chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 70 year old female with borderline diabetes and no allergies who had a history of oral contact with herpes but no reaction and took GAMOGLOBULIN (manufacturer unspecified) (at 19 years of age). On 18-APR-2008 the patient was vaccinated with a dose of ZOSTAVAX (Oka/Merck). There was no concomitant medication. About 3 weeks after vaccination, on appropriately 02-MAY-2008, the patient experienced a cold sore on her mouth, "feeling very bad for awhile, very bad stomach pains", and had an ulcer in her mouth. The patient visited her druggist for information and tried ABREVA. No laboratory or diagnostic studies were performed. About 10 days after cold sore developed, the patient recovered. Additional information has been requested.
pt recv vax 14AUG96 & AUG96 pt exp swollen lymph nodes & a rash all over body (hundreds of lesions);
Immediately I had a spasm in the muscle or site she injected into. I had a sharp pain shoot into my top shoulder area. She either injected it into the nerve or shoulder socket. I was unable to lift my arm for 3 days after injection and now 7 weeks later, I have constant pain in my shoulder that has now moved down into my arm. It interferes with my ability to raise my arm above my head and to lift things.
Covid vaccine syringe would not fully plunge into PT's arm. Syringe plunger was stuck at .25 ml. Pt was given a second full dose on the opposite arm. Malfunction was documented.
81-year-old male, who was admitted t on August 28, 2021, with shortness of breath, some lower extremity edema, and hematuria. He denied fever and chills prior to presentation, but was found to have low-grade fever on admission with a peak to 100 degrees Fahrenheit on August 30th. Several weeks ago, he underwent hip surgery and had a Foley catheter that was continued postop. Another postop complication was lower extremity DVTs and the patient was started on anticoagulation therapy and had subsequent hematuria.  His initial hematuria resolved and then reportedly he was working with Physical Therapy and there was some trauma to the Foley and his hematuria returned.  His past medical history also includes prostate carcinoma, and he is status post radiation therapy.  Additionally, he underwent testing for COVID-19 virus earlier and was found to be positive.  A chest x-ray done earlier showed no infiltrates or congestion with only minor atelectasis involving the left lower base. His white blood cell count was elevated to 14.8 on admission and has resolved. Patient is currently still admitted to the hospital.
p/vax swelling around inj site;skin turned red & child limp on lt leg;c/o leg hurt & irritable;
no energy,nothing in her; tired and not functioning; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no energy,nothing in her) and FATIGUE (tired and not functioning) in a 72-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (no energy,nothing in her) and FATIGUE (tired and not functioning). At the time of the report, ASTHENIA (no energy,nothing in her) and FATIGUE (tired and not functioning) outcome was unknown.            No treatment information provided by Reporter.
6/10/21 unknown pmhx, presents with worsening abdominal pain, increasing vaginal bleeding, and fever of 100.7
This case was reported by a lawyer and described the occurrence of nerve damage in a male subject of unspecified age (identified as "minor child") who was possibly vaccinated with hepatitis B vaccine (manufacturer unspecified) and/or Tdap for prophylaxis.  A physician or other health care professional has not verified this report.  The legal complaint alleged that the subject was exposed to airborne mercury vapor and mercury through the food chain.  Concomitant medications and/or vaccinations were not specified.  According to the complaint, subject experienced mercury exposure from products including but not limited to hepatitis B vaccine and/or Tdap, in addition to mercury exposure from other products and via the environment.  The complaint alleged that as a result of "toxic mercury exposure", the minor child experienced "serious and permanent neurological damage.  Said damages include past and future mental, intellectual, developmental, and neurological incapacity and associated learning disabilities, disorders, and impairments."  Additionally, the complaint alleged that the subject "has suffered and will suffer in the future impairment of enjoyment and loss of quality of life and other injuries".  At the time of reporting the outcome of the events was unspecified.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unspecified dates, the patients were vaccinated with an unspecified number of improperly stored doses of VAQTA (lot # K012457, expiration date 04-JUN-2017, lot # K018181, expiration date 04-JUN-2017, lot # L002717, expiration date 02-JUN-2017, route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient reported induration up to 4 inches at the injection site with itching of her entire arm around the injection site. She also reported chest congestion, similar to bronchitis. Symptoms started 1-2 days post-vaccination and have improved by 5 days post-vaccination, with only itchiness and bruising of her arm at injection site remaining. She used hydrocortisone topical cream for her symptoms.
