chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to a patient of unknown age and unknown gender. No information regarding the patient's concurrent condition, medical history and concomitant medications was reported. On an unspecified date in June 2015, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 12-MAR-2018, the patient was vaccinated with additional dose of ZOSTAVAX injection, subcutaneous, lot#: N025565, expiration date: 13-DEC-2018, (exact dose, anatomical location were not provided). No adverse event was reported.
This spontaneous report as received from a licensed vocational nurse refers to patients of unknown age and gender. The patients' concurrent condition, medical history or concomitant medications were not reported. The nurse reported that on unspecified date in August 2015, since 05-AUG-2015, the patients were vaccinated with improperly stored ZOSTAVAX # L003216, expiry date 30-APR-2016 (dose and route of administration unspecified). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
No additional AE reported; The Gardasil-9 expired on 5/30/2021 and was administered on 8/9/2021; This spontaneous report was received from a nurse and consumer and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 09-AUG-2021, the patient was vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R024259, expiration date 30-MAY-2021 for prophylaxis (dose, route of administration and anatomical location were not reported). No additional adverse event reported.
24 hours after injection 3" warm, red area at site of injection. Applied ice, 48 hours after injection site is red, hot and moderately itchy. Red area 6" long. Referred to PCP. Seen by MD on 4/18/13 recommended ALLEGRA and BENADRYL. 4/19/13 Redness subsiding. 4/25/13 Much improved.
The pharmacy Intern had a minor headache; the pharmacy intern stated she was preparing a syringe to administer GARDASIL 9 and while drawing up the vaccine there was a mist in her face, and she felt some particles go into her eyes; the pharmacy intern stated she was preparing a syringe to administer GARDASIL 9 and while drawing up the vaccine there was a mist in her face, and she felt some particles go into her eyes; the pharmacy intern stated she was preparing a syringe to administer GARDASIL 9 and while drawing up the vaccine there was a mist in her face, and she felt some particles go into her eyes; the pharmacy intern stated she was preparing a syringe to administer GARDASIL 9 and while drawing up the vaccine there was a mist in her face, and she felt some particles go into her eyes; This spontaneous report was received from a pharmacy intern referring to herself, a 26-year-old female patient. The patient had no pertinent medical history, nor concomitant medications. The patient's concurrent conditions were not reported. The patient's previous drug allergies or reactions included peanut allergy.  On 04-MAR-2020, the pharmacist intern was preparing a syringe to administer hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dosage regimen, and route of administration were not reported; and lot number R026716 has been verified to be valid, expiration date reported and validated as 30-MAY-2021) as prophylaxis, and while drawing up the vaccine there was a mist in her face, and she felt some particles went into her eyes (occupational exposure to product, exposure via eye contact, exposure via skin contact, accidental exposure to product). The pharmacy intern cleaned out both eyes with an advance eye rinse kit containing purified water, and experienced a minor headache the same date. The pharmacy Intern was encouraged to follow up with her physician. Laboratories diagnostics or studies were not performed.  There had been no vision problems and she was feeling fine at the time of the report.  The causal relationship between therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the headache was not reported.
numbness, weakness; sx returned 21JAN95 worse than initially w/worse numbness & tingling in legs & clumsiness in rt hand; has warm spots on arms; had painful jerking especially of the rt arm; has had painful jerking; low energy level;clumsi
-Patient was supposed to received first round of imms. -Physician ordered Pentacel (Hib-IPV-DTaP), Hep B, and PCV13. -Instead, pt was given Pediarix (HEP B-IPV-DTap), Hep B, and PCV13. -This occurred in Feb 2020. Noticed by office on June 3, 2020. -Baby had no adverse effects, signs, symptoms, etc.
PATIENT RECIEVED SECOND DOSE ON  11/12/2021. BOOSTER DOSE WAS ADMINISTERES ON 02/23/2022 AND THE 5 MONTH PERIOD WAS NOT COMPLETED
Patient had nausea and vomiting for approx. 30 hours after vaccine admin. Recovered at home.
Pt recv vax & devel a local rxn.3 day p/vax pt devel flu-like sx. Pt also devel a urticarial rash which came in AM & lasted a few hr.Rash all over body but not face.
Pt recvd 1st dose of Hep B vax & began w/rash & itching w/in a day or two took OTC med w/o relief & saw MD who prescribed med;
DID NOT TAKE LAST DOSE ON TIME; This spontaneous case report (PVX2019-2904) was received from a consumer on 25-Nov-2019. It described a female consumer who "did not take last dose on time" (PT: Product dose omission) while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer reported that she had completed 3 doses of Vivotif but, she did not take her last dose of Vivotif which was due on 24-Nov-2019.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the event was unknown.  Company Comment: A patient did not take her last Vivotif dose on due date (Missed dose). Considering the nature of the event, the causality of missed dose is assessed as not related to Vivotif.; Sender's Comments: A patient did not take her last Vivotif dose on due date (Missed dose). Considering the nature of the event, the causality of missed dose is assessed as not related to Vivotif.
