chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gave moderna vaccine at 3:23pm in right deltoid. During observation period, patient was experiencing tingling in both of his hands. Due to past history of allergic reactions, gave him diphenhydramine at 3:42pm. He felt okay for a short period of time and then started to have tightness in his chest.  He could still breathe fine, but called 911 due to past anaphylactic reactions.  While on the phone with 911 he stated feeling more tightness in his  and then decided to give epi-pen shot in left upper left thigh at 4:02pm.  The EMT showed up immediately after and took patients vitals.  EMT advised if wanted follow up monitoring could take him to ER. Patient wanted to go to ER for further monitoring.  We followed up with patient's wife and she said he was still not feeling very good and had follow up appointments with his cardiologist.  He also came in the store on 2-26-21 and all his test were normal, but still was not feeling like himself.
Bruise on back of the right leg about size of a base ball; Bruise purple in color; Sudden chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruise on back of the right leg about size of a base ball), SKIN DISCOLOURATION (Bruise purple in color), CHILLS (Sudden chills) and NAUSEA (Nausea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 05-Nov-2020. Concurrent medical conditions included Blood pressure high and Anxiety.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced CHILLS (Sudden chills) and NAUSEA (Nausea). On an unknown date, the patient experienced CONTUSION (Bruise on back of the right leg about size of a base ball) and SKIN DISCOLOURATION (Bruise purple in color). At the time of the report, CONTUSION (Bruise on back of the right leg about size of a base ball), SKIN DISCOLOURATION (Bruise purple in color), CHILLS (Sudden chills) and NAUSEA (Nausea) 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.   Concomitant products included high blood pressure pill and anxiety pill for an unknown indication.  Patient experienced sudden chills and nausea but the next day she felt fine. The patient described, the Sunday night was worse and miserable. Probably a week later the patient's granddaughter noticed she had bruise on back of the right leg about size of a baseball and another bruise in right below her left knee about a size of a quarter coin and it was purple in color. On 05-Nov-2020 patient tested positive for COVID-19. Patient informed that she was doing well, and evets were resolved. She received her second dose and did not experience any events.  No treatment medication was reported.    This case was linked to MOD21-075148 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information received on 18-May-2021, outcome of the events was updated to resolved. Rechallenge was updated to negative.; Sender's Comments:  MOD21-075148:
Herpes-Like Rash on the injection arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE RASH (Herpes-Like Rash on the injection arm) in a 99-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Previously administered products included for an unreported indication: SHINGRIX.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 15-Jan-2021, the patient experienced VACCINATION SITE RASH (Herpes-Like Rash on the injection arm). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Adverse event, at an unspecified dose and frequency.   At the time of the report, VACCINATION SITE RASH (Herpes-Like Rash on the injection arm) 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.   Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Reporter information updated.
Tested PCR positive for COVID on 5/5/2021, Symptom onset 5/2/2021.
Pain at injection site; Inflammation; Redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 95XF7, expiry date 29th October 2021) for prophylaxis.   On 21st August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site pain, injection site inflammation and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site inflammation and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site inflammation and injection site erythema to be related to Shingrix.  Additional details were received as follows: The reporter stated that the patient experienced pain at injection site, inflammation and redness. The reporter called in to inquiry about any additional information on the reaction to Shingrix 2nd dose. The reporter did not consent to follow up.
Headaches from the booster shot; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches from the booster shot) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headaches from the booster shot). At the time of the report, HEADACHE (Headaches from the booster shot) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
felt weak; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak), NAUSEA (nausea) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D2M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included THYROID.    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced ASTHENIA (felt weak), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, ASTHENIA (felt weak), NAUSEA (nausea) and HEADACHE (headache) had not resolved.            No Treatment information  provided
This case meets criteria for vaccine breakthrough review. SxS include dizziness, neck pain, cough, change in appetite.
Information has been received from a physician's wife concerning her daughter, an 15 year old female who was on unspecified dates vaccinated with two 0.5ml doses of GARDASIL (lot number not reported). Subsequently the patient experienced blue color around mouth, dizziness, headache and bleeding problems. The patient had sought unspecified medical attention. At time of reporting, the patient was not recovered. The patient's blue color around mouth, dizziness, headache and bleeding problems were considered to be immediately life-threatening. The patient's sister also experienced blue color around mouth, dizziness, headache and bleeding problems after vaccination with GARDASIL (MSD WAES 0905USA00188). Additional information has been requested.
12/17 Discovered during a routine CT scan and the doctor found lump on chest and diagnosed as cancer. After this the full force of the medical facility was put on this issue. All test were done. At the end of hospitalization I was given discharge with Metoprolol and every three weeks I get tests done and chemo treatment.
A few minutes after receiving the first dose of moderna vaccine on my right arm, my arm felt numb and tingly.  My heart rate increased and I felt like I was having a panic attack and difficulty breathing even though I was very calm before and during the injection.  I felt lightheaded and had to elevate my legs while I waited in the observation area for 15 minutes. I never experienced this before with any vaccine or injection. That night and the next day, I had extreme fatigue and muscle weakness that I was not able to go to work for one day. On the second day, I felt joint pain in both knees.  By the fourth day, I felt better.
Exactly a week after receiving the first dose of the Moderna vaccine I had hives on the injection site and my throat swelled and was itchy and my tongue also swelled and was itchy to the point that it scalloped and I had trouble with breathing and being light headed for a few days. I was worried about getting the second shot, but the pharmacist just brushed off my symptoms and concerns and injected the opposite arm. I immediately had a huge hive on the injection site and the itchy throat and tongue came back worse. It has been over a month and the itchy throat and tongue have not subsided. No allergy meds are helping.
Diarrhea after vaccine, 3rd-7th day up to 16 x per day, bloody on 4th day streaks/mucousy, remained hydrated.
At 6:45AM on 1/19/21 patient developed numbness and tingling on right side of body which progressed to right hemiparesis and right-sided facial droop.  Brought to ED by EMS and worked up for stroke. Found to have acute infarct on MRI and treated with dual antiplatelet therapy.
Chills, intermittent headache, muscle aches, pain at injection site (resolved by 2/14); rash developed on 2/13 around 8pm on chest.  On 2/14 rash was over entire body--most prominent on chest, stomach, back and neck.
Mom lost hearing in both ears after receiving the flu short.  Her right ear has gradually regained hearing, but the hearing loss comes and goes.  Her left ear has shown some improvement, but limited.  Even though when she can, she isn't always able to comprehend what is being said.  She normally doesn't have a problem with hearing loss or understanding conversation.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-APR-2017, the patient was inadvertently vaccinated with a dose of PROQUAD lot # M007963 with an expiration date 15-AUG-2017 for prophylaxis instead of VARIVAX (dose, route of administration, lot# and expiration date was not reported). On the same day, the patient was vaccinated also with M-M-R II lot# M016234 with an expiration date 31-MAR-2018 (dose, route of administration was not reported). According to the reporter there was no product confusion. No adverse vent was reported. Additional information has been requested.
Severe pain and tightness in injection site first and second day of being vaccinated, nausea on the first day, headache on the second day of being vaccinated
pt recv vax & was believed to have been exposed to rubella p/vax;pt exp rash, joint pain, a runny nose, runny eyes & other minor sx indicative rubeola;lab eval came back negative for rubeola in IgG & IgM but positive to rubella;
14OCT91 pt called c/o nausea, instructed phenergan suppository; 305PM pt called stated vomited p/taking phenergan suppository; instructed go to ER for eval of vomiting & c/o leg cramps;
Had twitching in muscle in leg; a A involuntary muscle spasm in both legs.; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Had twitching in muscle in leg) and MUSCLE SPASMS (a A involuntary muscle spasm in both legs.) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included ALLERGY MEDICATION for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced MUSCLE TWITCHING (Had twitching in muscle in leg) and MUSCLE SPASMS (a A involuntary muscle spasm in both legs.). At the time of the report, MUSCLE TWITCHING (Had twitching in muscle in leg) and MUSCLE SPASMS (a A involuntary muscle spasm in both legs.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received first Moderna vaccine on 3-31-2021 first. Patient stated shortly after he had twitching in muscle in leg. Patient stated it got progressively more noticed. Patient stated its like a involuntary muscle spasm in both legs. Patient stated it is now progressively near both ankle and feet. Patient stated he can notice the most in his calf. Patient expressed he has always been in good health. Patient wants to know has anyone reported his side effects. Consent to Safety
On Monday at around 2pm I started having severe pain in my chest near my right breast, and as the day progressed it got worse with a horrible migraine. It began to radiate to the left, and Wednesday I went to Urgent Care because I was scared. My EKG & chest x-ray were clear. Today I feel even worse with migraines, chest pain (that radiates up my neck and around my back), and overall feeling gross and exhausted. My head is what?s bothering me the most along with my joint pain.
The pt experienced 10 varicella like lesions on upper thighs, arm abdomen, one had fluid in it, lasting about one week. The 2nd round started approximately one month later with 6 lesions on the arm which had fluid.
Patient received her second Moderna vaccination, after having a localized reaction (likely COVID arm) with the first vaccination. The same day she received her second vaccination she developed a rash all around the injection site and extending down to her elbow. Itchy
I experienced fatigue and my (lead) legs and thighs felt were very heavy and painful. I also experienced SOB since the vaccine that I still have now. I had complained SOB for years, but this is different. I do not know whether my symptoms are caused by the vaccine. They have done ultrasound blood clots in my legs and exam was negative. I has also an MRI of the lumbar spine due to spinal injections in the middle of August 2021. I also have history of scoliosis.
