chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Erythema, Rash, Rash morbilliform, Skin lesion
Clinical narrative: RASH in the shape of measles in the arms; rash; still felt the lesions in the arms and they developed from red to purple until they slowly faded over between 3 to 4 months; This is a spontaneous report from a contactable consumer, reporting for himself. A 76-year-old male patient received the second dose of the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) and the first dose of the varicella zoster vaccine rge (cho) (SHINGRIX), via unspecified routes of administration on 14Jan2020 at single doses for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) for immunization in May2019. On an unknown date, the patient experienced shape of measles in the arms, rash, and still felt the lesions in the arms and they developed from red to purple until they slowly faded over between 3 to 4 months. The clinical course was as follows: on the same day, he was administered with the second dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), he was administered with the first dose of the varicella zoster vaccine rge (cho) for Herpes Zoster. After the administration of the vaccines, he developed a rash that affected the knees and legs, arms in the elbows and inside the arms. It was further specified that the lesions were red and with the shape of a pencil eraser in the knees and legs and the shape of measles in the arms. He still felt the lesions in the arms and they developed from red to purple until they slowly faded over between 3 to 4 months. The clinical outcome of the events was unknown.   The batch/lot number for the vaccine, pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), was not provided and will be requested during follow up.
Sex: M
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Erythema, Measles, Rash, Skin discolouration, Skin lesion
Clinical narrative: RASH in the shape of measles in the arms; rash; still felt the lesions in the arms and they developed from red to purple until they slowly faded over between 3 to 4 months; This is a spontaneous report from a contactable consumer, reporting for himself. A 76-year-old male patient received the second dose of the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) and the first dose of the varicella zoster vaccine rge (cho) (SHINGRIX), via unspecified routes of administration on 14Jan2020 at single doses for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) for immunization in May2019. On an unknown date, the patient experienced shape of measles in the arms, rash, and still felt the lesions in the arms and they developed from red to purple until they slowly faded over between 3 to 4 months. The clinical course was as follows: on the same day, he was administered with the second dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), he was administered with the first dose of the varicella zoster vaccine rge (cho) for Herpes Zoster. After the administration of the vaccines, he developed a rash that affected the knees and legs, arms in the elbows and inside the arms. It was further specified that the lesions were red and with the shape of a pencil eraser in the knees and legs and the shape of measles in the arms. He still felt the lesions in the arms and they developed from red to purple until they slowly faded over between 3 to 4 months. The clinical outcome of the events was unknown.   The batch/lot number for the vaccine, pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), was not provided and will be requested during follow up.
Age: 3.0
Sex: F
Vaccine: DTAP, DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A 3 year old patient received Quadracel, no AE; Quadracel was administered to a 3 year old patient rather than Daptacel, no AE; Initial information was received on 15-Jul-2020 regarding an unsolicited valid non-serious case from a other health professional  This case involves a three year old female patient who was administered 0.5 ml first dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number: C5656AA, Expiry date 11-Aug-2021) once via intramuscular route in the left thigh for prophylactic vaccination on 15-Jul-2020 rather than DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]. (product administered to patient of inappropriate age and wrong product administered)  The patient's past vaccination(s) included DIPHTHERIA VACCINE;HIB VACCINE;PERTUSSIS VACCINE ACELLULAR;POLIO VACCINE INACT;TETANUS VACCINE for prophylactic vaccination.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB); PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate age at vaccine administration and Wrong vaccine administered.  The patient had no vaccinations since her 2 month series. She came in for catch-up vaccinations. As part of that vaccine series, Quadracel was administered rather than Daptacel.  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: 0.75
Sex: F
Vaccine: HIBV, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received a double dose of Acthib and Ipol on the same day / no AE; Initial information received on 15-Jul-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 9 months old female patient who receive double dose of IPV (VERO) [IPOL] (lot number and Expiry date unknown) and HIB (PRP/T) VACCINE [ACT-HIB] (lot number UJ180AA and Expiry date 03-Jul-2021) via unknown route in unknown administration site on an unknown date for Prophylactic vaccination.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due extra dose administered.   At a time of vaccination No adverse events were 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.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: 4 year old was given expired daptacel/no AE; Initial information was received on 16-Jul-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old female patient who was vaccinated with once 0.5 ml fifth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (vial) which was already expired (batch number C5367AA, expiry date 30-Jan-2020) via intramuscular route in the left thigh on 17-Jul-2020 for prophylactic vaccination (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination.  It was an actual medication error case 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: 11.0
