chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness, nausea, headache, slurred speech.  4/17/09 MR received from PCP from 3/25 to 3/27/2009. Seen for PE and vax 3/25/09. Seen 3/26/09 for c/o dizziness, feeling hot, flushed and sweaty. Pt has vertigo when eyes are closed. Also had 1st dose Straterra that am. DX:  prob viral, possible vaccine rxn.  Seen again 3/27/09 for continued dizziness and "zoning out".  Sways when standing.  Eyes puffy, lightheaded, hot sweats. DX:  Probable Gardasil rxn-dizzy, H/A, faint. Back to normal by 4/2/09
ADMINISTRATION ERROR OF A VACCINE SYRINGE AFTER 2.5 HOURS; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced administration error of a vaccine syringe after 2.5 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration error of a vaccine syringe after 2.5 hours was not reported. This report was non-serious.
while giving the shot to the patient and there was some leaking from the syringe, no AE; while giving the shot to the patient and there was some leaking from the syringe, no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a female patient of an unknown age who received a partial dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number: UJ282AA and expiry date: 23-May-2020) via unknown route in unknown administration site on an unknown date.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of vaccine underdose and syringe leak.   The pharmacist stated that while giving the shot to the patient and there was some leaking from the syringe. It did not leak until giving the shot. Needle was tightened like it was supposed to be. It was not known how much of a dose that the patient received. The syringe was not available for return. It was discarded. Replacement product was not requested.  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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
1st dose in 2019/Patient was willing to get 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2019, batch number 79E7B, expiry date 30th Apr 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix and wanted to know how to proceed with schedule since the patient was willing to get 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
She got her vaccine on Tuesday, just felt a little bit tired and achy.  She had a dentist APT on Thursday and they took her BP and it was very elevated, which she normally has a low BP.  Said it was 210/109 and thought it was the machine and retook it and it was again elevated at 206/104 (approximate #'s).  She has subsequently taken it at home and it was still elevated yesterday was 142/80, then again on left arm was 146/89.  The most recent one this morning was 139/90.  She is a retired nurse, and knew to take it on the  opposite arm.  The dentist informed her to monitor her blood pressure.  She still has joint achiness from the vaccine and fatigue, not quite the pep that she had prior.    She took a diuretic last night and rechecked her BP this morning so her readings are after the diuretic.
Pt developed rash on forearms and tops of ears. C/O pruritus. All symptoms appeared about 18 hours after vaccination. Still visible on 5/12/2014 when presented to health dept. Rash still present 5/12/2014.
Pt recv vax on 11/23/98; on same day pt exp raised, red, edematous, warm area of LA; vax supposed to be given IM
the dry cough became worse and its now lasted 8 weeks and is ongoing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (the dry cough became worse and its now lasted 8 weeks and is ongoing) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced COUGH (the dry cough became worse and its now lasted 8 weeks and is ongoing). At the time of the report, COUGH (the dry cough became worse and its now lasted 8 weeks and is ongoing) outcome was unknown.     Relevant concomitant medications were reported i.e., blood pressure medication.  Treatment information was provided i.e., cough drops   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Pt recvd vax & became diaphoretic and dizzy; pt was seen in ER & dx w/systemic allergic react to the 4th Hep B shot (skin was pale, warm & moist);
After about 24 hours after recieving the second shot, I noticed a rash forming on my arm. It?s now been 48 hours after the shot and the rash is growing larger. It itches and burns slightly, but not to the point where it is unbearable.
I experienced a vertigo phenomenon on 1/21/2021, especially in the morning when I turn my head either left or right. It is still going on. I also experience an itching rash since 1/25/2021. It develops into a redish itching patch.
Starting evening of 3/18 noticed right side of face was numb.  It continued to worsen during day on 3/19.  Went to ER, Sat. AM and was admitted same day.  Tests were run and it was determined no Stroke had happened and the was told it was Bells Palsey.  Spent 2 days in hospital while they ran more tests. Numbness continues.
