chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Resident received Moderna 1st dose on April 14, 2021 prior to admission  Family (HCP) requested Jansen vaccination from the local fire department to be administered at the facility. Family and staff were unaware that the resident had received the 1'st dose of Moderna. No adverse reaction to the vaccination. Reported to epidemiology 5/13/21 with recommendation to monitor and report to VAERS and HCFR's.
No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; Information has been received from a medical assistant concerning a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.    It was reported that hepatitis a vaccine, inactivated (VAQTA) (lot # T013205, expiration date was reported as 02-DEC-2021 but upon internal validation established as 03-DEC-2021; lot # T023913, expiration date was reported as 30-MAR-2022 but upon internal validation established as 31-MAR-2022; lot # T018229, expiration date was reported as 13-DEC-2021 but upon internal validation established as 14-DEC-2021) underwent a temperature excursion. On 07-JUN-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (dose and route were not reported) for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion above 46 Fahrenheit degrees (47.2 Fahrenheit degrees) for 52 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2106USA004356:
Redness, swelling. Told to give Benadryl and Zantac.
Headache - across the back. Approx began 7-12-12 - comes and goes. FIORICET takes care of it temp. but then comes back, previous history of headaches --> FIORICET 1 tab/month max.
Fever above 101 degrees, severe chills, severe headaches and fatigue for 48 hours. Two days later when appetite returned, I realized I had completely lost my sense of taste and smell, which has not yet returned. Still experiencing fatigue, mild headaches, and nasal stuffiness.
Fine rash developed on arms and legs; Red, itchy patches on abdomen, back, neck and chin; Hot, burning sensation to palms of hands and soles of feet; Red, itchy patches on abdomen, back, neck and chin; Hot, burning sensation to palms of hands and soles of feet; This is a spontaneous report from a contactable nurse, the patient.  A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EJ1685), via an unspecified route of administration on 25Dec2020 at 03:00 PM (at the age of 46-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. Medical history included anemia. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included Concomitant medication included ethinylestradiol, etonogestrel (NUVARING) (MANUFACTURER UNKNOWN) and iron (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took sulfa (MANUFACTURER UNKNOWN), from unknown dates to unknown dates for unknown indications and experienced allergy. On 25Dec2020 at 08:00PM, a fine rash developed on arms and legs. Red, itchy patches on abdomen, back, neck and chin. Hot, burning sensation to palms of hands and soles of feet. The patient did not receive any treatment for the events. The clinical outcome of the events rash on legs & arms, Red, itchy patches on abdomen, back, neck and chin, and Hot, burning sensation to palms of hands and soles of feet was recovered on an unspecified date in Dec2020.  It was also reported that since the vaccination, the patient had not been tested for COVID-19. There were no other vaccines the patient received within 4 weeks of the vaccination.
A patient received a non-viable FLUZONE QUADRIVALENT from shipment no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (MI) (Reference number- 00890492) and transmitted to Sanofi on 08-Dec-2021.  This case is linked to case 2021SA415315 (Same reporter).  This case involves a 56 year old male patient who was received non-viable INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on 08-Dec-2021 from shipment which was in transit since Sept 20, 2021 (Product storage error).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 08-Dec-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7376MA, expiry: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to Incorrect product storage (latency same day).  It was reported "Pharmacist called to report that two patients were administered "non-viable" FLUZONE QUADRIVALENT today 08Dec2021. Pharmacist reports that they received a shipment of (12) FLUZONE QUADRIVALENT today. Pharmacist reports that two (2) patients received the FLUZONE QUAD vaccine today from that shipment. RPh reports that it was discovered later in the day that the packing slip says the package was in transit since September. Registered Pharmacist (RPh) reports the product was cold upon receipt so no one noticed the packing slip date. RPH spoke with and was advised that vaccines were non viable since the packaging slip reports that it was in transit since Sept 20, 2021. Pharmacy also received (11) boxes of FLUZONE HD in that same package. No patients received the FLUZONE HD vaccine. RPh is inquiring about re-vaccination for these patients and how soon?"  No other 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 the 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.
Chest Pain, Tachycardia, Resting heart rate stayed around 130 for the approx 11 hours we were in the emergency room.