Sex: U
Vaccine: DTAP, DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: a 11-year-old patient for which Tdap was ordered inadvertently received Infanrix vaccine/No AE; Initial information was received on 16-Jul-2020 regarding an unsolicited valid non-serious case received from a consumer or other non-health professional (Clinic Manager).   This case involves a 11-year-old patient for which DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [Tdap] (produced by unknown manufacturer) was ordered, but on an unknown date, inadvertently the patient received a dose of suspect DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID [INFANRIX] (not produced by Sanofi Pasteur) [batch number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination (wrong product administered).   Medical history, medical treatment, vaccination and family history were not provided. Concomitant medication if any, not reported.  It was a case of an actual medication error due to wrong vaccine administered.  It was also reported that, Infanrix was intended for infants and not indicated for this age (for 11 year old patient).   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.  There will be no information available on the batch number for this case.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Broke out in shingles within 10-12 days on chest, both arms, both legs ,stomach, waist
Age: 0.08
Sex: F
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Rec'd Hepatitis A in error, should have received Hepatitis B.  Mom notified of error.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Dyspnoea
Clinical narrative: Chills, upset stomach, some difficulty in breathing
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Dysphemia, Feeling abnormal
Clinical narrative: Patient reports she was immediately feeling strange immediately after the vaccine. She didn't think much of it and did not mention it to us at the time. She got to her car where she started to feel very unwell. She drove herself to the Emergency Room where she was told she had low Blood Pressure, stuttering speech and low O2 Sat.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypotension, Immediate post-injection reaction, Malaise, Oxygen saturation decreased, Urinary tract infection
Clinical narrative: Patient reports she was immediately feeling strange immediately after the vaccine. She didn't think much of it and did not mention it to us at the time. She got to her car where she started to feel very unwell. She drove herself to the Emergency Room where she was told she had low Blood Pressure, stuttering speech and low O2 Sat.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Urine analysis
Clinical narrative: Patient reports she was immediately feeling strange immediately after the vaccine. She didn't think much of it and did not mention it to us at the time. She got to her car where she started to feel very unwell. She drove herself to the Emergency Room where she was told she had low Blood Pressure, stuttering speech and low O2 Sat.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Hyperaesthesia
Clinical narrative: Patient reports pain in his knees and scalp sensitivity following the vaccination.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse effects; administered doses of Rotateq underwent temperature excursion on 10/02/2019 prior to being administered to approximately 8 patients; This non-valid, spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On unknown dates, approximately 8 patients were vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # S004251, expiration date 22-SEP-2020 (dose, frequency, route of administration were not provided), for prophylaxis.  Administered doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced the temperature excursion of 47 Fahrenheit degrees (F) for 1 hour. There was no previous temperature excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported.  The case is non valid due to lack of the patients' identifiers.
Sex: U
Vaccine: HPV9, UNK
Symptoms: No adverse event, Underdose
Clinical narrative: no known adverse effects; a patient only received a partial dose of GARDASIL 9; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.       On an unknown date, the patient was vaccinated with a partial dose (underdose) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (route of administration, anatomical location, and dosage regimen were not reported; lot number 1637642, which has been verified to be valid, expiration date reported and validated as 28-MAY-2022) as prophylaxis. No known adverse effects. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637642; expirationdate: 28-MAY-2022; 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 meet the criteria for Reportability
Sex: F
Vaccine: MMR
Symptoms: Dermatitis atopic, Insomnia, Loss of personal independence in daily activities
