chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2:30 pm pain in left breast and arm pit.  Around 3:30 pm slight headache lasting until 6:40 pm.  12:50 am woke to hot sweating and cold lightheaded and dizzy, nauseous and dry heaves.  Rash on shot spot and surrounding area. Skin peeling at bandage area. 11:00 am shot area sore.  Bandage area still a rash and slight peeling of skin.Dizziness is gone and nausea is gone.  No headache
Flu like symptoms, severe headache, severe joint pain and muscle pain, fever, extreme chills, coughing, swallowing, pain,  and itching of the injection site, chest pain, inner organ pain, kidney pain both, Extreme exhaustion or tiredness, foggy brain.
Pt experienced tingling at the injection site. She described it as though she had laid in her arm too long and it fell asleep. She went home. I followed up with her an hour later and she said she still had tingling but it wasn't worse or better.  She called me back about 15 minutes later and said the tingling stopped shortly after I got off the phone with her and that she feels fine now (just the usual sore arm).
01/24/22 presents to ED for "Breathing Problem". PMHx of "bladder cancer on keytruda, DMII, CAD, CKD"
Diagnosed with Dermatographia 10 days after receiving my booster shot (extreme hives, itching, red ears, uncomfortable scalp).
pt recv vax 1FEB96 & pt devel lesions all over body to include arms, legs, stomach, & back;the lesions were not so much around the inj site;MD reported that on 7FEB96 pt devel a re-activation of urticarial vasculitis pt had w/EBV infect;
Injection site pain from hour 6 of the day the vaccine was given (12/19/20) until day 3 (12/21/20).
10 minutes after vaccinated c/o large swelling at RD (injection site), hives spread to RLE, LUE, c/o itching all over body, c/o HA, pale and coughing.  Called 911, epinephrine 1:1000 (1/2 cc IM at LD), transferred to ER.
A few months after receiving the vaccine I started to experience brief heart palpitations.  At that time did not realize what it was that I was experiencing.  These sensations were very brief, random and were months apart.  In the last 6 months these sensations increased in frequency,  and intensity, starting to happen weekly.  On 1/23/2023 in the early morning (4:30) while at rest I experience the sensation again.  but this time my heart started to feel like it was pounding,  My heart rate elevated to 130 BPM and would spike to 150+.  This did not resolve.  By 7PM I went to the  Emergency Room.  I was diagnosed with Atrial flutter/fib.  The end result was needing a cardioversion, and now a life long medications of Metoprolol and Eliquis.
Patient started to feel light headed and sweaty approximately 5 minutes after receiving her vaccine. She lost consciousness for a few seconds and was weak and light headed after regaining consciousness.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an approximately 57-year-old patient with unknown gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or about 09-SEP-2015, the patient was administered the ZOSTAVAX vaccine at a pharmacy (strength, dose, route, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on or about 21-SEP-2015, patient was treated at a hospital and, then, by a doctor for the following injury resulting from ZOSTAVAX use: shingles. The outcome of shingles was not provided. The reporter considered the event to be related to ZOSTAVAX.
Body Ache; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body Ache), FATIGUE (Fatigue) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced MYALGIA (Body Ache), FATIGUE (Fatigue) and HEADACHE (Headache). On 29-Jan-2021, MYALGIA (Body Ache) and FATIGUE (Fatigue) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
I was ill with side effects about 4-6 hrs following the second dose with headache, fever 101.8 and fatigue. I felt fine the next day and at 7 am I went to give blood for my health insurance and I was told my BP was high 190+/85+ and repeat in second arm was similar. I was told to come back in a few weeks since my BP was high. I've never had high BP. I felt like my internal organs were inflammed and had random pain in the abdomen including a mild pain which felt like a costochondritis. I bought a BP monitor and it remained elevated for about 3 weeks, slowly went down and has been normal since. All the pains subsided around the same time. i continue t omonitor my BP and it has been normal (114/62 last check).  Nore : I am a career public health RN and am reporting because I understand the importance of vaccine monitoring especially for new vaccines. I have to say I am very healthy and this was unexpected for me. I did not visit the DR because I thought it may be from taking the ES Tylenol every 4-6 hr for the day for the side effects, something which I rarely do. Please contact me if you need additional info. I wish now I would have had the bloodwork done that day as it may have shown some irregularities supporting my symptoms. Unfortunately I have no testing or documentation. My subsequent annual bloodwork was normal (CHEM 20, CBC, AIC)
Headache, extremely bloodshot eyes, dizziness, fatigue, mild fever (100.5), pain in back of neck.
