chrisvoncsefalvay/vaers-outcomes huggingface dataset:
THE ITCHING HAS BECOME BREAKOUTS OF HIVES.  AREAS AFFECTED: WRIST, NOW ARMS.  AREAS OF CONTINUED ITCH: WRIST, ARMS, FINGERS, ANKLES, BOTTOM OF FEET, NEW  AREAS OF ITCH:  THIGHS AND NECK.  NOTICEABLE LUMPS JUST UNDER SKIN ON FOREARMS AND THIGHS.  I HAVE NOT CHANGED SOAPS, PERFUMES NOR LOTIONS.
Information has been received from a consumer concerning her 13 year old daughter with sickle cell anaemia who on 20-MAY-2008 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL vaccine (lot # not reported). The consumer reported that "her daughter has been experiencing hair loss since getting her first dose of GARDASIL vaccine. The patient's hair loss persisted (reportedly began "2 or 3 days after vaccination"). There was no concomitant medication. The patient sought unspecified medical attention. The consumer reported that her daughter "will not be continuing the series." Additional information has been requested.
Tested positive for Covid-19 on 5/14/22 with Binax home test. Tested negative previous day 5/12/22 with Binax home test.
BLOOD CLOT; RIGHT LEG PAIN; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included COVID-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 at 02:19 for prophylactic vaccination. No concomitant medications were reported.  The patient reported that she had a blood clot/pain in right leg 2-3 days after she received the vaccine. She reported that she used compression socks for a week. The patient also reported that she experienced headaches (date unspecified), which still come and go every other day. The patient stated that she had the same blood clot pain in the same leg as when she had COVID-19 infection in MAR-2020.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of blood clot and right leg pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: A patient of unspecified age and sex reported a "blood clot/pain" in right leg 2-3 days after vaccine. The patient had a history of "blood clot pain" in the same leg when she had COVID infection one year ago. History of thrombosis would provide a plausible alternative explanation for the event, although there are insufficient details to make a meaningful medical assessment. The patient was contacted and could not be immediately reached. Additional information has been requested for further assessment.
Injected flu vaccine to right deltoid, checked for blood return, seen none, vaccine given then immediately observed an induration (topical) and slight redness. Dr. notified. Ice apply and BENADRYL 50mg given via G tube. V/S as follow BP 130/97 HR: 111, RR 21, and O2 sat 94% on room air, no respiratory distress noted, at this time. After 30 minutes no redness, no swelling, and no respiratory distress, and no rashes noted, at this time.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2021 at 16:00 as dose 1, single (Lot number: el3246), in left arm, on 02Feb2021 at 15:00 as dose 2, single (Lot number: el9262), in left arm, on 04Oct2021 at 16:00 as dose 3 (booster), single (Lot number: rr2589), in left arm and on 18May2022 at 12:30 as dose 4 (booster), single (Lot number: rm7553), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart Condition" (unspecified if ongoing); "Stage 3 Kidney Disease" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19. The case was reported as non-serious. There was no other medication in 2 weeks. The patient received Paxlovid (lot number= ge1498) from 01Aug2022 to 04Aug2022 for COVID-19 treatment. On a ship (withheld) 23Jul2022 - 30Jul2022. The patient had no known allergies.
Middle ear infection diagnosed in her right ear on Jan. 19. Diagnosed by doctor on Jan. 20.  She never had any other cold symptoms and tested negative for covid on a Binax test. I don't think it's related to her vaccine but maybe a new, odd Covid symptom? She has never had an ear infection before.  Still no other symptoms.
Approximately 12 hours after injection, body aches started. Soon after chills and fever. Temp  spiked from 101.5 at 2200 to 104.1 at 2315. Slept all night, waking  with low grade temp of 100.7. Following day experienced nausea, vomiting, body aches and lethargy. Extreme vertigo. No difficulty breathing. No respiratory effects.
mild fever, headache and muscle aches on day 2; ipsilateral adenopathy on day 3 and pain in the neck, possible also due to lymph node reactivity, which lasted about 24 hours; painful pulpable contralateral axillary lymph nodes that already lasted 2 days without any signs of improvement
This spontaneous report was received from a nurse regarding a patient of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 29-SEP-2016, the patient received improperly stored VAQTA (lot# M022556 and expiry date: 26-MAY-2017) (dosing details were not reported). No adverse reaction were not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Mom called 7-23 to she was diagnosed with shingles on 7-19. On 7-20 this child with 5-10 pox vesicles on trunk. By 7-22 child increased of vesicles up to 25-30. By 7-30 completely resolved.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATENOLOL, start date: 01May2022, stop date: 16Jul2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 07Jul2023 to 12Jul2023 for COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300252538 Same patient, different drug/ AE;
Pt called and stated that she was having a chemical type reaction.  Stated that she was having swelling and itching around the eyes.