Clinical narrative: Atopic dermatitis from all over the body; unable to sleep at night; cannot perform daily functions; This spontaneous report was received from the patient's husband and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  In July 2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, route, frequency, vaccination site, lot # and expiration date were not reported), for prophylaxis.    In the same date, the patient experienced atopic dermatitis from all over the body, unable to sleep at night (insomnia) and cannot perform daily functions (loss of personal independence in daily activities).  At the time of reporting, the patient had not recovered from dermatitis atopic, loss of personal independence in daily activities and insomnia. The reporter did not provide a causality assessment between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)  and the events.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: no adverse event-pregnant
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Pt was seen in office for 11 yr wcc @ 2:45pm  by Dr.  11 Year vaccines were requested & given at 3:30pm- TDAP, MENVEO & HPV. Pt "felt dizzy" immediately after vaccines were given and was instructed to lay down on the exam table & drank a cup of water. Asked pt what they ate today & stated they ate before they came in to office. Pt sitting up on table and observed for 15 minutes to assure safety. Pt stated he felt "good and was not dizzy"when the 15 min was up. at 3:45pm.  Walked to receptionist desk and told mom he was startng to "feel dizzy" again. Myself, a co-worker and mother slowly lead patient to the floor as he "passes out". Pt walked back to room to lay on exam table and had more water  &was offered 2 packages of crackers as he admitted he only ate ice cream all day today. Pulse 83 & BP  92/50 was obtained once in room & normal. Dr. reassessed pt to assure safety. Pt laid on exam table for another 15 minutes to be observed and finished both packs of crackers. Pt then stated he "felt better and was not lightheaded or dizzy- just hungry" after the 15 minutes was up. Encouraged to call with any concerns or questions.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: Patient states ~ 20 minutes after vaccine, she felt a burning sensation in her left arm.  She then noticed numbness and tingling in the left arm.    Several minutes later, numbness and tingling occured in her lips and face but no burning.  States she then took 50 mg Benadryl by mouth.  Symptoms did not worsen and no other symptoms occured.  ~ 26 hours later, she states she felt back to her normal self.  She later phoned her PCP about it.  He advised her to take 50 mg Benadryl by mouth 30 minutes prior to her 2nd Varivax vaccine.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: PATIENT CONTACTED ME 7/21 NOTING REDNESS, SWELLING, INFLAMMATION AT THE SITE OF THE INJECTION AND THE SURROUNDING AREA.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Influenza A virus test positive, Wheezing
Clinical narrative: shortness of breath and wheezing; went to Er 9 days after receiving the vaccine for these symptoms
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Alcoholism, Antisocial behaviour, Autism spectrum disorder, Depression, Drug dependence
Clinical narrative: Shortly after he was given the shot patient became lifeless and lethargic, almost in a comatose state, with a high fever. I did report to Dr..  When patient's next MMR shot was due I was against giving him another shot but the Dr. insisted on giving him a pediatric dose, which he said should not cause a reaction. Patient suffered even a worse reaction than from the first time, laying lethargic for days with a  high fever. He appeared to finally recover after about a week.. I strongly believe his Autism spectrum disorder he suffers with today are a direct result of his reaction to the MMR vaccine shots given to him as a child.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Feeling abnormal, Impaired work ability, Legal problem, Lethargy, Personal relationship issue
Clinical narrative: Shortly after he was given the shot patient became lifeless and lethargic, almost in a comatose state, with a high fever. I did report to Dr..  When patient's next MMR shot was due I was against giving him another shot but the Dr. insisted on giving him a pediatric dose, which he said should not cause a reaction. Patient suffered even a worse reaction than from the first time, laying lethargic for days with a  high fever. He appeared to finally recover after about a week.. I strongly believe his Autism spectrum disorder he suffers with today are a direct result of his reaction to the MMR vaccine shots given to him as a child.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Schizophrenia, Social anxiety disorder, Substance abuse, Suicidal ideation
Clinical narrative: Shortly after he was given the shot patient became lifeless and lethargic, almost in a comatose state, with a high fever. I did report to Dr..  When patient's next MMR shot was due I was against giving him another shot but the Dr. insisted on giving him a pediatric dose, which he said should not cause a reaction. Patient suffered even a worse reaction than from the first time, laying lethargic for days with a  high fever. He appeared to finally recover after about a week.. I strongly believe his Autism spectrum disorder he suffers with today are a direct result of his reaction to the MMR vaccine shots given to him as a child.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Lymphadenopathy, Oropharyngeal pain, Rash, Rash erythematous, Rash papular
Clinical narrative: Pt reported that following administration of vaccine she began to develop small, localized red raised rash on neck, just below ears,  swollen anterior lymph nodes and mild sore throat.   Rash was not itchy and lasted several days.  Denies any cough, congestion, pain, d/c, h/a, n/v/d/f.  Resolved without medical intervention.
