chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP
Symptoms: Antibody test negative, Therapy non-responder
Clinical narrative: was instructed to get booster dose of ENGERIX-B for low titer after series completion; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 19-year-old male patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B at an unknown dose. On an unknown date, unknown after receiving Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Engerix B.  Additional details were received as follows: The age at vaccination was not reported. The patient was instructed to get booster dose of Engerix-B for low titer after series completion.  It was unknown when series was completed and no details provided when titers were drawn. HCP unsure of when series was completed or any specific details. No further details were available.      Lab Comments: On an unknown date, the patient did lab test
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: a sore arm which was the injected arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult 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 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 case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and has experienced a sore arm which was the injected arm, for 6 weeks. The reporter consented to follow up. Very limited information was provided.
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine Quadrivalent unspecified season.  Additional case details were reported as follows: The age at vaccination was not reported. The patient was over the age of 70. No additional details were available. The reporter did not consent to follow up.
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Interchange of vaccine products
Clinical narrative: Interchange of vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a male patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included HEPATITIS A VACCINE (VAQTA) for prophylaxis.   On an unknown date, the patient received Havrix at an unknown dose and the 1st dose of VAQTA. On an unknown date, unknown after receiving Havrix, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown  Additional details were received as follows: The age at vaccination was not applicable for this report.. The patient received a first dose of Vaqta (non GSK vaccine) about 6 months ago and wants to continue the series with Havrix, which led to interchange of vaccine products. The patient have not received till the time of reporting. The reporter consented to follow up. No lot number or expiration date of any vaccine .
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Pain, Pain in extremity, Swelling
Clinical narrative: arm sore; Pain; a red mark below the vaccination area on the arm; swollen; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 29RD5, expiry date 16th April 2022) for prophylaxis.   On 17th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm, pain, erythema of extremities and swelling. On an unknown date, the outcome of the pain in arm, pain, erythema of extremities and swelling were unknown.   It was unknown if the reporter considered the pain in arm, pain, erythema of extremities and swelling to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and experienced arm sore, pain, a red mark below the vaccination area on the arm, swollen but not warm.  The reporter wants information about the administration of a second dose. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site swelling
Clinical narrative: arm sore; Pain; a red mark below the vaccination area on the arm; swollen; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 29RD5, expiry date 16th April 2022) for prophylaxis.   On 17th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm, pain, erythema of extremities and swelling. On an unknown date, the outcome of the pain in arm, pain, erythema of extremities and swelling were unknown.   It was unknown if the reporter considered the pain in arm, pain, erythema of extremities and swelling to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and experienced arm sore, pain, a red mark below the vaccination area on the arm, swollen but not warm.  The reporter wants information about the administration of a second dose. The reporter consented to follow up.
Age: 0.58
Sex: U
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: an infant was given the second dose of Fluzone Quad early at 3 weeks instead of 4 weeks, 10 days early, no adverse event; Initial information was received on 09-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a seven month old patient (gender was not reported) who was vaccinated with the second dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT, on an unknown date in the third week instead of 4 weeks after the first dose (10 days before). Lot number and other dosing details were not reported.  Medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate schedule of vaccine administered.  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: received an expired Quadracel on 14-Nov-2019/no ae; Initial information received on 09-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is a linked case of 2020SA010010, 2020SA010007, 2020SA010008 by the same reporter.  This case involves female patient of 3 year 11 months who received an expired vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] on 14-Nov-2019 (expired product administered) (lot C5325BA, via unknown route at an unknown administration site).  It was a case of actual medication error due to Expired vaccine used.  It was unknown whether adverse event was experienced or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: 54 years old received a Fluzone High-Dose in error/no AE; 54 years old received a Fluzone High-Dose in error/no AE; Initial information received on 09-Jan-2020 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 54 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and reported that 54 years old received a Fluzone High-Dose in error/ no AE (product administered to patient of inappropriate age) and (overdose).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for Immunisation.  On 08-Jan-2020, the patient received a dose of suspect 0.5 ml INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ311AA and expiry date: 30-Jun-2020 via intramuscular route in the left deltoid.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Two patients were vaccinated with adacel which was not viable, no AE; Initial and additional information was received on 31-Dec-2019 regarding an unsolicited valid non-serious case from a consumer/non-hcp (office staff).  This case is linked to case 2020SA001845 (same reporter).  This case involves a 38 years old female patient who was vaccinated with a 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot: U6602AA, expiry date: 25-Feb-2022) via intramuscular route at right deltoid on 30-Dec-2019. It was reported that the vaccine was not viable due to delayed transit.   The patient's medical history, past medical treatment, past vaccination and family history were not provided. At the time of the event, the patient had ongoing cough and nasopharyngitis. Concomitant medications included INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT) on 28-Dec-2019 for Immunisation.  It was an actual medication error due to incorrect product storage.  At the time of reporting, the patient did not experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Pyrexia
Clinical narrative: I had a red circle about one inch around the location of the vaccination and three days of fever and headache. The fever was 101, 102, 100, 102.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Localized redness 3" X 4" with soreness and hot to touch lasting over 4 days.
