chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash is on my chest and on my upper back; Can barely breath; I can't really eat or swallow because my throat is swollen; I can't really eat or swallow because my throat is swollen; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 02Feb2021 at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization. Medical history included asthma, diabetes, autism and attention deficit hyperactivity disorder (ADHD). The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 03Feb2021, the patient had rash on the chest and upper back; can barely breathe; and could not really eat or swallow because the throat was swollen. The patient did not receive any treatment for the reported events. The outcome of the events, 'rash on the chest and upper back', 'can barely breathe', 'could not really eat or swallow because the throat was swollen', was unknown. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.  Information on the lot/batch number has been requested.
Sever pain (8) lasting about 30 seconds, upon stretching of left leg. The pain occurred at the site of a sever burn (partial thickness) to that area of the leg. The burn occurred June 18, 2018. Subsequent pain upon stretching or use has occurred in the following days, but at a much lower level (3). Incidence of pain is diminishing with time. Vaccination was received 10/10/2019. There has been no pain in the site since about 6 months after the injury.
medication error due to administering an expired vaccine to a patient with no reported adverse event; Initial information was received on 21-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an infant of (<1 year enter as 2m, 4m) and unknown gender patient who experienced medication error due to administering an expired vaccine  hib (prp/t) vaccine [ACT-HIB] to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of 0.5 ml of suspect hib (prp/t) vaccine (Powder and solvent for solution for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for immunization. The information on batch number was requested.  On an unknown date the patient had medication error due to administering an expired vaccine to a patient with no reported adverse event (expired product administered) (latency: same day).  Action taken with haemophilus type b (hib) vaccine (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event medication error due to administering an expired vaccine to a patient 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 and Regulatory Authority 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.
Rightness to throat and difficulty swallowing. Received 50mg Benadryl at vaccination site before arrival at ED
pt recv vax;devel a rash & high fever of 104;f/u fr MD stated did not know pt's name;
Within 24 hours of administration, mom notes redness and swelling of eyes-eyes swollen shut.
Pt was administered Moderna on 07/14/2021. Pt called on 7/20/2021, left a Voice Mail stating he would like a call back to discuss side effects to the vaccine. I called patient back the morning of 07/21/2021, the patient states to me that two hours after the vaccine was administered he started to shake uncontrollably and was very cold, then he blacked out (Patient states he may have had a seizure.) Pt woke up outside behind his vehicle in a pool of his own vomit. I asked if 911 was called and the patient said no because he could not move or walk. The patient also stated that he felt bad all day, Thursday (07/15/2021), the day after the vaccine was administered, woke up on Friday (07/16/2021) feeling relatively normal still feels the urge to vomit when eating certain foods.
soreness left arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's wife. The reporter consented to follow up.
patient states 3 days after vaccine she had congestion, cough, and trouble breathing.  She saw her doctor and was prescribed medication but continued to be sick and also disoriented.   Patient was taken by ambulance on 9/7/2021 to the hospital and has since recovered.
The day after the second injection, I became extremely dizzy and disoriented and passed out.  My family picked me up off the bathroom floor.  I remained weak, sweaty and confused for about 30 minutes.
Vaccine administered was 4 days beyond use date. Contacted patient to make aware and he reported no adverse effects. Contacted patient's MD.
pt w/ guilian barre syndrome vs AIDP (acute inflammatory demyelinating polyneuropathy). pt has been hospitalized for 35 days and has a trach and peg; remains on ventilator. pt also w/ pe and dvt.
Sore arm Fever 99.9 took Tylenol  and it went away.
Patient had throbbing pain from the waist up that started approximately 5 minutes after receiving the vaccination. She sat down for about 5 to 10 minutes and they pain went away. I offered to call an ambulance if patient thought it was severe enough, but she declined.  I also offered to have her BP and HR checked, but she also declined. The pain subsided in less than 10 minutes and she was able to leave on her own accord.
Headache, Myalgia,  chills, body aches, joint aches, extreme thirstiness Narrative:
On Wednesday during the night in the middle of night with a feeling that her right ear was on fire.  It hurt under the ear in a straight line about 3-4".  The next day she had the same hurting, the straight line, but then the pain started to go around the back of her neck and up the right side of her head.  That was this way Thursday and Friday.  She got into her chiropractor, seemed to be a little better after that.  She got up Saturday morning and took a drink of water and it came right back up, and looked in the mirror and saw that her face was drooping, and worried she was having a stroke and went to the ER at the Hospital.  They did stroke protocol in the ER and they determined that she was not having a stroke but was having Bell's palsy.  Gave her some medications (steroids and antiviral) and told her to see her PCP.    She saw her PCP yesterday and he advised her to get the vaccine and advised her about Guilllain Barre.
This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch at the injection site), VACCINATION SITE PRURITUS (itchy knot at the injection site) and VACCINATION SITE ERYTHEMA (Red knot at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0004M20A) for COVID-19 vaccination. No Medical History information was reported. On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch at the injection site), VACCINATION SITE PRURITUS (itchy knot at the injection site) and VACCINATION SITE ERYTHEMA (Red knot at the injection site). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (warm to the touch at the injection site), VACCINATION SITE PRURITUS (itchy knot at the injection site) and VACCINATION SITE ERYTHEMA (Red knot at the injection site) was resolving.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. Treatment information included Benadryl and Ice pack.
pt cried for 4 hrs-unable to comfort; rt thigh red, warm & swollen from knee to hip; mom states pt felt hot but did not take temp
Pt had grand mal seizure approximately 10 minutes post vaccination. Seizure lasted about 3 minutes, then another seizure resulted approximately 2 minutes later lasting about 3 minutes, then ambulance arrived. Pts blood sugar was checked and was slightly low as well according to EMS. Pt seemed to stabilize. as being brought away, but in post-ictal phase.
injection site had pain; injection site had swelling; injection site had redness; received third dose of product; Received third dose of product; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 via an unspecified route of administration, administered in Arm Left on 27Aug2021 09:30 (at the age of 67years), (Batch/Lot Number: FD0809) as DOSE 3, SINGLE for covid-19 immunisation. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2, on 15Jan2021 (at the age of 67 years) dose 1 (Batch/Lot Number: EL3247) as DOSE 1, SINGLE for covid-19 immunisation. Dose 2 on 08Feb2021 (at the age of 67 years) as DOSE 2, SINGLE for covid-19 immunisation. She's calling about the Pfizer vaccine. Clarified Pfizer Covid 19 vaccine. She has had her first 2 doses and she used the (withheld) website and after she received her third dose of the Pfizer Covid 19 vaccine, she tried to report her symptoms to the (withheld) website but was having trouble with the online system. She knows reporting information was good and helps back the research. She was calling to report pain, swelling, and redness at the injection site after the third dose for about 7 days. She reports her symptoms began on 28Aug2021. She received the third dose on 27Aug2021. She states at this point she barely feels it at all. The last 2 days she's had not problems with her arm at all. She would say she was completely recovered at this point. The clinical outcome of the event injection site had swelling, injection site had pain, injection site had redness was recovered on 03Sep2021, remaining all other events was unknown at the time of report.  Follow-up attempts are completed. No further information is expected.
Presented to clinic with chills, fever 103 degrees, lethargy, flank pain on palpation.
had a "golf ball sized" bubble or lump appear on her arm where she received the injection; administration error from the injection/does not know if she received the full first dose of the vaccine or if it would be counted as a valid dose; really tired, like too tired to play with my kids because I did not even want to get out of the chair; I did not even want to get out of the chair; some body aches; chills; This is a spontaneous report from a contactable consumer or other non hcp.     A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA COVID19 SOLUTION FOR INJECTION), dose 1 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, on 2021, The patient experienced had a "golf ball sized" bubble or lump appear on her arm where she received the injection administration error from the injection/does not know if she received the full first dose of the vaccine or if it would be counted as a valid dose, really tired, like too tired to play with my kids because did not even want to get out of the chair on,  did not even want to get out of the chair, some body aches, chills  with outcome of unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 02-FEB-2017 at 16:12, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457
Death after 2-3 days of stomach ache, sore throat and chest pain; two weeks after receiving the vaccination
Was given a tetanus vaccine routinely at her PCP office 3/11/16 (she believes it was a Tdap, but not completely sure).  Pt presented to occupational health clinic today (not same clinic that she was given the vaccination) with a large local reaction on the left upper arm, ~10cm x 6.5cm erythematous reaction.  Area ~4cm in diameter is firm directly around the injection site. Does not appear infected, +pruritis.  Antihistamine given in clinic, recommended ice pack and continued antihistamine use.  Told to return with any worsening or swelling of arm. Recommended that she contact her PCP to make them aware as well.
after the pain, itching and swelling  subsided, I developed a 3 inch round red area that is hard, itchy and is tender to touch
mom reports pt had diarrhea day p/vax followed by temp of 103 & vomiting on 20MAR94; seen by MD 16MAR93; seen in hosp ER; MD does not think MMR & illness stated are related;
Injection site became itchy followed by hard swelling and redness at site.  Started 4/3 late in day with itching.  Redness and swelling started this afternoon.  Mild headaches started today.  I am not prone to headaches.
