chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Soreness in the right arm; right pectoral muscles soreness; Fatigue; Weakness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, 1 day after receiving Shingrix, the patient experienced pain in arm, fatigue, weakness and muscle pain. In April 2019, the outcome of the fatigue and weakness were recovered/resolved. On an unknown date, the outcome of the pain in arm and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, fatigue, weakness and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right arm. The patient experienced mild fatigue and weakness which lasted for two to three days. Also, the first two days after receiving Shingrix, the patient experienced soreness in the right arm and that soreness has spread to the right pectoral muscles. No further details were provided. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's father. The age at vaccination was not reported. After vaccination with Shingrix, the patient experienced sickness for a week and then it went away. No further details were provided.
Age: 20.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: Itchy rash; This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 20-year-old female patient who received Herpes zoster (Shingrix) (batch number KC9C4, expiry date 30th March 2020) for prophylaxis.   The patient's past medical history included lymphadenectomy (lymph nodes removed in the past on her left arm).   On 30th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 30th April 2019, 30 min after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in the left arm. The patient experienced itchy rash from her elbow to her shoulder on the left arm. No further details were provided.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Erythema, Headache, Pain in extremity
Clinical narrative: redness, arm was red; soreness, sore arm; chest broke out, rash on her chest, spine, ribs and pelvic area all on her right side; headache; diarrhea; achy joints; itching; This case was reported by an other health professional via sales rep and described the occurrence of erythema of extremities in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th January 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced erythema of extremities, pain in arm, rash, headache, diarrhea, joint pain and itching. On an unknown date, the outcome of the erythema of extremities, pain in arm, rash, headache, diarrhea, joint pain and itching were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, pain in arm, rash, headache, diarrhea, joint pain and itching to be related to Shingrix.  Additional details were provided as follows: The medical assistant reported that the patient received the 1st dose of Shingrix on an unknown arm.  The patient called the physician's office after the vaccination and reported that her arm was red and sore and her chest broke out and she had a headache, diarrhea, achy joints, rash on her chest, spine, ribs and pelvic area all on her right side.  The patient had no pain but only itching.  All of her symptoms resolved after two weeks. The reporter provided the consent to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: redness, arm was red; soreness, sore arm; chest broke out, rash on her chest, spine, ribs and pelvic area all on her right side; headache; diarrhea; achy joints; itching; This case was reported by an other health professional via sales rep and described the occurrence of erythema of extremities in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th January 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced erythema of extremities, pain in arm, rash, headache, diarrhea, joint pain and itching. On an unknown date, the outcome of the erythema of extremities, pain in arm, rash, headache, diarrhea, joint pain and itching were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, pain in arm, rash, headache, diarrhea, joint pain and itching to be related to Shingrix.  Additional details were provided as follows: The medical assistant reported that the patient received the 1st dose of Shingrix on an unknown arm.  The patient called the physician's office after the vaccination and reported that her arm was red and sore and her chest broke out and she had a headache, diarrhea, achy joints, rash on her chest, spine, ribs and pelvic area all on her right side.  The patient had no pain but only itching.  All of her symptoms resolved after two weeks. The reporter provided the consent to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Nausea, Vomiting
Clinical narrative: vomiting; nausea; shivering; weakness; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th April 2019, the patient received Shingrix. On 29th April 2019, less than a day after receiving Shingrix, the patient experienced shivering and weakness. On 30th April 2019, the patient experienced vomiting and nausea. On an unknown date, the outcome of the shivering, weakness and nausea were not recovered/not resolved and the outcome of the vomiting was unknown.   It was unknown if the reporter considered the shivering, weakness, vomiting and nausea to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in unknown arm on monday and started having shivering and weakness that day.  One day after receiving Shingrix, tuesday night she vomited and she felt like she was going to vomit again.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Fatigue, Myalgia, Pyrexia
Clinical narrative: low grade fever; fatigue; myalgia; Overdose; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number 4LH35, expiry date 11th September 2021) for prophylaxis.   Previously administered products included Shingrix (1st dose received in fall of 2018) and Shingrix (2nd dose received on 30th January 2019).   On 30th April 2019, the patient received the 3rd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever, fatigue, myalgia and extra dose administered. On an unknown date, the outcome of the fever, fatigue, myalgia and extra dose administered were unknown.   It was unknown if the reporter considered the fever, fatigue and myalgia to be related to Shingrix.  Additional details were provided as follows: The patient was forgot that, he received 2nd dose of Shingrix in the month of January. The patient received 3rd dose of Shingrix, which led to extra dose administered. Less than a week after vaccination with Shingrix, the patient experienced low grade fever, fatigue and myalgia. The reporter did not consent to follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Blindness unilateral, Visual impairment
Clinical narrative: Partial blindness in one eye/visual disturbance; This case was reported by a pharmacist via call center representative and described the occurrence of partial sight in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced partial sight. Shingrix was discontinued. On an unknown date, the outcome of the partial sight was unknown.   It was unknown if the reporter considered the partial sight to be related to Shingrix.  Additional details were provided as follows: The patient was a physician assistant. Approximately two months after receiving the Shingrix, the reporter made a routine call to the patient to schedule him to receive the second dose. The patient's wife answered the phone and told the reporter that the patient experienced visual disturbances, and partial blindness in one eye after receiving the Shingrix vaccine. The patient did seek medical assistance. Currently it was unknown if these symptoms were related to the vaccine. The patient's wife indicated that her husband had chosen not to receive the second dose of the product.  The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vertigo, Vomiting
Clinical narrative: vertigo; vomiting; arm sore; This case was reported by a consumer via call center representative and described the occurrence of vertigo in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included vertigo. Concomitant products included methylprednisolone.   On 25th April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, less than a month after receiving Shingrix, the patient experienced pain in arm. On 26th April 2019, the patient experienced vertigo and vomiting. On an unknown date, the outcome of the vertigo, vomiting and pain in arm were unknown.   It was unknown if the reporter considered the vertigo, vomiting and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient had a history of vertigo that was managed by her prescriber. The patient received a dose of Shingrix and the following morning experienced episode of vertigo and vomiting.  She reported that she also experienced a sore arm. The patient gave consent to contact the physician and provided contact details for the same.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: Fever; flu-like symptoms; chills; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 4LH35, expiry date 11th September 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 10 hrs after receiving Shingrix, the patient experienced fever, influenza-like symptoms and chills. On an unknown date, the outcome of the fever was recovering/resolving and the outcome of the influenza-like symptoms and chills were unknown.   The reporter considered the fever, influenza-like symptoms and chills to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in right arm. The patient experienced flu-like symptoms, fever of 103F and chills, ten hours after receiving her 1st dose of Shingrix. Her fever was slightly better the day after receiving Shingrix. The patient did not get medical treatment for this, except for reaching out to reporter to report her symptoms. The reporter believed that the symptoms were 100 % likely to be caused by the Shingrix. The reporter provided the consent for follow-up      Lab Comments: On an unknown date, patients body temperature was 103 F
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Fever Blister on Nose; This case was reported by a pharmacist via call center representative and described the occurrence of fever blister in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number CF9K4, expiry date 11th September 2021) for prophylaxis.   On 29th April 2019, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was unknown.   It was unknown if the reporter considered the fever blister to be related to Shingrix.  Additional details were provided as follows: The patient had developed fever blister on nose. The reporter asked the question that if the patient could take Valtrex without causing Shingrix to be less effective and gathered patient's information.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspeified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, but taken as an adult as per vaccine indication. The pharmacist said that she had heard complaints from patients that the Shingrix injection gave soreness at the injection site. The reporter did not consent to follow up. .
Sex: U
Vaccine: TDAP
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: vaccine has not been fully administered; less than a full recommended dose of a vaccine is administered because of syringe or needle leakage; when vaccine was given to patient a few drops ran down patients arm; Initial information received on 25-Jan-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves patient of unknown demography who did not receive vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] fully as few drops ran down patients arm while administration via unknown route and unknown site on an unknown date (not number not reported).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   This is a case of exposure via skin contact   It was also a case of actual medication error due to vaccine underdose and syringe or needle leakage.  It was not reported if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Follow up information was received from a physician on 04-Apr-2019.  No new information was reported.  List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: administration of the Adacel vaccine to a pregnant patient/ No AE; Initial information received on 25-Jan-2019 regarding an unsolicited valid non-serious case received from a Pharmacist.  This case involves female patient of 26 year old who was vaccinated with 0.5 mL single dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6141AB, expiry date: 15-Dec-2020 via unknown route in the left deltoid on 24-Jan-2019 while she was pregnant.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines were given on that day.  It was a case of vaccine exposure during pregnancy   No adverse reaction occurred after vaccination.  It was reported that the baby not due until 4-Aug-19.  Pregnancy outcome was unknown at the time of report.  List of documents held by sender- none.  Follow up information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  Patients age was updated.  List of documents held by sender: none.  Follow up information received on 05-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  No new information reported.  List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: vaccine was too long in transit and they administered it yesterday; Initial information received on 25-Jan-2019 regarding an unsolicited valid non-serious case received from a Consumer/Non-HCP.  This case involves patient of unknown demography who received a dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot number not reported via unknown route in unknown administration site, that was too long in transit on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to incorrect product storage.  The Adacel was shipped on the 21st and we got it on the 24th. Reporter thinks that they were cold when they arrived but not sure of the temperature. They did not notice until after the vaccine was given that it took more than two days for vaccine to get here.  It was not reported if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Follow-up report received from a consumer or non-healthcare professional on 07-Mar-2019.  No new information received.  List of documents held by sender: none.
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 16 month old female received Adacel instead of Daptacel/ No AE; a 16 month old female received Adacel instead of Daptacel/ No AE; Initial information received on 01-May-2019 and additional information also received on same day regarding an unsolicited valid non-serious case, from a nurse.  This case involves a 16 months old female patient who received 0.5 mL dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot number: U6103AA, expiry date: 25-Oct-2020, via unknown route in the right leg instead of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] on 29-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation; POLIO VACCINE (POLIO) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  No side effects were reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Pruritus generalised
Clinical narrative: Patient started itching all over within an hour after receiving a shot of Adacel; Initial information received on 30-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a female patient of unknown age who experienced itching all over within an hour after receiving a shot of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number: C5560A, expiry date not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious itching all over within an hour after receiving a shot of Adacel (Pruritus generalised) within an hour following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Other relevant tests included were not reported.  Final diagnosis was Pruritus generalised.   It was not reported if the patient received a corrective treatment.  The event outcome was not reported.  List of documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Injection site discomfort, Pain
Clinical narrative: Body aches, headache, fatigue, arm soreness at injection site
Age: 54.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: I do not know for sure if this is a side effect of the vaccine, but wanted to report.  I experienced uncontrollable, whole body shivering, severe headache, and fatigue. The shivering was accompanied by alternating chills and fever.  I received the vaccine on Monday, 5/6/2019.  I started shivering Wednesday, 5/8/2019, after being in bed for about 45 minutes of sleep.  The shivering lasted about 3 hours.  The headache lasted through the night and into the next day (Wednesday, 5/8/2019-Thursday, 5/9/2019).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Abnormal behaviour, Aggression, Anger, Hair metal test, Intentional self-injury
