chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 5 hours after shot, had severe adominal cramping with acute explosive diarrhea which has continued through today.  I awoke at 7:30am on 3/5/2021 with headache, fatigue, congestion, and no appetite. By 12:00pm, the glands in my throat were painful and it hurt to swallow and I was have body aches. At approximately 1:00pm, I began to have chills which progressed to teeth chattering, body shaking chills. My temperature at this point was 100.6.  At 1:30pm, I took some over-the-counter cold medicine and at 2pm I took 2, 200mg tablets of ibuprofen. I went to bed until 4:30pm and my temp at this time was 101.3. I took 2 more ibuprofen. I continued to have diarrhea and had severe nausea but did not vomit. My fever did not drop under 100 until about 10:30 am on 3/6/2021.  By 2pm on 3/6 my fever dropped to 99.5. For the duration of 3/6, I had intermittent nausea and diarrhea. When I awoke on 3/7, I felt fatigued but felt much better.  Currently, I continue to have intermittent diarrhea and nausea.
Cough, Sneezing, sore throat, runny nose, clogged ears. Upset stomach.
Pt mother reported fever 104.5, pt mother reported child was delirious - pt was admitted to hospital for cellulitis right arm post immunizations.  9/25/07 Reviewed hospital medical records which reveal patient admitted 8/8-8/9/2007 after experienced fever w/confusion,  and erythema, warmth, induration, redness, pain at right arm vax site x 2 days & vomiting x 1. FINAL DX: cellulitis of right arm, dehydration.
Information has been received from a 70 year old female with sciatica and no drug reactions/allergies, "approximately 1.5 months ago" was vaccinated with one dose of ZOSTAVAX. Concomitant medication included Montelukast sodium (MSD), ALprazolam, Nexium, and Gabapentin. Approximately one week after receiving ZOSTAVAX, she initially developed ulcer sores in her mouth. Subsequently, these sores spread to her throat as well. Also, she has had difficulty eating and swallowing food and every time she eats she experiences nausea. Since all this began, she has lost 17 lbs. She said that she has had a colonoscopy, a CAT scan, and blood tests but all of the test results have come back normal. As of the reporting date, the events have not recovered. Additional information has been requested.
Patient felt funny after vaccine. Felt like her lips and tongue were tingling and became hypertensive and dyspneic. Taken by ambulance to hospital.
Left arm pain/tenderness that extends clear to his wrist. Redness visible over entire deltoid area. Warm to touch.
Body aches, severe diarrhea, loss of appetite, headache, fatigue that has continued since time of vaccination.
Patient developed signs and symptoms of meningitis with classic triad of fevers, headache, and neck stiffness. Patient was treated for bacterial meningitis with IV antibiotics. The patient's condition improved over the course and was able to be discharged back to home to complete course of IV antibiotics.
TOOK STICKY CAPSULE WITH RESIDUE; This spontaneous case report (PVX2019-1734) was received from a nurse on 01-Jul-2019. It describes a 65-year-old male consumer who "took sticky capsule with residue" (PT: Product physical issue), while being on Vivotif (lot number: 3003277 and expiry date: 31-May-2019) for an unknown indication.  Case report: The consumer took two dose of Vivotif but when he was taking the third dose, he observed that the capsule stick on the pack and some residue was left inside the pack. He took that capsule.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took sticky capsule with residue" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took sticky capsule with residue" was considered as not applicable.
Sleep more than normal 1st 48 hours after vaccinations. Tylenol given x1 next day of immunizations, rash noted by mother next AM. Described as red, fine, bumpy rash. Rash decreased after mother gave 1 dose of Benadryl.  Fever of 99.5F.
Second vaccine had some side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Second vaccine had some side effects) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (Second vaccine had some side effects). At the time of the report, VACCINATION COMPLICATION (Second vaccine had some side effects) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  No treatment medications were provided.   This case was linked to MOD-2021-383898 (Patient Link).
