chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initially had severe fatigue, chills, headache, fever, then on December 3, I suffered bell's palsy right side, eye stroke (per ophthalmologist surgeon) on left side of face, tachycardia, shortness of breath, high glucose level, A1C went from 5.8 to 6.6, tinnitus, 2 sounds on left side and 4 on right side. All these events started on December 3, 2021 and worsened over the next several days.  It has been difficult dealing with this events as they still continue to this day.  I was unable to report sooner due to vision issues and lightheadness.
Moderna COVID-19 vaccine EUA given to parent and recipient who was under age 18. Recipient was 17 years and 8 months of age. Parent signed consent for son to receive vaccine. Moderna vaccine given in Right Deltoid. Recipient was monitored for 15 minutes. No adverse reaction noted. Recipient was released to care of parent. Supervisor caught the error later and re-instructed vaccination team on Moderna administration procedure.
Mother phoned to say client had rash on legs and back last night. Received vaccines earlier. Told by ER allergic reaction to vaccines given Benadryl and Prednisone.
Patient experienced a papular rash with clear pustules located on face and trunk about 2 days after vaccine; pruritic.
Had vaccine, didn't feel much at all.  Came home, did not feel bad, day and half later started feeling bad, as  well as kind of like a cold with drainage to her throat, a little coughing.  Has had diarrhea for the last 3 days, nausea and generally feeling bad.  The first week had a lot of drowsiness, had fogginess as far as thinking.   The first few days took Tylenol and did not take anymore as her daughter said it contained aspirin for the pain.  Still having the headache, feeling like she is not thinking real good.  About a month ago had blood work and everything was perfect, no problems.  Due to the fact that she is still having these reactions 2 weeks from the injections wanted to report it.
Rash at the injection site; Red rash at the injection site; Itchy, red rash at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site rash, injection site erythema and injection site itching. On an unknown date, the outcome of the injection site rash, injection site erythema and injection site itching were unknown.   It was unknown if the reporter considered the injection site rash, injection site erythema and injection site itching to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. After the first Shingrix shot, the patient broke into an itchy, red rash at the injection site.  The patient questioned of they should get the second shot.
pt recv vax & devel induration @ the inj site;no further details as of the reporting date;this is 1 of 3 patients from this site who exp above reaction;
On December 17th, I was traveling. When I returned, I started feeling symptoms at 03:00 on December 21,2022. I went to an Urgent Care on 12-22-2021 to be tested. I did have some type of an infection in my throat, but my Covid test came back negative. I thought I had Covid, I had nausea, diarrhea, and sore throat, low grade fever. I was prescribed an antibiotic and better by the 26th. I did not have any symptoms after my 3rd dose.
Persisting, inconsolable crying for 5-6 hrs from the time vax administered; Inject area swollen; Tx hot soaks; APAP; Phenergan elixir;
Information has been received from a nurse practitioner concerning a 16 year old female with not sexually active and a history of meningitis as a baby who in August 2008, was vaccinated with the first dose of GARDASIL (Lot# not reported), on 20-OCT-2008, was vaccinated with the second dose of GARDASIL (Lot# not reported). There was no concomitant medication. And the patient had had an unspecified number of urinary tract infections, frequent lower back pain, abdominal pain and got the flu for the first time. The first dose and second dose were given by another unspecified provider's office. Prior to receiving GARDASIL, the patient had "always been healthy all her life" (as reported by the patient's mother). The patient went to emergency room in January 2009 for the flu. The nurse practitioner assumed urine culture and sensitivity test done by another unspecified provider's office. The reporter nurse mentioned although she did not feel the patient's symptoms were related to the GARDASIL, the third dose of GARDASIL would not be given. Subsequently, the patient recovered from unspecified number of urinary tract infections, frequent lower back pain, abdominal pain and flu on unknown date. It was reported that the patient sought medical attention: office visit. Additional information has been requested.
4/16/21 Second Dose received.  4/17 and 4/18  noticed light swelling in ankles. No other effects.  4/19 - Emailed my Cardiologist about swollen ankles. Didn?t think about the vaccine as a potential cause. He scheduled an Echocardiogram for May.  4/20 to 4/22 - Edema is ankles and lower legs with pain on bottom left. Tried heat and elevation with no relief.  4/23 - Called Advice Nurse with recommendation to go to ER. ER determined a blood clot in left leg at the left posterior tibial vein measured at 6.3cm.
Sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Endocrine disorder (Endocrine insufficient). Concomitant products included HYDROCORTISONE for Endocrine disorder.   On 25-Feb-1900, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) outcome was unknown.            No treatment medications were reported.   This case was linked to MOD-2021-403248, MOD-2021-403252 (Patient Link).