Information from the parents.  I am not the physician who gave the shots.   Spasms are happening when he's stimulated/excited, took him to the ER b/c she didn't know what to do.   Fed him oatmeal for dinner and he had 7-8 spasms in a few minutes.   They  didn't know what to do, so they took him to the ER EEG was normal.  Each episode is only a few seconds long, but his eyes widen and it looks like an infantile spasm.  Mostly upper body.   These symptoms were not present prior to his 6 month vaccinations.
11/1/07 mother of above said child seen thru clinic.  Verb. last vaccines given child had few areas on L thigh, on 5th day after.  By 6th day full blown hives, no resp. problems, no fever.  Hives cleared with Benadryl.  Hives lasting 5 days.  F/u with physician with stated possible from MMR.  No previous comp/problems with any prior vaccines.  Vaccines on this date of 8/17/07 given were MMR, VZV, Hep A & Hib.
about 2months p/vax pt exp severe myalgias & arthralgia w/o fever, rash & URI sx; last about 5 days & is gradually clearing;
10 hours after shots roughly she vacate feverish had a 101.8 temp. She also had a rapid heartbeat and projectile vomited twice
There was itching and swelling in arm couple of days after shot.  After nearly 1 week  there was a increased itching and swelling in the same arm. Also a little fatigue.  This lasted for 3-4 days.
Henoch Schonlein purpura with associated bilateral purpuric rash on lower legs, bilateral knee arthralgia with associated algic gait, bruising of gums, swollen eyes, abdominal pain with appetite loss
Several days after first dose I experienced chest pain that I never had before,  fast heart rate ,  dizziness. I work as a dentist and had to cancel patients due to severe dizziness when I was putting my head down.  If my heart rate continues to be greater than usually I will see my PCP.
Patient received the second dose three weeks apart from the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose three weeks apart from the first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose three weeks apart from the first dose). In 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose three weeks apart from the first dose) had resolved.            No concomitant medication were provided. No treatment information were given.
Patient received the flu vaccine on Friday 9/18/2015 at approx 11AM-she developed shaking chills at 8:30PM Fri evening temp 100.6 degrees given TYLENOL XST 2 tabs-at 9:30PM temp increased 103 degrees she was delirious, confused, limp when gotten out of bed->to hospital by ambulance-received IV fluids, vancomycin IV-stress dose cortisone in ER. Admitted to hospital-discharged 9/20/15.
Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 34 years old female patient for whom FLUZONE HIGH DOSE was administered to someone under 65 was reported, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site. The patient developed a non-serious FLUZONE HIGH DOSE was administered to someone under 65 (drug administered to patient of inappropriate age) Unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Reporter stated that they were unsure it was administered yet because the paperwork was done incorrectly. Lab data not reported. Final diagnosis was FLUZONE HIGH DOSE was administered to someone under 65. This case is actual medication error case due to inappropriate age at vaccine administration. The outcome of event of FLUZONE HIGH DOSE was administered to someone under 65 was not applicable. 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. Documents held by sender: none.
Migraine, night sweats, fever, arm pain, sever joint pain, difficult catching breathe, tiredness
s it normal to feel achy and achy after 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (s it normal to feel achy and achy after 1st dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (s it normal to feel achy and achy after 1st dose). At the time of the report, MYALGIA (s it normal to feel achy and achy after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Flu like symptoms that began the day after vaccination, lasting for 1 day. Reported severe residual joint aches in shoulder, scapula, hips, wrists, ankles. Right sided pain persisted, left side lessened. Relieved by NSAIDS
Fever, acute joint pain, mental confusion, elevated blood pressure, limited arm movement range and injection site soreness.
4 hr p/vax given t102.4; gave APAP which brought temp down; APAP was given thru the noc; t102.4 again next morning-APAP given; temp came down; 6PM 30APR94 pt began crying turning blue in the face; did not respond to stimulation; stiffened
Shot given Friday at 11:30.  Saturday morning she felt a little  nauseous.  Sat down at table to eat breakfast, and suddenly collapsed.  Fortunately I caught her before she hit her head on table.  Seemed unresponsive. but by shaking her I was able to  get her to the couch.  Very unstable.  Upper body was calmy.  Speech and sight were ok.  No severe headache or numbness or tingling.  On verge of calling 911.  She seemed to stabilize and is now resting comfortably on couch.