chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MMRV, PNC13
Symptoms: Blepharospasm, Muscle twitching, Pyrexia, Viral infection, Vomiting
Clinical narrative: Fever given Tylenol,  later had emesis then temp went up to 102. Eyes got wide open, legs, eyes and shoulder  was twitching. Call EMS transported to Hospital . Was observed at hospital temp at 99.5 discharged home.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Neck pain
Clinical narrative: Fever, muscle aches, restlessness, headache, chills, neck pain, fatigue
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Restlessness
Clinical narrative: Fever, muscle aches, restlessness, headache, chills, neck pain, fatigue
Age: 18.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The patient experienced no symptoms; an 18 years old patient was administered an adult dose of VAQTA; This spontaneous report was received from a nurse referring to an 18 year old patient of unknown gender. Information about the patient's concurrent condition, concomitant medication, medical history and drug allergy/reaction was not reported.   On 13-MAY-2020, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) 50/1.0 Units/milliliter, lot # S007265, expiry date: 07-JUL-2020 via intramuscular route for prophylaxis (dose number and anatomical location were not reported) (incorrect dose administered). The patient experienced no symptoms (no adverse event). No product quality complaint was involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S007265; expirationdate: 07-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic, Rash vesicular
Clinical narrative: acute urticaria; shingles like rash/rash on her chest; blistery area/Vesicular rash; red, puffy, itchy, and some blistery area; red, puffy, itchy, and some blistery area; puffy rash; This case was reported by a nurse via sales rep and described the occurrence of urticarial rash in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number EG3A3, expiry date 12th October 2021) for prophylaxis.   In May 2020, the patient received the 2nd dose of Shingrix. In May 2020, less than a day after receiving Shingrix, the patient experienced urticarial rash, red rash, blistery rash, papular rash, itchy rash and puffy skin. The patient was treated with ALOE BARBADENSIS + LEVOMENTHOL + PRAMOCAINE HYDROCHLORIDE (GOLD BOND CREAM). On an unknown date, the outcome of the urticarial rash, red rash, blistery rash, papular rash, itchy rash and puffy skin were not recovered/not resolved.   It was unknown if the reporter considered the urticarial rash, red rash, blistery rash, papular rash, itchy rash and puffy skin to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix 3 days ago and at the time of reporting had painful shingles like rash on her upper torso.  The rash started on her chest that day and spread to right shoulder and back over the weekend.  The patient called the clinic and the physician recommended she come in to be seen. At the clinic, she was noted to have red, puffy, itchy, and some blistery area with slight vesicular rash on her arm that did not follow the dermatome. A diagnosis of acute urticaria was made and the treatment recommendation provided to the patient was to utilize cream for itch.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin swelling, Urticaria
Clinical narrative: acute urticaria; shingles like rash/rash on her chest; blistery area/Vesicular rash; red, puffy, itchy, and some blistery area; red, puffy, itchy, and some blistery area; puffy rash; This case was reported by a nurse via sales rep and described the occurrence of urticarial rash in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number EG3A3, expiry date 12th October 2021) for prophylaxis.   In May 2020, the patient received the 2nd dose of Shingrix. In May 2020, less than a day after receiving Shingrix, the patient experienced urticarial rash, red rash, blistery rash, papular rash, itchy rash and puffy skin. The patient was treated with ALOE BARBADENSIS + LEVOMENTHOL + PRAMOCAINE HYDROCHLORIDE (GOLD BOND CREAM). On an unknown date, the outcome of the urticarial rash, red rash, blistery rash, papular rash, itchy rash and puffy skin were not recovered/not resolved.   It was unknown if the reporter considered the urticarial rash, red rash, blistery rash, papular rash, itchy rash and puffy skin to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix 3 days ago and at the time of reporting had painful shingles like rash on her upper torso.  The rash started on her chest that day and spread to right shoulder and back over the weekend.  The patient called the clinic and the physician recommended she come in to be seen. At the clinic, she was noted to have red, puffy, itchy, and some blistery area with slight vesicular rash on her arm that did not follow the dermatome. A diagnosis of acute urticaria was made and the treatment recommendation provided to the patient was to utilize cream for itch.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Pyrexia, Rash
Clinical narrative: fever of 101 degrees F; chills; fatigue; weakness; Rash on the lower back, right side; rash that appear a purplish brown; This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on 26th November 2019, refer case US2020086074).   On 4th May 2020, the patient received the 2nd dose of Shingrix. In May 2020, 16 days after receiving Shingrix, the patient experienced fever, chills, fatigue, weakness, rash and skin discoloration. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, chills, fatigue, weakness, rash and skin discoloration were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, fatigue, weakness, rash and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The reporter was wife of the patient. The patient received Shingrix and 16 days after experiencing fever of 101 degrees F, chills, fatigue, weakness and rash. The rash was most apparent on the lower back, right side and was becoming thick and yellowish, and there are portions of the rash that appear a purplish brown. The symptoms at time of report had not improved. The reporter did not consent to follow up. Did not wish to provide contact information for provider until after discussion with her husband and the doctor. She provided a case number if the decision was to allow contact with the doctor.