Severe soreness in arm, fever in arm & whole body at 5 pm.  Took two ibuprofen - 200 mg about 6 pm.  Fever subsided by 7 pm, but soreness in arm becomes more severe and swelling is noted at vaccination site.  Arm so sore that I was unable to position on left side.  On 9/4/2010 I awoke at 5:30 am and prepared to lead a hike on the a trail.  Took two 200 mg Ibuprofen at 6 am.  Left arm is still very sore and swollen.  Began hike at 9:30 am - not feeling very chipper.  Hiked until 12:00 noon, then the group took a lunch break.  Ambient temperature was 60 degrees and quite windy at 12 noon - I became really cold - my hands became numb.  Resumed hiking at 12:30 pm and I warmed up.  Completed hike about 3:45 pm and arrived home at 5 pm.  Had sandwich, took two 200 mg Ibuprofen, which greatly relieved the soreness in the arm, but arm is still quite swollen from the elbow to shoulder.  I was able to sleep on the left side during the night of 9/4/2010.  On morning of 9/5/2010 the arm is still sore and swollen, but the soreness is subsiding.  Redness is noted on the left bicep and swelling is still apparent.  Overall feeling is much better than yesterday.  I think that I'm on the mend.  BTW, I took two 200 mg Ibuprofen this about 9am on 9/5/2010.
Pt recvd 1st dose of Engerix-B on 7JUN90 & 2nd dose on 9JUL90; 10JUL90 devel fever & h/a which cleared on 12JUL90; On 11JUL90 exp dizziness, visual disturbance; burning, itching & general discomfort of eyes & allergic type rxn in eyes;
Vaccine administered IM (R) deltoid on 8/11. On 8/12/14 mom noticed upper (R) arm taut, red, swollen and warm - went to the ER. Follow-up with Dr. on 8/13/14. Started on cephalexin x7 days.
Fever since 12/5/04 night, low grade and on 12/05/04 mom noticed erythematous discoloration of site of vaccine applied ice packs as she had been advised to do child seen with area of erythema left buttock of site of vaccine and surroundings.
FOR BOOSTER ONLY - 10/19/21 Fever beginning 4 hours after injection reaching 103.6 Splitting headache for 24 hours Dry hacking cough for apx 36 hours
1055 AM Pt was given FLUARIX Lot AFLU611A to RDI. Went to holding area for observation. 1107 to FNP due to feeling faint, looking pale, states difficulty swallowing and questioned thick tongue. 1110 FNP gave EPIPEN. 1120 EMS transported to Hospital ER.
right knee pain starting the day after receiving his 1st vaccine; he is not able to get much sleep due to the pain; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (he is not able to get much sleep due to the pain) and ARTHRALGIA (right knee pain starting the day after receiving his 1st vaccine) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 020B21A) for COVID-19 vaccination.     Concomitant products included LABETALOL, TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), FAMOTIDINE (PEPCID AC) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INSOMNIA (he is not able to get much sleep due to the pain). On 26-Feb-2021, the patient experienced ARTHRALGIA (right knee pain starting the day after receiving his 1st vaccine). At the time of the report, INSOMNIA (he is not able to get much sleep due to the pain) and ARTHRALGIA (right knee pain starting the day after receiving his 1st vaccine) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Caller states taking aspirin to help relieve side effects, with no symptom relief.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Action taken updated to not applicable, second dose regimen added, no adverse event deleted from relevant history, event onset date and onset latency added for both events
Pt has vaccine at pharmacy at approximately 3.54PM, adverse effects did not occur until approximately 2:00AM 05/28/2018. Symptoms include (per wife) uncontrollable shivers, temperature (no documentation of temp), sweats, rapid heartbeat, nausea, hardening around injection site, heard 'raining' in the ears for several hours and headache.
Several hours after the vaccination patient had the following symptoms: throwing up, sweating, chills, tightness in chest, throat constricting, weakness, hot feeling in vaccination arm and down back, weakness, eyes glazed.
Patient previously healthy , started having episodes of abnormal movements later recognized as infantile spasms, that mom identifies they started after receiving Vaxelis vaccine at 2-month-old.  Mother noticed that after his 2nd and 3rd dose of Vaxelis, the number of episodes intensified after the vaccination of this combination vaccine.  The infantile spasms were witnessed by a nurse 1 week after receiving his 3rd dose of Vaxelis (dose given 11/08/2023), and there was an immediate workup and admission for diagnosis and treatment for this condition.  Note that baby only received 1 type of vaccine per week per mother's preference, so she was able to identify the frequency of episodes was different when other vaccines were given.
