chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: RAB, VARZOS
Symptoms: Pain in jaw, Rash, Rash erythematous, Rash pruritic, Scab
Clinical narrative: 50 y/o female here today with c/o itchy rash, blisters on her body since Friday. She received her final rabies vaccine and a shingles vaccine on the same day. Patient states she felt very fatigued after immunizations. She immediately fell asleep on hammock and slept for 8 hours. She first noticed rash on her arms when she woke up. She says her voice has been raspy, but she denies difficulty breathing. She said that since then she started having jaw pain and a headache. Rash has continued to spread since Friday, now she has it on her torso as well. She reports her husband has a similar rash. She has been taking OTC meds to try to help. She is not sure if maybe she got into poison ivy on her farm or not. She said she has not changed any soaps, lotions, detergents, etc. Vesicles were seen Lesions noted to bilateral arms, thighs, lower extremities, stomach, and chest. ranging in patient described progression from flat red rash to chest and between breasts to small (less than 1/4cm) vesicles to flat rash with scabbing.
Age: 50.0
Sex: F
Vaccine: RAB, VARZOS
Symptoms: Skin lesion
Clinical narrative: 50 y/o female here today with c/o itchy rash, blisters on her body since Friday. She received her final rabies vaccine and a shingles vaccine on the same day. Patient states she felt very fatigued after immunizations. She immediately fell asleep on hammock and slept for 8 hours. She first noticed rash on her arms when she woke up. She says her voice has been raspy, but she denies difficulty breathing. She said that since then she started having jaw pain and a headache. Rash has continued to spread since Friday, now she has it on her torso as well. She reports her husband has a similar rash. She has been taking OTC meds to try to help. She is not sure if maybe she got into poison ivy on her farm or not. She said she has not changed any soaps, lotions, detergents, etc. Vesicles were seen Lesions noted to bilateral arms, thighs, lower extremities, stomach, and chest. ranging in patient described progression from flat red rash to chest and between breasts to small (less than 1/4cm) vesicles to flat rash with scabbing.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site urticaria, Urticaria
Clinical narrative: 5:50 pm urticaria 5 minutes after vaccine right upper thigh welt 2 cm x 1 cm with surrounding pinkness no cough/wheeze or vomiting Benadryl 3.5 ml oral given 5:55 pm small welts on back Prednisolone 6 ml given 6:15 pm right thigh welt resolving, hives on back resolved monitored further and sent home  Referred to allergist for follow-up
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pyrexia, Rash, Rash papular, Rash vesicular
Clinical narrative: Patient present to clinic on 6/12/19 with complaints of progressing rash for 4 days. Week prior (6/4/19) patient with fevers 100-101 degrees F.  SKin appeared normal with sl rashes noted papular and raised about 0.5-1mm around and older lesions crusting on the posterior trunk and individual about 5-8 and newer lesions are more vesicular, dew drop on a rose petal with erythematous base that is broader by about 4mm or so.  Symptomatic treatment recommended.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Scab, Skin lesion
Clinical narrative: Patient present to clinic on 6/12/19 with complaints of progressing rash for 4 days. Week prior (6/4/19) patient with fevers 100-101 degrees F.  SKin appeared normal with sl rashes noted papular and raised about 0.5-1mm around and older lesions crusting on the posterior trunk and individual about 5-8 and newer lesions are more vesicular, dew drop on a rose petal with erythematous base that is broader by about 4mm or so.  Symptomatic treatment recommended.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Malaise, Pain, Pyrexia
Clinical narrative: Body aches, malaise at 24 hrs post vaccine Streak down left arm 72 hrs post vaccine Fever 5 days post vaccine with increased redness distal to vaccine injection site Worsening redness 6 days post vaccine, malaise
Age: 2.0
Sex: M
Vaccine: UNK, VARCEL
Symptoms: Pyrexia
Clinical narrative: fever if 102 F; This spontaneous report was received from a health professional (Medical assistant) via company representative refers to a 2-year-old male patient. The patient's concurrent conditions, medical history and concomitant medications were not provided.             On 13-JUN-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis from varicella (Dose, frequency, route, lot number, expiry date unspecified). Other suspect therapies included sterile diluent (STERILE DILUENT) (Dose, frequency, route, indication, lot number, expiry date unspecified). The patient's temperature had been taken and was normal prior to administration.      On 13-JUN-2019, the patient developed a fever (pyrexia) of 102 degree fahrenheit, within 30 minutes of administration of his first dose of varicella virus vaccine live (oka/merck)(VARIVAX).  The patient's mother administered MOTRIN to the patient and brought the patient back into the physician's office where it was determined the fever resolved, and the patient was sent back home. The patient sought medical attention. No cancer diagnosed, no significant disability, no prolonged hospitalization, no overdose and no PQC involved. No additional information provided.      On 13-JUN-2019, the outcome of pyrexia was reported as resolved. Reporter's causality was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Myalgia, Pain, Rash erythematous
