chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Outer side Right Foot-Weakness, pain when pressure placed on outer foot, difficult to walk.  Taking 1 Motrin every day (too many can raise blood sugar level). Went and saw podiatrist after a week had gone by (4/15).  Podiatrist diagnosed arthritis.  Gave brace to wear.  Foot not red or warm to touch  Left Foot paid started day after podiatrist seen (4/16).  Top of foot very painful.  Could not bend at ankle.  Foot did not look swollen.  Very difficult to walk.  Left Foot very difficult to raise up.  Felt like it was encased in concrete.  Woke up on 4/18.  Could not get out of bed.  Both feet very painful.  Called Endocrinologist and saw Physician Assistant.  Went for office visit. PA said that the top of left foot very swollen.  Could not bend left food ankle.  She was checking my toes and they were fine.  She confirmed it's not gout.   Pressed down & could see fluid moving.  Same with side of right foot.  Ordered blood tests and recommended volatrain gel and motrin.   4/19: Top of left foot less painful.  Big Toe on left foot red, swollen and warm to the touch.  Other four remaining toes are starting to swell.  Right foot still same.  No swelling noticed, pain on outer side of foot.  4/20:  Left foot big toe very swollen along with all the other toes now.  I am now able to start bending my left foot however when I do, my toes all hurt.   Starting to be able to bend big toe on left foot.    Left foot noticeably swollen when placed by right foot.   Spoke with PA today.  Both she & I do not think this is arthritis at all.  Next Podiatrist appt is Friday 4/29.  Recommendation is for a cortosone shot at that time on right foot if not better.  At this point, he has not been notified of what is going on. Will bring him up-to-date then
Body aches, High-grade fever of 101.7, Chills, Nightsweats; Treatment with Ibuprofen.
No adverse event occurred at this time but patient did receive second Pfizer vaccine 15 days after first dose instead of on day 21.
Patient returned to pharmacy approx 2 weeks later saying he has been experiencing shoulder pain ,possibly nerve related since shot ws given
4/20 diarrhea and nausea, loss of appetite; 4/21 cold sweats, fever, chills, fatigue, loss of appetite;   4/22-4/23 fatigue, intermittent fever, headaches; 4/24 cognitive difficulties, disorientation, highly susceptible to suggestions that were counter to self interest and needs, headache, fatigue
Triggered atrial fibrillation within 4 hours after receiving 2nd dose. Double-loading Amiodarone for one week after speaking with doctor's office on 3/10/21 (3/10/21 - 3/16/21) and for another week (3/16/21 - 3/22/21) did not convert my heart back to normal sinus rhythm.   During Kardia readings (taken 2-3 times per day), heart beat jumps back and forth repeatedly in the range of 92 to 110+.
h/a & myalgia p/inject; 30MAR93 no addtl event info recvd; not the vax provider;
Patient received Bivalent Booster, but she had actually received the booster 10/19/22. Discovered AFTER giving the dose.
Information has been received from a 74 year old female with no pertinent medical history, drug reactions or allergies who "11 months ago" in approximately February 2007, was vaccinated subcutaneously with 0.65 ml of ZOSTAVAX.  Concomitant therapy included alendronate sodium.  In approximately October 2007, the patient developed shingles.  The patient reports being seen by her doctor for the "breakthrough" and was given antibiotics.  At the time of reporting the patient was recovering.  There was no product quality complaint.  There were no lab diagnostic studies performed.  At the time of reporting the patient's status was recovering.  Additional information has been requested.
MA administered Covid vaccine. When she was going to document, she noticed that patient had already received 2 doses.
Soreness at injection site, fatigue, headache, body aches. All lasting for about 48 hours post injection.
