chrisvoncsefalvay/vaers-outcomes huggingface dataset:
little swollen; horrible rash underneath the arm; light head ache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (little swollen), RASH (horrible rash underneath the arm) and HEADACHE (light head ache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     Concomitant products included BUPROPION for an unknown indication.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced PERIPHERAL SWELLING (little swollen), RASH (horrible rash underneath the arm) and HEADACHE (light head ache). At the time of the report, PERIPHERAL SWELLING (little swollen), RASH (horrible rash underneath the arm) and HEADACHE (light head ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medication includes Ftmmtnessenct Mecapause  of unknown indication. Treatment information was not provided.      This case was linked to MOD-2021-281410.
has always has strong side effects, like 2 or 3 days; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (has always has strong side effects, like 2 or 3 days) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (has always has strong side effects, like 2 or 3 days). At the time of the report, IMMUNISATION REACTION (has always has strong side effects, like 2 or 3 days) outcome was unknown.            No relevant concomitant medications were reported.  The patient got all the Moderna shots and had always had strong side effects, like 2 or 3 days. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743238 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743238:
i got really weak at first with brain fog. Then at night I could not sleep due to shakes, fever, chills, stomache ache, this lasted for two days. I went to the hospital and checked out fine they reported.  I have had brain fog and bouts of tiredness / fatigue and extreme nusea. resulting in vomiting and diarrhea.
Very mild tiredness; Felt like he had tiny bit of flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like he had tiny bit of flu-like symptoms) and FATIGUE (Very mild tiredness) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included Premature ventricular contractions (Caffeine related.).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like he had tiny bit of flu-like symptoms) and FATIGUE (Very mild tiredness). On 23-Jan-2021, INFLUENZA LIKE ILLNESS (Felt like he had tiny bit of flu-like symptoms) and FATIGUE (Very mild tiredness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The  concomitant medications on use were not provided. No treatment information was provided.   This case was linked to MOD-2021-370446 (Patient Link).
Patient is stating since she has had the vaccine she has had high blood pressure, feeling hot, and the chills.
Patient's wife called the pharmacy around 2pm and complained that her husband has been "feeling sick" for the past 2 hours.  He has been vomiting, "has the shakes", and is running a high fever of 104 degrees F.  I told her to take him to the ER immediately.
Sharp pain between should blades, pain eased slightly with trunk extension (laying on a foam roller on floor). The following day the pain in back disappeared, but had bilateral kidney pain that lasted 2 days.
received an extra dose of Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number C472T, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Kinrix (1st original dose received in March 2022).   In August 2022, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. In August 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comments: The medical assistant reported that the patient received an extra dose of Kinrix. The reporter consent to follow up via email. Additional supportive information: The patient received 2nd dose, which led to extra dose administered.
2/9/21 @1500 started with shivers, chills, @ 7:30 eye twitching and complete body aches and server joint pains. ( fingers, wrist hips and ankles) 2/10 blisters found on tongue  in the AM, server muscle pain and joint pain still present . Very exhausted.
First experienced dizziness/vertigo when I first woke up.  Had that for 2 days. Then the cough & sniffles started with body aches about the 3rd day.  Did a home COVID test and it was positive.  Cough and fever got worse so I went to an care clinic and I tested positive on their antigen covid test. They prescribed me a cough medicine during the day versus a liquid cough medicine at bedtime and a medicine for my dizziness.  Had slight fever, no sore throat, and fatigue that lasted 3-1/2 weeks.  Finally tested negative 12 days later from when I first contracted it.  Post Covid, I'm still experiencing some coughing and a hoarse voice 4 weeks after contracting Covid.
I was diagnosed with a Deep Vein Thrombosis. I recognized it and went to the ER. They called in an ultrasound and confirmed it. They prescribed Eliquis. I started it that day. In a follow-up with my PCP, I pointed out that the swelling had not gone down, so he set me up for another ultrasound. I could barely walk for the first week. Three months later, I'm walking fine, but the second ultrasound showed little to no improvement. Currently, the swelling has gone down considerably, and I'm on blood thinners.
rash on torso; fatigue; headache; muscle pain; Joint pain; nausea; fever; A spontaneous report  was received from a consumer concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fatigue, headache, muscle pain, joint pain, nausea, fever, rash on torso. Patient's has no historical conditions. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 12 Mar 2021, 1 day prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 048A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 13 Mar 2021, the patient experienced the events fatigue, headache, muscle pain, joint pain, nausea, fever. On 14 Mar 2021, the patient experienced the events rash on torso.  Treatment details included as patient has taken ibuprofen for necessary events.  Action taken with mRNA-1273 in response to the events was not applicable. On 14 Mar 2021 the outcome of events such as fatigue, headache, muscle pain, joint pain, nausea, fever was resolved.  On an unknown date the outcome of events rash on torso was unknown.
Pain at injection site - 6 weeks after injection -  Other two office workers who received same vaccination 1 day after mine also experienced the same issue
Sore throat; Bumps in mouth; Bumps in throat; Large hives on entire body; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in the left arm on 13Apr2021 at 14:00 (at the age of 29-years-old) as single dose for COVID-19 immunisation. The medical history of the patient included hashimotos disease and COVID-19. The patient did not have any allergies to medications, food, or other products. Concomitant medication included levothyroxine (MANUFACTURER UNKNOWN), clavulanate potassium and amoxicillin trihydrate (AMOXICLAV), cefalexin (MANUFACTURER UNKNOWN) and colecalciferol (VITAMIN D3); all for an unspecified indication and unknown start date. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 14Apr2021 at 17:00, the patient developed large hives on entire body, sore throat, bumps in mouth and throat. Therapeutic measures were taken as a result of the events and included treatment with steroid cream(unspecified). The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events of large hives on entire body, sore throat, bumps in mouth and bumps in throat were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Recurrence of "hot flashes" noticed about 2 weeks after injection.  "Hot flashes" had subsided after breast cancer treatment with Arimidex; treatment ended in 2018.
received the VARIVAX vaccine while she was one month pregnant; No additional AE information reported; This spontaneous prospective pregnancy report was received from the consumer's mother, a female patient patient of unknown age. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided      On an unknown date, when the patient was one month pregnant, was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (dose, route of administration, lot number and expiration date were not reported) for prophylaxis (exposure during pregnancy). No adverse events were reported      The patient became pregnant on an unknown date. The LMP and EDD were not reported. The pregnancy outcome was unknown.
Despite all the vaccine and boosters, we did finally catch it; Despite all the vaccine and boosters, we did finally catch it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Parkinsons" (unspecified if ongoing), notes: perhaps 12 years now. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Despite all the vaccine and boosters, we did finally catch it". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed lot 031L20A and advised vaccine maintained activity necessary to protect against covid 19 on date vaccine was administered. Also patient did not call in to complain of adverse event.  This is administrative error without adverse event.
pain to touch; (Injection site )Itching; Knot; Swollen at the injection; Redness about 2 inches; Hot to touch at injection site; Sore arm; Achy arm; Tired; A spontaneous report was received from a consumer concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, swollen at the injection, (injection site )itching, redness about 2 inches, hot to touch at injection site, knot, painful to touch, achy arm, tired.  The patient's medical history was not provided.  concomitant medications included unspecified medications.  On 4 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the event(s) sore arm . On 12 Feb 2021, the patient experienced the event(s) swollen at the injection. (injection site )itching, redness about 2 inches, hot to touch at injection site, knot, painful to touch, achy arm, tired.  Treatment details included Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm, swollen at the injection,(injection site )itching,redness about 2 inches,hot to touch at injection site,knot,painful to touch,achy arm,tired was Recovering/Resolving.
Hives on (L) arm, upper and mid back, itchy. Given BENADRYL 50 mg by school nurse. VSS at school and in office.
1 hr after shot, felt numbness in right forearm.  Had redness around bandaid.  Numbness was from elbow down to fingertips then only from midarm to fingertips.
got a half dose instead of a full dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (got a half dose instead of a full dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cardiovascular disease, unspecified and Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (got a half dose instead of a full dose). At the time of the report, ACCIDENTAL UNDERDOSE (got a half dose instead of a full dose) outcome was unknown.            No concomitant medication was reported.  Patient's doctor gave him a note stating that he needs a full third dose. When he went to get the vaccination he saw the card said "Moderna COVID-19 booster 0.25mL".  Consent for Safety to follow up was not obtained.  No treatment information was reported.
Swelling of the right upper arm after DTAP was given 24 hours ago. It is itchy and red.
Patient's age was misrepresented on consent form.  Consent form was filled out by patient with an incorrect DOB, causing her age to appear as 12 years old.  No adverse ieffect reported.
Pt's wife called with husband complaining about soreness in arm yesterday 10/20/16 after shot, then today pt had severe stiffness in arm and neck, could hardly move.
Within 12 hours experienced fever, chills general feeling of illness.  Felt exhaustion the next day and slept most of the next 24 hours. The site of injection became red, (a circle approx. 3 inches round.)  A large, hard lump appeared and took almost a week to dissipate.  The injection area was also very itchy.
Had 3rd HEP B injected on 9/25/2009 at approximately 6pm at 9:30 pm complaint of migraine, tiredness, nausea and soreness in neck and behind ears. On 09/26/2009 reported temperature of 101.1 shortness of breathe along with symptoms listed above. 9/27/2009 temperature 99.2 and above symptoms same except with decrease nausea being totally resolved. 9/28/2009 temperature 98.8 with all symptoms decreased greatly. 9/30/2009 reported of feeling completely well no complaint of any kind. (Reported history of migraines with medication prescribed.
Narrative:  Dose #1 The patient received Moderna COVID-19 Vaccine 0.5 ml IM. MVX (Manuf); Lot#; Exp Date: MOD; 012A21A; 08/17/2021 Administration Anatomic site: Right Deltoid
My throat hurt, couldn't shallow, hot and cold chills, fever, and coughing. My body was sore. Couldn't even get out of bed. Also my back and bones were hurting as well.
Systemic: Tachycardia-Severe, Additional Details: Patient has history & family history of palpitations that are sporadic & last few seconds. 4 days after 2nd shot, patient had worsened   & severe palpitations that lasted for days & throughout the entire day which is abnormal for him; it stops for few minutes & then returns. Cardiologist workup showed nothing abnormal & MD isn't sure if vaccine exacerbated tachycardia or if it was multi-factorial.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 5 (booster), single (Lot number: GL0446) at the age of 75 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Mar2021 as dose 2, single (Lot number: ER2613), in left arm, on 09Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 21Jul2022 as dose 4 (booster), single (Lot number: FP7139), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Demarol, reaction(s): "known allergies: DEMAROL". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Aug2023) Positive. Paxlovid was taken as therapeutic measures as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300290286 same patient, different drug/event;
1/28/11: 1800 had whole body shaking with chills..very painful arm with heat & swelling. 2400 was febrile 1/29/11: 0400 awoke with bedding and gown wet with no fever. 0700 was weak..incurred 3 falls with no injury (am a distance runner and this was atypical). 2200 arm less sore shows well demarcated erythmic circle about 6.35cm in diam 1/30/11: 2200 arm only mildly sore, less heat & erythemic area reduced to 5cm diam & no longer well demarcated 1/31/11:  Arm to mildly sore, erythemic, still have obscure circle @5cm diam.  Have a call into precsriber's nurse to assess of sensitivity.  Never had problems with breathing.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Patient reported rash that covers her stomach and back. She also stated that she received the same rash after her first 2 doses as well.
My blood pressure has ALWAYS been 95/65 and is now 135/85.  I have not changed my lifestyle.  I used to get a cold every 10 years and now I've had two and tested positive for COVID twice. I've had 2 vaccines and one booster.  I do believe these vaccines will kill us all.
Immunization at 12:45 PM on 10/29/09. 10/29/09 woke up at 11:00 PM. Heart rate was 128 and felt heart "pounding" and dizzy. Went back to sleep, about 2 hours later dizziness continued until 21:00 on 10/30/09.
Had fever over 103F within 24 hours, post vax. Seen in ER and MD told mom the association of fever to immunizations was coincidental. Child had URI and conjunctivitis.
I had a very severe sore throat, achy headache, stuffy nose, and body aches and chills. For one day, I got sick on Sunday so I made an appointment for the next day to see if it was strep throat since my at-home COVID-19 test came back negative. However, the next day, I couldn't smell or taste anything so I took another test which came back positive. My physician initially prescribed me a steroid for the initial strep throat, but after determining it was COVID-19, she prescribed me PAXLOVID to aid my symptoms. Currently, I'm doing so much better and finally recovered.
NO ADVERSE EVENT REPORTED, PATIENT WAS ADMINISTERED THE VACCINE WHICH HAD EXPIRED BY 2 DAYS
COVID-19; feeling really tired; Having little trouble breathing; brain fog; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (brain fog), FATIGUE (feeling really tired), DYSPNOEA (Having little trouble breathing) and COVID-19 (COVID-19) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product MACITENTAN for Pulmonary hypertension.    Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included SILDENAFIL for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and MACITENTAN (Oral) 10 milligram. On 04-Nov-2020, the patient experienced FEELING ABNORMAL (brain fog) (seriousness criterion hospitalization prolonged) and COVID-19 (COVID-19) (seriousness criterion hospitalization). On an unknown date, the patient experienced FATIGUE (feeling really tired) (seriousness criterion hospitalization prolonged) and DYSPNOEA (Having little trouble breathing) (seriousness criterion hospitalization prolonged). The patient was hospitalized for 5 days until 05-Nov-2020 due to FEELING ABNORMAL, then until 05-Nov-2020 due to DYSPNOEA and FATIGUE. At the time of the report, FEELING ABNORMAL (brain fog), FATIGUE (feeling really tired), DYSPNOEA (Having little trouble breathing) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2020, SARS-CoV-2 test: positive (Positive) Positive.     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.   No treatment information was provided.  The patient got first dose of vaccine on March 2021 and second dose on April 2021.  Company comment: Very limited information regarding the events have been provided at this time. Medication Macitentan can be a confounding factor. Based on the mechanism of action of mRNA 1273 and the timing of the event Covid 19 which happened prior to the vaccine schedule, the event is unlikely related to the vaccine. No further information is expected at this time.   This case was linked to MOD-2021-163029 (Patient Link).; Sender's Comments: Very limited information regarding the events have been provided at this time. Medication Macitentan can be a confounding factor. Based on the mechanism of action of mRNA 1273 and the timing of the event Covid 19 which happened prior to the vaccine schedule, the event is unlikely related to the vaccine. No further information is expected at this time.