Age: 21.0
Sex: F
Vaccine: UNK
Symptoms: Fall, Gait inability, Paralysis, Sensory loss
Clinical narrative: Paralysis the next day, unable to feel my legs upon getting out of bed in the morning, fell to the floor, lasted about a few hours. I had another similar paralysis in about 2002, falling to the floor with no feeling in my legs for about 2 hours.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Culture urine, Pyrexia, Urine analysis
Clinical narrative: Onset of fever, tmax 102 in the evening on 7/20/2020. Had well child exam the same day in the morning, received vaccines. Was well at the exam. seen in the office today, fever 103.8. exam essentially negative. observing with symptomatic care at this time.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Fatigue
Clinical narrative: PATIENT DID NOT REMEMBER FIRST DOSE 12/18/2019, SHE HAD SECOND AND FINAL DOSE 02/21/2020.  SHE IN DECEMBER SHE ALSO RECEIVED PREVNAR AND THERE WAS SOME CONFUSION ON HOW MANY SHINGRIX SHE HAD BECAUSE SHE ASKED FOR HER SECOND ON 7/16/2020 BUT IT WAS ACTUALLY HER THIRD. PT STATES SHE WAS MORE FATIGUED THIS TIME THAN SHE REMEMBERED. PREVIOUSLY THIS WAS ONLY ADVERSE REACTION TO THE THIRD VACCINE.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: patient had a small, red and swollen area where vaccine was given
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Injection site reaction, Middle insomnia, Pain in extremity, Rotator cuff syndrome
Clinical narrative: after second Hep B shot patient said they had pain in arm that keeps them awake at night.  Even a year later it is still bothering them.  Feels like a torn rotator cuff and pt can still feel the injection site
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, X-ray normal
Clinical narrative: After administering vaccination, patient presented to the pharmacy a week later with obvious swelling in her left arm. Patient states that she received an x-ray to see if bone was hit at time of vaccination, which returned negative. Patient was prescribed triamcinolone cream to put on the site of swelling by her primary care physician.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient experienced redness(some rash) and itching around the injection site which is still there 4 days later but not getting any worse.
Age: 74.0
Sex: M
Vaccine: UNK
Symptoms: Abdominal discomfort, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Shingles vaccine, Shingrix,  second. Glaxo Smithlline Fever 100F,  tiredness, upset stomach, tenderness at injection site
Age: 67.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Dizziness, Pain in extremity
Clinical narrative: customers wife called Monday evening stating  patient's left arm was still hurting 3 days later,  and that he had been dizzy the evening of the 17th, the day he received the immunizations
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Patient reported experiencing redness, tense, hotness, itching and pain from upper arm to wrist later in the day of the vaccination. She thinks it's the phenol in the vaccine that caused the reaction.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Tension
Clinical narrative: Patient reported experiencing redness, tense, hotness, itching and pain from upper arm to wrist later in the day of the vaccination. She thinks it's the phenol in the vaccine that caused the reaction.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Severe swelling, and redness at the injection site which lasted for 3 days. Muscle aches, headaches and fatigue lasted 2 days
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Lethargy, Pyrexia, Vomiting
Clinical narrative: Approx 30 hours after the vaccine, around 4:00pm on Saturday, Patient got a fever, seemingly out of the blue, that spiked to 103. He was lethargic and we also noticed a large red splotch at the injection site on his upper right arm, coming out from the bandaid still there. Over the next 90-120 minutes, the fever went back down to 100, with no medicine or other treatment. Shortly after, it rose again to 101 and he threw up the small amount of food he tried to eat for dinner. Over the next couple hours, his fever receded and his temperature returned to normal. Overall, the adverse reaction lasted around 4 hours. He had no fever or complaints before or after that time period and slept normally that evening. In the morning he felt well and ate normally.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: Day 1  - Minor headache, then sore arm shortly after injection...soreness became worse as day progressed Day 2  - Tiredness (afternoon) and some shivering (late morning)
Age: 73.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Inflammation
Clinical narrative: Patient receiveds 4 vaccines on the same day 2 in the right arm and 2 in the left.  Pharmacy records indicate all in left arm.  Though he stated two were in each arm, it is unclear which 2 were in his left arm.  The Deltoid muscle was read and inflamed.  he stated it isn't going away.  I advisced to follow up with his primary doctor for a course of antibiotics.  He stated he will also speak to the pharmacy manager tomorrow.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient returned to pharmacy on second day after immunization stating arm was painful, swollen, and warm to the touch. Recommendations included ice, analgesics, benadryl. MD was called by pharmacist and patient had an appt on the third day and received keflex prescription for a possible cellulitis. On 7/21 patient was contacted and stated she was doing much better and the MD advised she should not get the second dose in the series.
