chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Ear disorder, Fatigue, Headache, Myalgia
Clinical narrative: Gardasil booster vaccine was administered to my 14 year old son on 2/21/20 at 8:30 am. 7 am on 2/22/20 he woke up with a fever of 101.5, dizzy, fatigued, sore throat sinus congestion, and closed ears and headache. Returned him to the pediatrician at 11:20am for the symptoms. Saw Dr. at Pediatrics. Assured us that his symptoms were simply a virus and not linked to the vaccine. He was told to drink water and take ibuprofen for the fever, then continue about his day. My son was extremely fatigued all day, falling asleep sitting up, laying down whenever he could. Fever finally broke the morning of 2/23/20. Extreme pain in muscles at the nape of neck, pounding headache, still congested in his sinuses. We will be monitoring him today, but these side effects were not told to us prior to the vaccine, and the pediatrician denies the causation from Gardasil. I am not convinced. After reading the common symptoms online, he seems to have a moderate case.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Oropharyngeal pain, Pyrexia, Sinus congestion, Somnolence
Clinical narrative: Gardasil booster vaccine was administered to my 14 year old son on 2/21/20 at 8:30 am. 7 am on 2/22/20 he woke up with a fever of 101.5, dizzy, fatigued, sore throat sinus congestion, and closed ears and headache. Returned him to the pediatrician at 11:20am for the symptoms. Saw Dr. at Pediatrics. Assured us that his symptoms were simply a virus and not linked to the vaccine. He was told to drink water and take ibuprofen for the fever, then continue about his day. My son was extremely fatigued all day, falling asleep sitting up, laying down whenever he could. Fever finally broke the morning of 2/23/20. Extreme pain in muscles at the nape of neck, pounding headache, still congested in his sinuses. We will be monitoring him today, but these side effects were not told to us prior to the vaccine, and the pediatrician denies the causation from Gardasil. I am not convinced. After reading the common symptoms online, he seems to have a moderate case.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Headache, Muscle twitching
Clinical narrative: extreme side effects from 2nd Shingrix shot - complete exhaustion with shivers and chills; headaches with twitching/piercing pain in neck; and worse of all terrible muscle pain in back muscles that would not allow me to roll over in bed or get out of bed. Not exaggerating to say it took at least 30 minutes to get out of bed moving a faction of an inch to try to roll over and get in position to get up from bed. I was so cold that I turned up the house heat and took long naps under the electric blanket. Problem started the day after receiving the injection (2 22 2020 and continued til today (Sunday 2 23 2020)
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Neck pain
Clinical narrative: extreme side effects from 2nd Shingrix shot - complete exhaustion with shivers and chills; headaches with twitching/piercing pain in neck; and worse of all terrible muscle pain in back muscles that would not allow me to roll over in bed or get out of bed. Not exaggerating to say it took at least 30 minutes to get out of bed moving a faction of an inch to try to roll over and get in position to get up from bed. I was so cold that I turned up the house heat and took long naps under the electric blanket. Problem started the day after receiving the injection (2 22 2020 and continued til today (Sunday 2 23 2020)
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Tremor
Clinical narrative: The night after receiving my second injection for shingles, I had severe chills and shaking and I couldn't get warm. Also, for 2 days after the injection, the muscle in my lower arm hurt when I used it.
Sex: M
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests, Deafness unilateral, Magnetic resonance imaging brain normal, Scan with contrast normal, Somnolence
Clinical narrative: at 18:30 on 2/28/2020 received my second shingles vaccine. (Zoster Vaccine (Recombinant)) Went home and ate dinner at about 19:30. Was feeling drowsy so sat in front of the television and fell asleep. Woke up about 20:45 and had no hearing in my right ear and kind of a low humming noise. Tried to clear my ears by holding my nose and blowing hard. There was no improvement. Called my dad, who is a retired MD and asked him what I should do. He advised me to go to the ER. Arrived at ER at approximately 21:45. They did some hearing tests and ordered an MRI Brain w wo Contrast. They did not find anything that would cause hearing loss. Hearing improved over the next 48 hours to pre-incident levels. Ordered a follow-up appointment with ENT. scheduled for Friday 3/6 @ 2:45.