Patient was given the COVID Pfizer Bivalent instead of the COVID Pfizer primary series. The was no adverse reaction from the vaccines that were given. Provider notified the parent of the incident using the translator and that the patient will need to complete the primary series with a Pfizer monovalent, Then with in 2 months after completion of the primary series another bivalent dose.
Patient was inadvertently given an additional Hep B vaccine. He was given a PEDIARIX combo vaccine that included a Hep B as well as an additional Hep B at todays visit. The parents were alerted while in the office.
Client was vaccinated with Moderna vaccine for Covid on Feb 1 and March 1, 2021.  Symptoms started 10/25 after exposure to Covid + family member on 10/22 - chills, myalgia, headache, nasal congestion, cough.
His gums began to ooze/bleed; This spontaneous case was reported by a nurse and describes the occurrence of GINGIVAL BLEEDING (His gums began to ooze/bleed) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced GINGIVAL BLEEDING (His gums began to ooze/bleed). At the time of the report, GINGIVAL BLEEDING (His gums began to ooze/bleed) outcome was unknown.        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.   No concomitant medications provided.  No treatment medications provided.
pt wa given APAP around 7PM; t105 @ 945PM;given APAP again called ER & then took pt to ER states that temp down to 103 when got to ER & er gave Ibuprofen;
pt recv vax; six hrs later,devel rash consistent with erythema multiforme;
Breaking out - rash on back and sides,itching; Breaking out - rash on back and sides; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program. A 67-year-old non-pregnant female patient (at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration, administered in arm left on 26Feb2021 at 15:30 as single dose for COVID-19 immunization. The patient history included penicillin allergies. The patient concomitant medications were not reported. The patient had penicillin allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 26Feb2021 at 19:00, the patient experienced breaking out - rash on back and sides, itching. It was reported that she called the pharmacy where she received her first dose yesterday afternoon to report the side effects she experienced after taking the vaccine but was referred back to report. According to her, she experienced itching and rash on her back and side last night and she said that Benadryl took care of it this morning and the rash was gone. The outcome of the events was recovered in on an unspecified date.  Information on the lot/batch number has been requested.
Initial unsolicited report received from a consumer on 16 March 2016. This case involves a 73-year-old male patient who was vaccinated with a series (four doses) of Imovax Rabies from 12 February 2016 to 26 February 2016 and a dose of Imogam (batch number was unknown, route and site of administration was not reported for both vaccines) on an unspecified date at emergency room. The patient had a medical history of cataract Surgery and retinal surgery. The patient had allergies of sulfa medications, numerous food, mold and dust. Patient did not have illness at the time of vaccination. Concomitant medications were not reported. On an unspecified date, three weeks following the vaccination, the patient experienced eye problem for depth perception. The patient visited physician for evaluation and treatment. Lab data corrective treatments were not reported. The patient was not recovered from the event. Upon internal review, the company decided to consider the event serious due to important medical event: Altered visual depth perception. List of documents held by sender: none. Sender's Comments: This is a poorly documented case of eye problem for depth perception after vaccination with RABIES (HDC) VACCINE and PASTEURIZED HUMAN RABIES IMMUNOGLOBULIN. This is not a medically confirmed case. In this particular case patient had a history of cataract surgery and retinal surgery. No further details (indication of surgery), regarding retinal surgery has been provided. It was reported that consumer received the vaccines post exposure, so the rabies status in the animal would be helpful for assessment of the case. Further information regarding medical confirmation of the case, investigation results if any to rule out the alternative etiology are needed for complete assessment of the case. Based on the available information it is not clear whether the reported event is related to patient's medical history or is of neurological origin or vaccine related complication, hence no conclusion can be drawn for now.
