chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had horrible lower abdominal cramps; vaginal bleeding for approximately 30 minutes.; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number Ff2589 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 22Sep2021 17:30 (at the age of 38-year-old), as dose 1, single, for COVID-19 immunisation in Pharmacy or Drug Store. Patient was not pregnant at the time of vaccination. Medical history included asthma, hypotension, and allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Sep2021 08:30, the patient experienced vaginal bleeding for approximately 30 minutes. After the bleeding ends, the patient experienced horrible lower abdominal cramps. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment for the event was unknown. The patient recovered from vaginal bleeding on 24Sep2021 09:00 while the outcome for abdominal cramps was unknown.
Headache, nausea, and strong flu-like symptoms for two days.  Mild headache, vertigo and brain fog remain at day 7.
This initial spontaneous case, was received from other non-health professional (consumer) on 09-Oct-2017, concerns a 10-year-old male patient. The patient had no history of sinusitis. On 30-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, expiry date: Mar-2018 and batch no: 195210). On 04-Oct-2017, 05 days after vaccination, the patient started out with a fever for 48 hours, reaching 102.1 (as reported) due to which the patient was consulted to a doctor on 06-Oct-2017 (reported as Friday). Subsequently the patient was diagnosed with sinus infection with double ear infection and was treated with amoxicillin. Outcome of the events was not reported. The reporter assessed the events as non-serious. Follow up received on 09-Nov-2017: It was reported that, the patient had no history of sinusitis. The narrative was amended accordingly.
Within 2 minutes of getting the vaccine the pressure in my head  and ears was unbearable and I had a pain in my left eye. I felt awful. I was kept in the doctors office for 15 minutes and then discharged to home. The headache increased throughout the day. My face began to feel like it was on fire and it felt tingly and my ears began to fill with more pressure and pain.. I had a terrible pain in my left ear which lasted days. My throat began to feel like it was filled with mucus and it became difficult and painful to swallow and felt scratchy which also lasted a number of days. My neck was painful to touch and my lymph nodes were swollen. My arm around the injection site became red inflamed, swollen and extremely hard and painful to touch. It was also extremely itchy. The area on my left arm looked like it had cellulitis. The arm continued to remain red for weeks and the diameter of the area spread.
Asthma Attack 5 and a half hours after vaccine. Wheezing and tightness.  Took Bendadryl and used inhailers and asthma attack stopped.
Elevated heart rate; Was sick as a dog; Left arm was killing her; Fever; Headache; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Elevated heart rate), ILLNESS (Was sick as a dog), PAIN IN EXTREMITY (Left arm was killing her), PYREXIA (Fever) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced ILLNESS (Was sick as a dog), PAIN IN EXTREMITY (Left arm was killing her), PYREXIA (Fever), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea). On 08-Apr-2021, the patient experienced HEART RATE INCREASED (Elevated heart rate). At the time of the report, HEART RATE INCREASED (Elevated heart rate), ILLNESS (Was sick as a dog), PAIN IN EXTREMITY (Left arm was killing her), PYREXIA (Fever), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.            Action taken with respect to m-RNA1273 was considered to be not applicable.
This case was reported by a other health professional via call center representative and described the occurrence of numbness in a 77-year-old male patient who received SHINGRIX. Concomitant products included lisinopril and metoprolol. On 12th May 2018, the patient received the 1st dose of SHINGRIX. On 12th May 2018, 2 hrs after receiving SHINGRIX, the patient experienced numbness. In May 2018, the patient experienced loss of sensation. On an unknown date, the outcome of the numbness was not recovered/not resolved and the outcome of the loss of sensation was unknown. The reporter considered the numbness to be related to SHINGRIX. It was unknown if the reporter considered the loss of sensation to be related to SHINGRIX. Additional details were provided as followed: This case was reported by the optometrist who himself was the patient. The patient's concomitant medications included statins. At 9:00, the patient received SHINGRIX vaccine on the left arm. The physician reported that after receiving the SHINGRIX vaccine, he began to experience numbness on the right side of his face and his right ear and his head became numb the same day. It started to resolve and was no longer present on the day before reporting and then on the reporting day it returned to both areas. When the physician brushed his hair on the right side, he could not feel it. The number for Medical Information was provided and the physician said he was about to see a patient and would call back. The physician was instructed to tell the representative that he had already filed an adverse event report with GlaxoSmithKline. This case was identified as duplicate of US2018085771. Case US2018085771 was deleted and all the future correspondence will be added in the present case which stands as case of record for this patient.
A few days after vaccine my lymp nodes swelled up and neck is still swollen.  A week later my eye lids swelled and had cold like symptoms so doctor put me on amoxicillin and prednisone. A week after that broke out in bad rash and have been diagnosed with vasculitis. Still not well and trying to get answers not able to work.
Immediate: metallic taste in mouth that has not completely gone away within a day, ringing in my ears, which has not gone away and has gotten louder brain fog (intermittent) difficulty sleeping (intermittent) racing heart (intermittent)
Client was given MMR and Varicella vaccines using ActHib diluent. Incident occurred on 01/19/06.
