chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax & tested positive for HIV infection;approx 1 wk later pt was retested & was negative;the testing facility reportedly told the pt the false positive was d/t vax;
This spontaneous case was reported by a consumer and describes the occurrence of MASS ("Goose egg" in arm), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE SWELLING (Swollen injection site) and VACCINATION SITE ERYTHEMA (Red injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hypercholesterolemia and Thyroid disorder. Concomitant products included AMLODIPINE for Blood pressure high, ROSUVASTATIN for Hypercholesterolemia, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 18-Feb-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 MASS ("Goose egg" in arm), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE SWELLING (Swollen injection site) and VACCINATION SITE ERYTHEMA (Red injection site). At the time of the report, MASS ("Goose egg" in arm), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE SWELLING (Swollen injection site) and VACCINATION SITE ERYTHEMA (Red injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported.
Information has bene received from a nurse referring to a male patient of unknown age. Medical history and current condition of the patient was not reported. On an unknown date, the patient was administered improperly stored dose of GARDASIL (lot# K001631, expiry date: 06-NOV-2016) dose, route unspecified. Other suspect and concomitant therapies were not reported. No adverse events were reported. No further information was provided. The nurse provided that there have been no need for revaccination and provided patient names and dates of birth who had received the vaccination (other patients were captured in MARRS# 1412USA002140, 1502USA006587, 1502USa006589, 1502USA006590). This is one of several reports from the same source. Additional information has been requested.
6 hours after the injection, I started having a lot of dizziness and ringing in my right ear and that continued up until 08/29/2021. I saw my Dr. on the 8/20/2021. I had an EKG for rapid heart rate and blood pressure. He a found a PVC. He does not think it is necessarily caused by the vaccine but may have been flared up by the vaccine and also induced by the stress of the media. I started a steroid, on 08/28/2021, methylprednisolone. As of 08/29/2021 the ringing in my ear has stopped.
Hearing loss in my left ear.  Tinnitus in my left ear.  Treated with 2 rounds of steroids, but hearing never fully returned.
Breakthrough case admission after four vaccines  Pfizer 2/2/21 Lot# EM9810; Pfizer 4/14/21 Lot# Ew0164;  Pfizer 11/2/21 Lot# 320308D;  Pfizer 4/5/22 Lot# FK9894
Starting 5/24/21 the base of my fingernail beds started to get red blotches. The blotches continued to move toward the end of the nails. By 7/22/21 the layers of the nails toward the base had started to peel away in layers. Meanwhile the front part of the nail had started to pull away from the bed of the nail. By 8/25/21 the first fingernail fell off, starting where the bed had pulled away. As of 10/21/21 9 of my fingernails are involved -  5 have fallen off, 2 more are ready to come off, 2 others are later, and 1 has never become involved. Likewise, I have one big toenail that has followed the same sequence, but not fallen off yet. There is no fever or any other symptoms. No pain until they fall off.
Patient came in for booster dose after receiving primary series of Pfizer. Moderna requested and given in error.
I called patient on 5/15/22 as a reminder for her second Shingrix dose.  She then said that a month after administration she developed shaking, the inability to walk, and memory loss.  She had also received Boostrix that day as well.  She also stated she was just released from the hospital after a 6 day stay.
(R) arm, red and swollen, painful from injection on 4-29-13.
redness on right arm; lump on neck; right arm sore; This is a spontaneous report from a contactable consumer (patient).  A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6200, expiration date not reported) via intramuscular route, in right arm, on 01Mar2021 12:00 (at the age of 57-years-old), at dose 2, single for covid-19 immunization. Patient had no medical history. There were no concomitant medications. Historical vaccine included (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EL9261, expiration date not reported) via unspecified route, on 08Feb2021 16:20 (at the age of 57-years-old), at dose 1, single for covid-19 immunization and experienced arm soreness and slight headache The patient did not take any medication for the events. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient experienced right arm sore on 02Mar2021, redness on right arm, lump on neck on 03Mar2021. The patient had no relevant test results. The outcome of the event redness on right arm  was recovering, and other events was not recovered.    No follow-up attempts are possible. No further information is expected.
causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; Nausea; repeated vomiting; This is a spontaneous report from a contactable consumer (reporting for herself). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 at 10:15 (Batch/Lot Number: ER 8737) as single dose for COVID-19 immunization. Medical history included drug amoxillin allergy. Concomitant medication included ibuprofen, simeticone (GAS X), cimetidine (TAGAMET [CIMETIDINE]) and colecalciferol (VITAMIN D [COLECALCIFEROL]), all taken for an unspecified indication, start and stop date were not reported. On 07Apr2021 at 23:00, the patient experienced causing burst blood vessels in face, eyes, nose and throat, nausea and repeated vomiting. The outcome of the events was recovering. The patient did not had COVID prior to vaccination and did not tested positive post vaccination.  No follow-up attempts are possible. No information is expected.
Today 4/15/21, patient was administered the Moderna COVID-19 vaccine. Prior to the vaccination, his wife mentioned to us that he has a severe phobia of needles and has passed out previously to other shots. He had no other issues on his PQCF preventing him from receiving the vaccine.  The PQCF was reviewed with the patient by pharmacist. Tech administered the vaccine under supervision of both pharmacist and other technician due to his phobia. Patient received the vaccine with no issues except obvious nerves and a few minutes later while still in the booth, he reported not feeling well. We got him a bottle of water and he went to the post-vaccination waiting area with his wife. We were monitoring him closely and noted that his head was slumping into his wife's stomach when he was sitting down, and he appeared ill. Immediately, we got patient in supine position on the floor with his feet on a chair elevated. Cold ice packs were put on his head, beck, and wrists. Within 5-10 minutes, he was feeling much better. He sat back up in the chair, still with ice packs, and drank water.  Patient was asked to stay for 30 minutes so we could continue to monitor him. After 30 minutes, he left with no issues.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 2-year-old female patient received 4 doses of PREVNAR 13, via an unspecified route of administration in right thigh, at single dose: first dose (Lot# F18963, Exp. date 28Feb2013, NDC 00005197101) on 05Mar2012, second dose (Lot# F29393, Exp. date 31Mar2012, NDC 00005197101) on 03May2012, third dose (Lot# F63666, Exp. date Jul2013, NDC 00005197101) on 05Jul2012 and fourth dose (Lot# G39292, Exp. date 31Jan2015, NDC 00005197101) on 25Nov2013. Relevant medical history included that the patient had preterm weight (premature birth) of 2000-2500 grams. Concomitant medications included DTAP vaccine, via an unspecified route of administration, on 25Nov2013, at unspecified dose, and HIB vaccine, via an unspecified route of administration, on 25Nov2013, at unspecified dose. Past drug history included ROTATEQ (at 2, 4 and 6 months), penicillin; MMR and varicella zoster vaccine. In Nov2014 the patient experienced Serotype 3 pneumonia with outcome of recovered. She was hospitalized in response to the event on 25Nov2014. Therapeutic measures were taken as a result of pneumonia and included treatment with intravenous ROCEPHIN. Blood culture performed in the hospital (Nov2014) was positive for pneumonia serotype 3. She also went into acute renal failure in Nov2014, from which recovered on an unspecified date. The reporter was unsure if she had dialysis for renal failure. Always in Nov2014 hemoglobin dropped from 10 to 2.9 in 6 hours. Symptom of dropped hemoglobin was that she started having more breathing problems. The event recovered on an unspecified date. Physician stated he believes this was a vaccine failure. There was no reason for which the patient should develop these events.
blood pressure went up; I was not feeling well; it went down (that night; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (blood pressure went up), MALAISE (I was not feeling well) and BLOOD PRESSURE DECREASED (it went down (that night) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included CARVEDILOL, CHOLESTYRAMINE, METOPROLOL, FINASTERIDE and VITAMINS NOS for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (blood pressure went up), MALAISE (I was not feeling well) and BLOOD PRESSURE DECREASED (it went down (that night). The patient was treated with LISINOPRIL for Blood pressure, at a dose of 10 milligram. On 12-Feb-2021, BLOOD PRESSURE INCREASED (blood pressure went up) had resolved. At the time of the report, MALAISE (I was not feeling well) and BLOOD PRESSURE DECREASED (it went down (that night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
cox- sockeye virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 Immunization. The following information was reported: COXSACKIE VIRAL INFECTION (non-serious) with onset Feb2021, outcome "unknown", described as "cox- sockeye virus".  Additional information: The patient had cox- sockeye virus 5 days after their second COVID vaccine in early February.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Injection site red and swollen with visible "knot" and painful to touch. Slight headache. Woke in the night to pain in joints and very painful injection site. Took Tylenol for pain.
11/30/2021 Patient reported heat on her chest and pain in left hand 6/10 15 minutes post flu vaccine and Pfizer booster. Rapid Response team activated. Vital signs and reported symptoms monitored continuously for 1.5hrs in clinic. Symptoms resolved and patient was released to self care. Telehealth visit f/u complete by provider 12/1/2021. Per note full resolution of symptoms.
Rash on left arm around vaccination area started on Monday morning, has increased in size since then.  Today is Thursday 4/15.  It is red, a bit swollen.  It is very itchy and hot to the touch.  Left hand also feel tingly on and off.   It is also a bit painful, feels sore like when I first received the shot.