Strong metallic taste in my mouth about 5-10 min after vaccination (lasted about 45 min); morning stiff shoulders and back of neck (still have it but it's better); This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration on 26Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included PVCs (Premature ventricular contractions), coronary artery disease (CAD) and allergies to NSAIDS, artificial sweeteners, sulfa, and mango. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included nicotinic acid (NIASPAN), vitamin d nos, metoprolol tartrate (LOPRESSOR), omega-3-acid ethyl ester (LOVAZA) and Nexlizet. No any other vaccines received within 4 weeks prior to the COVID vaccine. On 26Jan2021 12:45, the patient experienced strong metallic taste in her mouth about 5-10 min after vaccination and morning stiff shoulders and back of neck (still have it but it's better). No treatment was received for the events. The patient has not been tested for COVID-19 since the vaccination. The patient was recovering from the events.
Patient fainted during the 30 minute observation period.  Patient was sitting in a chair and slumped over, but did not hit their head or fall.  Pt regained consciousness quickly, was taken to a room to lay down and was given gatorade.  They were observed for 30 minutes with no issues, vitals went back to normal quickly.
Suspected vaccination failure; flu; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patients had stated they got the flu after receiving a flu shot (unknown brand). No additional details were available regarding patient or vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
Patient had local reaction. Redness, swelling, and warm to the touch at site after 15minutes, kept patient an additional 20 minutes in clinic for observation. No change to reaction did not decrease or increase.
Headache, Fever pain at injection site, chills, muscle aches, mild nausea Narrative: states: had pain and redness at injection site. Also experienced fever (102.3 F) headache, chills, muscle aches, with mild nausea, All sx resolved within 24 hours
Moderna COVID-19 Vaccine EUA Injection site is red, hot, bruised at bottom, and has 4 lumps inside. Felt the bumps on day 8 after shot, but did not look at arm until day 9 where i  see it is red swollen and very HOT.  The injection spot is visible. (Where the needle went in, there is a red spot)  The hard lumps hurt when touched. (NO itchiness is present)
right hand and wrist was swollen and painful to touch; right hand and wrist was swollen and painful to touch; right hand and wrist was swollen and painful to touch; right hand and wrist was swollen and painful to touch; fingers were like pins and needles; like his hand falls asleep; numbness at times in fingertips; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 18Oct2021, this case now contains serious adverse reactions. Information processed together.   This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right arm on 12Aug2021 at 14:00 (Lot Number: FC3181, unknown expiration) as dose 1, single; and via intramuscular in right arm on 02Sep2021 at 14:00 (Lot Number: FC3184, unknown expiration) as dose 2, single at the age of 46 years old for COVID-19 immunisation.  Medical history and concomitant medications reported as none. No family medical history relevant to events. No prior vaccinations (within 4 weeks). No relevant tests. No history of all previous immunization with the Pfizer vaccine considered as suspect. No other vaccines administered on same date with the Pfizer vaccine considered as suspect.  On 13Aug2021 at 05:00, after receiving the first dose, the patient reported that his right hand and wrist was swollen and painful to touch. The event further described as fingers were like pins and needles from time to time, like his hand falls asleep, and has numbness at times in fingertips. He thought he was sleeping on his arm awkwardly, but it was not that, it's like a numbness at times in his fingertips. It was ongoing sporadically, not every day, and was persisting. He confirmed that it began on 13Aug2021. Right hand/wrist is still swollen, and this condition has not subsided. Ice has been applied to the hand to reduce swelling. There has been no sign of swelling prior to receiving the first Pfizer injection. No treatment was received for the remaining events. The patient confirmed that he hasn't seen him by HCP since it started. The patient has not yet recovered from the events. The events were assessed as serious (Important medical event).   No follow-up attempts are possible; information about batch number was already obtained.
No additional AE; Caller reported AE for inadvertent administration of PROQUAD following a TE.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not provided.  On 12-JUN-2023, the patient was inadvertently vaccinated with the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA))(PROQUAD) injection (0.5 ml, lot # X011437 has been verified to be valid, expiration date reported as established as 18-JUL-2024; strength, and route of administration were not provided) for prophylaxis following a temperature excursion (TE) (product storage error). The storage temperature of the vaccine was 6.4 degree Celsius for a time frame of 191 hours. There was no previous temperature excursion. TE assessment was not evaluated, and products were not back in recommended range. No symptoms were reported. No additional adverse event (AE)/product quality complaint (PQC).
Patient's arm was numb the night of the vaccination day per daughter of patient. Was seeking treatment from neurologist which is pending response.
Had vaccine on Wednesday and on Thursday had soreness and a knot the size of a quarter, initially. Had a low-grade fever that night. At work Thursday night, felt "lousy" and temperature was 102.5F and arm at the site, now the size of a grapefruit with erythema, induration and warmth. Fever continued and Friday 1/2 of arm was swollen and pt had chilling and then fevers. By noon Friday, her whole arm was swollen and continued through Saturday with fever and pain all over body. Sunday swelling diminished and low-grade fever. No fever on Monday, but still had a knot at site of the injection. It took 2 weeks for the knot to go down and now on 10/24/00 still has a small knot the size of a Lima bean.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Patient Received vaccine beyond 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine beyond 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine beyond 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine beyond 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient Ethnicity:  Dose description included: Booster.  Concomitant products were not provided. Vaccine went into 2 to 8 degree Celsius thaw state on about 24 Dec 2021. The vaccine was administered up until its manufacturing expiry date of 04 Apr 2022 Treatment medications were not reported.
During evening and next day pretty short of breath especially during activity. Shortness of breath lasted for a couple of days, used more oxygen.
pt recvd vax in 1991 & 21AUG93 had last menstrual period & subsequently became pregnant; pregnancy screening revealed that pt had pos antigen & core antibody w/neg surface antibody;
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 16-JUN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml VIs 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had multiple excursions ranging from 28.9 degrees Fahrenheit (-1.72 degrees Celsius) (lowest recorded temperature) for 48 hours to 64.8 degrees Fahrenheit (18.22 degrees Celsius) (highest recorded temperature) for 24 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Swelling hot red and pain and the next day swelling to the left elbow inflammation and pain.
Approx 7 minutes after injection became flush, rapid heart rate, short of breath. Nurse had me lie on stretcher and monitor my vitals. My blood pressure was high. After about 15 minutes heart rate and blood pressure came down. I was feeling very jittery for approx 45 minutes.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 08-DEC-2015 at 14:25, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 5.6 and 1.4 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Information has been received from a medical assistant referring to a 15 months old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K016153 with expiration date 24-SEP-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Patient received an PROQUAD that contains MMR and Varicella. After injection mom states redness start within 24 hours and she Vicks and alcohol to injection site. Patient had redness measuring 6mmX9mm. Patient instructed to take BENADRYL, apply ice, and take Ibuprofen or TYLENOL as needed.
Combined initial health care professional report received on 20 Jul 2010 and follow up report received on 22 Jul 2010: This patient with medical history of scarlet fever within four weeks before vaccination, received MENVEO (batch number 030011) 0.5 ml intramuscularly into the right arm deltoid muscle on 28 Jun 2010 in the evening. The patient was concomitantly vaccinated with HCD (rabies vaccine) 1ml intramuscularly in the right arm deltoid on 28 Jun 2010 also. On 30 Jun 2010, two days after vaccination with MENVEO, the patient experienced severe local reaction on the right (vaccinated) arm with discoloration and signs of inflammation and pain at injection site (right arm). On an unknown date, three days after vaccination, the patient experienced defective hearing in right ear and dizziness which persisted for one week. On an unknown date, the patient had laboratory test done whose result was normal. The outcome of the event was reported as recovered on day 9 after vaccination. The causality was not reported.
Pt stated had Flu vaccination 8yrs ago and broke out in rash and hives. Hadn't had any vaccinations since. Advised pt that receiving vaccination may have same results. Pt still requested the H1N1 and signed consent. 1000 pt called stating that she had hives and rash no SOB at time. Instructed pt to go to CR if s/s get worse. The next day reported that she did go to CR and received medication.
Approximately five minutes after administration of Td, employee verbalized feeling a hot flash, then cold sweat.  Then approximately 10 minutes later while escorting to Emergency Dept via wheelchair, she reported some shortness of breath and headache.
Narrative: COVID infection following COVID vaccine series 03/08, Pfizer, dose# 03/29, Pfizer, dose #2 05/25 COVID swab, result: not detected 08/07 pt cc: cough, fatigue, fever, myalgias exposure: unknown 08/09 COVID swab, result: detected 08/10-08/18 pt symptoms continue
Severe Headache, Dizziness. Pale and Nausea. Passed within 2Hrs after side affect took place. Took Tylenol 500MG x2 and the the headache subsided. Slept and awoke feeling great.
Nurse given Tdap 6/16/2006 AM. Evening of 6/17 and 6/18 c/o Temperature to 104, headache, nausea, aching in neck, spine, legs. Lasted 24 - 36 hours.