chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Evening of vaccine (Monday):  fatigue, chills, head pressure.  Then next day, more of same symptoms + low grade fever (99-100.8 degree range).  Extreme fatigue and weakness, lack of appetite and no sense of taste.   Wednesday (3rd day) - beginning of rash on face and neck.  More of all of above-listed symptoms.  Thursday - 4th day - rash was red and raised.  Discovered it over his entire body - legs, arms, torso.  Blood red spots on torso, legs, arms and raised full continuous rash on neck and face.  Very alarming.  Called Dr's office but felt we could treat it at home.  He was not in pain, it did not itch.  Treated it with over the counter Benadryl - 2 tablets at first and then one every 4 hours.  We stopped the antibiotic on Thursday, the day we discovered the rash.
Breakthrough case admission after 4 vaccines MOderna 1/28/21 Lot# 007M20A;  Moderna 4/20/21 Lot# 007B21A;  Moderna 1/25/22 Lot# 033H21A;  Moderna 9/27/22 Lot# 083B22A
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 13-NOV-2012 at 23:50, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
rosacea flare up; facial flushing; This is a spontaneous report from a contactable consumer (reported for himself). A 62-year-old female patient (not pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1658), via an unspecified route of administration on 06Jan2021 12:15 at single dose at left arm for COVID-19 immunization. Medical history included asthma; osteoporosis; dry eye; Known allergies: Omnipaque CT injection fluid; environmental allergies including pollen and dust mites; rosacea he had many years ago including facial redness and burning. Concomitant medication included fluticasone propionate (FLOVENT). The patient previously took denosumab (PROLIA) injection last taken on 06Aug2020. Facility type vaccine was Hospital. No other vaccine in four weeks. About eight hours after the injection the patient started having facial flushing and was advised to go to an emergency room. Patient saw Dr. (Name) at (Institution name) who prescribed Benadryl, Prednisone and Pepcid and the facial flushing subsided but came back the next day. The patient had been experiencing a recurrence of symptoms due to a rosacea flare up that he had many years ago including facial redness and burning. Adverse events start date on 06Jan2021 20:00 and resulted in Emergency room/department or urgent care. The patient didn't have COVID prior vaccination and didn't have COVID tested post vaccination. The outcome of the events was recovered with lasting effects.
PFIZER VIAL SHOULD HAVE BEEN RECONSTITUTED WITH 1.8 ML NOMAL SALINE AND WAS ONLY RECONSTITUTED WITH 0.8ML NS. PATIENT RECEIVED ULTRA CONCENTRATED VACCINE DOSE.  PATIENT AND DOCTORS WERE NOTIFED AND INFORMED OF POTENTIAL INCREASED RISK OF SEVERE SORE ARM FOLLOWING INJECTION.
Erythematous postule on the face, chest.  No lesion, no itching developed 3-5 minutes after shots.  No sneezing, wheezing or respiratory distress. Temperature 97.5.  Benadryl 2cc given by mouth.  Erythema disappear within 5 minutes.
No adverse event; Dose administered >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Spikevax) (batch no. AS1417B) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:None.     On 12-Jan-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. On 12-Jan-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered &gt;12 hours post puncture).    Concomitant medications were not reported.                                       No treatment information was provided by the reporter.
Serious HIB Disease-meningitis, intensive care, ventilator, ATB, hospitalized;
100.5 degree fever, muscle/body aches at the site and all over the body due to fever.
Received injection in left deltoid around 3 pm. At about 9:00 am my left axillary lymph node was the size of a quarter. It was very sore and painful to touch and movement. Pain scale 7/10. I treated it with warm compress infused with lavender oil, Ibuprofen 400 mg orally, self-massage, and rest. Symptoms lasted 24 hours. After 24 hours the lymph node was still swollen with dissipated soreness and pain. Pain scale 0-1/10.
A week later, I also experienced some minor bleeding for about 6 hours; On the same day as my second dose of the Pfizer Covid-19 vaccine (12Jun2021), I experienced very, very heavy menstrual bleeding. The amount was similar to what is typical a few days after giving birth; This is a spontaneous report from a contactable consumer (reporting on herself). A 32-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration, administered in left arm on 12Jun2021 09:45 (age at 32 years) as dose 1, single for COVID-19 immunization. The patients medical history include 7 weeks postpartum with second child at time of vaccine. No known allergies. No covid prior vaccination and the patient not tested for COVID-19. There were no concomitant medications. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration, administered in left arm on 22May2021 10:30 as dose 1, single for COVID-19 immunization. There was no other vaccine in four weeks, no other medications in two weeks. It was reported that on 12Jun2021, on the same day as my second dose of the Pfizer Covid-19 vaccine, patient experience very, very heavy menstrual bleeding. The amount was similar to what is typical a few days after giving birth. The bleeding lasted for a day and a half. A week later, I also experienced some minor bleeding for about 6 hours. On 12Jun2021, I was about 7 weeks postpartum. The outcome of event some minor bleeding for about 6 hours was recovered and the outcome of events very heavy menstrual bleeding and vaginal haemorrhage was unknown.  Information on the batch/lot number has been requested.
Started with fatigue on March 25. Increased fatigue, Nausea, stomach tighness, lack of appetite began on the 26th. By March 30th my heart start beating out of my chest and I felt like I was having a heart attack.  I could barely breath.  Went to get something to eat, walked half way and felt like I would fall on the ground, and returned to my room.  Called my parents because I wasn't sure if I would wake up the next morning. My team leader gave me a ride to the emergency room. They drew my blood and it was dark and thick.  They sent me home.  Still feel fatigue.
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium
Information has been received from a licensed practical nurse referring to an unspecified number of unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (lot # L040422 with expiration date 15-OCT-2017, dose and route were not reported). No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Symptoms include: Extreme Hypertension, Chest pain, Difficulty Breathing, Paresthesia, Cough, Diarrhea, Joint pain, Chest Congestion which became unbearable on the 16th of September 2021. I went to the Emergency Room on the 16th of September 2021 but had to wait for an unreasonable amount of time so I left. I went to the Emergency Room on the night of 17 September 2021 at approximately 11:45pm after choking in my sleep and feeling like I couldn't breathe. The Emergency Room conducted a chest X-ray, drew blood, monitored my blood pressure and monitored my oximetry. ER administered COVID-19 test with results coming back negative. Also took a Molecule PCR test for COVID-19 at clinic which came back negative.  Treatment: Emergency room visit, blood drawn,
I had Covid back in late Sept/ early October, the evening of the injection I started feeling like I had Covid again. (Chills, low fever, headache, fatigue, etc) The next morning my arm was very sore and painful to the touch, by Monday morning the injection site was red, swollen, and very itchy. My arm is still the same.
A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a five-year-old female who received FLUMIST.  The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009.  Neither the patient's medical history nor concomitant medications were reported.  The patient is one of a pair of twin girls who received the FLUMIST on 02-Jan-2009, which expired on 30-Dec-2008.  All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2008.  All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines.  The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients.  There was no adverse event associated with this medication error as of 15-Jan-2009;  therefore, treatment and reporter/sponsor causality assessment are not applicable, and the event is considered resolved.  Additional information received on 15-Jan-2009 and incorporated into the narrative:  patient's demographics and outcome of adverse  event.
I had the same reaction after both shots.  I don't believe either was serious however enough people have told me that my reaction was atypical that I felt I should report it.  I understand the side effects that are expected post-vaccine and did experience mild symptoms the day after(shot was Friday afternoon so day one was Saturday) but very little if any effect.  The second full day after, I felt a bit tired and a little achy but again nothing serious.  I was extremely active both days in the mornings but tired a bit as the day went on and relaxed in the afternoons and evenings. The third full day afterward  (Monday) I felt like I had been hit by a bus immediately upon waking. Symptoms were exponentially worse than the prior two plus days: exhausted, entire body ached,  sweating and chills, headache and eye pain.  I was well hydrated, full of electrolytes and took ibuprofen to treat the symptoms but I then forced myself to sleep the entire day and that night.  The fourth full day I awoke as if nothing had happened.  I felt completely normal.   I am on meds for BP, thyroid, hypoadrenalism, testosterone deficiency, and take a number of natural supplements (multivitamin, B complex, etc...), am generally in good health (though medicated), rarely ill (meaning one day a year), exercise regularly and eat a healthy diet.  I am 5' 10" tall, roughly 215 lbs and 23% body fat.  I prefer to lift weights so I have more of a strength vs lean build.
Left arm swollen; Bump at the injection site; It is tender; felt Tired; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left arm swollen), INJECTION SITE MASS (Bump at the injection site), INJECTION SITE PAIN (It is tender) and FATIGUE (felt Tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CHLORPHENAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (ADVIL ALLERGY SINUS) and MULTI VITAMINS & MINERALS for an unknown indication.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PERIPHERAL SWELLING (Left arm swollen), INJECTION SITE MASS (Bump at the injection site), INJECTION SITE PAIN (It is tender) and FATIGUE (felt Tired). At the time of the report, PERIPHERAL SWELLING (Left arm swollen), INJECTION SITE MASS (Bump at the injection site), INJECTION SITE PAIN (It is tender) and FATIGUE (felt Tired) outcome was unknown.        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.   Concomitant product reported was blood pressure medication, cholesterol medication. No treatment information provided.
About 1 to 2 minutes after injection, I got extremely lightheaded and dizzy. I felt myself becoming hot and over the next few minutes became extremely sweaty. There was a loud ringing / buzzing in my ears. I sat down in the chair near the pharmacy for observation and the lightheadedness, mental fogginess, ear ringing and excessive physical sweating lasted for approximately 10 - 12 minutes post injection.
Patient told this RN during pre operative phone interview that he was seen in hospital ER 22 hours after receiving third phizer booster shot on 11/10/21. for a TIA (stroke).   He was being interviewed for upcoming transesophageal echocardiogram pertaining to his cardiomyopathy.  His last known procedure was a mitral valve repair on 9/23/21.  On the date of the phone interview in February 2022 he stated he had no residual effects from his stroke on 11/11/21, which he suspected was related to receiving the third Pfizer shot on 11/10/21.
