chrisvoncsefalvay/vaers-outcomes huggingface dataset:
All the symptoms only started in the year of 2021 . Pitting Edema worsened over the months after shots. Night sweats started mid summer. Night time chills started around early August, or Mid August off and on . End of August I noticed extreme nausea, 24-7 , never easing up unless i took Dramamine, and it only helped for a very short time, then the nausea always returned quickly. First week of September, I started to have shortness of breath , really bad when I bent over, climbed the outside stairs, and especially when I'd lay down on either side for bedtime. I've always only slept on my side, so this really worried me.  On the night of September 11th 2021, I had hard, lightning type, sharp, chest pains, on my left side that really hurt so much that I sat down on the bed, grabbed my phone to call 911
Patient, while waiting for for the 15 minutes post-vaccination, fainted. The mom, accompanying the patient, started helping him off the floor and as I was helping her, the patient immediately woke up and regained consciousness, but was a little pale. I brought water for the patient, took his blood pressure which was about 100/50. His mom brought him orange juice and as I was sitting with the patient, he stated that he usually faints when getting blood drawn and such. I sat with the patient for about 10-15 minutes, and  he was improving, regaining color and more talkative. I then had the patient slowly get up and had his blood pressure measured again and it was 105/75 which according to himself and his mom was his normal. They then decided to leave and the patient was doing well by then.
Sweating with pulse 74-taken by mother. Mother took picture with and face was red, flushed.
1st dose: no side effects. Swollen gums - 2 days. Unsure if related. 2nd dose: got shot at 10am. Experienced side effects in the evening after dinner. Was in bed Sat. Recovered by Sunday afternoon. Lingering headache a few days until Wed, May 12. Seem to have recovered May 13.
Began 30 minutes after shot and has continued to various degrees since then: Head pressure, headache, ear pressure and pain, jaw pain, knee joint pain, tingling and numbness in arms and legs, nausea.
Numbness and tingling to right side of body; from top of head (scalp) to right thigh area. burning sensation to right ear. extreme headache. have had persisting symptoms since day of vaccination.
Local reaction to DTaP hot and painless 4 1/2 x 3 1/2cm. Benadryl 8cc Q 6H PRN, warm comress to area.
Initial information regarding an unsolicited valid non-serious case received on 10-Oct-2018 from a nurse. This case is linked to cases 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284733, 2018SA284732, 2018SA284734, 2018SA284735, 2018SA284736, 2018SA277767, 2018SA284721, 2018SA284755, 2018SA284751, 2018SA284747, 2018SA284748, 2018SA284749, 2018SA284753, 2018SA284754, 2018SA284750 (same reporter). This case involves a three year old patient (gender was not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (lot number U1997AA and expiry date 30-Jun-2019) via intramuscular route in the left thigh on 02-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (patients were given vaccines that were outside of the recommended temp range (below 32F)). No information about any adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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.
Onset c/o pain/swelling the evening of injection. Redness(mild) down to knee, with minor swelling.  decreased c/o pain. Mom states greatly improved, resoloution in progress.
Client reported within 1-2 hours - swelling at site - progressed to size of palm of her hd. with bluish discoloration, hot to touch and itching - no SOB - saw MD 10/23/15. No treatment other than BENADRYL PRN.
aches; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 16:30 (Lot number: Er2613) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ibs-d" (unspecified if ongoing); "PCOS" (unspecified if ongoing). Concomitant medication(s) included: CELEXA [CELECOXIB]; SINGULAIR; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PRILOSEC [OMEPRAZOLE]. Past drug history included: Tramadol, reaction(s): "Known allergies: tramadol.", notes: Known allergies: Darvocet, Vicodin, tramadol.; Darvocet, reaction(s): "Known allergies: Darvocet", notes: Known allergies: Darvocet, Vicodin, tramadol.; Vicodin, reaction(s): "Known allergies: vicodin", notes: Known allergies: Darvocet, Vicodin, tramadol. The following information was reported: PAIN (non-serious), outcome "unknown", described as "aches"; NAUSEA (non-serious), outcome "unknown", described as "nausea".  No follow-up attempts are possible. No further information is expected.
