chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  Pt reported a new tickle in the back of his throat 15 minutes after his covid vaccine dose #2. He also stated he felt "different".Nurse manager escorted pt to the ER for further evaluation. Pt was seen in the ER. Per note from ER MD: "43-year-old male presents emergency room complaining of tingling in the back of his throat. Started after getting his second Covid vaccine around 09:30 AM this morning here. Patient states the tingling has since resolved. Has no complaints. He never had shortness of breath. Never had any trouble swallowing. Never had any nausea vomiting or diarrhea. Never had any rashes. Patient states he feels fine now." Pt was then discharged home from the ER. No treatment was needed. Pt's chart was flagged with ADR to covid vaccine.
pain; swelling; redness of arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), SWELLING (swelling) and ERYTHEMA (redness of arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain), SWELLING (swelling) and ERYTHEMA (redness of arm). At the time of the report, PAIN (pain), SWELLING (swelling) and ERYTHEMA (redness of arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications was provided by the reporter.  No Treatment medications was provided by the reporter.
No adverse event; Patient received expired dose; Patient received first dose on 18-MAY-2022 and second dose on 24-JUN-2022; This spontaneous case was reported by a patient and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 18-MAY-2022 and second dose on 24-JUN-2022) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 065F21A and 053B22A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Jun-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 24-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose). 24-Jun-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 18-MAY-2022 and second dose on 24-JUN-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 18-MAY-2022 and second dose on 24-JUN-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.  No relevant concomitant medications were reported. It was reported that second lot number was expired on the date that it was administered. Treatment medication was not provided by the reporter.
Redness and swelling at site of injection and keeps swelling. Causing discomfort. Advised to take Benadryl and ice the area for swelling.
I had a skin infection diagnosed a cellulitis in my right ear. I had redness and swelling of my right ear. I went to a quick clinic who prescribed Cefalexin & who recommended I go to the emergency room since it was not getting better after the antibiotic. I went to the emergency room, and they gave me a CT scan of my face and put me on an additional antibiotic called Doxycycline for 1 week. My symptoms improved the next day. I have since completely recovered from these symptoms.no fluid in face or jaw or anywhere in the face
Child given Proquad before recommended age. No signs or symptoms of adverse reaction. Parents took child to Family Physician no adverse reaction reported.
75 patients received doses from vials that were past the beyond use date; One group of patients received vaccination within 12 hours of the beyond use date; One group of patients was received dose 12 hours past the beyond use date; certain patients received doses up to 6 days past the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (75 patients received doses from vials that were past the beyond use date), EXPIRED PRODUCT ADMINISTERED (One group of patients received vaccination within 12 hours of the beyond use date), EXPIRED PRODUCT ADMINISTERED (One group of patients was received dose 12 hours past the beyond use date) and EXPIRED PRODUCT ADMINISTERED (certain patients received doses up to 6 days past the beyond use date) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (75 patients received doses from vials that were past the beyond use date), EXPIRED PRODUCT ADMINISTERED (One group of patients received vaccination within 12 hours of the beyond use date), EXPIRED PRODUCT ADMINISTERED (One group of patients was received dose 12 hours past the beyond use date) and EXPIRED PRODUCT ADMINISTERED (certain patients received doses up to 6 days past the beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (75 patients received doses from vials that were past the beyond use date), EXPIRED PRODUCT ADMINISTERED (One group of patients received vaccination within 12 hours of the beyond use date), EXPIRED PRODUCT ADMINISTERED (One group of patients was received dose 12 hours past the beyond use date) and EXPIRED PRODUCT ADMINISTERED (certain patients received doses up to 6 days past the beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: No specific follow-up information recorded.
I believe on  5/4/2021 I noticed my mouth my tongue felt numb when I ate or drank. I could taste but numbness was noticeable.  Wednesday, May 5 it was still numb and I had a headache.  Thursday, numbness remains headache is worsening. . On Friday, May 7, same but my right was watery. May 8, right side of my face is numb to the point that eating or drinking is difficult.   Went to the Emergency Room because I thought I was having a stroke.