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: at 18:30 on 2/28/2020 received my second shingles vaccine. (Zoster Vaccine (Recombinant)) Went home and ate dinner at about 19:30. Was feeling drowsy so sat in front of the television and fell asleep. Woke up about 20:45 and had no hearing in my right ear and kind of a low humming noise. Tried to clear my ears by holding my nose and blowing hard. There was no improvement. Called my dad, who is a retired MD and asked him what I should do. He advised me to go to the ER. Arrived at ER at approximately 21:45. They did some hearing tests and ordered an MRI Brain w wo Contrast. They did not find anything that would cause hearing loss. Hearing improved over the next 48 hours to pre-incident levels. Ordered a follow-up appointment with ENT. scheduled for Friday 3/6 @ 2:45.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Rash
Clinical narrative: Patient received second dose of shingrix on 2/12/20, on 2/17/20 she developed a shingles rash on her face, she was treated within 8 hours, the rash was painful for 4 days, and mostly cleared up within 6 days though she is still experiencing headaches as a result.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: None observed
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Chiropractic, Hypersensitivity, Injection site swelling, Injection site warmth
Clinical narrative: Patient was fine after receiving vaccine 15 to 20 minutes later after leaving vaccination room, she stopped and bent down to pick up a book in the aisle. She glanced through the book, put it down and proceeded to leave the store. Suddenly an excruciating pain down her back and she cannot move. She proceeded back toward the pharmacy and Pharmacist and intern pharmacist helped Patient into the clinic room and sat down with her. After 15 to 20 minutes, patient felt better and called for ride home. On 3/2/20 around 8pm, I called to check-in on patient. She had been using ice and hot pads rotating every 20 minutes and is feeling less pain. I urged patient to see her PCP. Today, 3/3/20 patient returned to pharmacy to pick-up Prednisone in which PCP had prescribed and patient stated PCP said her had allergic reaction to vaccine and to also take some Benadryl. The site of injection looked swollen and warm to touch. Patient also saw chiropractor and said back was feeling better but her arm is sore.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient was fine after receiving vaccine 15 to 20 minutes later after leaving vaccination room, she stopped and bent down to pick up a book in the aisle. She glanced through the book, put it down and proceeded to leave the store. Suddenly an excruciating pain down her back and she cannot move. She proceeded back toward the pharmacy and Pharmacist and intern pharmacist helped Patient into the clinic room and sat down with her. After 15 to 20 minutes, patient felt better and called for ride home. On 3/2/20 around 8pm, I called to check-in on patient. She had been using ice and hot pads rotating every 20 minutes and is feeling less pain. I urged patient to see her PCP. Today, 3/3/20 patient returned to pharmacy to pick-up Prednisone in which PCP had prescribed and patient stated PCP said her had allergic reaction to vaccine and to also take some Benadryl. The site of injection looked swollen and warm to touch. Patient also saw chiropractor and said back was feeling better but her arm is sore.
Age: 29.0
Sex: F
Vaccine: HPV9
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient experienced itching and hives 5 days after injections requiring ED visit.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: Fever and headache
Age: 30.0
Sex: M
Vaccine: RAB
Symptoms: Blood electrolytes normal, Blood potassium decreased, Chills, Dizziness, Influenza like illness
Clinical narrative: Patient experienced dizziness, palpitations, chills, myalgia, flu like symptoms.
Age: 30.0
Sex: M
Vaccine: RAB
Symptoms: Myalgia, Palpitations
Clinical narrative: Patient experienced dizziness, palpitations, chills, myalgia, flu like symptoms.
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling
Clinical narrative: possible injection site granulomas; bump under the skin; This spontaneous report was received from a medical assistant and refers to a 42-year-old female patient. The patient did not have any pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 17-DEC-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 1 dose, lot # R025729, expiration date 18-JUN-2021, intramuscularly (site of administration was not provided). On the same day, the patient developed a bump under the skin and possible injection site granulomas. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
Age: 0.33
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; a patient was administered improperly stored PEDVAXHIB and ROTATEQ; Information has been received from a licensed practical nurse referring to a 4 months old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.       On 13-FEB-2020, the patient was administered improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were unknown; lot # R027329 and expiration date 12-JUL-2021) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose were unknown; oral, lot # R033251 and expiration date 29-JUN-2020) for prophylaxis. The vaccines were exposed to temperature excursion below 2 degrees Celsius (0.3 degrees Celsius) multiple for 45 minutes (incorrect product storage). There was no previous temperature excursion. The call was due to digital data logger. No adverse effects were reported.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: the patient received VARIVAX in 1995 when the patient was 9 years old and received a second dose at age 18.; No adverse effects are being reported; This spontaneous report as received from a consumer (patient's mother) refers to her 9 years old child (gender was not reported). The patient's medical history, concurrent conditions and concomitant medications were not reported.       On an unknown date in 1995 and subsequently in 2004, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) first dose at the age of 9 years and second dose at the age of 18 years (lot # and expiry date was not reported) for prophylaxis (inappropriate schedule of product administration). The patient had no adverse events.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: No additional adverse event reported; a patient who is 30 weeks pregnant was administered a GARDASIL 9; administered a GARDASIL 9 vaccine instead of a TD APP vaccine; This spontaneous prospective pregnancy report as received from a nurse practitioner referring to a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 26-FEB-2020 the patient who was 30 weeks pregnant was administered a hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1602283, expiration date was reported as 16-AUG-2021, but upon internal validation established as 18-AUG-2021; dose and indication were not reported) for prophylaxis instead of a diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (TDAP) vaccine (exposure during pregnancy and wrong product administered). Verified this was not product confusion because the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was a syringe and the diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (TDAP) vaccine was a vial. The provider who administered the vaccine did not read the carton. No additional adverse event was reported. Last menstrual period (LMP) was assumed as 31-JUL-2019, date of conception was assumed as 14-AUG-2019 and the estimated due date (EDD) was 06-MAY-2020.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: child received an expired dose of Daptacel/no AE; 24 months old male patient received a first dose of Daptacel, no AE; Initial information received on 24-Feb-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 24 months old male patient who received an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) for Immunisation; and HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation.  On 12-Feb-2020, the patient received a first dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5366AA, expiry date: 07-Feb-2020) via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of actual medical error due to expired vaccine used and inappropriate schedule of vaccine administered as a 24 months old male patient received a first dose (expired dose) of Daptacel.  At the time of this 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: 1.58
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired dose of deptacel vaccine/No AE; Initial information was received on 25-Feb-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 19 month old male patient who was vaccinated with expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  On 24-Feb-2020, patient received Concomitant vaccine HIB VACCINE CONJ (TET TOX) (ACTHIB) for prophylactic vaccination.  On 24-Feb-2020, the patient received a dose 4 of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot C5367AA, 30-Jan-2020] via an intramuscular route at the left thigh for prophylactic vaccination.  It was a case of actual medication error due to Expired vaccine used. Patient received expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (expired product administered).  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.
