chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"very red" body rash; circular rash (left arm)/splotchy" body rash\prickly heat" body rash\tarso rash\back rash\leg (both) rash\right arm rash; headache; This spontaneous case was reported by a patient and describes the occurrence of RASH ERYTHEMATOUS ("very red" body rash), HEADACHE (headache) and RASH (circular rash (left arm)/splotchy" body rash\prickly heat" body rash\tarso rash\back rash\leg (both) rash\right arm rash) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013N20A. and 048A21A.) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE (headache). Concomitant products included PARACETAMOL (TYLENOL) and DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (BENADRYL ALLERGY & SINUS HEADACHE) for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 29-Mar-2021, the patient experienced HEADACHE (headache). On 30-Mar-2021, the patient experienced RASH ERYTHEMATOUS ("very red" body rash) and RASH (circular rash (left arm)/splotchy" body rash\prickly heat" body rash\tarso rash\back rash\leg (both) rash\right arm rash). At the time of the report, RASH ERYTHEMATOUS ("very red" body rash), HEADACHE (headache) and RASH (circular rash (left arm)/splotchy" body rash\prickly heat" body rash\tarso rash\back rash\leg (both) rash\right arm rash) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-064525 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-064525:case for first dose
Flu-like symptoms. Aches, pains, fever,  Nausea.   Woke up at 5:00am feeling aches, and the entire day I felt like I could not move. Similar to the flu. Symptoms gradually improved late in the evening, and the next day, I felt 100% better.
I got Pfizer booster on 12/29/2021. The injection site swelled up about the of a half a walnut shell and was red and swollen. The site is still raised but no longer painful. The site is still discolored. I had a fever of 100 degrees for two days. It may not be related to the injection, but for a week I have experienced an allergy attack with clear nasal discharge and itching.
Woke up in the middle of the night (early Friday morning) about 12 hours after the shot with such severe soreness that it was painful. In the morning, I nearly fainted then vomited. The rest of the day, my fever rose and became the worst at night, going up to 103.5. Tylenol did not help the fever break, it only slightly lowered my fever each time I took a dose. The following day, Saturday, I woke up still with a fever and chills, vomited everywhere with no advanced warning from my body. Had fever the rest of the day. On Sunday, I had a fever in the morning, and then my temperature turned normal. In the evening, it went up again to about 100.3. My temperature was consistently normal by Monday morning. Throughout the entire reaction, I had severe pain in my right arm, swelling and redness that covered a wide area. I also had diarrhea and no appetite throughout the reaction.
my eye floaters ate now bad; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VITREOUS FLOATERS (my eye floaters ate now bad) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VITREOUS FLOATERS (my eye floaters ate now bad). At the time of the report, VITREOUS FLOATERS (my eye floaters ate now bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported
This spontaneous report as received from a registered pharmacist refers to a 67 years old female patient with iodides allergy, penicillin allergy, sulfa allergy and no medical history. The patient was subcutaneously vaccinated with 0.65 ml ZOSTAVAX (lot # 672675/0068AE, exp 03-APR-2013) on 16-AUG-2012. Concomitant medications included: TYLENOL. It was reported that on 17-AUG-2012 the patient developed an inch and a quarter redness at the injection site which extended 6 inches in length and 2 and 1/2 inches in width with puffiness, redness and itchiness. Pharmacist noted that the patient stated that the swelling, redness and puffiness seems to be spreading each day. BENADRYL was given as treatment for the events. No lab diagnostic study was reported. The outcome of patient was reported as not recovered/not resolved. The patient sought medical attention via contacting pharmacist. Additional information is not expected.
Patient returned to the pharmacy the following day from receiving vaccination.  The immunized arm was swollen, red, warm to touch from shoulder down to elbow.  After notifying PCP, patient was directed to have it looked at that afternoon.