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: fever of 101 degrees F; chills; fatigue; weakness; Rash on the lower back, right side; rash that appear a purplish brown; This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on 26th November 2019, refer case US2020086074).   On 4th May 2020, the patient received the 2nd dose of Shingrix. In May 2020, 16 days after receiving Shingrix, the patient experienced fever, chills, fatigue, weakness, rash and skin discoloration. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, chills, fatigue, weakness, rash and skin discoloration were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, fatigue, weakness, rash and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The reporter was wife of the patient. The patient received Shingrix and 16 days after experiencing fever of 101 degrees F, chills, fatigue, weakness and rash. The rash was most apparent on the lower back, right side and was becoming thick and yellowish, and there are portions of the rash that appear a purplish brown. The symptoms at time of report had not improved. The reporter did not consent to follow up. Did not wish to provide contact information for provider until after discussion with her husband and the doctor. She provided a case number if the decision was to allow contact with the doctor.
Sex: U
Vaccine: FLUX
Symptoms: Ex-tobacco user, Malaise, Muscle strain
Clinical narrative: Strain; sick; This case was reported by a consumer via interactive digital media and described the occurrence of strain in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included smoker.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced strain and sickness. On an unknown date, the outcome of the strain and sickness were unknown.   It was unknown if the reporter considered the strain and sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient did get a flu shot, and came down with strong strain. The patient was so sick that the patient quit or stopped smoking.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: shingles rash; second Shingrix vaccination ten months after first dose was given; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 9th July 2018.).   On 3rd May 2019, the patient received the 2nd dose of Shingrix. On 3rd May 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the shingles and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient received second Shingrix vaccination ten months after first dose was given, which led to lengthening of vaccination schedule. The patient developed a shingles rash last week. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site extravasation
Clinical narrative: clear fluid leaked from the injection site; Possible the dose was given subcutaneously; This case was reported by a pharmacist via call center representative and described the occurrence of injection site leaking in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 43GJ4, expiry date 1st December 2021) for prophylaxis.   On 20th May 2020, the patient received the 2nd dose of Shingrix. On 20th May 2020, 3 min after receiving Shingrix, the patient experienced injection site leaking and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site leaking and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site leaking to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient received the second dose for Shingrix and 3 minutes after the vaccine was administer, a clear fluid leaked from the injection site. The pharmacist stated that the injection was administered through an onion-skin adhesive bandage according to the pharmacy procedures.  The patient had a large amount of adipose tissue, and it was possible the dose was given subcutaneously instead of intramuscular into the deltoid which led to intramuscular formulation administered by other route.  The pharmacist was unsure how much volume leaked from the site, but he did believe the liquid that leaked was the vaccine. It was reported that the patient did not experienced any adverse events. The reporter consented to follow up.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: levels were too low; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 19-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B, the 2nd dose of Engerix B and the 3rd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, Engerix B and Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Engerix B, Engerix B and Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. The nurse stated that a 19 year old female patient had serologic testing completed for work to check immunity for Hepatitis B.  Despite completing the Hepatitis B series as a child, the patient's antibody levels were too low, so she received a 1ML booster dose of Engerix-B on 28th April 2020. The reporter consented to follow up.  No further details provided by nurse.      Lab Comments: on an unknown date patient's serology test showed Antibody titre level low
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chemotherapy, Extra dose administered, Plasma cell myeloma, Stem cell transplant
Clinical narrative: myeloma; Extra dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of myeloma in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 3rd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced myeloma (serious criteria GSK medically significant) and extra dose administered. The patient was treated with chemotherapy, nos (Chemotherapy) and stem cells (Stem Cell Transplant). On an unknown date, the outcome of the myeloma and extra dose administered were unknown.   It was unknown if the reporter considered the myeloma to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received two doses of Shingrix in 2018. The patient was diagnosed with myeloma in 2019, received chemo and a stem call transplant and his oncologist ordered for him to get Shingrix again. The reporter believed the patient received another dose of Shingrix in February 2020. The health care professional had no details about first two doses of shingrix or patient DOB or initials.
