chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hyperacusis, Influenza like illness, Injection site erythema, Injection site induration
Clinical narrative: I developed flu-like symptoms within 24 hours. I was very tired in general and was overly tired by any exertion, and had significant muscle pain all over. I took 2 200mg ibuprofen (Advil) tablets when the pain would get really bad. This was 2-3 times/day. I was also sensitive to loud noises. The injection site was very painful, swollen, hard, and red. The worst lasted for 2 full days. On day 3 of the reactions, the injection site is still red, warm, painful and somewhat hard. I could not have gone to work (this happened over the weekend).  I had this reaction with both the first and second shot. I had shingles when I was around 44 and was treated with an antiviral.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Myalgia, Vaccine positive rechallenge
Clinical narrative: I developed flu-like symptoms within 24 hours. I was very tired in general and was overly tired by any exertion, and had significant muscle pain all over. I took 2 200mg ibuprofen (Advil) tablets when the pain would get really bad. This was 2-3 times/day. I was also sensitive to loud noises. The injection site was very painful, swollen, hard, and red. The worst lasted for 2 full days. On day 3 of the reactions, the injection site is still red, warm, painful and somewhat hard. I could not have gone to work (this happened over the weekend).  I had this reaction with both the first and second shot. I had shingles when I was around 44 and was treated with an antiviral.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Anxiety, Asthenia, Heart rate increased, Hyperhidrosis, Photophobia
Clinical narrative: Pt felt weak, he was sweating, he felt very anxious and he had a fast heart rate.  Also pt  c/o  "If I open my eyes I'm going to die, Get me out of here and the light bothered his eyes".
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Malaise, Nausea, Pain
Clinical narrative: Flu like symptoms (achy, tired, slight/ brief nausea, general malaise)
Age: 6.0
Sex: F
Vaccine: UNK
Symptoms: Condition aggravated, Cough, Ear pain, Pneumonia, Productive cough
Clinical narrative: Hey so here's the facts.   My 6yo daughter was given first dose of Hep B on a Thursday 12-5   Friday night 12-6 she developed bad asthma cough, Saturday morning coughing a lot. Saturday night she comes down with fever. Sunday 12-8  we head to hospital for asthma treatment. Then sent home. Monday coughing up and vomiting of phlegm. Wednesday 12-11 we see Doctor. Dr says nothing to do with vaccine. doesn't want to file a report. She is given Antibiotics for possible lung infection... pnuemonia.  Two weeks after vaccine, her lungs are clear..shes been well. Then she has ear pains for the First time morning of 12-23 Doctors prescribe Antibiotics for possible ear infection.
Age: 6.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia, Vomiting
Clinical narrative: Hey so here's the facts.   My 6yo daughter was given first dose of Hep B on a Thursday 12-5   Friday night 12-6 she developed bad asthma cough, Saturday morning coughing a lot. Saturday night she comes down with fever. Sunday 12-8  we head to hospital for asthma treatment. Then sent home. Monday coughing up and vomiting of phlegm. Wednesday 12-11 we see Doctor. Dr says nothing to do with vaccine. doesn't want to file a report. She is given Antibiotics for possible lung infection... pnuemonia.  Two weeks after vaccine, her lungs are clear..shes been well. Then she has ear pains for the First time morning of 12-23 Doctors prescribe Antibiotics for possible ear infection.
Age: 0.17
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling. Instructed to apply ice, mom also gave patient Infants Acetaminophen.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Antibody test negative, Measles antibody negative
Clinical narrative: the patient had titers drawn and was negative for varicella and measles immunity; the patient had titers drawn and was negative for varicella and measles immunity; This spontaneous report was received from a nurse prescriber referring to a 15 years old male patient. Information about pertinent medical history, drug reaction/allergy and concomitant medication was unknown.  On 10-MAR-2005, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (1 dosage form; therapy type strength, route of administration, lot# and expiration date were not reported) and the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (1 dosage form; strength, route of administration, lot# and expiration date were not reported) for prophylaxis.  On 27-MAR-2008, the patient was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (1 dosage form; therapy type, strength, route of administration, lot# and expiration date were not reported) for prophylaxis. On 29-APR-2008, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (1 dosage form; strength, route of administration, lot# and expiration date were not reported) for prophylaxis.    On 06-NOV-2019, the patient had titers drawn and showed negative for varicella and measles immunity. The patient sought physician's medical attention and on 30-NOV-2019, the patient's pediatrician administered one dose of PROQUAD to the patient. It was unknown if lab diagnostics was performed or not. The outcome of the events was unknown. The causality between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), varicella virus vaccine live (oka/merck) (VARIVAX) was not provided.
Sex: U
Vaccine: HPV4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 38 week old patient was given the HPV vaccine. Gardasil; Information has been received from a other health professional (nurse manager) via Pfizer referring to a 38 weeks old patient of unknown gender. There were no patient's pertinent medical history, concurrent conditions nor concomitant therapies.  On unknown date, the patient received quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, route, strength, lot# and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age).
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine adminsitered; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On 16-DEC-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (strength, dose, route of administration and anatomical location were unknown) lot # S010727 and expiration date 26-JUL-2020 for prophylaxis (product storage error). It was reported that the vaccine was exposed to a temperature of 48.5 degree Fahrenheit for a time frame of 1 hour. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: injection site pain and warmness; injection site pain and warmness; injection site redness, swelling, itching; injection site swelling; injection site itching; headache; joint aches; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th December 2019, the patient received the 2nd dose of Shingrix. On 9th December 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site itching, headache and joint pain. On 10th December 2019, the patient experienced injection site pain and injection site warmth. On 10th December 2019, the outcome of the joint pain was recovered/resolved. On 11th December 2019, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site itching, injection site pain and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site itching, headache, joint pain, injection site pain and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. After vaccination the patient had injection site redness, itching and swelling and joint aches and a headache and developed injection site pain and warmness. The patient reported that, the injection site reactions have all improved, but are still there. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: injection site pain and warmness; injection site pain and warmness; injection site redness, swelling, itching; injection site swelling; injection site itching; headache; joint aches; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th December 2019, the patient received the 2nd dose of Shingrix. On 9th December 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site itching, headache and joint pain. On 10th December 2019, the patient experienced injection site pain and injection site warmth. On 10th December 2019, the outcome of the joint pain was recovered/resolved. On 11th December 2019, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site itching, injection site pain and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site itching, headache, joint pain, injection site pain and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. After vaccination the patient had injection site redness, itching and swelling and joint aches and a headache and developed injection site pain and warmness. The patient reported that, the injection site reactions have all improved, but are still there. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Injection site pain
Clinical narrative: Headache, chills, body aches, tired, swollen, sore  and blotchy injection site  , night sweats,  ( today is day 3), loss of appetite
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Night sweats, Pain, Rash macular
Clinical narrative: Headache, chills, body aches, tired, swollen, sore  and blotchy injection site  , night sweats,  ( today is day 3), loss of appetite
Age: 0.17
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given Kinrix off label.  The parameters for Kinrix are 4-6 years and the patient was only 2 months old.
Age: 51.0
Sex: F
Vaccine: FLUR4
Symptoms: Full blood count abnormal, Injection site pain, Joint range of motion decreased, Metabolic function test abnormal
Clinical narrative: Complaining of pain in her left upper arm. Having issues with range of motion.  She states that the pain is improved with ibuprofen.  She is without fever, weakness, nausea, vomiting. Patient came into the office on 12/20/19 and was placed in a sling and was prescribed diclofenac sodium (VOTAREN XR) 100 mg 24 tablets and told to take 1 tablet by mouth daily  . Patient ended up in the ER that night. And was prescribed Tramadol 50 mg and told to take 1 tablet by mouth every 8 hours as needed for pain. Spoke with patient today 12/30/19 and she stated that she if feeling a lot better. Pain is gone but still having issues with range of motion.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site mass, Injection site swelling
Clinical narrative: Arm swelled up and got really puffy around the injection site about 4 inches in diameter for 2 to 3 weeks before slowly going down. Her skin is still slightly discolored after the shot, and there is also still a lump about the size of a nickel where the injection was given. She had no systemic effects such as fever or itching.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional adverse effects reported; administered via intramuscular routes; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported. On 14-DEC-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHA), lot # S007811, expiration date 14-MAR-2021 (strength and dose were not provided) and with varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011952, expiration date 16-APR-2021 (strength and dose were not provided); both vaccines were administered via intramuscular route (incorrect route of product administration) for prophylaxis. The vaccines were reconstituted with sterile diluent (lot #S005076, expiration date 05-NOV-2021). No additional adverse effects were reported.
Sex: F
Vaccine: HPV9, UNK
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: no adverse event; vaccine exposure during pregnancy; wrong vaccine administered; This spontaneous report was received from a nurse regarding a 32-year-old female pregnant patient.   The patient's medical history, concurrent conditions and concomitant medications were not provided.   At the time of reporting the patient was pregnant with 38 weeks.           On 12-DEC-2019,  (while the patient was 38 weeks pregnant) the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9)  (lot no S026372, expiration date: 01-APR-2022) (dose, frequency, route of administration, lot#, and expiration date were not provided) for prophylaxis (vaccine exposure during pregnancy). The patient experienced no symptoms. It was verified that product confusion was not a factor in the administration of this dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). The nurse states that "the nurse who administered the dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) had intended to administer Tdap." The HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) which was administered was taken from a shelf where the nurse thought the Tdap was stored (wrong product administered). No further information provided. No adverse event was reported. At the time of the report, the pregnancy outcome was unknown.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: the patient was administered an improperly stored dose of vaqta; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions/allergies were not reported. On 19-DEC-2019, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) with lot number S010727, expiry date 26-JUL-2019 (dose, strength and route of administration were not reported) for prophylaxis (product storage error). The storage temperature was reported as 48.5 degree Fahrenheit in time frame of one hour. There was no previous temperature excursion. There was no product quality complaint (PQC). The outcome of the event was unknown.
Sex: U
Vaccine: TDAP
Symptoms: Bronchitis, Cough, Nasopharyngitis, Secretion discharge
Clinical narrative: Ilness that started as a cold; Bronchitis; Coughing; lots of mucos; This case was reported by a consumer and described the occurrence of cold in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix at an unknown dose. On an unknown date, less than 3 weeks after receiving Boostrix, the patient experienced cold, bronchitis, cough and mucus discharge. On an unknown date, the outcome of the cold and bronchitis were unknown and the outcome of the cough and mucus discharge were not recovered/not resolved.   It was unknown if the reporter considered the cold, bronchitis, cough and mucus discharge to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. Illness that started as a cold or bronchitis. After 2 weeks still coughing and lots of mucus. No further details were provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Some aches; Chills; Tired; This case was reported by a consumer via call center representative and described the occurrence of pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine (received Flu vaccine on an unknown date, not had a reaction to the annual flu shot).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain, chills and tiredness. On an unknown date, the outcome of the pain, chills and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain, chills and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had not had a reaction to the annual flu shot. The patient reported that she had a slight reaction some aches and chills in the evening and tired the next day.. The patient asked she was female if that makes a difference. The case has been linked with case US2019AMR229177, reported by same reporter for same patient.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Chills, Discomfort, Dizziness, Heart rate increased
Clinical narrative: Some aches; Chills; Tired; This case was reported by a consumer via call center representative and described the occurrence of pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine (received Flu vaccine on an unknown date, not had a reaction to the annual flu shot).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain, chills and tiredness. On an unknown date, the outcome of the pain, chills and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain, chills and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had not had a reaction to the annual flu shot. The patient reported that she had a slight reaction some aches and chills in the evening and tired the next day.. The patient asked she was female if that makes a difference. The case has been linked with case US2019AMR229177, reported by same reporter for same patient.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nightmare, Pain
Clinical narrative: Some aches; Chills; Tired; This case was reported by a consumer via call center representative and described the occurrence of pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine (received Flu vaccine on an unknown date, not had a reaction to the annual flu shot).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain, chills and tiredness. On an unknown date, the outcome of the pain, chills and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain, chills and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had not had a reaction to the annual flu shot. The patient reported that she had a slight reaction some aches and chills in the evening and tired the next day.. The patient asked she was female if that makes a difference. The case has been linked with case US2019AMR229177, reported by same reporter for same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Pain in extremity
Clinical narrative: Arm is still very sore; Arm is still very inflammed; This case was reported by a consumer and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced pain in arm and inflammation localized. On an unknown date, the outcome of the pain in arm and inflammation localized were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and inflammation localized to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's parent. The age at vaccination was not reported. The patient had Shingrix vaccination one week ago.  The patient's arm was still very inflamed and sore. Inflammation was about 6 by 4.  The reporter asked if this was normal and what could be done to relieve the inflammation and soreness.