Clinical narrative: muscle aches; very hot rose cheeks; headache; upset stomach; pain; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th May 2019, the patient received the 2nd dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced muscle pain, red confluent rash cheeks, headache, upset stomach and pain. On an unknown date, the outcome of the muscle pain, red confluent rash cheeks, headache, upset stomach and pain were unknown.   It was unknown if the reporter considered the muscle pain, red confluent rash cheeks, headache, upset stomach and pain to be related to Shingrix.  Additional details were provided as folows: The age at vaccination was not reported. The patient was having muscle aches, very hot roses cheeks plus a headache and upset stomach. The patient asked should they call their primary care physician (PCP). The patient asked could they take anything for the pain.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: injection site reaction--redness/swelling approximately 4in by 2.5in in size. patient reported itching
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: SHE GOT HER 2ND SHOT ON THURSDAY AND NOTICED FRIDAY THAT SHE WAS GETTING SHINGLES. SHE CONTACTED THE PHARMACY TO REPORT ON MONDAY EVENING AND I ENCOURAGED HER TO CALL HER DR.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Impaired work ability, Injection site pain, Injection site swelling, Pain
Clinical narrative: Injection site swelling and pain.  Fever (102 F). Pain in feet, legs, arms, torso.  Headache.  Sensitivity  to light.  Reactions severe enough to prevent me from going to work today.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Photophobia, Pyrexia
Clinical narrative: Injection site swelling and pain.  Fever (102 F). Pain in feet, legs, arms, torso.  Headache.  Sensitivity  to light.  Reactions severe enough to prevent me from going to work today.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain, Asthenia, Dizziness
Clinical narrative: WEAKNESS, DIZZINESS, AND SEVERE ABDOMINAL PAIN 1-2 DAYS AFTER INJECTION, SYMPTOMS IMPROVED 4  DAYS AFTER INJECTION
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Asthenia, Chills, Diarrhoea, Fatigue
Clinical narrative: Chills- Started Saturday continued until Tuesday Feeling weak-Started Saturday ,still feel very tired Feeling "out of it"- Saturday until Tuesday (feel a little more with it Tuesday) Soreness and redness at injection site- Sunday, continuing on Tuesday Diarrhea and abdominal cramping- Began Sunday evening, continuing on Tuesday
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site erythema, Injection site pain
Clinical narrative: Chills- Started Saturday continued until Tuesday Feeling weak-Started Saturday ,still feel very tired Feeling "out of it"- Saturday until Tuesday (feel a little more with it Tuesday) Soreness and redness at injection site- Sunday, continuing on Tuesday Diarrhea and abdominal cramping- Began Sunday evening, continuing on Tuesday
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: provider ordered hpv vaccine, vaccine given , pt had hpv series previously
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt was given an intramuscular injection of Tdap vaccine on 2/21/19 that had expired on 1/21/19. The adminstering RN attempted to contact the patient, but was unable to reach him due to pt's homeless status. Pt returned to clinic 5/2/19 and this RN discussed vaccine with him. Pt denies any adverse reaction and refuses a new Tdap vaccine. Pt states that he does not want to be vaccinated again. Educated patient about tetanus- patient verbalizes understanding and denies questions at this time.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia, Pain
Clinical narrative: About 8 hours after vaccine, I felt muscle and body aches all over similar to flu symptoms
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Myalgia
Clinical narrative: Headache, muscle ache, chills (shivering), extreme soreness at injection site
Age: 0.58
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Patient was given this a 4th time vs the recommended 3 times.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Abdominal pain, Abdominal pain upper, Headache, Injection site erythema, Injection site swelling
Clinical narrative: My son's area where the shot was given got red, swollen, and hot to the touch. He also developed a fever about 7 hours after he received the shot. His fever has lasted since Friday. This is the 5th day with the fever. He also complains of tummy aches, head hurting, and stomach pain.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: My son's area where the shot was given got red, swollen, and hot to the touch. He also developed a fever about 7 hours after he received the shot. His fever has lasted since Friday. This is the 5th day with the fever. He also complains of tummy aches, head hurting, and stomach pain.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: muscle pain; whole body hurts; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th May 2019, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced muscle pain and general body pain. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the muscle pain and general body pain were unknown.   It was unknown if the reporter considered the muscle pain and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient expereienced a listed side effects  as muscle pain.  The patient's whole body hurts and asked how long would  the side effects last. The patient took 2 Advil about 20 minutes ago from the repoerting date. The muscle pain didn't concern the patient and just want to know how long it's going to last.
Sex: M
Vaccine: FLU4
Symptoms: Apgar score normal, Blood bilirubin increased, Foetal exposure during pregnancy, Hyperbilirubinaemia neonatal, Jaundice neonatal
Clinical narrative: Drug exposure in utero; Physiological jaundice; Hyper bilirubinemia; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of neonatal jaundice in a male neonate exposed to Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) (batch number Y53NN, expiry date 30th June 2019) in utero. The mother received the product for prophylaxis.   Co-suspect product exposures included Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) (batch number Y53NN, expiry date 30th June 2019).   The parent's medical history included Family history of uncle included Down's syndrome. On a certain date, preterm delivery occured.   On 19th September 2018, the 29-year-old mother received Fluarix Quadrivalent 2018-2019 season .5 ml. On 17th October 2018, the mother received Fluarix Quadrivalent 2018-2019 season .5 ml. The mother's last menstrual period was on 6th March 2018 and estimated date of delivery was 11th December 2018. The neonate was exposed to Fluarix Quadrivalent 2018-2019 season at week 28 of gestation and during the third trimester of pregnancy. At 37 weeks and 5 days, the neonate was born via vaginal delivery and weighed 3628 grams (8lbs) at birth. APGAR scores were 9 and 9. The neonate was diagnosed with neonatal jaundice and bilirubinemia newborn. On an unknown date, the neonate experienced drug exposure in utero. The neonate was treated with ascorbic acid + ergocalciferol + retinol palmitate (Trivisol). On 4th December 2018, the outcome of the neonatal jaundice and bilirubinemia newborn were recovered/resolved. On an unknown date, the outcome of the drug exposure in utero was unknown.   It was unknown if the reporter considered the neonatal jaundice and bilirubinemia newborn to be related to Fluarix Quadrivalent 2018-2019 season and Fluarix Quadrivalent 2018-2019 season.     See case US2018190948 for details regarding the mother case.  Additional details were provided as follows: The gender of baby was male. The length was 20 and half inches. The head circumstance was 37 centimeters. On 30th November 2018, lab test for total bilirubin was performed. This case has been linked to mother case US2018190948, reported by same reporter.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Peripheral swelling
Clinical narrative: Shingles like reaction on back; Swelling on Arm; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   On 30th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 11 days after receiving Shingrix, the patient experienced shingles and swelling arm. On an unknown date, the outcome of the shingles and swelling arm were unknown.   It was unknown if the reporter considered the shingles and swelling arm to be related to Shingrix.  Additional details were provided as follows: The pharmacist stated that the patient was administered Shingrix vaccine and about 11 days later the patient experienced a shingles like reaction on her back.  The patient visited her physician before the date of reporting and as per the physician it was Shingles.  Less than a month after receiving Shingrix, the patient also experienced swelling on the arm which was almost gone. No further details were provided.
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Hard red lump at injection site, RT thigh, Varicella and Hep A given in that thigh. A photograph was taken of the adverse event.   Treatment is: continue taking Vitamin D, follow up at home  and parents are to call if it is getting larger or if it is getting worse in any way.
