chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient was given expired Fluzone Quadrivalent/No AE; Initial information was received on 15-Sep-2020 regarding an unsolicited non-serious case received from a other health care professional.  This case involves patient (unknown demographics) who received expired dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ244AA and expiry date 30-Jun-2020) via unknown route at unknown administration site prophylactic vaccination on an unknown date (expired product administered).  It was an actual medication error case due to expired vaccine used (latency: same day). Vaccine was expired on 30-Jun-2020.  At a time of reporting no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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: 72.0
Sex: M
Vaccine: UNK
Symptoms: Exposure via skin contact, Injection site extravasation
Clinical narrative: a big drop of liquid running down from the site of vaccination; Initial information received on 15-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 72-year old male patient who experienced a big drop of liquid running down from the site of vaccination (injection site extravasation), while he received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Sep-2020, the patient received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported via unknown route in the left deltoid for prophylactic vaccination.  On an unknown date in Sep-2020, the patient developed a non-serious a big drop of liquid running down from the site of vaccination (injection site extravasation) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Case Details: It was reported that, pharmacist did not notice anything wrong with the syringe and he knew he attached the needle securely but when the patient got home he noticed a big drop of liquid running down his arm which they think came out of the site.  No laboratory data was reported.  It was not reported if the patient received an corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient fainted as he was scared of getting an immunziation
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Lip pain, Lip swelling, Oral discomfort
Clinical narrative: Lips hurting and swollen when awake 2 days after receiving the vaccine. Continued to get worse, now hurting and burning more 10 out of 1-10 pain after taking Motrin for the pain.
Age: 70.0
Sex: F
Vaccine: FLUA4, PNC13
Symptoms: Cellulitis, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient came back 1 week after and reported a big red rash area below deltoid  which is more likely close to elbow area. Patient complained it was itchy and painful. She claimed that the rash appeared on 9/19 and started spreading on 9/20.  I recommended the patient to see the doctor immediately since it might related to infection or other diseases. Patient came back and was prescribed antibiotic. I spoke to the doctor who examined and prescribed the medication at urgent care. Per MD, it is cellulitis it might be related to side effects of vaccinations. Patient will start the course of antibiotics for 10 days.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: mild fever onset about 8 hours after vaccine administration - continued to rise despite Tylenol - reached as high as 103 degrees, even at peak time of Tylenol dose. resolved at approximately 24 hours.
Age: 1.08
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure on 9/17; taken to ER; evaluation unremarkable and patient back to baseline
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Roughly 3 hours after vaccination I developed chills, body aches, and a measured fever of 39.1 C. The fever lasted roughly 6 hours; remaining symptoms largely resolved 12 hours after onset.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Patient vomited approximate;ly 5 minutes after immunizations were completed. Reported he felt fine 15 minutes after vomited episode.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain, Joint range of motion decreased, Magnetic resonance imaging, Musculoskeletal discomfort
Clinical narrative: Patient had pain at injection site shortly after injection and then pain from shoulder down arm later in the day.  Over the next few weeks and months she had decreased range of motion and then a frozen shoulder.  This was brought to attention of the pharmacy in July of 2020 when asked if she wanted a flu vaccine this year.  At the time she told the pharmacist she did not want one as she was having shoulder issues.  The pharmacist asked her if it was related to the vaccine the previous year and if she wanted us to report an adverse event and she did not at this time.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Periarthritis
Clinical narrative: Patient had pain at injection site shortly after injection and then pain from shoulder down arm later in the day.  Over the next few weeks and months she had decreased range of motion and then a frozen shoulder.  This was brought to attention of the pharmacy in July of 2020 when asked if she wanted a flu vaccine this year.  At the time she told the pharmacist she did not want one as she was having shoulder issues.  The pharmacist asked her if it was related to the vaccine the previous year and if she wanted us to report an adverse event and she did not at this time.
