chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Clots in the leg; Legs started hurting; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Clots in the leg) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRAVASTATIN, OMEPRAZOLE and LISINOPRIL for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced THROMBOSIS (Clots in the leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Clots in the leg) had not resolved.            Treatment medication include Comodit 5 mg. The patient said that now has blood clots and in June it started bothering, started hurting, The patient said the legs started hurting.  Company comment: This is a spontaneous case concerning a 71-year-old, female patient with no relevant medical history, who experienced the unexpected, serious, AESI event of thrombosis. The event thrombosis occurred approximately 2 months after the second dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 71-year-old, female patient with no relevant medical history, who experienced the unexpected, serious, AESI event of thrombosis. The event thrombosis occurred approximately 2 months after the second dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
8 days post vax the pt developed generalized rash accompanied by fever of 103F. The rash was described as fine red spots located mainly on the trunk and legs.
fever up to 100 degrees; chills; sweating a lot; tired; hurting all over; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HYPERHIDROSIS (sweating a lot), FATIGUE (tired), MYALGIA (hurting all over) and PYREXIA (fever up to 100 degrees) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031a21a and 030m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced CHILLS (chills), HYPERHIDROSIS (sweating a lot), FATIGUE (tired) and MYALGIA (hurting all over). On 15-Mar-2021, the patient experienced PYREXIA (fever up to 100 degrees). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 15-Mar-2021, CHILLS (chills), HYPERHIDROSIS (sweating a lot), FATIGUE (tired), MYALGIA (hurting all over) and PYREXIA (fever up to 100 degrees) had resolved. Not Provided          No concomitant medication is included.
Acute onset of chest pressure radiating to left shoulder, 10 days after smallpox vaccination, associated with diaphoresis and slight improvement with leaning forward. Pain resolved with Motrin and Colchicine. Discharged on 1 week on Motrin and 3 months of Colchicine.
pt recvd vax & exp sz; reporter indicates that the sz may not be related to the vax;
Patient's mother reported that the patient had a 15 second seizure 20 minutes after administration. The patient's mother reported that the ambulance came and the patient's vitals were all normal. Patient did stay in the store for the recommended 15 minutes after the vaccine and felt ok before leaving. Recommended patient to follow up with pediatrician for full work up.
Obtained H1N1 vaccine 11/25/2009. On 11/26/2009 about 1330 hrs. Suffered gran mall seizure & was transported to hospital via ambulance. He reported to hospital I had H1N1. On 11-30-09 followed up w/nuerologist who asked me to report to proper authorities.
She got the vaccine, she had no reactions at all and then approximately 11 days later she had a severe rash and swelling on her face, around her eye and around her mouth stemming from what she has concluded to be consuming wheat or yeast since the vaccine with no previous allergic reactions to these items.  She has been to the hospital and they told her it was an allergic reaction.   The rash is itchy and reoccurs when she eats those few things.  She has been watching what she eats and then had something yesterday that had a tiny bit of wheat in it and broke out in hives again.  She has been taking Claritin for this, which has pretty much no affect on reducing the reactions.  The reaction is not sustained, it lasts for 4-5 days and then dissipates slowly as she treats with ointments, (Aquaphor).   She has been in contact with dermatology center but was not breaking out at that time and is going to contact them when she is having an issue.
pt recv vax;on 16nov94,pt exp muscle weakness in hip area w/ diff crawling & standing;17nov94,to MD w/ apparent diff w/ strength in lower legs;exam was unremarkable, recovered eventually;
Sore arm; mild tenderness; A spontaneous report was received from a 42-year-old, female, consumer (nurse) who received Moderna's COVID-19 vaccine and experienced the event "a sore arm; mild tenderness".  The patient's medical history, as provided by the reporter, included rheumatoid arthritis, osteoarthritis, diabetes and hypothyroidism. Concomitant medications reported included levothyroxine sodium, dulaglutide, insulin glargine and upadacitinib.  The patient received their first of two planned doses of mRNA-1273 on 28 Dec 2020 for prophylaxis of COVID-19 infection.  On 29 Dec 2020, the consumer called to report a "sore arm but no sorer than any other vaccine, just mild tenderness". She stated that she has medical conditions which she takes medications for and thought it would be valuable information. She consented to being contacted, along with her health care provider. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event sore arm; mild tenderness was not reported.   The reporter assessed the event sore arm; mild tenderness as related to study drug.; Reporter's Comments: This case concerns a 42-year-old, female patient with medical history of rheumatoid arthritis, diabetes and hypothyroidism, who experienced an expected event of pain in arm. The event occurred 1 day after the first dose of mRNA-1273 administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
When I woke up on 04/23/2021, I felt a general feeling of malaise throughout. I had a massive headache, my joints were extremely painful and I had a lot of pressure in my head.  I went to work and later I went to lunch and as I was leaving the restaurant, I started to feel extremely sick as if my heart was exploding. I went to the restroom. I wear an Apple watch and checked my pulse. My heart rate which is normally in the 60-70 bpm was in the 120's. My chest felt like it could not hold my heart. I waited for about 20 minutes to see if my heart rate would slow down. My heart was working very hard and I felt like my head was going to burst. The feeling in my head subsided somewhat but my pulse continued to be basically very high as it was still in the 120's.  Eventually I drove myself home and my heart rate had not slowed down. I felt my entire left torso front back (ribs/chest and back on left side) to be very painful. This was due to the extreme pain I felt and the extreme muscle contractions I endured when my heart rate first started racing. I felt like I could not fit in my skin.  I tried to take it easy when I got home as I could not move, had extreme fatigue, no energy, pain everywhere where I was touched by something.  I went to bed early and continued wearing my Apple Watch through the night and had similar high heart rate (120's) through the night. When I woke up this morning. I saw that I had a heart rate in the 60-70 bpm's range for only 3 hours of sleep I had through the night.  I continued having a high heart rate through the first half of 04/24/21. It is not 9:40 in the eve and my heart rate has now finally settled down to  80+ bpm.  I plan on contacting my physician for an appointment Monday morning. They do not take appointments by phone on the weekend.  I am still not feeling 100%. I checked doctor appointment to be made below.
