chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chronic headaches; threw up; continues runny nose; blood sugar out of whack; Pain; small cough; terrible fatigue; blood pressure out of whack; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (chronic headaches), VOMITING (threw up), RHINORRHOEA (continues runny nose), COUGH (small cough) and FATIGUE (terrible fatigue) in a female patient of an unknown age 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.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (chronic headaches), VOMITING (threw up), RHINORRHOEA (continues runny nose), COUGH (small cough), FATIGUE (terrible fatigue), BLOOD PRESSURE INCREASED (blood pressure out of whack), BLOOD GLUCOSE INCREASED (blood sugar out of whack) and PAIN (Pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HEADACHE (chronic headaches), VOMITING (threw up), RHINORRHOEA (continues runny nose), COUGH (small cough), FATIGUE (terrible fatigue), BLOOD PRESSURE INCREASED (blood pressure out of whack) and PAIN (Pain) outcome was unknown. Not Provided          No concomitant medications were reported.   Reporter did not allow further contact
Cellulitis of the left arm; Blisters; Left deltoid was super itchy; Barely slept; Intermittent flushing; Horrible headache; Felt exhausted; Body aches; Chills; A spontaneous report was received from a nurse concerning a 46-years old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) experienced cellulitis, chills, body aches, headache, flushing, exhaustion, itching at the injection site, trouble sleeping, and blisters.   The patient's medical history, as provided by the reporter, included shingles, hysterectomy, acid reflux, and allergies to penicillin and sulfonamides. Relevant concomitant medications included estrogen patch.   On 31 Dec 2020, the same day as the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   The patient developed pain in her left arm on 31 Dec 2020, which she treated with ice.  On 01 Jan 2021 she had chills, temperature of 100 degrees Fahrenheit (F), body aches, headache, and intermittent flushing.  She felt exhausted and her left deltoid became itchy, red, and there was a knot at the injection site.  On 07 Jan 2021 the injection site became more red, hot, painful, and itchy and she had a temperature of 99.4 F.  On 07 Jan 2021 at approximately 8:00 PM she presented to the emergency room where she was prescribed cefalexin.  On 08 Jan 2021 she applied ice and elevated the affected area.  On 09 Jan 2021 she developed bumps around the injection site that developed into blisters that began to weep.  On 11 Jan 2021 her temperature was 99.4 F.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events cellulitis, chills, exhaustion, itching at the injection site, had trouble sleeping, and blisters were not reported. The outcome for the event, headache, was considered recovered/resolved on 03 Jan 2021. The outcome for the event, body aches, was considered recovered/resolved on 04 Jan 2021. The outcome for the event, flushing, was considered recovered/resolved on 07 Jan 2021.; Reporter's Comments: This case concerns a 46-year-old female subject with medical history of shingles, hysterectomy, acid reflux, and allergies to penicillin and sulfonamides, who experienced a serious, unexpected event of cellulitis, and nonseries events of flushing, injection site pruritus and blister, insomnia, headache, fatigue, myalgia and chills. These events occurred within 1 week after the first dose of the mRNA-1273 study medication administration. Treatment for these events included cefalexin, with no reported outcome for the events of cellulitis, chills, exhaustion, itching at the injection site, insomnia, and blisters. The outcome of the events headaches, body aches, and flushing are reported as recovered/resolved. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient is fully vaccinated.  COVID  + on 12/8/2021.  Hospitalized 12/8-12/17.   Presented with dizziness,  Active problems: COVID, normocytic anemia, + d dimer, cough, HTN, late onset alzhemer's dementia with behavioral disturbances.  87-year-old male with history of Alzheimer's dementia, recurrent falls presents to the ED from his group home due to dizziness and cough. Per EMS stated the patient has been coughing repeatedly dry in nature. Patient also had an episode of dizziness with fall but was quickly caught by staff for falling to the ground. No head trauma, no LOC, not any blood thinners. History was obtained via charting and medical staff, as patient has dementia and does not answer questions. Patient is A&Ox1 referring to himself. Vitals: Blood pressure 127/67, pulse 70, temperature 97.6 °F (36.4 °C), temperature source Oral, resp. rate 18, SpO2 99 %. Treatments:  IV Decadron.Breo inhaler daily, albuterol nebulizer p.r.n.Remdesivir, Lovenox. Transfuse 2 units of blood if hemoglobin less than 7.  oxygen.  Discharged
On 10/30/2022, in the morning at around 8:00AM. I had fever of 100.03, runny nose, chills, sore throat, dizzy, body aches, fatigue, and weakness. On 10/31/2022 I had cough and shortness of breath. I also lost sense of smell. I tested positive on 10/31/2022. On the same day my doctor gave me antiviral injection and I started feeling better the next day.