Age: 64.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Pain, Paraesthesia, Pruritus, Rash
Clinical narrative: Slight rash developed on left side of back.  Itching and then pain radiating along the nerve trunk to the abdomenal side Valtrex was prescribed and taken as directed.  Symptoms subsided, however rash seems to have appeared after completion of medication and itching and tingling sensation are still present as of 9/21/2020
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Nausea, Pyrexia
Clinical narrative: fever, nausea,  weakness
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dyskinesia, Eye movement disorder, Hyperhidrosis, Hypotonia, Immediate post-injection reaction
Clinical narrative: Immediately after shots she became limp and lost consciousness. Was sitting on exam table & nurse was at her side and laid her down on table. She did have some jerks and generalized stiffening of arms and body. Her eye rolled back. No tonic-clonic jerking. No lateral eye movements. Very Pale and Diaphoretic. Entire event 1 minute with syncope post vaccination. Wish myoclonic jerks, watched for 30 min. Better when left.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Pallor, Syncope
Clinical narrative: Immediately after shots she became limp and lost consciousness. Was sitting on exam table & nurse was at her side and laid her down on table. She did have some jerks and generalized stiffening of arms and body. Her eye rolled back. No tonic-clonic jerking. No lateral eye movements. Very Pale and Diaphoretic. Entire event 1 minute with syncope post vaccination. Wish myoclonic jerks, watched for 30 min. Better when left.
Age: 50.0
Sex: M
Vaccine: FLUR4
Symptoms: Bone pain, Hypoaesthesia, Muscular weakness, Neck pain, Paraesthesia
Clinical narrative: Significant pain under my under my scapula and in my clavicle, and all the way up to the base of my neck.  All of these pains were on my right side where the vaccine was administered.  I also have significant weakness, tingling and numbness in my fingers and forearm
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis
Clinical narrative: cellulitis of right arm at injections site
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: extreme body aches starting around 7 hours after vaccine. Low grade fever also.  Lasted for approximately 48 hours after vaccine.
Age: 50.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: patient had swelling, redness, tenderness below injection site
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Joint swelling, Pruritus
Clinical narrative: Patient describes itching in legs and swelling around ankles.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Lymph node pain, Lymphadenopathy, Swelling, Tenderness
Clinical narrative: Staff member received influenza vaccine from employee health nurse.  Received flu vaccine in right deltoid on 9/11/20. Later in the day developed enlarged painful lymph node. Tenderness & swelling persisted for 2-3 days and gradually subsided.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Altered state of consciousness, Dizziness, Immediate post-injection reaction, Injection site pain
Clinical narrative: Staff member received influenza vaccine from employee health nurse.  Received flu vaccine in right deltoid on 9/11/20. Complained of sharp pain in right shoulder immediately after vaccine injected. Advised to massage the area, apply ice and use ibuprofen or acetaminophen if needed. Stated that when she returned to her department she felt lightheaded & like she was going to pass out. Sat down for a few minutes & lightheadedness subsided. Stated that pain in shoulder was "pretty bad" for a couple days and on 9/15 was slowly improving.