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: Developmental regression, Emotional disorder, Fear, Sensory processing disorder, Speech disorder
Clinical narrative: Speech regression, emotional stagnation, abnormal fears. Sensory processing issues
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT WAS GIVEN THE PROQUAD AND A SEPERATE VARICELLA VACCINE TOGETHER ON DATE 06/17/19 HE HAS HAD NO REACTION TO THE VACCINES AT THIS DATE. THE VACCINATION WAS GIVEN BY, CCMA BY MISTAKE. PARENT HAS BEEN NOTIFIED OF THIS ACCIDENT.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effects were reported; patient was inadvertently administered a dose of PNEUMOVAX 23 (unknown lot/expiration date) instead of a dose of Prevnar 13; This spontaneous report was received from a physician and refers to an almost 2-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in May 2019 (reported as unknown date last week), the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency, route of administration, lot# and expiration date were not reported) instead of pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (dose, frequency, route of administration, lot# and expiration date were not reported), for prophylaxis.The physician confirmed that this was not a product confusion. No adverse effects were reported.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Culture stool positive, Diarrhoea haemorrhagic, Haematochezia, Incomplete course of vaccination, Stool analysis abnormal
Clinical narrative: Bloody diarrhoea; The patient did not finish the ROTATEQ series; This spontaneous report has been received from a physician, via a company representative, and refers to a 2 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant therapies, drug allergies or reactions were not reported.    On an unknown date (reported as "several months ago"),  the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), oral (lot #, expiration date, dose and frequency were not reported) to prevent rota-virus. On an unspecified date (reported as " the next day"), the patient experienced "bloody diarrhea"  (haematochezia) and went back to the physician office. A stool culture test performed to the patient was positive for blood in stool. On an unspecified date (reported  as "4 - 6 days later"), the diarrhea cleared on his own but the patient did not finish the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) series.  The causality assessment between haematochezia and Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ) was unknown.   Upon internal review the event haematochezia was considered as medically significant.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect; one dose of expired vacine administered; This spontaneous report was received from a nurse  regarding to a 4-year-old female patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 10-JUN-2019, the patient was vaccinated with one dose of expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) via subcutaneous, lot # N035176 and expiry date 09-JUN-2019 (strength was not reported) for prophylaxis,(expired product administered). No adverse effects were reported. The nurse described there was no product quality complaint.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a physician via sales rep and described the occurrence of fever in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patients experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The reporter wanted us to know they just started giving shingrix in office. and have had a lot of patient complain of fevers reviewed package insert with them again. They were good with information and realize fevers might happen. The reporter did not agreed to follow up with GlaxoSmithKline.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: soreness at injeciton site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine Quadrivalent 2018-2019 season.  Additional details were provided as follows: In 2019, the patient received a flu shot product name unknown and she experienced pain at injection site that resolved. The reporter did not consent to follow up. This case has been linked with case US2019104323, reported by the same reporter for same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient had a small rash after vaccination with Shingrix. The reporter declined to provide contact information. The reporter had no other information to provide. The reporter stated that the adverse event was reported to VAERS two months ago.
