injection site swelling and pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling and pain to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, within 12 hours after vaccination with dose of shingrix, the patient experienced soreness and swelling in arm at the injection site and also felt itchy. The reporter stated that, the injection site was more swollen on the date of reporting than it was before the day of reporting. The reporter unable to obtain additional information. The reporter consented to follow up.
Age: 47.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; This case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 47-year-old female patient who received DTPa (Infanrix) (batch number J947T, expiry date 30th May 2021) for prophylaxis.   On 14th November 2019, the patient received Infanrix. On 14th November 2019, unknown after receiving Infanrix, the patient experienced adult use of a child product. On an unknown date, the outcome of the adult use of a child product was unknown.  Additional details were provided as follows: The case was reported by medical assistant. The patient received Infanrix in the left deltoid. The reporter stated that, the patient was prescribed with Boostrix but inadvertently received a dose of Infanrix and also the patient's age was above the indicated age range for Infanrix, which led to adult use of a child product. The reporter consented to follow up.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: swelling on the right arm; hot/ the area being hot; redness on the right arm; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax. Concurrent medical conditions included glaucoma.   On 11th November 2019, the patient received the 1st dose of Shingrix. On 11th November 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site warmth and injection site erythema. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site swelling, injection site warmth and injection site erythema were recovering/resolving.   It was unknown if the reporter considered the injection site swelling, injection site warmth and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient received 1st dose of Shingrix in the right arm. In the evening, she experienced swelling and redness on her right arm as well as the area was hot. The patient was told to take Benadryl. The area was improving a little bit. The patient consented to follow up directly with her.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: swelling on the right arm; hot/ the area being hot; redness on the right arm; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax. Concurrent medical conditions included glaucoma.   On 11th November 2019, the patient received the 1st dose of Shingrix. On 11th November 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site warmth and injection site erythema. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site swelling, injection site warmth and injection site erythema were recovering/resolving.   It was unknown if the reporter considered the injection site swelling, injection site warmth and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient received 1st dose of Shingrix in the right arm. In the evening, she experienced swelling and redness on her right arm as well as the area was hot. The patient was told to take Benadryl. The area was improving a little bit. The patient consented to follow up directly with her.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Musculoskeletal stiffness, Neck pain, Temporomandibular joint syndrome
Clinical narrative: jaw joint pain; neck stiffness and pain; neck pain; This case was reported by a consumer via call center representative and described the occurrence of temporomandibular joint arthralgia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, less than a week after receiving Shingrix, the patient experienced temporomandibular joint arthralgia, stiff neck and neck pain. The patient was treated with prednisone. On an unknown date, the outcome of the temporomandibular joint arthralgia, stiff neck and neck pain were unknown.   It was unknown if the reporter considered the temporomandibular joint arthralgia, stiff neck and neck pain to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient experienced jaw joint pain and stiff and painful neck. He recently treated with a prednisone shot to help. The patient did not consent to follow-up.
Age: 19.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Fatigue, Laboratory test, Malaise, Migraine
Clinical narrative: extreme fatigue; migraine like headache; body aches; nausea; dizziness; issues with vision focusing; muscle weakness; sick; low grade fever 100-101; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 19-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) (batch number PVT-36633 ?, expiry date June 2020) for prophylaxis.   Concurrent medical conditions included celiac disease.   On 21st October 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On 21st October 2019, less than a day after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced fatigue, migraine type headaches, general body pain, nausea, dizziness, blurred vision, low grade fever, muscle weakness and sickness. On an unknown date, the outcome of the fatigue, migraine type headaches, general body pain, nausea, dizziness, blurred vision and muscle weakness were unknown and the outcome of the low grade fever and sickness were recovered/resolved.   It was unknown if the reporter considered the fatigue, migraine type headaches, general body pain, nausea, dizziness, blurred vision, low grade fever, muscle weakness and sickness to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The reporter was the patient's mother. The patient received a flu vaccine in her left arm. Within hours of vaccination, she developed extreme fatigue, migraine like headache, body aches, nausea, dizziness, muscle weakness, vision focusing issues and a low grade fever of 100 to 101 degree F. The patient was sick for ten days and the fever lasted for four days.  The reporter stated that, the nurse provided a paper with information regarding the flu shot, but the name of the medication was not given just GlaxoSmithKline with lot number: pvt-36633 and Expiry date June/2020. The reporter took the patient back to the doctors three to four days after receiving the flu vaccine, the doctor ran several tests including for Mono, but no results were given. The patient in the past had been positive for Mono. The reporter consented to follow up and provided her doctor's details. The reporter was referred to daughter's physician to obtain additional information on the flu vaccine. The reported batch number PVT-36633 was not found in sales data sheet, however it was captured as PVT-36633 ?      Lab Comments: in past, the patient was positive for mono
