chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It is possible that the vaccine administered was an expired one. The reason we are suspecting this is because we had recently received two different shipments of the COVID Pediatric Vaccine (5 - 11 year olds - Orange Cap). One was in Feb of 2022 (expired), and one was in April of 2022 (valid until 7/6/22). The two different shipments unfortunately have exact identical lot numbers and NDC numbers - and were inadvertently intermingled in storage to the point of being unable to tell which was which. We discovered this a few days after the administration.   When we reached out to the family afterwards - the mom relayed to us that patient did not have any notable reactions to the vaccine shot that day or afterwards.
Soreness at injection site, soreness in armpit, red splotches around injection site, swollen hands.
Leg pain started in the afternoon 5/8/202. By evening he had swelling from his (L) hip to (L) knee. Rash started at injection site and spread up to left hip + down to L knee. Mother says Saturday 5/9/20 was the worst day. She called PA on call and was told to give Benadryl + use ice packs to area. By 5-11-2020, swelling + redness was minimal + he was walking normally.
Information has been received from the mother of a 4 year old male with chronic sinus infections who on 05-DEC-2007 was vaccinated with Pneumovax 23. Concomitant therapy included cefixime (SUPRAX) and influenza virus vaccine (unspecified) "in the other leg". On 05-DEC-2007 the patient developed a fever of 104 degrees and "could not walk". On 06-DEC-2007, he was taken to the emergency room and was admitted to the hospital. The mother reported that an infection had begun in her son's leg at the injection site. She reported that his leg had to be drained via a leg tube in his leg. She stated that he had to have two emergency surgeries and six stitches in his leg. She reported that he was hospitalized for four days and then discharged home to continue with unspecified antibiotics for 6 weeks. She stated that he is recovering at home. Additional information has been requested. 1/4/08 Reviewed hospital medical records which reveal patient experienced fever, swelling, pain & induration of left thigh. Admitted 12/6-12/10/2007.  Taken to OR 12/6 & again on 12/9 for I&D of left thigh.  Allergy/Immunology, ortho & ID consults done.  ID consult mentions that patient also received flu vax. Tx w/multiple IV antibiotics.  Progressed well & d/c to home on continued oral antibiotics.  FINAL DX: myofasciitis, left thigh; chronic otitis media bilateral ears; and yeast infection left axilla. 1/8/08 Received vax record which confirms patient received flu & pneumo.  VAERS database updated w/same.
Pt. reported that her arm is sore with swollen about 2.5 to 3.0" diameter. She came to pharmacy at 4:00 PM.
My menstrual cycle was different than normal; I had terrible cramping which is very abnormal for me, and instead of having a normal period, I just had spotting the days of my period.; I had terrible cramping which is very abnormal for me, and instead of having a normal period, I just had spotting the days of my period.; This is a spontaneous report from a contactable healthcare professional, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 27Mar2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, the patient experienced her menstrual cycle different than normal. The patient had terrible cramping which was very abnormal for her, and instead of having a normal period, she just had spotting the days of her period. The patient typically always had normal menstrual cycles and this was the only thing that had changed. The patient was on zero medications and not pregnant. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events menstrual cycle was different than normal, had terrible cramping which was very abnormal, and instead of having a normal period, just had spotting the days of period was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
High fever 104 overnight.  Still have chills today.  Had chills, headache, nausea and loss of equilibrium.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Second moderna  shot @ 1:30pm on 4/5/21.   7:00pm -developed neck and shoulder cramps.  9:00pm-2:30am  chills and headache   4/6/21 Headache all day (Advil every 4 hours) Fever all day (100-101 degrees) Muscle aches all day Nauseous all day (no vomit)  4/7/21 Body aches but no fever Lingering headache  Lethargic
Husband w/ Tingling tongue a few days after the first shot and it last about 2 weeks w/fluctuation in intensity; This is a spontaneous report from the Pfizer sponsored program, Pfizer RXPathways via a contactable consumer. A male patient (reporter's husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient experienced tingling tongue a few days after the first shot and it lasted about 2 weeks with fluctuation in intensity but decreased to almost non-existent yesterday. Reporter asked should the patient get the second shot and was this a sign of allergic reaction? Outcome of the event was resolving.  Information on the lot/batch number has been requested.
Fatigue. Starting early afternoon, like around 2, overwhelming. Over months, came later in day but would fall asleep. Now, comes around 4 PM. If overdo in the day, symptoms will come earlier and last rest of evening. Still feel fatigue in the morning after awakening. This is daily every day since the second vaccine dose.
