chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Onset of left, substernal throbbing chest pain and dyspnea. Pain worse on 6 Jun after 4-mile run. 3 Jun 16 (post-vaccine date (PVD) 9), onset of chest pain (CP) and shortness of breath. CP increased with deep breaths, also reported nausea, and diaphoresis. 6 Jun 16 (PVD 12), sought evaluation for continued CP (10/10) following 4-mile run. Treated with ZOFRAN, morphine, DILAUDID and TORADOL. ECG with NSR, sinus arrhythmia, rightward axis - borderline ECG. Elevated Troponin, CXR showed pneumomediastinum. Admitted to Hospital for pain management and observation. Discharged on OXYCONTIN for chest pain. Placed on limited duty. 13 Jun 2016 (PVD 19), ER evaluation - c/o SOB, CP and vomited blood x 3; anxious --> ATIVAN. CXR normal. Discharged: anxiety, hematemesis, CP, insomnia r/t medical problems. REC: PFTs, GI eval, albuterol inhaler, repeat ECG, referral to behavioral health. As of FEB 2017, patient continues to have ongoing chest wall pain. Additional cardiology evaluations do not support pain is cardiac in origin.
Pt stated in a conversation that occurred on 1/22/21 that her flu shot this year gave her a temperature, chills and a rash. She was not able to tell how long it lasted.
1121- Patient reported to Observer that she felt nauseated and wanted to go to the car to lie down.  1122  - VS 99/55. HR 68 R- 24 SpO2 - 100; patient pale, c/o nausea. Vocal response slow. Feet elevated 1124 - patient unresponsive; EMS called 1125 - 123/58, 78, 20, 100  1127 - 123/68, 80, 22, 100 - patient responsive 1128 - Fully responsive assisted to stretcher,  HOB 20 1129 - 130/60, 79, 20, 99 - given H2O. Refused soda, juice, crackers. States has slight nausea andhead hurts but has chronic headaches and recently had negative CT. 1134 - 137/60, 78, 98%, EMS arrived 1136 137/60, 76, 22, Sitting 1138 - 152/ 65 95, 22, 98- Standing More details 1153 - 110/59, 68, 18, 98 - Awake alert and oriented, no nausea, H/A improved.
On multiple unspecified dates, multiple unspecified patientes received improperly stored vaccine; No adverse effect; This spontaneous report has been received from a medical assistant, concerning an 9-week-old female patient.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 05-APR-2019, the patient was vaccinated with improper stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, frequency, route of administration unknown) Lot#R016790 and expiration date 20-APR-2020 for prophylaxis. No adverse effects reported.  Additionally, temperature for vaccines were total time and highest temperature above 9°C (9.9 C); time frame: 4 hours; with no previous temperature excursion. The error was identified via a data logger.; Sender's Comments:  US-009507513-1903USA013366:
pt recv vax 23OCT95 & pt devel a severe inj site rxn characterized by pain & inflammation;pt has recovered;this is one of six patients from this site who exp the above rxn;
Large lymph node (2 inches circumference ) above collarbone, smaller lymph nodes in neck and armpit, following low-grade fever, headaches, chills, joint pains, fatigue and diarrhea on first day of vaccine.
Moderna COVID-19 Vaccine EUA Fever, body aches, night sweats, nausea, chills, sore throat, insomnia
J&J vaccine 3/15 and on 4/2/2021 I thought I pulled a muscle and my leg started swelling, but my right leg only.  I thought it would go down and my leg and foot started swelling up and my foot got really cold. I went to the hospital on 4/11 and they said it was a DVT and they checked my lungs and said I had small blood clots in my lungs as well. They put me on Eliquis to keep my blood thinned out.
2nd vax 2/11/2021; Admitted on 8/29 to Hospital for severe constipation and swollen colon. No COVID symptoms. Tested (+) 8/29 followed by two (-) tests.  Antibody positive 8/31.  Still in hospital as of 9/2/2021
Not sure if this was a delayed reaction or not but starting on Mon April 5 (day 12 after shot), I had terrible pain in my joints that I'd never had before. Index finger swollen, painful knuckle. Knees hurt. Toes hurt. Back of my Neck hurt.
Muscle weakness in bilateral upper and lower extremities pain in bilateral upper thighs and forearms. Symptoms occurred approximately 2-3 hours after vaccine given. She had no reactions to first hep B vaccine given 11/4/02.
