chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TDAP
Symptoms: Hypersensitivity
Clinical narrative: allergy; This case was reported by a physician via other manufacturer and described the occurrence of allergy in a adult patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concurrent medical conditions included anxiety. Concomitant products included atorvastatin and hydroxyzine hydrochloride.   On an unknown date, the patient received Boostrix at an unknown dose. On an unknown date, unknown after receiving Boostrix, the patient experienced allergy. On an unknown date, the outcome of the allergy was unknown.   The reporter considered the allergy to be related to Boostrix.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema
Clinical narrative: injection site redness; swelling size of softball; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number E3Z7E, expiry date unknown) for prophylaxis.   On 12th February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site erythema and extensive swelling of vaccinated limb. On an unknown date, the outcome of the injection site erythema and extensive swelling of vaccinated limb were unknown.   It was unknown if the reporter considered the injection site erythema and extensive swelling of vaccinated limb to be related to Shingrix.  Additional details were provded as follows: The patient experienced redness at injection site and had swelling of the size of softball after receiving Shingrix vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling hot, Pain of skin, Pruritus
Clinical narrative: Itchy skin; Hot skin; painful skin on my face ears torso and arms; This case was reported by a consumer via call center representative and described the occurrence of itchy skin in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th April 2019, the patient received the 1st dose of Shingrix. In April 2019, 1 day after receiving Shingrix, the patient experienced itchy skin, feeling hot and pain of skin. On an unknown date, the outcome of the itchy skin, feeling hot and pain of skin were recovered/resolved.   It was unknown if the reporter considered the itchy skin, feeling hot and pain of skin to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had itchy, hot and painful skin on face ears torso and arms for the last six weeks. In the 24 hours following the 1st vaccine, the patient had all of the adverse effects listed. The reporter asked could this be an adverse effect.  The reporter scheduled to have the 2nd dose on the day after reporting, and did not know if the patient should have it.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Discomfort, Injection site discomfort, Insomnia, Therapeutic response unexpected
Clinical narrative: discomfort; couldn't sleep; joint pain; Injection site discomfort; unexpected benefits; This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced in late January or early February 2019). Concurrent medical conditions included joint pain (from shingles).   On 20th May 2019, the patient received the 1st dose of Shingrix (intramuscular). In May 2019, 3 days after receiving Shingrix, the patient experienced joint pain. On 20th May 2019, the patient experienced unexpected therapeutic effect. On 17th June 2019, the patient experienced sleeplessness. On an unknown date, the patient experienced discomfort and injection site discomfort. On an unknown date, the outcome of the unexpected therapeutic effect and sleeplessness were unknown and the outcome of the discomfort, joint pain and injection site discomfort were recovered/resolved.   It was unknown if the reporter considered the unexpected therapeutic effect, discomfort, joint pain, sleeplessness and injection site discomfort to be related to Shingrix.  Additional details were provided as follows: The patient had to wear a special belt around his waist and brace on his knee due to joint pain from shingles. The patient received the Shingrix dose in left deltoid. After receiving the Shingrix, right away the joint pain went away and he was able to take off the belt and brace, which was unexpected therapeutic effect from the Shingrix. 3 to 4 days after receiving the Shingrix, the joint pain started coming back. On an unknown date, less than a month after receiving the vaccine, the patient had discomfort in his arm at the injection site, that lasted 3 days. On 17th June 2019, the day before reporting date, the patient walked around a lot and last night couldn't sleep due to the discomfort. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Pain, Pyrexia, Skin depigmentation
Clinical narrative: brownish discolored spot on arm/ lower down on his arm than the injection site; soreness/ achy; tired; fever; This case was reported by a consumer via call center representative and described the occurrence of depigmentation spot in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced depigmentation spot, pain, tiredness and fever. On an unknown date, the outcome of the depigmentation spot, pain, tiredness and fever were recovered/resolved.   It was unknown if the reporter considered the depigmentation spot, pain, tiredness and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of Shingrix in left deltoid and less than a day after vaccination, it was sore afterwards. The next day, the patient noticed a brownish discolored spot on his arm lower down on his arm than the injection site. The patient also felt a little achy and tired and was running a fever, less than a week after vaccination. The spot took a long time to resolve, but the other symptoms resolved with 3 to 4 days. The patient noted that when he got a tetanus vaccine, he had similar symptoms. The reporter consented to follow up.