This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergies/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported.The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Follow up information has been received from 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 2 years old. The patient demographics were updated. On 08-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
The pt experienced edema at the injection site that covered a 4 x 4 inch area. Started occurring at 10 minutes post vax. Shortness of breath started at 1 hour and 10 minutes post vax. Benadryl was given.
Pain and redness at the injection site of left deltoid s/p had Moderna Covid injection 01/28/21, noticed a bump on her arm 02/02/21 mostly discomfort lop 3/10 w/itching.
Bad body ache Severe headache Insomnia High fever Circular rash on left arm at  injection site
Progressive moderate pain in deltoid 2 days after injection was given which progressed on to severe pain with limited mobility.  Pain is worse with abduction and less with rest.
Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 16-May-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
pt was sore all over body t103 the day got shot; a wk of soreness & fever h/a; got lock jaw for 1 1/2 wks;
Painful Body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Painful Body) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041AZI) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced PAIN (Painful Body). At the time of the report, PAIN (Painful Body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient is taking concomitant medication (unspecified)  Treatment information was not provided.
Discharge Provider: MD Primary Care Provider:  PA Admission Date: 12/26/2022 Discharge Date: 1/4/2023  Clinical Narrative: Patient was recently discharged from this hospital on 12/12/2022 after a knee surgery, however while at the rehabilitation facility she was said to have contracted COVID and she was readmitted on 12/26/2022, managed for COVID-19 and also had antibiotics for possible superimposed bacterial pneumonia.  She has remained afebrile she is presently on room air saturating 94%, no leukocytosis today and cultures negative to date.  She was waiting for placement, I discussed with a case manager today and arrangements have been made for patient to be discharged back to facility.  I understand that the ultimate goal for this patient is to end up in facility afterwards.
Initial report was received on 07 October 2013 from a consumer who is also the patient. A 75 year-old male patient had received "probably in September 2012" an Influenza vaccine (manufacturer, lot number, route, site and exact date of administration not report) and approximately two months later had the "flu". According to the reporter, he had a fever of 102F and flu symptoms for 10 days. The patient was not evaluated by a physician and did not have a confirmed diagnosis. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 20-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  They accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage. No adverse event was reported for any of the patients.  Treatment medications were not reported.  This case contains information for patient 22 out of 25.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2023: Live follow-up contains significant information. Patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:master case
October 6th had 100.8 fever, fatigue and just didn't feel good. No fever on October 7th. Fatigue and didn't feel good until October 13th. Left Arm very sore from October 6 through October 12.
Within 6 hours of receiving the vaccine for Hep-B (1st in series), the pt started to develop a rash on her arm. By morning, the rash covered most of her body, except her face. Had some joint aches especially in left shoulder and left arm. Rash was erythematous, macular and pruritic.
This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 46-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: ER8736, Expiration date: Unknown) via an unspecified route of administration in left arm on 01May2021 11:45 as dose 1, single (at the age of 46-year-old) for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included spironolactone (SPIRONOLACTONE) 25 mg per day taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at the time of vaccination. Patient had no COVID, prior vaccination. Patient was not tested for COVID, post vaccination. Patient had no known allergies. On 01May2021 13:45, the patient experienced facial flushing, entire body and face felt very hot, sweating profusely all over, runny nose, scratchy throat, temperature check showed 100.5, pelvic pain and pressure /extreme bloating, felt like bladder infection, couldn't empty bladder well at all, increased urinary urgency and frequency and increased urinary urgency and frequency. On 01May2021, the patient underwent lab tests and procedures which included body temperature: 100.5. Therapeutic measures were taken as a result of events felt like bladder infection, couldn't empty bladder well at all, increased urinary urgency and frequency, increased urinary urgency and frequency. The patient was treated with Cranberry extract pills (D mannose) for bladder. The outcome of all the events was not recovered. No follow-up attempts are possible. No further information is expected.
Subsequent to third dose of Orimune, 24 hours later, the pt developed respiratory congestion. The mother stated, that each time her son received Orimune with or without concomitantly administered vaccines, he developed respiratory congestion which "often led to dx of viral URI which was treated with antibiotics". She also stated that if her son received immunizations without Orimune, then he did not develop respiratory congestion. As of 2/18/00, no further information was available.
This case was reported by a physician via call center representative and described the occurrence of fever in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and injection site induration. On an unknown date, the outcome of the fever and injection site induration were unknown. It was unknown if the reporter considered the fever and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient. After receiving SHINGRIX, the health care professional reported that she experienced greater than expected local and systemic reaction (induration about 80 into 100 mm, fever over 100.5 degree F and lesser side effects). No vaccine lot number or expiry date and no date of birth provided.
Sweats, severe and uncontrollable shivering - actually more like shakes lasting for about 30 minutes, fever, tired to point of not wanting to engage in normal light duties - lots of sleeping.