Hand tremor; BP 167/78; 156/78 (pulse 84, 78). Advised to f/u with PCP regarding high BP.
right arm hurt for 2.5 days after the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (right arm hurt for 2.5 days after the injection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included Cataracts, Carpal tunnel syndrome, Tinnitus and Ear injury (Busted ear drums (years ago)). Concurrent medical conditions included Diabetes, Inflammatory arthritis, Blood pressure high, Kidney disorder, Heart disease, unspecified, Allergy NOS and Thyroid disorder. Concomitant products included INSULIN for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (right arm hurt for 2.5 days after the injection). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pain, at an unspecified dose and frequency and ALCOHOL (topical) for Vaccination site pain, at an unspecified dose and frequency. On 28-Feb-2021, VACCINATION SITE PAIN (right arm hurt for 2.5 days after the injection) had resolved.        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.   Historical condition included other health issues (unspecified).   The right arm hurt for 2.5 days after the injection. The patient was treated with Tylenol and massaged arm with clear rubbing alcohol. The patient reported right arm hurts 90% of the time and stated it is possibly due to diabetes (onset date unknown).  The patient received the flu shot yearly. She stated she takes a lot of medications daily (did not report the names of the medications), including Insulin. She stated that she doesn't consider herself immunocompromised, but stated she is high risk for COVID-19 infection.     This case was linked to MOD-2021-325019 (Patient Link).
FLU; NAUSEA; FEVER 102; GENERALIZE ACHES AND PAIN; This spontaneous report received from a consumer concerned a 50 year old. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included ethnicity background. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) 0.5 ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-MAR-2021, the subject experienced flu. On 08-MAR-2021, the subject experienced nausea. On 08-MAR-2021, the subject experienced fever 102. On 08-MAR-2021, the subject experienced generalize aches and pain. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu, nausea, fever 102, and generalize aches and pain. This report was non-serious.
Shortness of breath, Aching muscles/body, extremely high heart rate, feverish chills, dizziness, painful to swallow, dry mouth and sleeplessness.
Neuroendocrine tumor - operation - Laparoscopic right hemi-colectomy. Recovery in hospital. Hospital admission within 6 weeks of receiving the COVID vaccine.
The Anthrax shot along with the smallpox shot was given on Sat. Feb. 8th. I developed a slight headache. Sunday my arm with the anthrax started itching and was getting red. By Sunday evening my arm was feverish, swollen from the elbow to about two inches below my shoulder. The swelling almost wrapped around my arm with a two inch gap. I could feel a lack of circulation developing in my arm. My arm was very red in color. This continued until I seeked treatment on Tuesday by the same medical facility. They gave me 800mg. motrin and cephrin(something like that) for the itching. Within two days the swelling went down but I still show some signs of a little redness on my skin. And the feeling came back and the fever went away.
Severe itching on her left arm at injection site down to her elbow 24 hours a day. It had gotten worse.; Redness on her left arm at injection site down to her elbow 24 hours a day.  It had gotten worse.; 2nd dose-25 Feb 2021 and 3rd dose-09 oct 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose-25 Feb 2021 and 3rd dose-09 oct 2021), VACCINATION SITE PRURITUS (Severe itching on her left arm at injection site down to her elbow 24 hours a day. It had gotten worse.) and VACCINATION SITE ERYTHEMA (Redness on her left arm at injection site down to her elbow 24 hours a day.  It had gotten worse.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose-25 Feb 2021 and 3rd dose-09 oct 2021). On 10-Oct-2021, the patient experienced VACCINATION SITE PRURITUS (Severe itching on her left arm at injection site down to her elbow 24 hours a day. It had gotten worse.) and VACCINATION SITE ERYTHEMA (Redness on her left arm at injection site down to her elbow 24 hours a day.  It had gotten worse.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form; AVENA SATIVA FLUID EXTRACT  at a dose of 1 dosage form and CORTISONE at a dose of 1 dosage form. On 09-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose-25 Feb 2021 and 3rd dose-09 oct 2021) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Severe itching on her left arm at injection site down to her elbow 24 hours a day. It had gotten worse.) and VACCINATION SITE ERYTHEMA (Redness on her left arm at injection site down to her elbow 24 hours a day.  It had gotten worse.) outcome was unknown.            No concomitant medication was provided.      Treatment medication include  Non-drugs treatment Icepacks   This case was linked to MOD-2021-350376, MOD-2021-350425 .