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: dizziness; nausea; occasional vomiting; inappropriate route of vaccination; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a month after receiving Shingrix, the patient experienced dizziness, nausea, vomiting and intramuscular formulation administered by other route. The patient was treated with dramamine (nos) (Dramamine). On an unknown date, the outcome of the dizziness, nausea, vomiting and intramuscular formulation administered by other route were unknown.   The reporter considered the dizziness, nausea and vomiting to be related to Shingrix.  Additional details were provided as follows: The patient received his 1st dose of Shingrix about a week or two ago from the date of reporting.  Since, then the patient had been experiencing dizziness, nausea and occasional vomiting.  The patient had took Dramamine as suggested by his pharmacist which helped a little.  The vaccine was given in his left shoulder but he could not say it was intramuscular, which might led to wrong route of vaccination. The patient saw his physician but had discontinued seeing him.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Injection site pain, Night sweats, Pain
Clinical narrative: Red areas - about 1 inch across - 5 areas on left arm below injection site - sore chills - 2 episodes -1 night of sweating generalized achiness Resolved all within one week
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chills, Injection site erythema, Night sweats, Pain
Clinical narrative: Red areas about 1" across - about 5 areas on left arm below injection site chills - sweating - 1 night Low back soreness - generalized aches Resolved within one week
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever to 101.7 rectally, resolved after Tylenol.
Age: 0.5
Sex: M
Vaccine: PNC13, RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Parents following alternative vaccine schedule. Came to office for PCV13 and asked nurse about  number of doses needed to be caught up. Nurse told mom needed 1 more dose of PCV13 in 4 weeks and 1 more Rota. Mom requested Rota be given on 6/25/19 and nurse gave it without checking previous date of last dose. Dose was given 6 days prior.
Age: 27.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site joint pain, Pain, X-ray limb normal
Clinical narrative: Morning after vaccine administration, sharp shoulder joint pain upon movement, especially when lifting arm above head. Dull pain when not moved. Pain persisted two weeks. After radiograph imaging saw no overt cause of the symptoms, one week of Alieve was prescribed. Dull pain was relieved by the Alieve but movement pain was not. Upon completion of Alieve course, dull pain returned and sharp movement pain persists at one month post vaccine injection.
Age: 0.58
Sex: M
Vaccine: MENB
Symptoms: Pyrexia, Wrong product administered
Clinical narrative: Medical Assistant gave Trumenba instead of Prevnar during patient's well-child visit.  Low-grade fever started the morning after vaccine given otherwise the patient is doing good. Immunization Registry recommended reporting this event to Vaers.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Bradycardia, Hypotension, Presyncope
Clinical narrative: Near syncopy with Bradycardia & hypotension shortly after Menveo administration lasting close to 1hr.- normalized in about 1 hr. with conservative management.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: Sorearm; Chills/Shivering; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 2nd dose of Shingrix (intramuscular). In June 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, chills and tiredness. On an unknown date, the outcome of the pain in arm, chills and tiredness were unknown.   It was unknown if the reporter considered the pain in arm, chills and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 86 years or 87 years. Six days ago from the date of report, the patient received 2nd dose of Shingrix vaccine.  The night of vaccination she experienced sore arm that lasted for about 3 days.  About 4 days post vaccination the patient was experienced chills, shivering, and feeling tired.  The reporter did not consent to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Altered state of consciousness
Clinical narrative: patient stated feeling like he was blacking out
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Dizziness, Fall, Head injury, Hyperhidrosis, Nausea
Clinical narrative: Patient had syncope and fell from a chair to the floor within 1 minute of receiving both vaccines.  He was conscious and talking within a few seconds and reported feeling light-headed before he fell. Skin was pale and warm.  Patient was diaphoretic for 20-30 minutes.  Initial BP was 130/66.  Rapid Response team arrived and took over vitals.  After 20 minutes patient was able to sit without feeling light-headed. He felt nauseous after sitting up, and did not vomit. Denied nausea at the time he left to go home. He sat and drank water for 10 minutes. During this time his father arrived.  After sitting up patient wished to stand up to prepare to walk with his father to the car.  As he fell the patient hit his head above his left ear on the floor. Floor was carpeted but not padded. No swelling appeared during the time the patient was present. Pt expressed some tenderness where he hit his head and denied headache.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Pallor, Skin warm, Syncope, Tenderness
Clinical narrative: Patient had syncope and fell from a chair to the floor within 1 minute of receiving both vaccines.  He was conscious and talking within a few seconds and reported feeling light-headed before he fell. Skin was pale and warm.  Patient was diaphoretic for 20-30 minutes.  Initial BP was 130/66.  Rapid Response team arrived and took over vitals.  After 20 minutes patient was able to sit without feeling light-headed. He felt nauseous after sitting up, and did not vomit. Denied nausea at the time he left to go home. He sat and drank water for 10 minutes. During this time his father arrived.  After sitting up patient wished to stand up to prepare to walk with his father to the car.  As he fell the patient hit his head above his left ear on the floor. Floor was carpeted but not padded. No swelling appeared during the time the patient was present. Pt expressed some tenderness where he hit his head and denied headache.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Feeling cold, Headache
