chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From physician note: Patient very pleasant 80-year-old female who presented to the hospitalist service with complaints of weakness and confusion after receiving second coronavirus vaccination.  Patient was confused overnight and then presented with blood sugar of 50.  During this hospitalization she received D5 normal saline in the emergency department with resolution of the hypoglycemia.  Her glipizide was held however with holding both glipizide and metformin her blood sugars became elevated in the 200-300 range.  Thus glipizide was restarted.  I did restart the glipizide at 5 mg twice daily however instead of the 20 mg twice daily she was taking at home.  Patient also reports that she recently has had weight loss that is unintentional.  She has a history of Barrett's esophagitis on an endoscopy which was performed in 2018.  In this regard she was seen by gastroenterology.  Plan is for an outpatient endoscopy and colonoscopy within the upcoming weeks.  Patient did have a CT scan of the abdomen and pelvis performed during this admission which revealed Stable abdominal lymphadenopathy from a prior scan, trace intrahepatic biliary duct dilatation and diverticulosis.  TSH was also sent and was within normal limits.  I did discuss with the patient the fact that she may benefit from being treated with Metformin plus an SGLT2 inhibitor or GLP-1 receptor agonist.  She will discuss this with her PCP.  I have also asked her to check her blood sugars 3 times daily for now.
This spontaneous report as received from a medical assistant refers to 2 unspecified patients of unknown demographics. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On an unknown date in 2016, these patients were vaccinated with improperly stored doses of VAQTA (lot # L009445 and expiry date 01-JUL-2017) (strength, dosing details, anatomical location were unknown). No adverse effects were reported. On 26-APR-2016, the vaccines were exposed to a temperature of 34 degree Fahrenheit for 15 hours. On 26-JUL-2016, the vaccines were exposed to a temperature of 35 degree Fahrenheit for 23 hours 30 minutes. On 27-JUL-2016, the vaccines were exposed to the temperature of 34 degree Fahrenheit for 17 hours 15 minutes. On 28-JUL-2016, the vaccines were exposed to the temperature of 33 degree Fahrenheit for 15 hours 30 minutes. The temperature excursion was detected by a data logger. No previous temperature excursion was reported. No product quality complaint was involved. This is one of the 3 reports received from the same reporter source. Additional information has been requested.
pt recv vax & exp urticaria w/in 6hr of vax;pt had a sl elevated temp but in good hlth;rash described as raised areas on arms & legs-no rash or swelling @ inj site;itching for 3-4wk;
My arm was a little sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm was a little sore at the injection site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE PAIN (My arm was a little sore at the injection site). At the time of the report, VACCINATION SITE PAIN (My arm was a little sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.
Constant raspy cough at 2:00 PM, red itchy watery eyes by 4:00 PM, nasal and sinus congestion by 5:00 PM.
HBIG administered PO, notified MD immediately, VS taken within 20 minutes within normal limits. Repeat VS in 30 min within normal limits. Poison control called because MD not immediately available no action required per their recommendation, vaccine not considered effective.
Pain at site immediately.  Severe stabbing pains at injection site about 1-2 weeks later that lasted for 8+ months.  Frozen shoulder developed after 2 months. Did physical therapy 3x per week for 2 weeks with no improvement.  Still pain at injection and frozen shoulder to date (11 months later).
Patient described having a tingly/numbness in her arm to her fingers after the shot was given.  Patient described that this lasted 3 days.  Patient is no longer experiencing the tingling or numbness.
Pt reports c/o severe throbbing pain to injection site approx 30 minutes after injections. Reports redness at site yesterday. Today (10/9/03) no redness around site of injection, but large area of redness covering inner biceps area. Area hot to touch. Referred to private MD today for evaluation.
rash after the second dose it got a lot worse; peeling of skin on the palms of hands and around fingers, after the second dose it got a lot worse; Low grade fever with second vaccine; Fatigue with second vaccine/Really tired with second vaccine; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 24-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6205), dose 2 via an unspecified route of administration, administered in Arm Right on 09Mar2021 12:00 as DOSE 2, as an unspecified dose SINGLE for covid-19 immunisation. The historical vaccine was bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: E19269), dose 1 via an unspecified route of administration, administered in Right Upper Arm on 16Feb2021 13:00 as DOSE 1, SINGLE as an unspecified dose for covid-19 immunisation. Medical history included, from an unknown date and unknown if ongoing Patient History: No. There were no concomitant medications. Patient mentioned she had time off from work because she had regular side effects. Patient stated that when it appeared after her first vaccine, she thought maybe she had gotten into something that caused it. On 10Mar2021 the patient experienced low grade fever with second vaccine, fatigue with second vaccine/ really tired with second vaccine, headache, rash after the second dose it got a lot worse on an unspecified date, peeling of skin on the palms of hands and around fingers, after the second dose it got a lot worse on an unspecified date. Therapeutic measures were taken as a result of rash after the second dose it got a lot worse, peeling of skin on the palms of hands and around fingers, after the second dose it got a lot worse. The outcome of the events low grade fever with second vaccine, fatigue, headache was recovered, rash after the second dose it got a lot worse was unknown, peeling of skin on the palms of hands and around fingers, after the second dose it got a lot worse was not recovered. No follow-up attempts are possible. No further information is expected.
Sluggish, mild sick symptoms starting at 3pm the day after. Around 8pm fever up to 102 degrees, chills, sweating, etc fever broke after 24 hours. Roughly 1 week later felt completely better
1/25/2021- Presented to ED with chest pain which radiated up his right shoulder, right armpit and across his chest.  The EKG showed a STEMI [acute inferior].  He was transferred to other Hospital.
arm pit swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "arm pit swelling". The patient had covid vaccine a week ago and just today has arm pit swelling and would like to talk to someone about delayed side effects.  No follow-up attempts are possible. No further information is expected.
Itching at injection site, pain at injection site, hard lump about the size of a quarter at injection almost 2 weeks after injection, slight discoloration like a bruise
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 19Aug2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: VUMERITY, start date: 01Sep2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received other medication in 2weeks. The patient had received anti-viral therapy with Paxlovid, from 08Oct2022 to 12Oct2022 for treatment of COVID-19. Full Covid Symptoms returned on 21Oct2022, stronger than initial symptoms. The patient received AE treatment with Dexamethason 4mg Tab. The patient had no Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
About 2 months after getting the shot, I came down with Shingles. I still have the Shingles after almost 2 months and may be coming down with another case in a different location. I am on the antiviral. This has been a large case and very painful. It reaches from my breast bone over my right breast, under my arm and around to the spine. I want to know if I should get the second shot. The Drs. and Pharmacist say yes. I would appreciate your feedback.
I got my shot, but still got shingles; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received Shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset was unknown.
Returned home , took Nap. Woke up at 4pm to chills  and started to have body shakes in my exTremities.  Took my temp. -101 . Benedril taken 5pm . Took 2 Advil tabletes. Body joints painful, stiff, Tried to rest. 8:30pm took temp. 102.5 Oxygen 94, BP 113/52 irreg. Took 2 Tylenol at 9 PM. Body shakes and painful joints con'd. 11pm - temp. 100. Oxygen 97 - BP 94-43. Fever broke in a sweat 3:00 AM. Urine test strip showed Urine Cloudy  and infectioN Calling Doc for visit 9/13.
Patient was inadvertently given the second dose of Moderna at 22 days instead of 28 days. Patient has not experienced any adverse effect from early vaccination.