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood glucose normal, Blood pressure normal, Syncope
Clinical narrative: Patient fainted after shot. 911 called and patient checked out ok. B/P and sugar levels normal. Patient left with father walking and was ok 2 days after as well.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: doses of improperly stored MMR II were administered to 9 patients on  unspecified dates; No additional adverse symptoms reported; This spontaneous report has been received from an officer manager, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and, previous drugs reactions or allergies were not provided by the reporter.  On an unknown date, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), (therapy type: Digital Data Logger), lot number S006051, and expiration date 27-FEB-2021 for prophylaxis. Details about strength, dose, dose number, route of administration, and anatomical location were not provided. It was unknown if the sterile diluent (DILUENT MRK) (lot number and expiration date were unknown by the reporter) used for reconstitution of the vaccine, was stored at proper temperature.  The highest temperature was above 47 degree Fahrenheit (°F) (53 F), for a timeframe of 17 hours, with no previous temperature excursion. The call was due to the digital data logger.  No additional adverse symptoms were reported.  This case is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2001USA005521: US-009507513-2001USA005522: US-009507513-2001USA005523: US-009507513-2001USA005524: US-009507513-2001USA005525: US-009507513-2001USA005516: US-009507513-2001USA005518: US-009507513-2001USA005520:
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: doses of improperly stored MMR II were administered to 9 patients on  unspecified dates; No additional adverse symptoms reported; This spontaneous report has been received from an officer manager, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and, previous drugs reactions or allergies were not provided by the reporter.  On an unknown date, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), (therapy type: Digital Data Logger), lot number S006051, and expiration date 27-FEB-2021 for prophylaxis. Details about strength, dose, dose number, route of administration, and anatomical location were not provided. It was unknown if the sterile diluent (DILUENT MRK) (lot number and expiration date were unknown by the reporter) used for reconstitution of the vaccine, was stored at proper temperature.  The highest temperature was above 47 degree Fahrenheit (°F) (53 F), for a timeframe of 17 hours, with no previous temperature excursion. The call was due to the digital data logger.  No additional adverse symptoms were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  2001USA005521: 2001USA005522: 2001USA005523: 2001USA005524: 2001USA005525: 2001USA005519: 2001USA005518: 2001USA005516:
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored MMR II were administered to 9 patient; No additional adverse symptoms reported; This spontaneous report has been received from an officer manager, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and, previous drugs reactions or allergies were not provided by the reporter.  On an unknown date, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), (therapy type: Digital Data Logger), lot number S006051, and expiration date 27-FEB-2021 for prophylaxis. Details about strength, dose, dose number, frequency, route of administration, and anatomical location were not provided. It was unknown if the sterile diluent (DILUENT MRK) (lot number and expiration date were unknown by the reporter) used for reconstitution of the vaccine, was stored at proper temperature.  The highest temperature was above 47 degree Fahrenheit (°F) (53 F), for a timeframe of 17 hours, with no previous temperature excursion. The call was due to the digital data logger.  No additional adverse symptoms were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA005516: US-009507513-2001USA005522: US-009507513-2001USA005523: US-009507513-2001USA005524: US-009507513-2001USA005525: US-009507513-2001USA005519: US-009507513-2001USA005518: US-009507513-2001USA005520:
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia
Clinical narrative: shivering; headache; muscle pain; This case was reported by a consumer via call center representative and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th January 2020, the patient received Shingrix. On 10th January 2020, 1 days after receiving Shingrix, the patient experienced shivering, headache and muscle pain. On an unknown date, the outcome of the shivering, headache and muscle pain were unknown.   It was unknown if the reporter considered the shivering, headache and muscle pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: got flu like symptoms; muscle aches; fever; sweating; shivering; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old 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 influenza-like symptoms, muscle pain, fever, sweating and shivering. On an unknown date, the outcome of the influenza-like symptoms, muscle pain, fever, sweating and shivering were unknown.   It was unknown if the reporter considered the influenza-like symptoms, muscle pain, fever, sweating and shivering to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced influenza-like symptoms, muscle pain, fever, sweating and shivering after receiving 1st dose of Shingrix. The patient asked was it likely would get the same reaction with the 2nd shot of Shingrix. No other information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Musculoskeletal pain, Pruritus, Rash papular, Tenderness
Clinical narrative: Skin itching; Slight tenderness on shoulder; Pimple-like clusters; Allergic reaction; This case was reported by a consumer and described the occurrence of itchy skin in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced itchy skin, shoulder pain, papular rash and allergic reaction. On an unknown date, the outcome of the itchy skin, shoulder pain, papular rash and allergic reaction were unknown.   It was unknown if the reporter considered the itchy skin, shoulder pain, papular rash and allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of the Shingrix vaccine about 3 months ago and for the last 6 weeks patient experienced on and off bouts of skin itching, with slight tenderness, confined to upper back (mainly on my shoulder blades). The area did not have a visible rash, only occasionally some very small pimple like clusters. The patient was doubtful that it was an allergic reaction to any new medicine, food, soap, or clothing as have not  changed any of these variables since before or after receiving the vaccine. The patient did not see delayed itching listed as a side effect for the vaccine but was wondering. If so, would this be a reason not to receive the 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Stiffness; Pain; This case was reported by a consumer via call center representative and described the occurrence of stiffness 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 stiffness and pain. On an unknown date, the outcome of the stiffness and pain were unknown.   It was unknown if the reporter considered the stiffness and pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not applicable for this report. The reporter stated that the unspecified number of patients had stiffness and pain after vaccination. This case has been linked with case US2020005633 and US2020AMR006218, reported for same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included genital herpes.   On 29th May 2019, the patient received the 1st dose of Shingrix. On 30th May 2019, 1 days after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovering/resolving.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The patient after vaccination experienced soreness at the injection site. The patient planned to follow up with the physician. The patient consented to follow up. For tolerance to 2nd dose, refer case US2020005551.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Issues going on; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th November 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than 2 months after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving the 2nd dose of Shingrix the patient had issues going on. No other details were provided. Consent to follow up was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Skin warm
Clinical narrative: Swelling; Pain at the injection site; Redness; Arm is warm to touch; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 59-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, unknown after receiving Shingrix, the patient experienced injection site swelling, injection site pain, injection site erythema and skin warm. On an unknown date, the outcome of the injection site swelling, injection site pain, injection site erythema and skin warm were recovering/resolving.   It was unknown if the reporter considered the injection site swelling, injection site pain, injection site erythema and skin warm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced  swelling,  pain at the injection site, redness and the arm was warm to touch,  No other information was provided. Patient was in a hurry so did not provide other information. Consent to follow up was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a other health professional 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, 4 months 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 case details were reported as follows: The age at vaccination was not reported. The patient received 1st dos of Shingrix and then 4 months later had shingles. No further details were provided. The reporter states that  shingles were diagnosed by a different provider, and she did not have any further information available at the time of chat. Consent to follow up was denied.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Vomiting
Clinical narrative: stomach ache; headache; vomiting; This case was reported by a pharmacist via call center representative and described the occurrence of stomach pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, 24 hrs after receiving Shingrix, the patient experienced stomach pain, headache and vomiting. On an unknown date, the outcome of the stomach pain, headache and vomiting were recovered/resolved.   It was unknown if the reporter considered the stomach pain, headache and vomiting to be related to Shingrix.  Additional details were provided as follows: The patient experienced stomach ache, headache, and vomiting after receiving 1st dose of Shingrix. The symptoms lasted for approximately 3-4 days. Consent to follow up was provided. This case has been linked to US2020005575, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Psychiatric symptom, Psychotic disorder
Clinical narrative: Psychosis; Psychiatric Symptoms; This case was reported by a physician via call center representative and described the occurrence of psychosis in a 73-year-old 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 psychosis and psychiatric symptom. On an unknown date, the outcome of the psychosis and psychiatric symptom were unknown.   It was unknown if the reporter considered the psychosis and psychiatric symptom to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced psychosis or psychiatric symptoms. The reporter did not consent to follow up. The physician declined to give any additional details and declined to respond to a letter from Safety.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Injection site swelling  no pain, or reddness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 9AB33, expiry date 6th December 2021) for prophylaxis.   On 19th December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site swelling to be related to Shingrix.  Additional details were provided as follows: The pharmacy manager reported that, the patient had injection site swelling after vaccination, but no pain or redness. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: she was down (like she came down with something).; This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal 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 feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the feeling abnormal to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and she was down like she came down with something.   She did not describe her symptoms. However, she said she was not getting the second dose due to the symptoms.   It was unknown when the vaccination happened. Caller declined providing details or accepting follow up about this adverse event.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Suspected Vaccination failure; every year I get the flu; This case was reported by a consumer via sales rep and described the occurrence of suspected vaccination failure in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received flu vaccine every year and experienced flu every year. The reporter did not have any other information. This case was considered as suspected vaccination failure as details regarding Time to onset for the event was unknown at the time of reporting.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Detoxification, Hyperaesthesia, Language disorder, Regressive behaviour, Tic