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: a pediatric patient who received a possibly expired DTAP vaccine/No AE; Initial information received on 22-May-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a child patient (age and gender unknown) who received a possibly expired vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number and expiry date not reported via unknown route in unknown administration site on an unknown date for prophylactic vaccination.  The patient's medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.  At the time of reporting, adverse event was not reported.  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.  There will be no information available on the batch number for this case.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Daptacel was administered, no adverse event; Initial information was received on 26-May-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 31 months old female patient who was administered an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].   Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A)   On 21-May-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (5th dose in series, lot C5366BA, expiry date 07-Feb-2020) via intramuscular route in the left deltoid for prophylactic vaccination  It was a case of an actual medication error due to expired vaccine used.  At the time of report, no adverse event was 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.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 4"x3" circular area, raised, hard & warm on right deltoid
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, MENB, MNQ
Symptoms: Abnormal behaviour, Pallor, Vomiting
Clinical narrative: Upon administering the last vaccine the patient was pale with a noticeable change in her body language.  Her head was relaxed and loose.  At that moment, the nurse checked patients vital signs.  Blood pressure 122/68, pulse 82, temp 98.3.   We monitored the patient and assess her mental status by asking simple questions. The patient responded correctly.  While sitting down the patient threw up.  Approximately 15 min later the patient regained her composure and stated she felt good enough to leave.
Age: 1.92
Sex: M
Vaccine: PNC13
Symptoms: Eye swelling, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Swollen thigh, deep red hot rash on thigh, eyes swollen/ drowsy, rash under eyes. No fever.
Age: 1.92
Sex: M
Vaccine: PNC13
Symptoms: Rash, Somnolence
Clinical narrative: Swollen thigh, deep red hot rash on thigh, eyes swollen/ drowsy, rash under eyes. No fever.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site papule, Injection site plaque, Injection site swelling, Injection site vesicles
Clinical narrative: On day of administration (05/11/2020) site appeared red and raised. On 05/19/20 Mother stated that 2 spots were noted with some bumpy appearance of the skin and was worsening. Physician noted that there was a pink plaque with pink papules and vesicles present. No crusting.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: left shoulder with 4cmx4cm erythema and 4cmx2cm hardness underneath- warm and firm to touch; no erythematous streaks or pain to touch
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Developed redness (14.5 cm x 10 cm), swelling, and pain on left upper arm on 5/28/2020.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; one patient received one dose of improperly stored VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's relevant history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 04-APR-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), lot # R020654, expiration date 18-JUL-2020 (upon internal validation established as valid lot # and valid expiration date) (route of administration and anatomical location were not reported), for prophylaxis. The temperature and the time frame of the excursion were not reported. It was not reported if the call was because of a "data logger". The vaccine was reconstituted with properly stored sterile diluent (lot # and expiration date were not reported). No additional adverse effects were reported.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: Side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a 62-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 19th May 2020, the patient received Shingles vaccine. In May 2020, less than a week after receiving Shingles vaccine, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was not recovered/not resolved.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. After receiving shingles vaccine, the patient experianced side effects. The patient had asked, how long the side effects normally last. The patient cannot do much of anything and had got a family that needed him/her.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Insomnia, Myalgia, Pyrexia
Clinical narrative: Arm ache at injection site; Fever; Difficulty Sleeping; Tired/extreme fatigue; Muscle Aches; 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 20th May 2020, the patient received the 2nd dose of Shingrix. On 20th May 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, fever, difficulty sleeping, tiredness and muscle pain. On an unknown date, the outcome of the injection site pain, fever, difficulty sleeping, tiredness and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever, difficulty sleeping, tiredness and muscle pain to be related to Shingrix.  Additional details were reported as follows: On 20th May 2020, the patient received 2nd dose of Shingrix and experienced fever, muscle aches, arm ache at the injection site, difficulty sleeping, and extreme fatigue. The patient reported that she had worked in the garden and she thought that might be the cause of her muscle aches. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: experience arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced arm pain that still persistent. The patient was asked whether the had a hand in developing the vaccine. The reporter did not consent to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb injury, Pain in extremity
