chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; The patient received improperly stored vaccine; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.    On 21-NOV-2019, the patient was vaccinated with improperly stored dose (product storage error) of Hepatitis A Vaccine, Inactivated (VAQTA) lot number S009943, expiration date 26-JUL-2019 for prophylaxis (dose and route of administration was not reported). There was no additional adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 Fahrenheit (°F) /9 Celsius (°C) (51.8 °F) degrees Fahrenheit  for 1 hour 25  minutes. Data logger was involved. There were no previous excursions reported.
Age: 1.17
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Adult dose vaccine given to pediatric patient. Patient received .5mL of Afluria Quad instead of .25mL
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; The patient was administered an improperly stored VARIVAX; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.    On 25-NOV-2019, the patient was vaccinated with improperly stored dose (product storage error) of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number R023736, expiration date 20-AUG-2020 for prophylaxis (dose and route of administration was not reported). The diluent that was used to reconstituted the vaccines was properly stored. There was no additional adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -9 Celsius (°C)  to 8°C (0.9°C) degrees Celsius for 15 hours and 15 minutes. The previous excursions reported was -14°C to -10°C (-13.04 °C) for 45 minutes. Data logger was no involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse events; improperly stored vaccine administered; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and drug allergies/reactions was not provided. On 25-NOV-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose, schedule, route of administration, anatomical location was not reported) of lot# R023736 having expiry date of 20-AUG-2020 for prophylaxis (product storage error). The diluent used to reconstitute the varicella virus vaccine live (Oka/Merck) (VARIVAX) was properly stored. No additional adverse events. The vaccine underwent a temperature excursion of -9 degree celsius to 8 degree celsius (0.9 celsius) for a duration of 15 hours and 15 minutes. The vaccine underwent a previous temperature excursion of - 14 degree celsius to -10 degree celsius (-13.04 celsius) for a duration of 45 minutes. There was no involvement of data logger. No associated product quality complaint.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Polymerase chain reaction positive, Varicella virus test positive, Viral titre increased
Clinical narrative: high VZV IGG titer greater than 4,000; Shingles infection related to a vaccine/positive VZV PCR; This spontaneous report was received from a manager, referring to a 17-year-old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.    The patient was vaccinated in February 2003 and in October 2006 with an unspecified vaccine which may have been varicella virus vaccine live (oka/merck)(VARIVAX) but could not confirmed (reporter assumed that the patient had vaccinated with Merck vaccine) for prophylaxis (strength, dose, frequency, route, lot number and expiry date were not reported).   On 24-NOV-2019, the patient had appeared to be shingles infection (herpes zoster) related to vaccine. On 24-NOV-2019, the patient had high VZV IGG (varicella zoster virus, immunoglobulin G) titer greater than 4000 (unit not reported) (viral titre increased), positive VZV PCR (polymerase chain reaction) from scrapping and IGM (immunoglobulin M) titer was still pending. The patient sought medical attention. No product quality complaint (PQC) was involved.     The outcome of herpes zoster, varicella virus test positive and viral titre increased was unknown. The causality assessment between varicella virus vaccine live (oka/merck)(VARIVAX) and shingles infection was related. The causality assessment between varicella virus vaccine live (oka/merck)(VARIVAX) and viral titre increased was not reported.
Age: 70.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Nasopharyngitis
Clinical narrative: Cold; This case was reported by a nurse via patient support programs and described the occurrence of cold in a 70-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for an unknown indication.   Co-suspect products included treprostinil (Orenitram) (batch number 2101407, expiry date 31st July 2020) and (batch number 2101408, expiry date 31st July 2020) for pulmonary arterial hypertension.   Concurrent medical conditions included pulmonary arterial hypertension (had primary pulmonary arterial hypertension). Concomitant products included amlodipine.   In October 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On 26th March 2019, the patient started Orenitram 3.5 mg at an unknown dose 3 times daily. On 26th March 2019, the dose was changed to an unknown dose and frequency. On an unknown date, less than 3 weeks after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced cold. On an unknown date, the outcome of the cold was unknown.   It was unknown if the reporter considered the cold to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received dose of Flu vaccine 3 weeks ago from the date of reporting. At the time of reporting, the patient had cold. On 26th March 2019, the patient took 3.5 mg of Orenitram every 8 hours as tolerated three times a day orally for primary pulmonary arterial hypertension as a treatment medication. The patient received dose of Amlodipine as a treatment medication. No further details were provided.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Rash with itching; This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 88-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash pruritic (received 1st dose on 14th August 2019).   On 6th November 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced itchy rash. The patient was treated with dermatologicals nos (Ointment) and prednisone. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient is the retired pharmacist. The patient received a dose of Shingrix on his right arm. The patient experienced rash with itching. The patient stated that the physician started the patient on an ointment for the rash which did not help. The patient was prescribed another tapering dose of prednisone for the rash with itching. Additional information not provided. The patient consented to follow up. This case has been linked with case US2019205756, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Bad flu symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 62-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. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, after vaccination with dose of Shingrix, had bad flu symptoms. The patient wanted to know whether she will experience same after 2nd dose of Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Immediate post-injection reaction, Tinnitus
Clinical narrative: the ringing in his ears got louder.; the ringing in his ears got louder.; This case was reported by a pharmacist via sales rep and described the occurrence of tinnitus in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included tinnitus.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced tinnitus and condition aggravated. On an unknown date, the outcome of the tinnitus and condition aggravated were unknown.   It was unknown if the reporter considered the tinnitus and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that, after receiving Shingrix, the patient went out to his car and read the vaccine Information Statement (VIS).  The patient noticed that, there was a warning on it to let your healthcare provider know if you experience ringing in the ears (people sometimes faint after medical procedures, including vaccination. Sitting or lying down for about 15 minutes can help prevent fainting and injuries caused by a fall. Tell your provider if you feel dizzy or have vision changes or ringing in the ears). The patient went back into the pharmacy and informed them that immediately after receiving Shingrix, he noticed the ringing in his ears got louder.  No additional information regarding how long it lasted was available.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site swelling, Vaccine positive rechallenge
Clinical narrative: swelling; Drug dose administration interval too long; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of swelling (1st dose received on 13th August 2018, for reference Kindly refer case US2019204789).   On 16th April 2019, the patient received the 2nd dose of Shingrix. On 16th April 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced injection site swelling. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site swelling and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient had Shingrix second dose in his right arm which was late, which led Lengthening of vaccination schedule. The patient had slight injection site swelling. Additional information was not provided. The reporter did not consent to follow.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: Body aches; Fatigue; This case was reported by a physician via sales rep and described the occurrence of general body pain in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced general body pain and fatigue. On an unknown date, the outcome of the general body pain and fatigue were unknown.   It was unknown if the reporter considered the general body pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of shingrix and experienced body pain and fatigue. The reporter did not consent to follow up. This case has been linked with case US2019AMR208451, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: Body aches; Fatigue; This case was reported by a physician via sales rep and described the occurrence of general body pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced general body pain and fatigue. On an unknown date, the outcome of the general body pain and fatigue were unknown.   