chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and MYALGIA (Sore arm) in a 57-year-old male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and MYALGIA (Sore arm). At the time of the report, CHILLS (Chills) and MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-103015 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-103015:Case for wife
RED SWELLING SPOT, SPOT TEMP 102.6, GREW OVER INCH IN 1 DAY ENDED UP BEING DX WITH CELLUTIS PRESCRIBED ANTIBIOTIC FOR 10 DAYS.WAS AT THE ER 2 DAYS IN A ROW FOR THIS.
Pfizer-BioNTech COVID-19 Vaccine  I got the vaccine on Friday, and on Saturday night I developed phantosmia. Until now, basically 55h hours after the first shot, I feel cigarette smell very frequently. Sometimes is weak, sometimes is strong, but there are rare moments that I don't feel it at all - usually noticed when I start to feel it again. In the beginning, I thought that it could be caused by a roommate, but when I talked with them no one was smoking or feeling the smoke smell. When I came to lab, a clean space, I felt it again and noticed that it was really abnormal and that I should report. Additional info: I had a positive test for COVID-19 on January 16th and recovered really well after having only a mild fever for one day and a sore throat for 4 days. I am sure I also had COVID-19 in January of 2020 after a trip, when I had very bad symptoms including heavy lungs, pain in the lungs, yellow mucus, coughing, sore throat, headaches, and fever - and also a negative test for Flu at my health center.  At that time, mainly because of the negative test, doctors described it as a strong cold. It lasted for two weeks. We didn't think it could be COVID at that time, though. I realized that later when we learned more about the symptoms.
Onset of diarrhea within <24hr after vaccine administration. Diarrhea has not improved with up to 30 episodes within 24hr period. Significant GI distress. Abdominal ultrasound has been ordered with STAT referral placed to GI.
GI symptoms; Diarrhea; weight loss; first vaccine in June 2021, has not gotten second; This case was reported by a consumer via call center representative and described the occurrence of gastrointestinal disorder in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 36 hrs after receiving Shingrix, the patient experienced gastrointestinal disorder, diarrhea, weight loss and incomplete course of vaccination. In February 2022, the outcome of the gastrointestinal disorder, diarrhea and weight loss were recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the gastrointestinal disorder, diarrhea and weight loss to be related to Shingrix.     Additional Information: GSK receipt date: 3-Aug-2022 Reporter's comment: The patient stated that she got 1st dose of Shingrix in left arm and 36 hours after getting the vaccine, she started with GI symptoms that included Diarrhea and weight loss.   These symptoms lasted until February 2022.   The patient has not gotten her second vaccine yet (inappropriate dosing schedule).   The patient did not had any further information about the vaccine itself. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Very high fever, 103-104,  chills, aches, headaches for 2/13 &2/14. Able to control the fever too 101-102 With over the counter medications.
Facial numbness that lasted for 2 hours. Flushing in the face that lasted for a few days. Fingertip redness and sensitivity that has continued since the vaccination.
No adverse event; Medication error, 0.25ml dose administered instead of 0.5mL; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 04-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL).    No concomitant medication information was provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2022: Live Significant follow up received: Patient demographics updated, Reporter phone no added, date of vaccine received and case narrative updated.
The client was driving home after injection with Moderna COVID19 vaccine Lot 009C21A, LA via IM, stated that her neck felt like it was on fire, and started to have difficulty breathing. Pt drove back to the clinic and wanted EMS assessment. Pt states nut allergy.
Prev dose brand=Janssen; Swelling and rash on injection arm; Swelling and rash on injection arm; Other vaccine same date product=Influenza; Other vaccine same date product=Influenza; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 at 11:15 as dose 3 (booster), single (Lot number: GH9693) at the age of 63 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 15Oct2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen". Vaccination history included: BNT162b2 (dose 2 (booster), administered in the right arm at 09:30, Lot number: Fm0173), administration date: 28May2022, when the patient was 62-year-old, for COVID-19 Immunization; janssen (dose 1, administered in the right arm at 14:00, Lot number: 207A21A), administration date: 26May2021, when the patient was 62-year-old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 15Oct2022, outcome "unknown" and all described as "Other vaccine same date product=Influenza"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE RASH (non-serious) all with onset 15Oct2022 at 19:00, outcome "not recovered" and all described as "Swelling and rash on injection arm"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Prev dose brand=Janssen". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site rash.  Additional information: Other medications in two weeks included "BP medications".
Immediately after vaccination pt reports pain in throat (no swelling), pain in throat when coughing, pt threw up, and had shakes and felt very cold did not take temperature. Pt reported to me 10/4/13.
