chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: At time of injection O adverse reaction till next day she had weltes itched all over instructed her to go to MD she also was taking antibiotic of some kind.
Age: 51.0
Sex: M
Vaccine: UNK, HEPA, PPV, TDAP, VARZOS
Symptoms: Dyspnoea, Pain
Clinical narrative: shortness of breath and a heavy heart. pt was sent to the ER for evaluation
Age: 51.0
Sex: M
Vaccine: UNK, HEPA, PPV, TDAP, VARZOS
Symptoms: Chest discomfort, Dyspnoea, Immune system disorder
Clinical narrative: shortness of breath and a heavy heart. pt was sent to the ER for evaluation
Age: 36.0
Sex: M
Vaccine: FLUC4
Symptoms: Biopsy skin, Pityriasis rosea, Skin lesion
Clinical narrative: PR occurred shortly after injection
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Seizure like phenomena
Clinical narrative: a fever with seizure like convulsions; This spontaneous report was received from a consumer referring to her 2 or 3 years old son. There was no information about the patient's drug reactions, allergies, pertinent medical history, and concomitant therapies provided.  In 2007, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown)(strength, dose, route, lot # and expiration date were not reported) for prophylaxis.    In 2007, the patient experienced a fever with seizure like convulsions. The outcome of the event was reported as recovered (reported as it took about 10 days for the symptoms to go away). The causality assessment was not provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; the patient received ROTATEQ following a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 28-OCT-2019, the patient received Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot #, expiration date, strength and dose were unknown) orally for prophylaxis following a temperature excursion (product storage error). The vaccine was exposed to lowest temperature below 36 degrees Fahrenheit/2 degrees Celsius (35 degrees Fahrenheit) for 430 minutes. No previous excursion was reported. No data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported in the patient.; Patient received a vaccine following a temperature excursion; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug reactions/allergies, and concurrent conditions were not disclosed.  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) vial, strength reported as 25/0.5 (units not reported) (dose number, anatomical injection site, route of administration, indication, lot number and expiration date were not disclosed).  It was reported that this vaccine had been on a temperature excursion and was stored below 36°F / 2°C (35F) during 430 minutes; but it was also noted that there had not been a previous temperature excursion.  At the time of this report, there were no adverse events reported. Digital data logger was not  involved.
Sex: F
Vaccine: MMR
Symptoms: Antibody test abnormal, Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: M-M-R II for "Was not in my system"; I got blood work done in April 2019 and it's now again showing low levels of measles, mumps, rubella; my blood work showed low levels for the measles, mumps, rubella; This spontaneous report was received from a 52 year old female patient. There were not concurrent conditions, medical history and concomitant therapies.  On an unknown date "as a child", the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, route, vaccination site, lot#, expiration date and indication were not reported).  Then in 2011, the patient's underwent an unspecified blood work that showed low levels for the measles, mumps, rubella (antibody test abnormal), so the patient received a second vaccination with another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, route, vaccination site, lot#, and expiration date were not reported), for "was not in the patient's system".  In April 2019, the patient underwent another unspecified blood work and it was now again showing low levels of measles, mumps, rubella (antibody test abnormal).  At the time of reporting, the patient had not recovered from both antibody test abnormal. The reporter did not provide a causality assessment between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and the events.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported.; a patient was administered a dose of improperly stored MMRll that was reconstituted with Merck DILUENT that did not undergo an excursion.; This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, concurrent condition, drug reaction/allergy and concomitant medication was not provided.  On 07-NOV-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S005249, expiration date 20-FEB-2021; vaccine dosage detail was not reported) subcutaneously for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with properly stored sterile diluent. The storage temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was above 47 Fahrenheit (46.9 Fahrenheit) for 37 minutes. There was no previous temperature excursion. No adverse effects reported. No product quality complaint (PQC) was involved in this case. Data logger was involved.