chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, lasting over 12 hours. No medication taken. Nausea, for 2 hours on the night of the 21st Vomited once the morning of the 22nd. Injection site pain, started several hours after administration, ongoing 16 hours later. High Temperature. 101.3 the morning of the 22nd. 103.0 at 10:00am
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: Pt recieved bivalent pfizer vaccine - about 10 min after administration, pt stated throat felt slightly swelling. pt received 1 tab of benadryl and 1 dose of epi pen. pt stated after 5 min throat swelling went from moderate to mild.
Complaints of nausea, vomiting, lightheaded. Pt given snacks and water after resting
Patient felt nauseous and vomited several times through the day (10/05/11) with some diarrhea on the second day after the flu shot. Patient is afebrile and appears well at urgent appointment on 10/06/11, but felt clammy yesterday. Patient was given ZOFRAN prescription and return if worsens. Patient is pregnant (33 wks, 4d) but did not have these complaints before the shot. Patient returned from a 2 week trip earlier this week where a couple people had upset stomach and diarrhea, but none with her severity.
FEEL LIKE STIR FRIED CRUD TODAY; HUGE RED SPOT ON THE TOP OF HIS FOOT; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 06-NOV-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 07-NOV-2021, the patient experienced feel like stir fried crud today. On 07-NOV-2021, the patient experienced huge red spot on the top of his foot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feel like stir fried crud today and huge red spot on the top of his foot was not reported. This report was non-serious.
I was to dizzy to drive myself home. Vomiting,  headache,  off balance, nausea, runny nose, horrible body aches.
I started to get cold sores less than a week from the time of the shot. I have never had a cold sore before. I had four sores on my face. The corner of my right mouth, above my left lip, my left nostril, and the side of my left nostril. I was prescribed an anti-viral and an antibiotic because it became infected. Since then I have 6 more incurrences of cold sores.
Rash in belly button area; This case was reported by a consumer via call center representative and described the occurrence of rash in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included mastectomy.   On 30th October 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: A rash presented on the belly button area of the stomach 2-3 days following administration of the 2nd vaccine.  It started small and became larger.   It started at 3 millimeters by 1 centimeter and was much larger measuring about 1 inch by 3 by 4 inch. Did not consent to follow-up.
Flu-like symptoms within 3-4 days of first dose of anthrax vaccine. Stiff joints, stiff neck with only 50% range of motion, widespread muscle and joint pain, headache, debilitating fatigue, IBS, hypersomnia, heavy menstrual bleeding with severe cramping, interstitial cystitis, low back pain, SI joint pain, pain in soles of feet, acne, eczema, severe sleep disturbances, increasingly lax joints (soon thereafter and with increasing frequency started dislocating both shoulders, some fingers, wrists, and one knee). Diagnosed with fibromyalgia in May 2003. Refused to order a sleep study despite repeated requests. Diagnosed with sleep disorder August 2011 after using civilian insurance to get sleep study and MSLT.  Got 2nd dose of anthrax vaccine 1 week later and 3rd dose 1-1/2 weeks after that despite reporting symptoms to doctor/medic administering the vaccines.
arm soreness and more fatigue the day after the vaccine; arm soreness and more fatigue the day after the vaccine; voice hoarseness; This is a spontaneous report received from a contactable other healthcare professional and a contactable consumer (Patient)from a Pfizer Sponsored Program. A 65-year-old female patient received second dose of BNT162B2 (reported as covid vaccine), via an unspecified route of administration on Mar2021 as single dose for COVID-19 immunisation. Medical history included muscle tightness in shoulder and neck causing shoulder pain (had bone metastasis)- improved, breast cancer. Concomitant medication included palbociclib (IBRANCE, 125 mg) taken for breast cancer from 04Jan2021 and ongoing. After start of palbociclib therapy, tiredness- more tired on "third week/off week and first week of cycle''; low white blood cell count from 2.3 to 2.0. MD aware. Per MD, she was off palbociclib 2 days before and 2 days after second dose of covid vaccine (Mar2021)- had "left arm soreness and more fatigue the day after the vaccine". No other adverse effects reported while off palbociclib. Had new report of voice hoarseness at times. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer reporting for him/herself. A patient of unspecified age ethnicity and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (unspecified trade name), via an unspecified route of administration, on an unspecified date 4 years before this report, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced stage 1 cancer and pneumonia all on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included x-ray: stage 1 cancer (unknown date). Pfizer is a Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report if another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities. No follow-up attempts possible. No further information expected.