Sex: U
Vaccine: TDAP
Symptoms: Pertussis, Vaccination failure
Clinical narrative: Suspected Vaccination failure; whooping cough; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis.   On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, 3 years after receiving dTpa vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown.   It was unknown if the reporter considered the vaccination failure and whooping cough to be related to dTpa vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got TPAP vaccination and 3 years later had whooping cough.  It was reported that the patient would never do that shot again. This case was considered as suspected vaccination failure, since the details regarding the number of doses and laboratory confirmation for whooping cough were not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Pain, Pain in extremity, Pyrexia
Clinical narrative: experiencing a fever; severe body aches; chills; feels terrible; This case was reported by a consumer and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received Shingrix. In December 2019, less than a day after receiving Shingrix, the patient experienced fever, general body pain, chills and feeling abnormal. On an unknown date, the outcome of the fever, general body pain, chills and feeling abnormal were unknown.   It was unknown if the reporter considered the fever, general body pain, chills and feeling abnormal to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and get a sore arm, fever, severe body aches, and chills.He spent Christmas eve in bed and Christmas day on the couch.He still feels terrible.  The Christmas celebrations are still on hold. It ruined a holiday he looks forward to all year.The reporter asked what kind of healthcare provider pushes this kind of vaccine two days before Christmas and who manufacturers this kind of vaccine.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: redness where I got the shot; Small blisters where I got the short; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 71-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, less than 2 months after receiving Shingrix, the patient experienced injection site erythema and injection site blisters. On an unknown date, the outcome of the injection site erythema and injection site blisters were unknown.   It was unknown if the reporter considered the injection site erythema and injection site blisters to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had redness and small blisters where got the shot. The patient asked would this go in several days. The patient just had SHINGRIX vaccination and know to wait 2 months until get my 2nd vaccination. The patient was more likely to get shingles during this 2 month waiting period.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site discomfort, Injection site pain
Clinical narrative: injection site pain; crummy/unpleasant; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 4M2C7, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in 3rd week of June 2019 and experienced pain in arm).   On 10th December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 10th December 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, injection site pain and discomfort. On an unknown date, the outcome of the influenza-like symptoms and injection site pain were resolved with sequelae and the outcome of the discomfort was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, injection site pain and discomfort to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's wife. The reporter stated that the patient had crummy unpleasant after effects or symptoms. The patient experienced flu like symptoms for 3 days. The patient was in bed Wednesday night by 9 pm and per the reporter he was a big crank head. The patient also experienced arm pain at the injection site. The reporter consented to follow up.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: Diarrhea; fatigue; her stomach is churning/nausea; abdominal pain; upset stomach; can't keep any food down; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 8th December 2019, 3 days after receiving Shingrix, the patient experienced diarrhea, fatigue, churning of stomach, abdominal pain, upset stomach and appetite lost. The patient was treated with loperamide hydrochloride (Imodium). On an unknown date, the outcome of the diarrhea was not recovered/not resolved and the outcome of the fatigue, churning of stomach, abdominal pain, upset stomach and appetite lost were unknown.   It was unknown if the reporter considered the diarrhea, fatigue, churning of stomach, abdominal pain, upset stomach and appetite lost to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and she stayed in bed for 3 days sleeping round the clock.  The patient had diarrhea in which her stomach was churning and she can hear it making noises. She reported that the last two days that she woke up at 4am and had diarrhea till 6 am. The caller stated that she did call her doctor and her doctor recommended she take Immodium.  She states she was not sure which Immodium to take.No additional information was given.Advised caller to follow up with her health care professional or pharmacist.  The reporter consented to follow up.The caller was questioning symptoms occurring after receiving Shingrix the reporter wanted to know if these symptoms can be from the shot symptoms included diarrhea, upset stomach, and fatigue.  The caller stated that she stays in bed and can't keep any food down. The reporter did not consent to follow up. The caller had mentioned that she also had nausea and abdominal pain when going through the side effects listed in the clinical trials. She initially reported fatigue and diarrhea but then mentioned the other two events later in the call when discussing side effect information in prescribing information.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersomnia, Nausea
Clinical narrative: Diarrhea; fatigue; her stomach is churning/nausea; abdominal pain; upset stomach; can't keep any food down; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 8th December 2019, 3 days after receiving Shingrix, the patient experienced diarrhea, fatigue, churning of stomach, abdominal pain, upset stomach and appetite lost. The patient was treated with loperamide hydrochloride (Imodium). On an unknown date, the outcome of the diarrhea was not recovered/not resolved and the outcome of the fatigue, churning of stomach, abdominal pain, upset stomach and appetite lost were unknown.   It was unknown if the reporter considered the diarrhea, fatigue, churning of stomach, abdominal pain, upset stomach and appetite lost to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and she stayed in bed for 3 days sleeping round the clock.  The patient had diarrhea in which her stomach was churning and she can hear it making noises. She reported that the last two days that she woke up at 4am and had diarrhea till 6 am. The caller stated that she did call her doctor and her doctor recommended she take Immodium.  She states she was not sure which Immodium to take.No additional information was given.Advised caller to follow up with her health care professional or pharmacist.  The reporter consented to follow up.The caller was questioning symptoms occurring after receiving Shingrix the reporter wanted to know if these symptoms can be from the shot symptoms included diarrhea, upset stomach, and fatigue.  The caller stated that she stays in bed and can't keep any food down. The reporter did not consent to follow up. The caller had mentioned that she also had nausea and abdominal pain when going through the side effects listed in the clinical trials. She initially reported fatigue and diarrhea but then mentioned the other two events later in the call when discussing side effect information in prescribing information.
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Injection site pain, Musculoskeletal pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: shoulder pain radiating to chest; arm and shoulder pain which radiates from the injection site; arm and shoulder pain which radiates from the injection site; arm and shoulder pain which radiates; Vaccine Administered at Inappropriate Site; This case was reported by a consumer via call center representative and described the occurrence of chest pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chest pain, pain in arm, shoulder pain, injection site pain and vaccine administered at inappropriate site. The patient was treated with ambiguous medication nos (Cortisone (Nos)). On an unknown date, the outcome of the chest pain, pain in arm, shoulder pain and vaccine administered at inappropriate site were unknown and the outcome of the injection site pain was recovering/resolving.   It was unknown if the reporter considered the chest pain, pain in arm, shoulder pain and injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. The reporter reported that, after vaccination with dose of Shingrix had arm and shoulder pain which radiates from the injection site. The symptoms have only slightly improved. The reporter stated that, the injection site was very high on the upper right arm and may have gone into the shoulder bursa sac, which led to vaccine administered at inappropriate site. The patient consulted with an orthopedic specialist and a cortisone injection was given in the shoulder. The  reporter consented to follow up. This case has been linked with case US2019229382, reported by same reporter.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site swelling
Clinical narrative: swelling of right leg; This case was reported by a nurse via call center representative and described the occurrence of swelling of legs in a 3-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced swelling of legs. On an unknown date, the outcome of the swelling of legs was unknown.   It was unknown if the reporter considered the swelling of legs to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The batch number was not reported. The patient received an unspecified flu vaccine this year and experienced swelling of his right leg. The reporter consented to follow up. The vaccine was given at a different clinic.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Itchy red dots near injection site; red dots; This case was reported by a nurse via call center representative and described the occurrence of itchy rash in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2019, the patient received the 2nd dose of Shingrix. On 9th November 2019, less than a day after receiving Shingrix, the patient experienced itchy rash and red rash. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the itchy rash was not recovered/not resolved and the outcome of the red rash was unknown.   It was unknown if the reporter considered the itchy rash and red rash to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had itchy, red dots near the injection site. The patient has attempted to treat the symptoms at home with ice and movement, but symptoms are ongoing. The reporter consented to follow up. The batch number and additional details not available at the time of this call, but nurse consents to follow up from safety.
Age: 68.0
Sex: M
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 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th December 2019, the patient received Shingrix. On 9th December 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was resolved with sequelae.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received vaccination in right deltoid. The patient had injection site pain for 4 days. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests abnormal, Deafness bilateral, Ear infection, Middle ear effusion, Tinnitus
Clinical narrative: Hearing Loss in both ears/ almost complete hearing loss in left ear; Ear Infection; Fluid Behind Ear Drum; Tinnuitis; This case was reported by a consumer via call center representative and described the occurrence of hearing loss bilateral in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received in 2017, was of other manufacturer's).   On 7th October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, less than 2 weeks after receiving Shingrix, the patient experienced hearing loss bilateral (serious criteria GSK medically significant), ear infection, fluid in middle ear and tinnitus. On an unknown date, the outcome of the hearing loss bilateral and tinnitus were not recovered/not resolved and the outcome of the ear infection and fluid in middle ear were resolved with sequelae.   It was unknown if the reporter considered the hearing loss bilateral, ear infection, fluid in middle ear and tinnitus to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in her left arm. Within 2 weeks of vaccination, the patient developed an ear infection and fluid behind ear drum which was resolved. The patient stated, this resulted in hearing loss in both ears and almost complete hearing loss in left ear. The patient's hearing test was done by an audiologist and noted unusual patterns of hearing loss with 40 percent in left ear and 30 percent in right ear. The hearing loss persisted up until approximately 2 weeks before the reporting date but she stated hearing loss in her left ear and tinnitus would never return to baseline. The patient consented to follow up and provided her physician's details.      Lab Comments: Noted unusual patterns of hearing loss with 40% in left ear and 30% in right ear.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Fever; body aches; feeling of sickness; This case was reported by a other health professional via call center representative and described the occurrence of fever 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 fever, general body pain and feeling unwell. On an unknown date, the outcome of the fever, general body pain and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the fever, general body pain and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not provided. The age group was not reported but was selected as adult as per vaccine indication.  The patient received dose of Shingrix and experienced fever of 101 degrees Fahrenheit, fever, body aches, and overall feeling of sickness for several days. The follow up consent was not granted.      Lab Comments: lab test performed on unknown date.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Muscle contractions involuntary, Pain in extremity
Clinical narrative: Pain in arm immediately and has continued in her shoulder, her hand curled up and she couldn't straighten fingers for 20 minutes after 2 weeks, but that has resolved now, she thought she was having a stroke, now only experiencing pain at the injection site area
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: approximately 9 hours after injection some tenderness at injection site.  I took one Advil at this time. This was followed by chills, headache, general muscle soreness, exhaustion.  Symptoms persisted through the night and during the day of 12/29/2019.  I took one Advil, twice during the day.  Also stomach ache. I spent until 2:30pm in bed sleeping.   I did not eat anything until 7:30 pm.  I did not take my normal morning medications.  I took one Advil at bedtime. I did not call my physician or go to any emergency site.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersomnia, Injection site pain, Myalgia
Clinical narrative: approximately 9 hours after injection some tenderness at injection site.  I took one Advil at this time. This was followed by chills, headache, general muscle soreness, exhaustion.  Symptoms persisted through the night and during the day of 12/29/2019.  I took one Advil, twice during the day.  Also stomach ache. I spent until 2:30pm in bed sleeping.   I did not eat anything until 7:30 pm.  I did not take my normal morning medications.  I took one Advil at bedtime. I did not call my physician or go to any emergency site.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Arthritis, Asthenia, Back pain, Blood test