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported.; a patient was administered a dose of improperly stored MMRll that was reconstituted with Merck DILUENT that did not undergo an excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, concurrent condition, drug reaction/allergy and concomitant medication was not provided.  On 06-NOV-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S005249, expiration date 20-FEB-2021; vaccine dosage detail was not reported) subcutaneously for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with properly stored sterile diluent. The storage temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was above 47 Fahrenheit (46.9 Fahrenheit) for 37 minutes. There was no previous temperature excursion. No adverse effects reported. Data logger was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Endodontic procedure, Neck pain, Otitis media, Periodontitis
Clinical narrative: right ear pain that radiated down the right side of her neck/ diagnosed with otitis media; irreversible pulpitis with symptomatic apical periodontitis which required a root canal; irreversible pulpitis with symptomatic apical periodontitis which required a root canal; she continued to experience severe pain after the root canal and was diagnosed with trigeminal neuralgia; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On or around 27-OCT-2016, she was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving the zoster vaccine live (ZOSTAVAX), the patient suffered right ear pain that radiated down the right side of her neck and was diagnosed with otitis media. On an unknown date, shortly after, she was diagnosed with irreversible pulpitis with symptomatic apical periodontitis which required a root canal. She continued to experience severe pain after the root canal and was diagnosed with trigeminal neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient's symptoms resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of vaccination, she sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, she suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events were considered to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Pulpitis dental, Trigeminal neuralgia
Clinical narrative: right ear pain that radiated down the right side of her neck/ diagnosed with otitis media; irreversible pulpitis with symptomatic apical periodontitis which required a root canal; irreversible pulpitis with symptomatic apical periodontitis which required a root canal; she continued to experience severe pain after the root canal and was diagnosed with trigeminal neuralgia; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On or around 27-OCT-2016, she was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving the zoster vaccine live (ZOSTAVAX), the patient suffered right ear pain that radiated down the right side of her neck and was diagnosed with otitis media. On an unknown date, shortly after, she was diagnosed with irreversible pulpitis with symptomatic apical periodontitis which required a root canal. She continued to experience severe pain after the root canal and was diagnosed with trigeminal neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient's symptoms resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of vaccination, she sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, she suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events were considered to be disabling.
Sex: M
Vaccine: VARZOS
Symptoms: Atrophy, Confusional state, Diplopia, Dizziness, Hypoaesthesia
Clinical narrative: episode of syncope; atrophy; chronic ischemic change; experience numbness on the right side of his face and arm with some endorsed confusion and was diagnosed with transient ischemic attack; extreme dizziness/vertigo and diplopia and was diagnosed with Meniere's disease; extreme dizziness/vertigo and diplopia and was diagnosed with Meniere's disease; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On or around 10-OCT-2016, he was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving the zoster vaccine live (ZOSTAVAX), the patient suffered an episode of syncope and was diagnosed with atrophy and chronic ischemic change. On an unknown date, a short time later, he started to experience numbness on the right side of his face and arm with some endorsed confusion and was diagnosed with transient ischemic attack. Around that time, the patient began to suffer extreme dizziness/vertigo and diplopia and was diagnosed with Meniere's disease. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient's symptoms resulted in physical limitations not present prior to using the vaccine. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of vaccination, he sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, he suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events were determined to be disabling. Upon internal review, the events of episode of syncope, transient ischemic attack and Meniere's disease were considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Ischaemia, Meniere's disease, Syncope, Transient ischaemic attack, Vertigo
