chrisvoncsefalvay/vaers-outcomes huggingface dataset:
seasonal sinus; no mucus for one day, then seasonal sinus with sinus drainage; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), ALLERGIC SINUSITIS (seasonal sinus) and RHINORRHOEA (no mucus for one day, then seasonal sinus with sinus drainage) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy and Back pain. Concomitant products included STEROIDS for Back pain, TOPIRAMATE (TROKENDI), PARACETAMOL (TYLENOL) and DICLOFENAC for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and RHINORRHOEA (no mucus for one day, then seasonal sinus with sinus drainage). On 29-Apr-2021, the patient experienced ALLERGIC SINUSITIS (seasonal sinus). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and BENZYDAMINE HYDROCHLORIDE, DICHLOROBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE (SORE THROAT [BENZYDAMINE HYDROCHLORIDE;DICHLOROBENZYL ALCOHOL;LIDOCAINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 29-Apr-2021, OROPHARYNGEAL PAIN (sore throat) had resolved. On 02-May-2021, ALLERGIC SINUSITIS (seasonal sinus) and RHINORRHOEA (no mucus for one day, then seasonal sinus with sinus drainage) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
This spontaneous report as received from a patient's mother concerning her daughter, 1 year old female patient with anaphylactic allergy to eggs. On 09-JUL-2014, the patient was vaccinated with a dose of VARIVAX (Merck), on unspecified thigh. Concomitant medications were not reported. On 09-JUL-2014, patient experienced severe reaction 30 minutes after receiving a dose of VARIVAX (Merck). The patient began to wheeze and had difficulty breathing as soon as they got home after receiving VARIVAX (Merck) and PREVNAR 13. The reporter and her husband rushed the patient back to the physician's practice where she received the immunizations, and the patient received Epinephrine, "three times the amount that an adult should receive." The patient turned pale, her lips turned blue, and she was rushed by ambulance to the Emergency Department of hospital. The patient was provided Oxygen therapy, and was administered Benadryl. The reporter states that some of the blood tests that were done in the Emergency Department included a thyroid test. The patient sought medical attention. She reports that the patient was stabilized and released five hours later. She states that her daughter has an appointment with her allergist next week. The outcome of the events was reported as recovering/resolving. The causality of the events with VARIVAX (Merck) was not reported. Product quality issues was not involved. Upon internal review, all the events were considered medically significant. Additional information has been requested.
Within 2 hours of receiving the vaccine, the patient reported that he became very dizzy and began vomiting, which he assumed was due to the overwhelming dizziness.  He had trouble staying upright and could not walk in a straight line and had a stumbling gait due to the dizziness.  The patient was luckily on his way home and went to bed as soon as he reached his home.  He slept the rest of the day and reported feeling normal once he woke up the next morning.
Left arm soreness 2PM 02/19/2021 until 10AM 02/21/2021 Chills 3:30AM on 02/20/2021 Nausea / vomiting 6:30AM on 02/20/2021 Fever 8:30AM-4:45PM on 02/20/2021 Swollen painful lymph node in right armpit 2PM on 02/21/2021, ongoing
At 1700 started with slight cough. By 1710 noticed slight throat swelling with increased cough. Chest tightness and upper back pain also noted. At 17:25 visualized nodules at back of throat along with redness. Now with sore throat and minor wheezing but no difficulty with breathing. Around 18:00 cough and chest tightness subsided but now with fever 101, body aches, chills and eye drainage. By 06:00 on 10/06/2011 symptoms were gone.
RN did not create a wheal the first ID attempt. Went 2 inches above on left arm for the second attempt and created a wheal.
Patient with mouth numbness that started a few hours after vaccine received and is still persistent 6 days later
15FEB96 t105.6 hospitalized for r/o sepsis, had BOM, put on rocephin;had 1mm x 1mm dot macular rash that progressed down body;final dx p/ 2 1/2 day hospitalization MMR rxn, BOM, diaper rash;
pt recv vax 4MAY96 & 4APR97 pt devel approx 12 chickenpox;11APR97 pt recovered;
Pharmacist mixed pediatric vial thinking it was the adult vial. Patient was given a vaccine out of the pediatric vial. Pharmacist on duty contacted Pfizer and staff was advised to administer correct adult dose as soon as possible. Patient received adult vaccine on 12/8/21.
Rebound infection, positive test result 7 days after finishing Paxlovid; COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Patient has no known allergies. Concomitant medication(s) included: LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 treatment"; DISEASE RECURRENCE (medically significant) with onset 05Sep2022, outcome "recovering", described as "Rebound infection, positive test result 7 days after finishing Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Sep2022) Positive, notes: Rebound infection, positive test result 7 days after finishing Paxlovid; (Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (treatment start date: 24Aug2022, treatment stop date: 29Aug2022). Therapeutic measures were not taken as a result of disease recurrence.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vaccine Administration Error - administered vaccine underage. No adverse effects were noted following 15 minutes wait period.
Burning , Itching , redness on top of both feet; Burning , Itching , redness on top of both feet; Burning , Itching , redness on top of both feet .; Skin came off after scratching; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning , Itching , redness on top of both feet .), SKIN EXFOLIATION (Skin came off after scratching), PRURITUS (Burning , Itching , redness on top of both feet) and ERYTHEMA (Burning , Itching , redness on top of both feet) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, the patient experienced BURNING SENSATION (Burning , Itching , redness on top of both feet .) and SKIN EXFOLIATION (Skin came off after scratching). On an unknown date, the patient experienced PRURITUS (Burning , Itching , redness on top of both feet) and ERYTHEMA (Burning , Itching , redness on top of both feet). At the time of the report, BURNING SENSATION (Burning , Itching , redness on top of both feet .), SKIN EXFOLIATION (Skin came off after scratching), PRURITUS (Burning , Itching , redness on top of both feet) and ERYTHEMA (Burning , Itching , redness on top of both feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications was not provided.   This case was linked to MOD-2021-141781 (Patient Link).
I felt like I was hit by a ton of bricks. I got feverish, the chills, and muscle aches and pains to the point that all I wanted to do was sleep. So I went to bed, but just as I would be close to falling asleep I'd have to get up to empty my bladder. This was happening almost every 15 minutes for a few hours. I knew I probably should hydrate, but I chose not to because I wanted to get some uninterrupted sleep which I finally did at about 4:00am which only lasted a couple of hours. Then up at about 6:30am when I took some acetaminophin and went back to sleep. I was in bed all day, sleeping most of the time. When I'd wake up I'd take my temperature and most of the time I'd hydrate. I haven't had anything to eat because I wasn't feeling  strong enough to even heat water for soup. My normal temperature is about 97.6 give or take. The highest temperature I had was 100 when I took another dose of acetaminophin. But one time it was 94.3!!! I started feeling better at about 8:30pm (3/1/21)  and was able to make myself some chicken noodle soup and had some cereal and cottage cheese with it. I finally felt "normal" on Tuesday morning (3/2/21) after getting a good night's sleep.
Patient claims "huge" bruise near elbow and quarter size bruise at injection site.  Red in between bruises.  Not painful, but states that she was on chemo about 2 years ago.
Swelling , sick and in bed, then found a large rash on left breast, small boil , covid arm, chills low energy for 4 days
Patient reported a tickle in her throat and feeling woozy about 2 minutes after receiving her first covid vaccination. Patient was given 50mg of liquid Benadryl 2 minutes after receiving the vaccination. She started to feel better and was left with her husband after 30 minutes of observation.