Clinical narrative: headache shivers freezing  pain arm and whole body nausea intense fatigue dizziness
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: headache shivers freezing  pain arm and whole body nausea intense fatigue dizziness
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 63-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date in November 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced herpes zoster and was treated by a physician. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested
Age: 16.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Incontinence, Seizure, Syncope
Clinical narrative: GARDASIL 9 (R017624, 3/17/2021); seizure; syncope; incontinence; This spontaneous report was received from a registered nurse via a company representative referring to a 16-year-old male patient. The patient's concurrent conditions included history of seizure. The patient's drug reactions or allergies were unknown by the reporter. No information was provided regarding the patient's medical history and concomitant medication.  On 24-JUN-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, anatomical location were not reported). The registered nurse reported hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) with lot number R017624 and expiration date of 17-MAR-2021 which was not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). However, lot number R017624 was valid for quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).   On the same day, post vaccination the reporter experienced syncope, seizure, and incontinence. No laboratory diagnosis or studies were performed. The patient did not seek for medical attention neither received treatment to the events.  The outcome of seizure, incontinence and syncope was reported as resolved on an unspecified date in June 2019. The reporter did not provide causality assessment between the events and vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).   Upon internal review, seizure and syncope were determined to be medically significant events.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Headache
Clinical narrative: patient received GARDASIL 9, a headache came on; Information has been received from a medical assistant referring to a 11 year old male patient. The patient had no medical history, drug allergies or concomitant medication.  On 24-JUN-2019 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose and frequency were unknown; lot # R009614, expiration date 30-NOV-2020) intramuscularly for Human Papillomavirus (HPV) prevention.  On the same day, 10 minutes after the vaccination, the patient experienced headache. Te patient didn't sought medication attention. There were no lab tests performed. The patient received treatment with acetaminophen (TYLENOL). The outcome of headache was unknown. The causality assessment between headache and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported by the reporter.
Age: 18.0
Sex: F
Vaccine: MMR, MMRV, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse effect reported; patient was inadvertently administered a dose of PROQUAD, instead of a dose o MMR II and Varivax; unspecified 18 year old patient was inadvertently administered a dose of PROQUAD, instead of a dose o MMR II and Varivax; This spontaneous report has been received from a medical assistant , concerning a 18 year old non-pregnant female patient with no allergies, drug reactions, concurrent conditions or pertinent medical history reported. There were no concomitant medications.  On 26-JUN-2019, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) albumin status rha, lot # R020675 with expiration date 15-JAN-2020, subcutaneously (dose and frequency were not provided) for prophylaxis instead of a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and varicella virus vaccine live (oka/merck)(VARIVAX). No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Chest pain, Muscle spasms, Palpitations, Rash
Clinical narrative: heart palpitations; chest pain; leg cramps; rash; This spontaneous report as received from a medical assistant refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (dose, lot and expiration date were not reported) for prophylaxis.  On an unknown date, a few day after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient experienced heart palpitations, chest pain, leg cramps and a rash. The medical assistant stated that the patient had seen her primary care physician for medical attention. No treatment was given for the events. There were no laboratory tests performed.  The outcome of the events was reported as recovered/resolved on an unknown date.  The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult 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 headache. On an unknown date, the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that after first dose the patient experienced slight headache. The reporter did not consented to follow up. The case has been linked with the case US2019111302, reported by same reporter for same patient.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site rash, Pain in extremity, Pyrexia, Skin reaction