Clinical narrative: Injured her left arm; Left arm is in pain; This case was reported by a consumer via call center representative and described the occurrence of limb injury in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included myeloma, malignant (and also had lymph node biopsy done during which her rotator cuff was injured.).   On 15th March 2020, the patient received the 1st dose of Shingrix. On 24th April 2020, 40 days after receiving Shingrix, the patient experienced limb injury and pain in arm. On an unknown date, the outcome of the limb injury and pain in arm were unknown.   It was unknown if the reporter considered the limb injury and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and she injured her left arm when she was checking her blood pressure.  Her left arm was in pain. About a week later she went to see her physician. She was having a MRI done later. She has had malignant myeloma of upper left arm in 2016, and had lymph node biopsy done during which her rotator cuff was injured. The reporter consented to follow up. No other details were provided. The caller did not know complete name and address for her physician.      Lab Comments: had lymph node biopsy done during which her rotator cuff was injured.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Awoke about 3 AM with nausea.  No retching or vomiting.  Mild nausea/queasiness persists now (11 AM).   Fatigue, but not sure if primary reaction to Shingrix or due to being awake intermittently with nausea.  Also arm swelling and soreness at injection site but these aren't severe.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lymph node pain, Malaise
Clinical narrative: patient complained of soreness in his left shoulder the evening of the day he got the vaccine and it was swollen a little. the next evening  his left bicep was turning red and started to swell.  The next day he stated the lymph nodes under his arm hurt badly and he didn't feel well.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: No additional adverse effects; received a pediatric dose of RECOMBIVAX HB; This spontaneous report was received from a medical assistant regarding an approximately 20-years-old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 14-MAY-2020, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) strength: 5 mcg/0.5ml, dose: 5 microgram (0.5 ml)/once, lot number R031055 with expiration date on 04-JUN-2021 (route of administration and anatomical location were not provided), as prophylaxis.(Incorrect dose administered)  No adverse effects were reported.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: 101.1 degrees fever; arm was sore/arm was sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th May 2020, the patient received the 2nd dose of Shingrix. On 19th May 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 20th May 2020, the patient experienced fever. On an unknown date, the outcome of the pain in arm and fever were unknown.   It was unknown if the reporter considered the pain in arm and fever to be related to Shingrix.  Additional details were reported as follows: On 19th May 2020, the patient received 2nd dose of Shingrix. On 19th May 2020 afternoon, the patient experienced arm at the site of short had been sore and at night the patient experienced arm pain. On 20th May 2020, 1 day after receiving the vaccination the patient experienced fever 101.1 degree F and 101.4 degree F.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: quite sick; This case was reported by a consumer and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were reported as follows: On 30th December 2019, the patient received 1st dose of Shingrix and experienced sickness. The patient's pharmacist informed to the patient due to COVID-19 they are not administrating the vaccine now. The patient asked recommendation form GSK, since the patient don't want to miss the prescribed protocol by putting off the 2nd dose of vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain at the injection 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 Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months 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 reported as follows: The age at vaccination was not reported. The patient experienced pain at the injection site after 1st dose of Shingrix The reporter did not consent to follow up.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient received Daptacel that had expired one day prior to administration/ No AE; Initial information was received on 15-May-2020 regarding an unsolicited valid non-serious case from a nurse via sales representative.  This case involves patient of unknown demographics who received  DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] that had expired one day prior to administration (expired product administered),  Medical history, concomitant medication, medical treatment, vaccination and family history were not provided. Concomitant medication was not reported.   In May-2019, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number not reported and expiry date May-2019) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used. It was reported that the vaccine was expired by a day while administered and parents of the patient did not want the patient to have to receive another injection.  At a time of reporting no adverse event 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.  There will be no information available on the batch number for this case.  Follow up information was received on 26-May-2020 regarding an unsolicited valid non-serious case from a nurse via sales representative.  Event as reported was updated.  Follow up information was received on 26-May-2020 regarding an unsolicited valid non-serious case from a nurse via sales representative.  Suspect product details (start date and expiry date) were updated.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Mom states that pt had a syncope episode in our parking lot after receiving the HPV vaccine
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itching at injection site (DTaP) followed by redness, then whole arm swelling and redness immediately after injection
Age: 0.5
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Diet refusal, Insomnia, Opisthotonus, Screaming
Clinical narrative: high pitched, prolonged screaming, arching back, refusing to eat and refusing sleep.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Bladder dysfunction, Cognitive disorder, Functional gastrointestinal disorder, Malaise
Clinical narrative: Family member called to report that the patient fell extremely ill, less than 24 hours after receiving the 2nd dose in his Shingrix series. He experienced loss of bladder and bowel function, and was cognitively impaired, requiring medical attention.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Right arm swelling/pain
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Decreased appetite, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Fever ranging from 99 to 102.  Loss of appetite.  Tiredness.  Nausea, confusion.  Redness and swelling at site of injection.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever ranging from 99 to 102.  Loss of appetite.  Tiredness.  Nausea, confusion.  Redness and swelling at site of injection.
Age: 1.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: No adverse event, Product preparation error
Clinical narrative: This was not an adverse event.  Nurse discovered that our open HIB box was missing a HIB(power vial) which means a HIB was given with sterile water instead of saline diluent making the vaccine invalid.  Connected mom who was very understanding.  She'll make an appt after speaking with Dr.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Malaise, Nausea, Pain in extremity
Clinical narrative: I had Shingrex 2 of 2 around 11 a.m. I woke up at ll:30 pm feeling nauseous and completely unwell.  Weak. Left injection arm EXTREMELY sore. It has been 54 hours since the vaccination and I am just now feeling decent.  Not yet strong, but much better.  Hope tomorrow ill be close to normal.  I've been in bed for most of two days.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope, Tonic clonic movements, Vertigo
Clinical narrative: PT w LOC and 2 episodes of tonic clonic movement immediately following injection of HPV. LOC x 45 sec. Immediately following gaining consciousness patient was appropriate w questions. Patient Noted Prior to syncope room began spinning. Minutes later as per patient Felling fine.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: PT STATES BY 11PM AFTER VACCINATION HER ARM WAS HURTING AND BY 2AM SHE HAD DIFFICULTY LIFTING UP HER ARM. PAIN SHE DESCRIBES AS A SHARP PAIN. BY THE NEXT DAY, RANGE OF MOTION RETURNED BUT STILL HAS A DULL PAIN AT SITE OF INJECTION AND A LITTLE AROUND THE SURROUNDING AREA.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Mild flu-like symptoms.  Fatigue, Headache, fever, body ache.  Onset a day after shot, lasted 4-5 days.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site warmth, Pain in extremity, Swelling
Clinical narrative: Patient has no issue with first dose of vaccine on 02/25/2020, but noticed nearly 24 hours after her 2nd dose that she had a 2 inch red circle of inflammation around the injection site. It is warm to the touch, does not itch, is not painful to the touch. She reported standard arm soreness with IM injection. She is using ice to help reduce the swelling and unfortunately cannot take NSAIDs d/t an allergy.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Gun shot wound, Pain in extremity
Clinical narrative: Patient said her arms been hurting for several months, but the shot was just given last month in April 08, 2020 and the even was reported today 05/28/2020.  She said she as gun shot wound to her right arm so she has to use her left arm for most of the work she does around the house. I ask if she has been doing a lot of work around the house and she said yes. I suggested that she give her arm a break and try not to do too much.  Suggested she take an NSAID and rest and follow up if the symptoms doesn't get any better.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient describes patchy rash on legs, back, and trunk.  She applied hydrocortisone and took Benadryl orally.  She also received a Medrol dosepak from physician. Patient picked up Medrol dosepak today 5-28-20.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash papular
Clinical narrative: RED RAISED RASH THAT DOES NOT ITCH ON RANDOM SPOTS AROUND THE BODY.  PATIENT CLAIMS THIS HAS HAPPENED BEFORE WHEN HER IMMUNE SYSTEM IS "TAXED"
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient's arm is still sore after 3 months have passed since vaccination.
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Flushing, Moaning, Muscle contractions involuntary, Posture abnormal, Seizure
Clinical narrative: Patient came into the pharmacy requesting Tdap vaccination accompanied with a friend. Within 1 minute after adminstering vaccination patient face was flushed, threw his head back and went into a seizure, both his hands were clenched and twisted, his right foot was twisted.cradled patient head to prevent injury, he groaned and had another episode by then with his friend's help i had the patient lay on the floor on his back. within 30 seconds patient was awake and questioned what just happened. The entire episode may have lasted less than 3 mins. After this patient was alert, had him drink some gatorade , which he threw up after 5 mins. after about 30 mins patient was well enough to be on his feet and left the pharmacy
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Patient came into the pharmacy requesting Tdap vaccination accompanied with a friend. Within 1 minute after adminstering vaccination patient face was flushed, threw his head back and went into a seizure, both his hands were clenched and twisted, his right foot was twisted.cradled patient head to prevent injury, he groaned and had another episode by then with his friend's help i had the patient lay on the floor on his back. within 30 seconds patient was awake and questioned what just happened. The entire episode may have lasted less than 3 mins. After this patient was alert, had him drink some gatorade , which he threw up after 5 mins. after about 30 mins patient was well enough to be on his feet and left the pharmacy
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Bursa injury, Injection site pain, Magnetic resonance imaging abnormal, Pain, Tendon disorder
Clinical narrative: Chronic pain in the Rt arm injection site x 7 months.  Chronic pain when lifting, stretching and reaching at the injection site.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: fever, chills, total body severe muscle ache, fatigue--lasted 36 hours--took a vicodin for pain at 5 AM on the 27th, was only conscious a few hours on the 27th. Woke up on the 28th feeling much better.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cyanosis, Electrocardiogram normal, Hypotonia, Irritability, Pallor
Clinical narrative: Around 9 pm, the night of receiving her 4 mth  vaccines, she was having her diaper changed and mother gave her Tylenol as she had been fussy since the vaccines. She went pale, bluish disolaration of her face, limp and eyes staring straight ahead. Mother unsure how long this lasted but recovered after splashing water on her. Happened a second while EMS was on their way. Again resolved quickly and was back to baseline by the time EMS Arrived. Admitting for overnight observation. Back to baseline for entirety of stay. Normal vitals and ECG. COVID testing negative.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: SARS-CoV-2 test negative, Staring
Clinical narrative: Around 9 pm, the night of receiving her 4 mth  vaccines, she was having her diaper changed and mother gave her Tylenol as she had been fussy since the vaccines. She went pale, bluish disolaration of her face, limp and eyes staring straight ahead. Mother unsure how long this lasted but recovered after splashing water on her. Happened a second while EMS was on their way. Again resolved quickly and was back to baseline by the time EMS Arrived. Admitting for overnight observation. Back to baseline for entirety of stay. Normal vitals and ECG. COVID testing negative.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pyrexia, Rash, Swelling
Clinical narrative: Had vaccine on 5/26/20.  vaccine Quadracel on (L)  upper arm. Had mild swelling  erythema & fever 101.5 F that  day. Rash until 5/28/20.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site paraesthesia, Paraesthesia
Clinical narrative: tingling starts from her Left arm and goes up to neck.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects; one patient received one dose of improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not provided.  On 08-MAY-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), lot # S002924, expiration date 28-JUL-2020, 1 dosage form, subcutaneously (exact dose was not reported) for prophylaxis. The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted in a properly stored sterile diluent. The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced a temperature excursion of 5.7 Fahrenheit (F), a previous temperature excursion of -13.3 degrees Celsius (C) for 18 minutes, and another excursion of 13.2 C for 18 minutes. The digital data logger was involved to capture the temperature excursion. No additional adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Skin infection
Clinical narrative: skin infection; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or around 22-SEP-2015, patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for routine health maintenance an for its intended purpose: the prevention of shingles (herpes zoster).  On an unknown date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered from and was diagnosed with a skin infection. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of skin infection was reported as not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX). The event of skin infection was considered to be disabling.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported; the patient was administered the first dose of GARDASIL 9 on 20-SEP-2018 and then the second dose of GARDASIL 9 on 26-DEC-2019; This spontaneous report was received from a pharmacist referring to a 23-year-old female patient. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.  On 26-DEC-2019, the patient was vaccinated with  first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), then on 26-DEC-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (concentration, route and anatomical location, lot number and expiration date were not reported) as prophylaxis (inappropriate schedule of product administration). No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: improperly stored dose of ROTATEQ on 26-MAY-2020; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug reactions or allergies were not reported.  On 26-MAY-2020, the patient received an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660704 with expiration date 20-MAR-2021 oral for prophylaxis). The vaccine was exposed to a temperature of 12.1 centigrade (C) during a time frame of 16 hours and 11 minutes, which was detected by a digital data logger. There were no previous temperature excursions.