chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Platelet level drop; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (Platelet level drop) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PLATELET COUNT DECREASED (Platelet level drop) (seriousness criterion medically significant). At the time of the report, PLATELET COUNT DECREASED (Platelet level drop) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Platelet count: low (Low) Drop in platelet count.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.  Company Comment:  This is a spontaneous case concerning a 83-year-old, male patient with no reported medical history, who experienced the unexpected serious AESI event (seriousness criterion medically significant) of Platelet count decreased. The event occurred after the administration of the first dose of mRNA-1273 vaccine. Leukemia was diagnosed after the second dose, which would be a confounder factor. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-474448, MOD-2022-474427 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 83-year-old, male patient with no reported medical history, who experienced the unexpected serious AESI event (seriousness criterion medically significant) of Platelet count decreased. The event occurred after the administration of the first dose of mRNA-1273 vaccine. Leukemia was diagnosed after the second dose, which would be a confounder factor. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Within 6 hours of receiving vaccine, she developed redness and swelling at injection site.  The following morning had a pea size round swelling on the clavicle, same side of injection.  Denies fever.  Complained of diminished range of motion.  Denies any color change or numbness.   On Monday, 04/25/2022 symptoms improving and didn't seek medical attention.
PATIENT CAME INTO THE PHARMACY ON 12/18/2018. HER CHIEF COMPLAINT WAS DECREASED RANGE OF MOTION IN HER LEFT ARM SINCE SHE HAD THE SHINGRIX VACCINATION. SHE IS UNABLE TO EXTEND HER ARM OUTWARD AND UPWARD.
Diagnosed with COVID after receiving the first dose; Chest cold; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Diagnosed with COVID after receiving the first dose) and LOWER RESPIRATORY TRACT INFECTION (Chest cold) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A, 017B21A and 031H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced COVID-19 (Diagnosed with COVID after receiving the first dose) and LOWER RESPIRATORY TRACT INFECTION (Chest cold). At the time of the report, COVID-19 (Diagnosed with COVID after receiving the first dose) and LOWER RESPIRATORY TRACT INFECTION (Chest cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Influenza virus test: negative (Negative) Patient Tested negative for flu.. In January 2021, SARS-CoV-2 test: positive (Positive) Patient diagnosed with COVID after receiving the first dose..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.  Company comment: This case concerns a 73-year-old male patient, with no reported medical history, who experienced the non-serious, unexpected AESI event of Covid-19 on unspecified date after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). Patient had chest cold a week or two after the first shot and tested negative for flu. The patient's age may have increased his risk of getting infected with Covid-19. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-416211 (Patient Link).; Sender's Comments: This case concerns a 73-year-old male patient, with no reported medical history, who experienced the non-serious, unexpected AESI event of Covid-19 on unspecified date after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). Patient had chest cold a week or two after the first shot and tested negative for flu. The patient's age may have increased his risk of getting infected with Covid-19. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sever left side flank pain and very tired. Out of work for a week and went to emergency room.
Initial symptoms tired, headache, body aches Hot raised red patch at injection sight. Itchy and painful.
4/15/17 presents with abd. pain and bloody BM, recurrent bilious emesis. CT showed concern for intussusception. On 4/15/17 pt. had right colectomy with primary end-to end small bowel to large bowel anastomosis.
Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 13-MAY-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a health center, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 16-MAY-2016, the patient was treated at a health center for a blistering vesicular outbreak that was diagnosed as severe shingles. The patient has been prescribed VALTREX, cyclobenzaprine, NORCO and ibuprofen for management of her painful symptoms and excruciating pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Partial vision loss right eye followed by full vision loss right eye.  Following many tests, I was diagnosed with NAION at both Eye Center, and also Eye Institute.  Initial treatment was eye drops: Brimonidine Tartrate for approximately one month and then Doctor advised to stop drops.  Outcome: No change in using eye drops. Loss of vision in right eye remained.
Received 1st dose on 03May19. When I woke up to get ready for work on the early morning of the 7th, I noticed a large swelling and lump on the lower part of my left armpit. I was able to see my PCP later that day for a checkup which resulted on having an ultrasound and mammogram which 1st available date was on the 21st of May.  Between then and now the swelling has gone down but I do still see some slight swelling in the area
I got the shot on 5/12/2021 at 1:00 p.m. arm start getting sore around 6:00 p.m. on 5/13/2021 by 10:00a.m. I started getting tired and my arm was beginning to swell and hurt to move, by 2:00 p.m. I could not move my arm had to leave work the pain was at a 7. by 5:00 p.m. I was having chills, pain in my back, knees legs, pretty much all over and server headaches. I was not able to sleep and could not reduce the pain even with Tylenol.  on 5/14/2021 could not move arm at all the pain move under my arm pit and near breast area. I had headaches and body pain as if I had COVID again. On 5/15/2021 the area where I received the shot the pain was at a 4 but the pain that generated from the shot under my arm and breast area is still at a 7.  I am  stilling having nausea and headaces.
Pain at injection site 6-7/10, Chest tightness, unable to take a deep breath, anxiety. Regular respirations, HRR at 74, Pulse Ox 99%, Lungs CTA, throat without swelling.  Patient able to speak and maintain conversation with provider.  Symptoms improved by 11:05 AM; discomfort at 2-3/10.  Symptoms resolved by 11:10 AM. Patient up and walking, in no apparent distress by 11:15 AM. No medication administered but I did give patient a prescription for Albuterol inhaler to take to the pharmacy; history of asthma but had no inhaler at home.
Injection site papule; Brain tumor; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4283169-00 (AbbVie).  A 74 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; leuprorelin acetate (LUPRON DEPOT) (Batch/Lot number: unknown) as unk, single. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRAIN NEOPLASM (medically significant) with onset Oct2021, outcome "unknown", described as "Brain tumor"; VACCINATION SITE PAPULE (non-serious), outcome "unknown", described as "Injection site papule". Clinical comment: The patient diagnosed with a brain tumor and had surgery in Dec2021.  Causality for Lupron depot (Leuprolide acetate depot): The reporter's causality for the event(s) of brain tumor and bump at injection site was not provided. Abbvie's opinion is that the event of brain tumor is not assessable. Abbvie's opinion is that there is a reasonable possibility that the event of bump at injection site is related to Lupron depot (Leuprolide acetate Depot).  Causality for PFIZER BIONTECH COVID-19 VACCINE: The reporter's causality for the event(s) of brain tumor and bump at injection site was Possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
redness in approximately 50 % of left arm; hot injection site; sore injection site; injection site is still a little swollen ,hot and red; injection site is still a little swollen ,hot and red; fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness in approximately 50 % of left arm), VACCINATION SITE WARMTH (hot injection site), VACCINATION SITE PAIN (sore injection site), VACCINATION SITE ERYTHEMA (injection site is still a little swollen ,hot and red) and VACCINATION SITE SWELLING (injection site is still a little swollen ,hot and red) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included High cholesterol on 06-Jan-2011 and Basal cell carcinoma on 06-Feb-2001. Concurrent medical conditions included Penicillin allergy and Seasonal allergy (pollen). Concomitant products included CETIRIZINE HYDROCHLORIDE from 03-Jan-2011 to an unknown date for Allergy, ATORVASTATIN and FISH OIL from 03-Jan-2011 to an unknown date for Cholesterol, MULTIVITAMIN [VITAMINS NOS] from 01-Jan-1980 to an unknown date for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced PYREXIA (fever) and CHILLS (Chills). On 28-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot injection site), VACCINATION SITE PAIN (sore injection site) and VACCINATION SITE ERYTHEMA (injection site is still a little swollen ,hot and red). 28-Mar-2021, the patient experienced VACCINATION SITE SWELLING (injection site is still a little swollen ,hot and red). On 31-Mar-2021, the patient experienced ERYTHEMA (redness in approximately 50 % of left arm). On 05-Apr-2021, ERYTHEMA (redness in approximately 50 % of left arm) had resolved. At the time of the report, VACCINATION SITE WARMTH (hot injection site), VACCINATION SITE PAIN (sore injection site), VACCINATION SITE ERYTHEMA (injection site is still a little swollen ,hot and red) and VACCINATION SITE SWELLING (injection site is still a little swollen ,hot and red) outcome was unknown and PYREXIA (fever) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   treatment included Tylenol. Action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-062360 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Follow up information received on 15-May-2021: patient demographics added, concomitant medications added, medical history added, event outcome updated for fever, chills and redness.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062360:
Pt recvd vax & reported fever of 105 & devel shaking & apnea (sz) taken to ER;
This spontaneous report was received from an office manager who is also a Health care worker and refers to a currently 50 years old male patient. None preexisting allergies, medical history and concurrent conditions were reported. The healthcare professional nurse informed that on 17-MAR-2015, the patient was vaccinated with the first dose of MMR II (lot# K020188, expiration date 22-OCT-2016) (strength, dosage and route were not reported) right deltoid reported as "Rt Del", that was shipped on 04-MAR-2015 and received on 10-MAR-2015. The product was in transit for 6 days, an the temperature was unspecified. None illness at the time of vaccination was reported. On 22-APR-2015, the patient was vaccinated with the second dose of MMR II (HSA) (lot no. K021950, expiration date not reported) (strength, dosage and route were not reported) left deltoid reported as "Lt Del". None adverse effects were reported. None relevant diagnostic tests and laboratory data were reported. Additional information is not expected because all information required was received.
1/28/2021 at 1:30 I Started having a hard time swallowing, numbing of lips and tongue. Epinephrine, and Benadryl medication was given was kept under observation for 11-12 hours.
Flu like symptoms, chills, severe body pain in neck and back, nausea, severe stomach cramping, severe headache. Inability to walk/stand. Pain non-responsive to ibuprofen and Tylenol.
Swelling of lymph nodes in Left armpit.  Very sore to touch.; Swelling of lymph nodes in Left armpit.  Very sore to touch.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were reported as no. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 02Mar2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. The patient had not received any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination. Since having the vaccine the patient had not undergone a COVID-19 test. The patient experienced swelling of lymph nodes in left armpit which were very sore to touch on 23Mar2021 at 20:00. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was taken as a result of the adverse events. The clinical outcome of the event swollen lymph nodes and the lymph node pain were not recovered at the time of this report.   No follow-up attempts possible. No further information expected.
Pfizer-BioNTech COVID-19 Vaccine EUA: Patient hospitalized with COVID-19 pneumonia and supraventricular tachycardia. Received intravenous fluids and metoprolol with cardiac monitoring. Discharged to home medically stable.
Patient developed 103.3 fever day after immunization. Refused liquids. Did not want to put weight on Left leg. Does have 1.5cm x 1.8cm redness at injection site of left lower thigh. Did throw up Tylenol. Irritable.
Reported Symptoms:  10008488:CHEST PRESSURE SENSATION OF; 10014218:EDEMA CONJUNCTIVAL; 10016558:FEVER; 10019211:HEADACHE; 10020772:HYPERTENSION; 10028411:MYALGIA; 10042680:SWELLING ARM;   Narrative:  Patient was instructed to see medical advice/ TX. Patient instructed to go to ER immediately for evaluation,  EKG, chest x-ray and appropriate treatment/evaluation. Also, per PCP recommendation, advised dose of Motrin 200mg which he has at home x 1 in setting of inflammation  and see if any improvement.   Other Relevant HX:  Other:  mild chest pressure on the left side, with mild swelling on the left arm pit and pectoral area and left eye mild swelling
Shortly after receiving the vaccine during the observation period, patient complained she was not feeling well. Symptoms include dizziness, shaking, nausea, and feeling hot. Patient was provided bottled water. Patient requested EMS response who arrived within 5 to 10 minutes. EMS checked on patient and carried her to emergency room.
after the shot he is having 150/85 for 2 days; This non-serious case was reported by a consumer via call center representative and described the occurrence of increased blood pressure in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-AUG-2023, the patient received the 1st dose of Shingrix (left arm). On 16-AUG-2023, less than a day after receiving Shingrix, the patient experienced increased blood pressure (Verbatim: after the shot he is having 150/85 for 2 days). The outcome of the increased blood pressure was not resolved.   It was unknown if the reporter considered the increased blood pressure to be related to Shingrix.     It was unknown if the company considered the increased blood pressure to be related to Shingrix.   Additional Information: Receipt date: 18-AUG-2023 The reporter was the patient. The patient received Shingrix first dose last Wednesday and his blood pressure was normally 120 by 70 but after the shot he was having 150 by 85 for 2 days now (at the time of reporting). The patient was referred to health care professional (HCP). The reporter consented to follow up.
Excessive gas, diarrhea, and belching to the point that I could not sleep and resulted in my chest being sore for a couple days. I did not take anything except some baking soda and water on Thursday (the day after my shot). The symptoms eased up on Thursday night and I was able to sleep.
Patient received the moderna vaccine January 6th, 2021. Patient came in for Jansen vaccine on July 23, 2021. I was not aware that he had already received the moderna vaccine. On the pre-vaccine paperwork the patient marked that he had not had any other covid vaccines prior.
Generalized Body Aches Fever 102.4 ( today AM) Nausea Rigors and Chills all Night. Severe Headache. Uneasy Gut. Pain at Site and Neck
Muscle pain achille tendon joint pain - knees, hips ankles nausea (L) arm pain at injection site - fingers numb.
Small node on left clavicle appeared on second day after vaccine. Noticed after 54 hours after receiving Covid 19 Vaccine
Vaccine given at 4:50pm, pt in observation area.  C/o feeling hot/flushed, skin pink, ears bright pink.  Asked to be taken to ED, stated "it could just be anxiety but I would rather be sure".  Taken via wheelchair to ED immediately and placed in room on gurney. Seen by ED staff, give hydroxyzine 25mg PO at 1732.  Discharged home from ED at 1847.
Patient wanted her BP checked as she was not abe to take this morning.  BP was taken and the BP was 260/127 HR 71. Patient Daughter stated she was recently discharged from the hospital last week due to a many stroke and the BP was high with little control at the hospital. Advise patient we will monitor BP, however if the BP remains high we will need to call EMS to transport. BP remained high 200/90 manual, patient denies any numbness, tinglings, or pain. Patient stated she felt fine, not issues. EMS was called to transport to the hospital. EMS arrive and took BP and it was 255/91
Sore arm - 6pm 3/30 Body aches and chills - 3am 3/31-1am 4/1 Headache 3am 3/31 - current 4/1
Ten minutes following the injection she began to c/o feeling lethargic.   A few minutes later I noticed her tugging at her shirt collar.  When I asked she said it felt a little tight.  We called our ED to let them know we were bringing her to them for evaluation. We obtain a W/C and took her to the ED. As we were leaving the office she was rubbing her nose stating she felt a little itching.  She never experienced difficulty breathing or speaking. She was assessed in the ED prior to what would have been the end of her 30 minute observation period.  I spoke with her a couple of hours later. She stated she felt fine. She took some Benadryl. She was at a restaurant with family when I spoke with her.