chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report was received from a health care professional on 3/26/04 concerning an 81 year old female vaccinee who developed an all over body rash except for her face and legs on 11/5/03 after receiving Fluvirin on 11/1/03. On 11/5/03, the vaccinee developed an all over body rash except for her face and legs after receiving Fluvirin on 11/1/03. The patient scratched at the rash creating sores. The patient was treated for scabies and her detergent was changed. At the time of the report the patient had not recovered. There was insufficient information to determine the reporter's causality assessment. Follow up received 8/30/04: Further information was received via our distributor. The vaccinee was treated with hydroxyzine, Lotrisone, and Eucerin. As at 8/11/04, the rash continues. She has an appointment with a dermatologist scheduled for 8/13/04. No additional information is available at this time.
Severe chills and body aches, high fever, sweats and now on day 5 still have dizziness and sever migraine. Brain fog
Starting on the evening of 12/17, I woke up around 11pm with intense itching around my neck, arm pits and groin area. I applied hydrocortisone cream and went back to sleep. In the days that followed, including today (12/20), I continue to experience waves of skin itching and hives all over my body. My skin has become incredibly reactive, where gently rubbing or scratching any part of my body flares up and turns red, with continued irritation and itching.
15 weeks pregnant Vomited about 35 minutes after shot and again 25 minutes after that Later nausea and muscle soreness
A 16-year old male patient who received the first dose of vaccine; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16-year old male patient who received the first dose of vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16-year old male patient who received the first dose of vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16-year old male patient who received the first dose of vaccine) had resolved. Not Provided      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.   Patient's pre-existing medical condition include some kind of developmental disability.  No concomitant medications were reported. No treatment medication was reported.
Patient called on 10/16 to say she had a reaction to her Pfizer booster vaccine she received on 10/14/21.  About 2 hours after she felt extremely exhausted, tired, fatigued and sleepy. She also had a fever, body aches, headache was dizzy and disoriented. She also said that her diabetic neuropathy was really acting up. She stated that she was feeling much better by the next day (10/15/2021). I told her that her symptoms were pretty consistent with normal vaccine reaction but to call md if she's any worse. I also advised her to stay hydrated and to take acetaminophen or ibuprofen if needed and to rest. She was also going to report reaction to VAERS
Patient had Hoarsness in her throat and felt like she could not breathe. Was given Benadryl, Prednisone and Pepcid.
VACCINE WAS NOT DISPOSED OF DURING THE PREVIOUS NIGHT. MORNING SCHEDULE WAS HECTIC WITH MANY PATIENTS EARLY FOR VACCINE APPOINMENTS AND REQUIRING TRANSLATORS. INTERN PHARMACIST CAME INTO ADMINISTER VACCINES AND DID NOT DOUBLE CHECK IF THE VACCINES WERE JUST OPENED AND DREW VACCINE THAT WERE OPENED THE DAY PRIOR. VACCINE WAS 4 HOURS POST 12 HOURS PUNCTURE EXPIRATION. PATIENT WERE GIVEN MODERNA AS 2ND BOOSTER. PATIENT WAS CONTACTED AND REPORTED NO ADVERSE EVENT FROM THE VACCINE
pt recvd vax & devel fever of 104; pt had tremors & inc crying;
Product storage error; Received expired booster dose beyond 12 hours after puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond 12 hours after puncture) and PRODUCT STORAGE ERROR (Product storage error) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond 12 hours after puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond 12 hours after puncture) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   She states that 1 booster syringe of Moderna COVID-19 vaccine (0.25ml) was pre drawn at another pharmacy and delivered to their facility on 17-MAY-2022 and on same day vial was initially stored in the refrigerator, time was not known. On transport the syringe was in a cooler with ice without a thermometer. She was not sure of the exact transport time. At the receiving facility, immediately after transport, the syringe  was placed in the refrigerator. The syringe had a pre written expiration date of 6 hours. She does not have the exact time of the source vial puncture. The syringe was used to administered to 1 patient on 22-MAY-2022.  Vial was first punctured date and time was reported as unknown.   The vial stored post puncture was One pre-filled syringe (0.25 ml booster dose) on transport was in a cooler with ice and without thermometer. After transport completed, the syringe was placed in the Refrigerator.  Vial underwent any temperature excursions was reported as unknown.  The syringe was exposed to refrigerated temperature for 4 days prior to administering.  No concomitant medication were reported.   No treatment drug were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2022: Follow up document contain Lot Number was updated.
The patient received the Moderna vaccine by mistake. They should have received the Pfizer Vaccine.