It was unknown if the reporter considered the general body pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of shingrix and experienced body pain and fatigue. The reporter did not consent to follow up. This case has been linked with case US2019AMR208449, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arms; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Post vaccination with Shingrix the patient had sore arms for several days. The patient had to revisit the pharmacy several times before he could get his second shot. This is 1 of the 3 cases reported by the same reporter for the same suspect.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arms; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received vaccine a few years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Post vaccination with Shingrix the patient had sore arms for several days. The patient had to revisit the pharmacy several times before she could get her second shot. This is 1 of the 3 cases reported by the same reporter for the same suspect.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Myalgia, Nausea
Clinical narrative: Some people experience noticeable side effects, including muscle pain, headaches, shivering, fever, stomach pain or nausea.; Some people experience noticeable side effects, including muscle pain, headaches, shivering, fever, stomach pain or nausea; Some people experience noticeable side effects, including muscle pain, headaches, shivering, fever, stomach pain or nausea.; Some people experience noticeable side effects, including muscle pain, headaches, shivering, fever, stomach pain or nausea.; Some people experience noticeable side effects, including muscle pain, headaches, shivering, fever, stomach pain or nausea.; Some people experience noticeable side effects, including muscle pain, headaches, shivering, fever, stomach pain or nausea.; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain 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 muscle pain, headache, shivering, fever, stomach pain and nausea. On an unknown date, the outcome of the muscle pain, headache, shivering, fever, stomach pain and nausea were recovered/resolved.   It was unknown if the reporter considered the muscle pain, headache, shivering, fever, stomach pain and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Post vaccination with Shingrix some people experienced noticeable side effects, including muscle pain, headaches, shivering, fever, stomach pain or nausea. This is 1 of the 3 cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Some people experience noticeable side effects, including muscle pain, headaches, shivering, fever, stomach pain or nausea.; Some people experience noticeable side effects, including muscle pain, headaches, shivering, fever, stomach pain or nausea; Some people experience noticeable side effects, including muscle pain, headaches, shivering, fever, stomach pain or nausea.; Some people experience noticeable side effects, including muscle pain, headaches, shivering, fever, stomach pain or nausea.; Some people experience noticeable side effects, including muscle pain, headaches, shivering, fever, stomach pain or nausea.; Some people experience noticeable side effects, including muscle pain, headaches, shivering, fever, stomach pain or nausea.; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain 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 muscle pain, headache, shivering, fever, stomach pain and nausea. On an unknown date, the outcome of the muscle pain, headache, shivering, fever, stomach pain and nausea were recovered/resolved.   It was unknown if the reporter considered the muscle pain, headache, shivering, fever, stomach pain and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Post vaccination with Shingrix some people experienced noticeable side effects, including muscle pain, headaches, shivering, fever, stomach pain or nausea. This is 1 of the 3 cases reported by the same reporter.
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Pertussis
Clinical narrative: My eldest daughter received her first DPT as an infant and came down with whooping cough immediately; This case was reported by a consumer via interactive digital media and described the occurrence of whooping cough in a infant female patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of DTPa vaccine. On an unknown date, immediately after receiving DTPa vaccine, the patient experienced whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the whooping cough was recovered/resolved.   It was unknown if the reporter considered the whooping cough to be related to DTPa vaccine.  Additional case details were provided as follows: The age at vaccination was not reported. The patient received DPT and came down with whooping cough immediately following. It lasted about two and half month and was terrible. The patient's parent was afraid to continue the vaccination but did eventually.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Pain; Rash; This case was reported by a consumer and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received Shingrix. In November 2019, between 1 and 3 months after receiving Shingrix, the patient experienced pain and rash. On an unknown date, the outcome of the pain and rash were unknown.   It was unknown if the reporter considered the pain and rash 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 was captured as an adult as per the vaccine indication. The patient received Shingrix vaccine in September 2019 and experienced Pain and rash recently in November 2019. The reporter was enquiring whether the patient can get shingles in between the administering of the 2 vaccines or not.
Sex: U
Vaccine: VARZOS
Symptoms: Full blood count, Haematocrit increased, Haemoglobin increased
Clinical narrative: showed increased Hemoglobin and Hematocrit.; Hemoglobin and Hematocrit.; This case was reported by a consumer and described the occurrence of hemoglobin increased in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2019, the patient received Shingrix. On 6th November 2019, 5 days after receiving Shingrix, the patient experienced hemoglobin increased and hematocrit increased. On an unknown date, the outcome of the hemoglobin increased and hematocrit increased were unknown.   It was unknown if the reporter considered the hemoglobin increased and hematocrit increased to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication.  The patient experienced hemoglobin increased and hematocrit increased after receiving Shingrix.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: flu like symptoms; fever; chills; This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 10 hrs after receiving Shingrix and Shingrix, the patient experienced influenza-like symptoms, fever and chills. On an unknown date, the outcome of the influenza-like symptoms, fever and chills were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever and chills to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had flu like symptoms that started about 10 to 12 hours after 1st or 2nd dose and lasted for about 10 to 12 hours. The reporter gave consent to follow up via mail. This case has been linked with case US2019AMR209598, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-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 injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient. The age at vaccination was not reported. For tolerance of 2nd dose, refer case US2019AMR209758.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: fever; headache; severe body aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (on an unknown date, the patient received the 1st dose of Shingrix, refer case US2019AMR209753).   On 14th November 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever, headache and general body pain. On an unknown date, the outcome of the fever, headache and general body pain were unknown.   It was unknown if the reporter considered the fever, headache and general body pain to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient. The patient had severe body aches. The patient asked if fever headache and severe body aches were common.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Skin discolouration, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Shingles; Rash on back; Skin discoloration; This case was reported by a pharmacist via sales rep and described the occurrence of Suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and skin discoloration. On an unknown date, the outcome of the vaccination failure, shingles, rash and skin discoloration were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash and skin discoloration to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient had rash on his back after getting both doses. The patient never experienced pain or symptoms but his PCP saw it last week and the discoloration and location was indicative that it was a shingles rash. The reporter agreed to follow-up from GlaxoSmithKline. This case was considered as suspected vaccination failure as details regarding time to onset for target disease was unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: fever; headache; This case was reported by a nurse via sales rep and described the occurrence of fever in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and headache. On an unknown date, the outcome of the fever and headache were unknown.   It was unknown if the reporter considered the fever and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. No other information was provided. Consent to follow up was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Insomnia, Pain, Pain in extremity, Pruritus
Clinical narrative: severe body aches; itchy arm; sore arm; awake for 3 nights; This case was reported by a physician via call center representative and described the occurrence of general body pain in a adult 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 general body pain, insomnia, itchy upper limbs and pain in arm. On an unknown date, the outcome of the general body pain, itchy upper limbs and pain in arm were recovering/resolving and the outcome of the insomnia was recovered/resolved.   It was unknown if the reporter considered the general body pain, insomnia, itchy upper limbs and pain in arm 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 it was selected as adult as per the vaccine indication. The patient experienced severe body aches for several days that kept her awake for 3 nights and an itchy sore arm well below the injection site that had lingered for 3 weeks but was very gradually subsiding. The reporter asked If the patient gets the recommended 2nd dose could the reaction be worse. The reporter asked if there was data about 2nd shot symptoms after having symptoms with 1st shot also, asked if there was data about immunity after having Zostavax followed by 1 dose of Shingrix having 2 doses.
Sex: U
Vaccine: MENB
Symptoms: Injection site cellulitis, Injection site swelling
Clinical narrative: Cellulitis at injection site; swelling at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site cellulitis in a adolescent patient who received Men B NVS (Bexsero) for prophylaxis.   In November 2019, the patient received Bexsero. In November 2019, less than a week after receiving Bexsero, the patient experienced injection site cellulitis and injection site swelling. On an unknown date, the outcome of the injection site cellulitis and injection site swelling were unknown.   It was unknown if the reporter considered the injection site cellulitis and injection site swelling to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Bexsero in the last week from the date of reporting. The parent of the patient called back and stated that, the patient had injection site swelling. The patient went back in and diagnosed with cellulitis. The reporter was not sure, if the cellulitis and injection site swelling was related with Bexsero. This case has been linked with case US2019AMR210855, reported by same reporter.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis
Clinical narrative: CELLULITIS; This case was reported by a other health professional via call center representative and described the occurrence of injection site cellulitis in a 4-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included Proquad for prophylaxis.   In November 2019, the patient received Kinrix and Proquad at an unknown dose and frequency. In November 2019, less than a week after receiving Kinrix, the patient experienced injection site cellulitis. On an unknown date, the outcome of the injection site cellulitis was unknown.   It was unknown if the reporter considered the injection site cellulitis to be related to Kinrix.  Additional details were provided as follows: The reporter stated that the week before the day of reporting, the patient received Kinrix and Proquad and experienced injection site cellulitis. The reporter could not comfirm, if the injection site cellulitis was due to Kinrix. It was unknown if the reporter considered the injection site cellulitis to be related to Proquad as well. This case has been linked with case US2019AMR210851, reported by same reporter.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Heart rate increased, Hyperthyroidism
Clinical narrative: hyperthyroidism; heart rate began to go up; This case was reported by a consumer via call center representative and described the occurrence of hyperthyroidism in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2019, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced hyperthyroidism (serious criteria GSK medically significant) and heart rate increased. On an unknown date, the outcome of the hyperthyroidism and heart rate increased were unknown.   It was unknown if the reporter considered the hyperthyroidism and heart rate increased to be related to Shingrix.  Additional case details were provided as follows: In 2019, within a couple days after Shingrix vaccination, the patient's heart rate began to go up significantly and was diagnosed with hyperthyroidism. The patient asked whether this injection could damage the thyroid gland.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: rash is now starting to itch.; This case was reported by a consumer via patient support programs and described the occurrence of itchy rash in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 2nd dose of Shingrix .5 ml. In November 2019, less than 2 weeks after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows:  The patient received Shingrix a couple of days before the date of reporting. The patient stated that had a rash since she received the 2nd dose of Shingrix. The patient stated it had gotten worse and that it was now starting to itch.  No further information was provided.
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat; Fever; This case was reported by a consumer via other manufacturer and described the occurrence of sore throat in a female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra) for prophylaxis.   On an unknown date, the patient received Fluarix Tetra at an unknown dose. On an unknown date, unknown after receiving Fluarix Tetra, the patient experienced sore throat and fever. On an unknown date, the outcome of the sore throat and fever were unknown.   It was unknown if the reporter considered the sore throat and fever to be related to Fluarix Tetra.  Additional details were provided as follows:  The age at vaccination was not reported. No further details were provided.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Feeling abnormal, Malaise, Nausea
Clinical narrative: Nausea; Loss of Appetite; Fever; Shivering; Malaise; Feeling bad; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number HY4GT, expiry date 21st September 2021) for prophylaxis.   On 9th July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced nausea, appetite lost, fever, shivering, malaise and feeling bad. On an unknown date, the outcome of the nausea, appetite lost, fever, shivering, malaise and feeling bad were unknown.   It was unknown if the reporter considered the nausea, appetite lost, fever, shivering, malaise and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix, and experienced some reactions including nausea, no appetite, fever, shivering, feels bad (malaise), and has been in bed all day a day. For tolerance to 2nd  dose, refer case US2019207606. The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Nausea; Loss of Appetite; Fever; Shivering; Malaise; Feeling bad; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number HY4GT, expiry date 21st September 2021) for prophylaxis.   On 9th July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced nausea, appetite lost, fever, shivering, malaise and feeling bad. On an unknown date, the outcome of the nausea, appetite lost, fever, shivering, malaise and feeling bad were unknown.   It was unknown if the reporter considered the nausea, appetite lost, fever, shivering, malaise and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix, and experienced some reactions including nausea, no appetite, fever, shivering, feels bad (malaise), and has been in bed all day a day. For tolerance to 2nd  dose, refer case US2019207606. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Syncope, Tachycardia
Clinical narrative: Syncope; Tachycardia; This case was reported by a nurse via sales rep and described the occurrence of syncope 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 syncope (serious criteria GSK medically significant) and tachycardia. On an unknown date, the outcome of the syncope and tachycardia were recovered/resolved.   The reporter considered the syncope and tachycardia to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The patient was monitored. The patient was okay. The reporter agreed to follow up contact.