Clinical narrative: Delayed rash; fever; tired; sore arm; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 26th April 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 27th April 2019, 1 day after receiving Shingrix, the patient experienced fever and tiredness. On 28th April 2019, 2 days after receiving Shingrix, the patient experienced injection site rash. On 28th April 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site rash was not recovered/not resolved and the outcome of the pain in arm and tiredness were recovered/resolved.   It was unknown if the reporter considered the injection site rash, fever, pain in arm and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm at 4:00 pm and he experienced a delayed rash reaction. The patient had a little fever the day following the vaccination and next day around 99 degree F. The patient claims that his arm was sore with arm pain the first night. The event fever was resolved but rash started on the injection site. The patient described the rash as 3 inches in circumference at the injection site on his left arm. It was also reported that he was tired the next day and in bed most of the day after receiving the Shingrix dose. The reporter did not consent to follow-up. The patient refused follow-up and preferred to remain anonymous.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Feeling cold, Headache, Injection site pain, Limb discomfort
Clinical narrative: sore arm; felt heavy arm; could not move arm; light headed; felt cold; headache and shooting pain in head; sit all day at work; injection site pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2019, the patient received the 1st dose of Shingrix. On 12th June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 13th June 2019, 1 day after receiving Shingrix, the patient experienced pain in arm, heaviness in arm, mobility decreased, light headedness, feeling cold, headache and loss of personal independence in daily activities. On 14th June 2019, the outcome of the pain in arm, heaviness in arm, mobility decreased, light headedness, feeling cold, headache and loss of personal independence in daily activities were recovered/resolved. On 16th June 2019, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the pain in arm, heaviness in arm, mobility decreased, light headedness, feeling cold, headache, injection site pain and loss of personal independence in daily activities to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine on left arm, last Wednesday evening from the day of reporting and woke up Thursday morning with a sore arm that felt heavy. The patient couldn't move it and that day he felt light headed to the point that he had to sit at work all day. The patient also had a headache and felt cold and needed to wear a jacket all day.  He had a shooting pain in his head every time he turned his head.  All the symptoms continued through out the day on Thursday from the day of reporting.  On Friday, most symptoms had resolved but the patient still had a slight headache and was slightly lightheaded.   By Friday evening slight headache and was slightly lightheaded was resolved. The only symptom that did not resolve was the soreness at the injection site. That symptom resolved by Sunday night. The reporter consented to follow up.; Sender's Comments: The patient received the vaccine last Wednesday evening and woke up Thursday morning with a sore arm that felt heavy.  He couldn't move it.  That day he felt light headed to the point that he had to sit at work all day.  He also had a headache and felt cold and needed to wear a jacket all day.  He had a shooting pain in his head every time he turned his head. All the symptoms continued through out the day Thursday.  On Friday, most symptoms had resolved but he still had a slight headache and was slightly lightheaded.  By Friday evening those remaining symptoms resolved.  The only symptom that did not resolve was the soreness at the injection site.  That symptom resolved by Sunday night.  ~~~~~~~Consented to follow up.Call Notes:The vaccine was administered at Pharmacy
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain, Pain in extremity
Clinical narrative: sore arm; felt heavy arm; could not move arm; light headed; felt cold; headache and shooting pain in head; sit all day at work; injection site pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2019, the patient received the 1st dose of Shingrix. On 12th June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 13th June 2019, 1 day after receiving Shingrix, the patient experienced pain in arm, heaviness in arm, mobility decreased, light headedness, feeling cold, headache and loss of personal independence in daily activities. On 14th June 2019, the outcome of the pain in arm, heaviness in arm, mobility decreased, light headedness, feeling cold, headache and loss of personal independence in daily activities were recovered/resolved. On 16th June 2019, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the pain in arm, heaviness in arm, mobility decreased, light headedness, feeling cold, headache, injection site pain and loss of personal independence in daily activities to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine on left arm, last Wednesday evening from the day of reporting and woke up Thursday morning with a sore arm that felt heavy. The patient couldn't move it and that day he felt light headed to the point that he had to sit at work all day. The patient also had a headache and felt cold and needed to wear a jacket all day.  He had a shooting pain in his head every time he turned his head.  All the symptoms continued through out the day on Thursday from the day of reporting.  On Friday, most symptoms had resolved but the patient still had a slight headache and was slightly lightheaded.   By Friday evening slight headache and was slightly lightheaded was resolved. The only symptom that did not resolve was the soreness at the injection site. That symptom resolved by Sunday night. The reporter consented to follow up.; Sender's Comments: The patient received the vaccine last Wednesday evening and woke up Thursday morning with a sore arm that felt heavy.  He couldn't move it.  That day he felt light headed to the point that he had to sit at work all day.  He also had a headache and felt cold and needed to wear a jacket all day.  He had a shooting pain in his head every time he turned his head. All the symptoms continued through out the day Thursday.  On Friday, most symptoms had resolved but he still had a slight headache and was slightly lightheaded.  By Friday evening those remaining symptoms resolved.  The only symptom that did not resolve was the soreness at the injection site.  That symptom resolved by Sunday night.  ~~~~~~~Consented to follow up.Call Notes:The vaccine was administered at Pharmacy