This spontaneous report was received from an unspecified reporter via company representative and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9, intramuscularly (strength, dose, lot# and expiration date were not reported). On an unknown date, after being administered with GARDASIL 9, the patient "fainted" and was rushed to the hospital. The outcome of the event was unknown. The relatedness between the event and GARDASIL 9 vaccination  was not reported. Additional information has been requested.
8 x 7 1/2 cm redness with increased warmth with mild induration. Moderate edema of left thigh and left knee. Left knee 28cm right knee 25cm. Placed on Benadryl 1 1/2 with every 6 hrs.
Extremely lightheaded, chills, headache, sensitive skin to the touch, dizziness, nausea, aches and pains, chest compression, sleeplessness . It was so bad that I was debating going to the hospital.
0755 - patient became dizzy, flushed and diaphoretic in appearance and temporarily lost consciousness. BP - 123/82 HR - 106 with strong radial pulse O2 sat- 100 on RA With verbal stimulation patient became arousable and was able to state name and where she was. Once fully conscious, pt stated she felt as if her "nerve" was hit when she received her vaccine which caused severe arm pain, muscle weakness in the arm and tingling. She then stated that it felt as if her "blood vessels in her head were all becoming smaller." VS taken again - BP-120/86 HR - 103 O2 - 100 on RA  Patient began feeling better & was sat up in chair, but after a few minutes sitting upright the chair, pt started to become pale and c/o "not feeling well again."  We safely lowered pt back to the floor and rechecked VS. BP- 80/32 HR - 130 - O2 - 98% on RA. Pt still conscious at this time and agreeable to be transported to ED for further evaluation. Received fluids and had labs in ED, stable and dcd home same day
Purpura noted to right hand/wrist/forearm shortly after injection of Pfizer COVID vaccine #2 and during platelet infusion for TTP.; This is a spontaneous report from a contactable other healthcare professional. A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular administered in left arm at doctor's office/urgent care on 02Mar2021 (at the age of 55-year-old) (Batch/Lot Number: EL9269) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient had no other vaccine in four weeks. It was unknown if patient had COVID prior to vaccination. The patient was not tested for COVID post vaccination. Medical history included thrombotic thrombocytopenic purpura (TTP), gastrooesophageal reflux disease (GERD), hypertension (HTN), cerebrovascular accident (CVA), chronic obstructive pulmonary disease (COPD), type 2 diabetes mellitus (DM), hyperlipidaemia (HLD), acute kidney infection(AKI), and known allergies to latex. The patient received unspecified other medications in two weeks. Historical vaccine includes first dose of bnt162b2 via intramuscular route on 05Feb2021 (at the age of 55-year-old) (Lot number: EL9262) for COVID-19 immunisation. On 02Mar2021, the patient experienced purpura noted to right hand/wrist/forearm shortly after injection of Pfizer covid vaccine #2 and during platelet infusion for TTP. No treatment was received for the event. The patient was recovering from the event.  No follow-up attempts are possible. No further information is expected.
pt recv vax 8JUL91 & on 1NOV91 pt exp chronic fatigue, fibromyalgia, & weight loss;no further details were provided;
Blood sugar has gone from average of 160 to 225 per day, I wear a pump and CGM so I track it closely.  the first 2 day after the vaccine my sugar dropped lower but then rose high and has remained since then.
4:30pm slight nausea; arm pain; mild headache 5:00 pm headache more severe; up the back of head, described as unusual pain; thought a migraine was coming on. 5-7:00pm headache continues to worsen; chills; research on line side effects of Pfizer vaccine and they coincide with symptoms; 7:05  gets up to urinate (no assistance needed); screams out in pain 3 times while on toilet; starts to vomit; right side of face (eye and cheek and mouth droop like a stroke; left hand starts to curl. Loses consciousness immediately thereafter. 911 call; paramedics on the way; airway was swept and clear; gurgled breathing. Rushed to Hospital and assessed as having massive brain bleed. Pronounced dead at 10:22pm.  Acute Hemorrhagic Stroke on Death Certificate.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-MAY-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056.