Initial report received on 30 July 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 3-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; dose 1 on 11 June 2010 (lot not reported), dose 2 on 06 August 2010 (lot not reported), dose 3 on 28 September 2010 (lot not reported), and dose 4 (lot number C3781AA) on 29 July 2011. The subject developed a cough on 30 June 2013, approximately 2 years after the last dose, and a paroxysmal cough without a whoop on 03 July 2013. The subject also developed posttussive vomiting, apnea, and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 13 July 2013 Chest x-ray findings were negative. Corrective treatments consisted of azithromycin starting on 13 July 2013 for 5 days. At the time of final contact on 25 July 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 25 days. The patient was hospitalized for 3 days. Investigator causality assessment is not required as per protocol. This is one case out of a cumulative total of 203 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 30 July 2013. These 203 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent condition were not reported. On 24-JUL-2015 the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (strength, dose, and route were unknown, lot # L007230, expiration date: 03-SEP-2016). No concomitant medication was reported. No adverse effects reported. Additional information has been requested.
Pt received Moderna COVID vaccine for 1st dose on 2/4/2021.  On 6/22/21 he returned for 2nd dose but indicated on registration form he had not previously had a COVID-19 Vaccination and wanted Pfizer Vaccine on 6/22/21.   No adverse event.
Initial information received on 07-Jan-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 18 months old patient who received injection of suspect ACT-HIB lot number, expiry date not reported via unknown route in unknown administration site. The patients past medical history, concomitant medication and family history were not provided. It was an actual medication error due to inappropriate reconstitution technique. It was reported that sterile water was used to reconstitute ACTHIB, invalid dose was given to a patient, 1.5 years old. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Onset of fever PM 2-4-11, 103.4, fever resolved 2-6-5-2011.  Onset of watery stools 2-5-11.  Office visit 2-8-11, well hydrated, negative provider assessment.
I had some heart palpitations off and on in November and December of 2021 since the vaccine. On 01/19/2022 I started having heart palpitations quite strongly. On 1/22 they were so bad I couldn't sleep so on 1/23, I went to ER for it. The ER doctor says I have high blood pressure and a right branch blockage was revealed by EKG. The doctor in the in the ER suggested the high blood pressure was possibly due to anxiety. The ER ordered a chest x-ray which was normal. The ER checked my cardiac enzymes which were normal. I was referred to a cardiologist.
rt deltoid area became red & inflamed approx size of a baseball, increased warmth, no tenderness;tx w//cold compress on 10/11/99 area w/o redness or warmth remains swollen;
Swelling; Breast pain; sugar spike; soreness/ major aches; tired; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), BREAST PAIN (Breast pain), BLOOD GLUCOSE INCREASED (sugar spike), MYALGIA (soreness/ major aches) and FATIGUE (tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018D21A and 001A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Cortisone shot (had a cortisone shot in Jan 2021 but that worn out by Sep 2021.) in January 2021. Past adverse reactions to the above products included No adverse event with Cortisone shot. Concurrent medical conditions included Lactose intolerance, Drug allergy (Metoprolol ER succinate 100 mg), Atrioventricular nodal reentrant tachycardia (SVT/AVNRT, PVC's, APC's), AFib since 2006, Vertigo (before 2006), Blood pressure high (Control High BP), Cholesterol, Osteopenia since 2009, Lyme disease since 2006, Pre-diabetic since 2009, Drug allergy (Macrobid), Drug allergy (Lisinopril), Drug allergy (Nifedical XL) and Drug allergy (Zyrtex).   On 24-Feb-2021 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced SWELLING (Swelling), BREAST PAIN (Breast pain), BLOOD GLUCOSE INCREASED (sugar spike), MYALGIA (soreness/ major aches) and FATIGUE (tired). At the time of the report, SWELLING (Swelling), BREAST PAIN (Breast pain), BLOOD GLUCOSE INCREASED (sugar spike), MYALGIA (soreness/ major aches) and FATIGUE (tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Blood glucose: 15-30 points (High) 15-30 Points.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered SWELLING (Swelling), BREAST PAIN (Breast pain), BLOOD GLUCOSE INCREASED (sugar spike), MYALGIA (soreness/ major aches) and FATIGUE (tired) to be possibly related.    Patient stated soreness Concomitant medications was not reported.  Treatment medications was not reported.   This case was linked to MOD-2021-029925, MOD-2021-375494 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow up received contains  no new information
Information has been received from a registered nurse and a dialysis technician concerning a 40 year old female dialysis patient with Parkinson's disease and glomerulonephritis who on 6/18/03 was vaccinated with the first dose of pneumococcal vaccine 23 polyvalent (lot #644129/1079M). There was no illness at the time of vaccination. Concomitant therapy included mirtazapine, trazodone HCl, ascorbic acid (+) folic acid (+) vitamin B complex, metolazone, furosemide, insulin human, isophane, levothyroxine Na, baby aspirin, amiodarone HCl, and Rena gel. On 6/21/03, the patient developed a cough. On 6/22/03, the patient was hospitalized as a diagnosis of pneumonia was made. Treatment and diagnostic tests while hospitalized were unknown. In June 2003, the patient was discharged from the hospital as her pneumonia resolved. The dialysis technician requested that a lot check be performed. The dialysis technician also considered the pneumonia to be disabling. The dialysis technician also reported that another patient developed pneumonia after being vaccinated with pneumococcal vaccine 23 polyvalent. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released.