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: injection site whelp; This case was reported by a pharmacist via call center representative and described the occurrence of injection site wheal in a 90-year-old female patient who received Herpes zoster (Shingrix) (batch number 47JA3, expiry date 12th May 2020) for prophylaxis.   On 19th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 19th June 2019, immediately after receiving Shingrix, the patient experienced injection site wheal. On an unknown date, the outcome of the injection site wheal was not recovered/not resolved.   It was unknown if the reporter considered the injection site wheal to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. The patient immediately developed a whelp the size of a gulf ball at the injection site. Reporter was unable to provide additional information.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Musculoskeletal pain, Myalgia, Neck pain
Clinical narrative: pain at the injection site; Swelling at the injection site; Muscle aches and pains; pains in their upper shoulders and neck; pains in their upper shoulders and neck; The area around where she previously had lymph nodes was also affected; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 9277N, expiry date unknown) for prophylaxis.   The patient's past medical history included lymph node disorder.   On 2nd February 2019, the patient received the 1st dose of Shingrix. In February 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling, muscle pain, shoulder pain, neck pain and localized skin reaction. On an unknown date, the outcome of the injection site pain, injection site swelling and localized skin reaction were unknown and the outcome of the muscle pain, shoulder pain and neck pain were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site swelling, muscle pain, shoulder pain, neck pain and localized skin reaction to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine at local pharmacy in left deltoid. Within 12 hours of vaccination, the patient had pain and swelling at the injection site and muscle aches and pains in their upper shoulders and neck. The area around where she previously had lymph nodes was also affected. On the 3rd day, the patient went to a massage therapist who was trained in lymphedema and after several treatments with the therapist the pain had improved. Any further details regarding vaccine, specific information for vaccine facility, or adverse events were unknown.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin reaction
Clinical narrative: pain at the injection site; Swelling at the injection site; Muscle aches and pains; pains in their upper shoulders and neck; pains in their upper shoulders and neck; The area around where she previously had lymph nodes was also affected; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 9277N, expiry date unknown) for prophylaxis.   The patient's past medical history included lymph node disorder.   On 2nd February 2019, the patient received the 1st dose of Shingrix. In February 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling, muscle pain, shoulder pain, neck pain and localized skin reaction. On an unknown date, the outcome of the injection site pain, injection site swelling and localized skin reaction were unknown and the outcome of the muscle pain, shoulder pain and neck pain were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site swelling, muscle pain, shoulder pain, neck pain and localized skin reaction to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine at local pharmacy in left deltoid. Within 12 hours of vaccination, the patient had pain and swelling at the injection site and muscle aches and pains in their upper shoulders and neck. The area around where she previously had lymph nodes was also affected. On the 3rd day, the patient went to a massage therapist who was trained in lymphedema and after several treatments with the therapist the pain had improved. Any further details regarding vaccine, specific information for vaccine facility, or adverse events were unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus, Skin exfoliation
Clinical narrative: redness; itchy; losing skin; This case was reported by a consumer via call center representative and described the occurrence of skin loss in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2019, the patient received the 2nd dose of Shingrix. On 12th June 2019, less than a day after receiving Shingrix, the patient experienced skin loss, injection site erythema and pruritus. On an unknown date, the outcome of the skin loss, injection site erythema and pruritus were unknown.   It was unknown if the reporter considered the skin loss and pruritus to be related to Shingrix. The reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's husband for his wife. The age at vaccination was not reported. Around the same time of receiving vaccine, the patient started to loose skin on the palms of her hands and on her toes and both became very itchy.  She also experienced redness at the site of the injection. When the patient's husband realized that the caller could not provide medical advice, he ended the call, hence limited information was available.
