chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Claustrophobia, Dizziness, Dry mouth, Erythema
Clinical narrative: At first getting up in the morning, I immediately felt light-headed and things were closing in. I called my husband to tell him I was feeling dizzy. By the time I got to the toilet I was feeling nauseated and very dry mouth. I peed and was making my way back to bed with my husband's assistance, my legs got very weak and I collapsed to the floor on my butt.  My husband had his arm around my back and was supporting me while I was sitting on the floor.  He said about 10 seconds after I went down my eyes rolled back, I gasped and lost consciousness.  I was out for about 30 seconds before I came out of it. My husband helped me to bed where I stayed until 1:00 p.m. I slept most of the time. I had all the other adverse reactions listed: pain, redness, myalgia, fatigue, headache, shivering.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fall, Fatigue, Gaze palsy, Headache, Hypersomnia
Clinical narrative: At first getting up in the morning, I immediately felt light-headed and things were closing in. I called my husband to tell him I was feeling dizzy. By the time I got to the toilet I was feeling nauseated and very dry mouth. I peed and was making my way back to bed with my husband's assistance, my legs got very weak and I collapsed to the floor on my butt.  My husband had his arm around my back and was supporting me while I was sitting on the floor.  He said about 10 seconds after I went down my eyes rolled back, I gasped and lost consciousness.  I was out for about 30 seconds before I came out of it. My husband helped me to bed where I stayed until 1:00 p.m. I slept most of the time. I had all the other adverse reactions listed: pain, redness, myalgia, fatigue, headache, shivering.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of consciousness, Muscular weakness, Myalgia, Nausea, Pain
Clinical narrative: At first getting up in the morning, I immediately felt light-headed and things were closing in. I called my husband to tell him I was feeling dizzy. By the time I got to the toilet I was feeling nauseated and very dry mouth. I peed and was making my way back to bed with my husband's assistance, my legs got very weak and I collapsed to the floor on my butt.  My husband had his arm around my back and was supporting me while I was sitting on the floor.  He said about 10 seconds after I went down my eyes rolled back, I gasped and lost consciousness.  I was out for about 30 seconds before I came out of it. My husband helped me to bed where I stayed until 1:00 p.m. I slept most of the time. I had all the other adverse reactions listed: pain, redness, myalgia, fatigue, headache, shivering.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Circulatory collapse, Dizziness, Dyspnoea, Erythema
Clinical narrative: At first getting up in the morning, I immediately felt light-headed and things were closing in. I called my husband to tell him I was feeling dizzy. By the time I got to the toilet I was feeling nauseated and very dry mouth. I peed and was making my way back to bed with my husband's assistance, my legs got very weak and I collapsed to the floor on my butt.  My husband had his arm around my back and was supporting me while I was sitting on the floor.  He said about 10 seconds after I went down my eyes rolled back, I gasped and lost consciousness.  I was out for about 30 seconds before I came out of it. My husband helped me to bed where I stayed until 1:00 p.m. I slept most of the time. I had all the other adverse reactions listed: pain, redness, myalgia, fatigue, headache, shivering.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Gait disturbance, Headache, Hypersomnia, Loss of consciousness
Clinical narrative: At first getting up in the morning, I immediately felt light-headed and things were closing in. I called my husband to tell him I was feeling dizzy. By the time I got to the toilet I was feeling nauseated and very dry mouth. I peed and was making my way back to bed with my husband's assistance, my legs got very weak and I collapsed to the floor on my butt.  My husband had his arm around my back and was supporting me while I was sitting on the floor.  He said about 10 seconds after I went down my eyes rolled back, I gasped and lost consciousness.  I was out for about 30 seconds before I came out of it. My husband helped me to bed where I stayed until 1:00 p.m. I slept most of the time. I had all the other adverse reactions listed: pain, redness, myalgia, fatigue, headache, shivering.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Muscular weakness, Myalgia, Pain
Clinical narrative: At first getting up in the morning, I immediately felt light-headed and things were closing in. I called my husband to tell him I was feeling dizzy. By the time I got to the toilet I was feeling nauseated and very dry mouth. I peed and was making my way back to bed with my husband's assistance, my legs got very weak and I collapsed to the floor on my butt.  My husband had his arm around my back and was supporting me while I was sitting on the floor.  He said about 10 seconds after I went down my eyes rolled back, I gasped and lost consciousness.  I was out for about 30 seconds before I came out of it. My husband helped me to bed where I stayed until 1:00 p.m. I slept most of the time. I had all the other adverse reactions listed: pain, redness, myalgia, fatigue, headache, shivering.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: -Mild fever -Decreased appetite -Runny nose -Rash on torso and face Onset Friday, May 10, stabilized Sunday, May 12.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine, Induration, Limb mass, Pyrexia, Rash
Clinical narrative: Patient received vaccine on 5/9/19. She arrived at office on 5/14/19, reporting allergy to vaccine. (L) arm red rash, warm, lump hard to touch. Patient reports fever on 5/10/19. Applied cool compress and APAP w/no relief. PCP (Dr.) evaluated patient. Advised to take Benadryl and call office back in 3days.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Patient received vaccine on 5/9/19. She arrived at office on 5/14/19, reporting allergy to vaccine. (L) arm red rash, warm, lump hard to touch. Patient reports fever on 5/10/19. Applied cool compress and APAP w/no relief. PCP (Dr.) evaluated patient. Advised to take Benadryl and call office back in 3days.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; patients were administered one dose each of improperly stored Rotateq; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 27-MAR-2019, the patient was vaccinated with one dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R016790, expiration date: 20-APR-2020 (also reported as 04-APR-2019) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of above 9 degrees Celsius (8.5 degrees Celsius) for 7 hours 1 minute. The digital data logger was involved in recording the temperature excursion details. Previous excursions were reported as above 9 degrees Celsius (9.6 degrees Celsius) for 33 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA008857:
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No symptoms; got the GARDASIL shot in April 2015 and received the 2nd dose of GARDASIL in January of 2016 and the 3rd dose in March of 2016"; This spontaneous report as received from a physician via a company representative refers to a patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in April 2015, the 14-year-old patient was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. The patient received a second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) on an unknown date in January 2016. On an unknown date in March 2016, the patient was vaccinated with a third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). There were no symptoms reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA005894:
Sex: F
Vaccine: VARZOS
Symptoms: Hypoacusis, Injection site rash, Oral herpes
Clinical narrative: Was experiencing cold sores; Her hearing had gone to 50% level in both ears.; The reporter stated that the patient developed an injection site rash.; This spontaneous report was received from  the patient's husband referring to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.     In 2013, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) VIAL 19400 PFU (strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis, reconstituted with sterile diluyent.        On an unknown date, the patient experienced an injection site rash, cold sores(oral herpes), and her hearing had gone to 50% level in both ears (hypoacusis), and due to this event she visited the audiologist, and the patient received treatment due to the events.  At the time of the report, the outcome of oral herpes, injection site rash and hypoacusis was reported as not resolved. The reporter did not mention the causality assessement between the events and zoster vaccine live(ZOSTAVAX) vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Injection site pain; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she experienced pain at the injection site for one week with her first dose of Shingrix. The patient stated that the pain resolved and did not limit her activity. The patient did not experience this with the second dose. The reporter did not agree to follow from GlaxoSmithKline.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Liver function test increased
Clinical narrative: High levels of liver function test; This case was reported by a pharmacist via call center representative and described the occurrence of liver function test increased in a 88-year-old male patient who received Herpes zoster (Shingrix) (batch number 99D9F, expiry date 14th April 2020) for prophylaxis.   On 26th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In May 2019, less than a month after receiving Shingrix, the patient experienced liver function test increased. On an unknown date, the outcome of the liver function test increased was unknown.   It was unknown if the reporter considered the liver function test increased to be related to Shingrix.  Additional details were provided as follows: The pharmacist stated that the patient received the 1st dose of Shingrix vaccine on right deltoid. About 1 week later patient had blood work done and the results showed high levels of liver function test. No further details were provided at time of reporting.
Age: 81.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Limb discomfort
Clinical narrative: Patient still has a sore arm from the vaccines administered two months ago on 3/13/19. Both vaccines were administered in the same arm about 1 inch apart. She has iced her arm many times and has seen her chiropractor for muscle soreness. The second dose of Shingrix was administered in her other arm today. I encouraged her to massage the arm several times throughout the day to try to prevent the extended soreness this time.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Eyelid ptosis
Clinical narrative: The morning after the hepatitis B vaccine my baby woke up with left eyelid ptosis.  It resolved throughout the day.  Then the following morning, my baby awoke with right eyelid ptosis.  This too slowly resolved throughout the day.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Painful site reaction with redness and swelling; systemic reaction including chills and low fever; headache.
