chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Varicella - Information has been received from a physician concerning a 5 year old while male who on 07 Apr 2000 was vaccinated with the first dose of varicella virus vaccine live lot 532370/14623 in the left arm . On 24 Apr 2000 the patient developed chicken pox with an unknown amount of lesions.  The patient sought unspecified medical attention.  On an unspeccified date.  The patient recovered.  Also reported was a female sibling who was vaccinated and experienced similar avents.  No further information is expected
My right arm developed an itchy rash that was hot to the touch at the injection site. Over the next few days the rash became circular and a lump formed that continued to be hot to the touch and itchy, at it's largest it measured 4 inches across and developed a downward spread from the circle.
arm hurts; felt pinched; heat; red spot on arm/pink spot now; swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts), NERVE COMPRESSION (felt pinched), VACCINATION SITE WARMTH (heat), VACCINATION SITE ERYTHEMA (red spot on arm/pink spot now) and VACCINATION SITE SWELLING (swollen) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (poisoning were noted), Diabetic, Hypertension, High cholesterol and Drug allergy. Concomitant products included METFORMIN for Diabetes, COLESEVELAM HCL for High cholesterol, VERAPAMIL HCL for Hypertension, VITAMIN D [VITAMIN D NOS] for Vitamin D low.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-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 experienced PAIN IN EXTREMITY (arm hurts), NERVE COMPRESSION (felt pinched), VACCINATION SITE WARMTH (heat), VACCINATION SITE ERYTHEMA (red spot on arm/pink spot now) and VACCINATION SITE SWELLING (swollen). At the time of the report, PAIN IN EXTREMITY (arm hurts), NERVE COMPRESSION (felt pinched), VACCINATION SITE WARMTH (heat), VACCINATION SITE ERYTHEMA (red spot on arm/pink spot now) and VACCINATION SITE SWELLING (swollen) had resolved.            As a treatment patient applied wet cloth with ice cubes to the area periodically.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow up received included patient medical history,concomitant drugs, allergy details, first dose information such as start date, Lot number, Location and outcome of events.
pain where the shot was and the pain is going down the arm, and it is almost past the elbow; pain in elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain where the shot was and the pain is going down the arm, and it is almost past the elbow) and ARTHRALGIA (pain in elbow) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026DZ1A, 023M20A and 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, the patient experienced VACCINATION SITE PAIN (pain where the shot was and the pain is going down the arm, and it is almost past the elbow) and ARTHRALGIA (pain in elbow). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of 2 dosage form. At the time of the report, VACCINATION SITE PAIN (pain where the shot was and the pain is going down the arm, and it is almost past the elbow) and ARTHRALGIA (pain in elbow) had not resolved.            About one and a half hour after getting the booster shot, patient started to have pain where the shot was and the pain was going down the arm and it is almost past the elbow. All this happened in the left arm.
Got shot at 1pm.  Started getting tickle in throat by 4pm.  Difficulty swallowing by 5pm.  Blood shot eyes.  Filmy eyes, with what looked like mucous.  Took 2 benedryl.
A couple of days after I was having shortness of breath and palpitation, I'm a nurse so I was concerned because then it became chest pressure. I made an appointment with the doctor. He advised it'll go away in a couple of weeks and it did. Then I started having bowel movement problems which I don't know if it was related with the vaccination but it was 1 month after, here recently I have a enlarge lymph node on my right side of my neck. I had an ultrasound just yesterday and I still haven't gotten the results.
Patient called requesting advice for possible immunization reaction. She states that she received the pneumococcal vaccine on 2/17. There was initially some soreness at the site which eventually resolved. She does not have any pain now. She developed redness on her upper right arm on 2/19 and it has been present since then. Redness was very pronounced, but it now appears to be mild. The area is about 2" diameter. It is also itchy. She was into office again on 02/23 for redness, warmth and swelling at the site. Was diagnosed with cellulitis.
severe h/a, fever to 101, body aches devel w/in 24hr of second inj;tx w/APAP;sx persisted 48hr;
arm red; arm hard lump; arm itchy; A spontaneous report  was received from a consumer concerning a 86-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm red(Injection site erythema), arm hard lump(Injection site mass), arm itchy(Injection site pruritus).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 038K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Patient experienced arm red, arm hard lump, arm itchy.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm red, arm hard lump,arm itchy was unknown.
patient developed large rash on chest.  Nausea and vomiting.  Also had tightness and scratchiness in throat but did not progress
Patient received vaccine around 3:00 pm on 2/14/21. Around 7:00 am on 2/15/21 she went outside to walk her dogs and began to have "tunnel vision".  She says she almost passed out. She proceeded to sit down on a chair nearby. Patient was feeling clammy and sweating. Husband came out to help her back into the house. He took her blood pressure reading and it was 79/50. He claims it came back up pretty quickly. Patient says she put wash cloth on face and relaxed for that half of the day. By 1:00 pm that afternoon she felt fine.
No Adverse Event; Caller reports that improperly stored vaccines were administered. No other adverse events reported. No product quality complaints. No further information.          ?    Names of vaccines involved (including lot/exp) GARDASIL 9 (lot: U031056 exp: 06; This spontaneous report was received by customer refers to a patient of unknown age and gender.    The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-JAN-2023, the patient was vaccinated with improper storage hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #U031056, expiration date: 16-JUN-2024, (, exact dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error).  Administered dose of vaccine experienced the temperature excursion of - 40.0 degrees Fahrenheit for 70 hours and 5 minutes. No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2305USA008279
itching, hives, swelling of eyes & lips; treated w/Atarax;
This spontaneous report as received from a physician refers to a 68 year old male patient. On 10-DEC-2010 the patient was vaccinated with ZOSTAVAX (lot# and dose unknown). No other co-suspects were reported. No concomitant medications were reported. On 18-MAY-2012, the patient experienced shingles. It was unknown if the patient had sought medical attention. Action taken was not provided. The outcome of shingles was unknown. The reporter did not provide assessment of the relationship of the adverse event to the suspect therapy. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of allergic reaction in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). There were no concurrent medications. On 25 October 2011 (morning 08:30 - 11:30) the subject received a dose of FLULAVAL in the right arm. Less than one year after vaccination with FLULAVAL, the subject experienced allergic reaction (prior to reporting on 09 January 2012). At the time of reporting the outcome of the event was unspecified.
Physician Discharge Summary     Patient: Age:65 y.o. DOB: Admit Date:  7/11/2022 Discharge Date:  7/12/2022      Principal Diagnoses:  Principal Problem:   Precordial chest pain Active Problems:   Acquired hypothyroidism   Diastolic CHF, chronic   PAF (paroxysmal atrial fibrillation)   Status post insertion of drug-eluting stent into left anterior descending (LAD) artery   Hypomagnesemia   COVID-19 virus infection   Essential hypertension     Discharge Diagnosis: Paroxysmal A. fib and Covid 19   Hospital Course: Patient is a 65 y.o. female  with past medical history per below  presented to the emergency room with complaints of sudden onset of midsternal chest pain nonradiating associated with dizziness. The patient rated her pain up to 4 on 1-10 pain scale and admitted to associated palpitations and diaphoresis. She denied any shortness of breath, nausea, vomiting, or any other GI or urinary symptoms. She denied any fever, chills, cough or sputum production. She is fully vaccinated against COVID-19 vitals and has received the booster. Patient had left heart catheterization done a few months ago with stents placed to the LAD and circumflex. The emergency room chest x-ray was done showing no acute findings and EKG showed sinus rhythm with no changes compared to previous. Labs showed CBC and CMP at baseline with normal CK and negative troponin with mildly low serum magnesium at 1.6. UA showed innumerable white blood cells and urine cultures pending. COVID-19 test is positive. Patient was admitted to Covid unit where she was managed and monitored closely. She has not required supplemental oxygen. She denies shortness of breath. She was seen by cardiologist this morning who recommended for her to continue NOAC.  Continue lopressor and dc labetalol. Change nifedipine to cardizem and add imdur. Cardiac stable for dc . F/u with Dr in 1 week. Patient's other comorbidities were managed while admitted. She has requested to be discharged home. She will be discharged home with strict instructions to observe Covid restrictions, stay masked and to follow-up with her PCP within 3-5 days.   Consults to: Cardiology   Significant Diagnostic Studies: Echo   Procedure(s): n/a   Disposition: Home   Discharge Condition: Stable
Patient had received flu immunization on 10/7/23. Patient came to clinic for flu immunization on 11/7/23. Patient received flu immunization in error. Provider was notified. Patient's parent was also notified of error.
