chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Watery eyes, redness in right eye-Medium, Additional Details: Pt's Wife reported pt took Benadryl and felt better. Pt began experiencing swelling and watering in left eye 3 hours after the vaccine was administered. He will continue to take Benadryl and will see his primary care doctor for a yearly physical and inquire about continuing the second dose in the Shingrix series
Developed hives the next day.   Came and went intermittently over the next few months.   2 weeks later developed sinus infection and rash and chest and belly.    Over sensitive to light and sound.  Refused eye contact.
Patient felt dizziness and sweating after the vaccination. She had not eaten anything so far today and stated she may have been dehydrated, so we provided water and glucose tablets. Initial BP was 80/60 but the pharmacist was uncertain if that is accurate due to small arm size. After a few minutes of resting and drinking fluids she started to feel better less nauseous and less dizzy. After 15 minutes patient has recovered enough to leave with her companion ( who was driving).
Bumpy, itchy, rash predominately on her trunk, and both legs although she has some bumps on her left elbow area; Bumpy rash; This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number EG55L, expiry date 7th December 2021) for prophylaxis.   On 4th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 5th November 2019, 1 days after receiving Shingrix, the patient experienced itchy rash and papular rash. On an unknown date, the outcome of the itchy rash and papular rash were recovering/resolving.   It was unknown if the reporter considered the itchy rash and papular rash to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient developed a bumpy, itchy, rash predominately on her trunk, and both legs although she has some bumps on her left elbow area. On 6th November 2019, the patient had more bumps but they were not as itchy. The reporter was  unable to provide any additional details.
2MAY91 evening got welts on lt anterior thigh; Recvd DTP 2MAY91 @ 3PM; Welts swelling approx 5" diameter; Seen by MD 6MAY91, performed WBC & given ATB; WBC sl elevated; Swelling & redness gone 7MAY91; Lump noted on palpation;
DTP given in rt thigh; 24 hrs later pain & noted redness, swelling, pt scratching area; 14FEB92 PM seen in clinic w/ 5.5" x 4" indurated non-tender area of thigh; no d/c; no limitation of activity or tenderness; no superficial excoriation;
Mild discomfort; Nausea; Intense stomach pain; Low grade fever; Headache; Pain in abdomen; Bloating; Soreness/muscle pain left arm injection site/ injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Pain in abdomen), ABDOMINAL PAIN UPPER (Intense stomach pain), ABDOMINAL DISTENSION (Bloating), DISCOMFORT (Mild discomfort) and NAUSEA (Nausea) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066H21A, 01J20A and 01J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced ABDOMINAL PAIN (Pain in abdomen), ABDOMINAL DISTENSION (Bloating), VACCINATION SITE PAIN (Soreness/muscle pain left arm injection site/ injection site soreness) and HEADACHE (Headache). On 17-Nov-2021, the patient experienced ABDOMINAL PAIN UPPER (Intense stomach pain) and PYREXIA (Low grade fever). On an unknown date, the patient experienced DISCOMFORT (Mild discomfort). an unknown date, the patient experienced NAUSEA (Nausea). In November 2021, ABDOMINAL PAIN (Pain in abdomen), VACCINATION SITE PAIN (Soreness/muscle pain left arm injection site/ injection site soreness), PYREXIA (Low grade fever) and HEADACHE (Headache) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Intense stomach pain), ABDOMINAL DISTENSION (Bloating), DISCOMFORT (Mild discomfort) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient experienced pain in abdomen, bloating, nausea, and soreness/muscle pain left arm injection site. The patient received the shot on 16-Nov-2021 with minimal pain and soreness. The patient also experienced low grade fever the following day with intense stomach pain. Reportedly, the pain had mitigated on 18-Nov-2021 but was still feeling discomfort.  No Concomitant product use was reported.  No medical treatment was received.   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Follow-up information received on 23-NOV-2021,Reporter details, facility information, patient details, dosing details, events outcome, action taken updated and events were added.
Pt states immediately after receiving his 3rd covid vaccine that he suffered from left arm pain that radiates from his shoulder to his left elbow. This pain has been ongoing since 12/31/2021. States "stabbing pain" that keeps him up at night and at times he loses grips of objects due to pain. He has taken OTC medications with no relief.
Herpes Zoster across anterior right T4 dermatome, accompanied by fatigue, mildly stiff neck.
Grandpa called and stated the school nurses called him and told him patient's arm is swollen and has hives on it from his shoulder to his elbow.
Rash, slight low fever, hoarseness, pulsating on arm of vaccine, swelling of groin area, rash on lower left leg.
pt recvd vax 6oct94 at 5:30pm;9:30pm woke up screaming like in pain;no redness or swelling in legs;given apap by foster mom;could not be calmed;turned ashen color;to med ctr;t 104 enroute;given meds to take home alternating w/ apap;
Patient went to Urgent care with red puffy face at 12:30 pm.  She was treated and provided with medications:  Hydroxyzine  tid po for itching, PRN, Famotidine  bid po x 7 days po; methylprednisone pack  dose pack, and 2 epi pens.
