chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Granuloma annulare; This is a spontaneous report from a contactable consumer.  A 79 year old female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 in Arm Left on 29Jan2021 (Batch/Lot number was not reported) (at the age of 78 year old ) as single dose for covid-19 immunisation.  The patient's concomitant medications were not reported.  Two days later the bnt162b2 injection the patient experienced granuloma annulare. She stated she had in the past, she was not taking nothing at the point. She went to a dermatologist and the dermatologist did a biopsy on the subcutaneous rash that she ended up diagnosed with Granuloma annulare. She did not have a Laboratory Test anymore. She had already had a biopsy and was diagnosed with it. The consumer reported she has right now it is not going away. Nothing is happening, nothing is curing it. It may take 3 years for it to go away. The consumer got the second shot on bnt162b2 in 21Feb2021. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. stated she was dizzy, then began crying uncontrollably and shaking. Pt continued for over 1-1 1/2 hrs and was then transported to hospital.
PVC's, headaches,systemic reaction,inflammatory reaction,Joint pain,fatigue, vertigo, Arm pain,arm tingles,facial spasms RT side,hand spasms,neck pain,tinnitus,ears plugged,shortness of breath,chest pain,sinus pressure, head and neck pressure,muscle pain, hand & feet cramping,  Since the Covid vaccine I have been diagnosed with Fibromyalgia, PVC's 15% of heart rate,migraine/headache disorder,Tinnitus, central sensitization. I have ongoing care on a weekly, monthly basis for an undetermined time frame. Have been told that the Fibromyalgia is a life long chronic illness with NO cure.
Patient verbalized having experienced headache, neck stiffness, heightened sensitivity to touch (generalized, especially legs), eyes hurt, very cold and could not get warm.
chest and shoulder muscles painful when inhaling.  Corrected with continuous CPAP use and 3-4 200mg ibuprofen tabs.
Patient had flu shot an then started to feel ill with aches and pains, leg cramps. Symptoms: Symptoms: 1. Myalgia. 2. pain Treatment Drugs Used: 1 - DIPHENHYDRAMINE Dose: 25 Units: MG Freq: ONCE Route: IV. 2 - METHYLPREDNISOLONE Dose: 125 Units: MG Freq: ONCE Route: IV. 3 - KETOROLAC TROMETHAMINE Dose: 30 Units: MG Freq: ONCE Route: IV
See attachment also.... Initially I had no symptoms at all. After 7 days I experienced large bruises and tiny red pin dots on my arms and sides of my torso along with small bruises around my knees and ankles. This made me concerned so the next day I went to my primary care physician and he did a full blood work panel along with a urine test. The next day I was called from my primary care doctor expressing concern over a extremely low platelet count of 3,000. I was requested to go to the clinic to go get another test just to make sure it wasn't a false positive. It also came back as extremely life threatening low platelete counts. I was admitted to the hospital the 3rd of April at or about 1:00.
miserable for several days; not sleeping well; The patient was injected in the wrong area of her shoulder; Initial information was received on 08-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional .  This case involves an 81 year old female patient who was miserable for several days (depressed mood) and not sleeping well (poor quality sleep) while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history included a bleed above her brain. The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. At the time of the event, the patient had ongoing multiple sclerosis (for 32 years), had a lot of fluid in her shoulder, immune system not good with having multiple health problems.   On 08-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number not reported) once via unknown route in the shoulder NOS for prophylactic vaccination.  On an unknown date, the patient had been miserable for several days (depressed mood) and was not sleeping well (poor quality sleep) (unknown latency, non-serious) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was a case of an actual medication error due to wrong technique in product usage process as the pharmacist gave the patient an injection too high on her shoulder which did not go into the deltoid because the band aid was on the top of her shoulder (latency same day).  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of clinical events was unknown.  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 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.  There will be no information available on lot number.
Mild flu symptoms - I had a little bit of fever but not much; nausea and aching all over. Mainly, everywhere ached. And then the day after that it was maybe at 20% and the next day after that it was gone. (It was about one day and 1/2 day event). Note: January 2021 - I had COVID.  I had a lot of lingering secondary events: Dry mouth at night (couldn't produce saliva at night at all) after that.   Recent health event that is new: History:  A few years ago I fractured my tibia and then got a blood clot in one of my veins and centered in one of the valves in my veins. And from that time on I've had a little swelling in my left leg and a little came in my right leg from time to time (about a third of the time). After getting COVID vaccines, I have noticed now major swelling in my legs. I have major swelling in my legs right now -both of them every day and before it was usually just my left leg with just a couple or few days a week and not every day for the other leg. I take water pills and use compression socks to limit swelling and limit salt. Dr. said they don't have a lot of luck dealing with a little valve that is in the leg. Had a  Dr chat about this health event. My mouth is still dry as can be some nights - but now it's not every night.
Information has been received from a consumer concerning a 15 month old female, with no relevant medical history, who in June 1991, was vaccinated with a dose of MMR (second generation), (no lot number reported). There was no concomitant medication. In June 1991, two days post-vaccination the patient had a seizure. The patient went to the physician's office and unspecified medical attention was sought. Upon internal review, the patient's seizure was considered an other medical event (OMIC). No additional information is expected.
Patient presented with redness, petechia, rash,  and warm.  This was near vaccine site.
Client received flu vaccine and 24 hours later experienced dizziness, blurred vision, and numbness to hand and nose which lasted approximately 5 minutes per report from MD clinic MD per nurse reports no symptoms since that time and there was no notable redness or swelling to the site. MD per nurse states that the client presented to the clinic as she had never experienced those symptoms with previous flu vaccines.
21SEP, 22SEP c/o fatigue 24SEP, 25SEP fatigue, cold, flu sxs & chest congestion; 25SEP rash noted on face; 26SEP maculopapular rash, scalp, face, chest & back & extremities also inj site approx 200-300 lesions;
RAISED AREA, HOT TO TOUCH MEASURING APPROX. 3" BY 2.5"  APPEARS TO RESEMBLE 1/2 A BALL AS REPORTED BY CAREGIVER.
Information has been received from a registered nurse via a company representative concerning a 62 year old female who in Oct 2005, was vaccinated IM in the right deltoid with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 649693/0456P). Concomitant therapy included a dose of influenza virus vaccine (unspecified) administered in the left arm. It was reported that within 15 minutes of being vaccinated, the patients arm began to hurt. She described the pain as feeling like a bee sting. She had a 2-3 inch circle of swelling and redness at the injection site. The spot was warm to the touch. Within 2 hours, the 2-3 inch circle spread all the way from her shoulder to her elbow. She went to the emergency room and they gave her a methylprednisolone (Medrol) dose pack and discharged her. Subsequently, on an unspecified date on Oct 2005, the patient made a full recovery. There was no product quality complaint involved. It was reported that the patients first vaccination with pneumococcal 23v polysaccharide vaccine was five years ago. The reporter considered the patients experiences to be other important medical events (OMIC). Additional information had been requested.
A couple of months after my vaccination, I had terrible flu symptoms. I had shortness of breath, heavy coughing, and felt like I had a cold. I went to my doctor late January when I first had these symptoms, and he prescribed Albuterol inhaler to help with my breathing problems. But my symptoms persisted. I went to my doctor on 03/04/2022 because I wasn't recovering on my own, and from there they transported me to the hospital via ambulance to treat me for pneumonia infection; I stayed from the 4th to the 9th. They drew a lot of blood for blood culture to test me for further infections. They prescribed me Amoxicillin and Prednisone to help me recover; I just finished those medications last night.