Pt recv vax on 6/8/98; on 6/11/98 pt exp red spots on his back then to chest, fever x 5 day; tx=Benadryl, Tylenol
My daughter is going into junior high and received her tetanus shot along with the first shot of 3 for Gardasil. That was three weeks ago. Yesterday morning I was curling her hair in the bathroom for school pictures and she fainted. Right before she passed out she said, "Mom, my stomach hurts really bad." The next thing I knew she was falling to the ground. She was completely out of it, she wasn't necessarily convulsing but her hands were in fists, her body rigid, and her hands were somewhat tremulous. When she came to she complained of severe chest pain. She has doesn't have epilepsy and has not done this before. I called the paramedics. When they got to my home and checked her out, her vitals were fine.  I called her primary care provider and asked if she should be seen, they stated that she most likely locked her knees and that's what caused the syncope episode. So I figured she probably didn't need to go and I would just keep an eye on her.  After reading about the adverse effects now I'm not so sure that she locked her knees. I will not get her the rest of the series.  It's not to say that many women and girls have these shots without any sequelae. However, I recognize that this incident with my daughter may be coincidence, the risk is far too great for me to take any chances.
1038-time of vaccination.1044-Pt honked horn for medical, this RN to care immediately,states heart is racing,pt tearful.HR palpated 124, pt denies SOB/CP or airway involvement.Pt denies history of anxiety and was not feeling "nervous" about receiving vaccine.1046 This RN noted pt having hives to neck/chest.EMS activated.Pt continues to deny airway involvement. HR 124 BP 139/90. This RN with patient for 1:1 continuous monitoring. 1104 EMS arrived, report given. Paramedic in to assess. At this time hives to neck and chest are much improved. HR 104. Pt's husband (ER nurse) also arrived.Pt declining EMS transport. 1108 EMS departed. 1110 Pt feeling better, hives resolved. HR 100. Pt discharged with husband, left vehicle in parking lot, husband will drive patient home and monitor her.
Tinnitus immediately in right ear, a week or so later progressed to complete hearing loss in right ear. Corticosteroids had no effect. Complete deafness in right ear still present 3 months later.
Information has been received from a physician's assistant concerning a 12 month old male pt who on 01/15/04 was vaccinated with a dose of MMRII (Lot # 645405/0132N). Secondary suspect therapy included vaccination on 01/15/04 with a dose of varicella virus vaccine live (Lot # 644251/1154M). Concomitant medications included influenza virus vaccine and tuberculin purified protein derivative (PPD test). About a week later the mother reported a maculopapular rash on the trunk (also reported as rash broke out on 01/21/04). It was reported that as of 01/27/04 the child also had conjunctivitis. The physician assistant did not believe that the conjunctivitis was related. Unspecified medical attention was sought. It was noted on 01/27/04 that the pt was still being treated for the events. Treatment included Benadryl, Caladryl and Bleph-10 ointment which was prescribed for the conjunctivitis. Additional information has been requested.
Patient received her COVID 19 moderna vaccine 2 weeks ago. I week ago she developed shortness of breath and chest tightness, She was diagnosed with extensive bilateral pulmonary emoboli with a left popliteal DVT.
Extreme Fatigue; Sleeping longer at nights more than usual; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 72-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 07Feb2021 at 09:00 AM as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Patient had no known allergies and no chronic health conditions. The patient concomitant medications included lisinopril, levothyroxine, fenofibrate, all drugs taken for an unspecified indication, start and stop date were not reported. 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. The patient had not been tested for COVID-19 post vaccination. On 09Feb2021 at 14:00 (02:00 PM), the patient experienced extreme fatigue, sleeping longer at nights more than usual. Adverse event: Extreme Fatigue ongoing since Tuesday, 2 days after shot. Able to function in morning, but by afternoon, fatigue sets in and have to go to bed. Sleeping longer at nights more than usual with naps in afternoon. The patient did not receive treatment for the events. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.  Follow-Up (PRD/SRD 31Mar2021): Follow-up attempts are completed. No further information is expected.