Worsening of polyarthritis and fatigue. Swelling and tenderness MCPs both hands, wrists, ankles and MTPs both feet
Unable to close eye fully or move right side of face night 12/26 called primary care doc 12/27 told me to go to emergency room. Diagnosed with Bells Palsy and prescribed presnidone and antiviral treatment and eye drops/eye patch for sleep. Symptoms improved after one month.
Lightheaded immediately after receiving vaccine. Reports next 3 days: nausea, low grade fever, sharp abdominal pain if eating. States he took tylenol and omeprazole. Was not effective.
Initial unsolicited report received from a consumer on 23 October 2015. This case involves a 65-year-old-male patient who was vaccinated with a dose of FLUZONE HD (batch number, route, dose and site of administration was not reported) on an unspecified date in 2014. The patient did not have illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not reported. On an unspecified date in 2014, immediately after the vaccination, the patient developed "flu-like" symptoms, was hot, and sweaty. Lab data and corrective treatments were not reported. The patient was recovered from the events (reported as symptoms lasted 24 hours). Follow up information received from consumer on 14 March 2016. Patient had no adverse events following prior vaccination and patient's concomitant medication was reported as none. It was reported that on an unspecified date, the first night post vaccination, the patient experienced the events. No additional information was provided. List of documents held by sender: none.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 65-year-old male patient who received SHINGRIX (batch number A2JL7, expiry date 22nd March 2021) for prophylaxis. On 17th September 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). In September 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling and injection site erythema. On 17th September 2018, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. A dose of SHINGRIX was inadvertently administered subcutaneously, which led to inappropriate route of vaccination. On 21st September 2018, the healthcare professional reported that the patient was experiencing redness and swelling at the injection site.
Received Tdap 9/28/11 in left deltoid. Returned to office at 2pm on 9/29/11 and explained (L) hand starting swelling in AM and by afternoon (L) hand was swollen and also fingers. Slight swelling to injection site.
Widespread, red, raised, itchy, hot rash in  area surrounding injection site (upper left arm). Started on 1/12/21, 12 days after injection but no other exposure to an allergen so not known if related to vaccine.  Treating with hydrocortisone and Benadryl. Methylprednosolone 4mg dospak prescribed but not started.
4:30 pm temp of 101.2, 11:30 pm temp of 105.1 extreme tenderness at injection sites, 7:00 am temp of 104.2 extreme tenderness at injection site
With the first shot last month I had achiness and cellulitis at the shot area. For the second shot I have run 103 fever well piggybacking Advil and Tylenol my joints ache my head is in pain and I have chills. I have a cookie size Red spot in my injection area.  This started midnight Sunday after the shot.  I feel like I have Covid (January) all over again.
Case reported to that she was admitted to hospital for care on 7/19/21 or 7/20/21.
Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 02Mar2021 at 12:00 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to products with sulfa. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to COVID vaccination. On 02Mar2021 at 13:00, the patient experienced sore arm alone. The patient did not receive any treatment for the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event pain in arm was recovered on an unspecified date in Mar2021.  Information about lot number cannot be obtained. No further information is expected.