Vaccine was exposed to 34.7 degree Fahrenheit for 5 hours and 36 minutes/ no AE; Initial information was received on 10-Sep-2021 regarding an unsolicited valid non-serious case received from a Physician via Medical Information (Reference number- 00763943) and transmitted to Sanofi on 10-Sep-2021.  This case involves a four-year-old male patient reported that DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] was exposed to 34.7-degree Fahrenheit for 5 hours and 36 minutes with no adverse event (Product storage error)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Prophylactic vaccination.  On an unknown date, the patient received a 0.5 ml (total) dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot C5772BA and expiry date 17-Sep-2022] via intramuscular route in the right deltoid for prophylactic vaccination.  It was reported, "Caller stated they had a temperature excursion of unknown cause. Caller stated it was a total of 5 hours and 36 minutes. Caller stated the refrigerator temperature reached 34.7 degrees Fahrenheit. Caller also stated 5 children received vaccines after the excursion occurred. Caller is checking on stability."   It was a case of actual medication error due to incorrect product storage (latency was on same day).  At the time of reporting, patient had no 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 guidelines. 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.; Sender's Comments:  US-SA-2021SA304325:
Note: following first vaccine patient had complaints on insomnia, and confusion for 1 and 1/2 days following the vaccination.   Patient call today 6/29 to inform clinic that he had has a stroke three days following the 2nd dose of the Pfizer vaccine.  Patient received vaccine 6/3 and on 6/6 patient noted numbness and weakness in right side and went to hospital,  Patient was diagnosed as having a stroke.  Patient was admitted to a hospital.  Currently patient feeling better  with some small limitations.
The patient was given monovalent instead of bivalent pfizer vaccine as a booster. Pt was notified.
WAS VACCINATED 03/27/2008.  24 HOURS LATER DEVELOPED FEVER OF 103F.  TODAY A 2 X 2.5 OF ERYTHEMOUS, INDURATED, PAINFUL AREA NOTED ON RIGHT UPPER ARM (DELTOID AREA).
Patient claims he blacked out for a second or so. he did not fall off of chair. Regained blood pressure quickly and steadily felt better. Stayed in the rx area for 30 minutes and felt good.
Typical symptoms post injection included mild fever, joint pain, tiredness.  Adverse event onset approx. 45 hours after injection of left arm,  left armpit swelling about the size of a grapefruit.  Painful & difficult to move or lower arm.  24 hours after onset, armpit swelling about half the size with less severe pain.  Alleviated with 600 mg ibuprofen every 6 hours.
Patient received a high dose vaccine when not age eligible on 10/18/23 and previously on 10/2/23 received a regular flu vaccine. On 10/31, patient was treated for pneumonia by a clinic and the provider at the clinic thought 2 doses of flu vaccine consecutively caused the condition.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No medical history and current conditions were reported. On 25-MAR-2015 the patient was accidentally administered a dose of VARIVAX (Merck) (dose and lot number was unknown), which was improperly stored. The outcome of the event was unknown. This case is linked to MARRS# 1504USA000709 with the same patient link. Additional information has been requested.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with (Merck) VARIVAX dose 1 (route, dosage and lot number unknown). Six weeks later the patient received (Merck) VARIVAX dose 2 (route, dosage and lot number unknown). On an unspecified date, the patient had varicella titers drawn, which came back negative. The outcome of varicella titers negative was unknown. Additional information has been requested.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On June 2009 the patient was vaccinated with 1st GARDASIL dose (dose, strength, route, indication and lot number were not provided). The 2nd dose of GARDASIL (dose, strength, route, indication and lot number were not provided) in August 2009. And the 3rd dose of GARDASIL (dose, strength, route, indication and lot number were not provided) on 09-JAN-2014. No adverse events reported. Co-suspect and concomitant therapies were not reported. Additional information has been requested.
IPOL being administered post excursion with no adverse event; Initial information regarding an unsolicited valid non-serious case received via nurse on 04-Oct-2022. GMI number: 01306677   This case involves a 9-year-old female patient to whom punctured vaccine IPV (VERO) [IPOL] being administered post excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2022SA409671.  Concomitant medications included Hepatitis B vaccine for Immunization.  On 23-Sep-2022, the patient received 3rd of suspect IPOL vaccine being administered post excursion at dose 0.5 ml once via intramuscular route in the left deltoid (lot: U1C571M, expiry: 17-Jun-2023) for prophylactic vaccination with no adverse event (poor quality product administered) same day latency.  Action taken: Not applicable.  At time of reporting, the outcome was Not Recovered.    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 the guidelines. 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.
