chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a consumer reporting herself, a 63 year old female patient with penicillin allergy, allergy to DURICEF and allergy to DIFLUCAN. The patient's medical history included stage four breast cancer and three prior cases of shingles. Approximately in November 2013, reported as three months ago, the patient was vaccinated with ZOSTAVAX (strength, lot number and expiration date were not reported)(dose reported as one injection). Concomitant therapies included LYRICA, exemestane, CYMBALTA, Bupropion hydrochloride and OXYCONTIN. On 14-FEB-2014, the patient reported that after administration of ZOSTAVAX, she experienced "a rash that is sensitive to the touch". The patient stated "the rash looks like it could be shingles". At the time of the report he outcome was unknown. The patient did not received any treatment or seek medical attention for these events. Also she did not performed any lab studies. Additional information has been requested.
A nurse reported that 70% of children who received their 1st dose of Prevnar at this facility developed injection site reactions described as "ugly and the size of an egg." The children recovered after 1 week. No further information was available at the date of this report.
Information has been received from a certified medical assistant concerning an 18 year old female who on an unspecified date was vaccinated with Gardasil vaccine (lot# unknown), 0.5 mL injection. Concomitant therapy included Synthroid. On an unspecified date the same day as the vaccination the patient felt dizzy like she may faint, on her way to the car, after receiving Gardasil vaccine. Medical attention was sought. The patient went back to the physician's office to lie down. The office gave the patient something to eat and drink, she was fine. No further information was provided.
Stiffness in arm and it gets very aggravated and achy on the outside of the upper arm.
My right arm pit was swollen for three days after I got the shot and all I did was take aspirin and it took the weekend and it went away.
This spontaneous report as received from a registered nurse refers to a 11 years old male patient without pertinent medical history, with allergy to: minoxidil, nifedipine, morphine, codeine, clindamycin, isradipine, clonidine and to an unspecified vaccine, who on 03-JAN-2013, was vaccinated in the right lateral thigh with a dose of PNEUMOVAX 23 (dose was not reported) (lot number reported as H016295, expiration date: 02-NOV-2013). On the same date, the patient also vaccinated with MMR II (dose, indication and lot number were not reported) and (Merck) VARIVAX (dose, indication and lot number were not reported). Concomitant vaccines included Tdap (dose, indication and lot number were not reported). The registered nurse reported that on 05-JAN-2013, the patient was seen in the emergency room of the hospital with a 104.7 F fever and red, warm, raised and swollen rash at the PNEUMOVAX 23 injection site that was 5.5 centimeters in diameter: no shortness of breath was noted. The patient sought medical attention. On the same date, the patient was admitted to the hospital. The patient was administered acetaminophen and on 06-JAN-2013 his fever was down to 100.6F. On 08-JAN-2013, the patient was discharged from the hospital. At the time of the report, the patient was recovering from the adverse events. The relatedness for the adverse events was unknown for MMR II, (Merck) VARIVAX and PNEUMOVAX 23. Additional information has been requested.
Starting the night of vaccine administration and continuing until current date: she can barely lift her arm, high fever, diarrhea, she cant keep anything down, dry cough, her chest burns, body soreness, lethargy, arm swollen and skin peeling- cellulitis, dizziness, pain when swallowing.
Immediately following the vaccine and for the next 1-2 days, she was experiencing significant pain at the injection site. Over the night, she began to develop a low grade fever. Around 2 AM, that night, she began vomiting. The vomiting continued for several hours and then gradually began to go away, along with the fever.
Gave the adjuvant portion only/ not reconstitute the adjuvant and antigen powder prior to giving the dose; Gave the adjuvant portion only/ not reconstitute the adjuvant and antigen powder prior to giving the dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number B257H, expiry date 26th June 2023) for prophylaxis.   On 9th June 2022, the patient received Shingrix. On 9th June 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-Jun-2022 Reporter's Comments: The reporter was a medical assistant. The reporter stated that she administered the Shingrix adjuvant portion only to a patient, she did not reconstitute the adjuvant and antigen powder prior to giving the dose. The reporter consented to follow up. Additional Supportive Information: The patient was administered Shingrix adjuvant portion only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
No additional AE reported; An improperly stored dose of PEDVAXHIB was administered to the patient on 12AUG2022; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender.  The patient's concurrent conditions, pertinent medical history, and historical drugs were not reported. Concomitant therapies included a dose of rotavirus vaccine live oral 1v (ROTARIX).  On 12-AUG-2022, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml (lot number U029145 has been verified to be a valid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), expiration date reported and confirmed as 30-MAR-2024) as prophylaxis (route of administration and anatomical location were not provided). The vaccine administered suffered a temperature excursion of 35.7 Fahrenheit degrees (F) for a time frame of 4 hours and 26 minutes (Product storage error). This vaccine had not suffered previous temperature excursions.  No additional information provided. No additional adverse events (AE) reported.