A patient administered the DAPTACEL instead of Adacel, no AE; A 11 year old patient administered Daptacel , no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00714481) and transmitted to Sanofi on 06-Aug-2021.  This case involves a 11-year-old male patient who was administered DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered and product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 28-Jul-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5765BA and expiry date: 28-Aug-2021) via an intramuscular route in the left deltoid for prophylactic vaccination instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered and product administered to patient of inappropriate age).  It was reported that "Will there be any harm related to this or will the patient require revaccination?"  This was a case of actual medication error due to Inappropriate age at vaccine administration and Wrong vaccine administered (latency same day).  At time of reporting, no adverse events were 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 the 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.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 12Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1), administration date: 11Jun2021, for COVID-19 Immunization, reaction(s): "Sore arm"; BNT162b2 (Dose: 2), administration date: 09Jul2021, for COVID-19 Immunization, reaction(s): "Sore arm"; BNT162b2 (Dose: 3), administration date: 21Jan2022, for COVID-19 Immunization, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: The caller stated in Dec2022 "I had Covid and I was annoyed, why am still getting Covid? I didn't die but I was very sick not throwing up, a lot of chills and fever. 2020 was a tough year for everybody, 1million people died. That is insane. That's worse than a war." "In 2023 the disease seems less severe than in 2020". Caller stated when he received his 4 vaccines the only thing he ended up with was a sore arm. His sister was very sick after her Covid vaccine." Caller stated he has taken 4 Pfizer Covid vaccines in the past. On 12Aug2022 he did not think he took the "newest one out there. He thought they started making the newest one the end of that month I believe" He wanted to know what is the newest one, Covid vaccine, you have, is that still the newest one or is there a newer one, What is the name of the current recommended vaccine, caller was asking What does Bivalent mean. Caller was asking since his last dose, does he still have immunity to Covid, he asked "If I got my last dose in August 2022 the ER doctor told me I should've still been immune" How long will the Bivalent dose last and How long does it take to work" also "I have no heart issue. Can these prior vaccines effect my heart down the road or will the newest vaccine", patient wanted to know "If he get the Pfizer covid vaccine today and in less than a week he get Covid 19. Then after he get Covid 19 he end up in a coma. He already had the vaccine before this, in a few weeks would he wake up from my coma", "Once he take this vaccine will he have to take another one in a few months".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M011117, expiration date: 07-DEC-2017 (route and dose were not reported). The reporter stated that the vaccine temperature excursions were of 35F for 30 minutes and 34.2F for 2 hours. No adverse event was reported in any patient. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as there is not consent to follow-up.
I got the shot at 4:30pm. Around midnight I became fatigued,  headachy, achy, very cold, and my legs felt heavy. This continued through Saturday the 6th
A few minutes after the vaccine felt heart racing, and lightheaded, they checked my pulse it was fast. I got better but not completely. when EMS arrived my pulse was still high 100 and something I don't remember the exact number, and my blood pressure was 142 over I think 80. I left once my pulse was back to normal. I did not want to go to the hospital, I didn't feel it was necessary and I went home. I don't believe it was anxiety related because I was not anxious at all, the symptoms started a few minutes after and where sudden and unexpected.
RESPIRATORY PROBLEMS; FLU-LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included: ex smoker, and massive heart attack (on life support for 10 days), and concurrent conditions included: baseline breathing problems (requiring 4L of oxygen 24/7). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the after receiving covid-19 vaccine ad26.cov2.s the patient experienced flu-like symptoms after getting the vaccine and eventually required a CPAP(Continuous positive airway pressure). The reporter stated that, the patient used to smoke and have a baseline breathing problems (coded as respiratory problems) requiring 4 L of oxygen 24/7 at the time of report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu-like symptoms and respiratory problems was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20211115315, 20211115081 and 20211115414.; Sender's Comments: V0: 20211115400-covid-19 vaccine ad26.cov2.s- flu-like symptoms. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211115400-Covid-19 vaccine ad26.cov2.s- respiratory problems . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Chief Complaint  R leg wound 1 week. Pain, edema +4, erythema. Denies fevers.  History of Present Illness  62 year old female patient who presented to the ER with progressive right lower extremity wound, swelling, pain.  Patient first noticed that there was a problem with her leg last Sunday evening.  She has not seen/called her doctor, been to urgent care/wound care center.  She has not put anything on the wound, nor started any antibiotics.  The affected area is quite painful, rated at 10/10, described as sharp, stabbing, burning.  Pain is worse with weight baring and at present she is unable to walk on the RLE at all due to pain.  She has noticed progressive edema, erythema, warmth and weeping of a serosangui fluid.  She denies fever, chills, chest pain, SOB, diarrhea, constipation, dysuria.  She reports urinating frequently, cold symptoms like runny nose, sore throat, dry cough.  She denies sick contacts or known COVID-19 exposure.  She has completed Pfizer COVID vaccine series.  She has tested positive for COVID-19 today.  She is aware that she was also positive pre-vaccination in 11-2020.
Patient was observed for 15 minutes and no adverse reactions were noted. However, it was later discovered that the vaccine given was not stored within the CDC guidelines, making it expired or unusable .
pt recv vax 27JUL95 & 12JUN96 pt exp chicken pox;No further details were provided;
received an expired Typhim vaccine with no reported adverse event; Initial information received on 05-May-2021 regarding an unsolicited valid non-serious case received from a other Healthcare Professional.  This case involves an 18 year old male patient who received an expired dose of 0.5 ml of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (lot R1B743M and expiry date: 23-Mar-2021) (Injection) (Frequency: Once) via an intramuscular route in the right arm for prophylactic vaccination on 24-Apr-2021 (expired product administered).   Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) and TETANUS VACCINE (TETANUS VACCINE).  It was a case of actual medication error due to expired vaccine used (latency on same day).  At the time of report, 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 the 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.
After receipt of the MMR, she had a few sips of a Starbucks "caramel Macchiato" (contains espresso (coffee), vanilla, milk and caramel - she added nothing else). Approximately 30 minutes following immunization, she noted flushing and intense itching of her palms, then feet, then scalp. Within about 5 minutes, she noted throat tightness and perhaps a degree of chest tightness, she denies cough or wheeze, and coworkers noted facial flushing/blotching. On the way back to medical, throat tightness worsened and she felt her tongue was swelling. In the clinic she observed to have "flushing over face and between eyes; both conjunctivas were injected; there were pinpoint red spots on neck and hands and palms of hands were very red. Bottom of feet were somewhat red. There was 1 fresh hive on her back; chest clear; throat and vulva normal; no obvious distress except for itching." She was treated with epinephrine (IM), BENADRYL (PO) and ALLEGRA (PO) 1 hr after receipt of vaccine. She was observed for 1.5 hours, by which time all the signs and symptoms had cleared and she was released with an EpiPen.
I experienced leg, feet, stomach, and brain swelling after flying: started swelling on flight on Wednesday, April 7th.  During the 3 days, I was in another city my feet were swelling so badly that I could only wear a pair of flip flops and I had blisters all over my feet and even in-between my toes.  I have never experienced swelling like I did after that flight.  I do not believe that I would have experienced any symptoms if I had not flown.    When I returned home , I did 2 rounds of prednisone and even the first pill immediately helped the brain inflammation.  I pushed back my second Covid shot to May 26, 2021.  I travelled last week to and I experienced feet and stomach swelling, but no brain swelling.  Once again I experienced these symptoms after flying.  I wore panty hose flying this time and that seemed to help a bit.  Side note: I believe I had COVID19 in December 2019 - March 2020.  I have exercise-induced asthma and my inhalers did not work.  The only thing that helped me to breathe was when my PA gave me 2 steroid shots (1/week) and right before Christmas I took a steroid pack that helped to get me over the hump.  I had been short of breath since that time; however, after receiving the 1st Pfizer vaccine on March 25, 2021, I felt like I could breathe deeply again.
This spontaneous report as received from a medical assistant (also reported as a physician) refers to a 5 day old patient. Information about the patient's concurrent conditions, medical history and concomitant therapy was not reported. On 17-DEC-2018, the patient received ROTATEQ (lot # was R005865, expiration date was 22-OCT-2019), dose, unit, frequency and indication were not reported (product administered to patient of inappropriate age). No adverse effects was reported. The outcome of the events was not reported.
Pt with a history of varicella who was exposed to her daughter who was vaccinated with varicella virus vaccine live, developed chickenpox that consisted of an unknown number of lesions. This was confirmed by a physician. The daughter did not have an adverse experience. However the husband had a similar experience following exposure to varicella virus vaccine live. It was also noted that the consumer was a teacher and "there was an outbreak of varicella in her school at the time". The physician felt that this experience "was strange" because the consumer had previously had chickenpox. Additional information has been requested.
pt recv vax & had shock like state-septic workup performed treated w/IV fluids, ATB, pressors;sx resolved p/8hr;
Body aches, headache, sore arm. Approximately 11 hours after second dose.
Chills for two days post second dose; pain in injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (pain in injection site) and CHILLS (Chills for two days post second dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lymphedema.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced VACCINATION SITE PAIN (pain in injection site). On 13-Sep-2021, the patient experienced CHILLS (Chills for two days post second dose). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency; NAPROXEN for Pain, at an unspecified dose and frequency and PARACETAMOL for Pain, at an unspecified dose and frequency. On 15-Sep-2021, CHILLS (Chills for two days post second dose) had resolved. At the time of the report, VACCINATION SITE PAIN (pain in injection site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter.
On 3/1/02, the vaccinee received her 1st injection of Engerix-B. On 3/1/02, at an unspecified time post vax, she experienced headache, stiff neck muscles, body aches, and "stiffness all over". The vaccinee was seen in the ER on 3/4/02. The headache resolved "after several weeks". As of 4/22/02, the other events had resolved.
I'm still having tiredness, headache, muscle pain and joint pain since I got 2nd vaccine on May 7. In addition, I don't know if this is associated with the vaccine but, I start having Sleep Apnea Syndrome 3 days after the 2nd vaccine.
Itching and swollen arm for 6 days. Patient was using calamine lotion. Primary care doctor advised using Benadryl.