had covid within the last 2 years; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (had covid within the last 2 years) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (had covid within the last 2 years). At the time of the report, COVID-19 (had covid within the last 2 years) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was reported that unlike the 8 people who were vaccinated and had covid within the last 2 years. Out of the 8 people 3 people received Moderna vaccine(S) and the others Pfizer. Patient nor product details were available for the 3 patients who received the Moderna vaccine.  Treatment information was not provided.  This case contains information about patient 2nd out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-748503 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748503:Master case (patient 1)
ache at the injection site; This is a spontaneous report from a 74-year-old male contactable consumer reported from himself that, he received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: FCK4176), via an unspecified route of administration on 24Jan2021 at 16:15 at single dose for covid-19 immunization. The patient's medical history included Known allergies: penicillin. Concomitant medication included hydrochlorothiazide. On 25Jan2021 08:00, the patient had very slight ache at the injection site. The patient did not take any treatment for the event. The outcome of the event was recovered on an unknown date.
Erythema & edema, about 20mm in diameter, on mid anterior thigh lt scant amt of white discharge @ ctr of lesion; Rectal temp 99.2; alert & smiling-no signs of systemic illness;
Heart attack; Fatigue; Chest Pain; Cough; Fever; Muscle pain in chest area; Chills; A spontaneous report  was received from a 72 year-old female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed heart attack (myocardial infarction), fever (pyrexia), cough, fatigue, muscle pain in chest area (myalgia), chills, and chest pain.  The patient's medical history and concomitant medications were not reported.  On 25-JAN-2021, 26 hours prior to the onset of events, the patient received her second of two planned doses of mRNA-1273 (lot#: unknown) intramuscularly for the prophylaxis of COVID-19 infection.  On 26-JAN-2021, the patient reported they have developed chills, fever, and muscle pain in the chest area. The reporter specified that it wasn't chest pain.  The patient took acetaminophen for the pain. On 27-JAN-2021, the patient reported her fever subsided but she was still having a little cough and chest pain.  On 28-JAN-2021, the patient had chest pain again during a nap and decided to call 911 because she was about to pass out. The patient was taken to the ER (emergency room) where an EKG (electrocardiogram) was performed. A few moments after the EKG, the patient had a heart attack. The cardiologist suspected the patient may have had a heart attack two days earlier because her cardiac enzymes were too high to be a result of a recent heart attack. The patient was admitted to the hospital from 28-JAN-2021 until 01-FEB-2021. Catheterization and stent placement were performed. Treatment medications included acetaminophen, clopidogrel, metoprolol, low-dose aspirin, and atorvastatin. At the time of this report, the patient was still feeling fatigued but other than that, she was feeling better.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcomes of the events, heart attack, cough, muscle pain in chest area, fever, chills, and chest pain, were resolved. The outcome of the event, fatigue, was not resolved.; Reporter'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.
This spontaneous report was received from a registered nurse refers to unknown number of patients (gender and age unspecified). On an unknown date (reported as for the past 18 years), the patients were vaccinated with a dose of VARIVAX (Merck), (lot number, expiry date and route was not reported) in the leg of children under the age of 4 years rather than in the arm. No adverse effect was reported. This is one the three reports received from the same reporter. Additional information is not expected.
metallic taste; she didn't lose taste completely; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), via an unspecified route of administration, on 01Jul2021 (Yesterday), as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 01Jul2021, the patient had experienced metallic taste in the mouth, she read up on it, she didn't lose taste completely. She wants to know if it is a normal side effects and how long it lasts. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Pt was given TD booster in her left arm on 12/18/02. On 12/24/02, pt first noticed red blotches on upper left arm near the injection site (not painful, tender or itchy). No difficulty breathing or swallowing. Seen by PCP on 12/24/02 and dx'd with localized urticarial reaction to TD shot.
Sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included premature ventricular contractions (but says this felt different).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient only reports a sore arm after the first dose of Shingrix. For tolerances of 2nd dose, refer case US2019191731, reported by same reporter for the same patient.