ERYTHEMA, ITCHING, WARMTH, SWELLING, PAIN AT INJECTION SITE 80MM
Case number PHEH2015US003035 is a combined initial and follow up spontaneous report received from a physician on 09 Feb 2015 and from a consumer on 11 Feb 2015. This report refers to a 51-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 14621P) intramuscularly on 22 Oct 2014. It was reported that the vaccine was administered incorrectly to the patient and she experienced bursitis on the same date. On 05 Nov 2014, 2 weeks after vaccination she experienced an ongoing pain in arm at shoulder joint. MRI of her arm showed severe tendonitis. The final outcome of the events was unknown. The seriousness and causality of the events were not reported. Seriousness assessment of the events (tendonitis, arthralgia and bursitis) was upgraded based on the available information in the source document.
fevers for three hours every night ranging from 101-103; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fevers for three hours every night ranging from 101-103) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 042B212A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fevers for three hours every night ranging from 101-103). At the time of the report, PYREXIA (fevers for three hours every night ranging from 101-103) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment Information was reported. No concomitant product information was reported.   This case was linked to MOD-2021-109873 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: No specific follow-up information recorded. On 06-May-2021: No specific follow-up information recorded. On 02-Jun-2021: Non significant follow up address updated and follow up document attached.
Temp of 101.9 (normal for me is 97.6), crushing headache, severe body aches making it extremely difficult to even get to bathroom, exhaustion but inability to sleep secondary to pain, very painful left arm making it difficult to move arm, loss of appetite, extreme malaise.  Symptoms lasted about 48 hours and have been abating - as of 3/30/21 remaining symptom is exhaustion and intermittent mild headache and general malaise.
Very sore swollen, red, slightly warm to touch, stiff neck, chills off and on. This is at a flu shot site. On Prednisone, TYLENOL, ice.
This was not an adverse event, but a medication error. The pharmacist never drew up the vaccine, resulting in ?administering? nothing upon injection. Not reported by pharmacy due to denial of the event.  Resulted in patient having records that indicate he was given his booster, however he was not.
Dizziness, whole body muscle aches (extreme like a bad flu), and nausea.  Dizziness noticed early a.m. when first woke up the day after the vaccine., but had difficulty sleeping due to muscle aches.  Dizziness /vertigo was bad enough to require me to lay down for the rest of the day Saturday. Needed some help walking early on, but that gradually improved  to where I could walk /stand up as long as I had something to hold onto (wall or counter, etc).  I was only able to eat toast and ramen .  Couldn't read or watch tv, too dizzy.  By the next morning (12/6/2020), muscle aches and nausea was gone but I still suffered dizziness if I moved too fast or bent over or turned my head. I could function, but was tired and "not quite right."  Still experienced very slight dizziness by Monday 12/7, continuing throughout that day, but manageable.   Today  12/8, I'm not quite feeling 100% but hopefully soon. Luckily I never need another dose of Shingrix!
sore arm began 2 hours after injection, chills began 9 hours after injection -  woke with body aches, fever, headache - Covid Arm began following day - hot, painful and swollen - no relief yet Hives started morning of Day 3
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Flu Seasonal QIV Dresden for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, immediately after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were recovered/resolved. It was unknown if the reporter considered the injection site pain and pain in arm to be related to Influenza vaccine Quadrivalent unspecified season. Additional information received as follows: The age at vaccination was not reported. The patient received a flu vaccine several weeks before the reporting time. She described that she experienced burning and pain during the injection of the medication. Her arm was sore for approximately 3 to 4 days. The patient discontinued the call before further details could be obtained.
Left arm with raised area at ? site injection below bruised in about a 12 inch area running down arm also yellowish area.
This spontaneous report as received from a pharmacist refers to an 80 year old female patient. On 07-OCT-2014 the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot # J014399, exp date 20-NOV-2014) via intramuscular route. On 07-OCT-2014, the patient experienced swelling, redness and pain after receiving PNEUMOVAX 23. The outcome of the events was unknown. Pharmacist declined to request a Lot check. Additional information has been requested.
Breakthrough COVID infection following  full 2-dose vaccination.  I tested positive for COVID 19  6 months after receiving second dose of Moderna vaccine.   Symptoms included fever lasting 8 days (99 - 101 degrees), body aches, fatique, headache, late onset dry tracheal cough, painful raised red rash on scalp and forhead with forehead edema, swollen and painful lymph nodes on head and neck, food tasted bland, single swollen/painful joint on right hand lasting 36 hours. I recovered at home and required no medical treatment.  I took over-the-counter cough suppresant, Tylenol, and Ibuprophen for symptoms.  I also took Vitamin D, Zinc, and Vitamin C during illness.
Around 2 pm that day (Friday, April 9th) I got an extremely bad headache and ringing in my ears. By 4 pm I had a fever of 100.7, really bad shaking chills, body aches, and nausea. My chills went away by the next day. My fever, bad headache, and ringing ears continued. My fever reached 101 but never went over. It lasted until Sunday evening. It has been 2 weeks and 1 day and my headache has never gone away, though it is manageable and mild now, although it was really bad last night. My ears/head continue to ring non-stop. Nothing helps with that.
Administration error, client was administered diluent component of Menveo before reconstitution with vaccine component occurred.  Client did not receive vaccine as intended.