Patient had what appeared to be a cold, runny nose and intermittent fever to 100.4.  This continued until 11/2/09, when the fever stopped.  Nasal drainage still excessive, so he was taken to primary care physician.  They mentioned that it might be a response to the flu mist vaccine.
patient had 3 doses of Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (patient had 3 doses of Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A, 016C21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (patient had 3 doses of Moderna vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (patient had 3 doses of Moderna vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.       Reporter did not allow further contact
This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lot # L018501, expiration date 22-JUN-2017, or lot # L033343, exp. date 13-SEP-2017, and/or lot # L048848 exp. date 09-AUG-2018(strength, dose number and route of administration were not provided) for prophylaxis. On 04-JUN-2017, the vaccines were exposed to temperature 47° Fahrenheit (F) during a time frame of 43 hours (hrs); on 06-JUN-2017, to 47°F for 18 hrs; 07-JUN-2017, to 47°F for 18 hrs; on 09-JUN-2017, to 47°F for 16 hrs; on 10-JUN-2017, to 47°F for 40 hrs; on 17-JUN-2017, to 47°F for 8 hrs 30 minutes (min); on 20-JUN-2017 and 22-JUN-2017, to 47°F for 18 hrs; on 23-JUN-2017, to 47°F for 19 hrs; on 26-JUN-2017, 29-JUN-2017 and 24-JUL-2017, to 47°F for 18 hrs. Total cumulative hours: 252 hrs 30 minutes. There was not previous temperature excursion, the temperature excursion was not called by a data logger. It was not reported if the administered vaccines were exposed to all temperature excursions. Adverse effects were not reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1709USA008835: US-009507513-1709USA004111: US-009507513-1709USA008836: US-009507513-1709USA008833.
*Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.) S: 35 yo F who received Pfizer vaccine at 16:47 w/acute onset of left sided facial swelling and difficulty swallowing.  Within five minutes of being administered vaccination, pt reported pain at the injection site radiating up to her jaw followed by left sided facial swelling. She started reported palpitations and subsequently reported a ball in her throat  O: Pulse was in the 60's,  BP of 128/72, pulse of 88-97 satting at 99% on RA. General: young female, anxious. HEENT: NC, AT, mild left sided cheek swelling, OP clear, MMM.  Neck: Supple, left sided tender cervical LN.  Lungs: CTAB. CV: tachycardic rate, regular rhythm. Extremities: Hands are clenched and cold.  Neuro: Alert & oriented.   A/P:  Anaphylaxis  -Given left facial swelling, 25 mg Benadryl PO administered. pt tolerated well.  -17:22-Throat swelling reported. EPI #1 administered right thigh.  -17:32-EPI #2 administered. Throat felt better at 17:35.  17:36-FD EMS arrived. BP 194/126.  -17:38-EPI #3 administered right thigh. HR 135, BP 154/105.  -17:43-EPI #4 administered left thigh.  -17:46 pt transported to ER via EMS.
Pt received Hepatitis A shot at 2 months.  Patient is thriving well, no adverse effects of the vaccines was reported at the time. Patient continues to be doing well.
Tinnitus, dizziness, exhaustion, arm and leg pain, weird taste (dissipating), slight nausea went away after drinking ginger ale. Concerned about the tinnitus mostly. Second day slept like the dead 16 hours.
No reported adverse events from patient. Reporting due to lack of approval for moderna covid -19 vaccine in those under 18 years of age.
Vial placed in refrigerator on 16-Oct-2021 and administered on 16-Dec-2021; Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Vial placed in refrigerator on 16-Oct-2021 and administered on 16-Dec-2021) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial placed in refrigerator on 16-Oct-2021 and administered on 16-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Vial placed in refrigerator on 16-Oct-2021 and administered on 16-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there was a confusion between the expiration date printed in the carton the expiration date when the QR code was scanned. No adverse events were reported. Vial did not underwent any temperature excursion. Vial was placed in refrigerator on 16-Oct-2021.  No treatment medications were reported.
Possible administration of improperly stored PROQUAD.; Possible administration of improperly stored PROQUAD.; No additional adverse events reported; This spontaneous report was received from a physician referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided.  The physician reported the possible administration of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) lot number U014798 and expiration date of 06-NOV-2022 for prophylaxis. The vaccine was exposed to a temperature excursion of -6.27°C with a time frame of 1 hour 15 minutes. There were previous temperature excursions: -14°C to-10°C for 0 hours 30 minutes 0 seconds; -10°C to 8°C for 0 hours 15 minutes 0 seconds; -14°C to-10°C for 0 hours 30 minutes 0 seconds; -10°C to 8°C for 0 hours 15 minutes 0 seconds. No additional adverse events reported.
Induration, redness, swelling, warmth at injection site.  Treated with Bactrim.
a hard lump on my chin; When pressed its hurts.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03Apr2021 at 16:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 19:00, the patient started to have a hard lump on her chin the same day after she got vaccinated. It had been 2 days and the lump was growing, when pressed it hurts and now the size was around a ping pong ball size. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the events hard lump on the chin and when pressed it hurts were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient given an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given an expired vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given an expired vaccine) 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.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-114626, MOD21-088359, US-MODERNATX, INC.-MOD-2021-114420, US-MODERNATX, INC.-MOD-2021-114456 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114626: MOD21-088359: US-MODERNATX, INC.-MOD-2021-114420: US-MODERNATX, INC.-MOD-2021-114456:
Body was achy; Arm was extremely sore; 103.5 degree fever; Dizziness/wooziness.; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness/wooziness.), PAIN (Body was achy), PAIN IN EXTREMITY (Arm was extremely sore) and PYREXIA (103.5 degree fever) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic rhinitis, Penicillin allergy, Sulfonamide allergy and Drug allergy (Patient is allergic to erythromycin.). Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) from 01-Jan-2018 to an unknown date for Allergic rhinitis.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced DIZZINESS (Dizziness/wooziness.) and PYREXIA (103.5 degree fever). On an unknown date, the patient experienced PAIN (Body was achy) and PAIN IN EXTREMITY (Arm was extremely sore). On 14-Mar-2021, PYREXIA (103.5 degree fever) had resolved. On 18-Mar-2021, DIZZINESS (Dizziness/wooziness.) had resolved. At the time of the report, PAIN (Body was achy) and PAIN IN EXTREMITY (Arm was extremely sore) outcome was unknown.            Patient took Advil and Tylenol to reduce the fever. Tylenol was more effective so he just took that after his first dose of Advil.  Company Comment: 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.
Severe allergy with skin eruptions on arms and body with itchiness weeping eczema.
Around 12pm on 1/12/21, patient began to experience severe dizziness, nausea, and multiple episodes of emesis.
I begin to relapse with my nephrotic syndrome (proteinuria). Not responding to my regular medication at all.
AUG91 irritability MD dx teething; SEP91 cough & t103 for several days; dx ear infect given APAP but became more lethargic started Ceclor, pt screamed when diaper changed, arms lifted following 4 mos cont to cry had painful joints; dx GBS
On January 6,2021 when I woke up my face was red, swollen and extremely warm. My face was like this for at least 16 hours (very uncomfortable). Also, on January 6, 2021 at 1130pm I had horrible stomach pains, then started vomiting,  after I was done vomiting I felt better.   I did take 2 Benadryl and aleve to help When I got back injections and had surgeries I had the same reactions happen to me usually after 8-10 hours after I was out of surgery.  I was given medicine to help with the discomfort either through IV or Benadryl.
Very sore arm, ibuprofen, 3 days Chills, ibuprofen, 6 hours Fever (100+), ibuprofen, 36 hours Body Aches, ibuprofen, 48 hours Fatigue, sleeping, 2 days
Patient reported to the health unit on Jan 9, 2013 with h/o of discomfort to her left elbow region which began shortly after receiving the Influenza vaccine on 12/18/2012 currently she reports persistent aching to (L) arm especially when she lifts, pulls or pushes with the left hand. Pain is mainly located in the mid elbow area.
Achylegs; weak; sore arm; Lightheaded; Short of breath; Rash at the injection site; Headache/head hurt; tired; 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 (Achylegs), ASTHENIA (weak), PAIN IN EXTREMITY (sore arm), DIZZINESS (Lightheaded) and DYSPNEA (Short of breath) in a patient of an unknown age and gender 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 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Achylegs), ASTHENIA (weak), PAIN IN EXTREMITY (sore arm), DIZZINESS (Lightheaded), DYSPNEA (Short of breath), VACCINATION SITE RASH (Rash at the injection site), HEADACHE (Headache/head hurt) and FATIGUE (tired). At the time of the report, PAIN IN EXTREMITY (Achylegs), ASTHENIA (weak), PAIN IN EXTREMITY (sore arm), DIZZINESS (Lightheaded), DYSPNEA (Short of breath), VACCINATION SITE RASH (Rash at the injection site), HEADACHE (Headache/head hurt) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported. Treatment medication were not reported.
Information has been received from a physician concerning a patient who was vaccinated with a dose of zoster vaccine live (Oka/Merck) and a couple of days later he had a small shingles case in his hip area. There was no concomitant medication. No further information provided. It was unknown if medical attention was sought. There was no product quality complaint. Additional information has been requested.
On May 25 (five months after booster shot and 4 days after my wife tested positive for COVID), symptoms started with a mild sore throat. On May 26, tested negative for COVID but mild sore throat continued On May 27, sore throat increased and started having a headache with muscular aches.  Later that day, tested positive for COVID.  Highest temperature was 99.8 degrees F that evening. On May 28, symptoms started to subside but felt exhausted. On May 29 and onward, no more symptoms.
February 2004 Anthrax vaccine. Rash of trunk and back.  Treated with Cipro.  Seen by Private Physician, resolved after treatment.
TRANSIENT CEREBRAL ISCHEMIA ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY
malaise, h/a, muscle & joint pain; t101, seen by MD given Atarax & Deltayne;
Approximately 15 minutes after receiving second vaccine dose, patient reported feeling light-headed and a subjective swelling of her left cheek.  Patient was tachycardic and hypertensive; taken to ER for observation.  Received a dose of oral diphenhydramine 50 mg.  Was ultimately discharged home in stable condition.