Patient has reported feelings of "brain fog".  Additionally, she has reported a heavy menses with clot/s following the vaccination followed by amenorrhea.
This is a spontaneous report from a non-contactable consumer (parent's patient). This consumer reported similar events for 2 patients. This is the first of two reports. A 16-month-old male patient received PREVNAR 13 at single dose for immunization on unknown date. Medical history and concomitant medication were unknown. On unknown date the patient experienced pneumonia with fever spiked about 105. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017113222 same reporter/different patient, same product, same event.
I received my second dose on March 4 at approximately 1:50 pm.  Approximately 12 hours after the second dose of the vaccine I developed chills, a fever - 100.4,  body aches and a severe headache. I took one extra strength Tylenol tablet 20 hours after the injection followed by one Tylenol tablet every 6 hours during the day (3/5/21) until bedtime when I took one Aleve tablet. The symptoms improved the next morning with my temperature returning to normal. On March 6 my upper left arm developed a rash from the injection site down my arm almost to my elbow. It is itchy and red and fells warm to the touch. This rash also developed 2 weeks after my first dose of the vaccine.
Got flu vaccine and PPD on 10/8/07 about 11am,  Around 1pm noticed red spots around abdomen area, spreading to back, no itching, no swelling, no difficulty breathing.  Rash gone by morning of 10/9/07
I started feeling sick on 03/23/22 and 03/25/22 was when I went to the urgent care and had a telehealth appointment. I haven't been sick for awhile. 03/23/22 I woke up with throat ache but I didn't think much of it because I have seasonal allergies. I went about my business but by the next day my throat was hurting more and I was looking into getting medical attention. That Friday 03/25/22 I went to the urgent care and they said it sounded like an upper respiratory infection and to make a telehealth appointment. I made that appointment and told Doctor what was going on and he prescribed Cipro and after the labs came back he said I had a throat infection and that I should take the medications. I took that medication and I missed work for 2 days because I wasn't feeling well and the side effect from the medication made me fatigued so I rested. I finished the medications and I feel good so far. I haven't had much interaction with people outside of my household and I wear masks and I haven't been sick and this is the first time I've been sick.
Sever pain all the way down arm and swelling at injection site to size of grapefruit- 24 hours after swelling is down but still present, pain is improved but still present.
Reporting for myself, one person.  Moderna Covid Vaccine:  I had many symptoms to the 2nd vaccine (Fever, itchy lower arm of the shot, chills, headache, dizzy, achy, 2nd day nausea and abdominal cramping, tired, 2nd night marked bed sweats).  The symptom that concerns me most that I'd not heard about or expect was a neurological tingly twitchy feeling in my head, neck, and throat area.  On day one, I did feel a subtle tingling in my throat/chest area.  It was more noticeable  on day 2 with about 4 or 5 neurologically-twitchy-feeling events.  Day 3, which is today, is particularly noticeable, feeling ongoing.
began itching around waist, then spread to lower back where a large area had small raised bumps, more larger bumps have appeared over the past week in various areas, itching on stomach and under breast area - itching only on body, not arms or legs
Myalgia, Fever, Fever, fatigue, was in bed all day with flu like symptoms the day after vaccine Narrative:
Patient described arm tingling after 15 min, following by itching in throat after 30min. patient left at 5:30 declining emergency services and Benadryl administration due to additional observation time needed. Patient stated she would seek emergency care if needed.
pt recv vax & devel a fever & a rash on torso, extremities & face;no prescription drug tx was required;pt recovered;
Case number PHEH2015US003134 is an initial spontaneous report received from a nurse on 10 Feb 2015. This report refers to a 10 years old patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. On 14 Jan 2015, MENVEO (batch number: M14071, expiry date: Nov 2015) was at 0.4 degree Celsius for 1 hour and 16 minutes and the patient received 0.5 ml intramuscular dose of this frozen vaccine with excursion on 20 Jan 2015. The vaccine had two more other excursion as follows: on 24 Jan 2015, the vaccine was at 0.8 degree Celsius for 36 minutes and on 31 Jan 2015 the vaccine was at 0.6 degree Celsius for 35 minutes. No adverse events were reported following the maladministration.