Age: 44.0
Sex: F
Vaccine: FLU4, TDAP, VARCEL
Symptoms: Exfoliative rash, Feeling jittery, Periorbital swelling, Rash pruritic, Rhinorrhoea
Clinical narrative: Itchy scaley rash face, neck, hands, ear lobes. Extremely puffy eyes and runny nose.  Jitters.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored PROQUAD; This spontaneous report was received from a medical assistant, concerning a 4-year-old female patient.  The patient's medical history, concurrent conditions, drug reactions or allergies were not provided.  On 31-AUG-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dosage, anatomical location and route of administration were not provided) lot # T005406 with expiration date on 12-AUG-2021, administered subcutaneously for well check; which was previously reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). The multiple temperature excursions included storage temperatures like -9 to 8 degrees Celsius (°C) (-6.1 °C) for 13 hours and -14 to -10 °C for 116 hours. There was no previous temperature excursion. No product quality complaint (PQC) was involved.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: headache; SHIVERING; This case was reported by a other health professional via sales rep and described the occurrence of headache in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 7PG2M, expiry date 5th June 2022) for prophylaxis.   On 9th September 2020, the patient received Shingrix .5 ml. On 9th September 2020, less than a day after receiving Shingrix, the patient experienced shivering. In September 2020, the patient experienced headache. On an unknown date, the outcome of the headache was unknown and the outcome of the shivering was recovered/resolved.   It was unknown if the reporter considered the headache and shivering to be related to Shingrix.  Additional details were provided as follows: The patient received one dose of Shingrix on 9th september 2020 and experienced shivering later that night ,which was recovered next day  and headache. The reporter consented to follow up. No further information was available.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired TENIVAC was administered to the patient/No AE; Initial information was received on 13-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 59 years old female patient who was administered with 0.5 mL once dose of expired vaccine  DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (Injection, lot U6021AA and expiry date 27-Jul-2020) via intramuscular route in the arm for prophylactic vaccination on 12-Aug-2020 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. No other concomitant vaccines were given.  It was an actual medication error case due to expired vaccine used (latency on same day).  At a time of reporting no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, IPV, MMR, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: doctor prescribed Daptacel but patient accidentally received Pentacel/no AE; Initial information received on 17-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional (Medical assistant).              This case involves a 4 year-old female patient who accidentally received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Wrong product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination.  On 17-Aug-2020, the patient received fifth dose 0.5 mL of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ259AA; UJ331AA and expiration date 14-May-2021, 23-Nov-2020) via intramuscular route at an right Vastus lateralis for prophylactic vaccination.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to wrong drug administered (latency: on same day).  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: 4.0
Sex: F
Vaccine: DTAPIPVHIB, IPV, MMR, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: the patient supposed to give Daptacel and gave Pentacel instead, no AE; the patient received fifth dose of Pentacel, no AE; Initial information received on 18-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 4 year old female patient who was supposed to receive a dose of DAPTACEL and instead received a 0.5 mL fifth dose of PENTACEL, (lot: UJ331AA, expiry date: 23-Nov-2020) via an intramuscular route in the right Vastus lateralis for prophylactic vaccination on 17-Aug-2020.   The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was an actual medication error due to wrong vaccine administered and extra dose administered (latencysame day).  At the time of reporting, 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: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient recieved a fluzone quadrivalent (multi dose vial from last season) vaccine that was expired, No AE; Initial information received on 20-Aug-2020 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a female patient (age not reported) who was vaccinated with an expired dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT] (lot UJ270AA and expiry date: 30-Jun-2020) via an unknown route at an unknown administration site for prophylactic vaccination on 20-Aug-2020 (expired product administered).  The patient's medical history, past medical treatment, past vaccination, family history and concomitant medication were not provided.  It was an actual medication error case due to expired vaccine used (latency same day).   It was reported that patient received this Fluzone Quadrivalent multi dose vial from last season.  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: 1.0
Sex: F
Vaccine: MNQ
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: patient received first dose of menactra at the age of one but did not the complete series/No AE; Initial information was received on 21-Aug-2020 regarding an unsolicited valid non-serious case received from the other health care professional (pharmacy intern).  This case involves 12-months-old female patient who was vaccinated with first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE but did not complete the series (batch number and expiry date not reported) via unknown route in unknown administration site on an unknown date in Feb-2003 for prophylactic vaccination (incomplete course of vaccination).  At the time of report, patient was 18 year-old and wanted to know if she needed to restart series.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due incomplete course of vaccination.  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 batch number for this case.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error, Product preparation issue
Clinical narrative: The patient received DTAP/IPV but not the ActHIB, no AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 1 year old male patient who received DTAP/IPV but not the ACTHIB part of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product preparation issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE for prophylactic vaccination.  On 02-Sep-2020, the patient received a 0.5 ml second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot U6736AA, expiry date: 21-Jun-2022, Single dose Vial) (Frequency: 2nd) via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate reconstitution technique (latency same day).  The nurse reported that a medical assistant went to administer Pentacel, however thought she mixed the dilutent with the powder when she actually had not. It was an oversight error.  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: 81.0
Sex: F
Vaccine: UNK
Symptoms: Depressed mood, Feeling abnormal, Poor quality sleep, Product administered at inappropriate site, Wrong technique in product usage process
Clinical narrative: miserable for several days; not sleeping well; The patient was injected in the wrong area of her shoulder; Initial information was received on 08-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional .  This case involves an 81 year old female patient who was miserable for several days (depressed mood) and not sleeping well (poor quality sleep) while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history included a bleed above her brain. The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. At the time of the event, the patient had ongoing multiple sclerosis (for 32 years), had a lot of fluid in her shoulder, immune system not good with having multiple health problems.   On 08-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number not reported) once via unknown route in the shoulder NOS for prophylactic vaccination.  On an unknown date, the patient had been miserable for several days (depressed mood) and was not sleeping well (poor quality sleep) (unknown latency, non-serious) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was a case of an actual medication error due to wrong technique in product usage process as the pharmacist gave the patient an injection too high on her shoulder which did not go into the deltoid because the band aid was on the top of her shoulder (latency same day).  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of clinical events was unknown.  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 lot number.