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Malaise, Pyrexia
Clinical narrative: felt faint; fever; sick; This case was reported by a consumer via call center representative and described the occurrence of felt faint in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced felt faint, fever and sickness. On an unknown date, the outcome of the felt faint, fever and sickness were unknown.   It was unknown if the reporter considered the felt faint, fever and sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix recently and experienced fever, felt faint and was sick. The reporter did not had any further details.  The reporter did not consent to follow up. This case has been linked with case US2019104323, reported by the same reporter.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Influenza like illness, Malaise
Clinical narrative: flu-like symptoms; sick; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number G72ZD, expiry date unknown) for prophylaxis.   On 10th April 2019, the patient received the 1st dose of Shingrix. In April 2019, several hours after receiving Shingrix, the patient experienced influenza-like symptoms and sickness. On an unknown date, the outcome of the influenza-like symptoms and sickness were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and sickness to be related to Shingrix.  Additional details were provided as follows: The flu-like symptoms began a few hours after the dose and the patient called out sick from work during this time.  The patient experienced flu-like symptoms for a few days after vaccination. The patient was uncertain about receiving the 2nd dose. The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Diaphragmatic paralysis, Inappropriate schedule of product administration, Pulmonary function test decreased
Clinical narrative: Inappropriate schedule of vaccine; paralyzed diaphragm; low right lung function; This case was reported by a consumer via call center representative and described the occurrence of diaphragmatic paralysis in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In March 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In July 2018, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced diaphragmatic paralysis (serious criteria GSK medically significant) and lung function decreased. On an unknown date, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the diaphragmatic paralysis, lung function decreased and inappropriate schedule of vaccine administered were unknown.   It was unknown if the reporter considered the diaphragmatic paralysis and lung function decreased to be related to Shingrix.  Additional details were provided a follows: The symptoms began around July 2018 and the patient was formally diagnosed in September 2018. The patient experienced paralyzed diaphragm on the right side as well as lowered lung function in the right lung. The reporter did not consent to follow-up. No lot number or specific dates were available. This case has been linked to case US2019105209, reported by same reporter.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Malaise
Clinical narrative: joint pain; malaise; This case was reported by a other health professional via call center representative and described the occurrence of joint pain in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number 92M54, expiry date 2nd June 2021) for prophylaxis.   On 31st May 2019, the patient received Shingrix. On 31st May 2019, less than a day after receiving Shingrix, the patient experienced joint pain and malaise. On 11th June 2019, the outcome of the joint pain and malaise were recovered/resolved.   It was unknown if the reporter considered the joint pain and malaise to be related to Shingrix.  Additional details were provided as follows: The patient had experienced joint pain and malaise for 11 days following the Shingrix shot.  No additional details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This case was reported by a pharmacist via call center representative and described the occurrence of diarrhea 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, an unknown time after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional stated the that patient experienced diarrhea after first dose of Shingrix.  The patient was not able to leave the house.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Grunting, Skin discolouration
Clinical narrative: Approximately 5-7 hours after vaccines administered, infant was sleeping, mom noticed infant grunting and color was grey . No vomiting,  no coughing, no known wheezing or aspiration, no fever.  Family called 911, once paramedics arrived (approx 20 minutes from discovery), pt was breathing well and paramedics "cleared" infant. Infant not taken to ER. Family noted similar but much more brief episode the next day as well.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Abdominal pain upper, Diarrhoea, Disorientation, Immediate post-injection reaction, Injection site erythema
Clinical narrative: 16 yo F presents to clinic with possible vaccine reaction or viral illness. Pts mother states pt came in on 6/12 for WCV and was given the 2 meningitis vaccines. Pt states immediately after the vaccine site on upper right arm became swollen, over the rest of the day it became progressively more swollen and irritated. Redness resolved over the next 1-2 days. However, pt states the next day she began experiencing stomach pain, nausea, diarrhea, night sweats and states felt "disoriented." Diarrhea has been loose, not watery and 2-3 times per day.  Pt has still eaten normally with her Weight Watchers  parameters and has not skipped meals or snacks or had abdominal pain.  Pt had gone to amusement park and a concert in the 2 days before her WCV and may have picked up something there.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Nausea, Night sweats, Vaccination site irritation, Vaccination site swelling
Clinical narrative: 16 yo F presents to clinic with possible vaccine reaction or viral illness. Pts mother states pt came in on 6/12 for WCV and was given the 2 meningitis vaccines. Pt states immediately after the vaccine site on upper right arm became swollen, over the rest of the day it became progressively more swollen and irritated. Redness resolved over the next 1-2 days. However, pt states the next day she began experiencing stomach pain, nausea, diarrhea, night sweats and states felt "disoriented." Diarrhea has been loose, not watery and 2-3 times per day.  Pt has still eaten normally with her Weight Watchers  parameters and has not skipped meals or snacks or had abdominal pain.  Pt had gone to amusement park and a concert in the 2 days before her WCV and may have picked up something there.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site oedema, Injection site reaction, Injection site swelling, Injection site warmth, Muscle spasms
Clinical narrative: Injection site swelling, edema, and warmth. Initial Tx with benadryl and icing with good relief. Then subjective complaints of intermittent muscle spasming and warmth at injection site without obvious physical exam findings X 1 week.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: Body aches and head aches started next day  after the vaccine was given.   We recommended to call his Doctor
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Muscle spasms
Clinical narrative: Around 10 minutes after vaccination, patient reported back spasms that radiating around to her chest.  After sitting to rest her back pain eased up but she reported to a hospital for examination.