Measles like rash all over the body. Patient is not sick or act sick. No fever.
No adverse event; a patient was administered MMRII that expired on 15MAY2021; This spontaneous non-valid report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an 07-JUN-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live recombinant human albumin (rha) (M-M-R II) 0.5 mL, lot # S015093, expiration date 15-MAY-2021 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. It was reported that measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live recombinant human albumin (rha) (M-M-R II) had not had any temperature excursions. No futher adverse event (AE) was reported.  This is a non-valid report due to lack of patient's identifiers.
After the vaccination on April 16th 2009 I noticed at the injection sight his arm was swollen, red and very hot to the touch. Everyone told me he was fine at the time. I gave him children's tylenol and some zyrtec to help ease the discomfort. This lasted until Sunday, April 19 2009. It was completely gone by Monday, the following day. On April 22, 2009 I had noticed some red spots on his torso, I had assumed he got bitten by a bug. April 23, 2009 at night I noticed many more bumps had appeared on his upper legs and belly. By April 24, 2009 his entire belly, both upper thighs and under his arms had dime to penny sized lesions covering them. He is extra tired and complains of his eyes hurting him. He complains of the lesions itching, I gave him an oatmeal bath to help eleviate the itching. No fever has been noticeable but he has been feeling clammy all day today, April 24. If they have spread further or a fever comes on I will take him to the doctor.
Probably 4 & half months ago or 5 months, I started noticing a new notable indigestion. I could feel gurgling in my stomach area on my left side and sometimes its audible. And that has been accompanied by the chronic need to burp. And then around the same time, I started noticing significant decrease in sensation in my genitals during intercourse. And then probably a month or so after that, I started developing what feels like a tightness in my throat and that is accompanied by congestion, sore throat, and a cough. I went to the doctor in particular around the sore throat thing because I thought it was potentially COVID. So I went in for a COVID test and it was negative for flu, covid, strep and another one. They said they assumed it was something viral and that it would go away. I would say that was probably three weeks ago. No medications prescribed. Scheduled appointment for blood work in the near future.
Pt experienced bleeding from right nostril after administration of FLUMIST. Pt had been crying & struggling during vaccines. Direct pressure was applied bleeding stopped. Pt examined by physicians.
Typhoid oral vaccine - Dose #1 8/2/10, Dose #2 8/4/10 8:30pm - on 8/5/10 6AM she had abdominal cramps, nausea, chills, sweats, fatigue & malaise 1 1/2 hrs - no treatment.
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 25-JAN-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA001558:
This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In 2010, the patient was inoculated with ZOSTAVAX (dose, route, and lot # were not provided) by a physician for routine adult health maintenance and for the long-term prevention. It was mentioned that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2010, the patient was treated by the physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX)for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. At the time of the report, the outcome of the aforementioned adverse events was unknown. The relatedness assessment between the aforementioned adverse events and ZOSTAVAX was related.
Pt vaxed w/1st & 2nd dose of vax 27SEP90 & 31OCT90 respectively; 4 to 5 hrs p/2nd dose exp light-headedness, disorientation, loss of memory, nausea, myalgia, fatigue, fever & a severe headache; Later recovered;
shingles diagnosis (pain, blisters, fatigue) Valtrex 7 day course  advil
Information has been received from a physician concerning a female who was vaccinated with 0.5 ml of Gardasil via injection.  The patient developed severe vomiting after receiving the vaccination.  Lot number was not provided.  The physician stated that the patient was hospitalized, but did not know for how many days.  No further information was provided.  As of 13-DEC-2007 the patient was recovering.  Additional information has been requested. Follow up information has been received on 22-FEB-2008. The nurse reported that the physician has no further adverse event information to provided. No further information is expected.
Vertigo; This spontaneous case was reported by a physician and describes the occurrence of VERTIGO (Vertigo) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection, solution for Psoriatic arthritis.    No medical history was reported.  Concomitant products included SODIUM CITRATE (CITRATE) for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment was reported.