Sex: M
Vaccine: FLUX
Symptoms: Death, H1N1 influenza, Vaccination failure
Clinical narrative: Suspected vaccination failure; swine flu; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and swine influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the swine influenza was fatal. The reported cause of death was swine influenza.   It was unknown if the reporter considered the vaccination failure and swine influenza to be related to Influenza vaccine.  Additional information was provided as follows: The age at vaccination was not reported. This case was reported by the patient's brother. The patient received Flu shot and had swine flu. As per reporter, the patient died from this flu shot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.; Reported Cause(s) of Death: Swine flu
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema
Clinical narrative: 1 1/4 IN X 1 IN REDNESS AT THE SITE OF THE INJECTION.  TREATMENT IS BENADRYL AND MOTRIN PRN, ICE PACK.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: A dozen red whelps my skin that itch.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: Approximately 5" red, raised welt on left thigh from the varicella vaccine given. Itchiness at site level. No fever, no cough, no vomiting, no runny nose, no diarrhea, no recent change sin appetite, no headache, no abdominal pain and no known history of sick contacts. No other concerns at time of report.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Herpes zoster, Pain, Pruritus
Clinical narrative: Symptoms started the following day with a headache, body aches and chills for two days, then I started to get what I thought was hives behind my left ear. Within 24 hours, they had moved throughout my hair on the left side of my head. Very itchy. I called the pharmacist that had given me the injection and she said that she didn't think they were hives. She thinks it's shingles based on the explanation I gave her. She said they usually follow a nerve and the ones behind my ear are in a row  like she described. She told me to report this to you.
Age: 37.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: Diarrhoea, Fatigue, Nodule
Clinical narrative: The patient received the vaccines on 6/25/2019 and called back on 6/28/19 to say that she has diarrhea, and a knot the size of a quarter on her chin, and feels very tired
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: He said that his arm has been sore since he got the shot and has not improved in the 3 weeks since.  He said it feels like he was punched in the muscle, but there was no  swelling or impairment of movement.  He did not want to go to the  doctor yet and would monitor for the next few days.  He did not seem overly concerned but wanted to let us know as it did not seem to be improving
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: swelling & pain at inject site x 5 days then had tingling at the arm & lower back. Now (6/24) has tingling on ribcage. Treatment - acyclovir, prednisone -> new RX *refill prescribed previously as preventative for HSV acyclovir was not new therapy Pt refilled old RX for HSV (previous diagnosis) MD called in prednisone as treatment 6/24/19
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Chills, Fatigue, Feeling cold
Clinical narrative: fatigue, shivering chills extremely cold, lasting several hours.  - burning  all over body all joints painful   - hands and feet felt very swollen and heavy -  headache  -  both shoulders ached  the injection site was not painful compared with  all the other  pain I experienced  - extremely tired slept next 2 days  took aspirin 3 x a day when I was able to get out of bed.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypersomnia, Injection site pain, Limb discomfort, Musculoskeletal pain
Clinical narrative: fatigue, shivering chills extremely cold, lasting several hours.  - burning  all over body all joints painful   - hands and feet felt very swollen and heavy -  headache  -  both shoulders ached  the injection site was not painful compared with  all the other  pain I experienced  - extremely tired slept next 2 days  took aspirin 3 x a day when I was able to get out of bed.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: fatigue, shivering chills extremely cold, lasting several hours.  - burning  all over body all joints painful   - hands and feet felt very swollen and heavy -  headache  -  both shoulders ached  the injection site was not painful compared with  all the other  pain I experienced  - extremely tired slept next 2 days  took aspirin 3 x a day when I was able to get out of bed.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: He received Kinrix on June 26th in right thigh.  He developed 2 x 2 1/2 inch area of warmth, redness and tenderness at injection site over past 48 hours.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Vomiting projectile
Clinical narrative: projectile vomited while giving Rota Teq
Sex: M
Vaccine: UNK, VARCEL
Symptoms: Aphthous ulcer, Insomnia, Peripheral swelling, Pyrexia, Rash generalised