7 Days after getting the vaccine I got a red, itchy, warm to the touch round rash just below the injection site.  It was similar to a bee sting or bug bite, and was mostly gone after 24 hours.
Patient experience slight swelling, redness then oozing with pain. It would scab, then fall off. It took 2 weeks to heal and scarred.
Child had a temperature of 105.3.  Got bright red, clenched his muscles and was shaking.  Was taken to ER were he was diagnosed with a febrile seizures.  Had a few "small" seizures while in the ER.
Patient c/o "feels some dizziness in head" while sitting in Covid Monitoring area; post 1 st dose Pfizer vaccine, administered est. time of 10 minutes prior. Assisted to monitoring cot into semi reclined position. Is alert, talking with no visible distress. 1317 Vitals 124/76, O2 sat 99%, P 71. Pt. mother at side. Notes allergy to PCN with no other health issues; does have speech impediment. 1318 notes continued feeling of dizziness and SOB with mask on; mask lower below nares: encouraged to deep breathe slow. 1318 EMS called. 1230 Vitals O2 sat 100%, P - 68. No noted skin rash / redness, denies itching and no tongue / lip edema. Remains alert and responsive to staff questions. 1322 Vitals - B/P 117/70, P 70, O2 sat 99%. 1325 EMS arrived. Pt notes decrease dizziness / SOB with P - 67 & O2 Sat 99%. 1328 EMS assessment in progress; O2 sat 99%, P 71. 1332 Pt transported from site via stretcher with EMS and mother at side.   Patient left without being seen in the Emergency Department
Body aches, extreme fatigue, breathing is not difficult, but feels like when you have been walking outside in the cold for a prolonged period of time, elevated rest heart rate of 116
Pt recvd Td vax & devel redness, warmth, swelling & pain @ inject site; abscess formed & required incision & drainage by a surgeon; no cult done;
The day following vaccine administration, patient developed knot at vaccine and rash, which is still present.
My hip was hurting and progressed from there and on my right leg. Everything started hurting. It was the worst I ever felt. Usually my arthritis it will go away and tolerable and this time it was more painful. Pain medication did not work with Tylenol. Doctor thought it was COVID. 11AUG2021 - PCP. 16 and 11 AUG2021 COVID Test. 19Aug2021 - more intense arthritis. Diagnosis was Trochanteric Proctitis. appointment soon for rheumatoid arthritis and got negative test. Had COVID in Dec, 2020. I am better but not completely back to normal. Still having trouble with my hip. 3rd dose - 9/2/2021.
FEELS AWFUL; CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced feels awful. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feels awful, chills, and fever. This report was non-serious.
This case was reported in a literature article and described the occurrence of diarrhea in a child unk subject who received Rotavirus vaccine. On an unknown date, 14 days after receiving Rotavirus vaccine, the subject developed diarrhea (Non-serious). The outcome of diarrhea was unknown. It was unknown if the investigator considered the diarrhea to be related to Rotavirus vaccine. Relevant Tests: An enzyme immune-assay of a stool sample was negative for Rotavirus antigen. Additional information received: This case was reported in a literature article and it described the occurrence of diarrhoea in a child of unspecified gender and at least 8 months old, who had received an unspecified Rotavirus vaccine (manufacturer unknown). The patient had been enrolled in a post-marketing vaccine effectiveness study that excluded children with a severely immunocompromising condition. No further information on the patient's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, the patient received 1 dose of an unspecified rotavirus vaccine (oral, dosage unknown; batch number not provided). On an unspecified date either between January and June 2010 or between January and June 2011, at least 14 days after the administration of the vaccine, the patient developed acute gastrointestinal symptoms defined by the authors as at least 3 looser-than-normal stools in a 24-hour period during the illness and the onset of the diarrhoea within 10 days of presentation to hospital. It was unknown if the patient was admitted. An enzyme immune-assay of a stool sample was negative for rotavirus antigen. Treatment was unknown. The outcome of the event was unspecified. The authors did not comment on any causal relationship between the vaccine and the event. The authors concluded that "This evaluation demonstrates that monovalent Rotavirus vaccine was highly effective in children against severe Rotavirus disease during at least the first 2 years of life, and confirms the high effectiveness of the pentavalent Rotavirus vaccine". This case is 1 of the 2 valid cases reported in the same literature article (see case US2014GSK051977).