No adverse event; monovalent dose ages 6-11 administered instead of bivalent booster dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (monovalent dose ages 6-11 administered instead of bivalent booster dose).    No concomitant drug information was provided.  It was reported that patient was supposed to receive the bivalent booster dose but instead they were given the monovalent vaccine ages 6-11.  No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-659987, US-MODERNATX, INC.-MOD-2022-661797, US-MODERNATX, INC.-MOD-2022-661798 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659987:same reporter US-MODERNATX, INC.-MOD-2022-661797:Same reporter US-MODERNATX, INC.-MOD-2022-661798:Same reporter
This case was reported by a other health professional via call center representative and described the occurrence of loss of consciousness in a patient who received BOOSTRIX (batch number 9NA32, expiry date 28th March 2017). On 11th June 2015, the patient received BOOSTRIX. On 11th June 2015, 10 min after receiving BOOSTRIX, the patient experienced loss of consciousness (serious criteria GSK medically significant). On an unknown date, the outcome of the loss of consciousness was unknown. It was unknown if the reporter considered the loss of consciousness to be related to BOOSTRIX. Additional information was provided as follows: BOOSTRIX was given to the patient and the patient experienced in and out of consciousness. The reporter had limited information.
Red Raised Lump, Some Slight Swelling. Patient Trying Warm Compress and Ibuprofen.
COVID-19 virus test positive; felt crappy; body aches; Fever mid-100; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), MALAISE (felt crappy), COVID-19 (COVID-19 virus test positive) and PYREXIA (Fever mid-100) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history reported). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and PARACETAMOL (TYLENOL) for an unknown indication, IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (ADVIL COLD).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced MYALGIA (body aches) and PYREXIA (Fever mid-100). On 08-Jan-2021, the patient experienced MALAISE (felt crappy). On 09-Jan-2021, the patient experienced COVID-19 (COVID-19 virus test positive). On 06-Jan-2021, MYALGIA (body aches) had resolved. On 09-Jan-2021, MALAISE (felt crappy) had resolved. At the time of the report, COVID-19 (COVID-19 virus test positive) outcome was unknown and PYREXIA (Fever mid-100) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, SARS-CoV-2 antibody test: (Negative) Negative. On 09-Jan-2021, SARS-CoV-2 antibody test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded except for the event of COVID rapid test positive. The event of COVID rapid test positive is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection resulting a positive test result.
Patient is a 63 yo morbidly obese female with a history of DM, HTN, and uterine cancer s/p hysterectomy, who presented to the ED complaining of generalized malaise, cough, and shortness of breath since 1/1/22. Patient states she had been having cough since 1/1/22. Starting the night prior to presentation patient started to have difficulty breathing, specifically orthopnea and exertional dyspnea. Patient is fully vaccinated against COVID since May 2021. She is yet to b boosted against COVID. She is a Florist and has a colleague at work with COVID. She denies fevers, loss of sense of taste or smell, abdominal pain, diarrhea, chest pain. She sees a Dr. for "heart racing" that is controlled with Bystolic. She does not use oxygen at home.  Upon initial presentation at ED, 101.3 degrees F, HR 101, RR 30, she was satting 89% on RA. 178/70. CXR showed increased airspace opacities. Suspect interstitial edema. EKG showed NSR at 96 bpm with nonspecific ST/T wave abnormalities. Laboratory values showed normocytic anemia, hyponatremia, metabolic acidosis, elevated troponins, elevated N terminal pro BNP.  COVID PCR positive 1/3/22. Patient was transferred to other medical facility for further evaluation and management.
This spontaneous report as received from a healthcare worker refers to a 26 year old female patient. On 28-JUN-1996 and 22-MAY-2007 the patient was vaccinated with VARIVAX (Merck). Route and dose were not provided. The patient failed to seroconvert. On an unknown date antibody titer was drawn and was negative. On 22-JUL-2013 the patient was vaccinated with VARIVAX (Merck) dose 3. It was reported that the patient is a college student and needs to have the Varicella vaccine. No adverse effects were reported. The patient sought medical attention by contacting the office. The outcome of antibody titer was drawn and was negative: failed to seroconvert, was unknown. Additional information is not expected.