The hair on my scalp and am beginning to lose body hair on my arms, legs, and pubic region.; I have been diagnosed with Alopecia Areata; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 (Lot number: 330308D) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing); "Behavioral health" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL; CITALOPRAM. Past drug history included: Augmentin, reaction(s): "Known allergies: Augmentin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: FW0170), administration date: 22Apr2021, when the patient was 28 years old, for COVID-19 immunization, reaction(s): "In Sep2021 I noticed a small quarter-sized bald patch on the back of my head."; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733), administration date: 01Apr2021, when the patient was 28 years old, for COVID-19 immunization.  The following information was reported: ALOPECIA AREATA (non-serious) with onset 2021, outcome "not recovered", described as "I have been diagnosed with Alopecia Areata"; ALOPECIA (non-serious) with onset Dec2021, outcome "not recovered", described as "The hair on my scalp and am beginning to lose body hair on my arms, legs, and pubic region.". The events "i have been diagnosed with alopecia areata" and "the hair on my scalp and am beginning to lose body hair on my arms, legs, and pubic region." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of alopecia areata, alopecia.  Additional information: In Sep2021 patient noticed a small quarter-sized bald patch on the back of her head. By Dec2021 she had lost approximately 75 percent of her hair and as of Mar2022 she has lost 90 percent of the hair on her scalp and am beginning to lose body hair on my arms, legs, and pubic region. She has been diagnosed with Alopecia Areata, an autoimmune reaction that attacks hair follicles. The patient received treatment for the adverse event with Corticosteroid injections and topical treatments. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No hospitalization Prolonged. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Rash (look like large insect bites - larger red bump and very itchy)upper left arm near injection site, further down and around arm, up halfway to neck, on left chest area, couple on side abdomen.  All on left side of body.  No rash on right side.
within 1 day, she was totally free of back pain, free of knee pain, free of muscle pain that she has had for 50 years; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (within 1 day, she was totally free of back pain, free of knee pain, free of muscle pain that she has had for 50 years) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A217 and DD1A2V) for COVID-19 vaccination.     Concurrent medical conditions included Back pain (had for 50 years), Knee pain (had for 50 years) and Muscle pain (had for 50 years).   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (within 1 day, she was totally free of back pain, free of knee pain, free of muscle pain that she has had for 50 years). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (within 1 day, she was totally free of back pain, free of knee pain, free of muscle pain that she has had for 50 years) outcome was unknown.            Concomitant medication product was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-373482 (Patient Link).
Still have the red discoloration at the site of injection; This case was reported by a consumer and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group at vaccination was not reported but was captured as an adult as per vaccine indication. The patient received Shingrix and experienced red discoloration at the site of injection. Till the time of reporting symptom was not resolved. The patient was asked to take the 2nd shot on same injection site or not.
ADMINISTERED EXPIRED PRODUCT; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: 11-MAR-2022) dose was not reported, administered on 24-MAR-2022 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2022, the patient experienced administered expired product. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired product was not reported. This report was non-serious.
rash, intense h/a, T100-101 occurred 10 days p/vax given;
EVENING OF 2/24 VACCINATED ARM (LEFT) DEVELOPED SWELLING FROM SHOULDER TO THE WRIST, 2/25 EXPERIENCED MUSCLE AND JOINTS ACHES ALL OVER AND LOW GRADE FEVER.
She had pain in the injection site and her shoulder and developed pneumonia after about a week. She felt perfectly fine before the vax. She got progressively worse. She had terrible pain in her right shoulder the evening of 8/28/201. She went to sleep. I went in to check on her about 1am 8/29/2021. She had stopped breathing. Ems couldn't revive her. She was pronounced dead early morning hours of 8/29/2021.
I had a high grade fever 103.1, chills, body aches. I took Tylenol and slept. The effects lasted for about 24 hours.
the patient was only given the ActHIB portion of the vaccine, it was not reconstituted with the DTap/IPV portion when administered vaccine Pentacel; Initial information received on 14-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA229462 (same reporter).  This case involves a patient (demographics unknown) was only given the Acthib portion of the vaccine, it was not reconstituted with the dtap/ipv portion when administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5) /HIB(PRP/T) VACCINE [PENTACEL] lot number not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to Inappropriate reconstitution technique.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Information on the batch number was requested.  List of document held by sender: none.
Difficulty breathing with cyanosis. Non-responsive, decreased muscle tone. transfer by ambulance to ER as a life threatening event. 8/2/07-records received-seen in ER for periods of apnea and choking, began coughing, alteration in consciousness and some decreased muscle tone.  Temp in ER 99, oxygen saturation 100% on room air. Admitted for observation.  Possibility of a seizure or adverse event to vaccination. No further events noted in hospital