chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain, limited range of motion in left shoulder. Numbness, pain and tingling radiating from left shoulder down arm to left hand. Pain, numbness to left shin area radiating down to foot on left side only.
pt recv vax & reported feeling sick w/aches & flu like sx;told to see MD if sx got worse;
Client received J&J on 4/12/21 and on the health screening disclosed she had not received any other Covid-19 vaccines.  On the day the Pfizer vaccine was given, the VIIS system, was not working and we were not able to check record status.  The client was given one dose of 0.3ml of Pfizer.  No adverse reactions during 15-30 minute client observation waiting period.   It was not until a random check was done 7/13/2021 that this event was noted.
Severe flu like symptoms, body ache, fatigue, hot/cold flashes. Temperature is 102.5 Dizziness Nausea
rash around site 8 days later/ second the next day had rash around site on 3/6/21 that continues
2 hours after vaccine, Pt noticed redness, swelling at injection site. It was also warm to the touch. This did go away on 9/28/21 she noticed redness, swelling at injection site and warm to the touch again. Patient says she has no fever, No other sx. As of 9/29/21, reaction is still there.
itching left imprint of plaque; itching left imprint of plaque; ulcerative colitis flare up; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4152990-00.  A 35 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Jan2021 (Batch/Lot number: unknown) at the age of 35 years as dose 1, single and intramuscular, administration date 12Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COLITIS ULCERATIVE (medically significant) with onset 2021, outcome "recovered" (2021), described as "ulcerative colitis flare up"; SKIN PLAQUE (non-serious), PRURITUS (non-serious), outcome "not recovered" and all described as "itching left imprint of plaque". The action taken for adalimumab was unknown.  The reporter considered "ulcerative colitis flare up" and "itching left imprint of plaque" not related to bnt162b2.  Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for adalimumab: The reporter's causality for the events of itching left imprint of plaque unknown onset was not provided. The reporter's causality for the event of ulcerative colitis flare up with humira was no reasonable possibility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and Ulcerative colitis, Skin plaque, Pruritus cannot be completely excluded.  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.
Severe swelling to lips; Two large ,areas of swelling to both jowls, slight swelling to NLF; Two pinpoint bruises to NLF, one bruise to left top lip, 2 bruises to left lower lip and 1 large bruise to right lower lip 3 hrs post injection.; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Severe swelling to lips), SWELLING (Two large ,areas of swelling to both jowls, slight swelling to NLF) and CONTUSION (Two pinpoint bruises to NLF, one bruise to left top lip, 2 bruises to left lower lip and 1 large bruise to right lower lip 3 hrs post injection.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII in September 2020. Concurrent medical conditions included Hypertension, Thyroid disorder, Penicillin allergy and Sulfonamide allergy. Concomitant products included LISINOPRIL and AMLODIPINE for Hypertension, HYDROCHLOROTHIAZIDE and LEVOTHYROXINE for Thyroid disorder.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (Severe swelling to lips), SWELLING (Two large ,areas of swelling to both jowls, slight swelling to NLF) and CONTUSION (Two pinpoint bruises to NLF, one bruise to left top lip, 2 bruises to left lower lip and 1 large bruise to right lower lip 3 hrs post injection.). The patient was treated with METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) on 08-Jul-2021 for Swelling, at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Severe swelling to lips), SWELLING (Two large ,areas of swelling to both jowls, slight swelling to NLF) and CONTUSION (Two pinpoint bruises to NLF, one bruise to left top lip, 2 bruises to left lower lip and 1 large bruise to right lower lip 3 hrs post injection.) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Restylane Defyne into marionette lines and Restylane Kysse into the lips (Lot numbers and exp. Unknown) on 8/6/2021 and developed severe swelling to lips, two large areas of swelling to both jowls, slight swelling to NLF.Two pinpoint bruises to NLF, one bruise to left top lip, 2 bruises to left lower lip and 1 large bruise to right lower lip 3 hrs post injection. She reported that she had taken ibuprofen prior to injections. She reported no illnesses in month prior to treatment and no dental procedures in last 6-12 months.
12/12/2021 I woke up with symptoms presenting congestion, trouble breathing, no fever, body aches, and extreme weakness. I felt as though I was going to die. No loss of sense of taste or smell. I woke up the next day feeling better, and on the 13th 2021 I got a COVID-19 test and then I came home and it was positive. I then got better slowly however would not have a lot of strength. It lingered for about 2 weeks. After that I felt much better however, and I didn't feel extremely well until mid January. I did have a virtual visit with my doctor in December and stated to stay hydrated and take Tylenol.
Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from non-health care professional (office staff). This case is linked to cases 2018SA256146 and 2018SA256161 (same reporter). This case involves an 87-year-old male patient who was vaccinated with a 0.5 ml expired dose of FLUZONE HIGH DOSE (Batch number: UI868AA, expiration date: 03-May-2018, dose in series, and site of administration were not reported) via intramuscular route on 04-Sep-2018 in the left arm. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. The patient had no adverse event following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Arm became swollen from shoulder to elbow.  Red blotch 3" by 2" formed that was stiff and hot to the touch.  Low grade fever below 100 degree.  Symptoms lasted for 4 days despite elevating, cool compresses and TYLENOL. Swelling was in the right arm.
Pt was given an expired vaccine. Vaccine expired 10/03/2021.  Vaccine to be re-administered as this dose is invalid.
The day after I received the vaccine I started having tingling in my feet and legs. By the fifth and sixth day I started having a burning sensation across my back, my legs and my feet.
Information has been received from a 23 year old female who on 18-JUN-2008 was vaccinated with the thirds dose of GARDASIL vaccine (yeast) (lot not reported). Concomitant therapy included hormonal contraceptives (unspecified). "A month after vaccination" the patient experienced pain and swelling at the injection site. The patient's pain and swelling at the injection site persisted. No further information is available.
Moderna COVID?19 Vaccine EUA Muscle and joint soreness Fever Chills Nausea  Headache
Post-vaccination evaluation:  Pt waiting in waiting area after receiving Pfizer vaccine 5 minutes prior.   Reported nausea.  Brought back to vaccine area, pt was sat in chair, cool cloth applied to back of neck.  Alcohol wipe given to help nausea.   Pt reports itching on chin, neck and chest.  No rash noted.  Vital signs taken B/P 110/85, pulse 95, O2 sat 100%,  R18.  Pt produced emesis of 100 ml of  drainage.  Pt continues to report nausea and itching.  Cool clothes applied, feet elevated.  Pt produced another 100 ml of emesis.  Pt given ice to back of neck.  States nausea easing up.    18:35 - patient continues to itch abdominal area.  No rash noted. Instructed to call PCP tomorrow to determine if second vaccine should be given.   18:38.  Pt discharged to significant other.  Ambulates with assistance of significant other.   Patient and SO instructed to proceed to ER if symptoms progress or if has any involvement with respiratory. Patient stated itching and nausea was improving.   30-45 minutes:  - Patient does exhibit signs and symptoms of adverse reaction to the vaccination.  - Plan for follow up: Patient will follow up with PCP and allergist.  Patient waiting to schedule 2 nd dose at this time
Pain and swelling at injection site immediately after and through the time of this report. Full body muscle aches overnight. Nausea, fever, fatigue, and muscle aches through time of this report (ongoing).
Patient / received only the liquid component of Menveo vaccine; Patient / received only the liquid component of Menveo vaccine; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 15-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA419A, expiry date 31st August 2022) for prophylaxis.   On 29th June 2021, the patient received Menveo. On 29th June 2021, unknown after receiving Menveo, 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 details were provided as follows: The reporter stated that, patient who received only the liquid component of Menveo vaccine, it was administered on the same day as reported it. The reporter consented to follow up.
Redness, swelling, hot. Recommend: Ice pack, BENADRYL and NSAID.
During patient's well check on his 21 months old well check, he was given the INFs pres free 3yr-adult Influenza vaccine while he was supposed to get the INFs pres free 6-35m Influenza vaccine. Shortly after he received the over-dosed vaccine, he started acting very differently than before such as losing social skills and self-stimming.  When we found out he was over-dosed with Influenza, we talked to his pediatric, we found that doctor put the correct order but nurse might give the wrong influenza.
got the flu; Initial information was received on 17-Jan-2023 regarding an unsolicited valid social media non-serious case received from a consumer via global digital media.  This case involves an unknown demographics patient who got the flu while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, route, batch number and expiry date: unknown in unknown administration site for prophylactic vaccination.  On an unknown date the patient had got the flu (influenza) (latency: unknown) following the administration of influenza vaccine.  No lab data was reported.  Action taken: not applicable.  Corrective treatment: not reported  Outcome: unknown
Patient informed medical assistant that she was not feeling well after the administration of the immunization. Patient then passed out. A Code was called and a team was called in to assess the patient to ensure patients safety and wellbeing.