Menstrual cycle is off; one week early after first dose of vaccine, and now currently 2+ weeks late and counting after second dose. Not pregnant.
Adverse reaction at injection site - redness, swelling, itching -> noticed for the 1st time approximately 48 hrs after vaccination, currently using BENADRYL. Spoke again after a few days - better, still red & itchy.
Died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died) in a 44-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medications were not reported. The treatment information was not provided.  Company Comment :This case concerns a 44-year-old, male patient with no relevant medical history, who experienced the unexpected event of death (unknown cause). The event occurred unknown duration after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-143352 (E2B Linked Report).; Sender's Comments: This case concerns a 44-year-old, male patient with no relevant medical history, who experienced the unexpected event of death (unknown cause). The event occurred unknown duration after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Spikevax is not affected by this report. MOD-2021-143352:; Reported Cause(s) of Death: unknown cause of death
Events are described by patient and her husband at time or emergency room evaluation on the day following injection. Patient described malaise and hot flushes 3 hours following immunization.  On awakening the following morning she experienced and episode of dizziness and weakness requiring holding on to the kitchen counter.  At this time her husband observed her to have diaphoresis and chills.  The husband helped the patient back to her bed and assister her to lie down to recover.  Symptoms improved within several minutes and the husband then assisted the patient to the car and drove to the emergency room for evaluation.
Myalgia, Fever, fatigue Narrative: Fever 99.8, severe muscle pain and severe fatigue. Resulted in unable to work 4/6 and 4/7/2021. Resolved with bed rest and self treatment with ibuprofen.
SUSPECTED COVID-19; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: almost died. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose was not reported, 1 total, start therapy date was 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 suspected covid-19, and was hospitalized (date unspecified). Number of days of hospitalization were 2. Reporter reported that ""I ended up in hospital for 48 hours after JNJ shot. One and done. Maybe the omicron and delta were worse dude. I almost died in October 2019 and no one knew why there was a dead bat under my pillow. Am I patient zero" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 was not reported. This report was serious (Hospitalization Caused / Prolonged). Sender's Comments: V0: 20220951453 -covid-19 vaccine ad26.cov2.s- Suspected COVID-19  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). Therefore, this event(s) is considered unassessable.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 at 15:00 as dose 1, single (Lot number: EN6205), in left arm, on 24Mar2021 at 15:00 as dose 2, single (Lot number: ER2613), in right arm and on 21Dec2021 at 12:00 as dose 3 (booster),single (Lot number: FJ8762) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Eczema" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM, start date: Jan2022; BUPROPION, start date: Jan2022. Past drug history included: Nickel, reaction(s): "known allergies"; Thimerasol, reaction(s): "known allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.Additional details include: Patient received antiviral (Pfizer brand)for COVID 19 Treatment From 12Aug2022 to 16Aug2022, Adverse event- Rebound - Foul taste in mouth despite regular oral hygiene. Chewing mint gum helped alleviate.Clinical course: Other medication in 2weeks product includedEscitalopram Tablets (brand- SOLCO Healthcare), Bupropion Extended-Release Tablets (brand- lupin pharmaceuticals). Patient was given anti-viral Paxlovid 12Aug2022 to 16Aug2022 for treatment of COVID-19.
Approximately 10 minutes after receiving vaccine, pt. c/o difficulty swallowing & very dry mouth. Became nauseated & experienced vertigo. BP - 120/90 -> 150/90 -> 148/90 - 911 called & pt. transported to hospital (pulse 66-104).
5 minutes after getting shot, started to feel same effects of Tree nut allergy anaphylaxis. Did not need an EpiPen, but still had trouble breathing for the day.
Twitching fingers and jerking fingers occurred 2 days after the shot. This happened only on my left hand, and my shot was on the left deltoid.
