chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARCEL
Symptoms: Pain, Personality change, Screaming, Social avoidant behaviour
Clinical narrative: Patient had a really severe reaction to VARIVAX that went on for several weeks; He was screaming in pain, and said the pain was all over his body; The vaccine changed his personality; This spontaneous report was received from the mother of a 23 year old male patient. The patient had none pertinent medical history, concomitant medications, drug reactions or allergies.  On an unspecified date in August 1999, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously (dose, lot #, expiration date and anatomical location were not provided) to prevent chickenpox. The patient's mother said that her son had a really severe reaction to varicella virus vaccine live (oka/merck)(VARIVAX) (vaccination complication) that went on for several weeks, described as that patient was screaming in pain which was all over his body. On an unspecified date in 1999, the patient's personality changed. His mother reported that before the vaccine he was more expressive and emotional, but since vaccination he was definitely more reserved and loner. Patient sought for medical attention and the physician advised against a second shot of the vaccine. Physician discovered that the reaction ocurred "in less than 0.5% of the population". Patient's mother did not remember if any specific treatment was received for the events. On an unspecified date in 1999 (reported as a few weeks after vaccination), the patient recovered from the pain. The outcome of the severe reaction to the vaccine was unknown. At the reporting time, the patient had not recovered from personality change.   The reporter considered vaccination complication to be related to varicella virus vaccine live (oka/merck)(VARIVAX). The causality between the events of pain and personality change was not reported.
Sex: M
Vaccine: HPV9, UNK
Symptoms: Hunger, Increased appetite
Clinical narrative: patient stated he is always hungry; This spontaneous report was received from a physician via company representative refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies, historical drugs, familial history and concomitant medications were not reported.   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) (strength, dose, route of administration, anatomical location, lot/batch # and expiration date were not reported) for prophylaxis. On an unknown date, the patient started therapy with ertugliflozin(STEGLATRO) (strength, dose, frequency, route of administration, lot/batch # and expiration date were unknown) for an unknown indication.   On an unknown date, the patient reported that he was experiencing hunger always (increased appetite). No product quality complaint was involved.   The therapy with ertugliflozin(STEGLATRO) was discontinued and also reported that the patient will restart ertugliflozin(STEGLATRO) in 1 week. The outcome of increased appetite was unknown. The reporter's causality assessment was unknown.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: redness on arm; pain on arm/ hurt arm; itching in arm; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced erythema of extremities, pain in arm and itchy upper limbs. On an unknown date, the outcome of the erythema of extremities, pain in arm and itchy upper limbs were unknown.   It was unknown if the reporter considered the erythema of extremities, pain in arm and itchy upper limbs to be related to Shingrix.  Additional details were provided as follows: The reporter mentioned that her friend received the first dose of Shingrix and she developed redness with pain on her arm with itching and her arm hurt. The reporter stated that her friend had pain and itching in her arm but no flu like symptoms. The reporter consented to follow up. There was discrepancy in date of birth reported, it was reported which is future date. The date of birth was captured.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: redness; swelling; pain to the touch; This case was reported by a consumer and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2019, the patient received Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced erythema, swelling and tenderness. On an unknown date, the outcome of the erythema, swelling and tenderness were unknown.   It was unknown if the reporter considered the erythema, swelling and tenderness to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. On Tuesday, the patient received Shingrix and experienced redness, swelling and pain to the touch. This is 1 of the 3 linked cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: redness; swelling; pain to the touch; This case was reported by a consumer and described the occurrence of erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2019, the patient received Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced erythema, swelling and tenderness. On an unknown date, the outcome of the erythema, swelling and tenderness were unknown.   It was unknown if the reporter considered the erythema, swelling and tenderness to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  On Tuesday, the patient received Shingrix and experienced redness, swelling and pain to the touch. The patient did not miss the work. The reporter stated follow up was not required. This is 1 of the 3 linked cases, reported by the same reporter.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity, Somnolence
Clinical narrative: Arm hurts; can't stay awake in the evening; Fatigue; This case was reported by a consumer and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm, sleepiness and fatigue. On an unknown date, the outcome of the pain in arm, sleepiness and fatigue were unknown.   It was unknown if the reporter considered the pain in arm, sleepiness and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and till the time of reporting her arm was hurting and could not stay awake in the evening (unusual for her).