Age: 1.17
Sex: F
Vaccine: MMRV
Symptoms: Rash erythematous, Rash maculo-papular, Rash vesicular
Clinical narrative: Erythematous macular popular rash (like dew drop on rose pedal) noted on multiple body surfaces - consistent with varicella rash in the absence of additional constitutional sxs
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site warmth, Lethargy
Clinical narrative: Pain at injection site, heat observed for at least 3 hours, fading away through the night. Chills and lethargy the following morning.
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Erythema, Fatigue, Headache, Pain in extremity
Clinical narrative: Slight headache, redness on arm, sore arm, chills (shivering) & mild fever, tiredness the following day.  Okay on second day.
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Slight headache, redness on arm, sore arm, chills (shivering) & mild fever, tiredness the following day.  Okay on second day.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Emotional distress, Fatigue, Guillain-Barre syndrome, Hypoaesthesia, Laboratory test
Clinical narrative: GBS/ Guillium Barre Syndrome, paralizied from neck down after recovery chronic numbness, tingling and fatigue. Also nerve pain in arms and legs. Providers didn't do anything, prescribed flexirill, 800 mg ibrphrion and not much help. Didn't get any mental help till 2017.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Neuralgia, Pain in extremity, Paraesthesia, Paralysis
Clinical narrative: GBS/ Guillium Barre Syndrome, paralizied from neck down after recovery chronic numbness, tingling and fatigue. Also nerve pain in arms and legs. Providers didn't do anything, prescribed flexirill, 800 mg ibrphrion and not much help. Didn't get any mental help till 2017.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Severe Rash, Dizziness, Severe Headache, Nausea, Fever, pain & swelling at the injection site. Treated with tylenol, Advil, Hydroxyzine, Prednisone Headache & fever came overnight on the 16th, rash, Dizziness & nausea was present when I woke up on the 16th. Arm was sore & swollen also.   Fever broke & nausea subsided  Evening of the 17th. Rash, slight headache & dizziness still present on the 18th.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Severe Rash, Dizziness, Severe Headache, Nausea, Fever, pain & swelling at the injection site. Treated with tylenol, Advil, Hydroxyzine, Prednisone Headache & fever came overnight on the 16th, rash, Dizziness & nausea was present when I woke up on the 16th. Arm was sore & swollen also.   Fever broke & nausea subsided  Evening of the 17th. Rash, slight headache & dizziness still present on the 18th.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: Client had a fever, nausea, and a headache the day after this vaccination.  She had a sore arm in the injection site from the day after continuing until today when someone reported it to me for her (6-18-19).  The fever, nausea, and headache have stopped but her arm is still sore today.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Malaise, Pallor
Clinical narrative: NURSE ADMINISTERED VACCINES- LEFT ROOM AS LAB TECH WAS ENTERING. CHILD OON THE TABLE AND ALREADY PALE.  ASKED CHILD IF SHE FELT OK- CHILD STATED "NO I FEEL LIKE SICK." IMMEDIATELY THE CHILD WAS LAID DOWN AND COLD COMPRESS APPLIED.  MOM IN ROOM AND CHILD INSTRUCTED TO RELAX AND BREATHE. AFTER ABOUT 5 MINS- LAB TECH LEFT THE ROOM TO GET A COLD DRINK. MOM STOOD AT HER SIDE WHILE STAFF NOT PRESENT. DR NOTIFIED AND LAB TECH AND DR ENTERED ROOM TOGETHER. CHILD ASSESSED AND RELEASED BY DR AFTER FURTHER 15 WAIT. TOTAL TIME OF EVENT25 MINS
Age: 51.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Arthralgia
Clinical narrative: Start having Arthritis pain in feet and fingers on 05/17/19 and symptoms gotten worse after second shot.