stomach cramps; diarrhea; weak; lethargic; horrible headache; has no energy; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), ASTHENIA (weak), LETHARGY (lethargic) and HEADACHE (horrible headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), ASTHENIA (weak), LETHARGY (lethargic), HEADACHE (horrible headache) and FATIGUE (has no energy). The patient was treated with PARACETAMOL (TYLENOL) for COVID-19 vaccination, at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps) was resolving and DIARRHOEA (diarrhea), ASTHENIA (weak), LETHARGY (lethargic), HEADACHE (horrible headache) and FATIGUE (has no energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication reported
Initially numbness and tingling in bilateral lower extremities, weakness, then Lhermitte's sign, then complete numbness in left side of body, intense brain fog, trouble forming sentences, heat sensitivity. Had a series of MRI's done and lumbar puncture. Diagnosed with Multiple Sclerosis on July 16, 2021. Had no previous signs or symptoms. Also has irregular, prolonged, heavy menstrual cycle with immense clotting.
This case was reported by a physician and described the occurrence of lethargy in a 2-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline), Hib and HepB. Concurrent medical conditions included bradycardia, bronchopulmonary dysplasia, dyspnea, premature baby and reflux (nos). Concurrent vaccination included OPV; non-GSK manufacturer; unknown; unknown given on 16 April 2012; pneumococcal vaccines (non-gsk); manufacturer unspecified; unknown; unknown given on 16 April 2012. On 18 April 2012 the subject received 1st dose of INFANRIX (unknown, unknown thigh). On 17 April 2012 the subject received unspecified dose of Hib (unknown), unspecified dose of HepB vaccine (unknown). On 19 April 2012, 1 day after vaccination with INFANRIX, 2 days after vaccination with HepB vaccine and Hib, the subject experienced lethargy. A male subject, in the NICU (neonatal intensive care unit) was administered INFANRIX on 18 April 2012 one day later the subject experienced lethargy. The subject did not receive any vaccinations on the same day, but received PREVNAR and Polio on 16 April 2012 as well as Hib and HepB vaccine on 17 April 2012. The physician noted "he s on the lookout" for sepsis. At the time of reporting the lethargy was improved, the outcome of possible sepsis was unspecified. The physician considered the events were possibly related to vaccination with INFANRIX, Hib and HepB vaccine.
Shortness of breath, severe chest pain, troponin levels severely high - nitroglycerin administered on way to ER.
Pt recv 1 dose vax & exp "non painful,non red knot @inj site.Info recv that rxn occurred in 3 pt & all " recovered w/no sequelae"
Discharge Provider: Primary Care Provider:  Admission Date: 9/29/2022 Discharge Date: Oct 1, 2022  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute on chronic combined systolic and diastolic CHF (congestive heart failure) (HCC) [I50.43] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 75 year old female with PMHx of chronic systolic CHF, HTN, CKD3, CAD, A-fib who presented to the hospital with shortness of breath and cough. She was found to be COVID-19 positive in the ER and had hypoxia. Patient had a CXR showing bilateral infiltrates. However the patient also had a significantly elevated BNP and was given IV lasix along with remdesivir and decadron. Patient improved quickly and was able to be weaned to room air off her O2. Patient diuresed well. She was afebrile after admission. Given her quick improvement  (and symptoms only a few days) decadron was stopped as COVID-19 pneumonia was unlikely. Patient was kept and given 3 days of IV remdesivir. Patient was feeling much better at the time of discharge, she was breathing well on room air with no shortness of breath or cough, no fever. Patient was then considered stable for discharge home. Patient was instructed on signs and symptoms of when to return to the ER.
Given injection-walked away from counter-almost immediately felt a "rush" surging through body, from head to legs. Felt very dizzy & lightheaded - This "rush" & dizziness lasted a couple of hours. Had tightness in throat area & lower neck/upper chest area. Legs felt "weak".
Systemic: Seizure-Severe, Additional Details: Pharmacist was informed that she was uncomfortable with needles and blood, but had not had a severe reaction to any vaccine previously. RPh checked if she had fainted before and told her to sit for 15 minutes then will check on her and if she is lightheaded or dizzy extend to 30 minutes. RPh administered Janssen shot to patient and asked if she was okay. She confirmed then patient got up. Patient moved to another chair & started seizing. RPh and mother took care until well enough to get up.
Vaccine brand other=Moderna/ Vaccine administration date=06Nov2021/ Vaccine dose number=2; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 at 12:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Nov2021 as dose 2, single (Lot number: 091D21A), in left arm and on 13May2022 at 13:00 as dose 3 (booster), single (Lot number: 004M21A), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 31Mar2021 as dose 1, single (Lot number: 041A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR, start date: Aug2016; LEVOTHYROXINE, start date: Jul1999; LOSARTAN POTASSIUM, start date: Jul2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Vaccine brand other=Moderna/ Vaccine administration date=06Nov2021/ Vaccine dose number=2". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Atrial Fibrilation with heart rate of 130-140, no shortness of breath, no chest pain, no other physical symptoms beyond tachycardia....required ing dose of metoprolol tartrate  25 mg by mouth to resolve
Papules/vesicles in various stages of development all over body, including scalp.  Approx 20-25 lesions.  Diagnosis-Varicella Treatment-Acyclovir
Chest pain; High blood pressure reaction; Some itching on her arm and aching.; Some itching on her arm and aching.; Some itching on her arm and aching.; Terrible shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), HYPERTENSION (High blood pressure reaction), BLOOD PRESSURE DECREASED (Some itching on her arm and aching.), PRURITUS (Some itching on her arm and aching.) and PAIN (Some itching on her arm and aching.) in a 75-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 was provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), ISOSORBIDE MONONITRATE (ISOSORBID MONONITRATE), VITAMIN B12 NOS, MULTIVITAMINS [VITAMINS NOS], CALCIUM CITRATE and PARACETAMOL (TYLENOL) for an unknown indication, PARACETAMOL (TYLENOL).   On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced ARTHRALGIA (Terrible shoulder pain). On 19-Feb-2021, the patient experienced HYPERTENSION (High blood pressure reaction), BLOOD PRESSURE DECREASED (Some itching on her arm and aching.), PRURITUS (Some itching on her arm and aching.) and PAIN (Some itching on her arm and aching.). On 24-Feb-2021, the patient experienced CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain), BLOOD PRESSURE DECREASED (Some itching on her arm and aching.), PRURITUS (Some itching on her arm and aching.), PAIN (Some itching on her arm and aching.) and ARTHRALGIA (Terrible shoulder pain) outcome was unknown and HYPERTENSION (High blood pressure reaction) had resolved.            Action taken with mRNA-1273 in response to the events was not Applicable.  No treatment information was provided. The patient did not receive any treatment. Lab details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Outcome of the event hypertension(from unknown to resolved)was updated.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 26-MAR-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-FEB-2016, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed gabapentin for management of his symptoms and pain. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
very high fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (very high fever) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 PYREXIA (very high fever). At the time of the report, PYREXIA (very high fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment details included Tylenol   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: No New Information.
This spontaneous report as received from a healthcare worker and a nurse refers to unspecified number of patients. Medical history and concomitant medications were unknown. It was reported that, improperly stored doses of PNEUMOVAX 23 (single dose vials, route of administrations, dose, lot numbers and expiry dates were not reported) were given to unspecified patients on unspecified dates. No adverse experience was reported. No product quality complaint (PQC) was involved. Follow up has been received from a healthcare worker on 06-JUL-2015: It was reported that on 13-JAN-2014, the patient of unknown age and gender was vaccinated with improperly stored PNEUMOVAX 23 (Lot number: J005011, Expiry date: 04-DEC-2014). This is one of several reports from the same reporter. Additional information has been requested.
(L) upper arm redness, warmth. Tx: Hydrpxyzine 25 ml, hydrocortisone cream, ice on/off x 2d.