She knows of a person who died after the Moderna vaccines; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (She knows of a person who died after the Moderna vaccines) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (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.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company comment: This is a spontaneous fatal case regarding a patient of an unknown age and gender, with no reported medical history, who died after receiving a dose of mRNA-1273.222 bivalent vaccine (Original/Omicron BA.4/5). Vaccination date was not provided. Death occurred on an unknown date. Latency cannot be assessed. The cause of death was not reported. It is unknown if an autopsy was performed. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 .222 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-706003, US-MODERNATX, INC.-MOD-2023-706020 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706003:Case for women US-MODERNATX, INC.-MOD-2023-706020:Trackin only case for REPORTER; Reported Cause(s) of Death: Person who died after the Moderna vaccines
A 44-year old male patient received an injection of TETANUS TOXOID (manufacturer and lot number not reported). Approximately 9 years post-vaccination, he was diagnosed with generalized tetanus. The patient had a history of multiple shrapnel and gunshot wounds from military service, and had no history of neuromuscular disease. He worked as a contractor and had sustained many nail-related injuries over the previous years, including an accident 6 months prior to presentation when he drove a nail into his left ankle with a nail gun. He removed the nail with a crowbar and did not seek medical care; he could not remember a more recent injury. Approximately 4 weeks prior to presentation, the patient developed an itching sensation in his right calf, which ascended to his right leg and began to involve his left leg. He subsequently developed muscle spasms in his right calf, which were intensely painful, sudden in onset, and up to 10 minutes duration. One week prior to presentation, the spasms began to occur more regularly. He developed trismus, dysphagia, and laryngospasms, with one episode resulting in several broken teeth. He had frequent, sudden urges to urinate, and lost 20 pounds unintentionally. Upon presentation, he had left cranial nerve VI palsy, an exaggerated gag reflux, and a positive jaw jerk. The wound on his left ankle had healed. Normal strength and sensation were noted in all limbs, but muscle tone was increased. His patellar and ankle reflexes were "pathologically brisk", and he had bilateral positive Babinski signs. A CBC and comprehensive metabolic panel were within normal limits. Creatinine kinase was elevated at 1446 units/L. A lumbar puncture showed a protein level of 57 mg/dL in the cerebrospinal fluid, but no pleocytosis. Nerve conduction studies were essentially normal, except for the presence of afterpotentials following slow repetitive stimulation, suggesting peripheral nerve hyperexcitability. Needle electromyography studies were normal. Tetanus antibody levels were noted to be 2.78IU/mL (protective level defined as 0.01 IU/mL). The patient was diagnosed with generalized tetanus, and was admitted to the hospital where he was treated with baclofen, benzodiazepines, 5000 unites of human tetanus immune globulin, and a 7-day course of metronidazole despite the absence of an obvious wound site. At a 3-month follow-up visit, all of the patient's symptoms had resolved. The authors noted that the patient's antibody levels could reflect "either prior vaccination or immunostimulation from active tetanus". They also speculated that the patient's milder course of disease "may also have been related to his high level of antibody". Documents held by sender: None.
"Zoned out" and twitched. 3 separate episodes while father in law & his girl friend were watching (babysitting) him. On 9/6/13 similar espisode (x1) while in the care of mom's girlfriend, but she is not sure if he was just acting afraid because of the new environment and person he was with.
2ND DOSE OF VACCINE GIVEN TOO SOON. FIRST DOSE ADMINISTERED 7/14/21 SECOND DOSE GIVEN TODAY 7/29/21
HAIR LOSS (AROUND 3 INCH DIAMETER PATCHES OF HAIR LOSS); ASTHMA/WHEEZING; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user (very rare possible social occasions), non smoker, and asthma (Patient had asthma in elementary school which he had outgrown and lately since receiving the vaccine, he had to take an inhaler even when he was not exercising), and other pre-existing medical conditions included: Patient had no known allergies and had no drug abuse or illicit drug usage. Patient was pretty healthy and hardly ever get sick. Patient never had hair loss before and didn't have any history of hair loss in the family and never had covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 15-SEP-2021 for covid-19 prophylaxis. Age at time of vaccination 41 years old. No concomitant medications were reported. On 2022, the patient experienced hair loss (around 3 inch diameter patches of hair loss), and asthma/wheezing. Treatment medications (dates unspecified) included: salbutamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hair loss (around 3 inch diameter patches of hair loss), and asthma/wheezing. This report was non-serious.