Clinical narrative: Symptoms -chest pain (it feels like something sharp is stabbing me from the inside but also as though there is a heavyweight placed on my chest; my entire chest but focused mostly on the center of my chest and sometimes on the left or throughout my entire chest; pain does not go away) -throbbing headaches (usually on the top of my head or like everywhere), sometimes feels like my brain is loose and bouncing or as though it's a bomb about to explode -abdominal pain (sharp and sometimes throbbing pain; usually only on the upper left side, sometimes also on the right side as well) -back pain (aching) -joint pain and inflammation (usually ankles, knees, and fingers) -overall full-body pain (aching) -left arm feeling heavy and painful sometimes -random aching jaw pain -random shortness of breath and difficulty breathing -rapid heartbeat/palpitations (sinus tachycardia) -random fluttering in the chest and abdomen & sometimes feels like my heart is dropping -chronic fatigue & weakness -dizziness/lightheadedness -nausea & loss of appetite -blurred vision -sensitivity to light and loud noise -trouble processing what is happening, focusing (easily distracted), and brain fog -cramping, numbness, and tingling of hands & feet (sometimes shaky) -insomnia and sometimes night sweats -random hot flashes and cold sweats -collapsing -nearly fainting & fainting (about 30 seconds to 10-15 minutes, depends)  Diagnosis -mitral valve prolapse -hyperprolactinemia -nonepileptic seizures/syncope, unspecified type -sinus tachycardia  -polyarthralgia -conversion disorder -temporomandibular joint disorder -sicca, unspecified type (HCC) -mild concussion from fainting (July 2019) - cleared  Medicine -Metoprolol Tartrate (12.5mg twice a day, more as needed) -vestibular rehabilitation (August 2019-present)
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Cardiac flutter, Cardiac stress test, Chest X-ray, Chest pain, Cognitive disorder
Clinical narrative: Symptoms -chest pain (it feels like something sharp is stabbing me from the inside but also as though there is a heavyweight placed on my chest; my entire chest but focused mostly on the center of my chest and sometimes on the left or throughout my entire chest; pain does not go away) -throbbing headaches (usually on the top of my head or like everywhere), sometimes feels like my brain is loose and bouncing or as though it's a bomb about to explode -abdominal pain (sharp and sometimes throbbing pain; usually only on the upper left side, sometimes also on the right side as well) -back pain (aching) -joint pain and inflammation (usually ankles, knees, and fingers) -overall full-body pain (aching) -left arm feeling heavy and painful sometimes -random aching jaw pain -random shortness of breath and difficulty breathing -rapid heartbeat/palpitations (sinus tachycardia) -random fluttering in the chest and abdomen & sometimes feels like my heart is dropping -chronic fatigue & weakness -dizziness/lightheadedness -nausea & loss of appetite -blurred vision -sensitivity to light and loud noise -trouble processing what is happening, focusing (easily distracted), and brain fog -cramping, numbness, and tingling of hands & feet (sometimes shaky) -insomnia and sometimes night sweats -random hot flashes and cold sweats -collapsing -nearly fainting & fainting (about 30 seconds to 10-15 minutes, depends)  Diagnosis -mitral valve prolapse -hyperprolactinemia -nonepileptic seizures/syncope, unspecified type -sinus tachycardia  -polyarthralgia -conversion disorder -temporomandibular joint disorder -sicca, unspecified type (HCC) -mild concussion from fainting (July 2019) - cleared  Medicine -Metoprolol Tartrate (12.5mg twice a day, more as needed) -vestibular rehabilitation (August 2019-present)
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Cold sweat, Computerised tomogram, Concussion, Conversion disorder, Decreased appetite
Clinical narrative: Symptoms -chest pain (it feels like something sharp is stabbing me from the inside but also as though there is a heavyweight placed on my chest; my entire chest but focused mostly on the center of my chest and sometimes on the left or throughout my entire chest; pain does not go away) -throbbing headaches (usually on the top of my head or like everywhere), sometimes feels like my brain is loose and bouncing or as though it's a bomb about to explode -abdominal pain (sharp and sometimes throbbing pain; usually only on the upper left side, sometimes also on the right side as well) -back pain (aching) -joint pain and inflammation (usually ankles, knees, and fingers) -overall full-body pain (aching) -left arm feeling heavy and painful sometimes -random aching jaw pain -random shortness of breath and difficulty breathing -rapid heartbeat/palpitations (sinus tachycardia) -random fluttering in the chest and abdomen & sometimes feels like my heart is dropping -chronic fatigue & weakness -dizziness/lightheadedness -nausea & loss of appetite -blurred vision -sensitivity to light and loud noise -trouble processing what is happening, focusing (easily distracted), and brain fog -cramping, numbness, and tingling of hands & feet (sometimes shaky) -insomnia and sometimes night sweats -random hot flashes and cold sweats -collapsing -nearly fainting & fainting (about 30 seconds to 10-15 minutes, depends)  Diagnosis -mitral valve prolapse -hyperprolactinemia -nonepileptic seizures/syncope, unspecified type -sinus tachycardia  -polyarthralgia -conversion disorder -temporomandibular joint disorder -sicca, unspecified type (HCC) -mild concussion from fainting (July 2019) - cleared  Medicine -Metoprolol Tartrate (12.5mg twice a day, more as needed) -vestibular rehabilitation (August 2019-present)