Age: 20.0
Sex: M
Vaccine: HPV9
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: patient states arm was swollen and hurt for 3 days. Symptoms started more than 15 minutes after administration when he was on his way home
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Injection site swelling, Myalgia, Nausea
Clinical narrative: swelling at inj site, muscle aches, headache, nausea
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Pain, Pruritus
Clinical narrative: swollen red upper arm  ER visit given Benadryl and Keflex  was itchy, tigh and painful mon
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Chills, Headache, Pyrexia, Urticaria
Clinical narrative: A few hours after vaccination, had chills, temp 100 degrees, HA. Given Tylenol X 1  On 7/19/20 AM, still had fever + HA. Had hives on forearms + thighs. Given Benadryl, Tylenol  7/19/20 afternoon, continued sx. Gave Benadryl  07/20/20 No fever, No hives, slight HA.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Chickenpox; This spontaneous report has been received from a physician and refers to a 13-year-old male patient. The patient's concurrent condition, medical history, concomitant therapies, historical drug or allergies were not provided.   On 30-JUN-2008, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot #, expiration date, dose and anatomical location of vaccine were not reported) reconstituted with 0.5 mL of sterile diluent, administrated via subcutaneous for vaccination. On an unspecified date in, after 2 doses of varicella virus vaccine live (oka/merck)(VARIVAX), the patient had recently developed chickenpox. At the reporting time, the patient had not recovered from chickenpox.  The causality assessment between chickenpox and varicella virus vaccine live (oka/merck)(VARIVAX) was not reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: he patient experienced no symptoms; on 7/16/2020 a patient was administered a dose of MMR II with expired sterile diluent; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 16-JUL-2020, the patient was administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHa) (M-M-R II) injection, subcutaneously (strength, vaccination scheme and anatomical site of injection were not reported; lot number R028002, expiration date: 01-OCT-2020) with expired sterile diluent (DILUENT MRK) (concentration, dose, frequency and indication were not reported; lot number M047667, expiration date: 25-JUL-2019), as prophylaxis (expired product administered). The patient experienced no symptoms.
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; The 16 year old patient was inadvertently administered an adult dose of VAQTA; This spontaneous report was received from a medical assistant referring to a 16 year old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 16-JUL-2020, the patient was inadvertently vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) lot # S021729 (expiration date: 20-AUG-2020) for prophylaxis (additional dosage regimen information was not reported). No adverse effects were reported.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Insomnia, Irritability, Pyrexia
Clinical narrative: Fever, sleep loss, irritability
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: Starting at about 5pm (5 hours after vaccination) patient experienced fatigue, headache, low-grade fever (37.5C) and mild pain at injection site. Starting at about 11pm, patient experienced chills and shivering. Chills persisted for a few hours, other symptoms persisted for approximately 24 hours after onset.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Altered state of consciousness, Asthenia, Dizziness, Dyspnoea, Fatigue
Clinical narrative: About two minutes after receiving the vaccine, I started to feel lightheaded. Everything looked bright and I saw circular tangles of bright yellow lines. Everything was loud and sounded like I was hearing it on a radio with static. I felt like I was going to vomit and pass out. Someone brought me water, and I drank a little bit. My throat started to cramp up, and it was getting hard to breathe. I sat up suddenly and started gasping for air, then I vomited a lot. This was maybe five minutes after I started to feel badly. Immediately afterwards, the nausea and lightheadedness started to disappear. The nurse said my pulse was relaxing. I felt weak, but my symptoms went away. After about ten minutes, I drove myself home. I was a little tired when I went home, and through the day, I felt more fatigue and irritability. By the evening, I just wanted to lay down and not talk to anybody.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling abnormal, Hyperacusis, Irritability, Nausea, Oropharyngeal discomfort
Clinical narrative: About two minutes after receiving the vaccine, I started to feel lightheaded. Everything looked bright and I saw circular tangles of bright yellow lines. Everything was loud and sounded like I was hearing it on a radio with static. I felt like I was going to vomit and pass out. Someone brought me water, and I drank a little bit. My throat started to cramp up, and it was getting hard to breathe. I sat up suddenly and started gasping for air, then I vomited a lot. This was maybe five minutes after I started to feel badly. Immediately afterwards, the nausea and lightheadedness started to disappear. The nurse said my pulse was relaxing. I felt weak, but my symptoms went away. After about ten minutes, I drove myself home. I was a little tired when I went home, and through the day, I felt more fatigue and irritability. By the evening, I just wanted to lay down and not talk to anybody.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Visual impairment, Vomiting
Clinical narrative: About two minutes after receiving the vaccine, I started to feel lightheaded. Everything looked bright and I saw circular tangles of bright yellow lines. Everything was loud and sounded like I was hearing it on a radio with static. I felt like I was going to vomit and pass out. Someone brought me water, and I drank a little bit. My throat started to cramp up, and it was getting hard to breathe. I sat up suddenly and started gasping for air, then I vomited a lot. This was maybe five minutes after I started to feel badly. Immediately afterwards, the nausea and lightheadedness started to disappear. The nurse said my pulse was relaxing. I felt weak, but my symptoms went away. After about ten minutes, I drove myself home. I was a little tired when I went home, and through the day, I felt more fatigue and irritability. By the evening, I just wanted to lay down and not talk to anybody.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Depressed level of consciousness, Dizziness, Fatigue, Nausea
Clinical narrative: About 2-3 minutes after the vaccine, I started to feel lightheaded, nauseous, dizzy, etc. I saw yellow spots. I felt like I would pass out. A nurse gave me water about 2 minutes into the reaction, and I poured it all over my head and back. Right after that I started to feel much better. I was much relieved, since I'd had a worse reaction the day before.  I sat hunched over until the feelings subsided, and I just felt weak and shaky. The nurses checked my blood pressure and monitored me for about 10-15 minuted, then had my mother drive me home. I still felt tired and weak, so I rested when I went home.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Tremor, Visual impairment
Clinical narrative: About 2-3 minutes after the vaccine, I started to feel lightheaded, nauseous, dizzy, etc. I saw yellow spots. I felt like I would pass out. A nurse gave me water about 2 minutes into the reaction, and I poured it all over my head and back. Right after that I started to feel much better. I was much relieved, since I'd had a worse reaction the day before.  I sat hunched over until the feelings subsided, and I just felt weak and shaky. The nurses checked my blood pressure and monitored me for about 10-15 minuted, then had my mother drive me home. I still felt tired and weak, so I rested when I went home.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: headache, nausea, fatigue, sore arm, muscle aches
Age: 13.0
Sex: M
Vaccine: HEPA, MMR, MNQ, TDAP, UNK, VARCEL
Symptoms: Rash
Clinical narrative: Patient develops rash allover after 10 days of vaccine administration per mother  Patient was see by his PCP and he advised Benadryl  as needed  Patient doing well per mother
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Gait disturbance, Injection site pain
Clinical narrative: Temp 100.8F, pain at injection site and limping, gave ibuprofen 24hrs after vaccines.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Vaccination was expired on 7/8/2020
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema multiforme, Injection site pain, Myalgia
Clinical narrative: ErythemaMultiform & MUSCLE PAIN; INJECTION SITE PAIN  CEPHALEXIN 1 TAB QID TAKE 1 CAPSULE ORALLY EVERY 6 HOURS
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash, Rash erythematous, Rash papular
Clinical narrative: Patient report she received her first Shingrix vaccine on 7/1. Less than a week later she developed a red rash on her chest. Overtime it has spread to her neck, behind her ear and to her arm. The rash is continues to spread.  Erythematous patchy rash with overlying papules. No vesicles. Most prominent on chest and abdomen with smaller patches and papules on flank, LEFT arm. Not present on back. It is itchy if aggravated only. It is not painful. Nobody else at home has this rash. No exposure to poison ivy. No fevers, chills. Overall is feeling well.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Patient report she received her first Shingrix vaccine on 7/1. Less than a week later she developed a red rash on her chest. Overtime it has spread to her neck, behind her ear and to her arm. The rash is continues to spread.  Erythematous patchy rash with overlying papules. No vesicles. Most prominent on chest and abdomen with smaller patches and papules on flank, LEFT arm. Not present on back. It is itchy if aggravated only. It is not painful. Nobody else at home has this rash. No exposure to poison ivy. No fevers, chills. Overall is feeling well.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: redness and inflammation around site of injection
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Lethargy
Clinical narrative: chills, severe lethargy, achey joints
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; MMR II that was reconstituted with DILUENT MRK that had expired; This spontaneous report as received from a physician refers to a 41-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 07-JUL-2020, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection for prophylaxis (strength, exact dose, frequency, route of administration, lot # and expiration date were not reported) that was reconstituted with sterile diluent, that had expired, lot # N029636, expiration date 29-MAR-2020 (formulation, strength, dose, frequency, route of administration, indication). No adverse event was reported
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; PROQUAD and VARIVAX were administered instead of M-M-R II and VARIVAX; Both vaccines had a "supported" temperature excursion; This spontaneous report was received from a pharmacy technician referring to a 1-year-old male patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       The pharmacy technician stated that on 13-JUL-2020, the patient was administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) lot S017239 and expiration date 01-DEC-2020 (dose and route od administration were not provided) and with varicella virus vaccine live (oka/merck)(VARIVAX) lot S030244, expiration date 26-SEP-2021 (dose and route od administration were not provided), instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and varicella virus vaccine live  oka/merck) (VARIVAX). Both vaccines were reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). No additional adverse effects reported.   The pharmacy technician also stated that both vaccines had a "supported" temperature excursion that was evaluated on 10-JUL-2020
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: itching under the skin near site of injection; swollen arm; This case was reported by a consumer via call center representative and described the occurrence of itchy skin in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer and chronic sinusitis.   On 17th February 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th February 2020, 1 days after receiving Shingrix, the patient experienced itchy skin and swelling arm. On 21st February 2020, the outcome of the itchy skin was recovered/resolved. On an unknown date, the outcome of the swelling arm was recovered/resolved.   It was unknown if the reporter considered the itchy skin and swelling arm to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced a swollen arm and itching under the skin near site of injection, lasting 4 days before resolution. The reporter consented to follow up. For tolerances of 2nd dose refer case US2020135560.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020135560:same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Shingles; Not completed the schedule yet; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 62-year-old female 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 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report for 2nd dose. The age at vaccination was not reported for 1st dose. The patient received Shingrix and had Shingles. All patient identifiers were reported.  The patient had a recent episode of Shingles and did not completed the schedule yet, which led to incomplete course of vaccination. The reporter consented to follow up. No further details were reported.
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: my arm still kills; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On 8th July 2020, the patient received Bexsero. In July 2020, less than a week after receiving Bexsero, 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 Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The primary reporter was an agent from GSK. The patient received Bexsero shot 6 days ago and reported arm still kills. The reporter asked was there something wrong because nothing showed up in and arm should have stop hurting. The reporter did not consent to follow up. Read internal comments for more information.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: LEFT LEG RED BUMP
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash, Rash erythematous, Rash papular
Clinical narrative: Per chart note documentation: "Developed a rash around injection site the same day.   The rash was faint pink initially, and then got significantly worse last night.   Rash was spreading and raised when called yesterday".
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Malaise, Myalgia, Pain, Pyrexia
Clinical narrative: PATIENT STARTED WITH MUSCLE ACHE AND PAIN, SHE DEVELOPED A FEVER OF 100.1 AND WAS SUPPRESSED WITH TYLENOL.  SHE ALSO EXPERIENCED SWELLING AT THE INJECTION SITE AND A GENERAL MALAISE THAT LEFT HER IN BED UNTIL TODAY.  SHE CAME TO THE PHARMACY ON 07/22/20 AT 12 NOON TO DISCUSS THIS SITUATION.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Swelling
Clinical narrative: The day after the vaccine patient developed painful rash at left posterior neck which proceeded to worsen in pain/swelling. Evaluated by myself (her PCP) on 7/20/2020 and felt to be consistent with shingles. Valtrex, topical lidocaine, and gabapentin started.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) thigh swollen, hot to touch, redness, crying cool compress and Tylenol with positive effect
Sex: U
Vaccine: HPV9
Symptoms: Product administered at inappropriate site
Clinical narrative: the patient received a dose of GARDASIL 9 intramuscularly in the unspecified area of buttock; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications were provided. On 15-JUL-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) one dose, intramuscularly in the unspecified area of buttock (lot # 1637642, expiration date 28-MAY-2022; exact dose was not reported; captured as vaccine administered at inappropriate site) for prophylaxis. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637642; expirationdate: 28-MAY-2022; 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 meet the criteria for Reportability