10/28/21 we held a Moderna Booster  vaccination clinic with 31 patients who received the full 0.5 dose instead of the 0.25 booster dose, All patients were notified by the nurse on 10/29/ 2021 when the mistake was noticed, all patients were well and not experiencing adverse reactions, if needed for all names we can be reached at clinic.
patient came to the pharmacy to get the first dose of the pfizer covid-19 vaccine. after the shot was administered patient reported feeling dizzy, she sat down and fainted for about 15 seconds, her name was called out and she slowly responded. she looked pale, and was sweating. this happened on febuary 22, 2022 around 4:30pm. her blood pressure was checked and was within normal limits. she has no chronic conditions, no allergies, and no history of adverse events to vaccine
My right thumb is the worst, it's killing me.  My right hand is worse than my left hand.; My right thumb is the worst, it's killing me.  My right hand is worse than my left hand.; The pain is really bad; Due to the pain being really bad, she had to get up last night and put an ice pack but the pain got worse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 12:10 (Lot number: EW0162) at the age of 48 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number - 01, Lot number: ER2613 , Location: Left arm), administration date: 22Mar2021, when the patient was 48 years old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Apr2021, outcome "unknown" and all described as "My right thumb is the worst, it's killing me.  My right hand is worse than my left hand."; PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "The pain is really bad"; CONDITION AGGRAVATED (non-serious) with onset Apr2021, outcome "unknown", described as "Due to the pain being really bad, she had to get up last night and put an ice pack but the pain got worse". Therapeutic measures were taken as a result of pain in extremity, pain in extremity, pain, condition aggravated.  Additional Information: No additional vaccines administered on same date of the Pfizer suspect. No AE(s) require a visit to ER or MD office. If the patient was hospitalized, how many days was the hospital stay was not applicable. No prior vaccinations (within 4 weeks). No relevant tests. Caller state she had to stay at the facility after her Pfizer COVID Vaccines for each dose due to her allergies she was under observation.   No follow-up attempts are possible. No further information is expected.
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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 at 10:00 as dose 1, single (Lot number: 011J20A), in right arm, on 17Feb2021 at 10:00 as dose 2, single (Lot number: 022M20A), in right arm, on 20Sep2021 at 10:00 as dose 3 (booster), single (Lot number: 011D21A), in right arm and on 13Apr2022 at 11:00 as dose 4 (booster), single (Lot number: 005M21) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "retinal vein occlusion" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies Amoxicillin", notes: known allergies Amoxicillin; Codeine, reaction(s): "known allergies Codeine", notes: known allergies Codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  clinical curse: Serious: No, Seriousness criteria-Results in death: No, Seriousness criteria-Life threatening: No Seriousness criteria-Caused/prolonged hospitalization: No, Seriousness criteria-Disabling/Incapacitating: No, Seriousness criteria-Congenital anomaly/birth defect: No. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a Covid-19 Vaccine. Covid rebound after Paxlovid. I tested Negative on a home test on day 10 and after completing 5 days of Paxlovid. Paxlovid was started on day 2. On day 14, I tested positive on a home test, with no symptoms.   No follow-up attempts are possible. No further information is expected
Pain at injection site, pain traveled to shoulder and deltoid, causes a decrease in mobility and tender to touch. Uncontrollably shaking/movement, electrical feeling in bones (legs area), right hand began to tremble randomly.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020). Concomitant products included CRESTOR and MEDROL. On 23rd May 2018, the patient received the 2nd dose of SHINGRIX. On 25th May 2018, 2 days after receiving SHINGRIX, the patient experienced injection site erythema and injection site bruising. On an unknown date, the outcome of the injection site erythema and injection site bruising were unknown. It was unknown if the reporter considered the injection site erythema and injection site bruising to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX in the left arm, slightly below the deltoid. The patient experienced redness and a bruise around the injection site, for which no medical intervention was required.
red area where shot was given with large lump, fever, upset stomach, for four days now. If not better tomorrow will contact physician.
