chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports on 10/31/22 to pharmacist that had reaction in arm after receiving Pfizer bivalent booster. Right arm swollen around injection spot and little bumps and red spots. Patient reported no issues with previous doses of Pfizer Covid-19 vaccines. Patient reported arm swelling has gone done and pharmacist counseled patient to take oral benadryl and put cold compress over area of injection and report to primary care doctor to make determination if true allergic reaction
now has a fungal infection, Aspergillus, that is a nodule in her lung; now has a fungal infection, Aspergillus, that is a nodule in her lung; This is a spontaneous report from a contactable consumer (herself).  A 75-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an un-specified date as dose 2, single for covid-19 immunisation. Medical history included, chronic obstructive pulmonary disease. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), on an unspecified date as  dose 1, single for covid-19 immunization. On an unspecified date, the patient experienced "now has a fungal infection, aspergillus, that is a nodule in her lung. It was reported that the patient received both doses of the vaccine and she now has a fungal infection, Aspergillus, that is a nodule in her lung. She was now taking Voriconazole and wants to know if she can receive a third Covid shot. She was researching that there may be a possible connection to the infection and the vaccine. Her main concern is that she would like to receive a third shot is that ok to do or should she wait. She stated she also has COPD which makes her vulnerable to infection. The patient asked if the third dose is approved, would there be any reason not to get the vaccine as she has Aspergillus. The patient reported the event as non serious. Treatment was received for the events. Outcome of the events were unknown.  Information about lot/batch number has been requested.
Fifteen to thirty minutes later she was extremely warm inside; Started sweating a little bit; All she can taste is metal; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on an unspecified date at 7:15, at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, fifteen to thirty minutes later, the patient stated she was extremely warm inside, she started sweating a little bit and all she could taste was metal. She could drink coffee but it tasted like a penny. At the time of the report the events outcome was unknown.  Information on the Batch/Lot number has been requested.
Vaccine was kept in regular freezer past date of viability. NO adverse reaction reported. Per CDC/Pfizer repeat dose.
pt recv vax 24SEP96 & 8NOV96 pt devel painful nodules on lower legs consistent w/erythema nodosum;pt visited MD on 12NOV96;reporter wondered if there was a possible relationship between the vax & erythema nodosum;
Patient received Pfizer bivalent booster and after 15-minute wait time, patient complained of tongue swelling.  Provider assessed and ordered Benadryl 50 mg po, patient sent to ER for higher level of care
Edematous and erythematous area on external (R) arm tender & warm to touch mild induration area about 10 x 8cm, fever x 2 days pt was given KEFLEX & ORAPRED to cover.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old patient received BNT162b2 (BNT162B2), on 10Oct2021 as dose 3 (booster), single (Lot number: Fe3590) and on 11Apr2022 as dose 4 (booster), single (Lot number: Pj4989) at the age of 68 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa, codeine; "Glaucoma" (unspecified if ongoing), notes: Other medical history: Glaucoma. The patient's concomitant medications were not reported. Past drug history included: Known allergies: codeine, reaction(s): "Known allergies: codeine", notes: Known allergies: codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Apr2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Apr2022) Negative, notes: Neg antigen 25Apr2022; (28Apr2022) Positive, notes: positive antigen test on 28Apr2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details: Product: COVID 19 Treatment Brand: Paxlovid Treatment start date: 19Apr2022 Treatment stop date: 24Apr2022 Indication: Treatment of COVID-19. Adverse event: Last dose AM 24Apr2022. Neg antigen 25Apr2022 Symptoms began to return 28Apr2022 positive antigen test on 28Apr2022 symptoms containing for 4 - 5 days tried reporting to Pfizer at that time and was brushed off.
Pt received TD shot at health dept on 9/25/2000 and, post vax, right arm began to twitch, 1 day later. 2 days, post vax, pt noted red rash. Student came to Student health office about rash. TD not given at our office. I called health dept and the nurse reported that they have had 3 recent similar reactions, post vax of TD shot.
Severe uterus cramping similar to when I had my IUD put in. I am mid-period, so my cramps are usually over at this point of the cycle. Cramps lasted for ~10 minutes off and on, and are persisting today in fits and spurts. Severity has gone from IUD insertion level pain to beginning of a heavy cycle pain (basically needing a second to let the cramp pass before moving on with my task)
Rash on arms, Back, Stomach and legs; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL 3247) via an unspecified route of administration at left arm on 10Mar2021 13:00 as single dose for COVID-19 immunization. Medical history included allergy to tide laundry de-tergent. Patient concomitant medications were not reported. On an unspecified date the patient ex-perienced rash on arms, back, stomach and legs. Patient received prednisone as therapeutic measure for the event. Outcome of the event was unknown.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Doesn't feel good), PAIN (Aching), CHILLS (Chills) and PYREXIA (fever) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Doesn't feel good), PAIN (Aching), CHILLS (Chills) and PYREXIA (fever). At the time of the report, FEELING ABNORMAL (Doesn't feel good), PAIN (Aching), CHILLS (Chills) and PYREXIA (fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.9 - 99.5 (Inconclusive) 98.9 - 99.5. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up information received on 28-JUN-2021 and contains significant information. Outcome of events updated.