Initial report received from healthcare professional on 30 September 2014. A 49-year-old male patient, had medical history of hypertension and concomitant medications were not reported, had received an intramuscular dose of FLUZONE quadrivalent (Batch number UI196AA, expiry date 30 Sep 2015 and dose number was not reported) in to the deltoid right on 29 September 2014. It was also reported that the patient had numerous FLUZONE or flu vaccines- received for past 9 years. The patient had experienced minor sinus headache, chills, sweats, muscle soreness and fever 102F on 29 September 2014. Lab investigations and corrective treatments were not reported. The patient had no illness at the time of vaccination, pre-existing diagnosed allergies and birth defects were included environmental allergies at this time of year reported. The outcome of the event was not resolved at the time of this report. List of documents held by sender: none. Follow up information received from a health care professional on 13 March 2015. It was reported that reviewed no additional information to add to the form.
fever; chills; exhaustion; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), FATIGUE (exhaustion) and NAUSEA (nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031220A) for COVID-19 vaccination.     Concurrent medical conditions included Iodine allergy, Hypertension, Acid reflux (oesophageal), Hyperplasia adrenal and Drug allergy. Concomitant products included PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]), SPIRONOLACTONE and SIMVASTATIN (ZOCOR) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills), FATIGUE (exhaustion) and NAUSEA (nausea). At the time of the report, PYREXIA (fever), CHILLS (chills), FATIGUE (exhaustion) and NAUSEA (nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.  Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-020695 (Patient Link).
The doctor offer me some ointment for the cold sore but I am using something so I declined.  Told me to take NSAID for bump under my chin.  I forgot to tell her about the pain in my left rib area.
tingling in the back of the throat. Pt was flushed and sweaty. Pt vitals  were 179/107, pulse 112.
Severe erythema/induration/warmth of large section of upper arm. Hospitalized after ER visit. Resolved overnite after IV SOLUMEDROL & IV ROCEPHIN.
elevated B/P and facial flushing.  Provider administered PO Benadryl and patient was discharged home.
About 3-4 weeks after the 2nd Dose I developed an itch in my ear that became a ras, I ended up with Bells Palsy, a rash and bad vertigo, after Many different appointments for help with individual issues resulting from the original issue, I recovered from most but I still have slight vertigo that persists
Pfizer-BioNTech was inadvertently administered to a 15 year old patient. Patient was monitored for at least 15  minutes and no adverse effects occurred.
My arm went limp for multiple days and then once I could move it again, I was in excruciating pain. I could not lift my arm over my head. I was diagnosed with a rotator cuff injury at the facility not long after.
Pt reports "my heart is beating outside of my body" Onset 2 weeks after 1st Moderna COVID vaccine on 4/17/21 Fatigued Chest feels tight Heart hurts Throbbing pain Felt palpitations Sxs did not get worse after the 2nd Moderna COVID vaccine shot Scheduled to fly on Monday (-) current SOB (-) pleuritic chest pain  (-) radiation to left arm or jaw (-) family hx of CAD or heart issues  (+) numbness in fingers, self resolved, 2 separate occasions over the weekend.
Arm pain, slight swelling in injection site area. Swollen lymph nodes on both sides of neck, overall malaise/body aches, fatigue, light-headedness resulting in fainting episode, headache
Patient complained of increasing heart rate and anxiety. Patient denied any symptoms/allergies. Nurse monitored and checked his vitals 2 times; did not show anything abnormal. At 9:30 - HR: 68. BP: 130/64. Room air: 99%. Resp: 19. At 10:10 - HR: 69. BP 110/64. Room air: 98%  Resp: 17.
LIGHT HEADED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested. No concomitant medications were reported. On an unspecified date, the subject experienced light headed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headed. This report was non-serious.
27MAR97 1130AM roof of mouth swell;lt side face swollen red;face hurt when blinking eyes, hurt @ cheek bone-throbbed-PM tingling;-numb;t100;28MAR97 woke up w/muscle stiff-hard to turn neck;feels real hyper;h/a lt temple;
redness at the injection site; Fever; chills; nauseous; sore arm; very tired; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th May 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th May 2021, 1 days after receiving Shingrix, the patient experienced injection site erythema, fever, chills, nausea, pain in arm and tiredness. On an unknown date, the outcome of the injection site erythema, fever, chills, nausea, pain in arm and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, fever, chills, nausea, pain in arm and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient reported this case for herself. The patient received 1st dose of Shingrix (50 mcg) in the left deltoid at the pharmacy and on the very next day, experienced side effects fever/chills, then a sore arm, redness at the site of injection, nauseous, and very tired and on next day this side effects gotten pretty hard and intense. Till the time of reporting, the symptoms had not been resolved. The patient stated that she was a very active person, and to be very tired was unusual for her. The reporter did not have the lot number or expiration date of the Shingrix vaccine, however she had NDC (national drug code) number on the receipt (NDC no.: 58160-0819-12) The reporter did not give a consent to follow-up with Health care practitioner. The reporter did not consent to follow up.; Sender's Comments: 0.5 mL
On June 25th, 2021 at around 4 A.M. I started feeling itchiness and warmth on my face, neck and arms. Shortly after I noticed red spots on my face, neck, elbows, and hands. Some of the red spots on my face and elbows were raised bumps that were itchy and other red spots were not raised or itchy. On the same day around 10 A.M., the spots on my face faded but others appeared around my knees that were warm to the touch and were raised and itchy. I took allergy medicine (Zyrtec) and applied anti-itch cream (Gold Bond) to the spots which helped with the itchiness and raised bumps but the red spots remained. The following day some of the spots faded on my neck and elbows but some had appeared on my legs, feet and chest. I continued taking the allergy medicine and cream until they completely faded away on like the 4th day, June 28th, 2021.
Starting on Day 7 post-vaccination, an erythematous, mildly pruritic rash began at the site of injection. It also had some mild swelling and tenderness to palpation. When I first noticed it, it was about 2-3 centimeters in diameter, growing to about 6 cm by the end of Day 8. On day 9 it began to resolve and was completely gone by morning of Day 10. I took 25mg diphenhydramine 3 times over the course of symptoms, but I don't think it helped.
Injection Site pain, tenderness, swelling, immediately after shot, continuing as of report .  Fatigue, within a few hours, continuing as of report. Headache, 8 hours after shot, continuing as of report. Muscle and joint pain 8 hours after shot, continuing as of report. Fever, 24 hours after shot, lasted 18 hours. Nausea, 30 hours after shot lasted 12 hours.
4-6 WEEKS AFTER RECIEVING SECOND DOSE OF SHINGRIX, PATIENT STARTED TO NOTICE 5 SMALL RED "CHICKEN POX" LIKE DOTS APPEARED  ON HIS RIGHT FORE ARM.  5 DAYS AFTER IT'S APPEARANCE,  IT BURSTED AND BECAME 5 LITTLE SORES THAT ITCHES ALL THE TIME. THE SMALL RED DOTS HAVE MIGRATED TO ALL OF HIS RIGHT ARM, TO HIS LEFT ARM, TOP OF SHOULDERS, AND BELLLY BUTTON. THESE SMALL RED DOTS TURNS INTO BLISTERS THAT BURSTS, HEALS UP, AND ITCHES ALL THE TIME.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 2/15/21 (en6201) Pfizer Dose 2 3/11/21 (EN6204) COVID Positive 9/13/2021  9/14/21:Patient is a 80 year old female with past history of lewy body dementia, hypertension, and DVT on Xarelto who was admitted with hypoxemia after recent diagnosis of COVID-19 infection.  History is obtained from chart review as well as discussion with the patient, her daughter at bedside, and the ED provider.  Patient does have underlying dementia so most of the history is obtained from her daughter.  She denies a history of heart or lung disease.  She is chronically on Xarelto for a left lower extremity DVT in the past.  Patient was vaccinated for COVID earlier this year.  Her grandson was not vaccinated and did become infected with COVID-19 a couple weeks ago. Patient started having symptoms on Saturday.  Initially was doing okay and mostly having just nausea, vomiting, fatigue, and poor oral intake.  She was scheduled to have a monoclonal antibody infusion tomorrow.  Patient's daughter was monitoring her oxygen saturations and she did drop into the 80s so she came to the ER today.  Chest x-ray did not show significant pneumonia however she did have O2 sats in the 80s and currently on 2.5 L of oxygen.  She has been afebrile.  Denies any chest pain.  Does have a slight cough.  9/16/21: Patient is a 80 year old female with past history of lewy body dementia, hypertension, and DVT on Xarelto who was admitted with hypoxemia after recent diagnosis of COVID-19 infection.  History is obtained from chart review as well as discussion with the patient, her daughter at bedside, and the ED provider.  Patient does have underlying dementia so most of the history is obtained from her daughter.  She denies a history of heart or lung disease.  She is chronically on Xarelto for a left lower extremity DVT in the past.  Patient was vaccinated for COVID earlier this year.  Her grandson was not vaccinated and did become infected with COVID-19 a couple weeks ago. Patient started having symptoms on Saturday.  Initially was doing okay and mostly having just nausea, vomiting, fatigue, and poor oral intake.  She was scheduled to have a monoclonal antibody infusion tomorrow.  Patient's daughter was monitoring her oxygen saturations and she did drop into the 80s so she came to the ER today.  Chest x-ray did not show significant pneumonia however she did have O2 sats in the 80s and currently on 2.5 L of oxygen.  She has been afebrile.  Denies any chest pain.  Does have a slight cough.