Sex: M
Vaccine: UNK
Symptoms: Death, Dyspnoea, Pneumonia, Pulmonary congestion
Clinical narrative: Pneumonia / Died this past week because his body couldn't fight it off; Lungs were congested; Couldn't breathe; This case was reported by a consumer via interactive digital media and described the occurrence of pneumonia in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Concurrent medical conditions included hospitalization (hospital this past month) and sedation (was in a sedative state).   In October 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. In October 2019, 1 day after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced pneumonia (serious criteria death, hospitalization and GSK medically significant), lung congestion (serious criteria hospitalization and GSK medically significant) and difficulty breathing (serious criteria hospitalization). The patient was treated with oxygen. In November 2019, the outcome of the pneumonia was fatal. On an unknown date, the outcome of the lung congestion and difficulty breathing were unknown. The patient died in November 2019. The reported cause of death was pneumonia.   It was unknown if the reporter considered the pneumonia, lung congestion and difficulty breathing to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient was in the hospital, and while he was in a sedative state, the patient was vaccinated with a flu shot without his permission, and never even told his wife and kids. The day after vaccination, the patient couldn't breathe, and his lungs were congested.  The patient was put on oxygen, because he got pneumonia. The patient died because his body couldn't fight it off.; Reported Cause(s) of Death: Pneumonia
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Coma, Death, Feeling abnormal
Clinical narrative: Went into a coma, and died 5 days later; Feeling really bad; This case was reported by a consumer via interactive digital media and described the occurrence of coma in a 54-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, 1 day after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced coma (serious criteria death and GSK medically significant) and feeling bad. On an unknown date, the outcome of the coma was fatal and the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the coma and feeling bad to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: This happened 2 years ago with the patient. Company started giving out free flu vaccines to the workers and their families. The patient was healthy. Right after getting the vaccine, she started feeling really bad, and the next evening when her husband came home, that night he had to call the squad. She went into a coma, and died 5 days later. This case has been linked to US2019AMR211990, reported by the same reporter.; Reported Cause(s) of Death: Coma
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Infection, Post herpetic neuralgia, Vaccination failure
Clinical narrative: suspected vaccination failure; have fairly minor but frequent recurrences of shingles; I have fairly minor but frequent recurrences of associated PHN; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and post herpetic neuralgia.   In February 2019, the patient received the 1st dose of Shingrix. In May 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, less than 6 months after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the vaccination failure, shingles and post herpetic neuralgia were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that, the patient experienced fairly minor but frequent recurrences of shingles and associated post herpetic neuralgia (PHN). It was reported that, since the patient received 2nd dose of Shingrix, the patient continued to experience regular outbreaks 4 in the 6 months. They are often less severe than before receiving Shingrix, but no less frequent.  The patient was treated with antiviral Valacyclovir for outbreaks. The patient asked if a third dose was warranted and asked was it possible that one of the doses received was somehow compromised, or not full-strength. It was reported that, Shingrix should be much more effective than it had been. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset for the event and laboratory test confirmation were unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Flank pain, Headache, Migraine
Clinical narrative: migraine/headache; migraine/headache; chills; myalgia; arthralgia; sensitive skin; flank pain; This case was reported by a physician via call center representative and described the occurrence of migraine headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain. On an unknown date, the outcome of the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain were unknown.   It was unknown if the reporter considered the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter believed that the adverse events were much more severe after 2nd dose compared with the 1st dose. No additional demographic information of patient was provided. The reporter consent to follow up. This is 1 of 11 cases, reported by the same reporter, for tolerance of 2nd dose, refer case US2019AMR208413.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Sensitive skin
Clinical narrative: migraine/headache; migraine/headache; chills; myalgia; arthralgia; sensitive skin; flank pain; This case was reported by a physician via call center representative and described the occurrence of migraine headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain. On an unknown date, the outcome of the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain were unknown.   It was unknown if the reporter considered the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter believed that the adverse events were much more severe after 2nd dose compared with the 1st dose. No additional demographic information of patient was provided. The reporter consent to follow up. This is 1 of 11 cases, reported by the same reporter, for tolerance of 2nd dose, refer case US2019AMR208413.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Flank pain, Headache, Migraine
Clinical narrative: migraine/headache; migraine/headache; chills; myalgia; arthralgia; sensitive skin; flank pain; This case was reported by a physician via call center representative and described the occurrence of migraine headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain. On an unknown date, the outcome of the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain were unknown.   It was unknown if the reporter considered the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter believed that the adverse events were much more severe after 2nd dose compared with the 1st dose. No additional demographic information of patient was provided. The reporter consent to follow up. This is 1 of 11 cases, reported by the same reporter, for tolerance of 2nd dose, refer case US2019AMR208414.