Swelling in right deltoid, warmth to touch, muscle spasms, body aches, fever and headache.
Information has been received from a pharmacist concerning an 82 year old female who on 26-APR-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (no lot number, expiration date provided). On 24-MAY-2011 the patient developed a case of shingles. Hydrocortisone and antibiotics (manufacturer unknown), rose hips (LITOZIN) were given for the treatment of shingles. The patient had sought unspecified medical attention. At the time of report, the patient's outcome was recovering. Follow-up information was received from a physician concerning the patient with allergies to DEMEROL, REQUIP, ZITHROMAX and no illness at time of vaccination who on 26-APR-2010 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) (Lot number NDC 00006496341 is an invalid lot number for ZOSTAVAX (Merck)). On 24-MAY-2011 the patient was diagnosed with H. zoster. No rash occurred at the site of injection or elsewhere within 42 days of the vaccination. No other systemic symptom. It was unknown if the patient had a history of chickenpox. There was no recent exposure to chickenpox or herpes zoster. No direct fluorescent antibody was done. The patient has recovered from the event on an unspecified date. The event was considered to be an other important medical event by the physician. Additional information has been requested.
@ 5-6PM on 27JAN92 devel fever varying from 101-103, painful, edematous rt thigh (site of inject) & "ear piercing", high pitched cry lasting 1-1 1/2 hrs @ time & cry that was nonconsolable; cried anywhere from 1 1/2 to 3 hrs;
Information was received on 26-MAY-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with ZOSTAVAX (dose, site, lot and expiration not reported) on or about 05-DEC-2014, at a  Public Health clinic as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 27-SEP-2013 (date conflicts with later vaccination date), the patient was treated by a physician at a health center for a vesicular outbreak that was diagnosed as severe shingles with ophthalmic involvement. (shingles in the eye).  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Upon internal review, ophthalmic herpes was considered medically significant. Additional information has been requested.
The patient reported an itchy, warm, nagging sensation in her upper left arm three days after the injection. It continued to itch and grow and become raised like hives. The area of the injection grew red and spread on the upper arm. It spread toward the patient's elbow. She saw NP who documented the area and diagnosed it as a histamine reaction. She prescribed cephalexin 500mg for the patient to use in case the area of redness spread after the patient uses Benadryl and ice for 24 hours.
Infant awoke after a nap and was red all over his body, with large white splotches. He was hot to the touch and at the injection sight it was very red and swollen. Baby was given Benadryl and taken back to the doctors office. He is fine now and we were told to continue to give Benadryl for 24 hours.
No adverse event; HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL); This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)) and NO ADVERSE EVENT (No adverse event) in an 8-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     Patient's relevant medical history/conditions, allergy, concomitant diseases and risk factor were unknown.    On 29-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Jul-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .25 milliliter. On 27-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 assessment was provided for WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)).    Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter. This case contains information about 11th patient out of 12.   This case was linked to US-MODERNATX, INC.-MOD-2023-737216 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737216:Master Case (Patient 1)
No symptoms first 8 hours, then fever and woke up with 102.5 temp x 24 hours; severe chills and rigors - I thought I was having a seizure x 4 hours; headache, body aches, brain fog, severe fatigue.
I received my second Shingrix shot, in my upper, outer left arm, at my local pharmacy. I've received several shots from this pharmacist over the years and never had any problems, but nearly a year after receiving this shot, the injection site continues to be uncomfortable. There is a small eruption, like a mosquito bite, which itches severely, and chronically, yet is too painful to itch. I hate to think I will have this problem for the rest of my life.
Vasovagal Response. Passed out for 2 minutes and when awoken she could not see for 10 minutes.
Symptom onset was 9-03-21; symptoms included cough, runny nose, congestion, wheezing, fatigue, myalgia, chills and eye redness. New symptoms developed around 9-7-21, including chest cramps and dehydration, prompting an ER visit. Case was admitted to Hospital, on 9-7-21; discharged on 9-9-21.
No adverse events. However, vaccine was administered twice to patient. First 11/23/15 and 2nd 2/4/16.
Fever (101.2°) Persistent pounding headache Extreme chills Profuse sweating at night (left puddles of sweat in bed sheets)  Inability to do normal daily functions  (All of this has been going on since Friday night, it?s now Sunday afternoon)
not feeling well; fever; headaches; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), PYREXIA (fever), HEADACHE (headaches) and CHILLS (chills) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Dec-2021, the patient experienced MALAISE (not feeling well), PYREXIA (fever), HEADACHE (headaches) and CHILLS (chills). At the time of the report, MALAISE (not feeling well), PYREXIA (fever), HEADACHE (headaches) and CHILLS (chills) had not resolved.            Concomitant medication of the patient was not reported.   No treatment information was provided by the reporter.   The patient asked if she could take Tylenol for the pain. The symptoms of the patient were ongoing.
Within 1 hr of vaccine given, pt c/o scratchy throat, itching, and hives. Mom gave BENADRYL, sx subsided by next morning. Then 2 days after vaccine given hives returned.
10:05am Post 2nd vaccination, c/o of increased dizziness w/ expressed sweaty feeling, noted as well; then witnessed 2-4 second LOC, thereafter, O2 via FM applied,  becomes alert w/ cohesive verbal response to stimuli; 10:10 EMS activated; BP138/78 P79. 10:24am Ox3, transported to hospital via EMS for further evaluation / treatment.
pt recv vax 9SEP97 & w/in min of vax pt devel soreness & redness, w/in 10min of vax;pt devel a fever of 102 & w/in 24hr pt devel bruising;
no adverse effects reported; improperly stored dose of VARIVAX was administered to a patient; This spontaneous report has been received from an office manager referring to a patient of unknown age an gender. No information has been received regarding the patient's medical history, concurrent conditions, drug and allergy history or concomitant medications.  On 25-JUN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, frequency and route of administration was not provided) lot # S025610 and expiration date 18-AUG-2021 for prophylaxis.        The doses of varicella virus vaccine live (oka/merck)(VARIVAX) were exposed to a temperature excursion of 22.3°Fahrenheit (°F) during a time frame of 4 hours and 25 minutes, which was detected by the data logger. There was a previous temperature excursion of 8.6°F for 1 hour and 51 minutes. No adverse effects were reported.
CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY
RED RAISED RASH DEVELOPED THE NIGHT OF IMMUNIZATIONS. PT SAW A DOCTOR ON 10/7 AND WAS GIVEN DIPHENHYDRAMINE AND PHARMACIST GAVE HYDROCORTISONE CREAM ON 10/7
Attempted Suicide Narrative:  93 year old received his 2nd dose of moderna vaccine on 3/11/21 in his home (nurse went there to give it). He attempted to take his life via gunshot wound to the head on 3/13/21. Sent to an outside hospital and passed away 3/16/21. He recently was diagnosed with cancer. Had an appointment with oncologist on 3/11/21 and found out cancer was limited to lung only and discussed treatment options. No Mental Health issues in the past. Cancer diagnosis and covid vaccine timing may have contributed.
The vial was punctured yesterday 28-Dec-2021 and used for up to 17 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was punctured yesterday 28-Dec-2021 and used for up to 17 hours post puncture) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was punctured yesterday 28-Dec-2021 and used for up to 17 hours post puncture). On 29-Dec-2021, EXPIRED PRODUCT ADMINISTERED (The vial was punctured yesterday 28-Dec-2021 and used for up to 17 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
Itching around face, lips and tongue. Lost hair in patches on my face and along my hairline. Itching around mouth lasted on and off for a couple of days. Second dose received at 11:30 am on 4/29.   Same itchiness + additional patchy hair loss started two weeks later. Occasional itchiness of lips and face continue through 5/24.
After I got vaccinated and some time passed, my right shoulder started hurting. Next day (today) when I shrugged, I felt pain where my neck and trapezius connect on the front next to the collar bone. To describe it more accurately it's where the indented part is on top of the collar bone. When I touch the place that hurts I feel like there's a small ball inside and that's not normal. Moreover, when I looked in the mirror I saw that my right collar bone area was a lot less defined then my left collar bone area, and it looks kind of swollen. (note: I got injection on my right shoulder, and the problems I am having are on the right side too.)
Patient received FLUZONE HIGH DOSE vaccination in Left deltoid at outpatient pharmacy at ~1500 on 12/17/12. Within 3 hours of the injection, patient reported subsequent uvula/throat swelling and reported to local hospital for treatment. On evaluation in the ER patient had noted uvulitis with no tongue or lip swelling. No injection site reaction, hives or rash noted. Patient had difficulties with throat swelling causing increased phlegm build up from mechanical issues causing at least one episode of vomiting. Patient had no other signs of recent viral infection or other possible causes for this reaction. Treatment: Patient received one dose of Dexamethasone 10mg PO in ER and swelling improved. No further treatment done. Patient discharged to home.
Patient was given the FLUZONE 11-12 vaccine IM via the pharmajet needles system. Patient developed a baseball size "welt" on the area she was given the shot. The welt was red, swollen and warm to the touch. Watching the patient for possible cellulitis.
fatigue, shortness of breath;  went to doctor; tachycardia (suggest my be due to booster advise no more booster) prescribed 25 mg Atenolol; follow up blood work indicated hyperthyroidism; referred to endocrinologist; prescribed Methimazole  5 mg (two tabs once day; been playing with dosage as per follow up blood work
Severe head and neck pains, joint aches, vomiting, 3 day fever. On 11/17/11 had onset of face paralysis (Bells Palsy was diagnosed) that effected left side: brow, eyelid & blinking, nose and mouth.