Information has been received from a licensed practical nurse concerning her 18 year old daughter, with "possible asthma" and an allergy to sulfamethoxazole (+) trimethoprim (SEPTRA), who on 25-FEB-2008 was vaccinated with the third dose of Gardasil.  There was no concomitant medication reported.  On 26-FEB-2008 the patient experienced a systemic reaction about "24 hours after vaccination with her third dose of Gardasil."  The reaction was not anaphylactic.  Her daughter developed hives, swelling, itching, pain, fever and had difficulty moving her joints.  She was taken to the emergency room and given prednisone and diphenyhydramine hydrochloride (BENADRYL).  No diagnostic laboratory studies were performed.  At the time of this report, the patient was recovering.  No product quality complaint was involved.  Hives, swelling, itching, pain, fever, and difficulty moving her joints were considered to be other important medical events.  Additional information has been requested.
Syncopal episode started immediately after vaccination. Patient was laid down on the ground with feet elevated. He was given water and food. Patient did not hit his head. Patient made a full recovery after 15 minutes.
acute onset of diarrhea; Pain at injection site/ pain at injection site have improved; Headache; Low grade fever; Myalgia; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  On 22-MAY-2023, the patient received the 1st dose of Shingrix (left arm). On 23-MAY-2023, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain at injection site/ pain at injection site have improved), headache (Verbatim: Headache), fever (Verbatim: Low grade fever) and myalgia (Verbatim: Myalgia). On 24-MAY-2023, the patient experienced diarrhea (Verbatim: acute onset of diarrhea). The outcome of the injection site pain and myalgia were resolving and the outcome of the headache, fever and diarrhea were not resolved.  It was unknown if the reporter considered the injection site pain, headache, fever, myalgia and diarrhea to be related to Shingrix.  It was unknown if the company considered the injection site pain, headache, fever, myalgia and diarrhea to be related to Shingrix.  Additional Information: GSK Receipt Date: 25-MAY-2023  The reporter was the patient. She reported of receiving the first dose of Shingrix in the left arm. She had experienced a low grade fever, dull headache, pain at the injection site, myalgia, and diarrhea. She also reported fever, headache, pain at site, and myalgia began on Tuesday and were ongoing.  2 days after receiving Shingrix, the patient experienced acute diarrhea. She reported that, the onset of diarrhea occurred so rapidly she would have soiled herself, had they not been able to reach a restroom. She reported myalgia and pain at injection site had improved. The reporter had consented to follow-up.
Patient was erroneously given Pfizer instead of Moderna for dose 2. Patient was contacted to notify patient and to follow-up if patient had any side effects. No side effects noted by patient during call.
Information has been received from a registered nurse through the Merck Pregnancy Registry concerning an 18 year old female patient with no known medical history or drug reactions/allergies, who on 25-JAN-2007, was vaccinated intramuscularly in the left deltoid with the first 0.5 mL dose of GARDASIL (lot# 654702/0011U).  On 27-APR-2007 the patient was vaccinated intramuscularly in the left deltoid with the second 0.5 mL dose of GARDASIL (lot# 657006/0188U).  On 07-AUG-2007 the patient was vaccinated intramuscularly in the left deltoid with the third 0.5 mL dose of GARDASIL (lot# 658100/0525U).  There was no concomitant medication.  The nurse reported that after receiving three doses of GARDASIL the patient is now pregnant.  The patient's last menstrual period was on 20-JUL-2007.  Her estimated conception date was 04-AUG-2007 which changed her estimate delivery date to 26-APR-2008.  An ultrasound done on the 10-DEC-2007 confirmed the change of her EDC.  Unspecified medical attention was sought.  It was also reported that the patient has not had any previous pregnancies or live births.  At the time of this report, the patient's outcome was unknown.  Follow up information by an other health professional confirmed that the baby was born and enrolled in a program but she could not provide any additional details at this time.  There was no product quality complaint.  Follow up information stated that on 28-APR-2008, the patient gave birth to a liveborn infant female weighing 8 pounds 12 ounces.  Her APGAR score was reported as 8 - 9.  The patient was 41 weeks from her last menstrual period.  The infant's head circumference was 13 inches.  The infant was reported as normal with no congenital anomalies.  There were no complications or abnormalities reported during the pregnancy or labor/delivery.  At the time of this report, the patient recovered.  On 14-JUL-2008, follow up information stated that the baby was now 2 months old and "seems fine."  Additional information is not expected.
The day after receiving the first dose of the Pfizer COVID-19 vaccine, the patient developed shingles on one side of the face. No history of recurring shingles in patient.
Mother noticed pt to have head turning to the left and rhythmic kicking movements @ 5:30 p.m. which were self resolved.  Throughout that night she had 2 more episodes consisting of arm raising, back arching, leg kicking and leftward gaze.  She was taken to her PCP on 11/16 found to be seizing, sent to local ED for stabilization of status epilepticus.
SEVERE BRACHIAL NEURITIS / LEFT HAND NUMB, LEFT THUMB USELESS / COULD NOT GRIP TOOLS SAFELY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced severe brachial neuritis / left hand numb, left thumb useless / could not grip tools safely. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe brachial neuritis / left hand numb, left thumb useless / could not grip tools safely. This report was non-serious.
suspected vaccination failure; Shingles; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter stated that the patient post vaccination developed shingles disease post vaccination. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The reporter agree to follow up from GlaxoSmithKline. This case has been linked with US2019AMR169849 reported by the same reporter.
Swollen and painful lymph nodes on back of neck. Fatigue. Red splotch at injection site
POSSIBLE ADVERSE REACTION TO COVID-19 VACCINE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the nurse provided information regarding a patient who was admitted to the hospital with a possible adverse reaction to her COVID 19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible adverse reaction to vaccine was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210450525-Covid-19 vaccine ad26.cov2.s-Possible adverse reaction to COVID 19 vaccine.. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
cold; a stuffy and runny nose; felt run down; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), RHINORRHOEA (a stuffy and runny nose) and FATIGUE (felt run down) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced FATIGUE (felt run down). On 12-Apr-2021, the patient experienced NASOPHARYNGITIS (cold) and RHINORRHOEA (a stuffy and runny nose). At the time of the report, NASOPHARYNGITIS (cold), RHINORRHOEA (a stuffy and runny nose) and FATIGUE (felt run down) outcome was unknown.            No treatments reported. No Concomitant medications reported.
I had like numbness in my face and along the left where I had the injection, like the left hand side on my body; I had like numbness in my face and along the left where I had the injection, like the left hand side on my body; This is a spontaneous report from a contactable consumer (patient).   A 70-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  via an unspecified route of administration in Feb2021 (reported as 3 weeks ago) (Batch/Lot number was not reported) single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced 'i had like numbness in my face and along the left where i had the injection, like the left hand side on my body' on Feb2021. The event outcome was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient is a 12 m.o. male who presents to the Emergency Department on 10/10/2017 @ 10:42 pm for evaluation of a spell. Child was sleeping in his bed. Mother noticed the child having some unusual breathing on the monitor. When she went in the room, child appeared limp and unresponsive. He was warm and diaphoretic. She states he was normal throughout the day. Eating and drinking well. No fever. Parents called EMS and child was noted to have a fever. No prior history of febrile seizures. No family history of febrile seizures. Mother is not concerned about any on accidental trauma. Child is up-to-date with vaccinations. No history of kidney or urinary disease. He is hitting his milestones appropriately.
Pt. states he is feeling light headed and fuzzy. Patient asked to lie down on cot. Skin pink, warm and diaphoretic. B/P 130/76, T- 96.8, P-85, R-16, Pulse ox-99%
Pharyngitis with URI, malaise, body aches, fatigue, headache. Urgent hypertension.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 at 10:00 as dose 1, single (Lot number: En6205), in right arm, on 25Mar2021 at 10:00 as dose 2, single (Lot number: Er8733), in right arm, on 20Jan2022 at 10:00 as dose 3 (booster), single (Lot number: Fl5683), in right arm and on 27Jul2022 at 10:00 as dose 4 (booster), single (Lot number: Ff7137) at the age of 61 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing), notes: Other medical history: Mild asthma; "Lupus" (unspecified if ongoing), notes: Other medical history: Lupus. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid.  Clinical course: Patient received Other medication in 2weeks. Patient had no known allergies.
Sharp quick pains up neck, across chest, in knees all day on day after vaccination along with  mild headaches.  Weakness second full day after vaccination.  Headaches all night leading into the third day. Woke with dry heaves on third day. Weakness on forth day.
got 2 shots and still got them/suspected vaccination failure; got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: got 2 shots and still got them/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 13-APR-2023 The case was received from the patient via interactive digital media. The patient had Shingles vaccine and still got them. The patient's friend was diagnosed with shingles and she could not believed how painful it was. The patient was at chapter in his/her life where he/she should be enjoying it to the fullest. The patient did not want to be on the sidelines because of shingles. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Itchiness all over body/ inside of mouth was itchy too; Itchiness all over body/ inside of mouth was itchy too; This is a spontaneous report from a contactable consumer (patient).  A 30-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on 15Feb2021 at 11:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history includes Augmentin allergy. Concomitant medications were not reported. There was no other vaccine within four weeks of vaccination. The patient did not had Covid prior vaccination and not tested for Covid post vaccination. On 15Feb2021 at 17:30, the patient experienced itchiness all over body and inside of mouth was itchy too. The event subsided with Benadryl. The patient recovered from event in 2021.   Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.