30 weeks pregnant, EDD 09/06/2017. Expected/disclosed side effects of injection site soreness and redness experienced immediately. By bedtime, general malaise including body aches and headache. Injection site welt visible. By 8am the next day, continued tiredness with shortness of breath. By 6pm and after a two hour nap, arm redness drastically increased, shortness of breath worsened, jaw soreness and coughing. Contacted pharmacy who advised contacting on call doctor. Doctor advised ice packs and TYLENOL. Should shortness of breath continue, advised to go to emergency room. No fever. At 2 AM, severe chills experienced for approximately 2 hours. Continued redness increased to upper left arm. Redness subsided by 06/03/2017.
Body aches, headache. Treated with IBU 600mg and Tylenol 1g. Symptoms lasted 48 hours.
diarrhea, low grade but constant headache, fever, whole body aches, chills.  Most of the symptoms had started to subside after 48 hours.
This was second dose. I experienced shivering for 8 hrs,  fever (100.2-101.5), muscle aches, tiredness through day two & a half,  just tired, worn out third day, fourth day all good again.  I only experienced sore arm for first dose (February 3, 2020). My husband had Shingrix vaccination at the same times, same places, and only experienced sore arm.
On 4/23/2018 at approximately 1:45 pm. Pt reported to the office manager that after injections which were given on 4/20/18, he experienced severe R and L arm pain that caused severe bilat arm weakness which lasted about 28 hours.
The Pfizer vaccine was given to me at 8:30 am on 03/28/2021, by 9:00 am I began to experience a dull ache at the base of my skull and involved both the occipital brain and perhaps the first 3 cervical vertebrae. It is now 2:35 pm and these symptoms are increasing in intensity with a pain score of 7 on a scale of 1 - 10, with a pain level of 2 at the onset of symptoms. I took 2 - 500mgTylenol at noon have not resolved symptoms yet.
Patient was received expired covid 6mo-4yr monovalent vaccine. Vaccine was drawn up on 2/28/23 at 1440. Vaccine was administered to patient on 3/1/23 at 1544.
Low grade temp. 100.5; chills, headache, leg/joint pain; nausea
She got dizzy, then passed out. Non responsive for over 2 minutes. Once she was responsive she was hysterical, still dizzy.  She was given water and candy after she could sit up. The rest of the day she acted like a concussion victim, lethargic and quiet.  It took 10 hours, tylenol,  and a long nap to get any pep out of her.
I had fever that night of the vaccination. I had headaches, chills, and body aches, this lasted about 4 days. I've also been dealing with UTI and Clostridium Difficile. I'm taking Vancomycin HCL 125mg capsules, I take two of these a day. I've been doing telehealth visits about related.
Information has been received from a physician concerning a 9 week old female, with no medical history and no allergies, but who had an unrelated family history of 2 siblings who had severe cases of rotavirus, who on 27 Nov 2006 was vaccainted with a first dose of rotavirus vaccine (lot 654794/0776F). Concomitant vaccines administered on the same day included a dose of Dtap, a dose of Hib vaccine, a dose of Ipol and a dose of Prevnar. Three days post vaccination, on 30 Nov 2006, the patient developed severe diarrhea and vomiting. The patient was taken to the emergency room where a stool culture showed that the child had rotavirus. The patient was not hospitalized and subsequently recovered. The physician felt that the patients experienced was related to vaccination with Rotavirus vaccine as none of the patients family members had been ill and since she does not see many rotavirus cases this time of year. No product quality complaint was involved. No other information was provided. The reporter considered the patient's experienced to be disabling and immediately life threatening. A lot check has been requested. Additional information has been requested.
Mother reported to Dr via phone call that child had non stoppable crying for 24 hours. Treated with Tylenol-Advised Motrin for the night
12 hours post shot shaking shivers cold lasting about 3 hours. Insomnia. 14 hours post shot..On scale of 1-10 headache at 8 in pain lasting about 8 hours then down to dull for additional hours into 3/19.  Red area  about palm size around shot with hardness and pain.
headache; threw up; shallow quick breathing; fever; Injection site sore arm 4 hours after vaccine given; very tire 10 hours after; chills; shallow quick breathing; heart racing; very uncomfortable; dry throat; arm extremely sore; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 12-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0187), via an unspecified route of administration, administered in Left arm on 06Jun2021 at 09:00 AM (at the age of 12-year-old), as single dose for covid-19 immunization. The patient's medical history was none. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Expiry Date: unknown, Lot number: EW0180), via an unspecified route of administration on 25May2021, 09:00 AM administered in left arm as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient was not tested for COVID 19. On 15Jun2021 at 13:00, the patient experienced injection site sore arm four hours after vaccination/ arm extremely sore; she was very tire 10 hours after chills; had fever; experienced shallow quick breathing, heart racing, dry throat; and she was very uncomfortable. On the same day, she fell asleep about 11:30pm and threw up at 3:00 AM. On 16Jun2021 (on next day), she had headache and still on day 3. Therapeutic measures were taken with Tylenol, cool compress, hydration as a result of reported events. The outcome of event was resolving.  Follow-up attempts are needed. Further information is expected.
Resident received booster vaccine prior to the 5 month mark.  No ASE symptoms at this time.
patient presents to the hospital on 12/13/2021 with a chief complain of chills, fatigue, weakness, poor oral intake, nausea ever since receiving his Covid booster on December 9.
On 11/24/2000 the patient developed 12 pox. Additional information has been requested.
Directly after injection of Typhoid Vi and Twinrix in L Deltoid client stated he had arm pain. Pain continued for 7 days post injection. Each day pain diminished slightly. First 4 days client had difficulty lifting arm. Client did not take any OTC or Rx pain medication for pain. Denies swelling/rash/itching. Client stated the site of pain is 1 to 2 inches below the acromion process.
Initial unsolicited report received from a consumer on 12 February 2015. A female patient whose medical history included severe corn allergies and concomitant medications were not reported, had received a dose of DTaP (Manufacturer unknown, batch number, expiry date, dose number, route and site of administration were not reported) and a dose of Polio (manufacturer unknown, batch number, expiry date, dose number, route and site of administration were not reported), both on an unspecified date. On an unspecified date, after vaccination, the patient experienced eczema, dark purple racoon circles under the eyes and diarrhea. The patient was treated with over the counter BENADRYL. Laboratory investigations were not reported. At the time of report, the patient outcome was unknown. Documents held by sender: none.
pt recvd vax; 2-3 hrs after vax face & arm became very red & flushed; pt devel "golfball-sized" swelling at inject site & exp fatigue & headache; pt tongue became swollen & had difficulty talking;
booster dose; it was painful; whole right side was severely inflamed and they could not lift their head up (with no headache) and arm; whole right side was severely inflamed and they could not lift their head up (with no headache) and arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3(booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster dose"; PAIN (non-serious), outcome "unknown", described as "it was painful"; INFLAMMATION (non-serious), MOBILITY DECREASED (non-serious), outcome "unknown" and all described as "whole right side was severely inflamed and they could not lift their head up (with no headache) and arm".  Follow-up (01Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
15 hours after vaccine, had sweats and 100.5 degree fever, along with a dead arm.  Fever passed within 12 hours with Tylenol and ibuprofen every 4-6 hours.  Arm pain subsided after 3 days.  1 week after the vaccine, now have ?Covid arm? which is a itchy rash below the injection site that is red and semi raised.  This had not appeared until 1 week later no signs prior to.
This patient was admitted to the Hospital ICU on 4/8/2021 after developing rigors, chills, hypotension and a fever to 105 F after getting her second dose of Pfizer vaccine on 4/7/2021. She also was noted to have a platelet count of 12 that responded to IVIG and she was diagnosed with Immmune Thrombocytopenia.
I, the patient,  have no previous medical conditions. I do not take any prescribed or OTC medications. I developed swelling and pain in both legs a week after second dose of vaccine. Leg swelling progressed to ankles and feet. Saw a Podiatrist who ran bloodwork that shows I know have developed Gout.
after shot patient came to nurse and said "she was itching and her mouth felt numb. She also said her throat felt tight and her legs were weak" Taken to Hospital. She spent 6 hours there on Oxygen and receiving steroids.
Inflamed the injection site and started spreading raised and hot to touch w/ bump in middle. Also carried a fever. Went to Medical Center prescribed KEFLEX which was changed to Azithromycin due to allergy.
Pt recvd vax & 6 wks p/2nd dose of vax pt had extreme generalized muscle pain from neck to legs, numbness, tingling in all extremities, weakness, low energy; seen by MD;