The following morning after my 3rd booster shot, the underarm on my left side became very swollen as well as the lymph node. The swelling and discomfort under my arm lasted about 5 days and finally went away.  However, the day after the shot, I also experienced extreme chest and heart pain.  This also included the feeling of severe tightness and swelling in my chest., and shortness of breath.  I have been dealing with this for 2 months now, and I continue to have chest pain, swelling, and am  now seeking treatment to see a pulmonologist as my breathing issues have become more severe to where I am on steriods and an inhaler to keep my lungs open until I can get in to see a doctor.  They are all booked until near the end of March which is probably to late for me to have to wait to be seen. I have been to the E.R. a few days ago and had a chest x-ray, blood work and a CT scan as well as an EKG. They all show my heart is functioning fine, however, I still continue to suffer from chest and heart pain, as well as the feeling of swelling and inflamation in the chest and the continued shortness of breath.
Excessive crying, low grade fever T max 101.5, shivering. Saw in office next-day - diagnosed with URI/allergic rhinitis.
Pt felt faint and flushed and had a vasovagal response after vaccine. Pt was assisted to ground where she quickly came to and was able to communicate. Pt was given an ice pack and water. Pt got up from the ground and sat in chair for about 10minutes then left on own accord. Called patient one hour later to check on her, and she appreciated the call and said she felt fine.
Congestion, out of body experience (like a fog where you cannot think), headache, syncope
Information has been received from a physician concerning a patient who on an unknown date was vaccinated with a second dose of VARIVAX (Oka/Merck). On an unspecified date the patient developed cellulitis and was hospitalized. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Woke up to red arm at injection site.  I am due to get my second shot on February  19 and my arm is still a little red, smaller than before and does not itch or hurt .
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients pertinent medical history or concurrent conditions was provided. On an unknown date, the patients were vaccinated with doses of LIQUID PEDVAXHIB (dose, frequency, route of administration, lot# and expiry date unspecified) which were improperly stored. No concomitant medication was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Had shingles earlier this month, saw provider 4/10/21. Began 4/6/21 with "some weird sensations in pain in the area". Rash that blistered and then scabbed. Scabbed areas are resolving.  No blistering any more.   "it never got bad". Took valacyclovir until completed. Taking ibuprofen occasionally at night mainly. No longer requiring med for pain. Denies fever, chills, numbness, tingling or pain.  She mentions getting first dose of Moderna COVID-19 vaccine 03/19/21.
Metallic taste, strange feeling of a coating on the tongue continuing over 24 hours after vaccination. Headache, muscle pain at injection site, dizziness, fatigue, irritability.
fever; chills; joint pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 042L20A) for COVID-19 vaccination.     Family history included Migraine since an unknown date.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). The patient was treated with ACETAMINOPHEN for Migraine, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), CHILLS (chills), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) outcome was unknown.            No concomitant medication were provided  Action taken with mRNA-1273 Moderna vaccine was Not applicable
Aches; sore arm from the injection site; swelling underneath the armpit of her right arm, size of "cutie oranges",; swelling from underneath the armpit is tender; swelling in the right arm , where the vaccine was administered; pain in the right arm , where the vaccine was administered; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Apr-2021 and was forwarded to Moderna on 05-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in the right arm , where the vaccine was administered), SWELLING (swelling underneath the armpit of her right arm, size of "cutie oranges",), TENDERNESS (swelling from underneath the armpit is tender), VACCINATION SITE SWELLING (swelling in the right arm , where the vaccine was administered) and MYALGIA (Aches) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain in the right arm , where the vaccine was administered) and VACCINATION SITE SWELLING (swelling in the right arm , where the vaccine was administered). On 03-Apr-2021, the patient experienced SWELLING (swelling underneath the armpit of her right arm, size of "cutie oranges",) and TENDERNESS (swelling from underneath the armpit is tender). On an unknown date, the patient experienced MYALGIA (Aches) and INJECTION SITE PAIN (sore arm from the injection site). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and ACETAMINOPHEN at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (pain in the right arm , where the vaccine was administered), SWELLING (swelling underneath the armpit of her right arm, size of "cutie oranges",), TENDERNESS (swelling from underneath the armpit is tender), VACCINATION SITE SWELLING (swelling in the right arm , where the vaccine was administered), MYALGIA (Aches) and INJECTION SITE PAIN (sore arm from the injection site) outcome was unknown.            No concomitant medication information was mentioned  Patient took acetaminophen q4-6hrs on Saturday for treatment.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the event was not applicable
Day after shot, exhaustion, extreme headache, light sensitivity, face swollen, bad vision, steroid injection given, didnt help, eyes swollen open, blood pressure had gone up, diagnosed with Bell's palsy (dry needle treatment), inflamed face muscles, given gabapentin, wears patch because eyes wont close completely,
Following the injection of GARDASIL my daughter developed epilepsy, and so far various doctors are trying various anti-seizure medications to try and control the seizures, but are not successful. A healthy child after being given the second shot of vaccine 3-dose regimen developed seizure a few days later, which has now repeats at least once a month. The EEG results determined that several areas of the brain have been affected, and that no cure is possible.
Acute hypoxic respiratory failure requiring hospitalization 2/2 COVID-19 pneumonia