Clinical narrative: Shortly after vaccination, my daughters behavior spiraled out of control. She began having rage episodes and sensory meltdowns multiple times a day, that lasted up to an hour per episode. She began stimming, wringing her hands, chewing on her fingers, scooting along the floor and needing constant physical stimulation. She was unable to sit still for more than 1-2 minutes at a time. She became extremely inflexible and rigid in personality, unable to handle even the slightest change in schedule. She began mixing up her letters. She was eventually diagnosed with PANDAS and multiple chemical sensitivity one year after her 5 year shots (as documented above), during which time we were actively trying to pinpoint what was wrong with her. It is obvious that it began with this vaccination.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Multiple chemical sensitivity, Organic acid analysis, Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection, Personality change, Psychomotor hyperactivity
Clinical narrative: Shortly after vaccination, my daughters behavior spiraled out of control. She began having rage episodes and sensory meltdowns multiple times a day, that lasted up to an hour per episode. She began stimming, wringing her hands, chewing on her fingers, scooting along the floor and needing constant physical stimulation. She was unable to sit still for more than 1-2 minutes at a time. She became extremely inflexible and rigid in personality, unable to handle even the slightest change in schedule. She began mixing up her letters. She was eventually diagnosed with PANDAS and multiple chemical sensitivity one year after her 5 year shots (as documented above), during which time we were actively trying to pinpoint what was wrong with her. It is obvious that it began with this vaccination.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Stereotypy, Streptococcus test, Streptococcus test positive, Toxicologic test, Urine analysis
Clinical narrative: Shortly after vaccination, my daughters behavior spiraled out of control. She began having rage episodes and sensory meltdowns multiple times a day, that lasted up to an hour per episode. She began stimming, wringing her hands, chewing on her fingers, scooting along the floor and needing constant physical stimulation. She was unable to sit still for more than 1-2 minutes at a time. She became extremely inflexible and rigid in personality, unable to handle even the slightest change in schedule. She began mixing up her letters. She was eventually diagnosed with PANDAS and multiple chemical sensitivity one year after her 5 year shots (as documented above), during which time we were actively trying to pinpoint what was wrong with her. It is obvious that it began with this vaccination.
Age: 48.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Feeling abnormal, Gait disturbance, Mobility decreased, Nausea
Clinical narrative: Per Patient: Arm became extremely sore the following morning, and remained sore for 3 days. Arm difficult to move the following day, and lasted one day Felt ?off? since receiving the shot, starting to feel normal Friday ? some feeling of nausea at times Right knee started to become sore Thursday morning, and became progressively worse during the day, difficult to walk at times.  Woke up this morning with the knee feeling a little sore.  Did not have this pain pre shot, and didn?t do anything that I am aware of to cause the knee pain
Age: 48.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Per Patient: Arm became extremely sore the following morning, and remained sore for 3 days. Arm difficult to move the following day, and lasted one day Felt ?off? since receiving the shot, starting to feel normal Friday ? some feeling of nausea at times Right knee started to become sore Thursday morning, and became progressively worse during the day, difficult to walk at times.  Woke up this morning with the knee feeling a little sore.  Did not have this pain pre shot, and didn?t do anything that I am aware of to cause the knee pain
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Diarrhoea, Keratosis pilaris
Clinical narrative: Soon after her 2 month shots, she developed watery diarrhea and keratosis pilaris on her skin.
Age: 76.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient reported swelling and redness in her left arm. She walked into the office to advise us of the reaction. She was seen by the provider in office.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Breech presentation, Caesarean section, Cow's milk intolerance, Exposure during pregnancy, Foetal non-stress test
Clinical narrative: Immediately after vaccination, I developed severe polyhydramnios that led bi-weekly non-stress tests and ultrasounds,  breech presentation and eventual C section delivery at 37 weeks.   I also developed an allergy to eggs and dairy post vaccination.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Food allergy, Immediate post-injection reaction, Polyhydramnios, Ultrasound antenatal screen
Clinical narrative: Immediately after vaccination, I developed severe polyhydramnios that led bi-weekly non-stress tests and ultrasounds,  breech presentation and eventual C section delivery at 37 weeks.   I also developed an allergy to eggs and dairy post vaccination.
Age: 0.17
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 59.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Pyrexia, Rash generalised, Varicella post vaccine
Clinical narrative: patient developed a rash at the injection site/patient developed a fever of 101F/On 4/12/2019, patient visited physician, who diagnosed the rash as chickenpox.; Information has been received from a physician referring to a 59-year-old male patient. The patient's concomitant medications included atorvastatin calcium (LIPITOR) and fluvoxamine maleate (LUVOX). The patient was allergic to shellfish. The patient's pertinent medical histories included anxiety and gallbladder removal. The patient also got fatty liver disease and borderline hypertension, which got improved with weight loss.  On an unknown date, the physician drew pre-vaccination titers on the patient with the result of negative for varicella zoster virus (vzv), Immunoglobulin M (IgM) and Immunoglobulin G (IgG). On 28-MAR-2019, the patient was administered his first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 ml once, lot# and expiration date unknown) with sterile diluent (dose, lot# and expiration date unknown) subcutaneously for the prevention of varicella. On 08-APR-2019, the patient developed a rash at the injection site. On 09-APR-2019, the rash began to spread to the patient's trunk and arms, and the patient developed a fever of 101 Fahrenheit (F). On 10-APR-2019, the patient's fever increased to 102 F. On 11-APR-2019, the patient's fever decreased to 101 F, but the rash continued to spread all over his entire body including his face. On 12-APR-2019, the patient sought medical attention by visiting the physician, who diagnosed the rash as chickenpox. The physician also drew repeat titers but the results were not yet available. The physician also reported that on 12-APR-2019, the rash had started to fade and the patient's fever had decreased to 100.6 F. There was no treatment given for the event. The patient did not overdose.  The causality assessment was not provided.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; improperly stored PEDVAX HIB were administered/patient received one dose; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 10-APR-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, lot # R027320 with expiration date on 08-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The vaccine underwent the temperature excursion of above 47 (55.4) degrees Fahrenheit for 10 hours 45 minutes and below 36 (34.4) degrees Fahrenheit for 20 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1904USA012969: US-009507513-1904USA012970: US-009507513-1904USA012971: US-009507513-1904USA012972: US-009507513-1904USA012973: US-009507513-1904USA012974: US-009507513-1904USA012975: US-009507513-1904USA012976: US-009507513-1904USA012977: US-009507513-1904USA012978: US-009507513-1904USA012979: US-009507513-1904USA012980: US-009507513-1904USA012981: US-009507513-1904USA012967: US-009507513-1904USA012968:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; improperly stored PEDVAX HIB were administered/patient received one dose; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 12-APR-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, lot # R027320 with expiration date on 08-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The vaccine underwent the temperature excursion of above 47 (55.4) degrees Fahrenheit for 10 hours 45 minutes and below 36 (34.4) degrees Fahrenheit for 20 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA012614: US-009507513-1904USA012968: US-009507513-1904USA012969: US-009507513-1904USA012970: US-009507513-1904USA012971: US-009507513-1904USA012972: US-009507513-1904USA012973: US-009507513-1904USA012974: US-009507513-1904USA012975: US-009507513-1904USA012976: US-009507513-1904USA012977: US-009507513-1904USA012978: US-009507513-1904USA012979: US-009507513-1904USA012980: US-009507513-1904USA012981:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; improperly stored PEDVAX HIB were administered/patient received one dose; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 15-APR-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, lot # R027320 with expiration date on 08-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The vaccine underwent the temperature excursion of above 47 (55.4) degrees Fahrenheit for 10 hours 45 minutes and below 36 (34.4) degrees Fahrenheit for 20 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA012614: US-009507513-1904USA012967: US-009507513-1904USA012969: US-009507513-1904USA012970: US-009507513-1904USA012971: US-009507513-1904USA012972: US-009507513-1904USA012973: US-009507513-1904USA012974: US-009507513-1904USA012975: US-009507513-1904USA012976: US-009507513-1904USA012977: US-009507513-1904USA012978: US-009507513-1904USA012979: US-009507513-1904USA012980: US-009507513-1904USA012981:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; improperly stored PEDVAX HIB were administered/patient received one dose; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 22-APR-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, lot # R027320 with expiration date on 08-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The vaccine underwent the temperature excursion of above 47 (55.4) degrees Fahrenheit for 10 hours 45 minutes and below 36 (34.4) degrees Fahrenheit for 20 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA012973: US-009507513-1904USA012967: US-009507513-1904USA012968: US-009507513-1904USA012969: US-009507513-1904USA012970: US-009507513-1904USA012971: US-009507513-1904USA012972: US-009507513-1904USA012614: US-009507513-1904USA012974: US-009507513-1904USA012975: US-009507513-1904USA012976: US-009507513-1904USA012977: US-009507513-1904USA012978: US-009507513-1904USA012979: US-009507513-1904USA012980:
Sex: F
Vaccine: FLUX
Symptoms: Adverse event
Clinical narrative: drug intolerance; This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   Previously administered products included INFLUENZA VACCINE (received vaccine when the patient was young and very healthy) and TETANUS VACCINE (received about 8 years ago, after standing on a rusty nail).   On an unknown date, the patient received the 2nd dose of Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Flu vaccine which the patient never wants. The patient wish that she could tolerate the vaccine but she can't.  The patient relies on those around me getting the vaccine so I did not get exposed.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The physician stated that she had a patient go to the pharmacy for a Shingrix vaccine and the patient claimed they got shingles after the fact from the vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The reporter agreed to follow up from GlaxoSmithKline.
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Lichen planus
Clinical narrative: lichenplanus; This case was reported by a nurse via call center representative and described the occurrence of lichen planus in a female patient who received Herpes zoster (Shingrix) (batch number G72ZD, expiry date 24th November 2020) for prophylaxis.   In January 2019, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced lichen planus. On an unknown date, the outcome of the lichen planus was unknown.   It was unknown if the reporter considered the lichen planus to be related to Shingrix.  Additional details were provided as follows: The licensed practical nurse (LPN) reported that patient developed lichenplanus after receiving Shingrix in January 2019.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th February 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 27th February 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient had injection site soreness that last for one month. The consumer did not consent to physician or any follow up regarding this adverse event.  She did not have any vaccine information for this adverse event. The reporter did not consent to follow up.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Arthralgia, Back pain, Headache, Injection site pain, Musculoskeletal pain
Clinical narrative: Received call 04/27/19 from mom in regards to final HPV and first Trumenba vaccine given 04/26/19 and possible reaction concern.  Per  mom Patient began with fever, temp 101 yet felt much higher, HA and some muscle and joint pain all over, neck pain. Mom states no rash, no signs of respiratory distress, this morning resting in bed HA better, alert, does not feel warm to touch and unable to take temp., some soreness at injection site only.  Parent advised if symptoms worsened to bring in for evaluation, currently out of town, and may continue to monitor symptoms, cool compress at injection site, Tylenol PRN and to encourage fluids, physician reviewed and agreed with recommendations, and to follow up if symptoms worsened.  Received call on 04/30 with progress report for symptoms. Mom described overall symptoms. Had 2 days of fever with tmax of 102, body aches all over " neck back and shoulder" described by mom " on scale from 1-10 his body aches were a 6", HA. Mom states today is asymptomatic as well as yesterday, fever free x 3 days now and no longer with body aches x 2 days. Currently at school and doing well.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Myalgia, Neck pain, Pain, Pyrexia