Age: 53.0
Sex: F
Vaccine: HEP, PPV, VARZOS
Symptoms: Initial insomnia, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Pain
Clinical narrative: PATIENT CAME TO PHARMACY AND REPORTED EXPERIENCING EXTREME ARM PAIN AFTER GETTING SHINGRIX INJECTION ON 3/13/2019 FOR ABOUT 3 DAYS. SHE SAID SHE HAS CONTINUED TO HAVE TROUBLE LIFTING ARM AND HAS CONTINUED TO HAVE SHOOTING PAINS IN SHOULDER, ABOUT INJECTION SITE AND UNDER ARM FOR APPROXIMATELY 6 WEEKS. THERE WAS NO VISUAL REDNESS, SWELLING OR WARMTH TO TOUCH ABOUT THE INJECTION SITE. THE PATIENT REPORTED USING A SLING AT TIMES AND TROUBLE SLEEPING WITH THE PAIN THE PATIENT REPORTED USING IBUPROFEN AND HOT AND COLD PACKS. WE RECOMMENDED THAT THE PATIENT SEE A HEALTH CARE PROVIDER FOR FOLLOW UP AND RECOMMENDED OTC ACETAMINOPHEN AND LIDOCAINE PRODUCTS TO ASSIST WITH PAIN MANAGEMENT. WE ASKED THE PATIENT TO CONTACT THE PHARMACY FOR FOLLOW UP AFTER SEEING HER HEATHCARE PROVIDER
Age: 53.0
Sex: F
Vaccine: HEP, PPV, VARZOS
Symptoms: Pain in extremity
Clinical narrative: PATIENT CAME TO PHARMACY AND REPORTED EXPERIENCING EXTREME ARM PAIN AFTER GETTING SHINGRIX INJECTION ON 3/13/2019 FOR ABOUT 3 DAYS. SHE SAID SHE HAS CONTINUED TO HAVE TROUBLE LIFTING ARM AND HAS CONTINUED TO HAVE SHOOTING PAINS IN SHOULDER, ABOUT INJECTION SITE AND UNDER ARM FOR APPROXIMATELY 6 WEEKS. THERE WAS NO VISUAL REDNESS, SWELLING OR WARMTH TO TOUCH ABOUT THE INJECTION SITE. THE PATIENT REPORTED USING A SLING AT TIMES AND TROUBLE SLEEPING WITH THE PAIN THE PATIENT REPORTED USING IBUPROFEN AND HOT AND COLD PACKS. WE RECOMMENDED THAT THE PATIENT SEE A HEALTH CARE PROVIDER FOR FOLLOW UP AND RECOMMENDED OTC ACETAMINOPHEN AND LIDOCAINE PRODUCTS TO ASSIST WITH PAIN MANAGEMENT. WE ASKED THE PATIENT TO CONTACT THE PHARMACY FOR FOLLOW UP AFTER SEEING HER HEATHCARE PROVIDER
Age: 0.17
Sex: M
Vaccine: HEP, MMR, RV1, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood test, Dehydration, Diarrhoea, Vomiting
Clinical narrative: SEVERE DIARRHEA AND VOMITING X 7 DAYS AND HASN'T STOPPED. HAD TO BE HOSPITALIZED FOR DEHYDRATION AND THEN AGAIN SEEN IN THE ER FOR DEHYDRATION.
Age: 0.17
Sex: M
Vaccine: HEP, MMR, RV1, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea
Clinical narrative: SEVERE DIARRHEA AND VOMITING X 7 DAYS AND HASN'T STOPPED. HAD TO BE HOSPITALIZED FOR DEHYDRATION AND THEN AGAIN SEEN IN THE ER FOR DEHYDRATION.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Patient presented to hospital clinic with c/o redness warmth tenderness measuring 8cm. Instructions to ice, Motrin, Preparation H applied to site and monitor
Age: 1.92
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Autism spectrum disorder, Head banging, Language disorder, Stereotypy, Toe walking
Clinical narrative: Started banging his head, toe walking, stimming, no adult connection, loss of language. Diagnosed with autism. Began a successful detox treatment to release the vaccine caused toxins from his body.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; Intramuscular Injection; the possibility of one separate dose of an improperly stored vaccine,VARIVAX, was administered to one patient; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-APR-2019, the patient was vaccinated with one dose of possibly improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) intramuscularly for prophylaxis (lot number R017768, 21-JUN-2020) (formulation and dose were not reported). No adverse effect was reported. The nurse reported the sterile diluent used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was stored in the correct temperature storage range. The temperature, time frame of excursion and previous excursion were unknown. The call was not because of data logger.
Sex: F
Vaccine: MMR
Symptoms: Erythema, Pyrexia, Rash, Swelling face
Clinical narrative: redness and swelling in the face; rash along her side; redness and swelling in the face; fever; This spontaneous report as received from a physician via a company representative, refers to a 21 month old female patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.     On an unknown date, the patient received only her first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, lot# and expiration date  were not provided). On approximately 25-APR-2019 (reported as 4 to 5 days ago), the patient experienced a rash along her side, redness and swelling in the face, and a fever. The patient was brought to the clinic. No treatment was given for the events. The outcome of erythema, pyrexia, swelling face and rash was reported as not recovered/not resolved. Causality assessment was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; The patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date since 22-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R017768, expiration date: 21-JUN-2020 (dose, frequency and anatomical location were not provided), administered subcutaneously as prophylaxis. The vaccine underwent a temperature excursion from -9 Celsius degrees (°C) to 8°C (-7.4C) during a time frame of 55 minutes as recorded by digital data logger. No previous temperature excursion was reported as well as no adverse effects. The sterile diluent used to reconstitute the vaccine (lot # S000130, expiration date: 21-JUN-2020) was properly stored.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-1905USA005506: US-009507513-1905USA005505: US-009507513-1905USA005488: US-009507513-1905USA005507: US-009507513-1905USA005503:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse effects; The patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date since 22-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R017768, expiration date: 21-JUN-2020 (dose, frequency and anatomical location were not provided), administered subcutaneously as prophylaxis. The vaccine underwent a temperature excursion from -9 Celsius degrees (°C) to 8°C (-7.4C) during a time frame of 55 minutes as recorded by digital data logger. No previous temperature excursion was reported as well as no adverse effects. The sterile diluent used to reconstitute the vaccine (lot # S000130, expiration date: 21-JUN-2020) was properly stored.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-1905USA005506: US-009507513-1905USA005488: US-009507513-1905USA005504: US-009507513-1905USA005507: US-009507513-1905USA005503:
Sex: U
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Herpes zoster
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of autoimmune disorder in a adult patient who received SHINGRIX for prophylaxis. The patient had a Family History of autoimmune disorder (it was runs in patient's family and might be unrelated). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 91 days after receiving SHINGRIX, the patient experienced autoimmune disorder (serious criteria GSK medically significant) and herpes zoster. On an unknown date, the outcome of the autoimmune disorder and herpes zoster were unknown. It was unknown if the reporter considered the autoimmune disorder and herpes zoster to be related to SHINGRIX. Additional details were provided as follows: The patient was a nurse. The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient got zoster within a week of vaccination. Three months after vaccination, the patient developed an autoimmune condition. The patient was also reported that to VAERS. This case has been linked with case US2019AMR084173 and US2018GSK096361, reported by the same reporter.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity, Rash, Rash erythematous
Clinical narrative: Red rash; Sore arm; not able to use the arm; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, 2 days after receiving Shingrix, the patient experienced red rash, pain in arm and mobility decreased. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the red rash, pain in arm and mobility decreased were unknown.   It was unknown if the reporter considered the red rash, pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: At 4 PM, the patient received Shingrix vaccine and at night of vaccination she experienced a sore arm, and she was not able to use the arm. In the morning of reporting day, 2 days after vaccination, she woke up with a red rash on her torso which was going to her neck. She took Benadryl at the time of reporting. The soreness was still present at the time of reporting. The reporter consented to follow up.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Injection site erythema
Clinical narrative: redness at injection site; shivering; sweating; This case was reported by a consumer via call center representative and described the occurrence of sweating in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Zostavax and Shingrix (1st dose received in January 2019).   On 29th April 2019, the patient received the 2nd dose of Shingrix. On 30th April 2019, 1 days after receiving Shingrix, the patient experienced sweating. On 1st May 2019, the patient experienced shivering. On an unknown date, the patient experienced injection site erythema. On 5th May 2019, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the sweating was not recovered/not resolved and the outcome of the injection site erythema was unknown.   The reporter considered the sweating and shivering to be related to Shingrix. It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: In January 2019, the patient had his first Shingrix shot and did not have any side effects from that shot. The patient had 2nd shot was administered. The next day patient started to experience severe sweating. The next night he awoke during the night experiencing both shivering and sweating. It had continued each night since then. Last night, he experienced only the sweating which does not seem to be improving. However he did not experience the shivering last night. On an unknown date, less than a week after receiving Shingrix, the patient had redness at the injection site. The patient had continued with his normal activities during the day. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Fatigue, Influenza like illness, Nausea
