chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergic reaction around my nipple area on both side; Redness In band area; Bruising at shot area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruising at shot area), HYPERSENSITIVITY (allergic reaction around my nipple area on both side) and VACCINATION SITE ERYTHEMA (Redness In band area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE BRUISING (Bruising at shot area). On 28-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness In band area). On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction around my nipple area on both side). At the time of the report, VACCINATION SITE BRUISING (Bruising at shot area) and VACCINATION SITE ERYTHEMA (Redness In band area) had resolved and HYPERSENSITIVITY (allergic reaction around my nipple area on both side) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  The patient slept with the band-aid and experienced redness next day. The bruising started 3 to 4 days after the dose. The patient had seen a specialist for the allergic reaction who conveyed that it might be something else that making it flare up  The patient was using an unspecified cream to help it to subside the allergic reaction.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up report received on 29-jun-2021 contains additional event of Allergic reaction NOS and the outcome for Vaccination site erythema was updated. On 19-Jul-2021: Significant FU received on 20-jul-2021 contains Outcome of the event updated.
Within 30 seconds after the injection, I could feel lightheadedness. Within 5 minutes there was an increase in heart rate and palpitations. 7-10 minutes I could feel itchiness along my face, neck, and chest. Reported to Pharmacist. At 10 minutes I began to feel throat tightness and fuzziness inside of my mouth. At 12-15 minutes I had difficulty breathing, rapid heart rate 120bpm (my normal resting is 46-54bpm), blue finger tips with no capillary refill. Pharmacist assisted in breathing coaching without success. Pharmacist asked team for an epipen and 911 assistance. Overall body color changes. Pharmacist reached for radial pulse and could not feel one. Pharmacist reached for carotid pulse and could not feel one due to weak grade. I felt near syncopal and pharmacist assisted me from chair to floor. I could not feel sensation in bilateral hands up to my elbows. Pharmacist injected epipen to right thigh.   Relief of respiratory distress was felt within 2 minutes. I still could not feel my hands. Paramedics arrived on scene and began a cardiac monitor and O2 monitoring. Heart rate was still rapid but O2 sats improved. Paramedics assisted me from floor to chair and injected unknown dose of Benadryl to right arm. Hives were still visible at this point and some facial swelling around the mouth.   I was transported to Hospital for observation. After discharge I am still experiencing rapid heart rate 120-130s bpm and experience slight chest pressure and discomfort.
fever to 104 for 9 days and neck Lymphadenopathy starting 2 wks after vaccine
shingles several times; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date :29-NOV-2022 Reporters comment: This case was reported by a consumer via interactive digital media (Shingrix GSK). The patient he/she received first dose of shingle vaccine and had shingles several times.
flu like symptoms; bad reaction; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 52-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms and adverse reaction. On an unknown date, the outcome of the influenza-like symptoms and adverse reaction were unknown.   It was unknown if the reporter considered the influenza-like symptoms and adverse reaction to be related to Shingrix.  Additional case details were provided as follows: The age at  vaccination was not reported. The patient had a bad reaction and flu like symptoms after receiving Shingrix.  The patient asks, would that be associated with bad effects of the 2nd dose as well.
Pt's arm felt sore that afternoon and the pain has persisted since. She c/o of pain from deltoid/shoulder radiating to wrist. +numbness in fingertips intermittently which she notes is new.
No adverse reaction.  Vaccine temperature excursion.  Vaccine was kept at a frozen temperature, not refrigerated   temperature upon receipt of shipment.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), on 19Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 05Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE; ATORVASTATIN CALCIUM; BENAZEPRIL; D3; DICLOFENAC SODIUM; VITAMIN B-COMPLEX WITH VITAMIN C [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CHOLINE BITARTRATE;CYANOCOBALAMIN;FOLIC ACID;INOSITOL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE MONONITRATE]; FISH OIL; OMEGA-3-ACID ETHYL ESTER. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Faint Positive, notes: Started Paxlovid after 2 home tests. Were ''faint Positive''; (03Aug2022) Faint Positive, notes: Still ''faint positive'' 03Aug2022; (05Aug2022) Very robust positive, notes: 05Aug2022 ''very robust positive'' at home test; (07Aug2022) Very robust positive, notes: 07Aug2022 ''very robust positive'' at home test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient started Paxlovid after 2 home tests were "faint Positive". Ended treatment 01Aug2022. Still "faint positive" 03Aug2022. 05Aug2022 "very robust positive" at- test. 07Aug2022 still "very robust positive" with at-home test. May have started treatment too soon. COVID 19 Treatment was started (Brand=Paxlovid) Treatment start date=28Jul2022,  Treatment stop date=01Aug2022,  Indication=Treatment of COVID-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Moderna COVID-19 Vaccine EUA sore injection site, itchy injection site, left side and lower back itchy with small bumps (hives)?  - have to put topical to relive itchiness. As o today, Mar 28, still somewhat itchy. Injection on left arm.  Injection site soreness and itchiness. Itchiness and small hives on the left side and lower back.