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood culture, Blood lactic acid increased, Blood test, Chills, Computerised tomogram
Clinical narrative: She was hypotensive, tachycardic, elevated WBC, elevated lactic acid, nausea, headache, fever (101), muscle aches, chills
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Electrocardiogram, Headache, Hypotension, Myalgia, Nausea
Clinical narrative: She was hypotensive, tachycardic, elevated WBC, elevated lactic acid, nausea, headache, fever (101), muscle aches, chills
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Pyrexia, SARS-CoV-2 test, Tachycardia, Ultrasound scan, White blood cell count increased
Clinical narrative: She was hypotensive, tachycardic, elevated WBC, elevated lactic acid, nausea, headache, fever (101), muscle aches, chills
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: X-ray
Clinical narrative: She was hypotensive, tachycardic, elevated WBC, elevated lactic acid, nausea, headache, fever (101), muscle aches, chills
Age: 63.0
Sex: M
Vaccine: FLU4, PPV, VARZOS
Symptoms: Blood test, Dyspnoea, Hypertension, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: He received pneumovax, 2nd dose shingrix, and fluarix Tuesday September 15, 2020 in the morning. That evening per Dr's office patient reported to hospital with 104F fever, Shortness of breath, high blood pressure. He was seen at the hospital for 2 hours bloodwork taken, Covid test done (was negative) the hospital discharged him hour per Dr.'s office with diagnosis of Hypertension.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Limb discomfort, Vaccination site warmth
Clinical narrative: Immunization site warm to touch. Area is red, swollen and uncomfortable when moving arm. Afebrile.     .
Age: 33.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Localized swelling/redness, warmth to Left arm.  25mg Benadryl PO, topical hydrocortisone.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chest pain, Chills, Feeling cold, Influenza like illness, Injected limb mobility decreased
Clinical narrative: Flu like symptoms, cold chills, nausea, redness in arm from point of injection traveling down to the elbow as days progressed, warm to the touch at injection site, chest pains on the left side, could not lift arm for 3 days
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site warmth, Nausea
Clinical narrative: Flu like symptoms, cold chills, nausea, redness in arm from point of injection traveling down to the elbow as days progressed, warm to the touch at injection site, chest pains on the left side, could not lift arm for 3 days
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: 3 days after receiving the Tdap vaccine, patient developed severe pain in left upper arm from below the shoulder to approx 3 inches above the elbow. Pain has improved but still persists today.  No other symptoms. Pt with full ROM, no redness or swelling.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Body temperature increased, Injection site pain, Injection site warmth, Lethargy
Clinical narrative: Four days after receiving vaccines child was lethargic, did not want to play per mom. She did have some bursts of energy that were short lived. Early this morning she woke up complaining of leg pain. Mom noted that her left leg was warm to touch. Mom took her temperature with a forehead scanner and her temperature was 100. Her leg is not red or swollen and she is now complaining of her right leg as well. Child was recently diagnosed with Anisocoria, as has her sibling.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Peripheral swelling, Pyrexia, Rash
Clinical narrative: Patient received flu shot on Saturday 9/19/20, reported to have mild fever on sunday 9/20/20 which she took ibuprofen and was able to alleviate the symptoms.  On Monday 9/21/20, patient reported to have rash on face and rash on both hands and swollen on fingers.  Will follow up with PCP to seek medical advice
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: temperature excursion; This spontaneous report was received from a nurse concerning a patient of unknown age. The patient's current condition, medical history and concomitant therapy were not reported.   On 20-AUG-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T002843, expiry date: 23-JAN-2022; at the dose of 0.5 ml, frequency and route were not reported) as prophylaxis.         The nurse was calling to report temperature excursion (product storage error) that was intermittent beginning since 20-AUG-2020 (also reported as 28-JUL-2020), but not previously reported, involving administered dose of varicella virus vaccine live (oka/merck) (VARIVAX). The call was because of data logger. The temperature was from -14 degrees Celsius to -10 degrees Celsius (max -9.5 degrees Celsius). The time frame was reported as total 38 hours and 30 minutes.
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VAQTA; second dose administered outside prescribing information; This spontaneous report was received from a medical assistant and refers to a 58 year-old male patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not provided.  On 01-JUL-2020, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) injection, intramuscularly (exact dose, lot #, expiration date and anatomical location were not reported). On 31-AUG-2020, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) injection, lot # S023220, expiration date 20-OCT-2020, intramuscularly (exact dose and anatomical location were not reported) which was improperly stored. The second dose was administered outside of the prescribing information. The vaccine underwent excursion above 9 degrees Celsius for 66 hours. No previous temperature excursion was reported. Digital data logger was involved.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines; This spontaneous report was received from a medical assistant referring to a 4-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions and previous drug reactions or allergies was not provided. Concomitant therapy included sterile diluent (manufacturer unknown).  On 27-AUG-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (dose, strength, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot # T002848, expiration date 23-JAN-2022) for prophylaxis (product storage error).   The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit (F) to 14 degrees F (10.56 degrees F) for 50 minutes, as recorded by a data logger. The previous temperature excursion reported was of 6 degrees F to 14 degrees F (8.47 degrees F) for 30 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA000749: US-009507513-2009USA000762: US-009507513-2009USA000777: US-009507513-2009USA000894: US-009507513-2005USA009352: US-009507513-2009USA000676: US-009507513-2009USA000699: US-009507513-2009USA000710: US-009507513-2009USA000736: US-009507513-2009USA000747: US-009507513-2009USA000757: US-009507513-2009USA000931: US-009507513-2009USA000958: US-009507513-2009USA000971: US-009507513-2009USA000976: US-009507513-2009USA000991: US-009507513-2009USA001003: US-009507513-2009USA001006: US-009507513-2009USA001097: US-009507513-2009USA001099: US-009507513-2009USA001111: US-009507513-2009USA001114: US-009507513-2009USA001123: US-009507513-2009USA001129: US-009507513-2009USA001135: US-009507513-2009USA001194:
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VARlVAX; This spontaneous report has been received from a medical assistant referring to a 3 years old male patient. Information about pertinent medical history, concomitant medication or drug reactions/allergies was not provided.  On 27-AUG-2020, the patient was administered improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX); lot # S024364, expiration date 06-AUG-2021 (strength, dose and route were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT).  The administered dose of the vaccine experienced a temperature in the range -14 degree Celsius to -10 degree Celsius (-13.04 degree Celsius) for 45 minutes recorded by a data logger. There was no previous temperature excursion.
Age: 24.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: no other reaction or symptoms; administered ZOSTAVAX instead of VARlVAX; This spontaneous report as received from a physician assistant and an office manager refers to a 24-year-old female patient. The patient's medical history and concurrent conditions were not reported. It was reported that, on an unknown date (within the 4 weeks before the administration of zoster vaccine live (ZOSTAVAX)), the patient received diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (Tdap) and hepatitis B virus vaccine (unspecified) (manufacturer unknown).   On an unknown date, the patient had a titer done prior to receiving zoster vaccine live (ZOSTAVAX) and had no protection for chicken pox. It was reported that, physician assistant ordered varicella virus vaccine live (Oka/Merck) (VARIVAX) for the patient.   However, on 27-AUG-2020, the patient was vaccinated intramuscularly with the first dose of zoster vaccine live (ZOSTAVAX) (lot # S016663, expiry date: 27-AUG-2020, right deltoid) instead varicella virus vaccine live (oka/merck) (VARIVAX). There was concomitant medication.  The patient had no other reaction or symptoms associated with this administration. No prescribing drug treatment was required.
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: fever 2 days after injection; patient "showed up with pain down her arm into her fingertips, swelling, decreased range of motion, and tenderness; patient "showed up with pain down her arm into her fingertips, swelling, decreased range of motion, and tenderness; patient "showed up with pain down her arm into her fingertips, swelling, decreased range of motion, and tenderness; patient "showed up with pain down her arm into her fingertips, swelling, decreased range of motion, and tenderness; This spontaneous report was received from a nurse practitioner who knew about the events from a medical assistant and refers to a female patient of unknown age. No information regarding her pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 02-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in the left arm (strength, dose, route of administration, lot # and expiration date were not reported), for prophylaxis.  On 04-JUL-2020 (reported as 2 days after injection), the patient experienced fever. Since an unknown date in 2020, the patient had been suffering from pain down her arm into her fingertips, swelling, decreased range of motion, and tenderness. She had been experiencing these symptoms for over a month. She sought medical attention. She was advised by healthcare provider (HCP) to treat the symptoms with ibuprofen and was offered with a methylprednisolone (MEDROL) pack but she refused it. The patient had no insurance and wanted to know who was going to pay for this. The outcome of the events was not reported. The causality assessment between the events and the suspect therapy was not provided.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VARlVAX; This spontaneous report has been received from a physician referring to a 4 years old patient of unknown gender. Information about pertinent medical history, concomitant medication or drug reactions/allergies was not provided.  On 17-JUL-2020, the patient was administered improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX); lot # S032355, expiration date 14-OCT-2021 (strength and dose were not reported) subcutaneously for prophylaxis (reported as routine vaccination) (product storage error). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (lot # S032591, expiration date 16-AUG-2022).  The storage temperature of the vaccine was reported as 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.6 Fahrenheit degrees) for a time frame of 12 hours (multiple excursions) and in the range of 15 Fahrenheit degrees to 46 Fahrenheit degrees (16 Fahrenheit degrees) for a time frame of 30 minutes recorded by a data logger. There was no previous temperature excursion. No product quality complaint involved.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Injection site pain
Clinical narrative: lump at the injection site; slightly sore; This spontaneous report was received from a physician assistant via a company representative and refers to a 15-year-old female patient. Her concurrent conditions, medical history and concomitant medications were not reported.  On 23-JUL-2020, the patient was vaccinated with the first dose of human papilloma virus (hpv) rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, intramuscularly (dose, anatomical location, lot # and expiry date were not provided) for prophylaxis.  In the evening of 23-JUL-2020, the patient's father noticed a lump at the injection site. He applied ice to the site and it relieved it a bit. On 24-AUG-2020, the patient returned to healthcare provider's office for a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The healthcare provider noticed that the lump was still present and it was slightly sore since an unknown date in 2020. The second dose was given at that time.  The outcome of the events was not reported. 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: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VARlVAX; This spontaneous report has been received from a physician referring to a 2 years old patient of unknown gender. Information about pertinent medical history, concomitant medication or drug reactions/allergies was not provided.  On 11-AUG-2020, the patient was administered improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX); lot # S032355, expiration date 14-OCT-2021 (strength and dose were not reported) subcutaneously for prophylaxis (reported as routine vaccination) (product storage error). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (lot # S032591, expiration date 16-AUG-2022).  The storage temperature of the vaccine was reported as 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.6 Fahrenheit degrees) for a time frame of 12 hours (multiple excursions) and in the range of 15 Fahrenheit degrees to 46 Fahrenheit degrees (16 Fahrenheit degrees) for a time frame of 30 minutes recorded by a data logger. There was no previous temperature excursion. No product quality complaint involved.