3/16/2021 1330 Injection. No immediate adverse reaction. 1350 Discharged. 2100 Chills begin. 2200 Very mild nausea. 2230 Fever 98.9. (I usually run between 97.8 and 98.3). Also, mild joint and muscle aches (knees and shoulders).  3/17/2021 0100 - 0300 Nausea, retching, dry heaves, chills, sweats. Fever 99.7. 0300 - 0400 Unable to sleep. Would awaken with spasm of nausea upon nodding off. 0400 - 0430 Got to sleep, but woke with muscle cramps in both ankles. 0500 - 1000 Fitful sleep. 1000 - 2400 General muscle aches and low grade headache all day.  3/18/2021 0000 - 0500 Fitful sleep. 0500 - 0900 Restful sleep. 0900 Woke with just mild muscle aches. 1600 Side effects gone.  No medical treatment sought. One night of discomfort worth it for protection against COVID.
9/25/09 Chief complaint: right arm pain/swelling s/p flu shot. HPI: patient came in today because of pain and swelling of the right upper arm after she got a flu shot yesterday. Patient was doing well after injection and then about 4 hours after patient has noticed increasing pain on the right upper arm area, not from the injection site but the whole upper arm including the right shoulder area, armpit, right side of the neck, and shoulder area. Patient denies any systemic symptoms. No fever, chills, or any rash. Patient denies any pruritus. Patient is feeling better today than yesterday. The swelling on the under side of the upper arm as well as the armpit area has improved. The pain has improved as well. Patient has been taking over the counter and says. Patient had flu shots in the past without any problems. Patient has no chest pain, shortness of breath, or any active cardiopulmonary symptoms. Patient has no abdominal pain, diarrhea, or vomiting. Patient has no active GI or GU problems. Appetite good, no fevers, night sweats or weight loss. No chest pain, shortness of breath or peripheral edema. No cough, wheezing or dyspnea. No nausea/vomiting, abdominal pain, or change in bowel habits. No dysuria, urgency or incontinence. No MS changes, no motor weakness, no sensory changes. BP: 110/82, HR: 76b/min, resp: 16 r/min, temp: 98.2, height: 63 in, weight: 156 lb, BMI: 27.6 kg/m2, BSA calculated: 1.74, BMI calculated: 27.63. GENERAL APPEARNCE: appears stated age, well appearing, NAD. HEENT: PERRL, EOMI, TMs normal, oropharynx clear. R UE: positive warm, swelling and tenderness on the R deltoid area, injection site (puncture site), no evidence of infection or cellulitis; there is tenderness on the R shoulder area and inner aspect of the upper arm, there is some tenderness on the R armpit but no swelling or tenderness. NECK: supple, no JVD, no tenderness on spinous process, slight tenderness on the lateral aspect of the R neck (lower portion), ROM of the neck is nl. LUNGS: clear to auscultation and percussion. HEART: normal S1, S2 without murmurs, gallops, or rubs; PMI not displaced. ABDOMEN: NABS, soft, non-tender, without hepato-splenomegaly. EXTREMITIES: without clubbing, cyanosis, or edema, no acute jt inflammation or involvement. R SHOULDER: grossly nl, no acute inflammation, ROM is limited up to 120 degrees on abduction, forward flexion due to pain on the upper arm, rotational motion is nl. NEUROLOGIC: alert and oriented x 3, cranial nerves II-XII intact, motor/sensory exam normal, DTRs symmetric, normal gait. Assessment: adverse effect of drug therapy. Plan: patient has soft tissue inflammation secondary to flu shot. There is no evidence of cellulitis or infection. Cold compress for 24 hours and then after that warm compress continue NSAIDs. Monitor for signs and symptoms of infection, start BACTRIM if develops any cellulitis or infection return to clinic if any worsening symptoms on Monday and , both of the ear in the weekend if worsen starch range of motion exercise in 48 hours.
after 2 hours, migraine, no treatment after 4 hours, body aches, headache, fatigue: no treatment next day:  low grade fever, body aches, headache , diarrhea, fatigue:  No treatment Monday:  low grade fever, body aches, headache, diarrhea, fatigue:  no treatment Tuesday:  diarrhea, fatigue:  no treatment
Headache, Sedation, Myalgia, Fever, NauseaVomiting, Chills, pain at injection site Narrative: