chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant referring to a 16 year old patient of unknown gender. There was no pertinent medical history. The patient was allergic to penicillin (unspecified) and egg. On 18-NOV-2015, the patient was vaccinated with first dose of VAQTA (lot number L015460, expiration date 20-JUL-2017, dose and route unknown) in unspecified arm. Concomitantly, the patient received an unspecified meningococcal vaccine (lot number, dose and route unknown) in the same arm. On the same day, the patient experienced a sore arm at injection site and red eyes later in the day of vaccination. The patient sought medical attention via contacting physician's office by the parent. No treatment was given for the events. No lab diagnostics studies were performed. The outcome of the events was unknown. The causality between the events and VAQTA was unspecified. This is one of two reports received from the same source. Additional information has been requested.
Hives/ Whelps all over body Redness  Skin warmth Intense itching/ pain
Initial unsolicited report received from a consumer on 26-Sep-2017. This case involves a female patient (onset age not reported) who was vaccinated with a 0.5ml single dose of FLUZONE QIV (batch number, expiry date was not reported) via intramuscular route on an unknown date. The patient had a medical history of necrosis of 2 inches on her forearm. The patient's concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed large raised red area at the injections site that took time to resolve. The patient's laboratory data and corrective treatment were not reported. On an unknown date the patient recovered from event. List of documents held by sender: none.
10 days after vaccination a 3x3in area became red, swollen,  and painful at the injection site.  No swelling prior.
Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 30-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 30-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 30-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 30-Jul-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 30-Jul-2022).    No concomitant product use was reported. Patient received half dose. The vial was initially stored in the refrigerator on 4Jun2022. Vial did not undergo any temperature excursions.  No treatment information was provided.
blood in urine; Whole arm hurt; Bruising at the injection site for several days; This spontaneous case was reported by a patient and describes the occurrence of BLOOD URINE PRESENT (blood in urine), PAIN IN EXTREMITY (Whole arm hurt) and VACCINATION SITE BRUISING (Bruising at the injection site for several days) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced PAIN IN EXTREMITY (Whole arm hurt) and VACCINATION SITE BRUISING (Bruising at the injection site for several days). On 11-Aug-2021 at 6:00 PM, the patient experienced BLOOD URINE PRESENT (blood in urine). On 12-Aug-2021 at 6:00 PM, BLOOD URINE PRESENT (blood in urine) had resolved. At the time of the report, PAIN IN EXTREMITY (Whole arm hurt) and VACCINATION SITE BRUISING (Bruising at the injection site for several days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was not taking any concomitant medications.  It was reported that the patient did not take any treatments for the events.
Suspected vaccination failure; Got shingles again now; No pain just itching in 3 places; 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 (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had them for almost a year).   On an unknown date, the patient received Shingrix. On an unknown date, 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pruritus. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that he/she had shingles for almost a year, he/she went to the doctor, had 2 different medications (unknown medication) which did not help. The patient got unknown shot when he/she was 50, discontinued that one. The patient had Shingrix shot 2 years before date of reporting and got shingles again then at the time of reporting, had no pain just itching in 3 places that were worse before. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Head cold and sinusitis, went to facility on January 15 and was to I was Covid positive
Extreme swelling in left arm, could not move due to horrific pain, trouble breathing slight temperature, fatigue, numbness in back and chest.
Well demarcated redness and swelling from proximal right shoulder to just distal to right elbow. There is lichenification and skin thickening.
general malaise, myalgias, fatigue;some frontal h/a;sx lasted 10-14 days p/vax;occurred w/2nd & 3rd dose anthrax;
Report received from Pharm D. July 9, 2011. Daughter called pharmacy pt received ZOSTAVAX 7/5, that evening redness & itchy rash at injection site. 7/6 redness spread to her back. 7/7 redness on back resolves. 7/8- pt felt weak/tired, arm still red and itchy, got "sick" after dinner (GI), chills and fever called primary MD- treated it like a flu/food poisoning that evening pt was resting. Spoke to pt today everything has resolved, no redness/swelling of arm. Thinks the GI issues was bad tuna fish.
Discharge Provider:  Primary Care Provider: Admission Date: 7/22/2022 Discharge Date: Jul 25, 2022  PRESENTING PROBLEM: Pulmonary embolism and infarction (HCC) [I26.99] Acute pulmonary embolism without acute cor pulmonale, unspecified pulmonary embolism type (HCC) [I26.99] Pneumonia due to COVID-19 virus [U07.1, J12.82]   HOSPITAL COURSE: Patient is an 86 year old male with PMHx of DM2, PVD, Esophageal carcinoma stage 3, who presented with COVID pneumonia and bilateral PE. Patient was admitted after he was found to be tachycardic and short of breath in his oncology office. He was found to be positive for COVID in the ER and CT scan showed bilateral PEs. Patient was admitted and started on a heparin drip and increased doses of steroids. Patient improved symptomatically. Patient never was hypoxic. He was transitioned from heparin to eliquis. Patient's symptoms improved. He was doing well at the time of discharge, he was not short of breath, his vitals were normal. He will need at least 3-6 months of anticoagulation, possibly indefinitely given his underlying malignancy, will leave that up to his PCP. Patient was then discharged home in stable condition.
"This is a verbatim narrative as reported to the FDA VAERS:" "Service member reporting that she developed Type 1 Diabetes in temporal association to receipt of anthrax vaccination #6 on 15 Sept 09. Stating she began to experience irritability, sluggishness, thirst and 'not feeling myself' over the next months. She was diagnosed in Feb '10 and has been followed by endocrine by out referral. Service member has learned that others have developed DM 1 and have linked it to receipt of the [sic] anthrax vaccine,"
sore throat, wheezing, nonproductive cough, headache, ear itching. starting 1/11/22
This spontaneous report was received from a register nurse and refers to multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions or concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L036301 with expiration date 20-DEC-2017 and lot #M018810 with expiration date 28-MAY-2018 (dosage and route of administration were not reported), which were exposed to temperature excursion (temperature was 51.6 degree F, time frame: 1 hour and 45 minutes) because of a data logger. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
got the first dose of the Moderna vaccine on 08Feb2021 and has not gotten the second dose yet; their back went out on them and lasted for 4-5 days; This spontaneous case was reported by a physician and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (their back went out on them and lasted for 4-5 days) and PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 08Feb2021 and has not gotten the second dose yet) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A or 001M20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  The patient's past medical history included Heart valve replacement (Aorta valve replacement). Concomitant products included TORSEMIDE, WARFARIN SODIUM (JANTOVEN), METOPROLOL, SPIRONOLACTONE, PANTOPRAZOLE, SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]) and PROBIOTICS NOS for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021 at 11:30 AM, the patient experienced MUSCULOSKELETAL DISCOMFORT (their back went out on them and lasted for 4-5 days). On 31-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 08Feb2021 and has not gotten the second dose yet). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (their back went out on them and lasted for 4-5 days) and PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 08Feb2021 and has not gotten the second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication also include stool softer and iron pill.
After pt was given the shot, pt experienced metallic taste in her mouth. Approximately 5 minutes later, she started wheezing, coughing and gasping for air. Pt also used her albuterol inhaler to help her breathe better. She has history of severe asthma. She was given a dose of adult EPIPEN at the pharmacy and paramedic was called. After paramedic arrived, her oxygen sat was 99%. She was given a breathing treatment and was taken to the hospital.
Information has been received from a Licensed practical nurse, concerning  her mother or mother in law (this was not specified), who in 2010, last year, was vaccinated with a dose of ZOSTAVAX (Merck) (lot #, dose and route not reported). The LPN reported that the patient now had zoster and on an unknown date, was admitted to hospital, however it was not known whether this was believed to be related to ZOSTAVAX (Merck). Unspecified treatment was given for the event. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Recurrent upward gaze of eyes w/ minimal brow furrowing. No prior hx of tics. Normal vision/exam (x mvmt issues) in office today.
Slurry speech; Swollen tongue; Sore arm; A spontaneous report was received from a consumer concerning a male patient of 72 year old, who was received Moderna's COVID-19 vaccine(Mrna-1273) and experienced sore arm,slurry speech and swollen tongue.  The patients medical history,as provided by the reporter, included chemotherapy.No Concomitant medications were reported.  On 12 feb 2021,prior to the onset of events, the Patient received their second of two planned dose of Mrna-1273(Lot number:026L20A) vaccine intramuscularly for prophylaxis of COVID-19 infection.  On 12 feb 2021,after taking vaccine patient experienced soreness in arm.On the second day he woke up with slurry speech and swollen tongue. Patient was Admitted emergency room where he was kept overnight for observation and treatment.  Treatment for the event included hospitalization.  The outcome for the event sore arm,blurred speech and swollen tongue was not mentioned.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Diaphoretic, some chest tightness, skin with what appears to be dermatographia not hives, pulse 129 - sent to ER.
Red circular rash around injection site. 5"x4". Multiple dots, warm to touch- Broke out 1 day after injection. Ice packs applies. Tylenol and Benadryl given PO.
This is a spontaneous report from a noncontactable consumer (patient's daughter). A 62-year-old male patient (reporter's father) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# and expiry date: not reported), via an unspecified route of administration, on Mar 21, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On Mar 29, 2021, patient experienced chills and mild fever/100.1ºF. The reporter asked if a patient who received the first dose of the Pfizer-BioNTech COVID-19 vaccine will experience chills and a mild fever. Was it possible to experience those symptoms 8 days after getting the vaccine? The reporter stated these symptoms and timeframe were experienced by her father. The patient underwent lab tests/procedures, which included body temperature of 100.1ºF on an unspecified date in 2021. The outcome of the events: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Case number PHEH2015US020165, is an initial spontaneous report received from a healthcare professional on 07 Oct 2015. This report refers to a 71 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with expired FLUVIRIN (batch number: 1413901 and expiry date: not reported) suspension intramuscularly at a dose of 0.5 ml on 06 Oct 2015. No adverse event was reported following the administration error.