Clinical narrative: Received call 04/27/19 from mom in regards to final HPV and first Trumenba vaccine given 04/26/19 and possible reaction concern.  Per  mom Patient began with fever, temp 101 yet felt much higher, HA and some muscle and joint pain all over, neck pain. Mom states no rash, no signs of respiratory distress, this morning resting in bed HA better, alert, does not feel warm to touch and unable to take temp., some soreness at injection site only.  Parent advised if symptoms worsened to bring in for evaluation, currently out of town, and may continue to monitor symptoms, cool compress at injection site, Tylenol PRN and to encourage fluids, physician reviewed and agreed with recommendations, and to follow up if symptoms worsened.  Received call on 04/30 with progress report for symptoms. Mom described overall symptoms. Had 2 days of fever with tmax of 102, body aches all over " neck back and shoulder" described by mom " on scale from 1-10 his body aches were a 6", HA. Mom states today is asymptomatic as well as yesterday, fever free x 3 days now and no longer with body aches x 2 days. Currently at school and doing well.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Pain, Pruritus
Clinical narrative: Started with redness & swelling at the site of injection (the size of my hand) that night. Next day flu-like symptoms (severe aching & low-grade fever) that kept me in bed the next 3 days. Used Advil for the aching which helped. Redness & swelling on my left arm that slowly spread down my arm continued for almost 2 weeks. Hot to the touch & itched badly. Within 5 days of the shot tiny red bumps (about 6 or 7) on my left arm that itched like crazy for almost 3 weeks.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Rash erythematous, Skin warm
Clinical narrative: Started with redness & swelling at the site of injection (the size of my hand) that night. Next day flu-like symptoms (severe aching & low-grade fever) that kept me in bed the next 3 days. Used Advil for the aching which helped. Redness & swelling on my left arm that slowly spread down my arm continued for almost 2 weeks. Hot to the touch & itched badly. Within 5 days of the shot tiny red bumps (about 6 or 7) on my left arm that itched like crazy for almost 3 weeks.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever, chills, muscle aches, nausea, some soreness at site of injection. Started about 7 hours after administration.
Age: 40.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Pain, Pain in extremity
Clinical narrative: The Anthrax vaccine was delivered to my right arm and the small pox in my left arm. My right arm has throbbed for several months. The pain is mostly when I sleep on my right arm. It was pretty bad for about 4 months. In the past couple weeks, it has gotten better. I went to the Dr for the first time today, he gave me some numbing patches.
Age: 56.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Bone pain, Dizziness, Pyrexia
Clinical narrative: Fever 102 Every bone/joint ached light headed (Lasted 24 hours)
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Chills, low grade fever (100.4) fatigue muscle aches
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Diarrhoea, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: left arm pain and hives fever, diarrhea, myalgias, abdominal pain
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: left arm pain and hives fever, diarrhea, myalgias, abdominal pain
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever, sweating,severe pain, swelling and redness at site and surrounding area
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood test, Dizziness, Erythema, Injected limb mobility decreased, Injection site discolouration
Clinical narrative: Fever, sweating,severe pain, swelling and redness at site and surrounding area
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Pain
Clinical narrative: Fever, sweating,severe pain, swelling and redness at site and surrounding area
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Fever, sweating,severe pain, swelling and redness at site and surrounding area
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness noted to right upper arm  Swelling
Age: 42.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Immediate post-injection reaction, Peripheral swelling
Clinical narrative: pt was given hep B and Pneumovac--  unsure which one--  arm started swelling immediately after injection
Age: 47.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Limb injury
Clinical narrative: patient states that he injured his shoulder and developed cellulitis which required cephalexin to treat.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Injection site reaction, Myalgia, Neuralgia
Clinical narrative: A sharp nerve like pain with administration. THe pain continued down the arm the next day and the following day.  It made my joints, muscles  and body ache along with fatigue.  By second day the soreness down length of arm continues but body wide aches are subsiding.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: A sharp nerve like pain with administration. THe pain continued down the arm the next day and the following day.  It made my joints, muscles  and body ache along with fatigue.  By second day the soreness down length of arm continues but body wide aches are subsiding.