chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received Tdap (Tetanus, Diphtheria, & Pertussis)and Pneumococcal vaccinations on Fri., 8/29/08.  On Sat.evening, 8/30/08, I started feeling flushed and a tight feeling in my forehead.  I then started itching all over my torso, arms and neck.  When I checked my body, I had hives-type rash on my chest and back.  I took 2 benadryl tabs to relieve symptoms.  Itching subsided, but rash remained.  A couple hours later it started again; I took 1 benadryl tab which carried me through the night.  The next morning, the itching and tightness in the forehead started again.  I made an urgent care appt. The doctor thought the reaction was from the Tdap vaccine.  He said that benadryl was appropriate course of treatment.  He also gave Rx for Prednisone should I need it within the next few days.  I didn't need it.  All was fine until the following Sat., 9/8/08 when I had the same reaction.  I then took 2 benadryl tabs and no further reaction has occurred since.
Sterile abcess @ inject site remains; Inject given @ 18mon in anterior leg;
(Statement from Patient) "Injection was very painful and my arm was very painful and couldn't more the arm easily for the first week. The pain has continued going down the arm. Saw my doctor who prescribed naproxen and exercises but it has not improved.  Will follow up with my doctor."
Low H/H, Low Iron, Low Ferritin, high TIBC, low iron sat %
Patient mother upset about pharmacy's billing process (new pharmacist wasn't aware that certain insurance was covered) mother mentioned pain the arm of the patient.
Observation 1.5 hr roa localized redness, swelling, c/o itchy at site. 25mg Benadryl given. 1030 am no SOB, no wheeze, no cough. Raised "itchy" 25mg addt. Benadryl given positive effect.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (318 patients received dose from vials beyond 30-day use by date) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19 immunization. No medical history reported. On Jul 14, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient administered expired product (318 patients received dose from vials beyond 30-day use by date). At the time of the report, administered expired product (318 patients received dose from vials beyond 30-day use by date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-364616 (patient link).
Intense joint pain at randomly changing locations, intense headache (seems to respond to pain reliever but will not wain), diarrhea, dry heaving nausea, dehydration, fluctuating temperature (between 97.2 and 98.5), chills for a little while and then intense sweating, occasional stabbing pains in chest and gut, intense weakness, nearly lost consciousness 2 times between 7:30 and 9am on 9/10.
Pt recv vax on 10/14/98; on 10/15/98 pt exp no hearing in left ear; pt saw M.D. 10/20; dx=wax build up.
11 am Vaccines administered. 11:15 Developed gen pruritus, throat tightening & SOB. Which resolved spontaneously. 12:00 Went to lunch, ate pizza, then developed facial & lip swelling with erythema.
patient reported acute illness of about 2 weeks of fever/chills after second dose. muscle and joint aches have persisted until now
Swelling of feet occurred 6-8 hours after flumist administration, trace pitting edema from ankle to knee bilaterally, swelling of face and eyes and abdomen, headache mild constant, sleepiness and fatigue.
Chills, injection arm ache, back ache, headache - symptoms disappeared overnight but lasted roughly 16 hours or so
Patient received SP/TIV at approximately 4:15PM on 11/18/2010 during a nurse visit. The child was upset, crying and walking around exam room after the TIV was administered and passed out for a few seconds, approximatly 5 minutes after the vaccine was administered.   She returned to consciousness within a few seconds with no postictal period. Mom promptly picked her up and placed her on the exam table.  She complained of nausea; then vomited and lost urinary control. No tremors noted.    No c/o headache, no injury from fall.  She was taken to see PA.  Exam was negative except for a right otitis media.  Mom was given a prescription for a 10 day course of Amoxicillin for patient and instructed to return to the office in 2 weeks for a recheck.
States within 8 hours after receiving shot arm began swelling, pain, rash, weak, shortness of breath. States saw a doctor but can't remember who. No documentation of any problems with previous shots. Reports reaction today.