She got the vaccine, she was fine at first, sent her home at 11:45, by 11:50 she started getting itchy around her lips, then she got tingling and numbness in her left cheek about 5 minutes later.  She then started to see slight swelling in the left cheek by 12:00.  She then took 2 Benadryl.  By 12:10 she had tightening of the throat, and by 12:20 she was in the ER at Hospital, and at 12:40 she was seen and they gave her Pepcid at 1:00 PM on top of the Benadryl.  She is currently in observation waiting to see the progress of the reaction.  She is feeling better now, she was not intubated.
About 2-3 hours later my heart was elevated (racing heartbeat), nausea, and body itching. I called vaccination site and told them. Every day it got better, but the nausea was worse, and every now and then I have a high heart rate. I had my cardiology and said it was a common side effect.
Low temp, low BP, then temp 100.4, nausea, vomiting, chills, headache, (which all lasted for several days. I didn?t feel better for a week after the first shot. ) Heart thumping which has lasted two months. I now have to take Lisinopril to lower my BP.  My pulse goes from 41 to 71 throughout the day, and this started when I had the sickness reaction after the first shot. I was sick for two and a half days (headache, chills, temp of 100.2) after the second shot. I had the second shot April 12 at 4pm and started to feel bad at 4:30am on April 13.
Patient called at approximately 10 am of the following day.   States she received the vaccine at approximately 1pm the previous day.  Later that evening she experienced some itching and then went to bed.  Today she states that her left ear is swollen completely shut and it is throbbing.  She also states her throat is on fire if she tries to swallow anything.  Instructed patient to go immediately to the nearest emergency room for evaluation.
Moderna COVID-19 Vaccine EUA  Up until recently, I have had a predictable cycle every 28 days, lasting 7 days, beginning heavy and tapering out.  At the beginning of 2021, I began to enter the perimenopause stage.  My first gap was 37 days (normal period length/strength) and my second gap was 48 days.  My most period came after my first vaccine (at the end of 48 day gap).  I felt it was lighter and less discharge.  It ended after the normal 7 days.  I had 2 days of nothing (as to be expected).  I then began to have some brown discharge and mild cramping/discomfort.  This was not heavy enough for a pad or tampon, only a panty liner was needed.  The brown discharge occurred for about 3-4 days when small amounts of fresh, bright red blood began showing.  This has been occurring for the past 3 days, along with continued mild cramping/discomfort.  I am still in the middle of this discharge which now alternates between fresh blood drops and brown discharge.  I was originally scheduled to have my second dose tomorrow but have decided to postpone it as I don't want to chance blood clots.  Additionally, I am 45 years old and have had 3 children.  I have never had a menstrual cycle closer than 26 days apart.  I have NEVER had any blood discharge after my normal 7 day cycle.  Another matter to consider is that I have a blood clotting disorder called Factor V Leiden, heterozygous.  I did hemorrhage after giving birth to my third child but have had no other clotting issues.
I've been with fever; cough; congestion; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 24Mar2021 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 56 years). The patient medical history and concomitant medications was not reported. On 26Mar2021, the patient experienced fever, cough and congestion. The clinical outcome of the events was unknown.  Follow-up (31Mar2021): This is a follow-up spontaneous report from a contactable male consumer.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recvd vax;almost immed rxn; burning at site & lt arm shaking, n, numbness of finger tips; disorientation; did not understand english language; lasted 4-5 hrs;er dx: poss hep B neuritis; paresthesia side effects;
swelling, redness, tenderness persisting longer than 48 hours. Swelling developed initially at site of injection and now there is large swelling at the armpit.