Clinical narrative: flu-like symptoms; left arm soreness; nausea; dizziness; tiredness; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st May 2019, the patient received Shingrix (intramuscular). On 1st May 2019, several hours after receiving Shingrix, the patient experienced influenza-like symptoms, pain in arm, nausea, dizziness, tiredness and upset stomach. On an unknown date, the outcome of the influenza-like symptoms, pain in arm, nausea, tiredness and upset stomach were recovered/resolved and the outcome of the dizziness was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain in arm, nausea, dizziness, tiredness and upset stomach to be related to Shingrix.  Additional case details were provided as follows: In the afternoon, the patient receive the dose of Shingrix vaccine in the left arm and in the evening, the patient started experiencing adverse events flu-like symptoms, left arm soreness, nausea, tiredness, upset stomach, and dizziness. All the adverse events resolved except for the dizziness which the patient continues to experience.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: flu-like symptoms; left arm soreness; nausea; dizziness; tiredness; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st May 2019, the patient received Shingrix (intramuscular). On 1st May 2019, several hours after receiving Shingrix, the patient experienced influenza-like symptoms, pain in arm, nausea, dizziness, tiredness and upset stomach. On an unknown date, the outcome of the influenza-like symptoms, pain in arm, nausea, tiredness and upset stomach were recovered/resolved and the outcome of the dizziness was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain in arm, nausea, dizziness, tiredness and upset stomach to be related to Shingrix.  Additional case details were provided as follows: In the afternoon, the patient receive the dose of Shingrix vaccine in the left arm and in the evening, the patient started experiencing adverse events flu-like symptoms, left arm soreness, nausea, tiredness, upset stomach, and dizziness. All the adverse events resolved except for the dizziness which the patient continues to experience.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: minor fever; Inappropriate Age at Vaccine Administration; overdose; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 19-month-old female patient who received HAV (Havrix adult) (batch number 37RY4, expiry date 6th March 2021) for prophylaxis.  On 22nd March 2019, the patient received Havrix adult. On 22nd March 2019, unknown after receiving Havrix adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.  Additional details were provided as follows: The medical assistant gave adult dose of Havrix to an infant patient, which led to inappropriate age at vaccine administration and overdose. The vaccine coordinator reported that he did not have the information and that the medical assistant would need to provide it. No additional details were provided.   Follow up information received from other health professional on 30th April 2019: The patient's demographic details were updated. The patient received the 1st dose of Havrix adult intramuscularly and less than a year after experienced minor fever. The reporter grabbed adult dose Vs. pediatric dose, container were labelled correctly in fridge. The medical assistant just took wrong vaccine. The patient's parent were contacted.  The reporter reported that the patient was doing fine with a minor fever. It was unknown if the reporter considered the fever to be related to Havrix adult. The VAERS details were updated. This was a medication error with harm.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pain, Swelling
Clinical narrative: Extreme pain and swelling
Age: 72.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Skin/ body rash. Patient is not getting better. On antibacterial soap and avoiding  fragrances in detergents.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Impaired healing, Scab
Clinical narrative: Patient Received the Shingrix vaccine in his left deltoid on 3/13/19. Two weeks later he developed a quarter-dollar sized blister on the top of his right thigh that had a burning sensation. ARNP saw the blister on 4/4/19. When I spoke to patient early May 2019, he said the blister had scabbed over but was still not healed. He saw another ARNP on 5/7/19 and it still had a painful burning sensation. ARNP recommends not receiving the second vaccine.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Dysstasia, Fall, Nocturia
Clinical narrative: No symptoms.  I just stood up and walked across the room, I didn't know what was going on.  No Warning.  Then I crumbled up against the kitchen table chair.  I than fell to the floor and could not get up myself.  I was in no pain.  I was awake at all time.  I stayed on the floor until my daughter arrived home from the grocery store a half hour later.  I did not feel I needed to go to the Dr.    Later that night while trying to sleep I had to go to the bathroom and urinate about 3 time during the night.    I
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effects; a 6 month old patient received the first dose of ROTATEQ; This spontaneous report was received from a licensed practical nurse and refers to a 6 month old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 09-MAY-2019 (in the age of 6 months), the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact dose, lot # and expiration date were not reported) for prophylaxis (it was considered as inappropriate schedule of vaccine administered). No adverse effects were reported.