Employee was given MMR vaccine on 04/11/16; 3 days later had temp. 99 degrees then had a few red, raised areas appear on neck, shoulder area; itching. Rash spreading - no other symptoms. Sent to Dr. for evaluation.
pt recvd inject 25FEB93 red raised rash buttocks trunk arms legs 1MAR93; denies resp sx rash itches; on med for breast CA since AUG92;
Left deltoid swollen, redden, burning, and tightness at back of upper arm. C/o of tingling lips, rash at lower left arm.
Patient claimed that after receiving the Spikevax  Moderna vaccine on October 19, 2023, 8 days later he experienced facial paralysis ("per patient Bell's palsy") and when to see an MD for treatment.  Patient is currently taking Acyclovir and Prednisone for 5 days. Will follow-up with primary care MD afterwards.
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 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 50 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: EN6200), on 10Apr2021 as dose 2, single (Lot number: EN6200), in right arm and on 30Aug2021 as dose 3 (booster), single (Lot number: EW0168), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Neuroendocrine/carcinoid cancer with syndrome" (unspecified if ongoing); "polymyositis" (unspecified if ongoing); "systemic scleroderma" (unspecified if ongoing); "MS" (unspecified if ongoing). Concomitant medication(s) included: SOMATULINE DEPOT, start date: 03Jan2017; GABAPENTIN, start date: 02Jan2020; BACLOFEN, start date: 02Apr2010. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Aug2023) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Treatment was Paxlovid from 10Aug2023 to 15Aug2023.
Patient was diagnosed with gallstone pancreatitis and was admitted to the hospital. Patient was given IV fluids, pain control. MRCP was done and it did not show stones in common bile duct. Patient had innumerable small gallstones in the gallbladder. There was no cholecystitis. Consultations to General Surgery and to Gastroenterology was requested. Patient had ERCP, biliary stent was placed after sphincterotomy was done. Patient had laparoscopic cholecystectomy. By the time of discharge, patient felt much better. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
I am  experiencing little red itchy bumps all over body, some are patches some are hives; I am  experiencing little red itchy bumps all over body, some are patches some are hives; some are patches some are hives; I am  experiencing little red itchy bumps all over body, some are patches some are hives; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULO-PAPULAR (I am  experiencing little red itchy bumps all over body, some are patches some are hives), ERYTHEMA (I am  experiencing little red itchy bumps all over body, some are patches some are hives), URTICARIA (some are patches some are hives) and PRURITUS (I am  experiencing little red itchy bumps all over body, some are patches some are hives) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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, the patient experienced RASH MACULO-PAPULAR (I am  experiencing little red itchy bumps all over body, some are patches some are hives), ERYTHEMA (I am  experiencing little red itchy bumps all over body, some are patches some are hives), URTICARIA (some are patches some are hives) and PRURITUS (I am  experiencing little red itchy bumps all over body, some are patches some are hives). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH MACULO-PAPULAR (I am  experiencing little red itchy bumps all over body, some are patches some are hives), ERYTHEMA (I am  experiencing little red itchy bumps all over body, some are patches some are hives), URTICARIA (some are patches some are hives) and PRURITUS (I am  experiencing little red itchy bumps all over body, some are patches some are hives) had not resolved.
Initial unsolicited report received from a non healthcare professional on 06-Oct-2015. This case involves a 40 years old male patient who was vaccinated with a dose of INFLUENZA VACCINE (INFLUENZA VACCINE) via intramuscular route (manufacturer: unknown, batch number, expiry date, site of administration were not reported) on 16-Sep-2015. The patient had no illness at time of vaccination. There was no known allergy. Birth defects and medical conditions were reported as none. Concomitant medications were not reported. On 19-Sep-2015, three days post vaccination, the patient began itching and broke out in a rash on his forearms. Symptoms progressed to uticaria all over his body. She required Emergency Room/doctor visit for the events. The patient took two courses of Solumedrol dose pack as corrective treatment with little improvement. No laboratory tests were done. The patient had not recovered from the above mentioned events. List of documents held by sender: none.
Patient experienced sore arm at first, but around 10 pm the next day the skin on her underarm and chest began to get hot and swell.  I advised her to take ibuprofen and diphenhydramine.  She mentioned she was going to urgent care because her throat was sore (not related to shot).
Sore arm , and hives around injection site on day 2 and itchiness  took benadryl  and zyrtec
Patient received Pfizer COVID vaccine on 5/7/21 and 5/28/21. On 12/31/21, patient tested positive for COVID and admitted to our inpatient facility (med/surg unit) with acute on chronic respiratory failure with hypoxia and hypercapnia secondary to COVID-19 pneumonia.  On 1/4/22, patient was transferred to CCU (BiPAP dependent) and is still here as of today (1/5/22).
Allergic Reaction on arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 7 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 10:30 (Batch/Lot number: unknown) at the age of 7 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE REACTION (non-serious) with onset 11Nov2021 10:30, outcome "recovering", described as "Allergic Reaction on arm". Therapeutic measures were not taken as a result of vaccination site reaction.  Additional information: Patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: No. Patient had known allergies: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I started having palpitations in my chest a lot like 6 times an hour. I didn't think much of it, but I did decrease my thyroid medicine and saw the doctor who did an EKG and blood work on October 18, 2022. She also checked magnesium, CBC, and thyroid levels and everything was normal expect thyroid TSH was elevated to 4.68. The doctor told me to resume my normal dose of the thyroid medicine and is placing me on a heart monitor on October 26, 2022. I will need to wear it for 2 weeks.
Local reaction (L) deltoid 5 x 6 cm not tender, slightly raised.
Pregnant wife received the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant wife received the vaccine) in a female patient of an unknown age (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage (Sometime in Oct-Nov 2020.).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 10-Feb-2021 and the estimated date of delivery was 17-Nov-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant wife received the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 12-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant wife received the vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Pregnancy test: positive positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  Patient tested positive for pregnant on 11-MAr-2021. Prenatal case has not been established.  No treatment of events was reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Internal review on 26-JUL-2021 resulted in update of Lab data,Gravida,Birth type and fetal outcome
Pt received all Prevnar doses. Had streptpneumonia bacteremia on 11/13/2001 with fever and increased WBC 36,000. Treated outpatient with Rocephin. Had bronchitis one week prior, was resolving.
facial drooping/Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient (not pregnant) received dose number 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6206) via an unspecified route of administration, administered in the left arm, on 11Mar2021 08:15 AM at a single dose for COVID-19 immunisation. Medical history included diabetes, thyroid, and hernia. The patient had no known allergies. Concomitant medication(s) included metformin hydrochloride (METFORMIN ER); levothyroxine; and omeprazole. The patient had no other vaccine in four weeks. On 12Mar2021 at 2AM, the patient woke up and had facial drooping; went to the ER and was admitted for possible stroke. It was further clarified that it was not a stroke but she has Bell's palsy. The adverse event (AE) resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization (duration for 1 day, from 12Mar2021 to 13Mar2021). AE treatment included medicine, methylprednisolone, valacyclovir, eyedrop. The patient had no COVID prior to vaccination. The patient underwent lab tests which included COVID test type post vaccination (nasal swab, rapid test): negative on 12Mar2021 (COVID tested post vaccination). The outcome of the event was not recovered.
HAS SORENESS WHERE THEY GAVE THE NEEDLE IN THE LEFT ARM; A LOT OF PAIN; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): US-BRISTOL-MYERS SQUIBB COMPANY-2022-125012.  This case was received via {BP} Pfizer Inc (Reference number: 7809768) on 20-Oct-2022. Information was received from a Consumer/other non health professional concerning a Male patient, who received Suspect product APIXABAN for Tablet; Suspect product COVID-19 VACCINE. On an unknown date, the patient experienced pain(a lot of pain) which was considered not serious. On an unknown date, the patient experienced pain in extremity(has soreness where they gave the needle in the left arm) which was considered not serious. Concomitant medications were not reported. The reporter did not provide a causal assessment for events pain and pain in extremity to product APIXABAN. The reporter did not provide a causal assessment for events pain and pain in extremity to product COVID-19 VACCINE. Tracking of Changes: 20-Oct-2022: Initial information was received.  Eliquis is under agreement with Company.
Subsequent to receiving the second dose of Engerix B the pt experienced an allergic reaction consisting of ear redness without itching or pain. Engerix B was discontinued. The most recent information received reported the condition of the pt as resolved.
Patient received a booster dose of a vial whose lot number had already expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of a vial whose lot number had already expired) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of a vial whose lot number had already expired). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of a vial whose lot number had already expired) had 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. No treatment information was provided by the reporter.  It was mentioned that reporter did not have the information on when the vial was initially stored in the refrigerator.   The 3 doses were from the Moderna COVID 19 Vaccine. It was confirmed that no temperature excursions were occurred.  Expiry date was on 8 Nov 2021.
Bullae at injection site within 24 h (as reported by mother) at the time of visit -vesicle 3mm at injection site with excoriated area. Monitor for infection.
26 y.o. female who arrived presented to the emergency department for concern of an allergic reaction. Patient reports being at the COVID-19 clinic just prior to arrival receiving her first dose of the vaccine. However, after walking a few minutes later she began to experience an abnormal sensation in the back of her throat, describing it as "spicy" accompanied by a general wave of feeling "hot and heavy" with some tingling in her fingers and toes. Patient currently states that overall her symptoms are improving with only a continued feeling of "hot and heaviness." Denies a history of allergic reactions to vaccinations or medications, besides a possible allergic reaction to Penicillin when she was younger. Denies shortness of breath, nausea, emesis, or any other complaints at this time. Denies a history of GERD, stating that she has not eaten anything today. Patient is otherwise healthy with no use of daily medications.  Patient was observed for one hour while here in the ED with no residual symptoms. Patient feels comfortable going home and will return for worsening symptoms. Agrees to follow up with her PCP. Vital signs are stable at time of discharge.
dose number=1, 08Sep2021;dose number=2, 14Nov2021; it started falling out to the point that you can see my scalp now through my hair.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Nov2021 (Batch/Lot number: unknown) at the age of 72 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATENOLOL; ATORVASTATIN; AMITRIPTINE; ALENDRONATE. Vaccination history included: Bnt162b2 (Dose Number: 1 , Batch/Lot No: FC3184 , Location of injection: Arm Left), administration date: 08Sep2021, when the patient was 72 years old, for Covid-19 Immunization, reaction(s): "Hair loss"; Flu (Anatomical location: arm right), administration date: 08Sep2021.  The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "not recovered", described as "it started falling out to the point that you can see my scalp now through my hair."; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 14Nov2021, outcome "unknown", described as "dose number=1, 08Sep2021;dose number=2, 14Nov2021". The event "it started falling out to the point that you can see my scalp now through my hair." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of alopecia.  Additional information: The patient had many with the first dose which she reported at that time. Shortly after her hair started falling out. Then after the second dose it started falling out to the point that it can see her scalp through her hair. Since the vaccination, the patient did not tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 12-NOV-2015 (today), the patient was inadvertently administered a dose of ZOSTAVAX lot # L003217 and expiry date of 30-APR-2015 (unknown route and dose) instead of the intended dose of VARIVAX (Merck). No adverse effects were reported. No product confusion was reported. There was no product quality complaint involved. Additional information has been requested.
Episode of partial consciousness w/food dribbling out of mouth, lying on floor, eyes blinking, grunting vocalizations lasted 1 min.;
Child's mom stated post vax, 2-3 hours pt developed fever of 104.7F, a blister rash which was generalized. Mom gave Benadryl. Blisters left but 2 hours later child broke out in hives. Given Tylenol but unable to reduce fever. Antibiotics given, stated fever was still present. Had fever for 6 days.
1) Per mother, night received Prevnar-13 vaccine left thigh, child itchy same night.  2) Following day became, red and swollen. 3) Father had administered cream for left thigh.  3) SEEN IN OFFICE 6-14-2010 - showed multiple bullous lesions left thigh, neg sloughing, PICTURE taken in chart.