SHINGLES(LEFT EAR HOT AND THROBBING); This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, non smoker, penicillin allergy, and sulphur allergy, and other pre-existing medical conditions included patient on antibiotic for shingles. The patient experienced drug allergy when treated with codeine non-company. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 16:45 for prophylactic vaccination on left arm. No concomitant medications were reported. On 18-MAR-2021, the subject experienced shingles (left ear hot and throbbing). Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shingles (left ear hot and throbbing). This report was non-serious.
first one made her real sleepy; A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: not provided), via an unspecified route of administration on 05Feb2021 (at the age of 77-year-old) as dose 1, single for COVID-19 immunization and cortisone(Lot number: not provided, Expiration date: not reported)for unknown indication on unspecified date. The patients medical history and concomitant medications were not reported. On an unspecified date, first one made patient real sleepy. The outcome of the event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100944492 same patient/drug, different dose/event
Drug Allergies: Yes; Pneumococcal vaccine (Rash); This is a spontaneous report received from a contactable reporter(s) (Physician).  An 82-year-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Drug Allergies: Yes"; RASH (non-serious), outcome "unknown", described as "Pneumococcal vaccine (Rash)".  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Pt recv vax on 10/22/92; on 11/1/98 pt exp shingles; Annual follow-up dated 02/21/01 provided no additional data.
Narrative: COVID infection following COVID vaccine series 03/25, Pfizer, dose #1 08/30, Pfizer, dose #2 12/7 COVID swab, result: not detected 12/26 COVID swab, result: detected 12/01 pt cc: Fatigue, body aches, headache., diarrhea. exposure: unknown 12/07 pt admit ED cc: Fatigue, body aches dx: Acute Viral Syndrome LOS: 1 day 12/26 SARS-COV-2 Variant Sequencing: pending
I started with COVID arm on the 8th day after the vaccine. A small raised warm bump at the injection site. I put ice on it and cleared up in a couple days.  I then started to have pressure on my neck. On September 1st, I started with a migraine.  I also felt like I had something stuck in my throat.  Pressure on the right side of my throat.  Hard to shallow.  I went up to the hospital and waited two hours without being seen.  I called the clinic and they said to go back to the hospital.  They took x-rays and took blood.  They advised everything was clear.  They told me to take some Pepcid.  They told to see a GI doctor.  I can not get into to see them until the 29th.  I changed my diet to all liquid.  On the 6th I started to lose feeling in my thumb.  It spread up to my hand and to my forearm.  It went all the way up my body to my left side of my tongue.  I went to the ER, and they told me I was having a panic attack.  They gave me a CT scan and they did more blood work to check potassium levels.  They told me to follow-up with a doctor I am supposed to see them on the 21st of September.  I will also get sporadic stiffness in my arm.  I have had tingling in my left big toe.  I still am unable to eat anything solid.
Information has been received from a physician's assistant concerning a healthy 34 month old (previously reported as 3 year old) white female patient, with no medical history, no allergies and no illness at the time of vaccination. On 5/19/04, the patient was vaccinated IM in the thigh with a first dose of MMR (lot # 646740/0822N). Concomitant therapy included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine and varicella virus vaccine live. On 5/19/04, the patient experienced swelling at the injection site. It was reported that a hematoma might form. It was reported that on 5/21/04, the patient would be evaluated and might be hospitalized. It was unknown if treatment was required. Follow up information from the physician's assistant reported that on 5/20/04 the patient experienced edema of right thigh (ultrasound report noted it as left thigh). An ultrasound of the left lower extremity was performed for swelling, warmth, redness of the thigh following vaccination. It was reported that there was no fluid collection or hematoma noted; edema in the soft tissues was visualized. Subsequently, the reporter indicated that the patient recovered and required only a doctor visit. No further information is available.
Took oral typhoid completed 7/28/12, rash developed 7/29/12 on thighs, & legs with she reports some bruising took BENADRYL for itching, instructed to contact PMD.
My face was bright red and very hot and swollen cheeks  I felt nauseous  Very bad headache  Very thirsty
Temperature 101.6, redness and swelling on left thigh. Swelling in left inguinal area.
