chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Altered taste (stomach acid or bile taste); Painful bowel movements (product not act); Indigestion; Increased flatulence; Increased eructation; Headache/light sensitivity; Headache/light sensitivity; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Altered taste (stomach acid or bile taste)), GASTROINTESTINAL PAIN (Painful bowel movements (product not act)), DYSPEPSIA (Indigestion), FLATULENCE (Increased flatulence) and ERUCTATION (Increased eructation) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Previously administered products included for Drug use for unknown indication: Septra/Suprax (Septra/Suprax) and Septra/Suprax (Septra/Suprax). Past adverse reactions to the above products included Allergy with Septra/Suprax and Septra/Suprax.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On 26-May-2022, the patient experienced TASTE DISORDER (Altered taste (stomach acid or bile taste)), GASTROINTESTINAL PAIN (Painful bowel movements (product not act)), DYSPEPSIA (Indigestion), FLATULENCE (Increased flatulence), ERUCTATION (Increased eructation), PHOTOPHOBIA (Headache/light sensitivity) and HEADACHE (Headache/light sensitivity). At the time of the report, TASTE DISORDER (Altered taste (stomach acid or bile taste)), GASTROINTESTINAL PAIN (Painful bowel movements (product not act)), DYSPEPSIA (Indigestion), FLATULENCE (Increased flatulence), ERUCTATION (Increased eructation), PHOTOPHOBIA (Headache/light sensitivity) and HEADACHE (Headache/light sensitivity) was resolving.            Concomitant medication was not reported.  Device date was reported as 29-May-2022.
-Vaccine site soreness , patient recovered.  -Employee received Moderna Vaccine on 12/30/20 and 1/27/21. Employee reports cold like symptoms, tested Covid positive on 3/27/21. Employee quarantining at this time.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No information about medical history, concurrent conditions was reported for the patients. On an unknown date the unspecified number of patients were vaccinated (Oka/Merck) VARIVAX (dose strength, route unspecified) that were improperly stored. No adverse experiences reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 52 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was subcutaneously vaccinated with a dose of 0.65 ml ZOSTAVAX (Lot# reported as H012523, Exp date: 09-OCT-2013) on 23-OCT-2012. There was no concomitant medications therapy. Subsequently on an unknown date in October 2012 the patient developed redness at the injection site. The affected area was the size of a softball. The patient had sought medical attention and it was stopped by at the pharmacy. No lab diagnostics studies performed and no treatment was given for the event. The outcome of redness at the injection site was reported as not recovered. Additional information is not expected.
Discharge Provider:  Primary Care Provider: MD Admission Date: 12/6/2022 Discharge Date: Dec 9, 2022 COVID positive Date: 12/6/2022 PRESENTING PROBLEM: Hypotension [I95.9] Acute cystitis without hematuria [N30.00] Septic shock (HCC) [A41.9, R65.21] COVID-19 [U07.1] COVID-19 virus detected [U07.1]   HOSPITAL COURSE: Per icu transfer summary 72 yo female with PMH significant for Alzheimer's and vascular dementia (lives at home with husband), COPD. She presented to the ED 12/6 for altered mental status. Husband provided history and told ER that the AMS began 12/6. CTH NEG, UA + nitrates, given Cefepime x1.  Hypotensive despite 2L, was started on NE and admitted to ICU. 12/8 12/8 Hemodynamically stable to transfer out of the ICU On the general medical floor, patient was reportedly at baseline and was medically stable for discharge.  Her symptoms were likely related to COVID infection and were expected to improve with conservative management in time.
SWELLING OF THE TONGUE; SWELLING OF THE THROAT; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced swelling of the tongue, and swelling of the throat. The action taken with covid-19 vaccine was not applicable. The outcome of the swelling of the tongue and swelling of the throat was not reported. This report was non-serious. This case, from the same reporter is linked to 20211046395 and 20211039784.
This spontaneous report as received from a certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On unknown dates, the patients were vaccinated with doses of improperly stored oral, ROTATEQ (Lot # reported as 1010126, expiry date: 22-JAN-2017). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports from the same reporter. Additional information has been requested.
10/27/04 @ 1700 - received vaccination in rt thigh; 10/29/04 @ 0010 to 10/31/04 @ 1130 - pt "fussy" and hives appeared on face, trunk (front and back),upper and lower extremities; Benadryl given during this time per PCP
pt recv vax 5AUG96 & 18NOV96 pt exp a breakthrough rash w/less than 50 lesions on chest, back, arms & face;
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Active COVID-19  infection), DRUG INEFFECTIVE (Drug ineffective) and TINNITUS (Right ear ringing) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A, 032L20A and 037K20A) for COVID-19 vaccination. Concurrent medical conditions included Hypothyroidism, Chronic bronchitis, Penicillin allergy, Allergy to antibiotic (Ceclor), Allergy to vaccine (Pertussis Vaccine) and Fruit allergy (Avocado allergy). Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (ESTARYLLA) from 2021 to an unknown date for Birth control, MONTELUKAST SODIUM (SINGULAIR) from 2020 to an unknown date for Chronic bronchitis, THYROID (ARMOUR THYROID) from 2021 to an unknown date for Hypothyroidism, ACYCLOVIR [ACICLOVIR] from 2010 to an unknown date for Prevention. On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2022, the patient experienced COVID-19 (Active COVID-19  infection), DRUG INEFFECTIVE (Drug ineffective) and TINNITUS (Right ear ringing). On 08-Jan-2022, DRUG INEFFECTIVE (Drug ineffective) had resolved. At the time of the report, COVID-19 (Active COVID-19  infection) outcome was unknown and TINNITUS (Right ear ringing) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive. Treatment information was not provided. Company comment: This is a spontaneous case concerning a 38-year-old, female patient with no relevant medical history reported, who experienced the AESI event of COVID-19. The infection was diagnosed about 4 months after the 3rd dose and almost a year after the second dose of mRNA-1273. Lack of effect cannot be ruled out as patient received primary vaccination with Moderna vaccine as approved on the label. The benefit-risk relationship of mRNA-1273 in not affected by this report. This case was linked to MOD-2022-456216 (Patient Link). Sender's Comments: This is a spontaneous case concerning a 38-year-old, female patient with no relevant medical history reported, who experienced the AESI event of COVID-19. The infection was diagnosed about 4 months after the 3rd dose and almost a year after the second dose of mRNA-1273. Lack of effect cannot be ruled out as patient received primary vaccination with Moderna vaccine as approved on the label. The benefit-risk relationship of mRNA-1273 in not affected by this report.
No additional AE reported; administered his second dose of VAQTA too early; This spontaneous report was received from a nurse and refers to a male patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.   On 21-JUN-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) first dose (strength, dose description, lot #, expiration date and route of administration were not provided) for prophylaxis. On 28-OCT-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) second dose, 0.5 milliliter, lot #W021491, expiration date: 14-DEC-2023 (strength and route of administration were not provided) for prophylaxis (Inappropriate schedule of product administration) No adverse events were reported (No adverse event).  It was stated that the patient received numerous other vaccines too early (names of other vaccines were not provided). It was confirmed that hepatitis a vaccine, inactivated (VAQTA) was the only Merck product given too early and the remainder of the other vaccines administered were other company vaccines.
Pt recvd 1st dose of Hep B vax & the next day devel achiness, malaise, fatigue, h/a & stated just didn't feel well at all; next day devel scleral hemorrhage in rt eye; MD felt sx could poss be related to vax;
positive for Coronavirus; positive for Coronavirus; His wife is still ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 2021 (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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 29Dec2021, outcome "unknown" and all described as "positive for Coronavirus"; ILLNESS (non-serious) with onset 2021, outcome "not recovered", described as "His wife is still ill". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive.  Additional information: Reporter (patient's husband) mentioned that he had an appointment at 12:30 for his second dose and wanted to reschedule it. His wife is still ill, and his wife was exposed to coronavirus. He wants information. His wife took a rapid test this morning and she got results back just now. She is positive for Coronavirus. She had Pfizer COVID vaccine months back. Caller declined to proceed with a report for himself and his wife and states he just wanted to reschedule his appointment.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Morning after vaccinations, woke to severe pain in left arm, unable to lift arm at all without pain rated by patient at 9 out of 10, described pain as achy all over affected arm and radiating under arm and to chest and back on affected side. Patient also reported low-grade fever (less than 102). Acetaminophen and ibuprofen only helped with fever, didn't relieve pain any significant amount. Symptoms improved slightly second day, but still very painful.
The patient experienced numbness in his forearm of the injection arm about 2 weeks following the first dose of the vaccine, The numbness spread to his thumb. He is still experiencing numbness today. He has an appointment scheduled with his doctor
Not feeling well; My body is just kind of hurting all over my aches and pains; Low grade fever all day, it was 99 this morning after work today it was a 100.7; Being sick; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer.  A 26-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number: EL3302, via an unspecified route of administration on 16Jan2021 (at the age of 26 years-old) as a single dose for COVID-19 immunization. Medical history included an unspecified allergy. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) daily for allergy relief.  On 20Jan2021, the patient reported that she was not feeling well/being sick, "My body is just kind of hurting all over my aches and pains, Low grade fever all day, it was 99 this morning after work today it was a 100.7." Clinical course verbatim as follows: "I took the vaccine on Saturday. My body is just kind of hurting all over my aches and pains kind of. I have been running a low grade fever all day, it was 99 this morning but then it got better but then after work today it was a 100.7 when I got home from work. So, I didn't know if it is just may be side effects of getting the vaccine or if I may be go to an urgent care and get checked out or what. I was just wondering if that was side effects of the vaccine or if it has been long enough that maybe I have something else and I may be go to an urgent care and checked out for being sick.". She added that I took EXCEDRIN this morning and it (EXCEDRIN) made me feel better, but then when it wore off like I still got again. I took 'two caplets every 6 hours, I have only taken it once for the day' (not clarified further). It has 250 mg of Acetaminophen in it and 250 mg of Aspirin in it and it also has 65 mg Caffeine." The clinical outcome of the events was not reported.
Case previously recorded as MA2009-4073. Initial case report received from a physician via Novartis Pharma on 10 NOV 2009. A 3-year-old male patient was vaccinated with 0.5 mL of S-OIV FLUVIRIN (batch no. 1008143P) i.m., on 06 NOV 2009. MedCom reference no.: NA09-007849.
By 5:00 PM upper arm was quite uncomfortable. By 9:00 it was extremely painful. Took Advil (3)- no help at all. Pain extended throughout right arm and into shoulder. Did not sleep at all. Went back to Dr. Examined arm - no redness or swelling but felt shot. My temp at 9 PM on 20th was 100.8, at 7:00 AM was 99.1. Dr took temp and said it was up. I had used moist heat during the night. At home the 29th, I used the moist heat off and on. They gave me a shot in the buttocks while I was at the doctors and to take 2 tablets daily of Biaxin XL 500 mg. Arm and shoulder remained painful throughout the day. Slept in a reclining chair night of 29th. Temp normal. Thursday 30th hand and lower arm pain free. Upper arm and shoulder still quite painful. Couldn't lift anything. Again, slept in recliner as upper arm and shoulder are more painful in flat bed. Follow up on 12/10/2003: "Previous reactions were written on the paper I filed on 10/03/03.  this was to and including 10/30/2003.  10/31/03-The arm and shoulder was worse today.  MD gave me ambin so I could sleep.  Did sleep in bed.  11/01-11/02/03- Pain still as bad.  11/03/04-Back to MD.  Was put on a med pack.  Prednisone 10mg, Mon, Tues, Wed, etc until finished and Vioxx 25mg.  By Friday 11/07/03 there was a noticeable difference in the pain.  I could use my arm and shoulder.  It has remained this way.  There still is pain when I lift or use it excessively.  I try to ignore it!  I have finished the Vioxx and am anxious to see what happens now.  At night, if I roll over on that arm, it still wakes me up.  I don't feel I should even take another pneumonia shot!  I have had pneumonia 3 times in the past 7 years-but-it wasn't as this experience has been.  Can I ever expect this arm to be back to normal?"
Motrin given 2x 29DEC94, ran fever (did not know how high) fussy off & on thru noc; woke 630AM 30DEC93 vomiting & gagging; called EMT checked by them & mom called MD sent to ER;
Erythema on arms, crusted papule on shoulder, forearm and upper lip. No fever. Reports intense itching of sites.
Patient experienced pain radiating from injection site to shoulder and neck. She also experienced generalized aches throughout body and had difficulty lifting arm (left) for several days. She took no meds for symptoms which are resolved as of reporting date (10/25/2012).
patient had redness in her right arm where the prevnar 20 was given. She said it got worse and the redness spread down her arm almost to her elbow. It was hot and painful to the touch.  She called 5 days after and I advised her to try some Benadryl oral or she could try topical benadryl or cortisone. I told her if it didn't improve to call her dr to make sure it wasn't infected.
swollen left parotid gland. He received the second dose of Moderna covid19 vaccine in April of 2021, 2 weeks later he noticed a swollen mass on the left side of his face. He went to his PCP who performed an ultrasound and biopsy then CT scan. Initial biopsy showed atypical lymphocytic infiltrate. Repeat core biopsy of left parotid gland lesion revealed a low-grade lymphoma.  Left parotid mass -- > He has low grade non hodgkin lymphoma favoring marginal zone lymphoma involving left parotid gland, BCL2 negative, likely stage 1E  NOTE:  He had BOTH doses of Moderna in SAME innoculation site -- L-Deltoid.  He has NO OTHER KNOWN RISK FACTORS for lymphoma (never smoker, Neg fam hx; Srogren's eval in process).  No other "typical"/B-symptoms aside from swollen parotid gland.  gAll imaging and pathology done at Yale.  He is now being managed by ENT, Smillow Cancer, and Rad Onc.
10/13/2022, about 10am noticed pain in my shoulder and neck. The pain was shoulder to elbow, no redness or swelling at injection site. This is new for me As I never had any reactions before.  Feeling tired and weak, sleepy, no appetite, I feel a sleep for 8 to 10 hours, waking up every 2 hrs because of pain
Patient experienced tingling in left fingers and hand that progressed to ascending numbness up the left arm and up the  left shoulder and left neck area up to under the left ear.  Patient feels like there is a "lump" in the throat that she has experienced during dental work when mouth is numb.  This occurred within 10 minutes of vaccination.  Symptoms progressed to feeling of having fluid in the ear approximately 50 minutes after vaccination.
I did not have an adverse reaction to the vaccine but I tested positive for Covid 19 on 5/24.  The first PCR test was on 5/20 and it was negative. I didn't feel well and got another PCR test at a community center testing site and it was positive on 5/24.  My symptoms felt like a basic head cold with a cough. I made sure to stay hydrated and rested but did not take anything for systems.  Within a few days after testing positive, I had trouble with nausea and vomiting.  My doctor prescribed something to help with that (can't remember the name). As of today, I feeling better but I still have symptoms with cough and fatigue.
Initial case received. A male patient received on an unspecified date, a dose 3 injection of ADACEL (lot number not reported) six weeks after dose 2. Within 24 hours the patient experienced pain in hand and arm, nausea and the site of the injection on an unspecified arm was swollen 4 and 1/2 inches "around", red and hot to touch. He also experienced a sensation of being cold and was dizzy. The two prior doses of ADACEL (dates not reported) were given 4 weeks apart and no reactions occurred following the first and second dose. The patient had no illness at the time of the vaccination and did not receive any other vaccinations within 4 weeks. He had no pre-existing medical conditions, no allergies and no concomitant medications. It was unknown if the patient  recovered. Documents held by sender: None.
pt with 6 days of menorrhagia after covid vaccine 01/11/2021. mense usually 3 days and light pt on contraceptive and not trying to conceive. pt denies purpura or any other sx
today 3/24/2021 Patient presents today stating that on 3/15/21 she got her first dose of the moderna COVID vaccine. She had no side effects afterwards, but she notes that this morning in the shower she noticed a firm, red, lump on her L upper arm that is warm to the touch in the area of her vaccine. She states it was not there before. She denies fever and states the lump really isn't painful, but itches a little.
hasn't received a phone call or notification for 2nd dose; started over and received Pfizer instead; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (hasn't received a phone call or notification for 2nd dose) and INTERCHANGE OF VACCINE PRODUCTS (started over and received Pfizer instead) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (hasn't received a phone call or notification for 2nd dose) and INTERCHANGE OF VACCINE PRODUCTS (started over and received Pfizer instead). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (hasn't received a phone call or notification for 2nd dose) and INTERCHANGE OF VACCINE PRODUCTS (started over and received Pfizer instead) had resolved. 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 product use was not provided by the reporter. Patient took Pfizer as second dose vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Event added (interchange of vaccine products)
Numbness and  weakness in left arm after a few hours of the Vaccine that has progress into very painful episodes involving the entire arm, symptoms still present as up today.