Reported generalized edema on face and hands. She was noted to have some flushing. She called 911 and was brought to ED for treatment. She received IV fluids and antihistamine in the ER. She was discharged the next day and was presccribed an antihistamine for 5 days. She is fully recovered.
administered a pediatric dose instead of a Adult dose; patient vaccinated with an expired dose; administered a pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 28-year-old female patient who received HBV (Engerix B pediatric) (batch number KC57F, expiry date 16th September 2021) for prophylaxis.   On 28th September 2021, the patient received Engerix B pediatric. On 28th September 2021, unknown after receiving Engerix B pediatric, the patient experienced underdose, expired vaccine used and adult use of a child product. On an unknown date, the outcome of the underdose, expired vaccine used and adult use of a child product were unknown.  Additional details were reported as follows: Nurse reported a female patient vaccinated with an expired pediatric dose of Engerix-B, which got expired on 16th September 2021, which led to expired vaccine used, adult use of a child product and underdose. Health care professional administered a pediatric dose instead of an adult dose of Engerix-B . The reporter consented to follow up.  Health care professional gave consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021203772:same reporter
warmth on red spots; spots moved to inner arm; spots moved to inner arm; joint pain in knees; red spot/blotches on arm; A spontaneous report was received from a consumer concerning a 86-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red spot blotches on arm, warmth on red spots, spots moved to inner arm, itching, joint pain in knees.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) red spot blotches on arm, warmth on red spots, spots moved to inner arm, itching, joint pain in knees.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), red spot blotches on arm, warmth on red spots, spots moved to inner arm, itching, joint pain in knees was unknown.
Acutely could not hear out of the right ear. Examined on 10/14/11 with no abnormalities visible. Audiology exam confirmed acute loss of all hearing in the right ear.
Injection arm was painful for the first few days after the vaccination, but didn't swell or appear abnormal. It woke me up in middle of the night for a few nights afterwards with the soreness.   Seven days later, injection site was itchy, and then that evening began to be painful, and again woke me up in middle of the night with the soreness and took Tylenol. Injection site is now red, swollen, sore, and itchy.   It's only been two days of the new side effects, and I'm not concerned as I read that this is a side effect with Moderna occasionally.
Pt c/o feeling hot, then cold. Then said she couldn't see. Passed out for a short time. c/o nausea.
Fully vaccinated patient presented to ED for evaluation of weakness, fever, cough, SOB. She was found to be COVID+ originally on 7/30 and discharged to home on Ivermectin .  Sx progressed and she was admitted on 8/5/21. She reports loss of taste and smell. No N/V/D. Some headache on admission. Patient was treated with remdesivir x 5 days, decadron (day 5 of 10), Breo, Singulair, Albuterol, Eliquis 2.5 mg BID x 14 days, and ordered home oxygen as pt has SOB on exertion. Discharged to home on 8/9/21.
Patient with 2 Varivax shots 11-7-02 and 2-12-07. Now with chickenpox approximately 30 lesions.
Patient repots going to car and feeling flushed. BP 173/92. Patient denies any SOB, chest pain, patient denies any swelling to the tongue or mouth. Patient was administered 25mg of PO benadryl. BP 148/84. Patient understands she needs to report to Ed if she has worsening symptoms. Patient was administered an additional 25mg of PO benadryl. As she would have a ride home. Patient was also given Tylenol 650mg for headache.
No additional AEs; expired dose of RECOMBIVAX was administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 05-DEC-2022, the patient was vaccinated with an expired dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, pre-filled syringe, 0.5 ml, lot # U019135, expiration date: 22-NOV-2022, administered intramuscularly for prophylaxis (Expired product administered). No additional adverse event were reported (No adverse event).  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2302USA008524: US-009507513-2302USA008440: US-009507513-2302USA008308: US-009507513-2302USA008328: US-009507513-2302USA008323:
fever; sugar went up and down; This is a spontaneous report from a contactable consumer (patient's wife) received via a Pfizer-sponsored program, Pfizer Patient Assistance and Savings Program. A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) (at the age of 68 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fever and his sugar went up and down. The patient underwent lab tests and procedures which included sugar (blood glucose): went up and down, on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
High temp, fever, severe aches and pains, shortness of breath, swollen lymph nodes, soreness at injection site, feeling of being disoriented.
Gave vaccination around 10 am 8/29/16. talk to pt 9/2/16 and said that swelling of gums, n/v, and diarrhea happened late Tuesday night(8/30/16)/early Wednesday morning (9/1/16). Pt is back to work today 9/2/16.
Initially and lasting a few days,  a circular red spot at the injection site on my upper arm was somewhat sore.   It was almost gone about 5-6 days after receiving the vaccine whenbecame very red and  sporadically itchy.  This has lasted a few days.  I?ve been applying OTC hydrocortisone cream and it seems to help.  I was initially somewhat concerned
Sore arm, 100.3 F. temperature, slight head ache and sluggish.
Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 Patients received bivalent booster with 38 having improvement of symptoms; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure systolic: 220. On an unknown date, Tachycardia: greater than equal to 150.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    No concomitant medication was provided by reporter.  No treatment medication was provided by reporter.  Reporter stated she has been administering the 65 plus bivalent dose to her patients who have symptoms of long-haul COVID and has seen 88-90% success rate in resolving the symptoms of long-haul COVID.  It was reported that, vaccine was given to patients for long COVID between 21-Mar-2023 and 01-Aug-2023. 42 Patients received bivalent booster with 38 having improvement of symptoms and 50s or more. Patient was treated skin lesions, scary brain, body aches. No adverse reactions occurred.    This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case
Redness and swelling at site where MMR vaccine administered, right arm. No other reactions noted per client's mother.
Large area of swelling below injection site. Next day began with varicella like rash on neck, chest and both arms. About 20 lesions in all over a 4 day period. Still had some more break out today.
fever; swollen lymph node in her left armpit; headaches for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), LYMPHADENOPATHY (swollen lymph node in her left armpit) and HEADACHE (headaches for 2 days) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced PYREXIA (fever), LYMPHADENOPATHY (swollen lymph node in her left armpit) and HEADACHE (headaches for 2 days). In April 2021, HEADACHE (headaches for 2 days) had resolved. At the time of the report, PYREXIA (fever) and LYMPHADENOPATHY (swollen lymph node in her left armpit) outcome was unknown.            No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2022-440806, MOD-2022-440720.
This spontaneous report from a consumer refers to her husband, an about 56 year old male patient with "blood pressure", no drug allergies. On 04-APR-2013 the consumer was vaccinated with a dose of ZOSTAVAX (dose and route was unknown). Concomitant therapies included cholesterol and beta blocker, blood pressure. On 14-APR-2013, the consumer called in and reporting that her husband got a case of the shingles 10 days after she received ZOSTAVAX. It started out with stingeling sensation and did mature to full blown shingles including blisters. The shingles came on his stomach wrapped to the back. Unspecified treatment was given. Lab diagnostics studies was performed. The outcome of shingles was unknown. Additional information is not expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 06Jun2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 47 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Adhesives" (unspecified if ongoing). Concomitant medication(s) included: HYDROMORPHONE, start date: 07Feb2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID positive test on the 10th day following initial symptoms; Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Adverse event: COVID positive test on the 10th day following initial symptoms and almost complete recovery that only had a minor cough. Return of headache, clogged sinuses, cough, sneeze and runny nose, minor body aches on day 11.
TESTED POSITIVE FOR COVID; This spontaneous report received from a patient concerned a 65 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for covid-19 prophylaxis. Age at time of vaccination 64 years old. No concomitant medications were reported.  On 25-NOV-2021, the patient experienced tested positive for covid. Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid was not reported. This report was non-serious.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around September 2016, the patient received the ZOSTAVAX from a physician for its intended purpose: the prevention of shingles. Shortly thereafter, the patient suffered a severe rash. In or around January 2017, the patient presented to a physician for this injury and was diagnosed with shingles. Subsequently, and because of the shingles that the patient had because of ZOSTAVAX, the patient began having troubles with his vision. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Shingles and trouble with his vision were considered disabling. Additional information has been requested.
On March 25, 2021, at 9:15am, patient had an appointment at 3323 to receive first Moderna COVID-19 vaccine. After PHARMACIST administered vaccine, PATIENT stayed in waiting area for 15 minutes for observation. PATIENT was conscious but called PHARMACIST over due to her feeling dizzy, sweaty, and pale. PHARMACIST called store director to assist while pharmacist monitored PATIENT. STORE MANAGER called 911. Paramedics arrived and checked/ monitored PATIENT?S symptoms and overall well-being. PATIENT was then taken to the emergency room. PHARMACIST called to follow up with PATIENT around 4:30pm and 7:40pm on March 25, 2021 when PATIENT was home. PATIENT spoke with PHARMACIST and per PATIENT reported that the Emergency Room Physician checked vital signs and symptoms, and everything was normal with PATIENT. ER physician confirmed that PATIENT?S symptoms was not related to the Moderna COVID-19 vaccine and still recommends that PATIENT still receive the second dose. PHARMACIST spoke with PATIENT and recommends that she speak with her primary care physician regarding the incident before receiving the second dose.
Violent shivers & chills, headache, body aches, arm so sore I can't lift it, tired, pain at injection site.