Pt experienced general malaise, joint pain, soreness in arm at injection site and pain in chest with deep breath.
Breakthrough Covid infection. Patient tested positive on 07/29/2021. Patient was fully vaccinated on 06/30/2021.
Fever 102  (lasted 3 days) Chills (lasted 2 days) Full body aches (lasted 3 days) Severe muscle and joint pain/throbbing (lasted 3 days) Severe headache (lasted 2 days) Dizziness (lasted 1 days) Light sensitivity (lasted 2 days) Chest pressure/pain (continuing) Cough (continuing)
After 2nd dose, 3 days later, he started with chest pain; back pain in left side; pain in left arm; neck pain in left side; He had shortness of breath.; He also had fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (After 2nd dose, 3 days later, he started with chest pain), BACK PAIN (back pain in left side), PAIN IN EXTREMITY (pain in left arm), NECK PAIN (neck pain in left side) and DYSPNOEA (He had shortness of breath.) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jul-2021, the patient experienced CHEST PAIN (After 2nd dose, 3 days later, he started with chest pain), BACK PAIN (back pain in left side), PAIN IN EXTREMITY (pain in left arm), NECK PAIN (neck pain in left side), DYSPNOEA (He had shortness of breath.) and FATIGUE (He also had fatigue). The patient was treated with IBUPROFEN for Adverse event, at a dose of 600 mg every eight hours. At the time of the report, CHEST PAIN (After 2nd dose, 3 days later, he started with chest pain), BACK PAIN (back pain in left side), PAIN IN EXTREMITY (pain in left arm), NECK PAIN (neck pain in left side), DYSPNOEA (He had shortness of breath.) and FATIGUE (He also had fatigue) outcome was unknown.            The concomitant medication was not reported.  The reported events symptoms was on and off.   This case was linked to MOD-2021-270234 (Patient Link).
Stomach Ache, Nausea, Diarrhea, Vomiting, Chills. 4 hours
This spontaneous report was received from a medical assistant regarding a 6 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 11-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
gave FLUZONE HIGH DOSE to a 56 year old patient in error with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via agency (Reference number- 00332289) and transmitted to Sanofi on 26-Oct-2020 .  This case involves a 56-years-old female patient who was vaccinated with an unknown dose of QUADRIVALENT INFLUENZA VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], (batch number: UJ537AB and expiry date: 30-Jun-2021) via intramuscular route in the left arm (product administered to patient of inappropriate age) on 26-Oct-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medication of the patient was not reported.  It was an actual medication error case due to Inappropriate age at vaccine administration (latency: same day).  At the time of reporting, no adverse event was reported.  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.  There will be no information available on the batch number for this case.
Unconsolable crying started, lasted for 12 hours, Leg where injection was given was red, swollen, warm to touch, temp up to 103.1
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Additional Details: contacted paramedics pt did not want epipen...did not want to go to er
Headache, Sedation, Myalgia, Arthralgia, Rash,  Chills
Caller wanted to report symptoms and some of the side effects. She is currently pregnant.; Improved, still a little swelling.; pain on her arm; really nauseous; Headache; feeling really tired; Dizzy; Insomnia; This is a spontaneous report from a contactable consumer (patient herself). This consumer or other non HCP reported information for both mother and fetus/baby. This is a maternal report. A 39-years-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0187; Expiration Date: 31Aug2021) via an unspecified route of administration, administered in Arm Left on 28Jul2021 (at age of 39-years-old) as DOSE NUMBER UNKNOWN, 0.3ML SINGLE for COVID-19 immunization. The patient was pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included omeprazole (OMEPRAZOLE) taken for nausea, vomiting from an unspecified start date and ongoing. Patient's Medical History (including any illness at time of vaccination) was None. Family medical history relevant to AE(s) was no. Patient had not AE(s) following prior vaccinations. Patient had not additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient did not receive any other vaccines prior to COVID vaccinations (within 4 weeks). Mother did not smoke, drink alcohol and not using illicit drugs during this pregnancy. The patient experienced caller wanted to report symptoms and some of the side effects. she is currently pregnant on an unspecified date. It was reported that, she got the vaccine on Wednesday and on 28Jul2021 started feeling pain on her arm. Then at the end of the day