This is a spontaneous report from a contactable physician via Pfizer sales representative. A patient of unspecified age, race and gender received TRUMENBA, via an unspecified route of administration at single dose and HPV9, via an unspecified route of administration, both on an unspecified same date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced high fever (40.5 Celsius) for two hours after administration on an unspecified date with outcome of unknown.
This spontaneous report was received from a nurse refers to an approximately 1 years old patient. The patient was vaccinated with dose 1, 0.5 ml VAQTA intramuscularly (lot # reported as H010437, expiry: 28-FEB-2015) on 18-JUN-2012. No concomitant medications were reported. On 04-OCT-2012, the patient was administered second dose of VAQTA intramuscularly (lot # not reported) four months after the first dose of VAQTA was administered. No adverse experience had been observed or reported. No medical attention was sought by the patient. Additional information has been requested.
Pt recv vax on 11/10/98; on same day pt exp swollen/ red vax site, fever (102.8F)
Patient developed nausea, dry heaving, vertigo, hypertension requiring admission to emergency department
A mother and a pharmacist reported that a 12 month old male received his 1st dose of Prevnar vaccine and subsequently was unable to bear weight on his right leg. Prior to immunization, the child was able to stand on his own, take 3 to 4 steps, lean on furniture and walk. He was seen by his doctor who described the symptoms as "no weight bearing". At the date of this report the event has continued for 2 to 2.5 months. No additional information was available as of the date of this report. Additional information received on 8/2/01, contained the name and address of Orthopedic MD. Additional information received on 8/6/01, contained name and address of pharmacist. A 15-day follow up report received 10/09/2001 adds: Laboratory data includes x-rays and blood tests (unspecified) with negative results. Orthopedic physician indicated that child was disabled for 4 months. This case was upgraded to serious based on new info stating that child was disabled for 4 months.
Soreness at the Injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the Injection site) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 013L20A) for an unknown indication.     The patient's past medical history included Thrombocytopenic purpura (Resolved). Concurrent medical conditions included Chronic lymphocytic leukemia (partial remission).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the Injection site). On 01-Feb-2021, VACCINATION SITE PAIN (Soreness at the Injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, SARS-CoV-2 antibody test: negative (Negative) Negative.         Treatment information not provided.  In Mar 2021 patient also undergone T-Cell test specific to Covid-19 which came positive.   This case was linked to MOD-2021-065382 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow-up received on 14 May 2021, investigations reported
Ill; Temperature; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Ill) and PYREXIA (Temperature) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Ill) and PYREXIA (Temperature). At the time of the report, ILLNESS (Ill) and PYREXIA (Temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  Treatment details not  included.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route unknown) on 30-JUL-2013, lot # H011350 expiration date: 21-FEB-2015. No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
Pain in arm that shot was given that started the day after shot was given and lasted 2 days. Large swelling and tenderness in armpit that shot was given that started 3 days after shot was given and and is still there.
expired dose of Daptacel was inadvertently administered to a patient /no AE; Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 14 months old female patient who inadvertently received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB).  On 11-Jun-2019, the patient received 4th dose (expired) of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5202AA and expiry date: 16-May-2019 via intramuscular route in the thigh NOS.  It was a case of actual medication error due to expired vaccine used. It was reported that expired dose of Daptacel was inadvertently administered to a patient on 11Jun2019.  No adverse event was reported.  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.  List of documents held by sender: none.
Covid Janssen vaccine 4/10/2021 at 2 PM. Symptoms noticed 4/11/2021- 7 AM- tinnitus, headache, injection site pain, fatigue. On 4/12, 7 AM- woke & noted shingles-type lesions on R ribcage, R side of body with burning sensation & pain, headache and fatigue- confirmed by MD. Prescribed Valtrex 1 gm TID x7 days.