Sex: F
Vaccine: RV5
Symptoms: Varicella
Clinical narrative: "possible varicella body rash" that may be "chicken pox" acquired from a parent; This spontaneous report was received from a Physician and refers to a 7-month-old female infant. No information was provided regarding the patient's medical history, concurrent conditions, allergies or concomitant medications.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally for prophylaxis (also reported as vaccination) (formulation, strength, lot # and expiration date were not reported).  On an unknown date, the patient developed "possible varicella body rash" that may be "chickenpox" acquired from a parent. The patient saw medical attention and treatment was given for the adverse event. However, no lab diagnostics or studies were performed. The physician report that the patient has only been administered rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and have not received varicella virus vaccine live (Oka/Merck) (VARIVAX), measles virus vaccine live (Enders-Edmonston), mumps virus vaccine live (Jeryl Lynn), rubella virus vaccine live (Wistar RA 27/3), varicella virus vaccine live (Oka/Merck) (PROQUAD) or zoster vaccine live (Oka/Merck) (ZOSTAVAX). At the moment of this report the patient was recovering from "possible varicella body rash" that may be "chicken pox" acquired from a parent.  The relatedness between the event occurrence and rotavirus vaccine, live, oral, pentavalent (ROTATEQ administration was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; The patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date since 22-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R017768, expiration date: 21-JUN-2020 (dose, frequency and anatomical location were not provided), administered subcutaneously as prophylaxis. The vaccine underwent a temperature excursion from -9 Celsius degrees (°C) to 8°C (-7.4C) during a time frame of 55 minutes as recorded by digital data logger. No previous temperature excursion was reported as well as no adverse effects. The sterile diluent used to reconstitute the vaccine (lot # S000130, expiration date: 21-JUN-2020) was properly stored.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-1905USA005506: US-009507513-1905USA005505: US-009507513-1905USA005504: US-009507513-1905USA005488: US-009507513-1905USA005503:
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Rash
Clinical narrative: Chills; Rash; This case was reported by a nurse via sales rep 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 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills and rash. On an unknown date, the outcome of the chills and rash were unknown.   It was unknown if the reporter considered the chills and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the personal assistant (PA) in her office experienced chills and rash with 1st dose of Shingrix. The reporter did not agree to follow up from GlaxoSmithKline. This case has been linked with US2019AMR081245, having same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Arm pain where injection was given; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The nurse stated that the physician that she works for wife experienced extreme pain in the arm where injection was given. The reporter did not agree to follow up from GlaxoSmithKline. This case has been linked with US2019AMR081235, having same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia
Clinical narrative: hair loss; This case was reported by a pharmacist via call center representative and described the occurrence of hair loss in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number D9474, expiry date 2021) for prophylaxis.   On 19th March 2019, the patient received the 1st dose of Shingrix. In March 2019, 3 days after receiving Shingrix, the patient experienced hair loss. On an unknown date, the outcome of the hair loss was not recovered/not resolved.   It was unknown if the reporter considered the hair loss to be related to Shingrix.  Additional case details were provided as follows: The patient received the dose of Shingrix in the left deltoid and after 3 to 4 days experienced hair loss. The patient's symptoms did not change when the reporter had last spoke with the patient a few weeks ago. As of the reporter knowledge, the patient has not sought medical attention for this event. The reporter was not able to provide expiration date due to an error in the pharmacy computer system, but the expiration year was either 2020 or 2021.