Clinical narrative: episode of syncope; atrophy; chronic ischemic change; experience numbness on the right side of his face and arm with some endorsed confusion and was diagnosed with transient ischemic attack; extreme dizziness/vertigo and diplopia and was diagnosed with Meniere's disease; extreme dizziness/vertigo and diplopia and was diagnosed with Meniere's disease; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On or around 10-OCT-2016, he was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving the zoster vaccine live (ZOSTAVAX), the patient suffered an episode of syncope and was diagnosed with atrophy and chronic ischemic change. On an unknown date, a short time later, he started to experience numbness on the right side of his face and arm with some endorsed confusion and was diagnosed with transient ischemic attack. Around that time, the patient began to suffer extreme dizziness/vertigo and diplopia and was diagnosed with Meniere's disease. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient's symptoms resulted in physical limitations not present prior to using the vaccine. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of vaccination, he sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, he suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events were determined to be disabling. Upon internal review, the events of episode of syncope, transient ischemic attack and Meniere's disease were considered to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects were reported in the patient; A patient received a dose of GARDASIL 9 5 years ago and is currently in the office to continue the series; This spontaneous information has been received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.  On an unknown date in 2014 (reported as 5 years ago), the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection as prophylaxis  (strength, route of administration, anatomical location, lot number and expiration date were not provided) and went to the office to continue the series (inappropriate schedule of drug administration).  No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient was administered a dose of improperly stored ROTATEQ; No adverse effects reported; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug reactions/allergies, and concurrent conditions were not disclosed.  On 07-NOV-2019, the patient was vaccinated with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) administered orally as prophylaxis (strength and dose number were not provided; valid lot number S005876 expiration date 25-NOV-2020). It was reported that this vaccine had been on a temperature excursion and was stored above 47°F (46.9F) during 37 minutes; but it was also noted that there had not been a previous temperature excursion.  At the time of this report, there were no adverse events reported. Digital data logger was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: multiple outbreaks of herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age.The pt's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the pt was prescribed zoster vaccine live(ZOSTAVAX) vaccine by a healthcare provider and vaccinated with zoster vaccine live(ZOSTAVAX)(dose, route of administration, anatomical location, lot#, expiration date were unknown) at a pharmacy for the long-term prevention of shingles and zoster-related conditions by a pharmacist. On an unknown date, the pt suffered multiple outbreaks of herpes zoster as a result of the zoster vaccine live(ZOSTAVAX) vaccine.The outcome of herpes zoster was unknown.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: the patient passed out about 3 seconds after the injection of GARDASIL 9/as soon as the immunization was administered, she fainted immediately; This spontaneous report was received from a office manager in a physician's office via company representative and refers to a 14-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reaction/allergies were not reported.  On 11-NOV-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot # 1621934, expiration date 29-JAN-2020, intramuscularly in the left arm for prevention of human papilloma virus (HPV) related cancer (exact dose was not reported). As soon as the immunization was administered, the patient fainted immediately. She passed out about 3 seconds after the injection of the vaccine and she had little headache and dizziness. Her blood pressure was 92/64 and heart rate 64 (units not provided). There was no treatment given for the event, the patient was just observed by the physician. The patient left the physician's office feeling fine. She had a little headache, however was walking fine (outcome reported as recovered). The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Upon internal review, the event was determined to be medically significant.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effect; second dose received after 5 years of interval; This spontaneous report as received from a healthcare student refers to a 18 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.      Approximately in 2014 (reported as 5 years ago) and subsequently on 13-NOV-2019, the patient was vaccinated with first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R026716, expiry date : 30-MAY-2021, intramuscularly) for prophylaxis (inappropriate schedule of product administration). No adverse events were reported.
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC13
Symptoms: Hyperhidrosis, Rash
Clinical narrative: perfuse sweating; rash; This spontaneous report as received from a nurse practitioner via a company representative refers to a 16 months old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.     On 04-NOV-2019 (reported as 10 days ago), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dose, lot # and expiry date was not reported) for prophylaxis. On the same day, other suspect therapies received by the patient included pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR) (dose, lot # and expiry date was not reported), diphtheria toxoid, hib conj vaccine (tet toxoid), pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid(PENTACEL) (dose, lot # and expiry date was not reported) and hepatitis a virus vaccine (unspecified) (dose, lot # and expiry date was not reported). On 04-NOV-2019, reported as after the administration of the vaccines, the patient experienced rash and profuse sweating reported as "perfuse sweating" (hyperhidrosis). The patient visited the physician office and there was no treatment given for the events. The outcome of hyperhidrosis and rash was reported as not recovered. The relatedness between the events and the suspect therapies was not provided.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, UNK
Symptoms: Intestinal obstruction, Volvulus
Clinical narrative: LADD bands; volvulus; Information was downloaded (US-EMA-20110128-raevhumanwt-144336890).  This spontaneous report was received from a physician via consumer and a health care professional and refers to a 2 month old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 02-FEB-1999, the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # reported as "1678H"(dose, frequency, route, vaccination site, expiration date and indication were not provided).  Other suspect therapies started on the same date, included diphtheria toxoid, pertussis acellular 4-component vaccine, tetanus toxoid(ACEL-IMUNE) Injection, lot# 456-819 "(dose, frequency, route, vaccination site, expiration date and indication were not provided), hib conj vaccine (unspecified carrier)(HIB-TITER VACCINE) lot# 393103A (dose, frequency, route, vaccination site, expiration date and indication were not provided), and rotavirus g1 g2 g3 g4 reassortant vaccine live (human-rhesus)(ROTASHIELD) oral solutio, orally, Dose Duration: 1 doses, for Immunisation.  On 15-FEB-1999, the patient experienced Ladd's bands (intestinal obstruction) and volvulus which caused hospitalization on an unspecified dates. At the time of reporting, the patient had recovered from intestinal obstruction and volvulus.  The reporter did not provide a causality assessment between suspect therapies and the events.  Lot number 1678H is an invalid lot number for hepatitis b vaccine (recombinant).
Sex: F
Vaccine: DTAP, HEP, HIBV, UNK, UNK
Symptoms: Intestinal obstruction
Clinical narrative: INTESTINAL OBSTRUCTION; Information has been downloaded from regulatory authority (US-EMA-20150330-tanvievhp-114818074).  This spontaneous report was received from a healthcare professional refers to a 3 month old female infant patient with milk protein allergy. The patient's historic conditions and concomitant medications were not reported.  On 16-FEB-1999, the patient was vaccinated with a dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) oral solution (lot/batch# 1372E; strength, dose number, anatomical location and expiration date were not reported) for prophylaxis. On 16-MAR-1999, the patient was vaccinated with Hib conj vaccine (CRM197) (HIB-TITER VACCINE) (strength, dose number, anatomical location and expiration date were not reported, lot # 403203A) via intramuscular route for immunisation, polio vaccine (unspecified) (also reported as "POLIO VACCINE "PASTEUR") (indication, strength, dose number, anatomical location, route and expiration date were not reported with lot # N0597), rotavirus G1 G2 G3 G4 reassortant vaccine live (human-rhesus) (ROTA SHIELD) one dose, oral solution (strength, dose number, anatomical location and expiration date were not reported with lot # 4988078) via oral route for immunisation and diphtheria toxoid, pertussis acellular biken vaccine, tetanus toxoid (TRIPEDIA) (strength, dose number, route, anatomical location, expiration date were not reported with lot # 097014D) for prophylaxis. On 11-MAY-1999, the patient experienced intestinal obstruction. The patient was hospitalized for the event on an unknown date in 1999. The outcome of intestinal obstruction was recovered. The relatedness between the suspect therapy and the event was not provided  The Agency considered the event, intestinal obstruction to be medically significant.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: body aches; fatigue; flu like symptoms; dizziness; headache; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, between 3 and 5 months after receiving Shingrix, the patient experienced general body pain, fatigue, influenza-like symptoms, dizziness and headache. On an unknown date, the outcome of the general body pain, fatigue, influenza-like symptoms, dizziness and headache were recovered/resolved.   The reporter considered the general body pain, fatigue, influenza-like symptoms and dizziness to be related to Shingrix. It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The patient had dose of Shingrix and felt as if was getting the flu having body aches and fatigue.  The patient also had headache and dizziness. For the tolerance of 2nd dose refer case US2019AMR201634.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Hypoaesthesia, Injection site discomfort, Pain in extremity