Clinical narrative: bumps on his body; his hand swelling; the patient has "not been able to sleep" and has had "many sleepless nights"; canker sores; a fever of 100 degrees and 101 degrees; This spontaneous report was received from a consumer (the patient's grandmother) and refers to a male patient of unknown age. There was no information about his concurrent conditions, concomitant therapies or medical history provided. On 30-MAY-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (exact dose, route of administration, lot # and expiration date were not reported), for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT) (exact dose, lot # and expiry date not provided), used to reconstitute the vaccine. On an unknown date in approximately 2019, the patient was not able to sleep and had many sleepless nights since receiving dose of varicella virus vaccine live (oka/merck)(VARIVAX). It was reported that he had a "fever of 100 degrees and 101 degrees (units not reported) in spite of being on a schedule of acetaminophen (TYLENOL) and ibuprofen (MOTRIN)", which were instructed by an unspecified healthcare provider to administer in unspecified doses. The patient also experienced "canker sores", "unspecified bumps on his body and his hand swelling". His parents sought medical attention and visited an unspecified emergency room (date not provided). The outcome of nodule, pyrexia, aphthous ulcer, insomnia and peripheral swelling was not recovered. The relatedness between suspect therapies and the events was not reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Facial paralysis, Product supply issue
Clinical narrative: Bell's Palsy; pharmacy was always out when I went for second dose; This case was reported by a consumer and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (experienced when the patient was child).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 183 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant) and product supply issue. On an unknown date, the outcome of the bell's palsy and product supply issue were unknown.   The reporter considered the bell's palsy to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. Six months to the vaccination date, the patient developed Bell's palsy.  The patient stated it seemed like, the patient should never have gotten Bell's palsy after receiving Shingrix. The patient stated that the pharmacy was always out when the patient went for the second dose.  It was reported that, 6 weeks in and the patient was referred to the university to the emergency medical technician (EMT) clinic for an evaluation for surgery. The patient would like to know how many other people had this side effect. The patient thought Bell's palsy was related to Shingrix vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Encephalitis, Immediate post-injection reaction
Clinical narrative: encephalitis; This case was reported by a physician and described the occurrence of encephalitis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced encephalitis (serious criteria GSK medically significant). On an unknown date, the outcome of the encephalitis was unknown.   It was unknown if the reporter considered the encephalitis to be related to Shingrix.  Additional details were received as follows: This case was reported during chronic obstructive pulmonary disease (COPD) speaker training by the attending trainees. The age at vaccination was not reported. The age group was not provided but was selected adult as per the vaccine indication. The reporter's friend presented with encephalitis shortly after vaccination with Shingrix. The reporter gave permission to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced pain in arm after receiving vaccine. This case has been linked with case US2019112046, reported for the dose 2 of the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Encephalitis, Immediate post-injection reaction
Clinical narrative: encephalitis; This case was reported by a physician via sales rep and described the occurrence of encephalitis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced encephalitis (serious criteria GSK medically significant). On an unknown date, the outcome of the encephalitis was unknown.   It was unknown if the reporter considered the encephalitis to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's friend. The age group was not reported, but was selected adult as per vaccine indication. Shortly after vaccination, the patient experienced encephalitis. The reporter would be happy to provide further details, if helpful. This case has been linked with case US2019AMR114835, reported by the same reporter (pharma case).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Rigors and chills; Headache; Dizziness; Nausea; Fever; Injection site redness; Injection site swelling; This case was reported by a physician via call center representative and described the occurrence of fever in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, 8 hrs after receiving Shingrix, the patient experienced fever, chills, headache, dizziness, injection site erythema, injection site swelling and nausea. The patient was treated with ondansetron. On an unknown date, the outcome of the fever, injection site erythema and injection site swelling were recovered/resolved and the outcome of the chills, headache, dizziness and nausea were unknown.   It was unknown if the reporter considered the fever, chills, headache, dizziness, injection site erythema, injection site swelling and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient who was also a physician reported the following adverse reactions to Shingrix The patient was vaccinated on an unknown deltoid and awakened with rigors, chills and a fever of over 101 degree F. The patient also reported severe nausea which was treated with ondansetron. headache, dizziness, and swelling and redness of her entire deltoid region. The event fever and swelling and redness resolved by the next day. No additional details were provided      Lab Comments: On an unknown date lab test was performed.