Sex: F
Vaccine: TDAP
Symptoms: Apparent death
Clinical narrative: Almost died; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a infant female patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced near death experience (serious criteria GSK medically significant). On an unknown date, the outcome of the near death experience was unknown.   The reporter considered the near death experience to be related to DTPa vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient almost died from DTPa vaccine and the physician told the family that they could do nothing more for her. The reporter thanked god for sparing her life and the reporters family no longer gets vaccines.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Headache, Nausea, Pyrexia
Clinical narrative: fever; headache; nausea; Feeling hot; This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2019, the patient received Shingrix (intramuscular). On 6th August 2019, 1 days after receiving Shingrix, the patient experienced fever, headache, nausea and feeling hot. On an unknown date, the outcome of the fever, headache and nausea were recovered/resolved and the outcome of the feeling hot was recovering/resolving.   It was unknown if the reporter considered the fever, headache, nausea and feeling hot to be related to Shingrix.  Additional details were provided as follows: The patient feeling hot like and he had fever, headache and a tiny amount of nausea.  On 7th August 2019, the patient was feeling better.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: got sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included autoimmune disorder and cancer.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 76 or 77 years. The patient got sick from the first shot of Shingrix.   The reporter mentioned that her friend had both shots of the Shingrix. The reporter consented to follow up. The case has been linked to the case US2019143866, reported by same reporter.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysphonia, Headache, Injection site pain, Insomnia, Myalgia
Clinical narrative: his voice was very nasally; myalgia involving his spine; Severe arm pain (localized to the injection site); diffuse myalgia involving his spine; Stuffy nose; severe headache; Impossible to sleep; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included intervertebral disc disorder (had underlying discs issue, which have not been causing problems lately).   On 6th August 2019, the patient received the 1st dose of Shingrix. On 6th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, myalgia, nasal stuffiness, headache, difficulty sleeping and pain in spine. On 7th August 2019, the patient experienced voice alteration. On an unknown date, the outcome of the injection site pain, myalgia, nasal stuffiness and headache were not recovered/not resolved and the outcome of the difficulty sleeping, voice alteration and pain in spine were unknown.   It was unknown if the reporter considered the injection site pain, myalgia, nasal stuffiness, headache, difficulty sleeping, voice alteration and pain in spine to be related to Shingrix.  Additional details were provided as follows: The physician who used to work as a Head of Safety calling and stated that the patient who received Shingrix and several hours later the patient developed a severe systemic reaction. Severe arm pain at injection site and diffuse myalgia involving his spine, severe headaches and stuffy nose. The caller could tell something was wrong when speaking with the patient at the time of reporting because his voice was very nasally. The symptoms made it impossible for him to sleep.  The reporter consented to follow up. Details regarding the vaccine given or responsible physician was unknown. This case linked with US2019143886, reported by same reporter.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Nasal congestion, Spinal pain
Clinical narrative: his voice was very nasally; myalgia involving his spine; Severe arm pain (localized to the injection site); diffuse myalgia involving his spine; Stuffy nose; severe headache; Impossible to sleep; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included intervertebral disc disorder (had underlying discs issue, which have not been causing problems lately).   On 6th August 2019, the patient received the 1st dose of Shingrix. On 6th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, myalgia, nasal stuffiness, headache, difficulty sleeping and pain in spine. On 7th August 2019, the patient experienced voice alteration. On an unknown date, the outcome of the injection site pain, myalgia, nasal stuffiness and headache were not recovered/not resolved and the outcome of the difficulty sleeping, voice alteration and pain in spine were unknown.   It was unknown if the reporter considered the injection site pain, myalgia, nasal stuffiness, headache, difficulty sleeping, voice alteration and pain in spine to be related to Shingrix.  Additional details were provided as follows: The physician who used to work as a Head of Safety calling and stated that the patient who received Shingrix and several hours later the patient developed a severe systemic reaction. Severe arm pain at injection site and diffuse myalgia involving his spine, severe headaches and stuffy nose. The caller could tell something was wrong when speaking with the patient at the time of reporting because his voice was very nasally. The symptoms made it impossible for him to sleep.  