Age: 42.0
Sex: F
Vaccine: HEPA
Symptoms: Tinnitus
Clinical narrative: Ringing of the ears; This case was reported by a nurse via call center representative and described the occurrence of ringing in ears in a 42-year-old female patient who received HAV (Havrix) (batch number F4EL2, expiry date 11th September 2021) for prophylaxis.   On 8th February 2019, the patient received the 1st dose of Havrix (intramuscular) 1 ml. In February 2019, 14 days after receiving Havrix, the patient experienced ringing in ears. On an unknown date, the outcome of the ringing in ears was unknown.   It was unknown if the reporter considered the ringing in ears to be related to Havrix.  Additional case details were provided as follows: The patient received the dose of Havrix in the left deltoid and about 2 weeks later, the patient started experiencing ringing in the ears. No further details were provided.
Age: 1.17
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Body temperature increased, Chest X-ray, Dyskinesia, Ear infection, Febrile convulsion
Clinical narrative: Approximately 3 hours after receiving vaccines child began vomiting and jerking and shaking uncontrollable and became unconscious; per mother, "had a seizure". Was taken to ER. Child was lethargic after coming around before becoming alert again. Vitals showed elevated temp. records did not show immediate temp, but when taken at 8:15, temp was 101.7 rectally. Child was given antipyretic. Temp showed steady decline at 9:15 and 10:15. No further seizure activity and child discharged to follow up with pmd next day. Diagnosis of Febrile Seizure. MD stated had ear infection and placed child on Amoxicillin. Has pending neurology consult. Mother states she has had history of seizure activity as well in the past.
Age: 1.17
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Full blood count, Laboratory test, Lethargy, Loss of consciousness, Seizure
Clinical narrative: Approximately 3 hours after receiving vaccines child began vomiting and jerking and shaking uncontrollable and became unconscious; per mother, "had a seizure". Was taken to ER. Child was lethargic after coming around before becoming alert again. Vitals showed elevated temp. records did not show immediate temp, but when taken at 8:15, temp was 101.7 rectally. Child was given antipyretic. Temp showed steady decline at 9:15 and 10:15. No further seizure activity and child discharged to follow up with pmd next day. Diagnosis of Febrile Seizure. MD stated had ear infection and placed child on Amoxicillin. Has pending neurology consult. Mother states she has had history of seizure activity as well in the past.
Age: 1.17
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Tremor, Vomiting
Clinical narrative: Approximately 3 hours after receiving vaccines child began vomiting and jerking and shaking uncontrollable and became unconscious; per mother, "had a seizure". Was taken to ER. Child was lethargic after coming around before becoming alert again. Vitals showed elevated temp. records did not show immediate temp, but when taken at 8:15, temp was 101.7 rectally. Child was given antipyretic. Temp showed steady decline at 9:15 and 10:15. No further seizure activity and child discharged to follow up with pmd next day. Diagnosis of Febrile Seizure. MD stated had ear infection and placed child on Amoxicillin. Has pending neurology consult. Mother states she has had history of seizure activity as well in the past.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site pain, Rash
Clinical narrative: Injection was in upper left shoulder muscle.  Very painful from the beginning and pain got worse and arm was black and blue for 2 weeks after injection was given.  The second injection was given 4 months later in the right upper shoulder muscle with same painful  symptoms along with rash in the area of muscle down to elbow.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Musculoskeletal disorder, Myalgia
Clinical narrative: I SPOKE TO PATIENT TODAY AND HE STATED HE HAS HAD PAIN IN HIS UPPER ARM MUSCLE SINCE HE RECEIVED HIS FIRST SHINGRIX SHOT ON 1/26/19.  HE STATED HE HAD A LOT OF PAIN AT THE TIME OF INJECTION AND HAS HAD PAIN SINCE.  HE STATED HE HAS A HARD TIME LIFTING THINGS, REACHING BEHIND HIS BACK AND HURTS AT NIGHT SLEEPING ON THAT SIDE.   HE HAS HAD THIS PAIN CONSITANTLY SINCE 1/26/19.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pruritus generalised
Clinical narrative: THE NEXT DAY PATIENT REPORTED RASH LOCALIZED TO THE AREA WHERE SHOT WAS GIVEN AND SEVERE ITCHING ALL OVER BODY EXCEPT FACE AND FEET.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: pain at injection site
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Erythema, Pallor, Rash, Skin lesion, Urticaria
Clinical narrative: Patient developed urticaria multiforme rash on lower extremities spreading from thighs to feet. Lesions are urticaria, red, blanching. The lesions persisted and spread for 5 days.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Axillary mass, Axillary pain
Clinical narrative: I had same side effects with series 1 from January 2019: swelling under arm ping pong/golfball size - extremely painful with flu like symptom for 1-3 days - lack of energy, aching all over. The swelling lump is most painful - Received series 1 on upper right arm and series 2 upper left arm - same side effects - arm that was vaccinated has swelling in armpit area.