I got a shot in my left arm. There was immediate pain in my arm. This was the most painful shot(by far) that I've ever had. My left arm became pretty much useless, I couldn't lift it above waist level without pain. I went to a doctor when after a month the pain was still there and not getting any better. The Doctor had no idea what was the problem. I had x-rays, but they found nothing. The Doctor after two months gave me a cortisone shot. This did nothing for me. After about 6 months, the pain finally went away. I was told that you could get that kind of reaction if the shot is given to high on the shoulder, I accepted that. When I got my next booster, I got it in my right arm. After about 3 days, I started feeling pain in my right shoulder and still do.
started hallucinating; I was dreaming but awake; started getting anxious; arm started to hurt really bad; felt a little chilly; minor headache; A spontaneous report was received from a consumer concerning a 66-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events felt a little chilly, minor headache, arm started to hurt really bad, started hallucinating, I  was dreaming but awake,  and started getting anxious.  The patient's medical history was not provided. Concomitant medications reported include baby aspirin and lipitor for unknown indication.  On 29 Jan 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced the events felt a little chilly and minor headache. On 30 Jan 2021, the patient experienced the events arm started to hurt really bad,  started hallucinating, I was dreaming but awake, and started getting anxious.  On 30 Jan 2021, the patient called 911 and was hospitalized. The results of hospital EEG, CAT scan, and MRI are unknown.   Treatment details were not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events felt a little chilly, minor headache, arm started to hurt really bad, started hallucinating, i was dreaming but awake,  and started getting anxious was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
PFIZER #3 COVID VACCINE GIVEN 9/29/21, LOT #FF2587; PFIZER #4 COVID VACCINE GIVEN 4/7/22, LOT #FK9893; pt had a positive COVID test on 7/1/22, PCP not known; no medical records on pt; pt passed away at home.
120x200 mm erythem indurated area on (L) arm with 40 mm vesicular rxn and a slight fever 4 days (100.8)-Treatment Benadryl. Motrin, Keflex
Patient felt like she had a "lump in her throat when swallowing" 15 min post vaccination, redness on chest.  BP 158/98, HR 108. R 22 30 minutes after reaction - symptoms subsided, refused ambulance.
This spontaneous report as received from a nurse refers to a 6 month old patient of an unknown gender. On 16-FEB-2015, the patient was vaccinated with improperly stored ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
muscle aches; experienced nausea; vocal cords to become inflamed; Drug ineffective; developed bronchitis; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included fluticasone propionate, salmeterol xinafoate (Advair Diskus) inhalation powder for asthma and bronchitis and fluticasone propionate+salmeterol xinafoate diskus dry powder inhaler device (Advair Diskus Dry Powder Inhaler Device) inhaler for asthma and bronchitis.   On an unknown date, the patient received the 1st dose of Shingrix and Advair Diskus at an unknown dose and frequency. On an unknown date, the dose was changed to an unknown dose and frequency. On an unknown date, the dose was changed to an unknown dose and frequency. On an unknown date, the patient started Advair Diskus Dry Powder Inhaler Device. In August 2019, less than 4 months after receiving Shingrix, not applicable after starting Advair Diskus and Advair Diskus Dry Powder Inhaler Device and an unknown time after starting Advair Diskus and Advair Diskus Dry Powder Inhaler Device, the patient experienced bronchitis. On an unknown date, the patient experienced muscle pain, nausea, vocal cord inflammation and drug ineffective. The patient was treated with fluticasone propionate, salmeterol xinafoate (Advair Diskus) and fluticasone propionate+salmeterol xinafoate diskus dry powder inhaler device (Advair Diskus Dry Powder Inhaler Device). The action taken with Advair Diskus was unknown. On an unknown date, the outcome of the muscle pain and bronchitis were recovering/resolving and the outcome of the nausea, vocal cord inflammation and drug ineffective were unknown.   It was unknown if the reporter considered the muscle pain, nausea, bronchitis and vocal cord inflammation to be related to Shingrix. The reporter considered the vocal cord inflammation to be related to Advair Diskus and Advair Diskus Dry Powder Inhaler Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the patient received 1st dose of Shingrix in May or June 2019 and experienced muscle ache and nausea. The reporter stated that, in August 2019, the patient developed bronchitis and the 250/50 was not helping. It was increased to 500/50 for 2 weeks and that caused vocal cords to become inflamed and the patient went back to the 250/50 after the bronchitis cleared up. The reporter did not consent to follow up. This was 1 of 2 linked cases reported by same reporter for same patient; Sender's Comments:  US-GLAXOSMITHKLINE-US2020228558:same reporter
Cytomegalovirus infection; This is a literature report. A 73-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: Unknown) for covid-19 immunisation. The patient relevant medical history included: "Heart transplant" (unspecified if ongoing), notes: Time since transplant- 14y, "kidney transplant" (unspecified if ongoing), notes: Time since transplant- 6 y, "schemic cardiomyopathy" (unspecified if ongoing), "prophylaxis" (unspecified if ongoing). The patient concomitant medications were not reported. Past drug history included: Tacrolimus for Immunosuppression, Mycophenolate for Immunosuppression, notes: 500 mg BID, Prednisone for Immunosuppression, notes: 5 mg. Vaccination history included: Bnt162b2 (Dose 1, Single) for COVID-19 immunisation. The following information was reported: CYTOMEGALOVIRUS INFECTION (medically significant), 30 days after the suspect product(s) administration, outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood immunoglobulin G: None of the recipients developed; Lymphocyte count: 1.35, notes: Admission; Polymerase chain reaction: 363 IU/ml, notes: CMV highest; SARS-CoV-2 antibody test: Negative; White blood cell count: 5.4, notes: Admission.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event CYTOMEGALOVIRUS INFECTION and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200004629 Same article/ drug/event and different patient;
9pm on 2/4/2021 moderate dizzyness; went to bed. Awoke 3AM on 2/5/2021 severe vertigo, unable to focus my eyes and unable to walk without holding on the wall. Vomited (no blood); called 911. In ER they administered Benedryl and Reglan, NS bolus. Symptoms improved significantly - only slight dizzyness.  Emergency Doc Dx: acute vestibular neuronitis.  Rx'ed methylPrednisolone, dospak. Symptoms should diminish in next few days. #20 question therefore noted as "Unknown"
Information has been received from a pharmacist concerning an 18 year old female student with no drug allergies, no medical history, and no illnesses at the time of vaccination, who on 13-FEB-2007 was vaccinated intramuscularly in the right arm with a first dose of Gardasil (Lot# 654741/1208F).  Subsequently, in an unspecified date, the patient experienced a fever of 102 F and dizziness. The patient sought unsoecified medical attention. The patient recovered on an unspecified date. No further information was available.  Additional information has been requested.  Additional information is not expected.
hive next to the band aid of the injection site; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE URTICARIA (hive next to the band aid of the injection site) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE URTICARIA (hive next to the band aid of the injection site). At the time of the report, INJECTION SITE URTICARIA (hive next to the band aid of the injection site) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported.
I started with shivers, then a few hours later I had a fever and a bad headache. I took one Tylenol but that did not help after several hours. I took another and that still didn't help. I started feeling sick to my stomach, then I vomited several times. After emptying my stomach, I started feeling better. After 24 hours after the shot, I felt fine.  Then, again, 12 days after the shot, I got another bout of similar symptoms. I had a headache, stomach ache, then vomited. After a few hours of rest, I felt fine again.
had just received last shot, MMR and had one hive on left thigh, left antecubital and bright red cheeks both sides.  mom told us she thought he had something wrong with his tongue - 30 min later and after dose of benadryl given
FEVER; NAUSEA; HEADACHES; This spontaneous report received from a patient via a company representative concerned an adult male. 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 was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced fever, nausea, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, nausea, and headaches on APR-2021. This report was non-serious.
about 2 minutes after receiving the shot I felt like I was having an allergic reaction in my chest area. My lower esophagus got extremely tight and then it worked its way up to the back of my throat. It felt like there was a lump in the back of my throat, along with burning in my throat. This same reaction also occurs when I eat certain foods I'm intolerant to. I felt very dizzy right after as well. After exactly one hour my throat symptoms went away but suffered from residual effects for the next few days.  The next day I couldn't lift my left arm(which went away 2 days later), I was out of breath with everything I did, dizzy, muscle cramps, chills, body aches(as though I had the flu) and had extreme fatigue. All of theses symptoms lasted for the next week almost two.
Initial unsolicited report received from a pharmacist (director of pharmacy) on 12 Oct 2016. This case was linked to 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189847, 2016SA189848. (same lot number). This case involves a patient (age, gender unknown) who was vaccinated with a dose of FLUZONE (batch number- UI669AA, expiry date: 30 Jun 2017) by intramuscular route in arm on 04 Oct 2016. Illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were not reported. On an unspecified date, following the vaccination the patient had arm soreness (local reaction) and nausea from last two days. The patient's lab tests was not reported. Sought of treatment was reported as: none. The outcome of the event was reported as unknown. List of documents held by sender: none.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female patient of an unspecified age, and ethnicity received PREVNAR, intramuscular on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced cellulitis on an unspecified date with outcome of unknown. The patient went to an orthopedic because of joint pain from the vaccine. The outcome of the joint pain was unknown. The action taken in response to the event for PREVNAR was not applicable.
High fever 104-105F X 10 days, night sweats, chills, shaking, muscle spasm, cold/hot, weakness, bowel control lost, syncope. Was discovered to have UTI during workup
Papular and pustular rash to left arm and shoulder with spreading to trunk. Sx began 3 days after vaccine administration. 10/2/07 Reviewed medical records from VHC which reveal patient developed low grade fever, oozing & pruritic rash on left  shoulder, arm, back & left arm vaccine site s/p vaccine on 8/7/07 while on board ship.  Symptoms developed 3 days s/p vax.  Patient was airevac'd from ship to base camp & then to higher level of care. FINAL DX: eczema vaccinatum.  1/4/08 Reviewed hospital medical records which reveal patient experienced fever, severe itching rash while onboard ship.  Transferred to higher level of care for isolation.  Admitted 8/21-9/11/2007.  Pustules noted on RUE & erosion, multiple papules (some open & some scabbed) on LUE w/few papules extending onto left scapula.  ID & Derm consults done.  Enrolled in ID research protocol.  Tx w/topical steroids & moisturizers.  Progressed well & d/c to home for additional 14 days before returning to active duty. FINAL DX: eczema vaccinatum.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "asthma" (unspecified if ongoing); "known allergies: tree nuts" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative, notes: Negative test for two days following treatment; (Jul2022) Negative, notes: Negative test for two days following treatment; (01Aug2022) Positive, notes: Three days after, I was positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course:Report about COVID treatment was yes.vaccine was received. No Other medication in 2 weeks.Anti-viral details: Product was COVID 19 Treatment, Brand was Paxlovid,Treatment start date was  24Jul2022 and Treatment stop date was 28Jul2022.Indication was Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician concerning a 4 year old male child who on 25-FEB-2008 was vaccinated with a second dose of MMR II (Merck).  The date of the first vaccination was not provided.  On 12-APR-2008 the patient was seen in the emergency room and an ultrasound showed epididymitis.  The patient was treated with an "unnamed antibiotic."  At the time of the report the patient's status was unknown.  There was no product quality complaint involved.  Additional information has been requested.
This spontaneous report as receivd from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On 11-JUL-2014, the patients were vaccinated with doses of VARIVAX (Merck) (lot # H020250 exp date 06-NOV-2014 also reported as 08-NOV-2014) (dose not reported) subcutaneously that were improperly exposed to 7 degrees C from 15-MAY-2013 to 11-JUL-2014. No known adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected. All follow ups requested to complete the case were received. Additional information has been requested.
Pt recv vax & on 02Feb98 devel rash that was slightly raised & red on the face,neck & trunk
Patient recieved a flu vaccination on 1/14/23 after they had already recieved one this season on 10/27/22. No adverse event or outcomes noted.
Stomach (Abdominal pain); Nausea, headache, feverish, but no temp; minor Body aches. Began around 9:00 A.M. (2 hrs After injection). Nausea & other symtoms gone by A.M. 12-29-20.