No adverse event; Patient received dose of the monovalent Moderna COVID19 vaccine/Date of administration April 21 2023; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received dose of the monovalent Moderna COVID19 vaccine/Date of administration April 21 2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Apr-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received dose of the monovalent Moderna COVID19 vaccine/Date of administration April 21 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received dose of the monovalent Moderna COVID19 vaccine/Date of administration April 21 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received dose of the monovalent Moderna COVID19 vaccine/Date of administration April 21 2023).    No concomitant medications was reported. No treatment medications was reported.  HCP wanted dosing information on patients 6 Months of Age and Older Not Previously Vaccinated with a COVID-19 Vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-721291 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721291:Master case
Terrible headache since Saturday. Dizzy, nauseous. Face swelling, I do have derma fillers. Face swelling since Sunday.
pt recv vax 6/95 & in 7/98 pt presented w/varicella
Lt. delt area with raised rash, erythema, itching, appeared 5 days after vaccine. Muscle pain for several days. Area affected is approx 100 mm x 50 mm (10 cm x 5 cm)
Felt fine directly after and started to feel numb around area and feeling tingling around area and tingling spread down arm over night.  Patients reports limb as feeling heavy.
Nausea (feeling of needing to throw up); Blurred vision; High pitched ringing noise
She had generalized weakness so severe her son had to pick her up and carry her up the steps she was hallucinating a "little person" and carrying on a conversation with him. She was extremely confused. She had diarrhea We ran bloodwork /testing everything was fine except for some hypokalemia likely from the diarrhea.  She recovered on her own within the week.
Pt presented to the ED  10/13 with syncope and what appeared to be a pulmonary embolism. Tried to resuscitate patient for 90 minutes but no success.
Moderna booster received 13Dec2021. 10 days post-booster(23Dec2021), widespread severe itchy rash developed with 1+ pitting edema. Urgent care was sought the next day (24Dec2021) when Benadryl failed to resolve the symptoms. Prednisone course, famotidine, and continued Benadryl were prescribed. Once medication course was completed, itching and hives returned, accompanied by dermatographia which is still persisting approximately 4 months later. Self-switched to Zyrtec 24-hr once daily when Benadryl proved to cause excess drowsiness when taken at dose needed to control itching.  Daily Zyrtec use since January 2022. If a dose of Zyrtec is missed, itching returns. Zyrtec does not resolve dermatographia. As of this writing, issue is ongoing.
The injections site began to swell and become inflamed right away. By the third day Oct 22 the pain/swelling and became intense and the location site began to bruise and turn brown/red. This day I went to the Dr. who prescribed me the ATARAX for itching and swelling in addition to KEFLEX... After a few days the site continued to remain red and swollen however at time the location site is now draining. By day 5 the pain was again too intense.. I went back to the Dr. who then prescribed sulfamethoxazole. The location redness and drainage has increase by day 10 I went back to my doctor who said "continue antibiotics for the next 5 days and follow up with him on the 12th and for me to follow with CDC.
Pt recv vax on 9/23/98; on 9/24/98 pt exp area of numbness under Rt arm.
Fever 103.7, joint pain, body aches. Nauseous. Taking Tylenol. Testing in bed
I felt like typical achy; this morning I noticed that I have red like, it's not rash, it's like a red circle, like filled in red circle rash, underneath where this injection site was; this morning I noticed that I have red like, it's not rash, it's like a red circle, like filled in red circle rash, underneath where this injection site was; The injection where it was is also red and it is warm to the touch; I had some, might be a localized reaction; The injection where it was is also red and it is warm to the touch; I had some, might be a localized reaction; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration on 11Feb2021 (at the age of 57-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included cholesterol. The concomitant medication included fluoxetine. On 13Feb2021, the patient felt like typical achy and this morning noticed red like, it's not rash, it's like a red circle, like filled in red circle rash, underneath where this injection site was and the injection where it was also red and it was warm to the touch. The patient reported that she took Tylenol yesterday and Benadryl last night, but she normally take that anyway with her allergies. The outcome of the events were not recovered.  Follow-up attempts completed. No further information expected.
shoulder sore; Sore: Vaccination Site and All over the body; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Sore: Vaccination Site and All over the body) and ARTHRALGIA (shoulder sore) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): unknown.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore: Vaccination Site and All over the body). On an unknown date, the patient experienced ARTHRALGIA (shoulder sore). At the time of the report, VACCINATION SITE PAIN (Sore: Vaccination Site and All over the body) and ARTHRALGIA (shoulder sore) outcome was unknown. Not Provided      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.   Concomitant medications were not reported. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow up contain NNI.