she started feeling really nauseous, headache, really tired, and dizzy. She was not sleeping much, a couple of hours yesterday and today she was having insomnia (She tried to go to bed around 10 o'clock. She fell asleep around 4 or 5 am) as well. She had a question, she just got a new job and did not have enough time. Should she go to her Primary care for something showing that she was missing work due to COVID. The adverse events did not require emergency room or physician office visit. Therapeutic measures were taken as a result of pain on her arm, really nauseous, headache, feeling really tired and dizzy. Patient was using warm cloth and moving arm as treatment for pain on her arm it was improved, still a little swelling. She has been taking omeprazole for nauseous; taking it in the morning, due to her pregnancy and having nausea. Tylenol every six hours for headache. Patient was trying to rest (as treatment; started- 2 to 3 pm) as she was feeling really tired. Patient laid down and plenty of fluids (started - 2 to 3 pm) as treatment for dizzy. Patient did not receive any treatment for insomnia. Relevant tests was reported as none. The outcome of event pain in her arm was recovering, really nauseous, headache, feeling really tired, still a little swelling, insomnia was not resolved while it was unknown for dizzy.
Started getting dizzy and stayed dizzy through night and still dizzy on Feb. 6, also had a slight pain in liver (right hand side)
Rash on back of left thigh that looks like crusted dots Started with one; now have 5. Itchy when they come in Then burn and warm to the touch
Within 2 days developed severe pains in upper arms and frontal shoulder. Within 1 week was diagnosed with polymyalgia rheumatica (PMR).
slight arm pain; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (slight arm pain) and INJECTION SITE PAIN (injection site pain) in a female patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (slight arm pain) and INJECTION SITE PAIN (injection site pain). At the time of the report, PAIN IN EXTREMITY (slight arm pain) and INJECTION SITE PAIN (injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitants medications were reported. No Treatments were reported.
itchy rash; red rash; itchy red rash on both legs up past groin area; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash), RASH ERYTHEMATOUS (red rash) and MUSCULOSKELETAL DISCOMFORT (itchy red rash on both legs up past groin area) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.  On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced RASH PRURITIC (itchy rash), RASH ERYTHEMATOUS (red rash) and MUSCULOSKELETAL DISCOMFORT (itchy red rash on both legs up past groin area). The patient was treated with TRIAMCINOLONE for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (itchy rash), RASH ERYTHEMATOUS (red rash) and MUSCULOSKELETAL DISCOMFORT (itchy red rash on both legs up past groin area) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: normal (normal) Patient had bloodwork done.   Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-035720 (Patient Link).
Moderna vaccine was administered outside of clinic - reported by patient ? NO LOT NUMBER WERE SUPPLIED  J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/21/2021 ADULT OBSTRUCTIVE SLEEP APNEA
Mother states noted hives both groin and arm pit areas less than 24 hr after injection. Hives giant size and spreading to face and trunk. Irritable no fever, cold symptoms prior to immunization. No reaction noted after 1st influenza shot.
Patient reported symptomatic (non-severe) case of COVID-19 August 2021 and recovered fully.  She reported receiving Pfizer COVID vaccine 9/3/21 and second dose 9/15/21.  She present to the emergency department of my hospital 10/23/21 with chest pain and dyspnea for 48h.  Was feeling completely well prior to onset of chest discomfort.  Symptoms were mild.  No sick contacts or family members.  ED evaluation remarkable for normal exam, no hypoxia, normal blood pressure.  EKG with diffuse ST elevation.  Troponin elevated at 20.  CTA chest negative for PE or pneumonia.  SARS-CoV-PCR positive but thought to be persistent positive rather than reinfection because of lack of clinical symptoms, recent COVID-19 and recent vaccination.  Cardiologist consulted, thought acute coronary syndrome unlikely based on age and lack of risk factors.  STAT Echo resulted depressed EF 40-45%.  Simultaneously she had become increasingly tachycardic and EKG appeared more ischemic.  Cardiac cath lab was activated and she was about to be transported when she suffered cardiac arrest.  Initial rhythm was VT.  Received ACLS protocol CPR x 65 minutes including multiple cardioversion, amiodarone, lidocaine, magnesium and other antiarrhythmics.  Unfortunately she was not able to be resuscitated and died.  Cause of death possible acute myocarditis.