Age: 19.0
Sex: F
Vaccine: UNK
Symptoms: Mononucleosis heterophile test, Muscular weakness, Nausea, Pain, Pyrexia
Clinical narrative: extreme fatigue; migraine like headache; body aches; nausea; dizziness; issues with vision focusing; muscle weakness; sick; low grade fever 100-101; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 19-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) (batch number PVT-36633 ?, expiry date June 2020) for prophylaxis.   Concurrent medical conditions included celiac disease.   On 21st October 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On 21st October 2019, less than a day after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced fatigue, migraine type headaches, general body pain, nausea, dizziness, blurred vision, low grade fever, muscle weakness and sickness. On an unknown date, the outcome of the fatigue, migraine type headaches, general body pain, nausea, dizziness, blurred vision and muscle weakness were unknown and the outcome of the low grade fever and sickness were recovered/resolved.   It was unknown if the reporter considered the fatigue, migraine type headaches, general body pain, nausea, dizziness, blurred vision, low grade fever, muscle weakness and sickness to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The reporter was the patient's mother. The patient received a flu vaccine in her left arm. Within hours of vaccination, she developed extreme fatigue, migraine like headache, body aches, nausea, dizziness, muscle weakness, vision focusing issues and a low grade fever of 100 to 101 degree F. The patient was sick for ten days and the fever lasted for four days.  The reporter stated that, the nurse provided a paper with information regarding the flu shot, but the name of the medication was not given just GlaxoSmithKline with lot number: pvt-36633 and Expiry date June/2020. The reporter took the patient back to the doctors three to four days after receiving the flu vaccine, the doctor ran several tests including for Mono, but no results were given. The patient in the past had been positive for Mono. The reporter consented to follow up and provided her doctor's details. The reporter was referred to daughter's physician to obtain additional information on the flu vaccine. The reported batch number PVT-36633 was not found in sales data sheet, however it was captured as PVT-36633 ?      Lab Comments: in past, the patient was positive for mono
Age: 19.0
Sex: F
Vaccine: UNK
Symptoms: Vision blurred
Clinical narrative: extreme fatigue; migraine like headache; body aches; nausea; dizziness; issues with vision focusing; muscle weakness; sick; low grade fever 100-101; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 19-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) (batch number PVT-36633 ?, expiry date June 2020) for prophylaxis.   Concurrent medical conditions included celiac disease.   On 21st October 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On 21st October 2019, less than a day after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced fatigue, migraine type headaches, general body pain, nausea, dizziness, blurred vision, low grade fever, muscle weakness and sickness. On an unknown date, the outcome of the fatigue, migraine type headaches, general body pain, nausea, dizziness, blurred vision and muscle weakness were unknown and the outcome of the low grade fever and sickness were recovered/resolved.   It was unknown if the reporter considered the fatigue, migraine type headaches, general body pain, nausea, dizziness, blurred vision, low grade fever, muscle weakness and sickness to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The reporter was the patient's mother. The patient received a flu vaccine in her left arm. Within hours of vaccination, she developed extreme fatigue, migraine like headache, body aches, nausea, dizziness, muscle weakness, vision focusing issues and a low grade fever of 100 to 101 degree F. The patient was sick for ten days and the fever lasted for four days.  The reporter stated that, the nurse provided a paper with information regarding the flu shot, but the name of the medication was not given just GlaxoSmithKline with lot number: pvt-36633 and Expiry date June/2020. The reporter took the patient back to the doctors three to four days after receiving the flu vaccine, the doctor ran several tests including for Mono, but no results were given. The patient in the past had been positive for Mono. The reporter consented to follow up and provided her doctor's details. The reporter was referred to daughter's physician to obtain additional information on the flu vaccine. The reported batch number PVT-36633 was not found in sales data sheet, however it was captured as PVT-36633 ?      Lab Comments: in past, the patient was positive for mono
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown 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.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The physician reported that he heard that of several patient developing shingles after receiving a Shingrix dose. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: the rash is itchy but not extremely bothersome, on the patient's inner legs, top of feet, and axilla; Itchy rash; This case was reported by a nurse via call center representative and described the occurrence of generalized rash in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received on 30th September 2014, subcutaneously).   On 6th November 2018, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized rash and itchy rash. The patient was treated with valaciclovir (Valacyclovir). Shingrix was discontinued. On an unknown date, the outcome of the generalized rash and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the generalized rash and itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced rash which was itchy, but not extremely bothersome and was on the patient's inner legs, top of feet, and axilla. The patient was given valcyclovir to treat the rash, but rash was ongoing at this time. The different provider instructed the patient to not to complete the series due to a rash after receiving dose 1. The previous dose was administered by a different provider, so lot and other details are unknown. The reporter consented to follow up.