Within 7 days of vaccine, I began experiencing aching of right posterior leg just below knee. Applied heat, elevated and just continued to ache intermittently, daily. Waited and disregarded as anything to worry about. After 2 wks of continued symptoms despite no redness, swelling or positive homans sign, being a health care professional (RN), I  decided to seek evaluation at local ER to rule out DVT. On April 1st, I presented to  ER, Address and number provided.completed and diagnosed with posterior tibial venous thrombosis on
Pt had redness, swelling below site, fever, and was treated with antibiotic.
pt recvd vax & exp cont soreness for 2 wks; p/soreness abated the pt had persistent burning sensation accompanied by intermittent pain; pt limits ROM; dx paresthesia;
1:11 Wed 10/3/18 Received Vaccination. That evening ( Wed 10/3/18), noticed pain in axilla and palpated a swollen lymph node. On Thursday evening 7pm, she noted painful to touch round red rash at left deltoid injection site, NO itching, No drainage. On Friday morning 9:00 am she presented to Health Center to report reaction. She was examined by CRNP. Findings: Integumentary Other findings raised erythematous round area 40x35mm on left arm deltoid region, no drainage, cool to touch, non tender to touch. Lymphatics Left: no lymphadenopathy axillary. Continue her allergy medication, plus Benadryl.
heart pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (heart pain) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (heart pain). At the time of the report, CHEST PAIN (heart pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications are provided. Treatment to the events not reported.   Reporter did not allow further contact
Soreness at injection site; but not real bad; both injections; Some slight shoulder ache' 2nd injection; Some slight diarrhea after 2nd injection.  Came upon approx 36 hrs after injection; This is a spontaneous report from a non-contactable consumer or other non hcp.  A 59-year-old male patient received bnt162b2 (COMIRNATY, formulation: solution for injection, lot number: EW0176, expiration date was not reported) via an unspecified route of administration, administered in arm right on 03May2021 14:45 (age at vaccination 59-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY, formulation: solution for injection, lot number: EW0162, expiration date: not reported) via unspecified route of administration, administered in arm right on 12Apr2021 15:45 as dose 1, single for COVID-19 immunization. No other vaccine in four weeks. No COVID prior vaccination. No COVID test post vaccination. On 05May2021 11:00, the patient experienced soreness at injection site; but not real bad; both injections, some slight shoulder ache' 2nd injection, some slight diarrhea after 2nd injection. came upon approx 36 hrs after injection, lasted approx 24 hours. No treatment received for AE. The outcome of the events soreness at injection site; but not real bad; both injections and some slight shoulder ache' 2nd injection was recovered on an unspecified date in May2021. The outcome of the event some slight diarrhea after 2nd injection, came upon approx 36 hrs after injection was recovered on 06May2021.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021535850 same patient/drug, different dose/event
began falling frequently-balance/coordination appeared off and would topple over while walking. Additionally,legs appeared to "buckle" @ knees at times while walking resulting in falling. did not appear to be in pain, did not appear disoriented, was alert, and was not irritable. Is diagnosed w/ epilepsy, however has been seizure free for over 1 1/2 years and no signs/symptoms of seizure activity appeared present during this time period. The symptoms lasted from Saturday afternoon until about 5 PM the next day on Sunday-woke up from a nap Sunday evening,got up and appeared perfectly fine-no longer appeared to be having problems w/ balance/coordination, knees weren't "buckeling" and wasn't falling.
L thigh sterile abscess with 5 X 3 cm redness and 2 cm non tender subcutaneous knot.
Vaccines on 8/8/16 To ER 8/9/16 for itching /Rash /Redness Mom described Hives - BENADRYL and Prednisone IM - refused po Returned to ER on 8/11/16 late pm for fever rash, vomiting and itching - repeated BENADRYL and Prednisone IM - F/U in our office 8/12/16 - Sx's resolved.
Stated she felt completely fine prior to and up to approx. 1 hour after donation and immunization. Donor than experience some dizziness and vomited. Donor's condition improved for a couple of days and today has felt dizzy, vomited, and is febrile at 100.6. No other s/s reported and denies fever s/s prior to today.
Approximately 35 minutes after vaccination patient fainted and fell into a cardboard makeup display in the store.  Patient reports that she normally  has to use her walker due to back and leg pain. Requested that 911 be called, patient was taken to ER. No further information given.