ON JUNE 23, 2021 I WOKE UP WITH TERRIBLE PAIN IN MY LEFT LEG FROM BEHIND MY KNEE ALL THE WAY DOWN MY LEG. I WENT TO AN URGENT CARE FACILITY AND THEY LOOKED AT  MY LEG AND SAID THEY THOUGHT IT WAS A BLOOD CLOT. THEY CALLED AN AMBULANCE THAT TOOK ME TO EMERGENCY ROOM. THEY TOOK A CAT SCAN AND ULTRA SOUND AND TOLD ME I HAD A DVT. THEY PUT ME ON HEPARIN AND ADMITTED ME TO THE HOSPITAL FOR 2 DAYS AND PUT ME ON HEPARIN FOR TWO DAYS AND RELEASED ME ON JUNE 28, 2021. I WAS GIVEN A PRESCRIPTION FOR ELOQUIS,
This spontaneous report was received from a nurse and refers to a 3 month old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 05-SEP-2017, the patient was vaccinated with improperly stored vaccines, RECOMBIVAX HB (dosing details not reported) (lot # N006321, expiry date: 08-NOV-2019) and ROTATEQ (dosing details not reported) (lot # M044397, expiry date: 20-JUN-2018, orally) for prophylaxis. No adverse effects were reported. The administered vaccines underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011.
Started with numbness & tingling of the right hand and traveled proximally up the right arm 10-15 minutes after the injection which progressed over the ensuing next several hours to include severe paresthesias also of the right leg and foot as well as right cheek and perioral area.  By 24-48 hours similar severe paresthesias were occurring in both the left upper extremity (hand, forearm), left lower extremity (leg & foot), and left face.  By 48-72 hours developed paresthesias of the lumbar back as well as pruritis. Paresthesias have been constantly present at some location but occasionally will diminish at one location or another.
Flu shot was given on November 29, 2006 at 10:30am. She comes on December 11, 2006 complaining of arm being numb.
Acute hepatits which led to a four day stint in the hospital and an eventual diagnosis of autoimmune hepatitis.
I went into a pharmacy to get a flu shot. I was told that for anyone over 65 the more high powered flu shot was better. I questioned whether I would have a bad reaction to this shot. I have had flu shots for many years and never had any reaction at all. I was assured no, no, there would be no reaction. That night I was wakened by a dreadfully sore arm-into which the shot had been given. It wasn't so terribly sore at the insertion point, the entire area throbbed and felt as if it has been beaten with a stick. The pain went up into my neck. I didn't feel as if I had the flu although I did have a bit of a headache. The pain has never completely left that arm. It will seem ok during the day, but then when I am sleeping the pain will come again. I can live with it but I will NEVER have the stronger flu shot again. I went back into pharmacy just to report my reaction. I don't know if they reported it. They didn't have me fill anything out or sign anything.
Patient had a large rash on the right arm 9 days after receiving the shot. Resolved 2 days later using Benadryl.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Batch/Lot number: EN62?1), in left arm, on 25Mar2021 as dose 2, single (Lot number: ER8730), in left arm and on 28Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 71 years, in right arm for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Jun2022 as dose 4 (booster), single (Lot number: 038A22A), in left arm for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "MVP" (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 Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: Counting 1st symptoms as day 0, new symptoms began day 11,; (Jul2022) Positive, notes: tested positive on day 12. Didn't test on day 11. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Developed hives all over body. Diagnosed with hives by pediatrician and allergy doctor. As per mom, started on oral prednisone.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Pt was pale and stated that he felt as if he was going to pass out,  Pt given orange juice and cool paper towel and monitored.  Symptoms improved within 10 minutes and pt was able to leave store unaided.
This spontaneous report as received from a licensed practical nurse refers to a 23 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of VAQTA (dose, route of administration, lot # and expiration date were not reported). It was reported that the patient received dose 2 of VAQTA 2 months after receiving dose 1. No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea). At the time of the report, NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD21-075634 (E2B Linked Report).; Sender's Comments:  MOD21-075634:
A couple days after second dose my arm has a red area that's spreading and pain and feels warm to the touch
Patient presents to the office for allergic reaction to pneumovax. Pt. developed pain initially, which resolved. However, she developed urticaria with erythema around the left upper extremity upper arm, involving circumference of arm. Pt. is currently on Cipro that started yesterday for UTI. She is also on warfarin, followed by Coumadin clinic. No fevers. On exam, there was erythema with urticaria formation that spanned the upper arm. no other region of involvement was present. a/p: 1. allergic rxn to pnNumovax-hydroxizine prn with side effects discussed. P.t has pt/inr ordered for 7/15/13. f/u in one week for reassessment. Pt. to go to ER should symptoms worsen
2 days following vaccinations she developed a fever lasting 4 days. 7/19/17 developed a rash (Mom initially thought bug bites) that became blistering and then scabbed. Started on arms and legs and some spread to head, neck and trunk.
pt recvd vax; pt became fussy for 6 hrs; pt had seizure in the morning which consisted of staring, stiffening & tongue protruding w/out tonic clonic activity;
About 20 minutes after getting vaccine pt. had sharp pain in jaw, dry mouth, scratchy throat. In the following days she developed severe leg pain and burning, fatigue, chills, and fever as high as 99.4. As of 4/22 patient has just started feeling better, no more leg pain, fever has resolved.
This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a elderly male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved. The reporter considered the feeling unwell to be probably related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. Reporter was the daughter of the patient. No concomitant vaccine was reported. Reporter was not aware of any concomitant medications. The reporter noted that the patient received SHINGRIX injection and began feeling sick. The patient's event fully resolved the next morning, no additional information provided. No vaccine administration facility information was provided. The reporter did not have lot number or expiration date of the product. Date of injection and dose of injection were unknown. Start date and stop date of event were unknown. Reporter denied hospitalization or need for hospitalization to treat this event. The patient had denied permission to contact their physician.
Arthritic-like pain in multiple joints in days preceding second dose and becoming severe following second dose. Pain specifically in hands, feet, ankles, knees, but originating in hands bilaterally; Arthritic-like pain in multiple joints in days preceding second dose and becoming severe following second dose. Pain specifically in hands, feet, ankles, knees, but originating in hands bilaterally; C-reactive protein at 14 mg/L; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6208), via an unspecified route of administration in left arm on 14Mar2021 (at the age of 47-years-old) as dose 2, single for COVID-19 immunization. Medical history included benign prostatic hyperplasia (BPH), eagle's syndrome, bilateral styloidectomy and paraoesophageal hiatal hernia repair. Concomitant medication included Tamsulosin 0.4 mg. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198), via an unspecified route of administration in left arm on an unspecified date in Feb2021 10:45 AM (at the age of 46-years-old) as dose 1, single for COVID-19 immunization and experienced Arthritic-like pain. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not having any allergies to medications, food, or other products. The patient experienced arthritic-like pain in multiple joints beginning in the days preceding the second dose and becoming more severe following the second dose. Pain specifically in hands, feet, ankles, and knees, but originating in the hands bilaterally and C-reactive protein at 14 mg/l on an unspecified date in Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included antinuclear antibody (ANA): negative, C-reactive protein: 14 mg/l and rheumatoid factor (RF): negative on an unspecified date in Mar2021. It might be coincidental timing but could possibly be related to vaccine. Patient was prescribed with diclofenac. Since the vaccination, patient has not been tested for COVID-19. Outcome of arthritic-like pain in multiple joints beginning in the days preceding the second dose and becoming more severe following the second dose. Pain specifically in hands, feet, ankles, and knees, but originating in the hands bilaterally was not resolved; outcome of C-reactive protein at 14 mg/L was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021304452 same patient/drug/event, different dose
Didn't receive second dose (9 weeks since first one); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Didn't receive second dose (9 weeks since first one)) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 21-May-2021, the patient received first 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) (Intramuscular) 1 dosage form.   On 23-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Didn't receive second dose (9 weeks since first one)).   On 23-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Didn't receive second dose (9 weeks since first one)) had resolved.            Concomitant and treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow up received contain second dose information and No adverse event after second dose
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, 1 in total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) Negative. On an unspecified date, the patient experienced confirmed immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint : 90000179522. The suspected product quality complaint has been confirmed to be voided: N based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20210526646 covid-19 vaccine ad26.cov2.s - Confirmed immunological vaccine failure.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:SPECIAL SITUATIONS
Rash around the mouth currently, lips are swollen and are peeling. Fever, chills, weakness.
child collapsed on the way out of MD office-became pale, diaphoretic & jerky movements;given 02;syncope;
Patient given a 3rd booster (Janssen to start, followed by 2 Moderna boosters, then received this fourth dose of Moderna).
Woke up on 1/6/2021 with hot flashes, palpitations, dizziness and heart racing.  Went to urgent care and they did an EKG which showed A-Fib, so I was sent to the ER and from there, I was transferred to an ICU at a different facility . I stayed  until 1/8/2021. No cause was found and no history of A-Fib or family history.
Drowsiness, tingling all over, itching all over, small facial muscle twitching, injection site soreness, difficulty focusing on complex things.
Pneumovax 23 use for Rupture spleen; Severe allergic reaction; This spontaneous report has been received from the patient's wife and refers to a 38-years-old male patient.  The patient's concurrent conditions included high blood sugar, high iron and ruptured spleen.   In September 1983, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot #, expiration date, dose, frequency, route of administration and anatomical location of vaccine were not reported) for splenic rupture.   In September 1983, the patient had a severe allergic reaction. At the reporting time, the outcome of the event was not reported.   The reporter considered allergy to vaccine to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).
swelling; generalized joint pain; This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING (swelling) and ARTHRALGIA (generalized joint pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication.    No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (unknown route) at an unspecified dose. On 05-Feb-2021, the patient experienced SWELLING (swelling) and ARTHRALGIA (generalized joint pain). In February 2021, SWELLING (swelling) and ARTHRALGIA (generalized joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact