chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CELIAC DISEASE; COLD SWEATS; TROUBLE WALKING DOWN STEPS; TINGLING TIP OF LEFT HAND; HOT FLASHES; TIP OF TONGUE SWEAT; FEET SWEATING; SHIVERS; OVERALL BODY NOT FEELING WELL; SUDDEN HIGH BLOOD PRESSURE; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use (stopped drinking), and nonsmoker, and other pre-existing medical conditions included the patient had no known drug allergies and had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 21-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 17-JUL-2021, the patient experienced cold sweats, trouble walking down steps, tingling tip of left hand, hot flashes, tip of tongue sweat, feet sweating, shivers, overall body not feeling well and sudden high blood pressure. On 19-JUL-2021 the patient was concerned about sudden high blood pressure and was admitted to the emergency room, the patient undergone stress test and was given lorazepam and was diagnosed with celiac disease. The patient was hospitalized for 1 day and was discharged on 20-JUL-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold sweats, shivers, trouble walking down steps, tingling tip of left hand, hot flashes, tip of tongue sweat, feet sweating, overall body not feeling well, and sudden high blood pressure, and the outcome of celiac disease was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210745177-COVID-19 VACCINE AD26.COV2.S-sudden high blood pressure, celiac disease, cold sweats, trouble walking down steps, tingling tip of left hand, hot flashes, tip of tongue sweat, feet sweating. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210745177-COVID-19 VACCINE AD26.COV2.S-shivers, overall body not feeling well. This event(s) is labeled per RSI and is therefore considered potentially related.
Rec'd vaccines in our afternoon clinic on 03/16/04.  Mom noticed a small red area on right arm at 7PM 03/17/04 when getting child ready for bed.  The next morning, the right arm was swollen,red (with an area of dark red), and hard.  Child was unable to see his Dr. that day.  Mom talked with me at the Health Dept. I advised she go to the ER.  By that evening the arm had doubled in size, so she took him to the ER.  ER prescribed steriods and antibiotic and told her it was a local reaction to an immuniztion.  I talked with mom on 03/19/04 and she said the child was fine--the swelling is down a little bit, the redness and hardness is less.  She has also been applying warm moist pack for 15 minutes four times a day. She has a follow-up appointment with his primary care physician on Monday, 03/22/04.
After having the second dose I had Flu type symptoms, fever for 24 hours, joint ache, less nausea than the first dose. Nausea and fever went away after 24 hours. I still had fatigued and joint pain. I had a doctor?s appointment scheduled and I let them know. They did not prescribed me anything. I had medical tests done for my condition but I do not know if they did something for the symptoms I was having.
mom reports pt recv vax 12noon & was given APAP on arrival home;mom reports 2-3PM pt stiffened & shook, then eyes rolled back in head;mom reports LOC x 1min;temp on arrival to ER 104;2nd sz in ER 6JUN96 @ 130AM;pt not adm;
I am gettng another more itch my rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (I am gettng another more itch my rash) in a male patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH PRURITIC (I am gettng another more itch my rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy rash, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (I am gettng another more itch my rash) outcome was unknown. Not Provided          No concomitant medications were provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-058928 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11-MAY-2021 contains non-significant information: Patient stated no additional information to report.
pt recvd vax 2PM & parents brought pt to ER 855PM & stated that pt has been crying uncontrollably for past 5hrs since 4PM; exam rash on face & neck & a few scattered spots on upper chest;tx APAP, DPH & return if worsens;appetite  dec
Heart palpitations, arrhythmia, drop in heart rate, dizziness. Happened strongly after the second vaccine. Heart rate dropped producing faintness dizziness. In the middle of the night about 12 hours after second injection. Heart rate dropped to 45. It happened both times after both vaccines. First vaccine it lasted 5 minutes. 2nd vaccine it last 1 hour.
lt arm swollen, malaise, chills, fever area erythematous; put on Hismanal 1 daily & Keflex;
9:47am Stated after vaccination started to feel a little lightheaded and shaky, heart racing.  BP 166/72, HR 112, O2 98%. 9:58am Stated heart felt better.  Advised if symptoms return, pull over safely and dial 911.
Patient stated he woke up on 06/22/2019 at 10:00AM with a rash on his arms, chest, and face.  Stated right eye was swollen as well.  Nurse Practitioner stated Patient has a pustular rash on anterior and posterior trunk of chest from waist up.  This rash is also on bilateral arms and face.  Patient's right eye is swollen as well.  She stated the rash looks like contact dermatitis.
This spontaneous report as received from a pharmacist refers to a female patient in her 60's. The patient did not have pertinent medical history, drug reactions or allergies. On 23-JUN-2016, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (strength, dose, frequency, lot number and expiration date were unknown). There were no concomitant therapies reported. In June 2016, after she received her ZOSTAVAX injection, the patient experienced a red mark at the injection site, a minor rash, a lump at the injection site, and slight heat at the injection site. The patient did not seek medical attention except to call the pharmacist. No laboratory diagnostics studies were performed nor treatment was given for the adverse events. The outcome of the aforementioned events and the causality between ZOSTAVAX and all the events were unknown. Additional information has been requested.
fatigue; Yellow urine; injection site pain; This is a spontaneous report from a contactable pharmacist (patient). A 35-year-old female patient received the first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: BL0142), intramuscular on the left arm on 31Dec2020 at 19:30 at a single dose for immunization. Medical history was not reported. There were no concomitant medications. The patient had no other vaccine in four weeks, no Covid prior vaccination and has not been tested positive for Covid post vaccination. The patient had yellow urine, injection site pain, and fatigue on 01Jan2021, and received Tylenol or ibuprofen as treatment for the events. The events had not resolved.
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unspecified dates, the RECOMBIVAX HB had two temperature excursions of 24 hours each one. The lowest recorded temperature for both excursions was 34 F (1.111111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". On 01-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB which had a lot number of K018986 and expiration date on 04-APR-2016 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Hot and uncomfortable (red, swelling, bumps) near the injection site. Reported chest pain overnight that has subsided.
I had the Pfizer vaccine on Jan 8 and 29 with significantly different side effects. After the first shot, I had a fever blister after 7 days, a pain in my lower spine area after 8 days and an excruciating pain in my right jaw from day 10-12. All symptoms cleared up without treatment. These may or may not have been due to the shot but are unusual for my normal events. After the second shot, hmy symptoms were much worse. I had aches and pains similar to the flu, chills, shortness of breath, a temperature that oscillated between 96.5 and 101.6 degrees, I was quite fatigued and my PulseOx varied between 91 and 97. The PulseOx was also unstable as it changed while the reading was being taken. All of these symptoms seem to be normal side effects but most people don't have them all.
Possible SIRVA.  Shoulder stiffness and pain, severe first day, continuing to lesser degree currently with use  shot reported to be administered  very high on shoulder;  that afternoon patient developed a very painful, frozen shoulder.   The weight of my arm itself was painful and patient reported sleeping in the shirt worn that day rather than attempt to pull my shirt over head.  Steadily improving, but it is not gone yet.  Arm was too weak to push the vacuum cleaner well.  (reported on 4.1.21)  Vaccine administered 3.30.21.
refrigerator containing Fluzone went down to 29.1F. After that excursion, vaccine administered to patient / no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2020SA032577, 2020SA038302, 2020SA038467, 2020SA038343, 2020SA038344, 2020SA038345, 2020SA038346, 2020SA038347, 2020SA038348, 2020SA038349, 2020SA038350, 2020SA038351, 2020SA038352, 2020SA038466, 2020SA038468, 2020SA038469, 2020SA038470, 2020SA038471, 2020SA038472 and 2020SA038473.  This case involves a 4 years old male patient who received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot UJ254AC (Expiry date 30-Jun-2020) via unknown route in the left thigh for Prophylactic vaccination on 17-Jan-2020 which was exposed to refrigerator down to 29.1F.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to Product storage error temperature too low.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 06-NOV-2012 at 11:17, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
patient fainted. we found out later she had not eaten recently and was terrified of needles.  the patient recovered within a few minutes.  we called the patient on 8-25 and she said she was ok after leaving the pharmacy
Arrived to ER on 8/21/21 and was admitted for COVId19 pneumonia. At baseline she is on 5L. Patient presented to the ED today with multiple complaints including worsening shortness of breath, cough, sore throat etc.  She denies nausea vomiting or diarrhea but appetite is very poor. Chest x-ray did show right lobe infiltrate but CT chest without contrast shows bilateral lower lobe and right middle lobe ground-glass infiltrates consistent with COVID-19 pneumonia.  Patient is fully vaccinated with Moderna 3 months ago. Blood pressure is borderline low initially 86/52 but upto 96/53, oxygen saturation in the mid 80s on 5-6 L. ABG with pH of 7.38, pCO2 30, PO2 67. Labs significant for acute kidney injury with BUN 84, creatinine 3.4, baseline usually around 1.5.  Bicarb 17. She has been started on IV Rocephin and azithromycin for 5 days. She required up to 10L of high-flow oxygen during her stay. Her AKI resolved and cultures remained negative. Oxygen was titrated to baseline. Discharged on 8/27/21.
Presented to emergency department with complaint of shortness of breath and chest discomfort.  She reports shortness of breath began last night.  States shortness of breath is exacerbated with exertion.  She also reports generalized chest discomfort with shortness of breath.  Recently placed on an antibiotic on the 22nd for a bilateral lower leg skin rash.  States dermatologist was unsure what kind of rash or what the rash is, so biopsies were obtained and patient is to return next Wednesday for results.  Otherwise respiratory history has had asthma as a child but has not had any exacerbation or symptoms as an adult.  She recently received her second COVID-19 vaccine.  Denies palpitations, fever, chills, congestion or cough.
2nd Moderna dose was administered to patient with knowledge of anaphylactic reaction to shellfish.  Patient was instructed to wait 30 minutes post vaccination.  Patient had no initial reaction with first dose.  She experienced dizziness and headache after she got home from the first vaccine.  After waiting in the post vaccination area (approx 10 minutes) patient had closed her eyes and put her head back.  Pharmacist asked her if she was feeling ok.  She said she was ok just feeling a little dizzy.  She said she just needed a drink of water so we got her a cold water bottle.  She was not feeling any symptoms of itching or problems breathing.  Approx 5 minutes later she said her hands felt tingly, then her arm and then her legs. Patient still seemed to be doing "okay".  She said she needed her medicine, but it was in her car.  I asked what kind of medicine and she said her epipen.  I told her I had one if she needed it to let me know.  I told the pharmacy to calI 911.  She said she was feeling funny and her ears were starting to feel full.  Still no sign of itching or visible issues with breathing.  I asked if she was okay because she was starting to get a little more nervous and she said no.  I asked if she needed the Epipen and she said yes.  Pharmacist adminstered 1 dose of Epipen (approx 20 minutes post vaccine).  At approx 25 minutes post vaccination patient started to get nervous again with the same symptoms coming on-tingly hands/arms/legs/full ears, then tingly mouth.  When asked she said she was beginning to have issues with her throat/mouth-swelling/breathing.  She started to go unconscious, but stayed with us.  Her BP was normal and she had a good pulse, but with the issues/signs/symptoms she expressed we administered a second Epipen.  The squad arrived about 2 minutes after.  Patient is now  home safe.  She said she lost all control of her senses during the incident and all she can remember was my voice keeping her present.  She said she closed her eyes and can't really remember anything else.
Headache, fatigue, hives No treatment, just rest Doing well, this lasted a few days
neck painful; collar bone painful; This is a spontaneous report from a contactable consumer or other non hcp reported for herself. A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date: was not reported) via an unspecified route of administration, administered on 12Sep2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were unknown. On an unspecified date of Sep2021, after the first dose the patient experienced neck painful and collar bone painful. First dose of Pfizer covid vaccine 12Sep2021 and began experiencing a knot in the back of her neck, collar bone that was painful. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
6/10/03 Pt presented to us as a new pt with complaints of numbness right arm; on exam he had no brachio-radiolis reflex on right or tricep reflex on right arm.
A year later I had a red circle skin rash that is at the site where I had the injection for shingles. Now that same spot has been removed and was basil cell carcinoma; Weight: 68.4 kg.
While sleeping the night after the vaccines, mom woke to him gasping.  He was having trouble breathing.  Tone went limp.  Was lethargic.  Responded after mother provided stimulation. Similar issues occurred after 4 mo vaccinations.
Received shot in left arm. Resulting in left arm pain/shoulder pain increasing in severity and continuing for months and still remains (toothache (like) severe down total arm to fingers hurts to raise arm or lift things or to lie on (L) side.
chilblains-toes; still bluish/red, but not any worse-we have been making sure her toes are warm and dry; decreased capillary refill; will monitor the next few weeks.  f/u w/pcp on 3/22.
Patient had syncopal episode and "possible seizure" within 15 minutes of vaccination.  Patient felt better after resting and was released to home.
Product storage error; No adverse event; 14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in a 53-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 13-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medication were reported. This case is of 07 out of 14 patients. 14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date. No patients have been administered monovalent vaccine after the beyond use date. Date the vial was initially stored in the refrigerator was 24-Oct-2022. No treatment medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-703586 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2023: Follow up - Patient demographics and Narrative updated On 24-Jan-2023: Follow-up no new information was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703586: case - 1st adult
Systemic: Left sided arm and head tingling-Mild, Systemic: Flushed / Sweating-Medium
Fever up to 102 and persistent crying 10 hours after administration of vaccine, fever for 36 hours. Rash 15-17 days starting on neck, moved to face, spread to torso.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 13th May 2018, refer case US2018219508). On 3rd December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 3rd December 2018, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too long. On 4th December 2018, the patient experienced injection site pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain and drug dose administration interval too long were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient received the SHINGRIX on the left arm. On the day of reporting, the patient woke up with pain and soreness at the injection site. The patient received the 2nd dose of SHINGRIX late, which led to lengthening of the vaccination schedule. No further details were provided. The reporter did not give consent to follow-up.
REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received concerned a female of unspecified age. 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, intramuscular, batch number: Unknown) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included bnt 162 for prophylactic vaccination.  On 03-JUN-2021, the subject experienced revaccination with different covid-19 vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Presented back, 48 hours post vax, with injection site red, hot and swollen. Area 5cm and firm to touch. No open areas observed but painful to touch and move. Denies temperature and feels well other than left upper arm. Follow-up call on 2/14/2000, all symptoms subsiding.