Tired/Fatigue; Lack of interest in doing anything (Used to read books); Pain Injection Site came back again and the pain spread to other body parts after second Shot; Aches and Pain on Both Upper Arms after second Shot; Pain on the Injection site after second Shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain Injection Site came back again and the pain spread to other body parts after second Shot), PAIN IN EXTREMITY (Aches and Pain on Both Upper Arms after second Shot), FATIGUE (Tired/Fatigue), VACCINATION SITE PAIN (Pain on the Injection site after second Shot) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Lack of interest in doing anything (Used to read books)) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus non-insulin-dependent and Blood pressure high. Concomitant products included METOPROLOL and ENALAPRIL for Blood pressure, METFORMIN for Diabetes mellitus, LOVASTATIN and INDAPAMIDE for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain on the Injection site after second Shot). On 20-Mar-2021, the patient experienced PAIN (Pain Injection Site came back again and the pain spread to other body parts after second Shot) and PAIN IN EXTREMITY (Aches and Pain on Both Upper Arms after second Shot). On an unknown date, the patient experienced FATIGUE (Tired/Fatigue) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Lack of interest in doing anything (Used to read books)). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) for Pain, at an unspecified dose and frequency and MELOXICAM for Pain, at an unspecified dose and frequency. On 11-Feb-2021, VACCINATION SITE PAIN (Pain on the Injection site after second Shot) had resolved. At the time of the report, PAIN (Pain Injection Site came back again and the pain spread to other body parts after second Shot), PAIN IN EXTREMITY (Aches and Pain on Both Upper Arms after second Shot), FATIGUE (Tired/Fatigue) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Lack of interest in doing anything (Used to read books)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had been having aches and pain on both upper arms for 3 months.
This spontaneous report as received from a nurse via a company employee refers to a 3 year old female patient. The patient was vaccinated for prophylaxis with ROTATEQ on 21-APR-2015 (lot # K012432; expiration 20-MAY-2016), 23-JUN-2015 (lot # reported as L005751, expiration date reported as 26-JUL-2016) and 25-AUG-2015 (lot # L008578, expiration date 14-DEC-2016). On 06-APR-2018, the patient was diagnosed with viral gastrointestinal infection (reported as viral GI). In April 2018, the patient experienced uremia. On 09-APR-2018, the patient continued to get worse and went to an unknown outside facility. On the same day, the child was sent to hospital, where she was admitted for dehydration with acute gastroenteritis, hypokalemia and uremia. The nurse reported that the patient received an unspecified treatment for the dehydration with acute gastroenteritis, hypokalemia and uremia and was then discharged from the hospital on 10-APR-2018. The outcome of events was reported as recovered/resolved in approximately 2018. Causality assessment was not provided. Lot number L005751 is an invalid lot number for rotavirus vaccine, live, oral, pentavalent.
36 year old patient received Fluzone High Dose, no AE; 36 year old patient received Fluzone High Dose, no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from other health care professional.  Linked case Number: 2019SA295789, 2019SA295846, 2019SA295848, 2019SA295849, 2019SA295850, 2019SA295851 (same reporter).  This case involves a 36 years old female patient who received a 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] Prefilled Syringe (lot: UJ285AA, expiry date: 02-Jun-2020), via intramuscular route in the left arm accidentally, on 21-Oct-2019  The patient's past medical history, medical treatments, vaccinations and family history were not provided. Pregnancy test was given- to the patient and was found to be Negative.   It was an actual medication error due to product administered to patient of inappropriate age and overdose.   At the time of reporting, the 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 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.
Fever of 102 degrees, swollen left arm from elbow to shoulder, throbbing arm.