chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Reported feeling dry throat and tightness.  History of anxiety. No shortness of breath.  No interventions. Left in stable condition at 12:35 p.m.
Intense pain in the arm that was injected. When I woke up the next morning I couldn't lift my arm without pain so bad I was getting chills, feeling lightheaded, and nauseous. After Tylenol the pain lessened a little but I still can't fully extend it or hold anything remotely heavy.
This case was reported by a nurse via call center representative and described the occurrence of injection site redness in a 24-year-old female patient who received FLULAVAL quadrivalent (batch number 93T79, expiry date 30th June 2016). On 21st October 2015, the patient received FLULAVAL quadrivalent (intramuscular). On 21st October 2015, less than a day after receiving FLULAVAL quadrivalent, the patient experienced injection site redness. On an unknown date, the outcome of the injection site redness was unknown. The reporter considered the injection site redness to be almost certainly related to FLULAVAL quadrivalent. Additional details were received as follows: This case was previously not reported to anyone. The patient received FLULAVAL quadrivalent in right deltoid. The patient experienced injection site redness approximately 3 to 3.5 cm.
Patient had normal liver panel levels prior to booster; then on 9/9/2021, liver enzymes became extremely elevates; patient diagnosed with Hep B hepatitis; also, patient had to have bladder cancer surgery postponed due to this;  staging scans prior to booster were clear from mets; after the booster in october, restaging scans showed mets!!!
About 4 hours later I began have tightness in my abdomen and cramping, followed by gastrointestinal upset and diarreha and pain in my upper abdomen. I will wait and see if it resolves by tomorrow before going to the hospital for care.
Had 2 Moderna vaccine got covid so no need for booster; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Had 2 Moderna vaccine got covid so no need for booster) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had 2 Moderna vaccine got covid so no need for booster). At the time of the report, COVID-19 (Had 2 Moderna vaccine got covid so no need for booster) outcome was unknown.            Concomitant medications details were not reported.  It was reported that the patient had received 2 moderna vaccine and got COVID, so patient does not wanted to take the booster dose. Besides that the patient know some people that had major problems after receiving the booster dose of Pfizer biotech vaccine.  No treatment information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns patient of unspecified age and gender with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 which occurred in context to second dose of mRNA-1273 vaccine. Latency cannot be assessed since vaccination date was not disclosed. No additional details of clinical course, concomitant medication was provided. The event outcome was unknown. Ongoing pandemic remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns patient of unspecified age and gender with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 which occurred in context to second dose of mRNA-1273 vaccine. Latency cannot be assessed since vaccination date was not disclosed. No additional details of clinical course, concomitant medication was provided. The event outcome was unknown. Ongoing pandemic remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
101 fever (8hours after injection), severe chills so bad they felt like seizures , bladder infection, vomiting , golf ball size lump under right arm, double vision, bloody mucos in nose, headache, earache, sore throat
The first 24 hours after the injection, I had the expected symptoms - feeling "flu-ish" and rash at injection site.  But what I'm opening this about started 16 days after my second injection. Not sure it it's related but the dr asked me to report it because he thought it was. My reaction is in my right arm (the opposite of the one with the shot) and there's no visible rash or swelling but it's been very itchy and a bit painful (tingly and a tad bit numb). This is in my forearm all the way through my fingertips.
5-year-old child; Extra dose administered; Vaccination Error; No Adverse Event; This case was retrieved during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2456155-1. The original narrative from the sender is the following:  Patient presented with caregiver to school health clinic for vaccine update. Immunization record indicated child was due for DTaP, IPV, MMR, Varicella. Child received Vaxelis (DTaP, IPV, Hib, and Hep B), IPV, and ProQuad (MMR, varicella) at 0900 on 9/23/22. No signs or symptoms of local or systemic reaction immediately noted after immunization administration in office. Vaccine error was noted by provider at 1000. Medical director for school clinic was notified of event. Caregiver contacted by phone at 1053 and was notified with vaccine error, potential local/systemic reactions, instructed to monitor and report known adverse reactions, provider contact information, and plan to follow up by phone in 48 hours. No adverse reactions reported by caregiver at time of phone call.  Due to the nature of events the causal relationship between Vaxelis and "Extra dose administered, Vaccination error, and No adverse event" was not applicable.  No further information is expected.
Coming down with shingles on their faces; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (Coming down with shingles on their faces) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Coming down with shingles on their faces). At the time of the report, HERPES ZOSTER (Coming down with shingles on their faces) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-036048, MOD-2021-036048 (Patient Link).
Approx. 4:00 pm on 7/13 was walking on river bank and slipped. Mom didn't witness him hitting his head. After sitting for a minute started shaking all over for a few seconds No LOC. He would not respond to mom or EMS personnel
fever of 103-104 x 2 days; devel a cough; PE neg;
Narrative:  COVID infection following COVID vaccine series 01/12, Pfizer, dose #1 02/03, Pfizer, dose #2 09/23, Pfizer, dose #3 12/21 COVID swab, result: detected 12/21 pt cc: fatigue, sore throat, exposure: unknown
Monovalent Pfizer vaccine was administered in error instead of the Bivalent Booster dose
vomiting; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administration date 18May2021 (Lot number: EW0179, Expiration Date: 31Aug2021) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Prediabetic", start date: 2021 (ongoing); "Cervical Cancer", start date: 2020 (ongoing); "Pre COPD", start date: 2021 (ongoing), notes: Pre COPD. Concomitant medication(s) included: LEVONORGESTREL, start date: 26May2020 (ongoing); SPIRIVA HANDIHALER, start date: 16Apr2021 (ongoing); ALBUTEROL SULFATE, start date: 06Apr2021 (ongoing). The following information was reported: FATIGUE (non-serious) with onset 18May2021, outcome "recovered" (21May2021), described as "tiredness"; VOMITING (non-serious) with onset 19May2021, outcome "recovered" (20May2021), described as "vomiting". Therapeutic measures were not taken as a result of fatigue. No follow-up attempts are possible. No further information is expected.
24-36 after injection, hives appeared on inner thighs, upper arms (tricep area, underarm), all over my glutes. Have taken Benadryl will no effect. Still have hives/rash in same area, not going  away. Just seem a lot larger and increased itching
numbness of upper left side including left eye. Difficulty walking, moving, getting out of bed due to scarce muscle strength. swelling of the site (COVID ARM) 4" in diameter, hard, rash,  itchy, sore + pain if touched. No overall swelling warmth at the injection site Fatigue - Slept for the majority of 36 hours. Woke only to eat a little & attend to pets Headache - began shortly after the vac but grew & continued despite taking meds. mental fog Back and forth mild fever switching to chills
Erythematous macular popular rash (like dew drop on rose pedal) noted on multiple body surfaces - consistent with varicella rash in the absence of additional constitutional sxs
splotchy rash on torso, arms, legs, and back; super super tired; fuzzy tongue which comes and goes; sides of her tongue feels weird; she has to be more deliberate when she speaks; could not get muscle testing to work; typing mistakes, reverses numbers and letters; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (splotchy rash on torso, arms, legs, and back), TRICHOGLOSSIA (fuzzy tongue which comes and goes), PARAESTHESIA ORAL (sides of her tongue feels weird), PEDANTIC SPEECH (she has to be more deliberate when she speaks) and MUSCLE DISCOMFORT (could not get muscle testing to work) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Stroke.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced FATIGUE (super super tired). On 15-Apr-2021, the patient experienced RASH MACULAR (splotchy rash on torso, arms, legs, and back). In 2021, the patient experienced TRICHOGLOSSIA (fuzzy tongue which comes and goes), PARAESTHESIA ORAL (sides of her tongue feels weird), PEDANTIC SPEECH (she has to be more deliberate when she speaks), MUSCLE DISCOMFORT (could not get muscle testing to work) and CONFUSIONAL STATE (typing mistakes, reverses numbers and letters). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Rash, at a dose of 1 dosage form. At the time of the report, RASH MACULAR (splotchy rash on torso, arms, legs, and back) had not resolved, TRICHOGLOSSIA (fuzzy tongue which comes and goes), PARAESTHESIA ORAL (sides of her tongue feels weird), PEDANTIC SPEECH (she has to be more deliberate when she speaks), MUSCLE DISCOMFORT (could not get muscle testing to work) and CONFUSIONAL STATE (typing mistakes, reverses numbers and letters) outcome was unknown and FATIGUE (super super tired) had resolved.            No concomitant medications were reported.  The treatment information was play music to help with the typing.
