chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11/1/21...10:46 AM, Received Flu Vaccine. 11/2/21...8:00 AM, Starting Feeling Queezy, Light Headed, Nervousness Muscle Aches. 3PM Took Blood Pressure Pill, 5MG Amlodipine Besylate. 11/3/21...9AM Same symptoms as 11/2/21 BUT Worse. Light Headed, Nauseaous, Fast Heartbeat, Headache, Head was Tingly, and numb in right arm. Took blood pressure pills at 3pm and 4pm didnt go away. Took another 1/2 of bp pill. 7pm still the same.  Checked BP at home, 189/102. Rushed to Emergency Room. Coded patient for a Stroke Alert. The ER staff checked heart Xray, MRI, blood work, urine test, all the lab work. They could not find anything wrong. Pulse rate 112. BP 180/95. They gave something to treat anxiety, it help  bring down the bp a little bit. 11/4/21...During the day, a little bit better. Took BP pill 3 pm. Around 7pm, Start the same symptoms as 11/3/21, but worse. Checked BP around 8pm, 200/102...Rushed to the ER again. The ER did more blood work and the ER could not find anything wrong. Gave Lorazepam 0.5 MG tablet for Anxiety. It helped to bring down the BP a little bit and then they sent patient home. 11/8/21...Still feeling very tired, muscle aches, pain in spine. A little light headed.
Began to feel discomfort on left hand side starting on 4/22, progressively worsening until pain woke me up from sleep on 4/29 resulting in a trip to the ER where I was diagnosed with Bilateral Pulmonary Embolism.
On 1/11 patient reported pain on her arm, there was significant bruising from injection site to slightly above the elbow.  no constitional symptoms
Diarrhea, vomiting, fever approx. 12 hours post vaccine administration.
C/o itching to arms/forehead. 99.4, 125/63, 90, 20 O2 sat - 98% No rash noted to body. L deltoid band aid dry & intact, no redness, no swelling.
Information has been received from a nurse practitioner concerning a 20 year old female patient who in May 2008, was vaccinated with a first 0.5 ml suspension IM dose of GARDASIL. The patient completed her GARDASIL regimen at the following schedule, 0, 2 months (in July 2008), 6 months (in November 2008). The patient had initiated sex in 2007. On approximately 07-FEB-2011 ("about a week ago"), the patient showed positive for (HPV). PAP smear and thin prep DNA were performed (no result provided). It is unknown if the patient sought medical attention. Additional information has been requested.
Multiple blood clots (DVTs) to BLLE with gross edema, decreased mobility, stasis ulcers, kidney stones and ?fluid on kidneys? (NOS), hematuria, wound clinic treatments required, loss of ability to work, increased depression and stress r/t above.
Rapid heart rate, more than double my normal resting.   120-140 bpm  When normally I?m about 65 bpm. Right arm is still sore many months after the vaccine
Pain and weakness in arm symptoms similar to rotator cuff pain, for 6 months. Pain starting to ease after 6 months.
Knot at injection site, rash, bumps at injection site; took APAP and applied Hydrocortisone at present still dry and itchy so advised to take BENADRYL.
Patient received vaccine, 5 minutes into the 15 minute observation waiting period he was in a panic-like state and reported he was not feeling well, pharmacist on duty asked if she needs to call 911, which he responded yes.  EMS came to the scene and took over, patient and wife left with EMS 10 to 15 minutes later.
Swelling of the right arm, entire posterior aspect of upper arm, with erythema and tenderness.  No restriction of movement at elbow or shoulder joint.
Fever 99.8 degrees and hives 20 hours after immunizations administered. Infant had no symptoms when put to bed at 10:30pm 11/16 but awakened at 8:30am 11/17and had generalized hives and fever. Taken to doctor who ordered Altarax 0.25 tsp tid. Mom states infant is acting normally with no fever now 11/14 4pm
administered after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a male patient who received HAV (Havrix) (batch number 2K57N, expiry date 11th December 2022) for prophylaxis.   Co-suspect products included DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th March 2022, the patient received the 1st dose of Havrix, the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022093645   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comments: The reporter stated that, on 29th March 2022 a female patient was administered the Havrix and Infanrix vaccine after a temperature excursion. The anatomical location was left arm for Havrix and Infanrix. The reporter give consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093643:Same reporter. US-GLAXOSMITHKLINE-US2022093600:Same reporter. US-GLAXOSMITHKLINE-US2022093597:Same reporter. US-GLAXOSMITHKLINE-US2022093602:Same reporter. US-GLAXOSMITHKLINE-US2022093645:Same reporter US-GLAXOSMITHKLINE-US2022093638:Same reporter US-GLAXOSMITHKLINE-US2022093640:Same reporter US-GLAXOSMITHKLINE-US2022093642:Same reporter US-GLAXOSMITHKLINE-US2022093644:Same reporter US-GLAXOSMITHKLINE-US2022093646:Same reporter US-GLAXOSMITHKLINE-US2022093648:Same reporter US-GLAXOSMITHKLINE-US2022093647:Same reporter.
tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appetite; stomach cramping; headache; site soreness; dizziness; full body aches; chills; diarrhea; This is a spontaneous report from a non-contactable nurse who reported for herself, a 42-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 21Jan2021, at the age of 42 years, at a single dose for COVID-19 immunization. Medical history included depression. Patient had no cardiac history. Patient had no COVID prior vaccination, and was not COVID tested post vaccination. The patient was not pregnant, and not pregnant at time of vaccination. Concomitant medication included celecoxib (CELEXA). On 22Jan2021, the patient experienced extreme weakness, slept 36hrs, tachycardia up to 201, up to BP 210/101, nausea, no appetite, stomach cramping, headache, site soreness, dizziness, chest pain, full body aches, chills, and diarrhea. No treatment was received for the events. The outcome of the events was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: The reported events including serious events hypertension, tachycardia, and chest pain were likely related to due to plausible temporal relationship.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
He had a burning sensation in his armpit afterwards for a couple days and a knot where it was administered in addition to a rash that is quarter size around the area.
Breakthrough case admission after 2 vaccines MOderna 1/28/21 lot# 028L20A;  Moderna 2/25/21 lot# 004M20A
Difficulty breathing; Cough; Body aches; Headache; Lower back pain; Fatigue; I received my COVID-19 booster; This is a spontaneous report from a contactable pharmacist. This 53-year-old male pharmacist (patient) reported for himself that. A 53-years-old male patient received BNT162B2 (formulation: Solution for injection, Lot Number: FG3527), via an unspecified route of administration on 03Nov2021 (age at vaccine 53-years-old as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported he was in excellent health otherwise, no use of medications. The patient previously received historical vaccine BNT162B2 (formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on unspecified date DOSE 1, SINGLE, received second dose BNT162B2 (formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on unspecified date DOSE 2, SINGLE, for covid-19 immunisation. The patient had difficulty breathing, cough, body aches, headache, lower back pain and fatigue from 04Nov2021. The clinical outcome of the events Difficulty breathing, Headache, Lower back pain was recovered 04Nov2021 and Cough, Body aches and Fatigue was not recovered.  Follow-up attempts are completed. No further information is expected.
right upper arm induration, warmth, 9cm c/o headache once 8/12 and tingling at injection site 8/10 and 8/11
THREE MINIUTES AFTER RECIVING THE VACCINE: RASH & TINGLING ON BACK  25 MINIUTES AFTER VACCINE: TOUNGE NUMBNESS IN THE MIDDLE SENT TO ED VIA EMS FOR TOUNGE NUMBNESS & SWELLING, PULSATING, HEADACHE, AND VERTIGO
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 17-OCT-2012 14:50, 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.
Parent gave an incorrect date of birth for their child, reporting them as 12 years old when they were actually 11 years old. Vaccine was given, no side effects or adverse events have been reported.
Day 1-3: moderate muscle aches, chills, tiredness, nausea   Day 4-14: mild muscle aches, chills, tiredness
I noticed the first welt on left breast on Tuesday December 7 and the skin on my face was bumpy and had marks.  I was traveling and attributed my face to mask wearing. I started itching in the car on the way home.   This was my booster shot. Back in June after I had had the 2 Pfizer shots I had an increase in blood pressure even though medicated that finally was gotten under control thru medicine. It happened in June and I got my first two shots in February and March.  It was VERY high.  So I was too scared while traveling to take my blood pressure but when I got back in town I took it and it had jumped again after the booster.  I'm going to give it a few months to see if it goes back down.  But since i've been home, in the two weeks after the shot, I have now broken out in little red bumps mostly on my stomach. back, a few on my legs, and breasts.  Not on my arms or lower legs.  It looked like measles at first.  I react to things medication wise and have some chronic health issues, and am on six prescriptions just for those, so I am concerned.  I'm not going to the dr. because I go to the clinic and they said they don't have anything to do with the covid shots.  I got my first two at medical center, but the actual drs office said they aren't involved in the covid shots.  So I'm waiting to see if the hives go away but thought somebody should know about the reaction.  I'm concerned if something is internally wrong to cause it.  And my legs just feel like they are dragging.  They aren't going away... they are just there.  I can't take antihistamines or anything because of the afib according to my old cardiologist, but they don't really itch too bad.   pharmacy gave me this address to report it.
A few spots were slightly itchy; red scaly spots; red scaly spots; This case was reported by a consumer and described the occurrence of rash scaly in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   In January 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced rash scaly, red rash and pruritus. The patient was treated with cortisone (non-proprietary) (Cortisone Cream), antibiotics nos (Antibiotic Ointment (Unknown Ingredients)), ketoconazole (Ketoconazole Cream) and emollients and protectives (Moisturizer). On an unknown date, the outcome of the rash scaly and red rash were recovered/resolved and the outcome of the pruritus was unknown.   It was unknown if the reporter considered the rash scaly, red rash and pruritus to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix vaccione about a month ago from reporting date and got few random red scaly spots on body. A few spots were slightly itchy. The patient tried cortisone cream, antibiotic ointment, Ketoconazole cream and moisturizer on the spots but nothing seems to affect them. They eventually fade after about 3 weeks. The patient wanted to know whether it was common after receiving shingrix vaccine. This case has been linked with US2020AMR032961, reported by same reporter.
Nausea, dry heaves, hot, dizziness after 12 minutes .  Observed for 40 minutes.  Gave water and snacks.  BP 121/83, HR 98.  Resolved after observation.  Husband picked up her.
States she feels her heart "flutter". Checked her vital signs, gave her water and crackers and provided support.  She has a history of palpitations and anxiety, Dr. spoke with her as well. She was feeling better before she was discharged. BP 127/60 P 75 SR R 18 O2 100%
Pt. said the vaccination when injecting felt funny, eyes rolled back into his head, slight convulsing, and passed out. Came back in a few seconds.
Hives on back, neck, and chest.  Took two Benadryl  and applied cortizone cream to skin.  Almost gone by morning
Received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment information was provided   This case was linked to MOD-2021-412773 (Patient Link).
Site of injection inflamed, warm, red, mild pain. Patient was sent to ER and started on cephalexin for bacterial skin infection. Patient has follow-up with primary physician and same diagnosis with second round of cephalexin given.
Product temperature excursion issue; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) 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 assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue).    The case was reported for 50th patient out of 77 adult patients who had received the vaccine as reported by the reporter.  No concomitant medication was provided.  It was reported that the doses were administered before it was known if the vaccine was ok to use after the excursion.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
I first started with body aches and did have a fever, my highest was 101. Later that evening I had a lot of armpit pain (right arm pit) It felt like I had lump and body aches. It got a little better, I took Ibuprofen. About 36 hours after the shot I got a fever again. The next day I felt better but had a lot of back pain for about two days after.
pt recvd vax 22DEC92 & mom stated when dad went to work pt was fine; 9AM pt was face down & dead; mom took pt to ER & CPR was done but pt did not recover;
Occurring within 5 minutes after injection Dizziness, fatigue, palpitations (HR>120),  feeling hot.   Occurring 3 days after injection and ongoing since for past 9 days abnormal vaginal bleeding (spotting)
Mom stated that this child cried for over 24hrs p/receiving inject on 26FEB91; leg swelled almost to his knee & he had a knot about the size of quarter; Ran mild fever-about 101; Given APAP q4hrs throughout the crying episode;
Pfizer 5/21/21 and 6/11/21. Positive on 1/6/22
Information has been received from a Certified Medical Assistant concerning a patient who on 17-FEB-2011 was vaccinated intramuscularly with a 0.5 ml dose of PROQUAD (lot#666374/0193z, expiration date 15-JUL-2011). On the same day, 17-FEB-2011 patient was vaccinated with a dose of VARIVAX (Merck) (route, dose and lot # unspecified). Medical assistant reported that patient received an extra dose of VARIVAX on 7-FEB-2011. She intended to administer a dose of MMR II (manufacturer unknown), following a dose of VARIVAX (Merck) administration for the patient, but she accidentally administered a dose of PROQUAD instead. No adverse event was reported. Additional information has been requested.
Significant and painful lymphadenopathy for several weeks extending from axillary region on the injection arm along clavicle, with lower, more typical lymphnode enlargement along left neck and jaw. Pain has subsided in axillary area at this time, but lymph nodes are still enlarged (can be felt at rest just by lowering my arm), and lymph nodes along left clavicle remain tender to palpation. Second dose of series is expected to be administered on 1/27/2021.
Information has been received from a certified medical assistant concerning a 19 week old (also reported as "4 months old") female who on 21-FEB-2008 was vaccinated with her first dose of ROTATEQ.  There was no product quality complaint.  Additional information has been requested.
Difficulty breathing, nausea, vision changes, stomach pain, diarrhea, pain right had and arm, swollen glands in neck, swelling in right arm and hand, difficulty walking or standing. Symptoms persisted throughout the night. No treatment. Did not seek medical care.
SITE OF THE INJECTION HARD; SITE OF THE INJECTION RED; SITE OF THE INJECTION SORE; This spontaneous report received from a health care professional concerned a 72 year old female patient of an unspecified race and ethnic origin.  The patient's height, and weight were not reported. The patient's concurrent conditions included: Rheumatoid arthritis (RA), and other pre-existing medical conditions included: Patient reports no fever or other side effects.  On an unspecified date the patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of administration, batch number and expiry were not reported) dose was not reported, for prophylactic vaccination. No adverse events were associated with pervious covid-19 vaccine ad26.cov2.s (unspecified manufacturer).  The patient received additional company suspect vaccine covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of administration, batch number and expiry were not reported) dose was not reported, 01 total, administered on 02-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included golimumab (SIMPONI) for RA.  On 02-NOV-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced site of the injection was hard, red and sore. (dose number in series 2)   The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the site of the injection red, site of the injection hard and site of the injection sore was not reported.  This report was non-serious.  This case, involving the same patient is linked to 20160420558 (SIMPONI) and 20200335343 (SIMPONI).  This case, from the same reporter is linked to 20140306760.