NONE COVID 19 VACCINE EXPIRES 2/8/2023 GIVEN 3/23/2023
felt like crap soon after I got the shot; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a patient via social media.  This case is linked to case 2020SA294157, 2020SA294125 (same source).  This case involves an unknown demographic patient who felt like crap (Feeling abnormal) soon after receiving of vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.  On an unknown date, the patient felt like crap (Feeling abnormal) soon after (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown for felt like crap (Feeling abnormal).  There will be no information available on the batch number for this case.
Initial information received on 11-Dec-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a four months old female patient and reported that she had a temperature of 102.9 plus vomiting, while she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR; and ROTATEQ. On 05-Dec-2018, the patient received a dose of 0.5 ml suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UI953AA and expiry date: Jun-2020) (dose in series and route was not reported) in the right thigh. On an unknown date, following the vaccination the patient experienced vomiting and body temperature. Relevant laboratory test results included: Body temperature - On an unknown date: 102.9. (Other relevant tests included no lab data). Final diagnosis was vomiting and body temperature. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as recovered on an unknown date. List of documents held by sender: none.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 21Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type II diabetes" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Aug2022) Positive, notes: Rebound. Tested positive for Covid on 16Aug. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was treated with Pfizer covid-19 treatment from 05Aug2022 to 10Aug2022. Clinical course: There were no other medication in 2weeks.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever, headache, and joint pain which were treated with ibuprofen and subsided within 36 hours.   Large red welt surrounding injection site lasting 4 days after injection.
The day after the vaccine I began to feel pain in my neck  and  a burning sensation. Five days after the vaccination I developed a rash and was diagnosed with Shingles after sending a picture of the rash to my doctor.
Pt was given Dtap instead of Tdap. Pt is 12 yrs old. No adverse events reported by parents. Doctor stated Dtap dose is valid. and does not need Tdap unless school needs Tdap to be given.
an expired dose of QUADRACEL was inadvertently administered to a patient yesterday with no reported adverse event; Initial information received on 21-Dec-2021 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 4 years old male patient to whom an expired dose of quadracel was inadvertently administered to a patient yesterday with no reported adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).  On 21-Dec-2021, the patient received a  0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE, Suspension for injection, (frequency: total) ( lot C5688AA; expiry date: 26-Nov-2021) via intramuscular route in the right thigh for immunization.  On 21-DEC-2021 the patient developed a non-serious event of "an expired dose of quadracel was inadvertently administered to a patient yesterday with no reported adverse event" (expired product administered) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (QUADRACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (an expired dose of QUADRACEL was inadvertently administered to a patient yesterday with no reported adverse event).  At time of reporting, the outcome was Unknown for the event an expired dose of quadracel was inadvertently administered to a patient yesterday with no reported adverse event.  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.
Tiredness; swollen lymph node by jaw; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration 24Mar2021 at 02:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as no. There were no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 24Mar2021 at 19:00, the patient experienced tiredness and swollen lymph node by jaw. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events tiredness and swollen lymph node by jaw was recovering at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Janssen COVID-19 Vaccine EUA Numbness and tingling feeling (akin to arm falling asleep) last until at least 8:00pm (2:45 after administration). At that time I had gone to sleep and issue was not present in the morning
3-4 hours after administration, pt experienced fever (up to 102.6 degrees F) diarrhea, vomiting, and chills. Sx resolved 3-4 hours later.
Pfizer COVID-19 Vaccine 2nd dose 9/29.  On 9/30 Rash appeared on abdomen that continued to spread R mid abdomen, then to R back and small rash on L anterior abdomen.  Also developed rash at site of injection.  On 10/2 4 days post vaccination had 4 hour episode of loss of motor skills, difficulty finding words and felt like he did not have control of arms and legs and sensation of dissociation, weakness.  Next day woke up fine.  Pt was not seen until 10/5 for rash.  Given triamcinolone cream with no effect per phone f/u on 10/12.