Clinical narrative: discomfort at the injection site; arm very sore / sore arm; numbness in my left hand / hand is slightly numb; Swelling; Fatigue; feel a sensation to my elbow; This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2019, the patient received the 2nd dose of Shingrix. On 5th November 2019, 5 days after receiving Shingrix, the patient experienced injection site discomfort, pain in arm, numbness in hand, swelling, fatigue and pain in elbow. On an unknown date, the outcome of the injection site discomfort was recovering/resolving and the outcome of the pain in arm, numbness in hand, swelling, fatigue and pain in elbow were unknown.   It was unknown if the reporter considered the injection site discomfort, pain in arm, numbness in hand, swelling, fatigue and pain in elbow to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. The patient arm was very sore and on day of reporting the soreness if much better, however, patient had numbness in left hand. The patient asked whether it was a normal reaction. The patient had the sore arm, swelling, fatigue. The patient still felt a slight discomfort at the injection site, but mostly gone. Every now and then patient felt a sensation to elbow and his/her hand was slightly numb. The reporter requesting consent to follow up.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Sensory disturbance, Swelling
Clinical narrative: discomfort at the injection site; arm very sore / sore arm; numbness in my left hand / hand is slightly numb; Swelling; Fatigue; feel a sensation to my elbow; This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2019, the patient received the 2nd dose of Shingrix. On 5th November 2019, 5 days after receiving Shingrix, the patient experienced injection site discomfort, pain in arm, numbness in hand, swelling, fatigue and pain in elbow. On an unknown date, the outcome of the injection site discomfort was recovering/resolving and the outcome of the pain in arm, numbness in hand, swelling, fatigue and pain in elbow were unknown.   It was unknown if the reporter considered the injection site discomfort, pain in arm, numbness in hand, swelling, fatigue and pain in elbow to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. The patient arm was very sore and on day of reporting the soreness if much better, however, patient had numbness in left hand. The patient asked whether it was a normal reaction. The patient had the sore arm, swelling, fatigue. The patient still felt a slight discomfort at the injection site, but mostly gone. Every now and then patient felt a sensation to elbow and his/her hand was slightly numb. The reporter requesting consent to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Rash erythematous, Rash pruritic
Clinical narrative: unconfortable red rash on face with slight pores on edges; itchy; This case was reported by a other health professional via sales rep and described the occurrence of red rash in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 25th June 2019).   On 7th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, 7 days after receiving Shingrix, the patient experienced red rash and itchy rash. The patient was treated with triamcinolone. On an unknown date, the outcome of the red rash and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the red rash and itchy rash to be related to Shingrix.  Additional details were provided as follows: Th patient received dose of Shingrix and 1 week after had red rash on face was not blistering or painful but it was uncomfortable with slight pores on edge. 3 weeks after vaccination, the rash was itchy and has not resolved. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Nausea
Clinical narrative: Chills; Nausea; This case was reported by a physician via call center representative and described the occurrence of chills in a adult 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 chills and nausea. On an unknown date, the outcome of the chills and nausea were unknown.   It was unknown if the reporter considered the chills and nausea to be related to Shingrix.  Additional details were provided as follows: The patient demographic details were not provided. The age at vaccination was not reported. The age group of the patient was not reported but selected as an adult as per vaccine indication. The health care professional stated that, after vaccination with 2nd dose of Shingrix, the patient had chills and nausea. No other details were available since this was a friend of MD's patient. for the tolerence of 1st dose refer case US2019201138, reported by same reporter for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Hyperaesthesia, Limb discomfort, Myalgia
Clinical narrative: Burning sensation; Discomfort on both legs; Sensible to touch; Pain; Blisters (like varicella or Shingles); Fever; Myalgia; This case was reported by a other health professional via sales rep and described the occurrence of burning sensation in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2015, the patient received Shingrix .5 ml. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced burning sensation, leg discomfort, touch sensitivity increased, pain, blister, fever and myalgia. On an unknown date, the outcome of the burning sensation, leg discomfort, touch sensitivity increased, pain, blister, fever and myalgia were unknown.   The reporter considered the burning sensation, leg discomfort, touch sensitivity increased, pain, blister, fever and myalgia 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 discomfort on both legs, burning sensation, sensible to the touch, pain, blisters, fever and myalgia. The course of treatment was the standard for Shingles. The reporter was very surprised by these side effects.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Burning sensation; Discomfort on both legs; Sensible to touch; Pain; Blisters (like varicella or Shingles); Fever; Myalgia; This case was reported by a other health professional via sales rep and described the occurrence of burning sensation in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2015, the patient received Shingrix .5 ml. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced burning sensation, leg discomfort, touch sensitivity increased, pain, blister, fever and myalgia. On an unknown date, the outcome of the burning sensation, leg discomfort, touch sensitivity increased, pain, blister, fever and myalgia were unknown.   The reporter considered the burning sensation, leg discomfort, touch sensitivity increased, pain, blister, fever and myalgia 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 discomfort on both legs, burning sensation, sensible to the touch, pain, blisters, fever and myalgia. The course of treatment was the standard for Shingles. The reporter was very surprised by these side effects.