Almost died with it, she got so sick; This is a spontaneous report from a contactable consumer. This is the second case out of two cases in which consumer reported for a female patient (brother's wife). A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced almost died with it, she got so sick. It was reported that "I had my first dose, Pfizer shot here almost three weeks ago and I am due for the second one in two days and I am really concerned about it because I did, not immediately had a reaction but within 24 hours, I ended up with severe chills that lasted for about 2 days and I had chills off and on, I mean we had 90 degree weather and I could not stand having the fan blowing or like just air conditioner on. I just didn't feel good at all, it made me feel, I just wonder and voice was not clear, I am an elderly person and usually pretty healthy but I am kind of concerned about going for the second shot with that kind of a reaction on the first one. My friends had the shot (Shot name not clarified, hence suspect captured as Unspecified Shot), my brother and his wife, his wife got, almost died with it, she got so sick. I am just feared you know. Also, my right leg, especially my ankle and foot are just been swelling more than normal, to more than, it was really tight". The clinical outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Numbness and tingling in my left fingers, left toes, left ear, and left side of my face. So far in my toes when walking it becomes painful. It feels like my toes are being placed over a flame.
4 DAYS AFTER THE FIRST SHOT I HAD FACIAL PARALYSIS ON RIGHT SIDE OF MY FACE WHICH PERSISTS TODAY - 6 MONTHS LATER. SOME IMPROVEMENT BUT I STILL HAVE NOT RECOVERED
Patient had episode of syncope, passed out for 10-15 seconds, became diaphoretic; BP low, 94/58 at lowest point, HR 52; patient monitored in clinic for 30 min following administration until BP returned to normal and remined stable and could take fluid by mouth, patient left with mother.
Raised area, below injection site, about size of small orange area was not warm or discolored.
4 days post  hives. Not resolved  with Otc  bendryal. Day 5 chest tightening with full body.
PT. COMPLAINING OF PAIN ON LEFT ARM WITH REDNESS AND SWELLING.  TOLD TO TAKE TYLENOL AND USE ICE PACK.
I woke up the morning after having the vaccine feeling extremely tired, (could not stay up - Had to go back to bed) no appetite, low grade fever, eyes burning, freezing cold, very sore arm that was red and a hard sore knot at the point of injection. That spot was also hot to the touch. This lasted thru that day and the next.  On the 4th day, my fever went down, but I still was extremely tired and my arm still a 3" diameter red spot.
PFIZER COVID VACCINE #3 GIVEN 8/30/21, LOT #FE3592; pt had a positive COVID test on 1/14/22 from medical facility; was being followed by a doctor; pt is immunosuppressed; 1/22/22 pt to ED; tested positive for COVID; pt has been having more dyspnea, weakness, and cough since COVID dx; hypoxic; O2 supplementation; given ABX, steroids; multifocal pneumonia; required intubation with mechanical ventilation; septic shock; poor prognosis; DNR; family chose to withdraw care and move to comfort measures; pt passed in the hospital
Injection site swelling rash redness arm pain started within 12h from Injection time and subsided in 5 days. First couple of days pain was severe. Acetaminophen alone was not helpful. Advil dual action (Acetaminophen 250mg, ibulroden 125mg) seemed to provide releif along with cold compression. (wet towel) Day 6 rash barely visible. Day 7 a quarter size lump at injection site noticed. Day 8 swelling and rash returned with suburn tyoe of surface pain. Day 9 rash growing. Aprox size 10cm radius
Patient mentions muscle soreness that has not gone down. In some moments the patient is unable to lift his arm out to the side, in others he is fine.