dizziness; Nausea; Not feeling well; Left arm pain; fever; Chills; Facial swelling; pain to neck; Muscle spasm in face (lips); This is a spontaneous report from a contactable consumer, the patient. A 23-years-old non- pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6207) via an unspecified route of administration in the left arm on 13Mar2021 at 14:00 (at the age of  23-years-old) as a first dose for COVID-19 immunisation. The patients medical history included diabetic, arthritis, fibromyalgia, High blood pressure, neuropathy and Gastrointestinal (GI) problems. Patient was allergic to Benadryl and certain anaesthesia. Concomitant medication taken within two weeks included ADVIL, HUMALOG, aspirin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), FURMIDE, gaba (MANUFACTURER UNKNOWN) all taken for unknown indications from unknown dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 13Mar2021, at 14:30 the patient developed dizziness, immediately after dizziness patient had nausea, the patient was not feeling well and had left arm pain, fever, chills, facial swelling and pain to neck and muscle spasms in face (lip). The facility where the vaccine was administered was reported to be other. No therapeutic measures were taken for these adverse events. The outcome of the events dizziness, nausea, was not feeling well, left arm pain, fever, chills, facial swelling, pain to neck and muscle spasms in face (lip) was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
CDC reports 5 yo experienced an episode of limpness & paleness 1-2 min duration followed by vomiting once & screaming episode p/receiving DTP/OPV immunization.
The patient received his vaccine at 6 pm, he stayed at our site until 6:25.  He reported throat tightness to mom in the next 5-10 minutes after they arrived home.  He returned to our site and was accessed.  He was stable and was given 50 mg Benadryl PO and ).3 Epi via Epi pen.  He was then transported to ER by ambulance for observation.  He was observed for 3-4 hours and was sent home with an EpiPen.  The ER did give one dose of 2 mg albuterol PO for reported stridor.
Vaccine brought on an acute episode of Myasthenia Gravis. About 20 minutes after vaccine I felt my symptoms start, right facial weakness and right arm tremors and weakness. When I got home about half hour after vaccine symptoms were worse and I could not swallow . I called 911 and was hospitalized for 12 days.
07/11/2021 ~5PM: Rapid heart beat while sitting tracked by FitBit device. Device reported 3+ combined hours of high and moderate intensity activity even though no activity occurred. Was home entire time either sitting or walking leisurely within home.  Highet BPM was 160+ 07/12/2021 ~10PM: Rapid heart beat up to approx. 114 beats per minute reported by FitBit device after leisurely walking around a store for approx. 15 minutes.
Extreme pain to the left arm.  Inability to move left arm. Fever.  All over joint pain. Nauseated. Confused.
she collapsed when she started to walk a few blocks; BP drops everytime; Adverse effect after having the Moderna Booster shot last 3weeks ago, around first week of November; nose started bleeding; difficulty of breathing; very very weak, cannot get up; can't get up; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (she collapsed when she started to walk a few blocks) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (she collapsed when she started to walk a few blocks) (seriousness criterion medically significant), BLOOD PRESSURE DECREASED (BP drops everytime), VACCINATION COMPLICATION (Adverse effect after having the Moderna Booster shot last 3weeks ago, around first week of November), EPISTAXIS (nose started bleeding), DYSPNOEA (difficulty of breathing), ASTHENIA (very very weak, cannot get up) and MOBILITY DECREASED (can't get up). At the time of the report, LOSS OF CONSCIOUSNESS (she collapsed when she started to walk a few blocks), BLOOD PRESSURE DECREASED (BP drops everytime), VACCINATION COMPLICATION (Adverse effect after having the Moderna Booster shot last 3weeks ago, around first week of November), EPISTAXIS (nose started bleeding), DYSPNOEA (difficulty of breathing), ASTHENIA (very very weak, cannot get up) and MOBILITY DECREASED (can't get up) outcome was unknown.            Patient was healthy before taking the vaccine.  No concomitant informations were reported.  No treatment informations were reported.  Company Comment: This case concerns a 74-year-old, female patient, with no reported medical history, who experienced the serious, unexpected event loss of consciousness. The event occurred  on unknown date after third dose of mRNA 1273 vaccine. The patient's blood pressure drops every time and she collapsed when she started to walk a few bloocks, she consulted the emergency room where tests were done but all were normal. Patient is said to see a cardiologist for the events. The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 74-year-old, female patient, with no reported medical history, who experienced the serious, unexpected event loss of consciousness. The event occurred  on unknown date after third dose of mRNA 1273 vaccine. The patient's blood pressure drops every time and she collapsed when she started to walk a few bloocks, she consulted the emergency room where tests were done but all were normal. Patient is said to see a cardiologist for the events. The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Headache, Myalgia, second dose: day 2 - headache, general body aching, chills Narrative: second dose: day 2 - headache, general body aching, chills
10 days after my vaccine I have a large itchy red rash on my arm that is very large  and is swollen a little bit and tender to the touch.