Smooth rash ,lots of itching, rash size 50cmx80cm .Started 3-17 & is still there on 3-20. What  reaction can I expect from the 2nd shot, due 04-06-2021
Neck and arms tightening; Swollen glands; Pain was everywhere; Headache; Had full blown chills; Nausea; To the 100th degree, fever; body aches; Hallucinations; vertigo; Dizziness; Fell over while trying to load dish washer; chest pain; Neck and arms tightening; heart racing 120bpm; I thought I was going to die,felt really bad so she tried to sleep it off,felt like someone was pricking me with a knife; A spontaneous report was received from a consumer concerning a 54-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hallucination,COVID-19,vertigo, dizziness, fall, chest pain, heart rate increased, limb discomfort, lymphadenopathy, vaccination complication, muscle tightness, heart rate increased, pain, pyrexia, headache, chills, nausea and myalgia.  The patient's medical history was not provided as exposed to COVID-19. Concomitant medications were not reported .   On 04 MAR 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011A21A) via unknown route in an unknown location for prophylaxis of COVID-19 infection.   After receiving vaccine, patient felt like she had COVID -19 and she was going to die. On 05 Mar 2021 the events started with neck and arm tightening, swollen glands and headache. The patient had full blown chills,nausea to 100 degree, fever, body ache, hallucinations. She reported that she felt pain everywhere, heartracing 120bpm, chest pain, dizziness. She fell down while loading dishes and also she reported vertigo.  The event hallucination was considered as medically significant.  The treatment taken for the events was reported as Tylenol once in every six hours.  Action taken with mRNA-1273 in response to the events was unknown.  All the events except headache, vertigo and nausea was considered resolved on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
2 days  after both shots had flu like symptoms. I week after both shots had all over body and muscle ache, numbness and tingling, nausea, migraine, shortness of breath, diarrhea
Eight minutes after receiving the vaccination, he reports feeling lightheaded. His heart rate was initially the 40s. He was taken to a private session of the arena and monitored. His initial blood pressure was in the 150s over 90s, and his heart rate normalized to the 69 bpm. He has a history of aversion to blood draws with similar sxs, but typically not with IM injections.
patient was administered a dose of PROQUAD intramuscularly instead of subcutaneously; No additional AE reported; This spontaneous report has been received from a pharmacist concerning to a 4-years-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unspecified date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dose number, dose, frequency, lot# and expiration date were not reported) intramuscularly instead of subcutaneously (incorrect route of product administration). No additional adverse event (AE) reported.
No adverse effects reported; a patient was administered an improperly stored dose of ROTATEQ; This spontaneous report was received from a medical assistant, regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 08-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally, lot # R029815 with expiration date 18-JUN-2020, for prophylaxis (strength, dose and frequency were not provided). The dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) underwent a temperature excursion below 36°F (32.5°F) during 1 hour as recorded by a data logger. No adverse effect was reported.
rash, itchiness, hives throughout the entire body (head to toe) originally went to urgent care twice, then primary care, then allergy center First symptom occurred on 2021, currently still on 3 medications and used to be on monthly Xolair shots
while injecting the vaccine into the child's arm, the child suddenly moved violently and I had to pull  out the syringe from the child's arm.  As a result, the needle scratched and cut the child's arm and a large amount of vaccine was splashbacked out from the injection site.
Due to mis-communication with pharmacist gave 1 mL dose instead of 0.5 mL dose.  No reaction reported
Ulcerative colitis; Bowel discomfort; Flu like symptoms; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (Ulcerative colitis), ABDOMINAL DISCOMFORT (Bowel discomfort), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (Moderate to severe).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COLITIS ULCERATIVE (Ulcerative colitis), ABDOMINAL DISCOMFORT (Bowel discomfort), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever). At the time of the report, COLITIS ULCERATIVE (Ulcerative colitis) had not resolved, ABDOMINAL DISCOMFORT (Bowel discomfort) was resolving and INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for the event of Bowel discomfort was assessed as reasonable possibility for cosuspect humira. The  reporter causality for the events of flu like symptoms,fever,ulcerative colitis was assessed as "Not reported" cosuspect humira. The Humira drug was available as Solution for injection in pre-filled syringe. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
warm to touch at injection site; hard at injection site; Injection site is red, size is 2 and half inches in diameter; extremely bad vomiting; extremely bad diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm to touch at injection site), DIARRHOEA (extremely bad diarrhea), INJECTION SITE INDURATION (hard at injection site), INJECTION SITE ERYTHEMA (Injection site is red, size is 2 and half inches in diameter) and VOMITING (extremely bad vomiting) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced DIARRHOEA (extremely bad diarrhea) and VOMITING (extremely bad vomiting). On an unknown date, the patient experienced INJECTION SITE WARMTH (warm to touch at injection site), INJECTION SITE INDURATION (hard at injection site) and INJECTION SITE ERYTHEMA (Injection site is red, size is 2 and half inches in diameter). On 24-Mar-2021, DIARRHOEA (extremely bad diarrhea) and VOMITING (extremely bad vomiting) had resolved. At the time of the report, INJECTION SITE WARMTH (warm to touch at injection site), INJECTION SITE INDURATION (hard at injection site) and INJECTION SITE ERYTHEMA (Injection site is red, size is 2 and half inches in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment information were not reported by the reporter.
Pt recvd 3 doses of Hep B vax 18JAN90, 26FEB90, & 16JUL90 & 25SEP90 it was determined that the titer was neg; booster dose was given 27SEP90 & 27NOV90 titer was neg; 2nd booster dose given 3DEC90 & 7FEB91 titer was neg;
104.8 degree fever and then a resulting seizure because we could not get the fever down.
Patient felt nauseous & lightheaded after vaccines, no loss of consciousness. Had patient lay down with legs elevated, blood pressures normal, felt normal after 10 minutes & walked out of office without difficulty.