Guillain Barre syndrome; numbness in the legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain Barre syndrome"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness in the legs". The patient had the Pfizer vaccine. The patient experienced numbness in the legs very soon after the shot. The patient was diagnosed with Guillain Barre syndrome. Event took place after use of product. The patient was walking with "walking sticks"/braces type crutches.  The lot number for bnt162b2 was not provided and will be requested during follow up.
presented w/ SOB, admitted for Covid PNA. Hx of CAD, CHF. Tx w/steroid, ax, remdesivir, zinc, Vit C. On O2 on the floor, condition worsened and transferred to PCU. Noted to be stable in PCU. Pt was noted to be having arryhmia on the monitor and was found unresponsive and pulseless. Code blue called. Responded  to code blue initially and transferred to ICU  but coded repeatedly and expired 8/22/2021.
pt recvd vax;w/in 1 wk pt devel 1 fluid filled blister or lesion at inject site;reporter felt that pt exp was probably related to vax;
Post menopausal heavy bleeding.  Scheduled for an ultrasound but no previous GYN issues and physical exam normal.
That night had a fever broke by the next am. body ache was bad was in bed still having some join pains for a week and got better but I still have the joint pains. End of JUne2021 came the rash with blisters mostly on my leg. Flood zone since hurricane came through on 1sep2021- Eczema for 3-4 month rash difficult to skin infection. more joint pains than usual . General sensitive skin. Teledoc and got oral antibiotics. Blisters are worst and diagnosed with skin infection 2 weeks after seeing my dermatologist. Got steroids tropical. Still have the lesions and rash. This is unusual to have these for so many months.
In June 1999, the pt developed chickenpox. The MD reported in follow up that information was provided.
Patient was given Pneumonia vaccine when he asked for Meningitis vaccine. No adverse event reported with incorrect vaccine requested.
Mother brought child into ER on 7/15/04 at 20:80, complained of child's left leg being swollen with quarter size redness and warmth. Physician checked temperature right 100 degrees, gave Recephin 500 mg IM given. Mother brought child back on 7/16/04 to immunization clinic, where child's leg was redder and more swollen 8cmx6cm. Notified put child on antibiotic for 10 days.
no adverse event reported - we are to log Pfizer vaccine with lot number that got administered October first after the recall came down concerning lot FL2757. told by manufacturer that dose was still viable but to still report.
Large  red and itchy rash around site of injection, started 1 week after injection.  Don't know how long it will last.  When it goes away, I will amend report.
01/27 chills, 101.3 fever, body aches, tachycardia 01/29 rash on back, torso and neck, itching
Patient had a seizure post vaccination lasting less than 5 minutes. Patient has a known history of seizure disorder. Patient observed for 30 minutes post seizure (no more seizure activity was observed during that time). Patient was sent home with spouse @0945.
Strong reaction(not moderate). High fever, labored breathing, vomiting, headache. Could not stand. Lasted about 12 hours and then started to feel better.
Swollen lymph node found on L clavicle area. Left side of neck and shoulder swelling. Pain at area. Observation at this time for two weeks per MD.
A patient who is immunocompromised (solid organ transplant) received a booster dose instead of a full 3rd dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (A patient who is immunocompromised (solid organ transplant) received a booster dose instead of a full 3rd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Solid organ transplant. Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (A patient who is immunocompromised (solid organ transplant) received a booster dose instead of a full 3rd dose). At the time of the report, ACCIDENTAL UNDERDOSE (A patient who is immunocompromised (solid organ transplant) received a booster dose instead of a full 3rd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Patient received a booster dose instead of a full 3rd dose. It has been 6 months since completion of the primary series.
VASCULLITIS:  Both lower legs. (I have photos) Eventually went to ER and was admitted to Hospital.  Stayed one night and one day.  Had many tests and 2 punch biopsies which confirmed diagonsis.  Treaded with Clobetasol Propionate .05% twice a day for 2 plus weeks, and condition resolved. (Unfortunately, develped staff infection from biopsies and had to take antibiotics for 20 days.  OK now)
Patient reports full body rash, fatigue, sore throat, and sleep walking  occurring a few hours after vaccination.