Menses bleeding increased immensely right after vaccine  Almost passed out Nausea  White lips, gums, eyes
Within 5 minutes of injection, felt mild tightness in throat and chest.  Did not report at time as it was mild.  Symptoms did not resolve after a few hours.  ~ 3 hours later, took Benadryl and bronchodiolator and symptoms improved.  Also since injection have had mild GI distress gradually improving.   Reporting now because I learned reaction could be worse to second injection, and 30 minute observation period would likely be prudent.
Day 1, Oct 12- onset of dizziness/vertigo. Day 2, Oct 13- continued dizziness/vertigo accompanied by body aches, headaches, fever. Day 3-5, Oct 14-17- still  dealing with dizziness/vertigo.
Swelling on arm right; Blood cots passing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Swelling on arm right"; HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "Blood cots passing".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Local erythema & induration & bullae formation without systemic sx. Suggestive of anaphylaxis.
The day after the vaccine my arm was very sore and was very sleepy and achy.  3-4 weeks later I started to get really dizzy so I took Dramamine.  The next day I was suffering from severe dizziness and nausea which caused me to vomit.  I kept taking Dramamine but that didn't help.  After 7 days I went to urgent care and I was told I didn't have fluid in my ears but I could feel it.  5-7 days later I went to the ER and was told I did have fluid in my ears which was causing vertigo.  They gave me Zoloft I think which cleared it up almost immediately
FLUMIST given 10/1/10. On 10/3/10 developed a rash-generalized. ON 10/4/10 slight temp, rash worsened and face began swelling. Was given DECADRON shot and BENADRYL before cleared eye.
Two days after this infant had his vaccines, he awoke from a nap (was in grandmothers lap) suddenly back "limp", with loss of consciousness. No tonic-clonic activity. No apnea of cyanosis. The infant felt hot, but no documented fever. This lasted  1-2 minutes, normal afterwards. Neg exam by me shortly after the episode. No problems since the episode.
Information has been received from a 76 year old female, with no known drug reactions/allergies and no pertinent medical history, who in approximately June 2008, "he last summer" was vaccinated with ZOSTAVAX (Merck). There was no concomitant medication. The patient reported that on 01-APR-2009, she developed shingles after receiving ZOSTAVAX (Merck). She had little blisters on her lower left back. She had no pain but the blisters were itchy. She had to take antiviral medications for 5 days. At the time of the report, the patient was recovering. The patient saw the physician. Additional information has been requested.
all the symptoms were similar to Covid-19 symptoms; nausea; extremely sore arm; Sick on the stomach in the morning; Arm is sore; Sleepless due to pain; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is sore), INSOMNIA (Sleepless due to pain), COVID-19 (all the symptoms were similar to Covid-19 symptoms), ABDOMINAL DISCOMFORT (Sick on the stomach in the morning) and NAUSEA (nausea) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm is sore), INSOMNIA (Sleepless due to pain) and PYREXIA (fever). On 12-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Sick on the stomach in the morning). On an unknown date, the patient experienced COVID-19 (all the symptoms were similar to Covid-19 symptoms), NAUSEA (nausea) and MYALGIA (extremely sore arm). At the time of the report, PAIN IN EXTREMITY (Arm is sore), INSOMNIA (Sleepless due to pain), COVID-19 (all the symptoms were similar to Covid-19 symptoms), ABDOMINAL DISCOMFORT (Sick on the stomach in the morning), NAUSEA (nausea), MYALGIA (extremely sore arm) and PYREXIA (fever) 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.   This case was linked to MOD-2021-176122 (2 DOSE CASE) (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Significant Follow up appended
Information has been received from a respiratory therapist concerning 7 pts with no medical history reported, who within the past month, were vaccinated (route unk) with a dose of Pneumococcal 23v polysaccharide vaccine. The therapist reported that 3 out of the 7 patients have had injection site reaction in the past month at the hospital. Some have not received Pneumococcal 23v polysaccharide vaccine prior to the vaccination but the majority have had the vaccine in the past. Unspecified medical attention was sought. No product quality complaint was involved. Additional information was received from the pharmacist concerning a 74 year old retired female with hypertension and arthritis. Illness at the time of the vaccination included nausea, vomiting, diarrhea and fever. On 7/24/06, the pt was vaccinated with first dose of Pneumococcal 23v polysaccharide vaccine (lot 651149/0088F) IM in the right deltoid at 1515 hours. On 7/25/06, at 1600 hours, the pts upper right arm was red, swollen, warm, and painful to touch. The pharmacist reported that the events required medical surgical intervention (other important medical events) (OMIC). On an unspecified date, the pt recovered. It was confirmed with the pharmacist via telephone call that the events were serious. The pharmacist reported that the pt required antibiotic therapy as intervention to prevent a serious outcome, and that it was not the pts illness at the time of the vaccination that required intervention. The pharmacist indicated that this was the only pt that they knew for sure who had a reaction. No additional information is expected.