Age: 21.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effect; patient that is 21 years old received a dose of PROQUAD on 6/5/2019; This spontaneous report was received from a nurse and refers to a 21 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 05-JUN-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)lsubcutaneusly, lot # R030797, expiration date 22-APR-2020, for prophylaxis.  No adverse effects reported.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Back pain, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: high fever of 101 degrees Farenheit; The patient had severe body aches, headache, and back pain.; The patient had severe body aches, headache, and back pain.; The patient had severe body aches, headache, and back pain.; He looked like he had the flu and his mother was so concerned that she took him to the emergency room; This is a spontaneous report from a contactable nurse via a Pfizer sales representative.  A 17-year-old male patient received meningococcal group b rlp2086 (TRUMENBA) and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), both via an unspecified route of administration on an unspecified date on the arm at single dose for an unspecified indication and paracetamol (TYLENOL [PARACETAMOL]), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication.  The patient medical history and concomitant medications were not reported. It was reported on an unspecified date that 24 hours later, the patient had a high fever of 101 degrees Fahrenheit (pending clarification) after paracetamol was administered. The patient had severe body aches, headache, and back pain. He looked like he had the flu and his mother was so concerned that she took him to the emergency room. They ended up leaving without being seen because it was such a long wait. The action taken in response to paracetamol was unknown. The outcome of the events was unknown.   Information on the batch number has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Extra dose administered, Injection site pain, Pyrexia
Clinical narrative: This man is 74 years old. He received his 12 month booster (2nd dose) of Prevnar; Had a fever; Intense muscle pain in his arm at the injection site; This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A 74-year-old male patient received second dose (referred to as 12 month booster) pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), via an unspecified route of administration in the arm on an unspecified date at a single dose for immunization in the physician's office. Medical history included cardiac events and low tolerance for pain. The patient's concomitant medications were not reported. On an unspecified date, it was realized that the patient experienced inappropriate dose of vaccine administered as this man was 74-years-old and received his 12 month booster (2nd dose) of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein). The patient left the doctor's office at 11 am on 04Jun2019 reported as yesterday, and by dinner, had a fever of 101 and intense muscle pain in his arm at the injection site. He finished a light dinner and immediately went to sleep. He woke up the next day (05Jun2019) and felt significantly better and his temperature has returned to 98.6. The adverse events took place after use of the vaccine. The outcome of fever was recovered on 05Jun2019 while recovering for the event of 'intense muscle pain in his arm at the injection site'. The information regarding the batch/lot number has been requested.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: - 5 x 6 cm area of Erythematous Swon, (+) Tenderness on Rt Shoulder at site of vaccine Administration  - Keflex 500 TID
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: Pt. mother reported child ran 103' fever after shots were given on 6/11/19. Treated with Tylenol. Fever lasted until 6/12/19 in late evening.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cold sweat, Hyperhidrosis, Pallor, Shock, Skin discolouration
Clinical narrative: Patient became pale & dusky, shocky, sweaty and clamy & ashen. Patient given epi 1:1000, 0.02 ml after which patient improved and transported by paramedics to hospital.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head normal, Confusional state, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: 6/12/19 after 12-18 hours with edema, raised red bumps, tender and red at injection site. 6/13/19 with neurologic episode of temporary confusion that resolved for now
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: 6/12/19 after 12-18 hours with edema, raised red bumps, tender and red at injection site. 6/13/19 with neurologic episode of temporary confusion that resolved for now
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left upper arm with pink swelling approximately 3"x4" in size, no induration, using arm normally, no apparent pain or itch. Symptoms occurred in 1st 24 hours after vaccine.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Malaise, Pyrexia
Clinical narrative: Fever 103-101 Chills Unwellness headache
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: -Rash in cape distribution across shoulders (bilaterally, upper chest, upper back) within minutes of TDaP. No wheeze or cough. Zyrtec 10 mg given; ice applied.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: L arm erythema, edema, pruritus, warmth, tenderness
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Headache Fatigue  Body Aches Chills Hot Rash on R. side Large, Red bump feeling Hot @ injection site and 4 inches below injection site symptoms Lasting 3 days Tylenol taken & Benedryl For Rash