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VARlVAX; This spontaneous report has been received from a physician referring to a 4 years old patient of unknown gender. Information about pertinent medical history, concomitant medication or drug reactions/allergies was not provided.  On 07-JUL-2020, the patient was administered improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX); lot # S032355, expiration date 14-OCT-2021 (strength and dose were not reported) subcutaneously for prophylaxis (reported as routine vaccination) (product storage error). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (lot # S032591, expiration date 16-AUG-2022).  The storage temperature of the vaccine was reported as 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.6 Fahrenheit degrees) for a time frame of 12 hours (multiple excursions) and in the range of 15 Fahrenheit degrees to 46 Fahrenheit degrees (16 Fahrenheit degrees) for a time frame of 30 minutes recorded by a data logger. There was no previous temperature excursion. No product quality complaint involved.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VARIVAX; This spontaneous report has been received from a physician referring to a 4 years old patient of unknown gender. Information about pertinent medical history, concomitant medication or drug reactions/allergies was not provided.  On 03-AUG-2020, the patient was administered improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX); lot # S032355, expiration date 14-OCT-2021 (strength and dose were not reported) subcutaneously for prophylaxis (reported as routine vaccination) (product storage error). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (lot # S032591, expiration date 16-AUG-2022).  The storage temperature of the vaccine was reported as 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.6 Fahrenheit degrees) for a time frame of 12 hours (multiple excursions) and in the range of 15 Fahrenheit degrees to 46 Fahrenheit degrees (16 Fahrenheit degrees) for a time frame of 30 minutes recorded by a data logger. There was no previous temperature excursion. No product quality complaint involved.
Age: 1.33
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: A 16 month old received both PROQUAD and VARICELLA at the same time; This spontaneous report was received from a nurse concerning a 16-month-old patient of unknown gender. The patient's concurrent conditions, medical history, historical drug, drug reactions/allergies and concomitant therapies were not provided.  On 09-SEP-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 mililliter and varicella virus vaccine live (oka/merck)(manufacturer unknown) (Overdose) both for prophylaxis. Dosage regimens, lot numbers and expiration dates were not provided.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored PROQUAD that was administered; Information has been received from a nurse, referring to a currently 4 years old patient of unknown gender. Information about medical history, concurrent condition and concomitant therapy was unknown.   On an unknown date, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T003833, expiration date: 01-AUG-2021, therapy type: recombinant Human albumin (rHA); dose, strength and route were unknown) for prophylaxis (product storage error). Temperature excursion was reported as range -14 Celsius degrees (C) to -10 C (-11.84 C) for time frame 40 minutes, range -9 Celsius degrees (C) to 8 C (-4.12 C) for time frame 30 minutes. There was no previous temperature excursion. A digital data logger was involved. No product quality complaint (PQC) was involved in the case.
Age: 12.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no other AE; an expired adult V AQTA given to 12 yo; an expired adult V AQTA given to 12 yo; This spontaneous report as received from a medical assistant refers to a 12-years-old patient of unknown gender. The patient's medical history and concurrent condition were not reported. On 04-SEP-2020, the patient was vaccinated with a dose of 1 ml of adult hepatitis a vaccine, inactivated (VAQTA) (pre-filled syringe, lot # S007265, expiry date: 07-JUL-2020, route of administration not reported). No adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S007265; expirationdate: 07-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored PROQUAD; This spontaneous report was received from a medical assistant referring to a 4 years old male patient. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On 26-AUG-2020, the patient was administered improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection recombinant Human albumin (rHA) (lot # T005406, expiration date 12-AUG-2021; strength and vaccine dosage detail were not reported) subcutaneously for prophylaxis (product storage error). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted with properly stored sterile diluent (STERILE DILUENT). The storage temperatures of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) were -9 Celsius degrees to 8 Celsius degrees (-6.1 Celsius degrees) for 13 hours and -14 Celsius degrees to -10 Celsius degrees for 116 hours. There was no previous temperature excursion. Data logger was involved.