R deltoid cellulitis with VARIVAX immunization. Seen today only (3/16/10) - 6x9cm area of inflammation, warmth, tenderness. Treated with KEFLEX and warm soaks.
Inflammation; Dizziness; Vertigo; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation), DIZZINESS (Dizziness), VERTIGO (Vertigo) and HEADACHE (Severe headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced VERTIGO (Vertigo) and HEADACHE (Severe headache). On an unknown date, the patient experienced INFLAMMATION (Inflammation) and DIZZINESS (Dizziness). At the time of the report, INFLAMMATION (Inflammation), DIZZINESS (Dizziness), VERTIGO (Vertigo) and HEADACHE (Severe headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Test performed for gout and everything was normal.         Action taken with mRNA-1273 in response to the events was not applicable.  No treatment medications were provided.  No concomitant medications information was reported.   This case was linked to MOD-2021-194267 (Patient Link).
pt had fever of 101 x 24 hrs & high pitched cry x 48 hrs; pvt MD notified & recommended that pt receive only DT; pt back to nl p/48 hrs according to mom;
pt had 15 min observation period, pt stated left sinus (cheek) areas was numb. No tongue tingling, or throat irritation Patient proceeded to do minor shopping and came back to ask about it but stated it as not progressing. He waited a few more minutes and his symptoms did not progress. I Informed him it "could" be a minor allergic reaction occurring or a effect of medication. I gave him 50 mg of Diphenhydramine orally and pt said he was going straight home. He live within 5 miles of sore. Pt was advised if any new symptoms occurred, especially trouble breathing or throat Irritation, to go to the doctor. I spoke to his wife w/n an hr, stated he said he felt okay.
Admitted to hospital with breakthrough covid 1/20/22.  Has received 1 J&J shot and no booster.
Woke up at 3am to use bathroom.  Got extremely dissy and feel down.  Could not get off the floor and was delerious for about 1 minute.  After a minute my balance returned, had a ringing in my ears for another 5 minutes and after that the side affects went away completely.
Very flush face immediately; hours later shortness of breath, muscle fatigue, dizziness, loss of taste, incessant sleep, temperature over 101.
Information has been received from a mother concerning her 17 year old daughter with no pertinent medical history or drug reactions/allergies who on 13-SEP-2007 was vaccinated with the first dose of Gardasil. There was no concomitant medication. Subsequently the patient experienced a delay in her menstrual period by 7-8 weeks. Medical attention was sought with the patient's physician. The patient did get her menstrual cycle around the time of 20-NOV-2007. No further information is expected.
Papular rash without symptoms of other illness 13 days after varicella vaccine. Fever controlled with Tylenol. T max 103.0.
pt recv vax 17JAN96 & exp inj site edema in the rt deltoid from shoulder to elbow;this is 1 of 2 patients to report from this site;
1) Fluzone High-Dose Quadrivalent administered to under 65 years. 2) No reported ADR's Reporter's recommendations 1) Verify DOB and highlight ages on consent form when conducting clinic's 2) Monitor pace of the clinic
Chest pain; Back pain; Migraine; Stomach bug; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), BACK PAIN (Back pain), MIGRAINE (Migraine) and ABDOMINAL DISCOMFORT (Stomach bug) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain), BACK PAIN (Back pain), MIGRAINE (Migraine) and ABDOMINAL DISCOMFORT (Stomach bug). At the time of the report, CHEST PAIN (Chest pain), BACK PAIN (Back pain), MIGRAINE (Migraine) and ABDOMINAL DISCOMFORT (Stomach bug) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Severe chills from 11pm to 6am.; mild nauasea; headache in morning
I received the Modern COVID-19 Vaccine EUA on Wednesday, April 1st, 2021 at 12:00 pm. By Friday, April 2nd, 2021 at 6:00 pm, I was experiencing fatigue and exhaustion. By 9:00 pm 04/02/2021, I was experiencing muscle aches. By 10:00 pm 04/02/2021, I was running a fever over 100ºF and experiencing chills.
Patient was given H1N1 and flu vaccine at primary care clinic on 12/07/09. He was called at home later that day about critical lab of blood glucose 45mg/dl. He woke up at 5am the next day gasping for air. He was taken to ER where his blood glucose was found to be 25mg/dl. He was observed for 5 hours and later discharged home. He has history of Diabetes type 2. He has recieved flu vaccine previous years with no such reaction.
Narrative: Patient was not previously Covid Positive and did not have any predisposing facts (PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was a resident of the CLC and on 4/1/2021 he was having stroke like symptoms, not responding to stimuli, and apparent altered consciousness. He later passed that day. Patient had a PMH significant for systolic CHF, chronic indwelling foley, persistent Afib on Eliquis, COPD, CKD, OSA, and CVA
Pt was very nervous getting the vaccine. After she left the office she had episode increased heart rate, felt anxious and flush, no shortness of breath, no reaction at injection site. Noted got home safely and the attacks where less. Called 6 PM, noted okay. She thinks just anxiety. No hx of egg allergy.
Breakthrough varicella-large outbreak- 50 lesions despite vaccination. Sibling also outbreak and vaccinated.
Got a high temperature - Patient was having seizure - turned blue- unable to breathe - had learning disabilities. Personality changed, weight size increased - hospital.
Fever to 101 and fussy. Started about 6 hours after vaccines and continued for about one day. No treatment added.
This spontaneous report was received from a registered nurse, via a company representative, referring to her son, a male patient of unknown age. The patient's medical history or concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL, either, GARDASIL 9 (it was unspecified which one)(dose, strength, route, lot number and expiration date were not reported). The patient's concomitant medication was not reported. Subsequently, on the same date of vaccination, the patient fainted. At the time reporting, the outcome of fainted was unknown. Additional information is not expected, since the reporter did not allow further contact.
pt recv vax in AM & sometime that noc exp edema of face & was reported that child was eval @ ER that noc;
ADMINISTRATION OF EXPIRED JANSSEN COVID-19 VACCINE; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, administered on 20-SEP-2021 08:30 for prophylactic vaccination. No concomitant medications were reported.  On 20-SEP-2021, the patient experienced administration of expired janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired janssen covid-19 vaccine was not reported. This report was non-serious.
Severe chills, tremors for 8 hrs.. TX.  Advil, mild relief  Severe frontal lobe headache with light sensitivity for 24 hrs.  TX.  ALEVE, no relief
Nose bleed; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 26Feb2021 at 15:15 (Lot Number: PAA165969) as dose 1, single for COVID-19 immunization.  Medical history included ongoing high blood pressure. The patient did not have COVID prior to vaccination. Concomitant medications include unspecified blood pressure medication and cholesterol medication. The patient did not receive other vaccines in four weeks from the COVID vaccine. On 27Feb2021 at 02:00, the patient experienced nose bleed. The patient did not receive treatment for the event. The outcome of the event was recovered.   No follow-up attempts are possible. No further information is expected.
Tetanus and pneumonia vaccines given 8/18/14 achy, coughing, fatigue, swelling of (R) upper arm with induration, pain and tenderness. (+) fever - Pneumonia 23.
This is a spontaneous report from a contactable consumer (patient). An 87-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on left arm single dose for COVID-19 immunisation on 22Feb2021, 02:00 PM, at 87-year-old. No medical history and concomitant medications were not reported. No other vaccine in four weeks and no other medications in two weeks. On 22Mar2021, 03:30 PM, the patient had lost consciousness 10 hours, could not walk, fever 101, extreme dizziness, vomiting, had to crawl when vomiting. No treatment. Outcome of the event was resolved on unknown date.  Information about lot/batch number has been requested.
Very large, very tender axillary lymph node under right arm.  Some soreness began day after injection but swelling and increased soreness began 4 days after injection and persists 8 days after injection
Bubble rash at site of inj, swollen, hot to touch, pain. Patient placed ice pack at site.
Approx 5 minutes after receiving the vaccine, client started c/o feeling hot, sweaty, Left side of tongue numb and she had pressure on the left side of her head, her BP dropped and she felt weak. No medications given. She felt better after 10 minutes. She called her doctor and he gave her an epi pen and told her not to take the 2nd dose of Pfizer. She says she felt dizzy and weak for 3 weeks afterwards, but fine now.
Hives to vaccinated arm only. No reaction at vaccination site. Feeling hot. Hives located on volar surface of right wrist and forearm.
got the shot, but I still got shingles/suspected vaccination failure; got shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 28-Feb-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shot but he/she still got shingles twice. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Aches, Runny Nose/Congestion, Cough Death due to COVID-19 complications
Tingling in hands and feet which started about 1.5 hour after I took the vaccine