The reporter consented to follow up. Details regarding the vaccine given or responsible physician was unknown. This case linked with US2019143886, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient mentioned that he received the full course of Shingrix and had no issue other than the arm pain. No further information was captured regarding caller, contact ok with follow up regarding brother. This case linked with US2019143875, reported by same reporter.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number 7A7H4, expiry date 19th September 2021) for prophylaxis.   On 3rd May 2019, the patient received the 1st dose of Shingrix. On 5th May 2019, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose and broke out in shingles 2 days later. The patient got repeat episode of shingles 2 months after first case. The patient did not receive a second dose. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Glossopharyngeal neuralgia, Pain
Clinical narrative: glossopharyngeal neuralgia; pain/ the pain is similar to shingles; This case was reported by a consumer via call center representative and described the occurrence of glossopharyngeal neuralgia in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 31st July 2019, 2 days after receiving Shingrix, the patient experienced glossopharyngeal neuralgia and pain. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the glossopharyngeal neuralgia was not recovered/not resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the glossopharyngeal neuralgia and pain to be related to Shingrix.  Additional details were provided as follows: A couple days later the patient started experiencing glossopharyngeal neuralgia. The patient stated the pain was similar to that from shingles. She was prescribed pain pills and steroids and she was doing better. The reporter did not consent to follow up Emergency room visit required.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: rash; itchy rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number XJ57B, expiry date 18th October 2019) for prophylaxis.   On 28th July 2019, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced rash and itchy rash. On an unknown date, the outcome of the rash and itchy rash were recovered/resolved.   It was unknown if the reporter considered the rash and itchy rash to be related to Shingrix.  Additional details were provided as follows: The pharmacist stated she was told the information by a patient's husband. He described the rash as itchy. Pharmacist believed the rash had resolved at the time of report. The batch number was reported as SJ57B from the reporter; however, based on safety batch number review, the batch number was corrected to XJ57B.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Gastrointestinal disorder, Headache, Influenza like illness
Clinical narrative: major flu-like symptoms; myalgia; fatigue; headache; shivering; fever; gastrointestinal symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received Shingrix (intramuscular). In May 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, myalgia, fatigue, headache, shivering, fever and gastrointestinal symptom nos. On an unknown date, the outcome of the influenza-like symptoms, myalgia, fatigue, headache, shivering, fever and gastrointestinal symptom nos were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, myalgia, fatigue, headache, shivering, fever and gastrointestinal symptom nos to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st shot of Shingrix and the next 48 hours he had major flu-like symptoms, he had to take the next day off work.  The patient experienced myalgia , fatigue, headache, shivering, fever, and gastrointestinal symptoms.  All event resolved after 3 days. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: major flu-like symptoms; myalgia; fatigue; headache; shivering; fever; gastrointestinal symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received Shingrix (intramuscular). In May 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, myalgia, fatigue, headache, shivering, fever and gastrointestinal symptom nos. On an unknown date, the outcome of the influenza-like symptoms, myalgia, fatigue, headache, shivering, fever and gastrointestinal symptom nos were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, myalgia, fatigue, headache, shivering, fever and gastrointestinal symptom nos to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st shot of Shingrix and the next 48 hours he had major flu-like symptoms, he had to take the next day off work.  The patient experienced myalgia , fatigue, headache, shivering, fever, and gastrointestinal symptoms.  All event resolved after 3 days. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: Lumps around injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump 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, less than 2 years after receiving Shingrix, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was recovered/resolved.   It was unknown if the reporter considered the injection site lump to be related to Shingrix.  Additional details were provided as follows: The patient developed lumps around the injection site following dose 1 of Shingrix. The reporter consented to follow up. The health care professional could not provide complete patient demographics, lot number, or expiration date. The health care professional describes lumps as quarter sized and lumps completely resolved within seven days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental underdose, Incorrect route of product administration, Injection site swelling
Clinical narrative: there was a bulge; Underdose / patient received about half the product; there was a bulge, so it was not in the muscle; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number AP257, expiry date 26th November 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site swelling, accidental underdose and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site swelling, accidental underdose and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site swelling to be related to Shingrix.  Additional case details were reported as follows: The pharmacist on the line stated while administering the product, the patient looked like she was surprised and moved away so the needle came out. Some of it came out and there was a bulge, so it was not in the muscle, which led to intramuscular formulation administered by other route. The patient received about half the product, which led to accidental underdose. The reporter gave permission to follow up. This case had been linked to the case US2019143920, reported for same patient.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMRV, PNC13
Symptoms: Influenza virus test negative, Oral mucosal eruption, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Patient developed rash on 6/13/19 & a fever. Patient had white spots in mouth. Child said things tasted funny. Possible Thrush-given tx for Nystatin 100,000 unit/mL. Apply to white spots on tongue 4xdaily for 14 days. Given Benadryl for rash. Diffuse maculopapular rash face to feet, sparring palms & sole. Dept. of Health was called and Rapid Flu test - Negative. Mom advised patient needed testing for measles. The patients mom refused any testing and was very upset. She took her children and left the building w/out finishing the visit. Dept. of Health stated they would take it from here and follow up w/the patients parents.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMRV, PNC13
Symptoms: Taste disorder, Tongue eruption
Clinical narrative: Patient developed rash on 6/13/19 & a fever. Patient had white spots in mouth. Child said things tasted funny. Possible Thrush-given tx for Nystatin 100,000 unit/mL. Apply to white spots on tongue 4xdaily for 14 days. Given Benadryl for rash. Diffuse maculopapular rash face to feet, sparring palms & sole. Dept. of Health was called and Rapid Flu test - Negative. Mom advised patient needed testing for measles. The patients mom refused any testing and was very upset. She took her children and left the building w/out finishing the visit. Dept. of Health stated they would take it from here and follow up w/the patients parents.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Injection site erythema, Injection site induration, Musculoskeletal stiffness, Pyrexia
Clinical narrative: redness at injection site; induration at injection site; stiff neck; headache; fever; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABX751AA, expiry date 29th February 2020) for prophylaxis.   On 19th April 2019, the patient received the 1st dose of Bexsero (intramuscular) .5 ml. On 20th April 2019, 1 days after receiving Bexsero, the patient experienced injection site erythema, injection site induration, stiff neck, headache and fever. On an unknown date, the outcome of the injection site erythema, injection site induration, stiff neck, headache and fever were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site induration, stiff neck, headache and fever to be related to Bexsero.  Additional case details were reported as follows: The patient received vaccine on unknown arm. The day after the patient received the vaccine, the patient experienced redness and induration at the injection site, stiff neck, headache, and fever. The reporter did not provide any additional information. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Needle issue, Pain in extremity, Underdose
Clinical narrative: Arm sore; Accidental underdose; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number XJ57B, expiry date 18th October 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm and accidental underdose. On an unknown date, the outcome of the pain in arm and accidental underdose were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, but it could be 58 or 59 years. The healthcare professional reported that needle leaked while Shingrix was being administered to the patient, which led to accidental underdose.  The healthcare professional would like to know how to proceed.  The patient was also concerned because her arm was not sore as it was for the first dose. The reporter gave permission to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Anal incontinence, Diarrhoea
Clinical narrative: uncontrollable loose bowel movements; uncontrollable loose bowel movements; This case was reported by a pharmacist via call center representative and described the occurrence of bowel incontinence in a 85-year-old male patient who received Herpes zoster (Shingrix) (batch number H549S, expiry date 1st October 2021) for prophylaxis.   On 6th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 7th August 2019, 1 days after receiving Shingrix, the patient experienced bowel incontinence and loose bowel. On an unknown date, the outcome of the bowel incontinence and loose bowel were unknown.   It was unknown if the reporter considered the bowel incontinence and loose bowel to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, but it could be 84 or 85 years. The patient received Shingrix in left arm The patient experienced uncontrollable loose bowel movements on the afternoon of the next day of reporting. The reporter gave permission to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Bruise; soreness / severe pain / burning is at injection site; redness; swelling / injection site puffy; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site swelling. On 5th August 2019, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site bruising were not recovered/not resolved and the outcome of the injection site erythema was recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling and injection site bruising to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient experienced soreness, redness and swelling in her arm the day of the injection, but it resolved after a couple days.  Two days ago, 9 days after receiving Shingrix patient started experiencing severe pain in her arm at the injection site, like someone was sticking a knife in and twisting it.  It also had a burning sensation.  The patient said it felt like the time she had shingles.  There was a round area around the injection site that was puffy, and there was a bruise in the middle. The reporter gave permission to follow up. In the XML document outcome of reoccurred events pain and puffy was reported as recovering, but in system its mentioned as not recovered, so kept as reported in system.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Myalgia, Pyrexia
Clinical narrative: FEVER; WEAKNESS; MUSCLE ACHES; FATIGUE; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th September 2021) for prophylaxis.   On 3rd July 2019, the patient received the 1st dose of Shingrix. On 3rd July 2019, 5 hrs after receiving Shingrix, the patient experienced fever, weakness, muscle pain and fatigue. On an unknown date, the outcome of the fever, weakness, muscle pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the fever, weakness, muscle pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient experienced a fever between 104 to 106.5 degree F.  Less than a day after vaccination, the patient experienced weakness, muscle aches, and fatigue. These symptoms lasted 5 days.  The health care professional would like to know if the patient should receive the 2nd dose based off these reactions.  The reporter consented to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Injection site pain, Somnolence
Clinical narrative: soreness at injection site; lightheadedness; sleepiness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2019, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, light headedness and sleepiness. On an unknown date, the outcome of the injection site pain, light headedness and sleepiness were unknown.   It was unknown if the reporter considered the injection site pain, light headedness and sleepiness to be related to Shingrix.  Additional details were provided as follows: The patient reported that he was experiencing soreness at injection site, lightheadedness and sleepiness. The reporter did not give consent to follow up.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Injection site pain, Pyrexia
Clinical narrative: sore arm; fever; Pain in left abdominal; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2019, the patient received the 2nd dose of Shingrix. On 8th August 2019, 1 days after receiving Shingrix, the patient experienced injection site pain, fever and abdominal pain. On an unknown date, the outcome of the injection site pain, fever and abdominal pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever and abdominal pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on the left arm and had a sore arm and a fever of 102. While speaking to her on the call, she mentioned she felt a pain in her left abdominal that presented at that moment while we were talking.  The reporter did not consent to follow up. There is discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Muscular weakness, Pain, Paraesthesia, Somnolence
Clinical narrative: tired/ feel wiped out; vomiting; Right arm tingling; sleepy; arm was sleeping; achy; This case was reported by a consumer via call center representative and described the occurrence of pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 7th August 2019, 1 days after receiving Shingrix, the patient experienced pain. On 8th August 2019, the patient experienced tiredness, vomiting, tingling, sleepiness and weakness of arms. On an unknown date, the outcome of the pain and tiredness were recovering/resolving and the outcome of the vomiting, tingling, sleepiness and weakness of arms were unknown.   It was unknown if the reporter considered the pain, tiredness, vomiting, tingling, sleepiness and weakness of arms to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The patient reported that she received Shingrix and she was achy the day after. On the day of reporting, she started vomiting. She had one episode on the day of reporting of her right arm tingling after awaking and it was the entire length of her arm. She was sleepy on the day of reporting so it also felt like her arm was sleeping. The achiness is improving today but she still feels wiped out. The patient also responded that she responds negatively to many medications so she was assuming it was just the Shingrix that was causing her side effects. The reporter gave consent to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: tired/ feel wiped out; vomiting; Right arm tingling; sleepy; arm was sleeping; achy; This case was reported by a consumer via call center representative and described the occurrence of pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 7th August 2019, 1 days after receiving Shingrix, the patient experienced pain. On 8th August 2019, the patient experienced tiredness, vomiting, tingling, sleepiness and weakness of arms. On an unknown date, the outcome of the pain and tiredness were recovering/resolving and the outcome of the vomiting, tingling, sleepiness and weakness of arms were unknown.   It was unknown if the reporter considered the pain, tiredness, vomiting, tingling, sleepiness and weakness of arms to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The patient reported that she received Shingrix and she was achy the day after. On the day of reporting, she started vomiting. She had one episode on the day of reporting of her right arm tingling after awaking and it was the entire length of her arm. She was sleepy on the day of reporting so it also felt like her arm was sleeping. The achiness is improving today but she still feels wiped out. The patient also responded that she responds negatively to many medications so she was assuming it was just the Shingrix that was causing her side effects. The reporter gave consent to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: soreness at injection site; redness at injection site; hardness at injection site; rash; heart palpatations; fever; headache; shivering; upset stomach; tired; difficulty sleeping; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2019, the patient received the 1st dose of Shingrix. On 8th July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site induration, rash, palpitation, fever, headache, shivering, upset stomach, tiredness and difficulty sleeping. On 11th July 2019, the outcome of the injection site induration, palpitation, fever, headache, shivering, tiredness and difficulty sleeping were recovered/resolved. On 13th July 2019, the outcome of the injection site pain, injection site erythema and rash were recovered/resolved. On 11th August 2019, the outcome of the upset stomach was recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site induration, rash, palpitation, fever, headache, shivering, upset stomach, tiredness and difficulty sleeping to be related to Shingrix.  Additional information received were as follows: The patient experienced soreness at injection site, redness at injection site, hardness at injection site and heart palpatations. The patient planned to follow-up with her physician on an unknown date. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Insomnia, Palpitations, Pyrexia
Clinical narrative: soreness at injection site; redness at injection site; hardness at injection site; rash; heart palpatations; fever; headache; shivering; upset stomach; tired; difficulty sleeping; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2019, the patient received the 1st dose of Shingrix. On 8th July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site induration, rash, palpitation, fever, headache, shivering, upset stomach, tiredness and difficulty sleeping. On 11th July 2019, the outcome of the injection site induration, palpitation, fever, headache, shivering, tiredness and difficulty sleeping were recovered/resolved. On 13th July 2019, the outcome of the injection site pain, injection site erythema and rash were recovered/resolved. On 11th August 2019, the outcome of the upset stomach was recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site induration, rash, palpitation, fever, headache, shivering, upset stomach, tiredness and difficulty sleeping to be related to Shingrix.  Additional information received were as follows: The patient experienced soreness at injection site, redness at injection site, hardness at injection site and heart palpatations. The patient planned to follow-up with her physician on an unknown date. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: soreness at injection site; redness at injection site; hardness at injection site; rash; heart palpatations; fever; headache; shivering; upset stomach; tired; difficulty sleeping; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2019, the patient received the 1st dose of Shingrix. On 8th July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site induration, rash, palpitation, fever, headache, shivering, upset stomach, tiredness and difficulty sleeping. On 11th July 2019, the outcome of the injection site induration, palpitation, fever, headache, shivering, tiredness and difficulty sleeping were recovered/resolved. On 13th July 2019, the outcome of the injection site pain, injection site erythema and rash were recovered/resolved. On 11th August 2019, the outcome of the upset stomach was recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site induration, rash, palpitation, fever, headache, shivering, upset stomach, tiredness and difficulty sleeping to be related to Shingrix.  Additional information received were as follows: The patient experienced soreness at injection site, redness at injection site, hardness at injection site and heart palpatations. The patient planned to follow-up with her physician on an unknown date. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Lip swelling
Clinical narrative: Swollen, hard lip; hard lips; This case was reported by a pharmacist via call center representative and described the occurrence of lip swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2019, the patient received Shingrix. On 8th August 2019, 1 days after receiving Shingrix, the patient experienced lip swelling and induration. On an unknown date, the outcome of the lip swelling and induration were unknown.   It was unknown if the reporter considered the lip swelling and induration to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's top lip was swollen and hard.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Seen patient in office, supportive care given for redness and induration
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Erythema, Headache, Nausea, Swelling
Clinical narrative: Redness, minimal swelling, headache, nausea 8/15/19
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: Excruciating pain, no flexibility, and weakness in right arm.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Eye swelling, Feeling abnormal, Lip swelling, Pain in extremity
Clinical narrative: Roughly 5 hours after receiving the injection, patient awoke at home wit arm pain. He quickly realized that his face did not feel right and discovered swelling in his eyes, lips and tongue. HIs arm was also swollen, red and hot. He reports taking benadryl, the exact amount unknown, to counteract the reaction. Patient still had residual swelling for 5 days after but did not go to physician.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Peripheral swelling, Skin warm, Swollen tongue
Clinical narrative: Roughly 5 hours after receiving the injection, patient awoke at home wit arm pain. He quickly realized that his face did not feel right and discovered swelling in his eyes, lips and tongue. HIs arm was also swollen, red and hot. He reports taking benadryl, the exact amount unknown, to counteract the reaction. Patient still had residual swelling for 5 days after but did not go to physician.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient's left arm between injection site and elbow is swollen, red, and hot.  She said it started on same day as the shot  I advised her to be seen in the adjacent urgent care.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Patient woke up with large hives on various parts of her body.  Some spots would go away and others would appear on different areas.
Age: 62.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Erythema, Insomnia, Mobility decreased, Pain, Pyrexia
Clinical narrative: Extreme pain could not sleep, could not move arm on second day, ran a 100.1 fever, arm was extremely red and hot to the touch three days now.
Age: 62.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Skin warm
Clinical narrative: Extreme pain could not sleep, could not move arm on second day, ran a 100.1 fever, arm was extremely red and hot to the touch three days now.
Age: 19.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: Fall, Head injury, Headache, Syncope, Tinnitus
Clinical narrative: Patient received vaccination w/o issue. Was then ready to leave pharmacy and mother reports the pt mentioned a ringing in her ears followed by fainting. The patient, according to a bystander, hit her head when she fell. She regainded senses shortly after and complainded of a sore head, but no difficulty breathing. The patient was sit up in a chair and EMS was called at pharmacist's offer. EMS arrived and noted no abnormalitites with BP,HR, or blood sugars. Family member (aunt) reports the next day the patient is at home and with  a headache but no other problems.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles; Right rib radicular rash w/ 2 dematomes; tx with valtrex and prednisone taper
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Injection site pain, Nausea
Clinical narrative: chills twice, body aches, nauseated 4 times twice with vomiting, weakness, tired, soreness at injection site
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Vomiting
Clinical narrative: chills twice, body aches, nauseated 4 times twice with vomiting, weakness, tired, soreness at injection site
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 referred to a currently 72 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 28-MAY-2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.