Significant localized reaction on the morning of 1/31/03 after receiving DTAP/HIB combined on 1/30/03. More than 4cm increase in circumference of arm. TX: Motrin q 6 hours/cool wraps tid X 24-48 hours.
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier.Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to five female patients vaccinated with improperly stored VAQTA (lot# N019924 with expiration date 02-SEP-2018) on 22-SEP-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter(link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004618, 1805USA004590, 1805USA004591, 1805USA004592, 1805USA004593, 1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).
Approximately two days after first injection I developed two red bumps on right forearm which were extremely itchy. Benadryl Extra Strength gel relieved itching for a few hours.  Red bumps spread to upper arms legs, feet and back over a period of two to three weeks. Saw dermatologist weekly for past three weeks. He prescribed antibiotic pills and topical cream including permethrin lotion which had no affect. Biopsy of one of the bumps on leg was done on 10 February which concluded the bumps were result of either a bite or allergic drug reaction. The rash/bumps are all over my body and itch intensely. Continuing to see physician in hope of finding a resolution to problem.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (reporting on behalf of the father in-law). A 78 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Feb2021 at 12:00 AM, at the age of 77 years, at single dose, for COVID-19 immunization. The patient's medical history included high blood pressure. COVID prior vaccination: no. Concomitant medications were not reported. On 27Aug2021 the patient exhibited symptoms of fatigue and fever. Positive COVID-19 test (nasal swab) on 30Aug2021. AE resulted in: Doctor or other healthcare professional office/clinic visit. The events were treated with monoclonal antibody therapy. The patient was recovering.  The lot number for BNT162b2 was not provided and will be requested during follow up.
lump in her arm below her elbow/ Lipoma; This is a spontaneous report from contactable consumer (patient) via Team. A 68 year old female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN6203, Expiration date and NDC number was unknown), via an unspecified route of administration on 28Feb2021 as dose 2, single (at the age of 67 years old) for COVID-19 immunisation. Patient had no medical history and received no concomitant medications. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EM9809, Expiration date and NDC number was unknown), via an unspecified route of administration on 07Feb2021 as dose 1, single (at the age of 67 years old) for COVID-19 immunisation and had no side effects. On 02Mar2021, 2 days after the vaccine, patient developed a lump in her arm below her elbow, it did not hurt or anything and this summer she was diagnosed to have a Lipoma and patient still have it. Patient had a Computerised Tomogram (CT) scan because it never went away and supposedly it was a lipoma. They also did a Magnetic resonance imaging (MRI) with contrast and said yes that was what it was, and it was not a medical concern if it did not cause any problems for her. Patient thought it was a coincidence and she still has it, popped up after the second dose. Patient stated that it got firm and hard, and she could feel. It was a muscular lipoma and maybe her muscle did something. Patient was curious as to getting the booster and wondering if that lump would get bigger. Patient thought it was just a coincidence with the lipoma in her arm but when this occurred with the booster patient was not so sure. It might be bigger, or it might not be, in her arm. On 05Oct2021 (two days ago, Tuesday morning), patient had her dose 3, booster shot of the Pfizer COVID vaccine. The outcome of the event was not recovered.
Syncopal episode. Tx: supine position-feet elevated ice pack to head. Pulse monitored. Patient fully recovered.
Vesicular rash started 8-24-08.  Progressive over 5 days.  Very pruritic.
At 1 AM the morning after the SHINGRIX vaccination, I developed fever and chills up to 100 degrees the following day. I felt like I was coming down with the flu and also had a local erythematous reaction at the vaccinations site as well as a serous otitis media that lasted 3 days. The fever and myalgia were pretty well cleared up at 48 hours.
bleeding  at the injection site; heat at the injection site; itching at injection site; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (bleeding  at the injection site), VACCINATION SITE WARMTH (heat at the injection site), VACCINATION SITE PRURITUS (itching at injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (bleeding  at the injection site), VACCINATION SITE WARMTH (heat at the injection site), VACCINATION SITE PRURITUS (itching at injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE HAEMORRHAGE (bleeding  at the injection site), VACCINATION SITE WARMTH (heat at the injection site), VACCINATION SITE PRURITUS (itching at injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included blood pressure medication.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up information was received on 03 May2021, event outcome updated to resolved. patient denied further follow-up.