chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feels like it is a migraine or sinus infection; Feels like it is a migraine or sinus infection; indigestion; Feels like her jaw hurts, into her ears and into back of her neck; Woke up feeling tired; Arm hurts a little; Woke up feeling groggy; sore throat; Started to feel worse; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Feels like it is a migraine or sinus infection), SINUSITIS (Feels like it is a migraine or sinus infection), DYSPEPSIA (indigestion), PAIN IN JAW (Feels like her jaw hurts, into her ears and into back of her neck) and FATIGUE (Woke up feeling tired) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), VITAMIN D NOS, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and EPIDURAL INJECTION for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced MIGRAINE (Feels like it is a migraine or sinus infection), SINUSITIS (Feels like it is a migraine or sinus infection), DYSPEPSIA (indigestion), PAIN IN JAW (Feels like her jaw hurts, into her ears and into back of her neck), FATIGUE (Woke up feeling tired), PAIN IN EXTREMITY (Arm hurts a little), SOMNOLENCE (Woke up feeling groggy), OROPHARYNGEAL PAIN (sore throat) and VACCINATION COMPLICATION (Started to feel worse). At the time of the report, MIGRAINE (Feels like it is a migraine or sinus infection), SINUSITIS (Feels like it is a migraine or sinus infection), DYSPEPSIA (indigestion), PAIN IN JAW (Feels like her jaw hurts, into her ears and into back of her neck), FATIGUE (Woke up feeling tired), PAIN IN EXTREMITY (Arm hurts a little), SOMNOLENCE (Woke up feeling groggy), OROPHARYNGEAL PAIN (sore throat) and VACCINATION COMPLICATION (Started to feel worse) outcome was unknown. 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.   Patient had epidural injection three weeks prior to vaccine. Treatment information includes  Ibuprofen  ,  Bayer migraine medicine and didn't help and Tylenol for Sinus but  it hadn't helped.
After Dose 1 I had a sore arm for about a day. Then I started coughing, low grade fever and it wasn't better after a week. I went to my PCP and was diagnosed with walking pneumonia. I was prescribed an antibiotic and after taking it I was better.
2/27/2021  9:00 am low fever, sore arm, headache, mild nausea, fatigue  2/27/2021   11:00 pm headache, sore arm, severe nausea, stomach pains, diarrhea, fatigue
The patient was given the pediatric doses of Pfizer on 11/16/21; however the patient was 12 at the time of vaccination.
Headache, fever, blurred vision, weak muscle tone, heart palpitations, injection site swollen left arm 3" x 3".
Narrative: Covid +, SOB, cough, incr oxygen, covid pneumonia, CHF, end stage COPD, awaiting double lung and heart transplant, J&J, d/c SNF
Pain left arm but the vaccine was administered on the right arm; Felt like having fever/Having temperature now; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain left arm but the vaccine was administered on the right arm) and PYREXIA (Felt like having fever/Having temperature now) 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 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain left arm but the vaccine was administered on the right arm) and PYREXIA (Felt like having fever/Having temperature now). At the time of the report, PAIN IN EXTREMITY (Pain left arm but the vaccine was administered on the right arm) and PYREXIA (Felt like having fever/Having temperature now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported  No treatment information was provided
PATIENTS VACCINE WAS GIVEN IN THE RIGHT GLUTE INSTEAD OF ONE OF HER DELTS
Initial information received on 30-Jan-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves Adult patient (date of birth and age was not reported) who experienced use of product outside of indication (60 and older), while he/she received vaccine FLUZONE HIGH DOSE (lot number, expiry date, dose in series, route and site of administration was not reported). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to Inappropriate age at vaccine administration. It was not reported that the patient had any adverse event. 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. List of documents held by sender: none.
Initial information received on 10-Dec-2018 regarding an unsolicited valid serious case received from a physician. This case is link to case 2018SA340739 and 2018SA340772 same reporter. This case involves three patients (6-7 years old) who experienced flu strain A, while he/she received vaccine INFLUENZA VACCINE [Flu vaccine]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, patients received a dose of suspect INFLUENZA VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, patients developed a serious flu strain A (influenza) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. It was reported that several kids that were properly vaccinated this year have the flu and it's documented strain A. Physician states there were 3 patients who went to the urgent care in the last 3-4 weeks that had been immunized for the flu come down with the flu. (Other relevant tests included no lab data.) Final diagnosis was flu strain A. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. Documents held by sender: none. Sender's Comments: 6-7 years old patients presented with Influenza type A after and despite receiving FLUZONE QUADRIVALENT vaccine. The time to onset is unknown. Additional information regarding patient's past medical history, condition at the time of vaccination, vaccine manufacturer, concomitant medications, lab /radiological investigation excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine and a case of vaccination failure cannot be assessed.
1st shot was on 6/2/21-was in bed sick for 3 days. 2nd shot was on 6/30/21-in bed sick for two days Then on 7/ 8 she start feeling  severe pain in left leg along with swelling. She couldnt put any weight on leg. She was taken to ER on 7/14. She was diagnosed with a blood clot in her left leg and discharged on 7/15. On 7/21 she saw her  primary doctor and was admitted back to hospital for 7 days to be monitored and to be given heparin.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID: Unknown. The reporter is the patient. A 77-year-old male patient received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EN5318, Expiration Date: 31May2021), on 01Mar2021 as dose 2, single (Lot number: EN6205, Expiration Date: 30Jun2021) and on 16Dec2021 as dose 3 (booster), single (Lot number: FE3594, Expiration Date: Feb2022) at the age of 77 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: RAMIPRIL taken for blood pressure abnormal. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "tested positive for Covid, had Pfizer Covid vaccines and booster". Patient had a real bad cold and taking cough syrup. About 6 weeks from time of report, had symptoms and didn't know that it was Covid. Thought he had a summer cold and had headache and cough. It went away with the syrup. When it came back, he got nervous and went to a walk-in clinic and doctor prescribed PAXLOVID. No tests were done at the time. They gave him blood work within the past year and his kidneys were clear so it was ok for him to take this. The events "tested positive for Covid, had Pfizer Covid vaccines and booster" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) his kidneys were clear; SARS-CoV-2 test: (2022) Positive, notes: tested positive for Covid. Therapeutic measures were taken as a result of vaccination failure, covid-19.
This spontaneous report was received from a non-pregnant female patient of unknown age who is also a nurse (via company representative) regarding herself. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On an unknown date, the patient was vaccinated with first dose of GARDASIL (dose, unit, route and frequency, expiration date and lot number not specified) for the prevention of human papillomavirus and on an unknown date in 2008 (reported as 10 years ago), the patient was vaccinated with second dose of GARDASIL (dosing details were not reported) for prevention of human papillomavirus. The patient experienced a severe adverse experience after receiving the second dose of GARDASIL 10 years ago. The patient experienced pain and an [unspecified] allergic reaction and had to be hospitalized at an unspecified hospital for an unspecified period of time. It was unknown, if the patient received any treatment for the event. The patient sought medical attention. The outcome of the events was reported as recovered. The reporter did not assess the causality of the events with suspect therapy. No product quality complaint involved.
Possible anxiety issues; This is a spontaneous report received from a non-contactable consumer (patient's child). A female patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced possible anxiety issues. The outcome of possible anxiety issues was unknown.  No follow-up attempts are possible. Information about lot/batch cannot be obtained.
Immediate moderate pain at injection site.  6 hours post injection: severe body aches, chills, tremors, weakness lasting 36 hours. Generalized fatigue and weakness continuing for 4 days.
This spontaneous report as received from a pharmacist concerning a 53 year old female patient who on 10-AUG-2012 was vaccinated with a single dose 0.65 ml subcutaneous in her left arm with ZOSTAVAX (lot number 671663/1159AA, expiration date 18-OCT-2013). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced an unspecified injection site reaction. No treatment information was reported. The outcome of injection site reaction was reported as recovering/resolving. This is one of several reports received from the same source (other cases number 1208USA011817, 1208USA010432). Additional information has been requested.
pt recv vax last year & devel an inj site rxn, which started out sl, & progressed to a silver-dollar sized welt 6-8hr later;the area was reddened & tender for approx 1-2wks;no systemic rxn was noted & pt was recovered;
Approx 3 days post second Pfizer vaccine experienced paralysis on (L) side - could not hold pencil. Went to ER x3 visits - went to primary MD - had MRI brain showing lesions, demyelinization process. Admitted for high dose steroid therapy - dx with MS. First MS - NO History! No family HX.
received word that the patient passed away on 3/5/2021.  Do not know the cause of death, nor where he passed away.  He does not have any significant medical history at Health Care Corporation, but did get his first vaccination here on 2/17/2021.
Patient received covid vaccine dose for ages 5-11. Patient is 12 years old. Should have received higher dose. Patient is not experiencing adverse event.
After receiving the first dose of the vaccine she had an injection site reaction; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (After receiving the first dose of the vaccine she had an injection site reaction) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE REACTION (After receiving the first dose of the vaccine she had an injection site reaction). At the time of the report, VACCINATION SITE REACTION (After receiving the first dose of the vaccine she had an injection site reaction) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  After receiving the first dose of the vaccine she had an injection site reaction and the pharmacist required her to stay at the vaccination facility for an hour for monitoring. They would not give her another dose of the vaccine without first talking to her physician. The physician recommended that the patient should receive an additional dose.  No treatment medication information was provided.   This case was linked to MOD-2022-681977 (Patient Link).
arm soreness; a welt on their back; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) and RASH (a welt on their back) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness) and RASH (a welt on their back). At the time of the report, PAIN IN EXTREMITY (arm soreness) and RASH (a welt on their back) outcome was unknown. Not Provided          No concomitant and no treatment medication were not provided by reporter .