Information has been received from a physician conerning a 12 year old male with no known drug allergies who on 07/09/2002 was vaccinated with a dose of hepatitis A virus vaccine inactivated.  There was no concomitant medication.  On 07/12/2002 the patient experienced diarrhea.  As of 07/29/2002, the patient's diarrhea was still present.  Unspecified medical attention was sough.  Additional information has been requested.
Redness; Fatigue; SWELLING; Tenderness at injection site; A spontaneous report was received on 15-FEB-2021, concerning a female patient of 80 years old, stated she experienced adverse event with the use of mRNA-1273 as prophylaxis for COVID-19 infection.   The patient's history was not reported.    The patient took second dose of Moderna COVID-19 Vaccine on 13-FEB-2021 in the patient's left arm intramuscularly for COVID-19 infection. Lot no:031L20A was provided.    After the vaccine administered, patient experienced sudden redness spot at the Injection site. The patient noticed redness, fatigue, swelling and felt resolved at present. Also, had diarrhea on and off after the vaccine administered, but not so sure of it.   Concomitant medications were not provided.  The outcome of the event was Unknown.  Consent given for Safety follow-up with patient.  The action taken for the adverse events were not provided.
severe buring pain upon administration swelling and discomfort at site 8-12 hrs later 24-36 hrs later redness swelling and tiny white pustular lesions scattered over the red raised base- about 4.5-6 cm2 No fever chills or Lymph node involvement but did have pretty svere lowewr back pain concurrently
The pt experienced persistent pain after the 5th Anthrax shot, she experienced numbness throughout entire left arm. The pt also stated that the pain has not subsided even after taking Tylenol, aspirin. etc.
Developed severe muscle weakness as well as migratory arthritis for 1 week.  Improved with prednisone burst
Patient developed symptoms a few hours after flu - high fever - ongoing for 2 days - diarrhea - fatigue.
Noted arm lesion only after asked ? L arm induration 18x18mm, erythema 25x25mm.
STAFF DECIDED TO GIVE EACH OTHER INFLUENZA VACCINATION.  CHOSE WRONG DOSAGE FORM AND ADMINISTERED THE IM FORM INTRANASALLY. STATE NO ADVERSE EFFECTS INSTRUCTED TO REPEAT INFLUENZA VACCINATION AS SOON AS FEASIBLE
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 28-OCT-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L018501, expiry date-22-JUN-2017) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Compliant (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Low Grade fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low Grade fever) and CHILLS (Chills) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PYREXIA (Low Grade fever) and CHILLS (Chills). At the time of the report, PYREXIA (Low Grade fever) and CHILLS (Chills) outcome was unknown.            No concomitant products were reported.  On unknown dates, the patient experienced bruise on thigh, going threw menopause, forgetfulness, anxiety, plaque psoriasis flare up, headache and fatigue. In 2021, the patient experienced low grade fever, chills and feeling like having the flu. Moderna covid-19 vaccine (covid-19 vaccine mrna (mrna 1273)) was also considered suspect. The patient had headache and fatigue three to five hours after injection. previous injection caused bruise on thigh. going threw menopause. She had forgetfulness. had itchy scalp, anxiety. it was unknown if she was enrolled in a covid-19 vaccine trial. On 12-Mar-2021, she received 1st dose covid-19 vaccine manufactured by moderna. On 09-Apr-2201, she received 2nd dose covid-19 vaccine manufactured by moderna and 2nd shot caused low grade fever and chills. She described it as feeling like having the flu for 14 hours.  Causality for skyrizi  The reporter's causality for the event (s) of bruise on thigh, plaque psoriasis flare up, headache and fatigue with skyrizi  was a reasonable possibility. The reporter's causality for the event(s) of going threw menopause, forgetfulness, anxiety, low grade fever, chills and feeling like having the flu with skyrizi was no reasonable possibility.  No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna