chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PAIN BY TAIL BONE (SHARP); MUSCLE PAIN; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced pain by tail bone (sharp). On 13-MAR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 14-MAR-2021, and muscle pain on 15-MAR-2021, and had not recovered from pain by tail bone (sharp). This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Information has been received from a physician concerning a 61 year old female who on 06-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) at a local pharmacy (not the physician's office). On 10-APR-2011, 4 days after the injection, the patient experienced injection site pain, a good deal of redness and swelling at the injection site. On 13-APR-2011, the injection site was still providing discomfort, redness and swelling and had steadily increase to be about the size of a half dollar at the injection site. It was noted that the injection site was at an atypical spot, and was almost at the arm pit on the underside of the arm which was unusual. The patient visited the physician's office and sought medical attention. Upon the time of the report, the patient's present status was unknown. This is an amended report. "Vaccinated at" and "Vaccine Purchased with" now read as "unknown" instead of blank. Additional information has been requested.
Patient said her arm swelled up similar to that of "Moderna arm," but has since gone away. She said after 2 weeks, she still has a fever around 100 degrees. She said she has been to the emergency room. They just told her to take acetaminophen and gave her a COVID-19 test, which turned out negative. She saw her primary care MD today and likely got another COVID-19 test. She said the fever has made her feel very tired and she may need a LOA from her job if this doesn't subside soon. I suggested trying ibuprofen or aspirin in conjunction with the acetaminophen to see if that could possibly help to get the fever down.
Beginning March 11 I began having a reaction that has affected both breasts.  The areolas and nipples began to be very sensitive to the touch,  experienced a "stinging" sensation and it felt as if needles were poking them when touching, they turned red and were swollen.  The reaction began to subside on March 18 and finally  dissipated; however, on April 10 they began again, very severe this time and continued until May 13 when they began to subside.  The sensations did not completely disappear and began again on May 25 with mild sensitiviy.  On June 7 the sensitiviy began to grow more severe and both have become just as sore as before.  I intend to contact my physician today to inquire about a resolution - possible antidote?  I cannot continue this as it is very painful!
SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer via other company manufacturer (Moderna) concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received booster dose of non-company suspect vaccine Spikevax (Moderna covid-19 vaccine, elasomeran) (dose number in series 2) (injection, intramuscular, batch number: unknown and expiry: unknown) dose not reported, administered on an unspecified date for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 2).  On an unspecified date, the patient experienced Covid soon after covid (suspected COVID-19 infection) and had it for a week and it was treated with pfizer medication (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Redness, swelling, warm to touch, pain at left upper arm. Ice put on site, tylenol, mortin.Pt seen in office told to do warm compress, benadryl and call back if developes sign of infection.
mild itchy rash on left forearm which stayed same x4 days, then day5 rash spread to right arm, then day 6 left arm worsened; Rash is spending to upper chest and left axilla; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in Arm Left on 25Feb2021 13:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Hx of ovarian, melanoma cancer, aortic.stenosis, asthma. Patient previously received sulfur and experienced known allergy. Patient previously received Compazine and experienced known allergy. Patient previously received proparapaine eye drops and experienced known allergy. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, from unknown start date; losartan (LOSARTAN) taken for an unspecified indication, from unknown start date; fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for an unspecified indication, from unknown start date; amlodipine (AMLODIPINE) taken for an unspecified indication, from unknown start date; montelukast sodium (SINGULAIR) taken for an unspecified indication, from unknown start date. The patient previously took sulfur for hypersensitivity, compazine spansule for hypersensitivity, proparacaine hcl for hypersensitivity. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 26Feb2021 08:00, the patient experienced mild itchy rash on left forearm which stayed same x4 days, then day5 rash spread to right arm, then day 6 left arm worsened, rash is spending to upper chest and left axilla. Doctor seen day7 given short acting cortisone and meds for itching rash improved day 8 then worsened day9 thru current date day11 is 08Mar21 rash was extremely itchy could not sleep itching only relieved with ice. Rash is spending to upper chest and left axilla. She was miserable with itching no other symptoms. Therapeutic measures were taken as a result of mild itchy rash on left forearm which stayed same x4 days, then day5 rash spread to right arm, then day 6 left arm worsened, rash is spending to upper chest and left axilla. Event resulted in Doctor or other healthcare professional office/clinic visit. The clinical outcome of events were not recovered.  No follow-up attempts are possible. No further information is expected.
The patient received a Heplisav-B vaccine on 9/22/2022 that had expired on 9/17/2022. The patient did not experience any adverse events from the expired vaccine. She was notified of the incident.
Severe muscular and bone pain/aches. Aches were so intense they led me to tears. Fever of 102.5 F. (sustained fever between 100-102.5 for 6 hours). Chills and susceptibility to cold. Painful, but less severe aches continued through the next day (24+ hours).
Rash; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration on 01Jul2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, I have gain a rash on all over my body as per, in my arms and my legs on an unspecified date in Jul2021. Patient took a vaccine on the 01Jul2021 and I was wondering, that's normal or do I have to go to ask. The outcome of event was unknown.  Information on the lot/ batch number has been requested.
Patient presented to the ED and was subsequently hospitalized on 2/17/21. He presented to the ED on 3/22/21. He presented to the ED on 3/24/21 and was subsequently hospitalized. These visits are within 6 weeks of receiving COVID vaccination.
Pt c/o mottling of palms, tingle in arm; pt became hypertensive with headache within 15 minutes of vaccine; symptoms resolved and pt dc from ED
tongue started to swell, it got red, it was burning; tongue started to swell, it got red, it was burning; tongue started to swell, it got red, it was burning; Canker sores; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (tongue started to swell, it got red, it was burning), TONGUE ERYTHEMA (tongue started to swell, it got red, it was burning), TONGUE DISCOMFORT (tongue started to swell, it got red, it was burning) and APHTHOUS ULCER (Canker sores) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced SWOLLEN TONGUE (tongue started to swell, it got red, it was burning), TONGUE ERYTHEMA (tongue started to swell, it got red, it was burning), TONGUE DISCOMFORT (tongue started to swell, it got red, it was burning) and APHTHOUS ULCER (Canker sores). At the time of the report, SWOLLEN TONGUE (tongue started to swell, it got red, it was burning), TONGUE ERYTHEMA (tongue started to swell, it got red, it was burning), TONGUE DISCOMFORT (tongue started to swell, it got red, it was burning) and APHTHOUS ULCER (Canker sores) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient said she had these mixed nuts containing peanuts, walnuts and almonds from Christmas and ate some on Jan14. The patient thought this was weird as she never had a nut allergy and she didn't see this as one of the side effects from the Moderna COVID-19 vaccine. No concomitant medication details were provided. No treatment medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021:  On 18-Jun-2021: Reporter contact information updated; Reporter's Comments: .; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pain in her legs; Lot of vascularity; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in her legs), PERIPHERAL VASCULAR DISORDER (Lot of vascularity) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Leg pain (Patient stated that she usually has leg pains before the vaccine, doesn't have pain while moving the gastrocnemius and the vascularity reduces when getting the leg up.).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in her legs), PERIPHERAL VASCULAR DISORDER (Lot of vascularity) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Pain in her legs), PERIPHERAL VASCULAR DISORDER (Lot of vascularity) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Treatment information not provided.
Approximately two hours after receiving Tdap right arm became numb from shoulder to the hand. No redness or swelling noted.
Fever 104.7 degrees, full body muscle aches, headache, nausea, chills Took Tylenol & drank water Resolved within 10 hours
Case number PHEH2013US017662 is an initial spontaneous report from the nurse received on 16 Aug 2013. This report refers to a 12-year-old female patient. She was vaccinated with MENVEO (batch number: M12129) via intramuscular route on 07 Aug 2013. On an unknown date, "a little while" after vaccination the patient experienced blisters that broke out around the injection site. The outcome of the event was not known at the time of reporting. The seriousness and causality of the event were not reported. No other information was available.
she felt run down; This case was reported by a consumer and described the occurrence of unwell in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd June 2020, the patient received the 1st dose of Shingrix. On 3rd June 2020, 1 days after receiving Shingrix, the patient experienced unwell. On 4th June 2020, the outcome of the unwell was recovered/resolved.   It was unknown if the reporter considered the unwell to be related to Shingrix.  Additional information was provided as follows: The next day of receiving vaccine, the patient felt run down but resolved after one day. The reporter did not consent to follow up. For tolerance of 2nd dose, refer case US2020252523.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020252523:same reporter
Information has been received from a nurse practitioner concerning a 14 year old female who, on an unspecified date, was vaccinated with a dose of Gardasil. On an unspecified date, the nurse practitioner stated that she "received an email from the CDC with a picture of a girl who had bruises and redness after receiving the Gardasil." At the time of this report, the outcome was unknown. No product quality complaint was involved. No further information is available.