Symptoms: muscle aches, swelling, redness, warmth, and pain in left arm; nausea , fatigue, cold sweats Onset: 3/24 day after vaccines Signs:  Warm, erythematous, indurated area from L proximal 2/3 of upper extremity (See pic) +tender to palpation Small area of bruising centrally
Two weeks after the vaccination,  the vaccination site is red, itchy, and swollen. The itchy red patch is about 3 inches in diameter and hard.
CHILD DEVELOPED AN URTICARIAL RASH AND COMPLAINED OF SWOLLEN HANDS AND FEET, NURSE FROM SCHOOL SUGGESTED MAY BE VACCINES. WHEN EXAMINED FEW RED ITCHY ELEVATED LESION, NO SWOLEN FEET OR HANDS.
5 minutes after getting MMR, IPOL, DTAP, Varicella patient started coughing and tongue began swelling and also has a rash.  Patient returned to office got 1 1/2 tsp of BENADRYL at 11:35 AM.  O2 stat was 98%.  Patient was given ORAPRED and was observed for 1 hour.  Patient was prescribed an Epi Pen to take home for emergency/anaphylaxis.
Patient falsified DOB when registering for vaccination. Guardian consented to the vaccination. Health department verified with records that the patients actual DOB which made the vaccine a contraindication.  No known adverse reactions noted.
ALL JOINTS LOCKED UP, NECK WOULD NOT TURN FEVER AND CHILLS THROUGH OUT 20151014 PM. LEFT BIG TOE STAYED LOCKED UP UNTIL 20151022 AM, WENT TO DOCTOR ON 20151019 TO HAVE TOE CHECKED OUT WAITING ON BLOOD WORK, TOE STILL HURTS TO MOVE, BUT I CAN BEND IT AS OF THIS MORNING.
pt recv vax & devel sand paper raised rash covering face & some on trunk;appeared w/in a few hr  p/vax;lasted about 1wk;mom reported this on 24MAR99 when pt in for 2nd dose;
pt pulled needle out of leg & scratched self w/needle; wound cleansed & covered w/ gauze;
No adverse effects reported; patients have been administered doses of vaccine which were improperly stored; This non-valid spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates (reported as since 29-NOV-2018), the patients were vaccinated with improperly stored doses of hepatitis b vaccine (recombinant)(RECOMBIVAX HB)(therapy types, exact doses, injection sites, routes of administration, lot numbers and expiration dates were not provided), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9))(exact doses, injection sites, routes of administration, lot numbers and expiration dates were not provided), hepatitis a vaccine, inactivated (VAQTA) )(exact doses, injection sites, routes of administration, lot numbers and expiration dates were not provided) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact doses, injection sites, lot numbers and expiration dates were not provided) for prophylaxis. Administered doses of vaccines experienced the temperature excursions of 47 degrees Fahrenheit to 77 degrees Fahrenheit (48.2 degrees Fahrenheit) for 13 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported.  This is a non-valid report due to lack of the patients' identifiers.  Follow-up information was received from the healthcare worker on 30-AUG-2019.   On 30-AUG-2019, a phone call was placed to the reporter. The phone call was answered by the medical assistant. The medical assistant stated that she would additional need time to conduct her research on the patient(s) who were administered the vaccines. A request was made for patient identifiers, lot and vaccine received and on what date. The company contact information was shared.  Additional information has been requested.  The patient's identifiers were provided. The reporter referred to a patient of unknown age and gender.  On 30-NOV-2018, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot number N021092, expiration ate was not provided, but upon an internal verification was established on 11-MAR-2019 (exact dose was not reported) for prophylaxis. Excursion of 29-NOV-2018 when the refrigerator temperature dropped was of 45.7 degrees Fahrenheit to 48.2 degrees Fahrenheit for 13 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA000371: US-009507513-1909USA000370:
pt recv vax; child began to cry; APAP given; child cont non-stop screaming, crying for 4 hrs; some swelling at inject site; relieved by ice pack
Bone marrow transplant; This is a spontaneous report received from a contactable reporter (Pharmacist) from Medical Information Team.  A 56-year-old female patient received BNT162b2 (BNT162B2), as DOSE 1, SINGLE (batch/lot number: unknown) and as DOSE 2, SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BONE MARROW TRANSPLANT (medically significant), outcome "unknown." The event "bone marrow transplant" required physician office visit. The Caller is a pharmacist who stated that they have a patient who was completely done with COVID-19 primary series and has a bone marrow transplant, now, patient was recommended by her physician to restart her primary series to dose 1. Caller clarified that it did not happen yet. Caller was informed that per CDC, an individual is considered as fully vaccinated once he/she completed her/his primary series, not including the booster. Caller was referred to CDC contact number, to make sure that there is no recommendation, but caller declined. Question about the dosing of the COVID-19 vaccine was again reported. Caller on the line had a patient that already got the primary series and has had a bone marrow transplant. The patient is looking to get the COVID -19 vaccine. The physician told the patient they would need to restart the vaccine series.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event BONE MARROW TRANSPLANT and the vaccine (BNT162B2) cannot be excluded. "The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate."
Traumatic pain-exasperating left groin impostor end one hour had one old oxycodon in cupboard and took twenty minute later calm enough to head to Urgency clinic. Second time could not stand up severe center of back pain never had ever and coworkers shocked how so looked.
On 11/21 started feeling achy and chills in the evening. I went to bed very early due to being very cold and tired. Slept rough all night. Woke up the next morning feeling much worse. Took a hot shower and it helped a little. Took 2 at home COVID-19 tests both were positive. Made telehealth appointment with PCP. PCP prescribed PAXLOVID. Began seeing an immediate improvement. Symptoms continued to improve until Thursday when I experienced a rebound symptoms. The rebound symptoms lasted 4 more days.
pain; discomfort; This case was reported by a nurse via call center representative and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain and discomfort. On an unknown date, the outcome of the pain and discomfort were unknown.   It was unknown if the reporter considered the pain and discomfort to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced lots of pain and discomfort after her first dose.  The nurse asked if Shingrix could be administered in the bottom instead of deltoid.  The reporter consented to follow up.
pt recv vax 2DEC98 & 4hr p/vax pt exp itchy hives @ the inj site above & below across chest on lt side of face & a couple on stomach;
Achiness, fatigue, fever, chills-started the following day, had to go home from work to take a nap, that evening must have had a fever, went straight to bed when I got home, chills, sleeplessness great pain, redness, hotness and injection site - it is now almost exactly 5 days later, heat and soreness on arm are gone but the redness is still evident.
An expired dose was administer to a patient; Dosing interval extended between 1st and 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired dose was administer to a patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dosing interval extended between 1st and 2nd dose) in a 27-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 033H21A and 032H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired dose was administer to a patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dosing interval extended between 1st and 2nd dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (An expired dose was administer to a patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dosing interval extended between 1st and 2nd dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medications was reported.
Tremor in her leg/tremors felt above the knee; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Tremor in her leg/tremors felt above the knee) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced TREMOR (Tremor in her leg/tremors felt above the knee). The patient was treated with GABAPENTIN for Adverse event, at a dose of 100 milligram once a day. At the time of the report, TREMOR (Tremor in her leg/tremors felt above the knee) outcome was unknown.        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.   Concomitant medications were not provided. The patient stated after 2-3 weeks after getting the vaccine, started experiencing tremor in her leg, tremors felt above the knee, felt like it was a poison.   This case was linked to MOD-2021-363548 (Patient Link).
Right deltoid pain with radiating to neck and forearm. Paraesthesia in right arm following Tdap immunization.
This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (I had two Pfizer shots and 2 weeks ago a Moderna booster. Is there any chance the booster can cause Covid-19) in a patient of an unknown age and gender 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 INTERCHANGE OF VACCINE PRODUCTS (I had two Pfizer shots and 2 weeks ago a Moderna booster.  Is there any chance the booster can cause Covid-19). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (I had two Pfizer shots and 2 weeks ago a Moderna booster.  Is there any chance the booster can cause Covid-19) had resolved. Concomitant medications were not provided.Treatment medication was not provided. Patient had two doses of Pfizer vaccine and received the Moderna booster dose two weeks ago.
Hi, I'm in good shape. I have no cholesterol in my arteries. No sign of heart disease. No sign of circulatory disease. I'm very active. Eat the Mediterranean diet. You name it. 12 days after my Johnson and Johnson shot, a bunch of blood clots went into my LAD and gave me a widow maker heart attack with heart failure. I have an overactive immune system and apparently the J&J shot convinced it to attack my blood and clot it. This went unreported. I have a complete medical history of the event I'm happy to share for the grater good. I nearly died. Everyone at the hospital kept commenting on how they couldn't believe I was in there with a heart attack.
sore arm for a couple days; Initial information received on 09-Nov-2021 regarding an unsolicited valid social media non-serious case received from a consumer/non-health care professional.  This case involves a patient (unknown age and gender) who had sore arm for a couple days (pain in extremity) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sore arm for a couple days (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "no side effects, just a sore arm for a couple days. Never had any side affects".  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Information has been received from an office manager who stated that she received this report from the patient's mother. The patient's mother had read about this report in a blog e-mail concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot number, site and route not reported). It was reported that the patient got sick and not able to go to school after she received GARDASIL. The outcome was not reported. The office manager could not confirm that this was a true report as the patient was not a patient of the physician at the office and she did not have a copy of the e-mail. The patient had sought unknown medical attention. Attempts to verify the existence of an identifiable patient have been unsuccessful. Additional information has been requested.
Patient reported having rash around injection site approximately 5 days after receiving his SHINGRIX vaccine. He said the rash spread to most of his body as the days went by and no longer red around injection site. He reported this to the pharmacy on 4-11-2019. His doctor prescribed triamcinolone acetonide 0.1% lotion on 4/11/2019.
After the second dose of moderna vaccine the next day she started with numbness to her right side, arm, hand, leg and foot. Monday woke up and her whole right side was numb she went to ER they did a MRI which showed she had a stroke.
h/a, lethargy c/o leg pain & weakness, inability to walk, fever @ onset;
Extreme swelling without streaking and  erythema, weakness in deltoid and mild numbness in fingers and weakness in fingers
One day after receipt of vaccine, had extreme pain in left arm (the injection arm) from top of shoulder to elbow.  Pain felt like I was having a bursitis attack with a pain level of 7 out of 10.   Took two days to get to a "2".   Did not sleep for two nights.  Extreme "fogginess" in head, numb feeling around nose, mouth and eyes.   Fatigue, depression, sadness .  Anxious feeling in the chest which is continuing as of this writing (3/21/21)   I do not take  any medications and do not have any history of depression or mental illness.   This is all very unusual for me.
Went through 6 months of hospital and rehab after taking pneumonia and flu vaccines which gave me CIDP and will be affected by the rest of my life. I am still taking medicine and getting IVIG infusions monthly.
Red - swollen, tender, painful from site of injection to below elbow - starting 12 hrs injection. Pt went ER - taken back to MD 48 hrs after: was diagnosed w/cellulitis.
Beginning the evening of my second shot I have developed, with no prior history, tinnitus in both ears. The sound is not terribly loud unless my house is silent - it is more like crickets or tree frog sounds rather than just a high pitch.  I plan to call my family dr if the sound persists into this next week.