New onset seizure, taken to hospital. Given lorazepam and loaded with dilantin. Non-responsive, intubated. Transferred to another hospital.
Pt was given extra dose of Hep A, instead of KINRIX as ordered by provider at well child visit.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium
Rheumatoid arthritis; Gait disturbance; Pain; This case was received via FDA VAERS on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Glaucoma, Cataracts, Barrett's esophagus, High cholesterol, Kidney stones (High Cholesterol, controlled by medication.) and Carpal tunnel syndrome. Concurrent medical conditions included Rheumatoid arthritis, Osteopenia, GERD and Hypertension (High Blood Pressure, controlled by medication.). Concomitant products included ATORVASTATIN, OMEPRAZOLE and LABETALOL HYDROCHLORIDE (LABETALOL [LABETALOL HYDROCHLORIDE]) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criterion medically significant), GAIT DISTURBANCE (Gait disturbance) and PAIN (Pain). The patient was treated with METHYLPREDNISOLONE for Adverse event, at a dose of UNK dosage form. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis), GAIT DISTURBANCE (Gait disturbance) and PAIN (Pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 11Mar2021, the day after receiving the first vaccine, it was noted by the patient that they experienced " the worst rheumatoid arthritis (RA) flare" they ever had. The patient stated the morning after was "very painful and that they had to crawl out of their bedroom." The patient reported being unable to walk due to the RA flare.  The following day, presumed 12Mar2021, the patient was back to normal.  For treatment, the patient received a script for methylprednisolone to alleviate the effects.  The patient additionally expressed concern that they were not made aware that this could happen after the vaccine. The patient reported being told by staff at the POD that this was "no different than a usual flu shot." The patient also felt as though they were not being truthfully informed.  Based on the information provided, which includes a temporal association between the reported event and the administration of mRNA-1273 vaccine, a causal association cannot be excluded.; Sender's Comments: Based on the information provided, which includes a temporal association between the reported event and the administration of mRNA-1273 vaccine, a causal association cannot be excluded.
Injection site pain is continuing at 48 hours; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: Injection site pain is continuing at 48 hours).  The outcome of the injection site pain was not resolved.   It was unknown if the reporter considered the injection site pain to be related to Arexvy.     It was unknown if the company considered the injection site pain to be related to Arexvy.   Additional Information: GSK Receipt date: 26-SEP-2023 This case was reported via (Open field AE monitoring) interactive digital media. The reporter reported that all the side effect was about for 36 hours. The Injection site pain was continuing at 48 hours. The follow-up could not be possible as the as no contact details were available.
Headache, Myalgia, Fever, Diarrhea & NauseaVomiting Narrative:  PATIENT EXPERIENCED PROJECTILE VOMITING, HEADACHE, PYREXIA 102, & DIARRHEA X 3 DAYS. PCP PRESCRIBED ZOFRAN AND ADVISED NOT TO TAKE SECOND COVID VACCINE DOSE. PT WAS COVID POSITIVE IN OCTOBER 2020. PT ALSO REPORTS REACTION TO TB VACCINE RASH IN 2012.  Other Relevant History:
A short time p/vax pt devel pain & swelling in the arm that was injected;pt states pain spread to all joint & can see swelling in fingers;feels it cont to worsen;
3/3/22 patient transferred to local hospital from outside hospital; found to be positive for COVID; AMS, generalized weakness, lethargy; enroute to hospital patient became hypotensive; AHRD secondary to COVID PNA; acute encephalopathy; septic shock; anemia; AKI; transferred to alternate hospital requiring BiPAP and eventually intubation; given dexamethasone and ABX; patient suffered tachypnea and HTN; tracheostomy placed; patient transitioned to comfort care; extubated and passed away in the hospital.
I started having like some itching and pain in different spots around my left trunk, my chest and back, then it formed like sort of kind of a rash and sort of scabs and at first I thought it was a bug bite but it did not go away so I thought it was shingles. I had a doctor's appointment on 03/04/2021 and they confirmed it was shingles. They gave me an antiviral. It got better in a week or week and a half. It was not too severe.