Friday: tired, achy, headache & stiff neck; Friday: tired, achy, headache & stiff neck; Friday: tired, achy, headache & stiff neck; low grade headache started 1 hr after injection and stayed with "me" the rest of the day/ Friday: headache; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 11Mar2021 at 12:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The medical history included diabetes and seasonal allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received varicella zoster vaccine rge (cho) (SHINGRIX) on 15Feb2021 within four weeks prior to the vaccination. The concomitant medications included metformin (MANUFACTURER UNKNOWN), atorvastatin calcium (LIPITOR), estrogens conjugated/medroxyprogesterone acetate (PREMPRO), estrogens conjugated (PREMARIN) and fluticasone propionate (ALLER FLO), all for  unknown indications from unknown dates and unknown if ongoing. On 11Mar2021 at 13:30, 1 hour after the vaccination, the patient experienced low grade headache and stayed with her the rest of the day. On 12Mar2021 at 13:30 Friday, the patient experienced tired, achy, headache and stiff neck. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events low grade headache, tired, achy, headache and stiff neck was resolved on a known date in Mar2021.   No follow-up attempts are needed. No further information is expected.
patient started bleeding a lot from the site of vaccination.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (patient started bleeding a lot from the site of vaccination.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (patient started bleeding a lot from the site of vaccination.). At the time of the report, VACCINATION SITE HAEMORRHAGE (patient started bleeding a lot from the site of vaccination.) outcome was unknown.            Patient was on concomitant medications like cholesterol pills. Pharmacist had to wipe and wipe with alcohol and had to put double band aid.
08/31/22 presents to ED for "fever, cough, sore throat, runny nose and mild chest pain". PMHx of "CAD,CHF, PVD, DM II , HTN , and CKD"
On 05/17/00 two days post vax, pt experienced flu-like symptoms - nausea, fatigue, low grade fever. On 05/19 pt experienced chest discomfort - substernal and radiating to jaw. Myocarditis dxed.   Also diagnosed wee acute pericarditis, hypertriglyceridemia.
Shot was received around 2pm, by 4pm on Oct 2,2021 is when I started to feel ill. 10/2/21 I couldn't stay awake I slept to 7pm woke up for 2 hours and slept till the following morning. I currently am still having all the following issues as of 10/5/21.  Headache, dizziness, foggy feeling in head,  All of my muscles are cramping, all of my joints hurt, chills, sweating, throat hurts/ burns bad, now have really bad cough,  chest hurts to take deep breathes,  Very congested
3/10/21 - got J & J vaccine  3/17/2021 - word finding difficulties  3/24/2021 - visit with HCP - no recurrence of word finding difficulties;  Right rib pain  4/11/2021 - trouble walking 4/12/2021 - 3 days of L. Hip, knee pain, saw PT, concern for L2/L3 dis herniation 4/15/2021 - sxs worsened Dec 2021 - still w/sxs, slowly improved  Today, April 2023 -  Residual sxs - Still feels a tingling from below the ankle to below the knee on the left foot only
first covid vaccine and all 3 of them ended up with UTIs; This is a spontaneous report from a Pfizer sponsored program. This consumer reported similar events for three patients. This is the second of three reports. A contactable consumer reported a female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included hydrocortisone acetate, neomycin sulfate, polymyxin B sulfate (CORTISPORIN) from an unknown date for an unknown indication. On an unknown date within 24 hours of the vaccine, the patient experienced a urinary tract infection (UTI). The outcome of UTI was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021391028 Different patient/ Same AE and suspect product (patient# 1);US-PFIZER INC-2021391051 Same reporter/suspect product/event, different patient.
10 days after getting the vacination I had sharp pains when I took a deep breath on the left side of my chest & pain running up the left side of my neck. It was not getting better 3 days later. I called my primary physician who advised me to go to the emergency room.  I feared a heart attack or blood clot. Tests came back negative/they diagnosed as Pleurisy. I felt better 2 days later. I found it odd that I had this pain after getting the vaccination.  I had no immediated side effects, they occured 10 days after the inection.
Intense pain at injection site and entire left arm which became stiff and painful to move. Exercise exacerbated symptoms, which last on and off six months. Symptoms would onset suddenly and last a few hours. Patient never sought treatment.
after receiving shot i had an headache later that day about 3pm. I took ibuprofen 800mg a,d went to sleep. I woke up about 10:30pm that night feeling sluggish. That Sunday I woke up with the same headache not as bad and i took another ibuprofen 800. My arm was very sore and swollen at the injection site. On Monday, when i woke up my right armpit had swollen up and bruised rally bad. My lymph nodes in my armpits had also swollen and very tender to touch. I went to SCS clinic and they gave me some Cyclobenzaprine for muscle relaxation and told me to follow up with my PCP. I went to my PCP on 3/4/2021 and she prescribed me some Prednisone for swelling.
Eight days after my 2nd vaccine I developed a skin rash of small pin sized soars mostly on my back some on arms and legs that were very itchy.
Pt states after a couple of hours of recieving the Anthrax vaccine he started to have nausea, shaking, and shortness of breath that lasted for a couple of hours.  Pt was not seen for these symptoms.