I went out of town for a conference and flew back on Friday. I started having symptoms Monday night. The symptoms were fatigue, sore throat, muscle aches and a low grade fever. The fever increased to 100.5. I had runny nose along with post nasal drip and chest congestion. I did a rapid home test on Tuesday which was positive. I went to a drive thru health center and also tested positive. I contacted my healthcare provider who provided a prescription for fluoxetine. I did not fill the prescription instead I took OTC Mucinex and Tylenol. My symptoms have improved but I am still easily fatigued, winded and have chest congestion. I am no longer running a fever. I have been taking index fever reads of my O2 levels and it has fluctuated between 95 and 99 but never lower than 95. I have not recovered. I cannot walk upstairs without getting winded.
Weakness in legs, trouble walking then a few days later arm weakness and then severe back pain and then hurt to breathe went to emergency room vomited and fainted.
pt exp SOB, hyperventilation, dizzy, diarrhea, cramps, fingers tingling, allergic event;
patient felt dizzy and thought she was going to pass out, she needed to sit down. after sitting for a few minutes (about 15 minutes), she felt fine and left the store.
Just reporting symptoms that started on 2/3/2021 and not 2/9/2021 as reported because I was not receiving daily updates for check in. Vaccine was at 5p on 2/2/21. Next morning I had fever,  fatigue,  chills and muscle aches and rash on torso. Left arm continues to itch from apparent rash.  No treatment.  Symptoms resolved in about 30-48 hours post injection but again just wanted to document appropriately the immune response I had. I don't know if I can correct data fir 2/9/21 but I'm back to 100%. Thank you
onset of pox 7DEC totalling approx 7-10 on chest, back, neck, leg, buttocks;no treatment;mom states is just fine;directed to keep child out of daycare till sores crusted over;
Patient experienced cold sweats, body aches, fever and difficulty breathing - symptoms lasted for about 1.5 day. She didn't need any treatments and didn't go to Dr. or hospital. She's feeling ok now.
Pt presented after an episode of amnesia/ confusion at home with possible facial droop, & headache. Found to have bite mark on tongue & cheek Evidence he fell onto face & broke glasses. Suspect 1st time Seizure with postictal confusion as MRI brain showed no stroke. Admit to hosp for further eval and treatment.
Initial information received on 10-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 54 years old male patient who was vaccinated with a 0.5ml dose of vaccine YF-VAX (lot UI6688AA and Exp. Date 04-JAN-2019) via intramuscular route in the right arm on 07-Jan-2019. The patient's medical history not reported and concomitant medications included MMR and MENACTRA for Immunisation. It was an actual medication error case due to expired vaccine used. It was unknown whether the patient experienced any 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 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. List of documents held by sender: none.
TAKEN TO ER FOR ABDOMINAL PAIN AND EMESIS. DIAGNOSIS: INTUSSUSCEPTION.
A nurse reported that a female, now 33 years of age, received an injection of 1992-1993 formula influenza virus vaccine in 1992 and subsequently, developed the flu. She recovered after 2 days. (This pt developed a swollen tongue, a painful knot in her neck, numb lips, pallor and felt strange following a recent receipt of Flu Shield 2000-2001 formula; see MCN HQ5928515JAN2001).
21 x 21 cm circumferential hot swollen (R) arm within 24 hours of flu vaccine. Unresponsive to BENADRYL, ZYRTEC. Required steroids. Flu vaccination Thu 11/17/site is swollen, hard to touch and inflamed. Mother says whole right arm is red and swollen shoulder to elbow/ at site of injection for influenza vaccine that he got yesterday/ no fever. Arm itchy mild pain on movement can use arm normally no numbness or tingling/ child is acting normal eating drinking and playful.
Multiple polymorphous erythematous lesions generalized with some target lesions with central clearing consistent with erythema multiforme.
Fever, malaise 24 to 48 hours after vax, sore arm around injection site for 4 days, itchy rash forming on day 5 around injection site.
My first shot had little side effects. Leg cramps similar to charlie horse for an hour or so, and then was fine. Second shot I did end up having a fever, which is fine and expected.  My heart rate has been consistently at 100-120 bpm still which I did not expect, though I know that infections can cause this. The vaccine clinician recommended I report any reactions like this to support ongoing data collection.
The pt developed an erythematous, maculopapular rash all over her body, including her palms and soles of her feet. It was also pruritic. Treated it with cetirizine and it resolved.