On 8/17/2022 - I felt flushed, body aches, respiratory stuff, sore throat, coughing and congestion. On 8/18/2022 I took a COVID-19 home test and the results were positive. I contacted my doctor, and I was prescribed Paxlovid.  It took 2 weeks to feel active again, but I still had a lingering cough for a week after the Paxlovid. But on 10/5/2022, I had a severe inflammatory issue in my hip from my arthritis.  I have heard, after having a bout with COVID-19, it seems like some people have reported issues with inflammation. In my case, it was my right hip and it sent me to the emergency room.
As soon as the injection was complete the patient started acting like he didn't feel well and that he might vomit.  Then he started to seem like he might pass out.  Then he was shaking for a few moments and his body straightened out on the chair and he seemed like he might be having a seizure.  I had someone call 9-1-1. I stayed with him until the paramedics arrived.  He kept seeming like he was nodding off, but when I spoke to him he was responsive.  By the time the paramedics arrived he said he was feeling better, but they checked him out, BP and HR and blood O2 were normal.  The paramedics offered transport to hospital but patient and his adult family member declined, and patient went home with his family member.
shortness of breath.  tingling in hands and lips   hyperventilation.  states similar to prior vaso vagal episodes that are triggered by stress
Day 1 & 2: chills, fully body muscle aches, headache.  Day 6: full body hives
has been more than 6 weeks and he still has not received the second dose.; 17 year old patient received the vaccine; A spontaneous report was received from a nurse concerning a 17 year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and had been more than 6 weeks and he still had not received the second dose..  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, was not reported.  On 13 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly for prophylaxis of COVID-19 infection.   It had been more than 6 weeks and he still had not received the second dose.  Treatment for the events was not reported.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events were considered recovered.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17-year-old) and product dose omission issue (second dose) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Just fluids and sore in those two areas - under left arm pit, left breast; Just fluids and sore in those two areas - under left arm pit, left breast; Just fluids and sore in those two areas - under left arm pit, left breast; The next morning (06Oct) left arm felt sore; noticed a swollen pocket of fluid under my left armpit.; swelling mass; swelling mass; accumulating fluid; sore; Dose number: 3; This is a spontaneous report from a contactable consumer. This 62-year-old male consumer (patient) reported that:  A 62-years-old male patient received bnt162b2 (COVID-19 MRNA VACCINE BIONTECH; Solution for Injection, Lot Number: FF8839; Expiration Date: Dec2021), dose 3 via an unspecified route of administration, administered in left arm on 05Oct2021 11:15 (at the age of 62-Years-old) as DOSE 3 (BOOSTER), SINGLE for Covid-19 Immunization. Medical history included patient had Waldenstrom cancer (blood) and had known allergies to sulpha and allergic to bees-all were from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: Unknown and Expiry date was not provided) via unspecified route of administration in left arm on 28Feb2021 12:00 as DOSE 1, SINGLE and also received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: Unknown and Expiry date was not provided) via unspecified route of administration in left arm on 21Mar2021 12:00 as DOSE 2, SINGLE both doses taken for COVID-19 immunization (at the age of 62-years-old). There were no other vaccine in four weeks and no other medications in two weeks. Patient did not have covid prior vaccination and did not covid tested post vaccination. On 06Oct2021 01:00 after the booster dose, the patient experienced the next morning (06oct) left arm felt sore and noticed a swollen pocket of fluid under my left armpit. On 06Oct2021 swelling mass, accumulating fluid and Sore. On 08Oct2021 the patient experienced Just fluids and sore in those two areas - under left arm pit, left breast. Patient took dose number 3 on 05Oct2021. it was reported that, Pharmacist stated, I am calling because I want to report an adverse effect for the booster COVID shot. Pharmacist was informed about Pfizer drug safety department. When asked to specify the adverse reaction: Pharmacist stated, The patient said, he has swelling mass that was accumulating fluid, sore and he said its not itchy but he said its about an inch big and he said once near where he got vaccine once shifted to under his, he said his chest area (Further clarification unknown hence not captured in event). No treatment was received for the events. The events were assessed as non serious. The outcome of events swelling mass and accumulating fluid and sore was reported as unknown, while the outcome of other events was reported as recovering.   Follow-up attempts are completed. No further information is expected.