20 to 30 yrs old & vaxed w/2 doses of MMR & lab eval revealed neg titers; No further details were provided; nurse reported 8 pts;
He has tested positive 30JUN2021 with symptoms of stuffy/runny nose; This is a spontaneous report from contactable reporter (patient mother) via COVAX US Support. A 15-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8729, Expiry Date: Unknown), via an unspecified route of administration, administered in the left arm on 24Jun2021 at 14:00 (at the age of 14-year-old) as a single dose for covid-19 immunisation at Hospital. The patient had no medical history and did not administered any concomitant medications. The patient does not take any regular medications or have any other medical conditions. Reporter stated no, thank God, he's healthy. Patient did not receive any prior vaccinations (within 4 weeks) and AE following prior vaccinations. The patient had no family medical history. The patient went through a drive through Covid-19 screening facility at the health department. Patient received his first dose of the Pfizer Covid-19 vaccine on 24Jun2021. He was exposed to Sars-COV-2 on 26Jun2021 on his birthday and after 6 days from vaccination, patient tested positive, which was confirmed by PCR test on 30Jun2021 and had a stuffy/runny nose. She (patient mother) reported that he had another Covid-19 PCR test done today, 02Jul2021, but they do not have results yet. She stated that there is a small chance that the patient received a false positive on Wednesday, 30Jun2021, but you never know, and she enquired if the patient's PCR test from today, 02Jul2021, came back negative, would he still be able to get the second dose of the Covid-19 vaccine after 3 weeks. Currently awaiting for PCR test, antigens test resulted negative. She enquired whether she should delay the second dose of the Covid-19 vaccine or not for her son. HCP indicated to wait ninety days for second dose. The patient underwent lab tests and procedures which included sars-cov-2 PCR test, which was positive on 30Jun2021, 2 Covid-19 antigen tests which were negative on 30Jun2021, Covid 19 PCR test unknown, has not resulted yet on 02Jul2021. The event did not result in emergency room or physician office. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
9/10/03 4:45 pm, received call from father states leg is swollen, painful. PHN instructed family to see MD and asked family to report back to health dept. 9/11/03 11:40 dad brought child to HD to show PHN he waso n his way to MD to have family physician leg was swollen from mid knee up to fold in leg. Given antibiotic Keflex.
Vaccine might have been stored under condition that departed from the manufacturer's recommended specification, so vaccine was deem not viable, so additional vaccine was recommended for patient.
Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.; No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) and NO ADVERSE EVENT (No adverse 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. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history/conditions, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis).     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) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) 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 EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.).    Patient did not received any other vaccines in the 4 weeks prior to Covid-19.  No concomitant medications were provided.  The vaccines were administered between 13-Mar-2023 to 05-Jun-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. Health care professional was looking for the availability of the vaccine.  No treatment medication was provided.  This case contains information for the 15th of 20 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master Case(Patient 1)
Swelling at injection site, fever, chills, body aches, headache, rash. This is 15 days later and i still have hives and a knot at injection site. It is very sore still and itches also have shooting pain in the arm at the site. I have been on prednisone now since 6/29/06.
Gave the wrong dose of 0.3ml or 30 ug Gray cap instead of 10 ug 0.2ml
Total body urticaria 2 weeks after receiving booster.   Same occurrence with previous dose of Moderna.
The day following the immunizations, Pt developed blood in stools. this continued on 12/31/20 when he was seen in clinic, noted to have hemoccult positive in clinic.  Placed on a dairy free diet.  Over following 2 days continued to have diarrhea with occasional blood in stools and developed increased spitting up.  Seen on 1/2/21 again and abdominal x-ray normal, infant with normal abdominal exam.  By 1/5/21 symptoms have all fully resolved
Muscle pain; Joint pain pretty bad; Very weird feeling on the throat like swollen; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported that female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, lot/batch number: not provided), via an unspecified route of administration on 11Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that the patient started to feel bad on the 18-21Jan2021 namely having muscle pain, joint pain pretty bad and very weird feeling on the throat like swollen. Outcome of the events were unknown.  Information on the Lot/Batch number has been requested.
Patient was under the appropriate age to receive Moderna Vaccination. When mother called to be made aware, she stated that patient did not have any abnormal symptoms to receiving vaccine. Mother states that patient only had arm soreness from the injection.
On 8/22/11, pt/parent described reaction to HPV vx 2/15/11 as "rash", per PA. On 8/26/11, pt/parent described "lip & (R) face swollen x1d then resolved" as rx to HPV vaccine 2/15/11.
Menstrual cycle is a week late (not sexually active and no other life changes); Getting period cramps sans the bleeding; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 13Apr2021 at 13:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to cinnamon. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medication within two weeks of vaccination. On 20Apr2021, the patient experienced menstrual cycle is a week late (not sexually active and no other life changes) and getting period cramps sans the bleeding. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events menstrual cycle is a week late (not sexually active and no other life changes) and getting period cramps sans the bleeding was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt received COVID vaccine on 4/9/21. Became COVID positive on 4/13/21. Admitted to the hospital on 4/18/21.
patient lost consciousness after sitting in post vacc. Stated it has normal reaction to vaccines. lost consciousness again. EMS dispatched treated and released patient
had an episode of syncope 1 day after 2nd vaccination after experiencing severe chills and weakness post vaccination
The pt experienced erythema and firmness at the site the evening of the vax. Returned to the office with increasing erythema.