Redness at injecton at the site of injection; Tender at the site of injection; Swollen at the site of injection; Itchy at the injection; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (Redness at injecton at the site of injection), INJECTION SITE PAIN (Tender at the site of injection), INJECTION SITE SWELLING (Swollen at the site of injection) and INJECTION SITE PRURITUS (Itchy at the injection) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at injecton at the site of injection), INJECTION SITE PAIN (Tender at the site of injection), INJECTION SITE SWELLING (Swollen at the site of injection) and INJECTION SITE PRURITUS (Itchy at the injection). At the time of the report, INJECTION SITE ERYTHEMA (Redness at injecton at the site of injection), INJECTION SITE PAIN (Tender at the site of injection), INJECTION SITE SWELLING (Swollen at the site of injection) and INJECTION SITE PRURITUS (Itchy at the injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information provided included the use of OTC antihistamines for this reaction.  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; Sender's Comments: 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
1) The following day after receiving the vaccine I started having headaches that felt as if my brain was swelling and on the 4th day my lip on the inside of my throat beginning to swell.  2) I've had several incidents where I was woken out of my sleep due to my heart feeling like it was going to jump out of my chest.  3) I've had several occasion where I felt like I was going to pass out 4) In addition, several months after the vaccine I start having tinnitus, which I still have today.
Flu like symptoms for 1-2   -extreme brain fog, concentration issues, dizziness, dry mouth, autoimmune flares - severe, severe depression, stomach issues including diarrhea - still ongoing.
Received vaccine Friday November 7, 2008 at ~ 8:35 am. At 12:45 pm Friday Nov. 7, 2008 experienced very sudden onset of: 1. congestion in area near epiglottis/upper trachea requiring continuous attempts to clear throat of mucous; mild-to moderate non-productive cough with mild wheeze-like sounds on expirations.  2. throat in above area had burning/raw and some itching sensations.  3. about 10 minutes later pharynx presented with same burning/raw and some itching sensations; uvula was reddened with mild swelling (approximate 1.25 - 1.5 X normal size).  4. about 15 minutes after onset of symptoms 1-3, took 2 mg. Chlorpheniramine.  5. at same time as #3, experienced start of mild headache but also moderate lightheadedness; there was no dizziness or vertigo.  6. about 1 hr later sensation in throat and pharynx progressed to nares. 7. was extremely cold but did not experience shaking chills; lasted for ~ 4hrs. after onset of pulmonary symptoms.  8. frequent hourly urination which started approximately 1/2 hour after initial symptoms (see #1 above) began; dipstick was negative for UTI (negative leukocyte esterase and nitrite).  9. symptoms in epiglottis area/upper trachea started to abate in about 20-30 minutes post administration of antihistamine noted in #4.  10. all symptoms were basically resolved by 9 hours post initiation of adverse reactions; did feel tired but next morning basically OK except some residual clearing of throat (not uncommon with concurrent ragweed/grass allergy symptoms at this time.
Started to have muscle spasms in the chest area; I had two quick short pains in chest after 1 hour of vaccine; This is a spontaneous report from a contactable consumer. This 47-year-old female consumer (patient) reported that:  A 47-years-old female patient (not pregnant at the time of vaccination) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: unknown), via unspecified route, in right arm on 05Apr2021 at 15:00 (at 47-years age) as dose 1, single for covid-19 immunization. The patient medical history was not reported. Known allergies were reported as none. Other medical history as none. The concomitant drugs included clonazepam (CLONAZEPAM) taken for an unspecified indication, start and stop date were not reported. Facility type Health Clinic. The patient had not received any other vaccines within 4 weeks. The patient had experienced chest pain on 05Apr2021 at 16:00 and muscle spasms on 12Apr2021 at 08:30 am. Pt had two quick short pains in chest after 1 hour of vaccine. Had muscle spasms in the chest area on Monday, 12Apr. No other critical symptoms. Pt still get them throughout the day but less often. Not sure if from the vaccine, or muscle strain from body exercises which includes modified pushups. It was not reported whether the patient had received treatment and the patient did not receive treatment before receiving medical attention. Not had covid prior vaccination. Not tested covid post vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Large finely defined floaters appearing in my left eye, along with shooting stars. Subsided within a half hour, but left eye still has a faint amount today (April 25) along with fuzzy vision out of that eye.
Varicella bumps on feet, back, neck, knees, thighs, belly, legs, and ankles.
Swelling in the mouth, flushing, stomach pain, nausea and vomiting. Hypotension. Epinephrine auto injector administered by clinic nurse. EMS called. IV fluid administered by EMS. Alert and stable before transport to ER.
about an hour after shot: Numbness on back of tongue, extreme tiredness. Took about an hour nap. Woke up feeling better.  Appx 3 days later ( 1/15/2021) from shot, soreness in both breasts. This symptom lasted for about a total of 1 week from date of noticing. 1/22/2021.