Sex: F
Vaccine: TDAP
Symptoms: Bursa disorder
Clinical narrative: something deltoid bursa or something; Initial information was received on 25-Feb-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves female patient who experienced something deltoid bursa or something (bursa disorder), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatments, vaccinations and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious something deltoid bursa or something (bursa disorder) (unknown latency), following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Laboratory data was not provided.  Final diagnosis was (unspecified) bursa disorder.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.  Information on batch number was requested.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Daptacel was given to a 2 year old patient/No AE; Initial information received on 24-Feb-2020 regarding an unsolicited valid non-serious case received from non-healthcare professional.  This case is linked to case 2020SA053845 (same reporter).  This case involves a 24 month old female patient who was administered with 0.5 ml fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5366AA) via intramuscular route in the left thigh on 24-Feb-2020 for prophylactic vaccination that had expired on 07-Feb-2020.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used.  At the 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.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: a child received an expired Daptacel/no AE; Initial information received on 24-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case is linked to case 2020SA053839 (same reporter).  This case involves a 24 months old patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and reported that a child received an expired Daptacel/no AE (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  On 24-Feb-2020, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5366AA and expiry date: 07-Feb-2020 via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  It was unknown if the patient had any adverse event at the time of reporting.  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.
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: injection site became red, swollen, and warm to touch; injection site became red, swollen, and warm to touch; injection site became red, swollen, and warm to touch; injection site became red, swollen, and warm to touch; Initial information received on 24-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2020SA053856 (same reporter).  This case involves a 59 years old female patient who experienced injection site became red, swollen, and warm to touch (vaccination site inflammation), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Jan-2020, the patient received a dose of suspect 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6628AA and expiry date: 04-Apr-2022 via unknown route in the left arm for prophylactic vaccination.  On an unknown date, injection site became red, swollen, and warm to touch (vaccination site inflammation) (unknown latency) with symptoms (vaccination site erythema), (vaccination site swelling) and (vaccination site warmth) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Laboratory data was not reported.  Final diagnosis was vaccination site inflammation.  The patient was given antibiotics as corrective treatment and told to use cold compresses.  The patient had recovered from event on an unknown date.
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nightmare, Pyrexia, Somnolence
Clinical narrative: nightmare; sleeps all the time, for 5-6 hours each day; fever; chills; Initial information received on 26-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves an elderly female patient (age not reported) who experienced nightmare (nightmare), sleeps all the time (somnolence), fever (pyrexia) and chills (chills), while she received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Past vaccination included Fluzone High-Dose and Pneumovax 23 on 23-AUG-2018.  Past medical history, medical treatment and family history were not provided.  Concomitant medications included ROSUVASTATIN CALCIUM (CRESTOR).  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UJ280AA) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious nightmare (nightmare), sleeps all the time (somnolence), fever (pyrexia) and chills (chills) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other relevant tests were not reported.  Final diagnosis were nightmare, chills, pyrexia and somnolence.   It was not reported if the patient received any corrective treatment.  On an unknown date, the event outcome was not reported from the all events.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient reported new onset leg pain on 12/23/2019.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Hot flush, Pyrexia, Rash, Rash erythematous, Tooth infection
Clinical narrative: Small red rash on chest , face, stomach, back, arms developed within 1 week of vaccine. Fever at night, hot flashing during day. Patient took clindamyacin for a tooth infection 2 days then discontinued after rash developed. Rash has continued for approximately 1 month. After 1 month, rash is still evident on chest, arms.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: The Vaccine was given Intramuscular instead of subcutaneous, patient will be contacted by her physician
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms being reported.; the patient received one dose of PEDVAXHIB vaccine that was improperly stored; This spontaneous report was received from a physician and refers to a female patient of an unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   On 27-JAN-2020 (previously reported as 23-JAN-2020), the patient was vaccinated with a dose of improperly stored dose haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, lot # S006471, expiration date 22-JAN-2022, (route of administration was not reported) for prophylaxis. The physician confirmed, that it was the only vaccine that the patient received. No adverse symptoms were reported. On an unknown date, the temperature excursion was 12.37 degrees Celsius, for a time frame of 44 hours and 15 minutes. There was no previous temperature excursion. The digital data logger was involved.   This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA005512: US-009507513-2002USA000472:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No further adverse effect reported; patient received a dose of improperly stored VAQTA; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions/allergies were not reported.    On 24-FEB-2020, the patient received improperly stored hepatitis a vaccine, inactivated(VAQTA) (lot #: S025993, expiration date: 17-OCT-2020) 1 dose (strength and route of administration were not provided) as prophylaxis (product storage error). The vaccines were exposed to temperature of below 36 degrees Fahrenheit (34 degrees Fahrenheit) for 27 minutes. No previous excursions was reported. The data logger was involved. No adverse effects were reported. No product quality compliance was reported.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Patient given adult dose of HBV at 19 years and 7 months old, patient informed that he was given adult dose.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Myalgia, Nausea, Pain, Pain in extremity
Clinical narrative: Patient had a very sore arm for 5 days, nausea for 45 minutes, and body aches.  Her primary complaint was very bad muscle pain, especially in her legs and groin.  She felt that it was very hard to walk for several days.
Age: 52.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Fever, flu-like symptoms the day following administration of vaccine.
Age: 52.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Feeling cold, Headache
Clinical narrative: Fever, flu-like symptoms the day following administration of vaccine.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: L arm bruised at injection site also purple blue, red and swollen area. The size of patient palm at injection site warmer than other skin. begins > 48 hours after shot.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Chest X-ray normal, Cyanosis, Febrile convulsion, Influenza virus test negative, Pyrexia
Clinical narrative: Immunizations administered 2-26-20. She developed a fever up to 103 degrees the morning of 2-28-20. She had an episode of perioral cyanosis. and tremors. Evaluated in ER. Dx with febrile seizure.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Respiratory syncytial virus test negative, Tremor
Clinical narrative: Immunizations administered 2-26-20. She developed a fever up to 103 degrees the morning of 2-28-20. She had an episode of perioral cyanosis. and tremors. Evaluated in ER. Dx with febrile seizure.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects were reported.; one patient received improperly stored PROQUAD on 2/4/2020; Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.       On 04-FEB-2020, the patient received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength and route were unknown; dose 0.5 milliliter, once, lot # S030208 and expiration date 25-MAR-2021) for prophylaxis, which was reconstituted with properly stored sterile diluent. On 03-FEB-2020, the vaccine was exposed to temperature excursion between 47 degrees Fahrenheit to 77 degrees Fahrenheit (9 degrees Celsius to 25 degrees Celsius) (8.7 degrees Celsius) for 2 hours (incorrect product storage). There was no previous temperature excursion. The call was due to digital data logger. No additional adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events; patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from a registered nurse and refers to a patient of unknown age. Information regarding the patient's pertinent medical history, drug reactions/allergies was not reported. On 27-FEB-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S002395; expiry date: 23-JAN-2021), (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The vaccine was stored at a temperature of 13.8°C for a time frame of 1 hour 45 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects provided. The outcome of the events was unknown.
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash
Clinical narrative: rash on upper and lower extremities, chest and shoulder Prednison taper given to pt
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Oral mucosal blistering, Rash
Clinical narrative: blisters in mouth on 2/26 then shingles rash on neck on 3/3 after neck rash patient went to PCP and was prescribed acyclovir
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dizziness, Injection site reaction, Loss of personal independence in daily activities, Rash pruritic
Clinical narrative: Dizzy to the point he could not compete in gymnastics meet on sat. 1/18. Felt better Sunday 1/19. Tues. 1/21 woke up with an itchy rash on left deltoid area and left upper flank.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine, Pyrexia
Clinical narrative: PT REPORTS SEVERE MIGRAINE LIKE HEADACHE AND LOW GRADE FEVER
Sex: M
Vaccine: MMR
Symptoms: Cough, Malaise
Clinical narrative: the patient ''became sick"; persistent cough; This spontaneous report was received from a physician and refers to a male patient of an unknown age. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.   On 31-AUG-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously for prophylaxis (lot number: R000550, expiration date was not reported but upon internal validation established as: 08-JAN-2020) (exact dose was not provided) used with sterile diluent (MERCK STERILE DILUENT) (formulation, dose, strength, frequency, indication, lot number, expiration date and route of administration was not provided).   On 02-SEP-2019, the patient became sick and developed a persistent cough which was currently unresolved. The patient sought medical attention and he saw the physician. On an unspecified date, unknown physician prescribed him prednisone (dose and frequency not provided), but the symptoms have persisted.   The outcome of malaise and cough was reported as not recovered. The causality assessment was not provided.
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: cellulitis at the injection site; This spontaneous report was received from a pharmacist via a company representative referring to an elderly female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were unknown.  On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route, lot number and expiration date were not reported) for prophylaxis, which was recommended by Centers for Disease Control and Prevention (CDC) for the patient's age.        On an unknown date the patient developed cellulitis at the injection site on the arm. It was unknown if patient sought any medical attention, received treatment or any lab/diagnostic tests were performed.  The outcome of the event was recovered. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the event was not reported.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Blood creatinine normal, Blood culture negative, Blood pressure decreased
Clinical narrative: In ER on 3/3/20, pt reports within the last days she has developed right arm pain which is localized primarily to right elbow and mid-humorous region. No skin changes and no history of fall. Pt presents febrile with generalized weakness and chills.  She denies any shortness of breath or sore throat denies any abdominal pain nausea vomiting or diarrhea. Denies any recent trips out of state. In the ER her temperature was 38.4 C heart rate 68 respiratory rate 16 blood pressure 144/76 then the blood pressure dropped 88/44. UA was normal, chest x-ray was normal, WBC count was elevated at 14.54 x 10^3/mcl. Creatinine was 1.26,  2 blood cultures were sent. No growth to date. Respiratory filmarray is negative. Treating for sepsis with broad spectrum antibiotics.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray normal, Chills, Pain in extremity, Pyrexia, Sepsis
Clinical narrative: In ER on 3/3/20, pt reports within the last days she has developed right arm pain which is localized primarily to right elbow and mid-humorous region. No skin changes and no history of fall. Pt presents febrile with generalized weakness and chills.  She denies any shortness of breath or sore throat denies any abdominal pain nausea vomiting or diarrhea. Denies any recent trips out of state. In the ER her temperature was 38.4 C heart rate 68 respiratory rate 16 blood pressure 144/76 then the blood pressure dropped 88/44. UA was normal, chest x-ray was normal, WBC count was elevated at 14.54 x 10^3/mcl. Creatinine was 1.26,  2 blood cultures were sent. No growth to date. Respiratory filmarray is negative. Treating for sepsis with broad spectrum antibiotics.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Urine analysis normal, White blood cell count increased
Clinical narrative: In ER on 3/3/20, pt reports within the last days she has developed right arm pain which is localized primarily to right elbow and mid-humorous region. No skin changes and no history of fall. Pt presents febrile with generalized weakness and chills.  She denies any shortness of breath or sore throat denies any abdominal pain nausea vomiting or diarrhea. Denies any recent trips out of state. In the ER her temperature was 38.4 C heart rate 68 respiratory rate 16 blood pressure 144/76 then the blood pressure dropped 88/44. UA was normal, chest x-ray was normal, WBC count was elevated at 14.54 x 10^3/mcl. Creatinine was 1.26,  2 blood cultures were sent. No growth to date. Respiratory filmarray is negative. Treating for sepsis with broad spectrum antibiotics.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Cough, Crying, Diarrhoea, Feeling abnormal, Food refusal
Clinical narrative: 6h after vaccines, high pitch screaming, vomiting, arching of back, explosive diarrhea, refused tummy time, stopped drinking formula, after 15h, excessive sleeping and hard to wake.   when to several dr visits within the next few days for excessive crying and fussiness, and refusing to eat with diarrhea,
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Hypersomnia, Infantile back arching, Poor feeding infant, Pyrexia, Screaming
Clinical narrative: 6h after vaccines, high pitch screaming, vomiting, arching of back, explosive diarrhea, refused tummy time, stopped drinking formula, after 15h, excessive sleeping and hard to wake.   when to several dr visits within the next few days for excessive crying and fussiness, and refusing to eat with diarrhea,
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Somnolence, Vomiting
Clinical narrative: 6h after vaccines, high pitch screaming, vomiting, arching of back, explosive diarrhea, refused tummy time, stopped drinking formula, after 15h, excessive sleeping and hard to wake.   when to several dr visits within the next few days for excessive crying and fussiness, and refusing to eat with diarrhea,
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Cough, Diarrhoea, Dyspepsia, Headache
Clinical narrative: Fever 101.9, myalgias, lethargy, headache, dry cough, dour stomach, abdominal cramping, loose stool
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Myalgia, Pyrexia
Clinical narrative: Fever 101.9, myalgias, lethargy, headache, dry cough, dour stomach, abdominal cramping, loose stool
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Patients mother stated child became febrile.  Child was taken to emergency room and had a febrile seizure.  Outcome child is doing well and is home at this time.
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Injection site reaction, Insomnia
Clinical narrative: The injection was administered in the left arm at the top of my shoulder and I felt a running of "water" inside my arm immediately.    I then tried to do regular activities in the evening and had to stop making supper due to pain in the left upper arm. Used heat, ice and ibuprofen until 10/18/19 when the pain had me in tears for several days in a row. Went to a walk in clinic and was then told to report to HR because this was a flu shot administered at work for the hospital.  I had lost range of motion in the left arm and pain was above a 5 on most days.  I could not sleep though the night and dressing myself became an issue. Sent to a orthopedic doctor on 11/14/19 for a cortisone shot.  That did not help with 90% of the pain, sent for an MRI on  12/12/2019 and results showed a 50% tear.  Did OT for 6 weeks  and was then sent to a surgeon.  Scope surgery on 2/19/2020 removed scar tissue and bursa sac and shaved down the bone.  Currently in physical therapy.
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Loss of personal independence in daily activities, Magnetic resonance imaging abnormal, Product administered at inappropriate site, Rotator cuff repair, Rotator cuff syndrome
Clinical narrative: The injection was administered in the left arm at the top of my shoulder and I felt a running of "water" inside my arm immediately.    I then tried to do regular activities in the evening and had to stop making supper due to pain in the left upper arm. Used heat, ice and ibuprofen until 10/18/19 when the pain had me in tears for several days in a row. Went to a walk in clinic and was then told to report to HR because this was a flu shot administered at work for the hospital.  I had lost range of motion in the left arm and pain was above a 5 on most days.  I could not sleep though the night and dressing myself became an issue. Sent to a orthopedic doctor on 11/14/19 for a cortisone shot.  That did not help with 90% of the pain, sent for an MRI on  12/12/2019 and results showed a 50% tear.  Did OT for 6 weeks  and was then sent to a surgeon.  Scope surgery on 2/19/2020 removed scar tissue and bursa sac and shaved down the bone.  Currently in physical therapy.
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Sensory disturbance
Clinical narrative: The injection was administered in the left arm at the top of my shoulder and I felt a running of "water" inside my arm immediately.    I then tried to do regular activities in the evening and had to stop making supper due to pain in the left upper arm. Used heat, ice and ibuprofen until 10/18/19 when the pain had me in tears for several days in a row. Went to a walk in clinic and was then told to report to HR because this was a flu shot administered at work for the hospital.  I had lost range of motion in the left arm and pain was above a 5 on most days.  I could not sleep though the night and dressing myself became an issue. Sent to a orthopedic doctor on 11/14/19 for a cortisone shot.  That did not help with 90% of the pain, sent for an MRI on  12/12/2019 and results showed a 50% tear.  Did OT for 6 weeks  and was then sent to a surgeon.  Scope surgery on 2/19/2020 removed scar tissue and bursa sac and shaved down the bone.  Currently in physical therapy.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Axillary pain, Chills, Feeling abnormal, Immediate post-injection reaction, Malaise
Clinical narrative: I had the first round of vaccine end of December (27th?) and had a bad reaction to it - fever, aches, chills for one day immediately after vaccine, and then general malaise for a couple of days afterward.  When I got the vaccine yesterday I had hoped it wouldn't be as bad but honestly the symptoms were worse.  I got the shot at 4PM, came home, had the normal arm pain at about 6:30/7PM.  It hurt to lift my arm and traveled around to underneath my armpit.  The fever and chills and aches started at 2AM.  I woke up to use bathroom and was shivering so bad and had aches EVERYWHERE.  Literally every part of my body was achy.  Right now as I'm typing this it's about 12:30 in the afternoon the next day.  I had fever this morning of 100 and that was with  tylenol.  Right now I'm on an Advil and have no temperature but I'm literally freezing and achy everywhere.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Vaccination complication
Clinical narrative: I had the first round of vaccine end of December (27th?) and had a bad reaction to it - fever, aches, chills for one day immediately after vaccine, and then general malaise for a couple of days afterward.  When I got the vaccine yesterday I had hoped it wouldn't be as bad but honestly the symptoms were worse.  I got the shot at 4PM, came home, had the normal arm pain at about 6:30/7PM.  It hurt to lift my arm and traveled around to underneath my armpit.  The fever and chills and aches started at 2AM.  I woke up to use bathroom and was shivering so bad and had aches EVERYWHERE.  Literally every part of my body was achy.  Right now as I'm typing this it's about 12:30 in the afternoon the next day.  I had fever this morning of 100 and that was with  tylenol.  Right now I'm on an Advil and have no temperature but I'm literally freezing and achy everywhere.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Influenza like illness, Pain
Clinical narrative: Dizziness; pain; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2019, the patient received the 1st dose of Shingrix. On 29th August 2019, less than a day after receiving Shingrix, the patient experienced dizziness and pain. On 30th August 2019, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the dizziness and pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms, dizziness and pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient experienced flu-like symptoms that lasted for 3 days. For tolerance to 2nd dose refer linked case US2020034250, reported by the same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Fall, Headache, Influenza like illness, Laboratory test normal
Clinical narrative: Dizziness; pain; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2019, the patient received the 1st dose of Shingrix. On 29th August 2019, less than a day after receiving Shingrix, the patient experienced dizziness and pain. On 30th August 2019, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the dizziness and pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms, dizziness and pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient experienced flu-like symptoms that lasted for 3 days. For tolerance to 2nd dose refer linked case US2020034250, reported by the same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of consciousness, Musculoskeletal pain, Pain
Clinical narrative: Dizziness; pain; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2019, the patient received the 1st dose of Shingrix. On 29th August 2019, less than a day after receiving Shingrix, the patient experienced dizziness and pain. On 30th August 2019, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the dizziness and pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms, dizziness and pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient experienced flu-like symptoms that lasted for 3 days. For tolerance to 2nd dose refer linked case US2020034250, reported by the same reporter.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Fatigue, Impaired work ability, Lethargy, Malaise
Clinical narrative: I received my 3rd Hep B shot on Friday. Actually, starting Sunday night I've been feeling lethargic/fatigued/lightheaded/dizzy. I went to the doctor, he said it could be a response to the Hep B vaccine. I  still am not feeling well and have had to either leave work/call out all week- I probably will leave early again today.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Feeling hot, Nausea
Clinical narrative: Donor received vaccination and started to feel nauseas, warm and lightheaded. Donor was taken back into office and was given ice packs and was monitored until he felt better. Donor was recommended to go see HCP and donor agreed to go see HCP.
Age: 26.0
Sex: F
Vaccine: HEPA
Symptoms: Pruritus, Urticaria
Clinical narrative: 02/26/20 itching the afternoon of vaccination, 02/27/20 hives and itching on head neck but not at injection site. 02/28/20 hives coming and going on back. No respiratory issues throughout. 03/01/20, petting her dog, hives on her hands.