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Hypoaesthesia
Clinical narrative: Numbness in my finger, toes and now right lower leg; This case was reported by a consumer and described the occurrence of numbness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th June 2019, the patient received the 1st dose of Shingrix. On 27th June 2019, less than a day after receiving Shingrix, the patient experienced numbness. On an unknown date, the outcome of the numbness was unknown.   It was unknown if the reporter considered the numbness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, the physician performed blood test were normal. Since from the day of vaccination, the patient started feeling of numbness in finger, toes and now right lower leg.      Lab Comments: Blood test performed on an unknown date
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Fall, Fatigue, Hypersomnia, Lethargy
Clinical narrative: Midly confused, had trouble comprehending conversation and tracking the newspaper articles; Unusually tired.; Lethargic could scarcely function; Fell; This case was reported by a consumer and described the occurrence of lethargy in a 91-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had 10 years before sever shingles) and shingles (had mild shingles last year). Concurrent medical conditions included blood pressure abnormal, vascular insufficiency and nerve pain (Taking Lyrica ). Concomitant products included pregabalin (Lyrica).   On 30th October 2019, the patient received the 1st dose of Shingrix. On 31st October 2019, 1 days after receiving Shingrix, the patient experienced lethargy and fall. On 1st November 2019, the patient experienced confusion and fatigue. On an unknown date, the outcome of the lethargy, fall, confusion and fatigue were unknown.   It was unknown if the reporter considered the lethargy, fall, confusion and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the late afternoon and experienced no ill effect tiil the reminder day. The next day after vaccination , the patient found herself so lethargic, could scarcely function. The patient took slept in until noon, took a four hour nap during the day. The patient was getting ready for bed felt and in less than twelve hours laterthe next morningshe felt again. The next day, the patient was mildly confused, had trouble comprehending conversation and tracking the newspaper articles, and continued to be unusually tired. The patient was alert and oriented, until was administered vaccine. It took until the third day after the immunization for her return to normal. Due to these side effects, the patient did not took 2nd dose of Shingrix. Till the time of reporting, the patient still recovering from fall and  could not risk another.
Sex: F
Vaccine: FLU4
Symptoms: Breast swelling, Contusion, Pain, Swelling
Clinical narrative: Pain like it was bruised; Pain like it was bruised; Extreme swelling under her right arm and breast area; Extreme swelling under her right arm and breast area; This case was reported by a other health professional via sales rep and described the occurrence of pain in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number ZY975, expiry date unknown) for prophylaxis.   The patient's past medical history included lymph node excision (previously had lymph nodes removed in right arm).   On 25th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On 25th October 2019, 12 hrs after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced pain, contusion, local swelling and breast swelling. The patient was treated with cetirizine hydrochloride (Zyrtec). On an unknown date, the outcome of the pain, contusion, local swelling and breast swelling were unknown.   It was unknown if the reporter considered the pain, contusion, local swelling and breast swelling to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Fluarix quadrivalent 2019-2020 in the right arm. About 12 hours after vaccination, the patient had pain like it was bruised. Within 24 hours after vaccination, the patient had extreme swelling under right arm and breast area. It was engorged and the patient could not get dressed because of it. The patient received 3 doses of Zyrtec over 2 days helped the swelling go down. The reporter consented to follow up.
Sex: F
Vaccine: MENB
Symptoms: Back pain, Dizziness, Local reaction
Clinical narrative: Lightheaded /Dizzy; Back pain; Local symptoms; This case was reported by a physician via sales rep and described the occurrence of light headedness in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced light headedness, back pain and local reaction. On an unknown date, the outcome of the light headedness, back pain and local reaction were recovered/resolved.   It was unknown if the reporter considered the light headedness, back pain and local reaction to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination with dose of Bexsero, the patient complained of lightheaded, dizzy and back pain. The patient went to emergency room and physician gave fluids. The patient also had some local symptoms but not significant. The lightheaded, dizzy and back pain and local reactions resolved in 72 hours. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Redness and swelling with pain to touch a couple of inches below the injection site; Swelling below the injection site; Pain to the touch below the injection site; This case was reported by a consumer and described the occurrence of localized erythema in a elderly 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, several days after receiving Shingrix, the patient experienced localized erythema, local swelling and pain localized. Shingrix was discontinued. On an unknown date, the outcome of the localized erythema, local swelling and pain localized were unknown.   It was unknown if the reporter considered the localized erythema, local swelling and pain localized to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. The patient received shingrix shot and had a reaction a couple of days after. The patient had redness and swelling with pain to touch a couple of inches below the injection site. The reporter gave consent for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Redness and swelling with pain to touch a couple of inches below the injection site; Swelling below the injection site; Pain to the touch below the injection site; This case was reported by a consumer and described the occurrence of localized erythema in a elderly 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, several days after receiving Shingrix, the patient experienced localized erythema, local swelling and pain localized. Shingrix was discontinued. On an unknown date, the outcome of the localized erythema, local swelling and pain localized were unknown.   It was unknown if the reporter considered the localized erythema, local swelling and pain localized to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. The patient received shingrix shot and had a reaction a couple of days after. The patient had redness and swelling with pain to touch a couple of inches below the injection site. The reporter gave consent for follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain lower, Herpes zoster, Incomplete course of vaccination
Clinical narrative: Shingles; Inappropriate Schedule of Vaccine; Pain / lower abdominal pain; This case was reported by a physician via sales rep and described the occurrence of shingles in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 3rd December 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 5th December 2018, 2 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced lower abdominal pain. On an unknown date, the patient experienced shingles and incomplete course of vaccination. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown and the outcome of the lower abdominal pain was not recovered/not resolved.   It was unknown if the reporter considered the shingles and lower abdominal pain to be related to Shingrix.  Additional case details were reported as follows: The patient was treated with valtrex and still had pain. Less than a year after receiving the Shingrix vaccine, the patient had shingles. The patient never came back for the second dose, which led to incomplete course of vaccination. The reporter consent to follow up.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal distension, Abdominal pain upper, Constipation, Malaise
Clinical narrative: Stomach issues / Stomach pain; Lots of blotting; Constipation; Sick; This case was reported by a consumer and described the occurrence of sickness in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th October 2019, the patient received Shingrix. On 30th October 2019, 1 days after receiving Shingrix, the patient experienced sickness. On an unknown date, the patient experienced stomach pain, abdominal bloating and constipation. On an unknown date, the outcome of the sickness was unknown and the outcome of the stomach pain, abdominal bloating and constipation were not recovered/not resolved.   It was unknown if the reporter considered the sickness, stomach pain, abdominal bloating and constipation to be related to Shingrix.  Additional case details were reported as follows: The patient had Shingrix shot 9 days ago from day of reporting and was sick the day after. Less than 2 weeks after vaccination, the patient had stomach issues that never had before. The patient asked could it still be from this vaccine. The patient had lots of blotting and constipation. The patient asked about the gastrointestinal does it last this long 9 days after the vaccine. The reporter requesting consent to follow up.