Pt states recvd DTP/Typhoid on 21OCT91 @ clinic; arm began itching & swollen since 24OCT91; rubbed site w/alcohol, no improvement; triage on 29OCT91 w/ lt swollen arm & infected area; Pt referred to ER for further eval;
April 6 lymph node on L clavicle swelled; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 (Lot number: EN6204, Expiration Date: Jun2021) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Exercise induced asthma" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Scoliosis" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; TYLENOL. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 06Apr2021, outcome "recovering", described as "April 6 lymph node on L clavicle swelled". The event "april 6 lymph node on l clavicle swelled" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: April 6 lymph node on L clavicle swelled, reduced by April 15. April 26 painful swelling in R armpit. Pain has continued for 4 days, extending into muscles of R arm. April 28 lymph node on R clavicle swelled. Other medications in two weeks: Birth Control. Facility type vaccine: Pharmacy or Drug Store. The patient had no other vaccine in four weeks, not diagnosed with COVID prior to vaccination and not tested for COVID since vaccination. Patient had no allergies.  No follow-up attempts are possible. No further information is expected.
The evening of the twins vaccinations (1-3pm appts), our daughter went into a shock-like state. She wouldn't respond to loud noises, talking, or movement. She just stared at the wall and would or could not make eye contact. No more smiles or cooing. She was a completely different baby. This lasted for 4 days. It was very scary. Also, her stool went from a normal, yellow, regular consistency baby stool (multiple times a day) to a very foul, black, thick (paste like) stool. It smelled very foul, almost chemical- like. It burned my nose to smell it. Her skin on her buttocks and female genitalia was very red and inflamed from the abnormal stool. Her stool stayed that way for months. She also experienced constipation and irregularity for several months following. Her eczema also worsened by quite a bit and will not go back to the state in was in prior to vaccines (on cheeks). I told 2 drs about it and neither said was vaccine related, although these reactions are listed as adverse in vaccine inserts. No treatment was recommended or provided.
Started vomiting 3 hrs after vaccination.  Resp symptoms began 2 days later, ER visit 4 days past vaccination diagnosed with bronchitis and upper respiratory infection.  Still having fatigue and frequent headaches as of 11/9/09.
Pt came to ER with SOB that began morning of.  Found to be hypoxic by EMS.
Chest pains (squeezing), pain traveling down left arm. First symptoms lasted 15-20 minutes (symptoms began 11 days after vaccination). 2nd incident lasted 20 minutes. Pateint stated he had frequent chest pains during hospital stay.
With Spanish interpreter mother states child had a rash, itching after immunization at pvt. Drs office.  Then mother states she was unsure of when child had problems after immunizations.  She has had immunizations at pvt. Dr, public clinic and other.  Inconclusive regarding when problems occurred.  Child has had immunizations of Hep B, DTaP, Hib, PCV, IPV, MMR and Varicella.
The night of the vaccine I started experiencing; cold chills, hot and cold feeling; severe abdominal pain. I in the evening I went to the ER, given fluids and discharged early morning.
Pt developed fever as high as 104.2; confusion, inability to form sentences; restlessness; inability to ambulate.; inability to form sentence; This is a spontaneous report from a contactable nurse. A 57-year-old male patient received the first dose of BNT162B2 (lot no. and expiry date were unknown), via an unspecified route of administration, administered in right arm on 30Mar2021 (at the age of 57-year-old) as single dose for COVID-19 immunization. Medical history included Cancer Stage 4 - renal with mets. The patient's concomitant medications were not reported. The patient previously took ciprofloxacin (CIPRO) and sulfamethoxazole, trimethoprim (BACTRIM) in which he experienced allergies to both drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021, the patient developed fever as high as 104.2, confusion, inability to form sentences, restlessness, and inability to ambulate. He was hospitalized on unspecified date due to the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient had nasal swab on 01Apr2021 with negative result. The outcome of the events was not recovered.  Information on lot/batch number has been requested.; Sender's Comments: The information currently available is extremely limited and does not allow a meaningful case assessment. However, based solely on an implied temporal association, a causal relationship between events fever,confusion,aphasia,movementdisorder adverse events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The case will be reevaluated should additional information become available. 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.