chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Paraesthesia
Clinical narrative: Redness under the injection site; Tingling in the arm; This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number KX52G, expiry date 1st December 2021) for prophylaxis.   On 3rd January 2020, the patient received the 2nd dose of Shingrix. On 3rd January 2020, less than a day after receiving Shingrix, the patient experienced localized erythema. In January 2020, the patient experienced tingling of extremity. On an unknown date, the outcome of the localized erythema and tingling of extremity were unknown.   It was unknown if the reporter considered the localized erythema and tingling of extremity to be related to Shingrix.  Additional details were received as follows: The reporter stated that the patient after vaccination experienced redness under the injection site and then tingling in the arm. The reported batch number KX526, was updated to KX52G, as per sales data sheet. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Lip swelling, Swelling face
Clinical narrative: pain in the cheek; swollen cheek; swelling lip; This case was reported by a pharmacist via call center representative and described the occurrence of facial pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On an unknown date, between 3 and 5 months after receiving Shingrix, the patient experienced facial pain, cheek swelling and lip swelling. On an unknown date, the outcome of the facial pain, cheek swelling and lip swelling were unknown.   It was unknown if the reporter considered the facial pain, cheek swelling and lip swelling to be related to Shingrix.  Additional details were provided as follows: The patient developed pain in the cheek, which also became swollen and a swollen lip. On the day of reporting the patient had arrived to receive the 2nd dose of Shingrix and reported about the adverse events experienced. The reporter inquired if this patient should receive the second dose. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort
Clinical narrative: upset stomach; This case was reported by a pharmacist via call center representative and described the occurrence of upset stomach in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 10th November 2019, 1 days after receiving Shingrix, the patient experienced upset stomach. On an unknown date, the outcome of the upset stomach was recovered/resolved.   It was unknown if the reporter considered the upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient experienced upset stomach 24 hours after receiving 1st dose of Shingrix. The upset stomach lasted for approximately 3-4 days. No other information was provided. Consent to follow up was provided.
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Drug dispensed to wrong patient
Clinical narrative: 15 year old consumer missed his dose of Ipol and Varicella due to the incorrect person was called into the clinic to receive these vaccines / no AE; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional (physician assistant).  This case is linked to case 2019SA300045.  This case involves a 15 years old male patient who had missed a dose of IPV (VERO) [IPOL] and VARICELLA VACCINE.  The patient's past vaccination(s) included Polio vaccine (Had not had a dose of a polio vaccine since after being 4 years old and has only had 3 doses of polio vaccine).  The patient's past medical history, medical treatment(s) and family history were not provided.   It was a case of actual medication error due to missed dose.  It was reported that 15 year old consumer missed his dose of Ipol and Varicella due to the incorrect person was called into the clinic to receive these vaccines that he was ordered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: female child received 0.4% Sodium Chloride instead of the reconstituting it with the ActHIB, no AE; Initial information received on 09-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 4 months old female patient who received a dose of 0.4% sodium chloride instead of reconstituting the vaccine HIB (PRP/T) VACCINE [ACT-HIB] (solution for injection, lot: UJ161AA, expiry date: 02-May-2021) via intramuscular route in the right thigh on 08-Jan-2020.  Medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ); and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Immunisation on 08-Jan-2020.  It was an actual medication error due to inappropriate reconstitution technique.  At the time of reporting, the patient had no 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 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: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient got a 1st dose in Oct 2019 in another pharmacy and then by mistake got another Fluzone HD in their pharmacy on 06Jan2020/no AE; Initial information was received on 09-Jan-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 76 years old male patient got a 0.5 mL dose of first dose in OCT-2019 in another pharmacy and then by mistake got another INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (prefilled syringe) in their pharmacy on 06-JAN-2020.  Medical history, concomitant therapy, medical treatment, vaccination and family history were not provided.   In October 2019, the patient received a first dose 0.5 ml of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UJ288AA) via an intramuscular route at the arm (not otherwise specified). On 06-Jan-2020 he also received  second dose 0.5 ml of the same vaccine (lot UJ288AA) via an intramuscular route at the arm(not otherwise specified).  It was a case of actual medication error due to extra dose administered.   At the time of reporting, no adverse event 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: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: patient received an expired Quadracel on 14-Nov-2019/no AE; Initial information was received on 09-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case was linked to cases 2020SA010008, 2020SA010010 and 2020SA010011(same reporter).  This case involves a 4 years old male patient who received an expired DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE [Quadracel] on 14-NOV-2019 (expired product administered) ( lot C5325BA, other dosing details, route and administration site not reported)  Medical history, concomitant therapy, medical treatment, vaccination and family history were not provided.  It was a case of actual medication error case 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: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: received an expired vaccine on 14Nov2019 Quadracel/no AE; 3 years 11 month received an expired on 14Nov2019 Quadracel/no AE; Initial information was received on 09-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 years 11 month old male patient who received an expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] vaccine.  Medical history, medical treatment, vaccination and family history were not provided.   On 14-Nov-2019, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to expired vaccine used and Inappropriate age at vaccine administration.  It was unknown if any adverse event occurred 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.
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: received an expired Quadracel/no AE; Initial information received on 09-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 years 11 month old male patient who received an expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Nov-2019, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to Expired vaccine used.  It was unknown if any adverse event occurred.  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.
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient was given 2nd dose of Fluzone vaccine too early, No AE; Initial information received on 08-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age patient who was vaccinated with second dose of INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE] too early. The lot number and expiry date not reported.  Medical history and concomitant medication was not reported.   It was a case of actual medication error due to Inappropriate schedule of vaccine administered.  At the time of report 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 holders 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.  Information on the batch number was requested.
Age: 4.0
Sex: M
Vaccine: FLUR4
Symptoms: Rash
Clinical narrative: 10 minutes after administration of Flublok, patient experienced  rash on torso and back. No shortness of breath or difficulty breathing.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored vaccine administered; no adverse effect; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.       On an unknown date, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S021925, expiry date : 15-JUL-2021) for prophylaxis. Other suspect therapies included sterile diluent(MERCK STERILE DILUENT). It was unknown if diluent used to reconstitute was stored at proper temperature.    It was reported that the vaccine experienced a temperature excursion total time in the range of 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees Celsius (C) to - 10 degrees C) for 30 minutes, 15 degrees F to 46 degrees F (-9 degrees C to 8 degrees C) for 7 hours and 47 degrees F to 77 degrees F (9 degrees C to 25 degrees C) for 9 hours (product storage error). There was no previous temperature excursion and it was reported that this call was due to a digital data logger. The patient had no adverse events. There was no product quality compliant involved.   This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA005705:Original Case : 2001USA005586 US-009507513-2001USA005680:Original Case : 2001USA005586 US-009507513-2001USA005703:Original Case : 2001USA005586 US-009507513-2001USA005686:Original Case : 2001USA005586 US-009507513-2001USA005688:Original Case : 2001USA005586 US-009507513-2001USA005691:Original Case : 2001USA005586 US-009507513-2001USA005685:Original Case : 2001USA005586 US-009507513-2001USA005684:Original Case : 2001USA005586 US-009507513-2001USA005687:Original Case : 2001USA005586 US-009507513-2001USA005678:Original Case : 2001USA005586 US-009507513-2001USA005707:Original Case : 2001USA005586 US-009507513-2001USA005704:Original Case : 2001USA005586 US-009507513-2001USA005701:Original Case : 2001USA005586 US-009507513-2001USA005699:Original Case : 2001USA005586 US-009507513-2001USA005697:Original Case : 2001USA005586 US-009507513-2001USA005696:Original Case : 2001USA005586 US-009507513-2001USA005682:Original Case : 2001USA005586 US-009507513-2001USA005690:Original Case : 2001USA005586 US-009507513-2001USA005698:Original Case : 2001USA005586 US-009507513-2001USA005681:Original Case : 2001USA005586 US-009507513-2001USA005702:Original Case : 2001USA005586 US-009507513-2001USA005695:Original Case : 2001USA005586 US-009507513-2001USA005689:Original Case : 2001USA005586 US-009507513-2001USA005683:Original Case : 2001USA005586
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Pyrexia
Clinical narrative: Fever; Cold sores; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number K2397, expiry date 17th December 2021) for prophylaxis.   Additional patient notes included Patient medical history-none.   On 11th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, immediately after receiving Shingrix, the patient experienced fever and cold sores. On an unknown date, the outcome of the fever and cold sores were unknown.   It was unknown if the reporter considered the fever and cold sores to be related to Shingrix.  Additional details were received as follows: The reporter stated that the patient had fever cold sores, since got first Shingle vaccine. For tolerance after 2nd dose refer case US2019205733.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Headache, Swelling
Clinical narrative: Swelling; redness; headache; This case was reported by a consumer via call center representative and described the occurrence of swelling 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, erythema and headache. On an unknown date, the outcome of the swelling, erythema and headache were unknown.   It was unknown if the reporter considered the swelling, erythema and headache to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had swelling, redness and headache. The reporter asked how long the swelling, redness and headache generally lasts.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Achiness on the arm; a very swollen arm after application, it lasted a day; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm and swelling arm. On an unknown date, the outcome of the pain in arm and swelling arm were recovered/resolved.   It was unknown if the reporter considered the pain in arm and swelling arm to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had pain in arm and swelling arm. For tolerances of 2nd dose, refer case US2020003258, reported by same reporter and patient. This case linked US2020AMR003672 and US2020003251, reported by same reporter. The reporter did not give consent to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old 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 case details were reported as follows: The patient received Shingrix and had pain in arm. For tolerances of 2nd dose, refer case US2020003266, reported by same reporter and patient. This case linked US2020003254, reported by same reporter.
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old male patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, 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 Influenza vaccine.  Additional case details were reported as follows: The patient received flu vaccine and had pain in arm. This case linked with US2020AMR003744, US2020003266, reported by same reporter for the same patient.
Sex: F
Vaccine: FLUX
Symptoms: Influenza like illness, Malaise, Pain, Pyrexia
Clinical narrative: Flu-like symptoms; fever; feeling achy; feels sick for a couple of days; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced influenza-like symptoms, fever, general body pain and feeling unwell. On an unknown date, the outcome of the influenza-like symptoms, fever, general body pain and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever, general body pain and feeling unwell to be related to Influenza vaccine.  Additional case details were reported as follows: The patient received flu and gets flu-like symptoms, which include fever, feeling achy, and just feels sick for a couple of days. The reporter did not consent to follow up. The reporter was would not provide any additional details. This case linked with US2020003252 and US2020003252, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: flu like symptoms; fever; Achiness; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th January 2020, the patient received Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, fever and pain. On an unknown date, the outcome of the influenza-like symptoms, fever and pain were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received vaccine a day before reporting. Post vaccination the patient had fever, achiness and flu like symptoms. The patient inquired that how long do the flu like symptoms last and was there a timeframe that the symptoms typically go away.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: aches; This case was reported by a consumer via call center representative and described the occurrence of pain 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 pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had experienced aches post vaccination. The patient asked what could I take to help with aches. The patient asked whether to take Tylenol or Advil. The patient would contact the pharmacy.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pain in arm; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. 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 recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in left arm and said hurt on injection like the dickens and lasted 5-6 days.  The patient said all pain in arm resolved. For the tolerances of 2nd dose, refer case US2020AMR003917, reported by same reporter for the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Severe pain in arm; Feverish; Tired; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, fever and tiredness. On an unknown date, the outcome of the pain in arm, fever and tiredness were unknown.   It was unknown if the reporter considered the pain in arm, fever and tiredness to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient experienced severe pain in my arm, feverish and tired after vaccination. The patient asked how long should expect to experience some of the side effects to shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Condition aggravated, Decreased appetite, Headache
Clinical narrative: no apetite; Joint pain; 102 fever; horrible headache; arthritis was acting up; sick as a dog; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (for tolerance of 1st dose refer case US2020AMR004497). Concurrent medical conditions included arthritis.   On 31st December 2019, the patient received the 2nd dose of Shingrix. On 31st December 2019, less than a day after receiving Shingrix, the patient experienced fever, headache, arthritis aggravated, sickness and joint pain. On 1st January 2020, the patient experienced appetite absent. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the fever, headache, arthritis aggravated, sickness, appetite absent and joint pain were recovered/resolved.   The reporter considered the fever, headache, arthritis aggravated, sickness, appetite absent and joint pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  On the day of vaccination by early evening, the patient had fever of 102 degrees Fahrenheit, had a horrible headache, and the patient's arthritis acted up. The patient stated that she had learned that joint pain was one of the side effects of Shingrix. By 9 pm, the patient was in bed sick as a dog. The next day the patient experienced the same things. Around noon the next day the patient took advil when the patient's temperature hit 101 degrees Fahrenheit. The patient had no appetite and once again nasty headache. By early evening the patient started to feel better and by the end of the day the side effects had passed. The patient stated that by all in all she was down for 1 day, not too bad.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: no apetite; Joint pain; 102 fever; horrible headache; arthritis was acting up; sick as a dog; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (for tolerance of 1st dose refer case US2020AMR004497). Concurrent medical conditions included arthritis.   On 31st December 2019, the patient received the 2nd dose of Shingrix. On 31st December 2019, less than a day after receiving Shingrix, the patient experienced fever, headache, arthritis aggravated, sickness and joint pain. On 1st January 2020, the patient experienced appetite absent. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the fever, headache, arthritis aggravated, sickness, appetite absent and joint pain were recovered/resolved.   The reporter considered the fever, headache, arthritis aggravated, sickness, appetite absent and joint pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  On the day of vaccination by early evening, the patient had fever of 102 degrees Fahrenheit, had a horrible headache, and the patient's arthritis acted up. The patient stated that she had learned that joint pain was one of the side effects of Shingrix. By 9 pm, the patient was in bed sick as a dog. The next day the patient experienced the same things. Around noon the next day the patient took advil when the patient's temperature hit 101 degrees Fahrenheit. The patient had no appetite and once again nasty headache. By early evening the patient started to feel better and by the end of the day the side effects had passed. The patient stated that by all in all she was down for 1 day, not too bad.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness
Clinical narrative: extreme flu like symptoms; extreme headaches on the right side of her head; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (over the past more than 20 years, some very severe.). Previously administered products included Shingrix (received 1st dose on unknown date).   In November 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced influenza-like symptoms and headache. On an unknown date, the outcome of the influenza-like symptoms and headache were unknown.   It was unknown if the reporter considered the influenza-like symptoms and headache to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in November and had extreme flu like symptoms. Within the last couple days, she was having extreme headaches on the right side of her head.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Nausea
Clinical narrative: not feel right; Nauseous; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included multiple sclerosis.   On 5th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced feeling unwell, nausea and influenza-like symptoms. On an unknown date, the outcome of the feeling unwell, nausea and influenza-like symptoms were not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, nausea and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient had 2nd shot and the patient did not feel right. The patient also had nauseous, flu-like symptoms. The patient asked how long side effects would stay.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Fatigue; Muscle pain at the injection site; Swelling; Chills; Headache; Sleepness night; Bit of redness; fever; stomach upset; painful; Muscle pain at the injection site; This case was reported by a consumer and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (the patient had shingles at the age of 40).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue, myalgia, injection site swelling, chills, headache, insomnia, injection site erythema, fever, upset stomach, pain and injection site pain. The patient was treated with naproxen (Aleve) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the fatigue, myalgia, injection site swelling, chills, headache, insomnia, injection site erythema, fever, upset stomach, pain and injection site pain were unknown.   It was unknown if the reporter considered the fatigue, myalgia, injection site swelling, chills, headache, insomnia, injection site erythema, fever, upset stomach, pain and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had shingles when the patient was 40, over a few days and it was painful.  The patient did experience some difficult for common symptoms all but fever and stomach upset. The patient experienced amount of fatigue and muscle pain at the injection site and the degree of swelling. The patient was treated with an ice pack that relieved the swelling fairly quickly.  The chills and headache were mild. The patient did use an Aleve for pain after experiencing a sleepless night after the injection.  At the time of reporting the patient had only a bit of redness left that was waning and minor pain at the injection site that did not require use of pain reliever. It was reported that the patient would take the second shot better prepared. The patient stated that the few days of discomfort was far better than the weeks suffered years ago with shingles.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Insomnia, Myalgia, Pain
Clinical narrative: Fatigue; Muscle pain at the injection site; Swelling; Chills; Headache; Sleepness night; Bit of redness; fever; stomach upset; painful; Muscle pain at the injection site; This case was reported by a consumer and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (the patient had shingles at the age of 40).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue, myalgia, injection site swelling, chills, headache, insomnia, injection site erythema, fever, upset stomach, pain and injection site pain. The patient was treated with naproxen (Aleve) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the fatigue, myalgia, injection site swelling, chills, headache, insomnia, injection site erythema, fever, upset stomach, pain and injection site pain were unknown.   It was unknown if the reporter considered the fatigue, myalgia, injection site swelling, chills, headache, insomnia, injection site erythema, fever, upset stomach, pain and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had shingles when the patient was 40, over a few days and it was painful.  The patient did experience some difficult for common symptoms all but fever and stomach upset. The patient experienced amount of fatigue and muscle pain at the injection site and the degree of swelling. The patient was treated with an ice pack that relieved the swelling fairly quickly.  The chills and headache were mild. The patient did use an Aleve for pain after experiencing a sleepless night after the injection.  At the time of reporting the patient had only a bit of redness left that was waning and minor pain at the injection site that did not require use of pain reliever. It was reported that the patient would take the second shot better prepared. The patient stated that the few days of discomfort was far better than the weeks suffered years ago with shingles.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fatigue; Muscle pain at the injection site; Swelling; Chills; Headache; Sleepness night; Bit of redness; fever; stomach upset; painful; Muscle pain at the injection site; This case was reported by a consumer and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (the patient had shingles at the age of 40).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue, myalgia, injection site swelling, chills, headache, insomnia, injection site erythema, fever, upset stomach, pain and injection site pain. The patient was treated with naproxen (Aleve) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the fatigue, myalgia, injection site swelling, chills, headache, insomnia, injection site erythema, fever, upset stomach, pain and injection site pain were unknown.   It was unknown if the reporter considered the fatigue, myalgia, injection site swelling, chills, headache, insomnia, injection site erythema, fever, upset stomach, pain and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had shingles when the patient was 40, over a few days and it was painful.  The patient did experience some difficult for common symptoms all but fever and stomach upset. The patient experienced amount of fatigue and muscle pain at the injection site and the degree of swelling. The patient was treated with an ice pack that relieved the swelling fairly quickly.  The chills and headache were mild. The patient did use an Aleve for pain after experiencing a sleepless night after the injection.  At the time of reporting the patient had only a bit of redness left that was waning and minor pain at the injection site that did not require use of pain reliever. It was reported that the patient would take the second shot better prepared. The patient stated that the few days of discomfort was far better than the weeks suffered years ago with shingles.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Injection site pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Soreness in arm at the injection site; Chills; Fever; Sweating; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on an unknown date refer case US2020004313).   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 pain, chills, fever and sweating. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, chills, fever and sweating were unknown.   It was unknown if the reporter considered the injection site pain, chills, fever and sweating to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. It was reported that the patient had soreness in her arm at the injection site for both the first and second vaccine. The patient had chills, fever, and sweating. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: had "flu-like symptoms" for 2 days and they resolved after 1st dose; This case was reported by a physician via sales rep and described the occurrence of unexpected therapeutic drug effect in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Illness at time of vaccination included influenza-like symptoms.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced unexpected therapeutic drug effect. On an unknown date, the outcome of the unexpected therapeutic drug effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic drug effect to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient had flu-like symptoms for 2 days and they resolved on their own after the patient received first of vaccine, which led to unexpected therapeutic drug effect. The reporter thought it was related to the vaccine.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Herpes zoster, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: shingles; shivering about 4  5 hours after injection; muscle pain; pain at the  injection site/enderness at the injection site; redness at the injection site; pain on his legs; flu like symptoms; overall skin hurt; low grade fever of 99.9 degrees; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2019, the patient received the 1st dose of Shingrix. On 18th November 2019, 4 hrs after receiving Shingrix, the patient experienced shivering, muscle pain, injection site pain, injection site erythema, leg pain, influenza-like symptoms, skin pain and low grade fever. On 27th November 2019, the patient experienced shingles. In November 2019, the outcome of the muscle pain, injection site pain, injection site erythema, leg pain, influenza-like symptoms, skin pain and low grade fever were recovered/resolved. On 18th November 2019, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the shingles was recovered/resolved.   The reporter considered the shingles to be unrelated to Shingrix. It was unknown if the reporter considered the shivering, muscle pain, injection site pain, injection site erythema, leg pain, influenza-like symptoms, skin pain and low grade fever to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had shingles.That was the first time he developed shingles. He realizes that it's unrelated to vaccination. He also experienced shivering about 4 to 5 hours after injection and it lasted about an hour. When he got up the next morning he felt better from the shivering. The patient also noticed the following symptoms the day of the injection muscle pain, pain at the injection site, tenderness at the injection site and redness at injection site, pain on his legs, flu like symptoms, his overall skin hurt, low grade fever of 99.9 degrees. All the symptoms lasted about 24 hours. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pain of skin, Pyrexia
Clinical narrative: shingles; shivering about 4  5 hours after injection; muscle pain; pain at the  injection site/enderness at the injection site; redness at the injection site; pain on his legs; flu like symptoms; overall skin hurt; low grade fever of 99.9 degrees; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2019, the patient received the 1st dose of Shingrix. On 18th November 2019, 4 hrs after receiving Shingrix, the patient experienced shivering, muscle pain, injection site pain, injection site erythema, leg pain, influenza-like symptoms, skin pain and low grade fever. On 27th November 2019, the patient experienced shingles. In November 2019, the outcome of the muscle pain, injection site pain, injection site erythema, leg pain, influenza-like symptoms, skin pain and low grade fever were recovered/resolved. On 18th November 2019, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the shingles was recovered/resolved.   The reporter considered the shingles to be unrelated to Shingrix. It was unknown if the reporter considered the shivering, muscle pain, injection site pain, injection site erythema, leg pain, influenza-like symptoms, skin pain and low grade fever to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had shingles.That was the first time he developed shingles. He realizes that it's unrelated to vaccination. He also experienced shivering about 4 to 5 hours after injection and it lasted about an hour. When he got up the next morning he felt better from the shivering. The patient also noticed the following symptoms the day of the injection muscle pain, pain at the injection site, tenderness at the injection site and redness at injection site, pain on his legs, flu like symptoms, his overall skin hurt, low grade fever of 99.9 degrees. All the symptoms lasted about 24 hours. The reporter consented to follow up.