Clinical narrative: She started having head ticks, toe walking, lost 90 percent of her vocabulary, didnt like much touch. Started hours after her shot. She was about to graduate OT and ST and drastically regressed.  Nothing was helping and she kept getting worse. Finally started using TRS and she went back to her normal self after 3 days of heavy metal detox.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Toe walking
Clinical narrative: She started having head ticks, toe walking, lost 90 percent of her vocabulary, didnt like much touch. Started hours after her shot. She was about to graduate OT and ST and drastically regressed.  Nothing was helping and she kept getting worse. Finally started using TRS and she went back to her normal self after 3 days of heavy metal detox.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site induration, Injection site warmth, Joint effusion, Pain, Vaccination site erythema
Clinical narrative: Patient reported warmth and hardness to left deltoid approximately 1 day and a half after vaccination. 5/10 pain. Visual presentation included 2in hematoma around vaccination site, area from site to elbow was Indurated and Erymatic  with skin warm/hot to touch.  Pooling decreased around the elbow joint. Vital signs WNL.  PT stated no history of any reaction with prior dose (2018).  PT given Tylenol and Ibuprofen and directed to follow up in the afternoon prior to departure to ensure swelling did not extend pass the elbow or any significant signs of cellulitis. Hardness disappeared within 2 days with no deformity.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Vaccination site haematoma, Vaccination site warmth
Clinical narrative: Patient reported warmth and hardness to left deltoid approximately 1 day and a half after vaccination. 5/10 pain. Visual presentation included 2in hematoma around vaccination site, area from site to elbow was Indurated and Erymatic  with skin warm/hot to touch.  Pooling decreased around the elbow joint. Vital signs WNL.  PT stated no history of any reaction with prior dose (2018).  PT given Tylenol and Ibuprofen and directed to follow up in the afternoon prior to departure to ensure swelling did not extend pass the elbow or any significant signs of cellulitis. Hardness disappeared within 2 days with no deformity.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Feeling jittery
Clinical narrative: About one day after I received the vaccination, I noticed that I felt a bit "wired" or stimulated, as though I had consumed too much coffee. This has continued for the last 6 days or so. It does seem to be abating, however.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia, Pyrexia
Clinical narrative: Approximately 10 hours after receiving this vaccine, I developed a immune response consisting of a fever and severe muscular aches. I was unable to get out of bed. By noon the next day, I was 90% recovered. It's probably important to note I received an influenza vaccine at the same time, in the same general location (Sanofi Pasteur Lot#UT6657LA). I have never had a reaction to a flu shot.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes virus infection, Rash
Clinical narrative: Per Pt/Employee; She reported a mild herpes like reaction on left lateral side of body. extending  from back to torso. She consulted be PCP; PA. confirming herpes rash
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Burning sensation, Feeling abnormal, Herpes zoster, Laboratory test abnormal
Clinical narrative: Per Pt/Employee; She reported a mild herpes like reaction on left lateral side of body. extending  from back to torso. She consulted be PCP; PA. confirming herpes rash
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Pain of skin, Rash
Clinical narrative: Per Pt/Employee; She reported a mild herpes like reaction on left lateral side of body. extending  from back to torso. She consulted be PCP; PA. confirming herpes rash
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Middle insomnia
Clinical narrative: My arm where the shot was given has hurt for some time.  When I lay on it at night it will wake me up aching.  It is not swelled, hot and no signs of why it is this way.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Muscular weakness, Pain, Pain in extremity, Weight bearing difficulty
Clinical narrative: The injection was painful and followed by soreness, which I thought was to be expected. However, since the injection, I have weakness and pain in my upper arm. Elevating  my left arm, in such motions required for washing my hair or removing clothing, results in sharp pain from my shoulder to my elbow, located behind my bicep towards my tricep. As a regular gymgoer who does weight training, the difference is quantifiable: I've had to greatly reduce the weight I can lift with my left arm, compared to prior to this vaccination.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Discomfort, Gait inability, Hypotonia, Insomnia
Clinical narrative: My son got extremely sick a day after the shot.  With a very high fever.   Uncomfortable, screaming, not sleeping, not eating.   Then one week later his right leg went limp and he could not walk.    This lasted for about a 24  hours.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Malaise, Pyrexia, Screaming
Clinical narrative: My son got extremely sick a day after the shot.  With a very high fever.   Uncomfortable, screaming, not sleeping, not eating.   Then one week later his right leg went limp and he could not walk.    This lasted for about a 24  hours.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse symptoms reported; the 22 year old patient was vaccinated with a first dose of PROQUAD; This spontaneous report was received from a nurse, regarding a 22-year-old patient of an unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 15-JAN-2020, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse symptoms (no adverse event) were reported. No product quality complaint was reported.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: girl dies hours after getting HPV vaccine; This spontaneous report as received from a journalist refers to a female patient of unknown age. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (lot number, expiration date, dose, frequency and route of administration were not reported) for prophylaxis.  On an unknown date, hours after getting HPV vaccine, the patient died. It was unknown if an autopsy was performed.  The relatedness between the patient's death and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; one patient received improperly stored vaccine on unspecified date since 1/8/2020 which was admmistered via unspecified route.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On an unknown date in January 2020 (reported as since 08-JAN-2020), the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot# S013683, expiration date 05-MAY-2021; strength, vaccine dosage detail and route of administration were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly sterile diluent (MERCK STERILE DILUENT). No additional adverse events. The storage temperatures were above 47 Fahrenheit degrees/9 Celsius degrees (9.1 Celsius degrees) for 45 minutes. Previous temperature excursion were -58 Fahrenheit degrees and +46 Fahrenheit degrees (from -50 Celsius degrees to +8 Celsius degrees) (-5.2 Celsius degrees) which were recommended storage temperatures range for 20 minutes. Data logger was involved.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Immediate post-injection reaction, Injection site erythema, Injection site pain, Peripheral swelling
Clinical narrative: pain at injection site; redness at the injection site; arm is warm to touch /huge patch which is sore and warm to the touch; feels like she is getting a headache; huge patch not too painful but swollen; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 8th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 8th January 2020, immediately after receiving Shingrix, the patient experienced injection site pain. In January 2020, the patient experienced injection site erythema, skin warm, headache and swelling arm. On an unknown date, the outcome of the injection site pain, injection site erythema, skin warm, headache and swelling arm were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, skin warm, headache and swelling arm to be related to Shingrix.  Additional details were received as follows: The patient did not experience any problems after the first dose of Shingrix. The patient had received the second dose of Shingrix and after that she experienced swelling, pain at the injection site, redness and the arm  was warm to touch. The patient felt pain during the injection.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: pain at injection site; redness at the injection site; arm is warm to touch /huge patch which is sore and warm to the touch; feels like she is getting a headache; huge patch not too painful but swollen; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 8th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 8th January 2020, immediately after receiving Shingrix, the patient experienced injection site pain. In January 2020, the patient experienced injection site erythema, skin warm, headache and swelling arm. On an unknown date, the outcome of the injection site pain, injection site erythema, skin warm, headache and swelling arm were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, skin warm, headache and swelling arm to be related to Shingrix.  Additional details were received as follows: The patient did not experience any problems after the first dose of Shingrix. The patient had received the second dose of Shingrix and after that she experienced swelling, pain at the injection site, redness and the arm  was warm to touch. The patient felt pain during the injection.
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal disorder
Clinical narrative: Loss all control of arm; This case was reported by a consumer via call center representative and described the occurrence of mobility decreased 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, unknown after receiving Shingrix, the patient experienced mobility decreased. On an unknown date, the outcome of the mobility decreased was unknown.   It was unknown if the reporter considered the mobility decreased to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient after vaccination lost all control of arm. This case has been linked with case US2020005633 and US2020AMR006219, reported for same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swollen arm; red arm; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a adult 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 swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were unknown.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient stated that after vaccination arm was swollen and red. The patient asked how long would arm be swollen and red from the shingles shot.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain, Nausea, Pain, Vaccine positive rechallenge
Clinical narrative: soreness at injection site; nausea; achiness; Drug dose administration interval too long; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose receivied on 29th May 2019, refer case US2020AMR006246). Concurrent medical conditions included genital herpes.   On 9th January 2020, the patient received the 2nd dose of Shingrix. On 9th January 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 10th January 2020, the patient experienced injection site pain, nausea and pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, nausea and pain were recovering/resolving and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain, nausea and pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced soreness at the injection site, nausea and achiness the next day after receiving 2nd dose of Shingrix. The patient planned to follow up with her physician on an unknown date. After receiving 1st dose the patient received 2nd dose later than the recommended interval of vaccination schedule, which led to drug dose administration interval too long. Consent to follow up was provided.