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain, Rash, Skin warm
Clinical narrative: Headache Fatigue  Body Aches Chills Hot Rash on R. side Large, Red bump feeling Hot @ injection site and 4 inches below injection site symptoms Lasting 3 days Tylenol taken & Benedryl For Rash
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; patient received an improperly stored dose of GARDASIL 9 on 23-MAY-2019.; This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.   On 03-OCT-2018, the patient was vaccinated with the first dose and on 15-JAN-2019, received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, anatomical location, lot # and expiration date were not reported) intramuscularly as prophylaxis.  On 23-MAY-2019, the patient was vaccinated intramuscularly with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) which was improperly stored (strength, dose, and anatomical location were not reported) involved lot # was R003557, expiration date reported as 10-NOV-2020, but upon internal validation established as 20-NOV-2020. The administered dose of the vaccine experienced a temperature excursion for an unknown time frame. It was unknown if a previous excursion occurred, and this call was not placed because of a data logger. There was no adverse effect reported. No product quality complaint was involved.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: site pain and minor swelling; site pain and minor swelling; This spontaneous report was received from a licensed practical nurse and refers to a 13-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 15-APR-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R003557 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 20-NOV-2020 in the right deltoid (exact dose and route of administration were not reported).  On an unknown date in 2019, the patient experienced site pain and minor swelling. The outcome of the events was unknown. The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.      This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1712USA007049:
Sex: U
Vaccine: MENB
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Trumenba was given to a patient yesterday and the patient called today with a fever of 102 degrees and flu-like symptoms; Trumenba was given to a patient yesterday and the patient called today with a fever of 102 degrees and flu-like symptoms; This is a spontaneous report from a contactable healthcare professional on behalf of a physician. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on 10Jun2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The meningococcal group b rlp2086 (TRUMENBA) was given to patient yesterday and the patient called today with a fever of 102 degrees and flu-like symptoms. The outcome of the events was unknown.  The following information on the batch number has been requested.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Crying, Drooling, Emotional poverty, Head banging, Influenza virus test negative
Clinical narrative: On Day 5 after the Fluzone Quadrivalent  vaccination, our son developed a high fever (greater than 103) and significant Malaise.  He became uninterested in all activities, even things that normally excite him.  All he wanted to do was sit/lay down and stare ahead.  At multiple points he was just sitting, staring, & drooling.   On day 6 after the vaccination (and 24 hours after symptoms) I took him back to the Doctor.  (12/16/2018).  The doctor recorded his fever as 103.8 & observed that he looked sick.  They tested him for influenza.  The in office nose swab test came back negative.  The doctor recommended children's Motrin or ibuprofen and to bring him back if the fever lasted more than 3-4 days. The high fever continued for 4 more days (total of 5 days) and remained above 103 deg F whenever the ibuprofen wore off.  With Ibuprogen it would lower to a 101-102 degree fever, but he always had a fever for 5 days.  At night our son would have outburts of unconsolable crying and toss and turn and hit his head against the wall. I called the dr again on Day 7 (2 days after sickness started) however they still recommended to wait out the fever.   After 5 days of  fever &  feeling very unwell, he began to return to normal temp and behavior.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Malaise, Pyrexia, Restlessness, Staring
Clinical narrative: On Day 5 after the Fluzone Quadrivalent  vaccination, our son developed a high fever (greater than 103) and significant Malaise.  He became uninterested in all activities, even things that normally excite him.  All he wanted to do was sit/lay down and stare ahead.  At multiple points he was just sitting, staring, & drooling.   On day 6 after the vaccination (and 24 hours after symptoms) I took him back to the Doctor.  (12/16/2018).  The doctor recorded his fever as 103.8 & observed that he looked sick.  They tested him for influenza.  The in office nose swab test came back negative.  The doctor recommended children's Motrin or ibuprofen and to bring him back if the fever lasted more than 3-4 days. The high fever continued for 4 more days (total of 5 days) and remained above 103 deg F whenever the ibuprofen wore off.  With Ibuprogen it would lower to a 101-102 degree fever, but he always had a fever for 5 days.  At night our son would have outburts of unconsolable crying and toss and turn and hit his head against the wall. I called the dr again on Day 7 (2 days after sickness started) however they still recommended to wait out the fever.   After 5 days of  fever &  feeling very unwell, he began to return to normal temp and behavior.