Received the Moderna COVID vaccine on Monday and then on Tuesday she was given the Pfizer COVID 19 vaccine; Received the Moderna COVID vaccine on Monday and then on Tuesday she was given the Pfizer COVID 19 vaccine; Experienced a sore arm; This is a spontaneous report from a contactable consumer via the Pfizer sponsored program . A 76-year-old female patient (reporter's aunt) received 1st dose of NT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unknown date (reported as "Tuesday") and Moderna COVID vaccine at an unknown dose on an unknown date (reported as "Monday") , both via an unknown route for Covid-19 immunization. Medical history included ongoing dementia that didn't realize how bad it was. It was only little things like forgetting to pat her cable bill. Patient had memory problems before getting Pfizer vaccine and the reporter stated that it was worse than they thought. The patient received the Moderna COVID vaccine on Monday and then on Tuesday she was given the Pfizer COVID 19 vaccine. A family member picked her up on Monday to take get to get her shot and then on Tuesday a different family member picked her up and asked her if she needed to get her shot and she said yes because she didn't remember getting the shot the day before. Patient experienced a sore arm after getting the Pfizer vaccine.  Outcome of the events was unknown. The report was assessed as non-serious.   Information about the lot/batch number has been requested.
Got first dose on April, has not gotten second dose yet.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Got first dose on April, has not gotten second dose yet.) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Got first dose on April, has not gotten second dose yet.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Got first dose on April, has not gotten second dose yet.) had resolved.            The patient stated that I was already fully vaccinated.  No concomitants were reported. No treatment was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2021: Follow up information include vaccine start date captured, Action taken updated to not applicable and narrative updated.
Itching on belly; Redness on belly; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 24th February 2022, 4 days after receiving Shingrix, the patient experienced pruritus and erythema. On an unknown date, the outcome of the pruritus and erythema were not recovered/not resolved.   It was unknown if the reporter considered the pruritus and erythema to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine on left deltoid 4 days ago from reporting date and experienced itching and redness on her belly today (day of reporting). The patient did not have lot number or expiration date for the vaccine.  The reporter also wanted to know if it could cause shingles. The reporter did not consent to follow-up.
After administering vaccine, patient started to bleed, enough for blood to start dripping down arm. Pressure applied, followed by bandaid. Vaccination site swelled within the first minute after administration. Patient reported severe headache and nausea. Cold pack applied to site, cold water provided to patient to sip. After 15 minutes, nausea diminished, headache and site swelling remained. Patient reported feeling "better besides headache".  Patient obtained some generic excedrin 250mg/250mg/65mg and took 2 before leaving pharmacy.
Patient received two booster doses of Moderna. First booster was 12/16/21 and the second booster dose occurred on 3/10/22.
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 32nd of 43 adult patients described by the reporter.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:
Headache that won't go away. (Even with rest, food, water, Tylenol, ibuprofen, aspirin, and/or a mixture of those.) I also have painful, swollen lymph nodes along my left collar bone and on the left side of my neck. I've used gentle heat, it only helps a little. Ibuprofen helps with the pain from the nodes in my collar bone but not my neck.
patient was underage when he got covid 19 moderna vaccine. Patients parents want him to receive second dose
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (large bump under the vaccinated arm) and HEADACHE (headache) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Down's syndrome.   On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 VACCINATION SITE MASS (large bump under the vaccinated arm) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (large bump under the vaccinated arm) and HEADACHE (headache) outcome was unknown.      Action taken with mRNA-1273 in response to the event was not applicable. No concomitant medications were reported.
This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On 13-JUN-2016, the patient received doses of improperly stored RECOMBIVAX HB with lot# L033343 and expiration date 13-SEP-2017; via intramuscularly route (dose was not reported). Administered dose underwent temperature excursions at 31 Fahrenheit degrees, for 10 hours. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected.
Confirmed that no symptomatic adverse events were reported/No additional AE; Administration of ROTATEQ that was expired to two patients; This spontaneous report was received from an office manager referring to a 4-months-old male patient. The patient's pertinent medical history, concomitant medications, and drug reactions or allergies were not reported.  On 30-MAY-2023, the patient received the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial 2 mL, once, orally, lot number: U038863 was verified to be a valid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), expiration date was provided and upon internal validation was confirmed to be: 27-MAY-2023 (expired product administered) administered as prophylaxis. It was confirmed that no symptomatic adverse events were reported (No adverse event). Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) did not have any previous temperature excursion outside recommended range in the past.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA000682:
Congestion; Chills; Cough; This is a Spontaneous report from Pfizer Sponsored Program. A contactable consumer reported for male patient (Husband) that: A male patient of an unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On an unknown date, the patient experienced congestion, cough and chills, after the first dose of the covid vaccine. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.