Information has been received from a physician regarding a 4 year old patient of unknown gender. The patient had no drug reactions/allergies. The patient was diagnosed with hand, foot and mouth disease on 24-AUG-2015 (reported as "one week ago") and the patient was treated with MOTRIN as needed. The physician stated that the patient had not received MOTRIN "in three days" (stopped date on approximately 28-AUG-2015) and that the patient had recovered from hand, foot and mouth disease in approximately August 2015. On 31-AUG-2015 the patient was vaccinated with a dose of PROQUAD (Merck) (lot # K018143, expiration date: 10-APR-2016, intramuscular). On the same day the patient experienced bleeding and the formation of an unspecified size hematoma at the injection site. The physician reported that the dose was administered into the patient's unspecified deltoid muscle, and the patient reported pain (incorrect route of drug administration). The physician stated that the bleeding lasted "15 minutes" and the bleeding resolved at the time of reporting. Liquid TYLENOL was given for the adverse events and no lab diagnostics performed. The physician did not think this infection was from one week ago or the MOTRIN therapy contributed to the formation of the hematoma. At the time of reporting, the outcome of hematoma at the injection site and pain were reported as recovering. Causality between the events and PROQUAD (Merck) was not provided. Additional information has been requested.
Had nausea, vomiting, diarrhea, and then I passed out and hit my head,  shoulder, and arm resulting in multiple bruising.
Patient hit her arm Friday afternoon and realized that it still hurt. She looked at it and it was swollen, hot, and itchy. That night she developed a fever. On 9/18/16 in the morning the patient sought medical advice and started putting ice on it and applying Benadryl cream. It has improved since.
Pt states she received vaccine around 10am. States "it ached going in and then was ok until noon". Reports she took Ibuprofen with no effect. States left arm "ached" and rated pain 8/10 at that point. Reports she took a 45 minute nap and after waking, could not lift her arm. Reports "by supper she could not grip, arm felt weak". Reports took APAP at supper and before bed with no effect. Reports she could "not cover herself up in bed nor dress herself before bed". States she woke up in the middle of the night to use the restroom and could not pull up her pants herself. Was then not able to go back to sleep due to the pain. Reports she then took an Excedrin (around 3am) and by noon she could move her arm "about
INCREASING IN CONVULSION; This spontaneous report received from a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: Cerebral palsy since born and convulsions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: not reported, expiry: UNKNOWN) dose was not reported, 1 total, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in APR-2022, a week later of vaccination the patient developed convulsions that persisted until the day of reporting. The patient was under treatment for convulsions associated with his diagnosis. The patient's mother did not know if the increasing in convulsions was an adverse reaction from the vaccine or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from increasing in convulsions. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220253459-COVID-19 VACCINE AD26.COV2.S- Increasing in convulsions. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: UNDERLYING DISEASE. Therefore, this event is considered not related.
This spontaneous report was received from Physician via a company representative referring to patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified date in 2016 (reported as "within the last 2 weeks", the patient was vaccinated with ZOSTAVAX (lot # M010486, expiry date 25-MAY-2017), 1 injection, subcutaneously. Concomitant therapies were not reported. It was reported that the patient had excessive swelling and pain for ZOSTAVAX in injection site for longer than physician advised. The patient was advised to take TYLENOL and use warm compress. At the time of the reporting the outcome of excessive swelling and pain in injection site was unknown. This is one of two reports received from the same source. (Linked report MARRS # 1608USA006626). The linked report refers to a patient who received ZOSTAVAX with the same lot number reported and experienced same events. Additional information has been requested.
dizziness, BP 8/40; itching and swelling of left arm; rashes on left arm and left side of neck (day after vaccination)
A 74 y.o. male who presented with worsening covid 19. He was managed with dexamethasone, tessalon perles, zinc, and empiric abx. He improved to room air. His recovery was complicated by bilateral upper extremity DVT. He was started on heparin drip with improvement in edema. Choice of oral anticoagulant was complicated as he was on primidone for essential tremor. Ultimately discharged on Eliquis.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, medical history, drug reaction/allergies and concomitant therapy were not provided. On an unknown date, the patient might be vaccinated with a dose of improperly stored either GARDASIL 9 (strength, dose and route were unknown, lot # M016193 with expiration date 24-APR-2018), RECOMBIVAX HB (strength, dose and route were unknown, lot # M023718 with expiration date 09-AUG-2018), M-M-R II recombinant human albumin (rHA) (strength, dose and route were unknown, lot # M008588 with expiration date 16-FEB-2018), PROQUAD recombinant human albumin (rHA) (strength, dose and route were unknown, lot # M031567 with expiration date 24-DEC-2017) or VARIVAX (strength, dose and route were unknown, lot # M027347 with expiration date 11-MAY-2018) for prophylaxis. No adverse effect was reported. The vaccines had been exposed under temperature 49.7 Fahrenheit for 2 hours and 10.6 Fahrenheit for 3 hours and 30 minutes, but did not undergo previous excursion. Data logger was used. Additional information has been requested.
PT HAS REDNESS, SWELLING, HEAT TO TOUCH AND TENDERNES SURROUNDING INJECTION SITE- THAT TURNED INTO CELLULITIS- TREATED WITH ANTIBIOTICS AND BY FRIDAY 3/10/23 WAS RESOLVING
"worse side effects with the second dose than with the first dose"; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION ("worse side effects with the second dose than with the first dose") in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT FOLLOWING IMMUNISATION ("worse side effects with the second dose than with the first dose"). At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION ("worse side effects with the second dose than with the first dose") outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was Not Applicable. No concomitant medications provided. No treatment information provided.   This case was linked to MOD-2021-095613 (Patient Link).
3RD DOSE MODERN COVID VACCINE GIVEN 10/28/21, LOT #071F21A pt resides in Hospice; pt had a positive COVID test on 8/16/22; admitted for respite care; pt went into respiratory distress; DNR; pt given O2 supplementation without improvement; pt passed away in the hospice facility
This case was reported by a consumer (the subject's father) and described the occurrence of fever in a 9-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included penicillin allergy. There were no concomitant medications or vaccinations. The subject had not experienced adverse events following previous vaccinations. On 10 June 2009 at 08:00 the subject received 1st dose of ENGERIX B (unknown route, left arm). On 10 June 2009, within hours of vaccination with ENGERIX B, the subject experienced fever and hot to touch. The subject received her 1st injection of ENGERIX B in the morning and was then sent off to school. The subject began to develop a fever around lunchtime. In the afternoon when she got home and her parents felt that she was hot, they measured her temperature and it read 101. They called the doctor, who instructed them to get her MOTRIN. However, she continued to have a fever and the reporter took the subject to the doctor's office. On 11 June 2009 her fever was still around 100. The subject was treated with MOTRIN. At the time of reporting the events were unresolved.
blood sugar is loudly out of control; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (blood sugar is loudly out of control) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Liver transplant in 1999. Concurrent medical conditions included Diabetic and Immunosuppression. Concomitant products included INSULIN, PARACETAMOL (TYLENOL), TACROLIMUS MONOHYDRATE (TACROLIMUS [TACROLIMUS MONOHYDRATE]) and MYCOPHENOLATE MOFETIL (MYCOPHENOLATE ACCORD) for an unknown indication.  On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 23-Jan-2021, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar is loudly out of control). At the time of the report, BLOOD GLUCOSE INCREASED (blood sugar is loudly out of control) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, Blood glucose: increased mg/dl (High) 24 hours after vaccine blood sugar rise.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment medication information were not provided.
Patient states that his wife recently had COVID-19.  He reports that he began having symptoms of COVID 1/10/2022.  He saw his PCP outpatient on 1/12/2022 and tested positive.  He was given azithromycin ( which he has completed) and steroids which she thinks may be Decadron.  He reports that he has had symptoms of cough with clear sputum production, shortness of breath, loss of taste and smell, general malaise, generalized aches and pains, neck stiffness, occasional nausea but no vomiting or diarrhea.  No abdominal pain.  Reports that today he began having fever for the first time as high as 102 and took ibuprofen.  He also has been watching his oxygen saturations with shift and 93 to 95% at home.  He reports worsening shortness of breath today.  Worse with exertion.  Rated 4 out of 10 in severity.  Now present at rest which was not the case over the past several days prompting his visit to the ER.
Reddened raised area at injection site. Warm to touch. Itchy. Looks like hive. Did not get this with the first shot. Appeared sometime after shot but after 8 hours. Unsure of exact timing because I went to sleep and woke up with it at 0200.