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-FEB-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R010369, expiry date 25-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
something wrong going on in his leg; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:   A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "something wrong going on in his leg".  Additional information : It was reported that, some random guy gave the vaccine and he had a doubt that it is not a Pfizer vaccine, though he is sure that it is a Pfizer Vaccine, ever since he received the vaccine there is something wrong going on in his leg.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt received shot at 14:35. at 14:40, pt reported feeling tingly and was given bottle of water. at 14:44, pt was given benadryl 25mg tablet. 2nd tablet was attempted at approx 15:02pm but unsuccessful (pt couldn't swallow) pt complained of feeling cold, was given blanket and taken outside to sit in warm sunshine. bp strong, as reported by RN. 136/40, pulse 80. pt's lethargy increased and 911 was called at 15:09. epi-pen was adminsitered at 15:11 upon pt unable to open eyes and beginning to drool. caller remained on phone with 911 until medics arrived at 3:16pm. emts assessed pt, loaded onto stretcher & departed approximately 15:30 to hospital.
Information had been received on 19-APR-2017 regarding a case in litigation. It was alleged in litigation that a male patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, lot # and expiration date were not provided) on or about 06-JAN-2016 by a physician at a military medical care facility, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported that the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 14-MAY-2016, the patient was treated by a physician (of a medical group)(not the same physician who administered the vaccine to him) for a painful rash that was diagnosed as shingles. On or about 13-MAY-2016 the patient was treated at the same facility for another incident of shingles. Herpes zoster, also called "shingles," is an incurable viral condition, but the patient has been prescribed Acyclovir and NORCO to manage his symptoms and pain. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested. Sender's Comments:  US-009507513-1704USA009733.
Soreness to the arm, feels broken, a lot soar, she cannot lift arm, hurts when moving and radiates to her index finger which is also difficult to bend, all on the side she received vaccine.
mom stating that pt c/o eyes itching, watering, swelling denies SOB, dyspnea, swelling of arms;mom gave DPH 12:30 saw child 2PM rt eye swollen;pt sneezing;also states cats in home;pt cheerful, alert;dx acute sinusitis, OM, tonsillitis
Onset of herpetic type lesion on the right side of the neck/jaw. Pt describe lesions a pruritic/burning sensation.
I woke up with nausea around 230 am and led to vomiting for about 3-4 hours straight. The rest of the day was extremely achy in the area where spot took place as well as the neck. This lasted about 24 hours and the following day was minimal aches. all symptoms gone by 48 hours
FLU LIKE SYMPTOMS (COUGH AND CONGESTION); This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: kidney disease, and macular degeneration. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 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 an unspecified date, the patient experienced flu like symptoms (cough and congestion). Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu like symptoms (cough and congestion). This report was non-serious. This case, involving the same patient is linked to 20210648086.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: G55342), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 13Jan2021 as dose 2, single (Lot number: EL1283), in right arm, on 24Sep2021 as dose 3 (booster), single (Lot number: 301308A), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FJ9943), in right arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "I used to be obese" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Metoprolol tartrate, start date: Jan1998; Rosuvastatin, start date: Jan2003; Dyazide, start date: Jan2000. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Initial report received from a consumer's parent on 07 October 2010. This is a case of misuse where the FLUZONE vaccine was given at an inappropriate age that is not recommended by the manufacturer. A 2-month-old female infant received on 05 October 2010 an injection (route and site not provided) a FLUZONE, lot number unknown. The patient's medical history was not reported. On 06 October 2010, the patient developed nasal congestion, diarrhea, and episodes of projectile vomiting. It was unknown if the infant received 0.25 milliliter (ml) or 0.5 ml. The outcome was reported as not recovered. Follow-up information received from a physician on 22 November 2010. The patient weighed 3Kg (8 pounds 7 ounces) at birth, and has one sibling. The patient had no concurrent illnesses, pre-existing medical conditions, or use of other medications at the time of vaccination on 05 October 2010. The patient has not experienced any other adverse events with prior vaccination. On 05 October 2010 the patient had received 0.5 mL of FLUZONE. Per the reporter, the patient also received additional vaccinations on the same day that included a first 0.5 mL right thigh injection of PENTACEL (lot number C3498AA); a first 0.5 mL right thigh injection of Hepatitis B vaccine (manufacturer Merck, lot number 1001X); an oral 2.0 mL dose of Rotavirus vaccine (manufacturer Merck, lot number D88183); and a 0.5 mL left thigh injection of PREVNAR (manufacture Wyeth, lot number 1442Y). The patient had not received any other vaccinations within 4 weeks of 05 October 2010. The patient's recovery status was not updated by the reported. Follow-up information was received on 10 January 2011 from a health care professional. The lot number for FLUZONE was UH224AC. The patient's symptoms of nasal congestion and occasional diarrhea lasted three weeks after injections were received on 05 October 2010. The patient recovered three weeks post injection. Documents held by sender: None.
Mild reaction. 9X9cm, red circular, warm to touch. No pain, slight itching. Treatment is cold compress. Diphenhydramine prescribed for any itching.