Pt turned white at 11:29. Asked if she was ok and she responded she was feeling light headed and dizzy. Told her to breathe and she fainted and had muscle shakes. She awoke 1 minute later. She was given some water and rested comfortably in the chair for 45 minutes and felt much better.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is aching), PAIN IN EXTREMITY (sore arm), PAIN (Body aches), INJECTION SITE PRURITUS (Arm was often itchy in the area of the shot) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy to antibiotic (augmentin), Blood pressure high (since many years), High cholesterol (since many years), Acid reflux (oesophageal) (since many years), Anxiety depression (since many years) and Breast cancer since 2017. Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), METOPROLOL for Blood pressure high, ANASTROZOLE (ARIMIDEX) for Breast cancer, SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression, SIMVASTATIN (ZOCOR) for High cholesterol. On 10-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm is aching) and HEADACHE (Headache). On 08-Apr-2021 at 6:00 AM, the patient experienced PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever). On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced INJECTION SITE PRURITUS (Arm was often itchy in the area of the shot). On 08-Apr-2021, PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm is aching) and HEADACHE (Headache) outcome was unknown and PAIN IN EXTREMITY (sore arm) and INJECTION SITE PRURITUS (Arm was often itchy in the area of the shot) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up was received include event, concomitant medications, patients demographics updated.
Yeast under armpits; This spontaneous case was reported by a consumer and describes the occurrence of FUNGAL INFECTION (Yeast under armpits) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced FUNGAL INFECTION (Yeast under armpits). At the time of the report, FUNGAL INFECTION (Yeast under armpits) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a covid-19 vaccine trial   No concomitant medication and treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Patient developed mesenteric venous thrombosis involving superior mesenteric vein and inferior mesenteric vein
Headache, NauseaVomiting, Local symptoms: Pain- discomfort. General symptoms: Chills, headaches, joint pains, muscle pains, nausea, back pain , eye pain Narrative:
No adverse reaction patient was given first dose at age 11 and 4 months was to receive gardasil today but MCV4 was given instead at age 12 years 9 months by mistake Contacting parent regarding vaccine and also spoke to medical at Sanofi pasteur Regarding patient receiving 2nd dose one year five months later after first dose
5/1/2015 Pt received vaccines DTaP and MMR and w/in 2-5 minutes, mom noted that pt was turning pale and witnessed pt "slumped over" and fell backwards while sitting on chair in exam room. Pt. was picked up and laid supine on floor. Pt. was noted to be apneic, pale, with perioral cyanosis, with copious oral secretions from mouth, eyes were rolled back. Pt was noted to be tonic with increased tone in extremities x 4. Additional help was summoned for as well as airway/emergency kit was retrieved. As suction was about to be applied to oral cavity pt. regained consciousness with return of color to face. Pt. had carotid/radial pulse present throughout event. Paramedics 911 was called but cancelled when pt. regained consciousness and cried. Vitals taken. Pulse 101 POX 98% RA BP 82/60 Blood glucose 123. Exam unchanged from 30 min prior. No focal findings on neuro exam. Pt. was observed in office for 90 minutes during which time, pt was postictal for about 45-55 minutes. After which pt regained normal disposition, laughing, smiling and telling jokes. Pt c/o of abd pain and was subsequently given Rx for azithromycin x 5 d as brother has strep (+). Gave mom referral for neurology outpt ASAP. Will telephone f/u with mom in next few days. Pt to return or mom to call for any concerns, observing for any neuro changes or vomiting or any abnormality.
Pain, swelling left knee found to be a blood clot when he went to the Emergency Room at hospital. Visit was on 3/31/2021 Treatment with rivaroxaban and bed rest.  Pain and muscle spasms persist as of 4/15/2021
4 inches wide by 2.5 inches long rash on the injection site; warm  to touch; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (4 inches wide by 2.5 inches long rash on the injection site), INJECTION SITE WARMTH (warm  to touch) and INJECTION SITE PRURITUS (Itchy) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced INJECTION SITE RASH (4 inches wide by 2.5 inches long rash on the injection site), INJECTION SITE WARMTH (warm  to touch) and INJECTION SITE PRURITUS (Itchy). At the time of the report, INJECTION SITE RASH (4 inches wide by 2.5 inches long rash on the injection site), INJECTION SITE WARMTH (warm  to touch) and INJECTION SITE PRURITUS (Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment or concomitant medications were reported.
Pt reports pain in left upper arm which started after she got the shot. Also has decreased ROM in the left shoulder. Pain has not gone away as of today 12/10/18. Have ordered physical therapy. Not a candidate for NSAIDS.