Sex: M
Vaccine: MMR
Symptoms: Abdominal discomfort, Fatigue, Influenza
Clinical narrative: He received a dose of MMR II via the intramuscular route.; Pharmacist reported he felt tired and experienced gastrointestinal upset.; Pharmacist reported he felt tired and experienced gastrointestinal upset.; This spontaneous report was received from a 51 year old male patient who is a pharmacist reporting on himelf. The patient's medical history, concurrent conditions, and historical drugs were not reported, the patient had no reactions or allergies. The patient took as a concomitan medication an unspecifed cholesterol medication. Patient reported he received a dose of zoster rgE vaccine (mammalian)( SHINGRIX) (lot number and expiration date unspecified) on an unspecified date in 2019 (reported as "9 to 10 weeks ago"). He also reported that he "felt totally wiped out" and that he "felt like I had a mini flu" and that he experienced muscle aches and tiredness on unspecified dates.  On 06-MAY-2019 (reported as "2 days ago"), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) intramuscular route (strength, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis reconstituted with an sterile diluyent.     On 07-MAY-2019, the patient reported he felt tired(fatigue) and experienced gastrointestinal upset (abdominal discomfort) but he did not sought for medical attention.  At the time of the report, the outcome of fatigue and abdominal discomfort was reported as resolving. The patient did not mention the causality assessment between the events and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) vaccination.
Age: 12.0
Sex: U
Vaccine: TDAP
Symptoms: Loss of personal independence in daily activities, Rheumatoid arthritis
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of rheumatoid arthritis in a adolescent patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis. On an unknown date, the patient received Tdap Vaccine at an unknown dose. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant) and activities of daily living impaired. On an unknown date, the outcome of the rheumatoid arthritis and activities of daily living impaired were unknown. It was unknown if the reporter considered the rheumatoid arthritis and activities of daily living impaired to be related to Tdap Vaccine. Additional details were provided as follows: This case was reported by the reporter's nephew. The patient was went full blown after his 12 years booster. The patient's mother investigated and she realized that the patient was always having side effects from his vaccines. The patient was missed a whole year of school (had to be home schooled).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Nausea, Vertigo
Clinical narrative: Headache; Vertigo; nausea; Diarrhea; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 7th May 2019, 1 days after receiving Shingrix, the patient experienced headache, vertigo and nausea. In May 2019, the patient experienced diarrhea. On 7th May 2019, the outcome of the diarrhea was recovered/resolved. On an unknown date, the outcome of the headache and vertigo were not recovered/not resolved and the outcome of the nausea was unknown.   It was unknown if the reporter considered the diarrhea, headache, vertigo and nausea to be related to Shingrix.  Additional details were reported as follows: After receiving Shingrix vaccine in right arm the day before reporting, twelve hours after the patient complains of diarrhea last night.  The morning of reporting, caller complains of nausea, a terrible headache, and vertigo. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: body ache, arm pain, swelling and redness of upper arm
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Vomiting
Clinical narrative: pt called our office (her PCP office) to report she got Shingrix vaccine at her pharmacy yesterday and is now vomiting, body aches, arm pain at injection site. Denies fever, chest pain, sob, wheezing.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash, Urticaria
Clinical narrative: per mom's report Hives all over body the next day. Shots given 5-9-19, rash began 5-10-19 and lasted for 24 hrs. 0 joint swelling or bruising. benadryl was given by mother.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Injection site cellulitis, Lymphadenopathy, Viral rash
Clinical narrative: (1) patient developed -Bilateral inguinal lymphadenopathy 11 days after with localized cellulitis at the sight of injection (2) Admitted to MC on 5/9/19. Dx with Viral Exanthema. See labs attach
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine Puevax -23 given at 5 pm (L) deltoid. At 7pm, pain, reden, swelling at site. Progressed today swelling at site and redes; 3 x 7 inches; Hot to touch, painful;