Patient is experiencing a rash on her midriff, a swollen bottom lip which is impeding speaking, eating, and drinking, and round red welts/lumps on arm and knee that are itchy.  I referred her to visit a hospital emergency room.
13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is third of 13 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 same reporter, similar suspect drug and event; different patient
later died.; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (later died.) in an 8-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Company comment: This is a spontaneous case concerning a 8-decade-old female patient with no reported medical history, who experienced the serious  unexpected event Death, on an unknown date after receiving  the second dose of mRNA-1273.  The cause of death was not reported. It is unknown if an autopsy was performed.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reported that she heard from her friends about their two aunts in their 70s that received the second Moderna COVID-19 dose and they each later died.  No additional information known or provided.  Consent not given for Safety follow-up.  Caller wished to remain anonymous.  No concomitant medication provided.   No treatment information mentioned.   This case was linked to MOD-2022-445768, MOD-2022-445950, MOD-2022-447065.   Reporter did not allow further contact; Sender's Comments: Company comment: This is a spontaneous case concerning a 8-decade-old female patient with no reported medical history, who experienced the serious  unexpected event Death, on an unknown date after receiving  the second dose of mRNA-1273.  The cause of death was not reported. It is unknown if an autopsy was performed.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Right armpit is hurting. Lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17May2021 18:00 (Batch/Lot number: unknown) at the age of 13 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPH NODE PAIN (non-serious) with onset 19May2021, outcome "unknown", described as "Right armpit is hurting. Lymph nodes". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymph node pain. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information:  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine  Device Date : 19May2021
This case was reported by a healthcare professional and described the occurrence of diaphoresis in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced diaphoresis, chest pain, shortness of breath and fatigue. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. Four additional subjects had similar symptoms. Linked cases include: A0751890A, A0751893A, A0751894A and A0751895A. Linked case A0751880A was more severe and included subject and event specifics.
Post vaccination client became diaphoretic/ dizzy then had a vasovagal response with nausea and vomited twice .  Clients legs raised, ice packs and water provided.  Extended observation for 30mins.  Client's symptoms resolved.  Was educated on adverse events and when to  call EMS.  Client left with steady gait, no apparent distress.
A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
pain + swelling around injection site, raised, erythematous, itchy hives around injection site, body aches + swelling in throat. No SOB or difficulty breathing. Admits headache as well. Lasted approx. 72 hrs.
patient under the recommended age range was given FLUZONE HD with no reported adverse event; Initial information received on 03-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 32 years old female patient who was represented with patient under the recommended age range was given influenza quadrival A-B high dose hv vaccine [Fluzone high-dose quadrivalent] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Sep-2022, the patient received a  dose of suspect influenza quadrival A-B high dose hv vaccine at a dose of 0.7 ml once (lot UJ901AA, expiry date - 30-Jun-2023) (formulation and strength: unknown) via intramuscular route in the left deltoid for Immunization.  On 22-Sep-2022 the patient under the recommended age range was given fluzone hd with no reported adverse event (product use issue) (latency: same day) following the administration of vaccine.  No lab data was reported  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Pain in left shoulder, hurts to move or lay on. No relief from cold compresses; some relief from Tylenol. Seeing physician next week for evaluation
three blisters at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Oct2021 16:00 (Lot number: 301551BA) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Seasonal Allergies" (unspecified if ongoing), notes: She has always suffered from them; "Asthamatic" (unspecified if ongoing), notes: She is Asthmatic and has not suffered from an attack in many years.  Diagnosed as a child at age 8-9. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, 1st dose given 06Feb2021 EL3247,, Injected in left arm), administration date: 06Feb2021, when the patient was 70 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2, 2nd dose given 01Mar2021, Lot EN6200. Injected in left arm), administration date: 01Mar2021, when the patient was 70 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE VESICLES (non-serious) with onset 13Oct2021 07:00, outcome "not recovered", described as "three blisters at the injection site".  Additional information: it was reported that patient took it yesterday afternoon and she had three blisters at the injection site after removing the bandage. She would like to know if this had been reported. She queried about why does she had them, referring to the blisters. No prior vaccinations (within 4 weeks) and any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). No Family Medical History Relevant to AE(s).  No follow-up attempts are possible. No further information is expected.
Confusion, dyspnea, hurting all over, puffy eyes, "out of it"
Severe tinnitus the next day after the vaccine.  I get tinnitus a lot, but this was bad.  At 3am Saturday morning I got up to use the restroom.  I couldn't walk.  I spun around and fell backwards hurting my shoulder back and buttocks mostly right side.  Then I got up and crawled a few feet and decided to stand up which I could not.  It was like a force pushing me down.  I fell forward hitting my forehead and ridge of my nose on the carpeting and I have rug burns.  I kept reliving my falls and with some research it sounded an awful lot like vertigo.  I had heard that vertigo is a side effect potentially of the vaccine.  After a little research I discovered that tinnitus and vertigo are both side effects.