chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No AE; HCP calling to report that 2 doses from PROQUAD lot, which expired on 4/6/2023, were administered on 4/11/2023. No further information provided, no additional AEs, no PQCs. (LOT U031564 EXP 4/6/2023); This spontaneous report was received from a site coordinator (also reported as medical assistant ), concerning to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 11-APR-2023, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter/once, (lot #U031564, pending lot validation expiration date: 06-APR-2023) (albumin status recombinant human albumin) administered for prophylaxis (strength, and route of administration were not provided).  This is one of the two cases created from the same reporter.; Sender's Comments:  US-009507513-2304USA003834:
I had a pretty debilitating immune response. Headache, body aches and fatigue. The worst problem though was that I started bleeding 2 weeks before my period was due and it was the most heavy period I have ever experienced. Large clotting and extremely uncomfortable.
body aches; chills; pain in arm injection site; really weak; wobbly; felt very ill; faint; persistent headache (worsening); Neck pain; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (body aches), CHILLS (chills), VACCINATION SITE PAIN (pain in arm injection site), ASTHENIA (really weak) and GAIT DISTURBANCE (wobbly) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (body aches), CHILLS (chills), VACCINATION SITE PAIN (pain in arm injection site), ASTHENIA (really weak), GAIT DISTURBANCE (wobbly), MALAISE (felt very ill), DIZZINESS (faint), HEADACHE (persistent headache (worsening)) and NECK PAIN (Neck pain). At the time of the report, MYALGIA (body aches), CHILLS (chills), VACCINATION SITE PAIN (pain in arm injection site), ASTHENIA (really weak), GAIT DISTURBANCE (wobbly), MALAISE (felt very ill), DIZZINESS (faint), HEADACHE (persistent headache (worsening)) and NECK PAIN (Neck pain) outcome was unknown.        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.
-Vaccine given 3 days beyond use-by date of 12/31/21 (in error) -Vaccine thaw date of 11/30/21 -Manufacturer contacted who recommended re-vaccination as no viability data available beyond 32 days from thaw date. -Child's mother informed who elected to discuss the issue with her PCP and possibly get re-vaccinated at another private facility -New policies adopted at Medical Center to improve tracking of the use-by date of every COVID vaccine.
Pt had near syncope after IM injections. BP 100/75 No problems breathing no syncope no skin rash. Does not appear to be allergic reaction. Pt observed in office 15 min.
Facial swelling on Lt side around outside of mouth and inside the lt side of mouth, sore inside lt cheek inside mouth. Went to walk in clinic today @ 230pm. Provider unsure of cause and instructed to gargle with salt water, continue benedryleevery 4-6 hours and was prescribed amoxicillin 500 BID x 7 days. Recheck appoint with PCP 1 week. If worsening symptoms go to ER
Information has been received from a 62 year old female patient, who is also a Registered Nurse, referring herself. Concurrent conditions included allergy to aspirin (manufacturer unknown) (Captured in Regulatory reference # 1608USA005348) and epinephrine. There was no pertinent medical history. On 22-JUL-2016, the patient was vaccinated with a dose of ZOSTAVAX, via subcutaneous route, frequency reported as "once", (lot number L044530 and expiration date o 09-FEB-2017) (strength was not reported). Other suspect medications were not provided. There were no concomitant medications. On 28-JUL-2016, the patient experienced a rash on the right side of neck after receiving ZOSTAVAX, and the next day, on 29-JUL-2016, the rash spread further on back of the head and then jaw and ears. It was reported that the patient sought medical attention (unspecified) on an unknown date in 2016, and treatment with VALTREX and an unspecified pain medicine was given for the rash. Laboratory diagnostic studies were not performed. No product quality complaint was involved. At the time of reporting, the patient was recovering from the rash (also reported as the adverse event did not improve). The relatedness between the rash and therapy with ZOSTAVAX was not reported. This is one of two reports from the same reporter. Additional information has been requested.
Patient experienced fever to 103 and seizure about 28 hours after vaccine administration. Also had some fatigue. Since vaccine notes ongoing fatigue and weakness. Having some chest discomfort without wheezing that has been responsive to albuterol.
If it's been longer than 6 months for the 2nd dose of Shingrix, will they have to start the series again; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received a dose of Shingrix on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: If it's been longer than 6 months for the 2nd dose of Shingrix, will they have to start the series again). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 18-May-2023 The reporter asked that if it was been longer then 6 months for the 2nd dose Shingrix, would they have to start the series again. The medical information did not speak with the health care provider, so please follow up with the sales representative for more information. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Right arm has severe to mild severe pain lifting it from the base of the body. Pain does not go away after 21 days and counting. Physician says I am victim of Arthritis which I do not accept as I did not have any arthritis in the right arm prior to this incident of taking the shot.
MMRV administered to 3 month old male due to medical facility error. No documented reaction at the time of administration.
Integumentary exam: (L) leg anterior thigh blanchable, erythematous area with small papules in the middle 3.5 cm x 2 cm (R) anterior thigh rash 2.5 cm x 1.5 cm, blanches, erythematous 1 papule in center-per Dr.
I had a painful lump in my right breast, nearish the armpit.  It started as a pea then grew in size as time progressed.  At its largest it was the size of a nickel, if it were a sphere.   I had an inconclusive mammogram and then an ultrasound.  No mass was seen and it was determined to be a stolen lymph node.  Over the last five weeks, the pain has been diminishing but it?s not totally gone.
right arm hurt for a couple of days, very exhausted for 2 days, developed large, round, red rash at injection site, not very itchy, going away slowly, no problems
Moderna Dose Number 3 / Pfizer Dose Number 1; Is pregnant: Yes/Last menstrual date: 22Oct2021/Delivery date: 28Jul2022; Lichen planus on vagina which is now causing infertility; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 20Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation. Date of last menstrual period: 22Oct2021. The patient was 4 weeks pregnant at the time of exposure to BNT162b2. The patient was 45 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 28Jul2022. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna covid-19 vaccine (Dose Number: 1, Batch/Lot No: Not sure), administration date: 09Apr2021, when the patient was 29-year-old, for Covid-19 immunization; moderna covid-19 vaccine (Dose Number: 2, Batch/Lot No: Not sure), administration date: 07May2021, when the patient was 29-year-old, for Covid-19 immunization. The following information was reported: LICHEN PLANUS (non-serious) with onset 07Dec2022, outcome "not recovered", described as "Lichen planus on vagina which is now causing infertility"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Moderna Dose Number 3 / Pfizer Dose Number 1"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Is pregnant: Yes/Last menstrual date: 22Oct2021/Delivery date: 28Jul2022". Therapeutic measures were not taken as a result of lichen planus.  Additional information: If covid prior vaccination: No. If covid tested post vaccination: Yes  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Mother called morning of 9/15/2010 to report that her son c/o sore arm on awaking today. This morning she reported that the arm was red, warm to the touch and was swollen about 4+ inches in diameter near site of the injection. She took her son to the doctors and she called to say that the site appears to have decreased in size since this morning. The doctor encouraged her to use ice and to call back if the swelling doesn't go down in 24 hours. Docotr did not prescribe any antibiotics at time of the visit. Mom did not bring him to the health department for  me to observe the adverse event. MOM indicated he didn't have a temperature. She did say doctor thought that perhaps the IM was given subq. I indicated to her that I did use a one inch needle routinely. Though he was an overweight child the arm diameter did not warrant and larger size needle.
This spontaneous report was received from a physician via a company representative and refers to a male patient in his 60's (exact age was not reported). The patient's pertinent medical history, drug reaction or allergies and concomitant medications were unspecified. On an unknown date (also reported as within the last year or two), the patient was vaccinated with one shot of ZOSTAVAX (lot #, expiration, date and dose were not reported), subcutaneously. On an unknown date after administration of ZOSTAVAX, the patient experienced vaccination failure. He developed a bad case of shingles. The patient sought medical attention, saw his physician and was administered unspecified antivirals and possibly gabapentin for shingles. The patient recovered from the events on an unknown date. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
another ache in the same arm on a different site/ on his inside bicep area/it's not real severe/it hasn't gone away yet; it feels like a tenderness/like when you work the muscle too much; he had a sore arm from the next day which lasted for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (another ache in the same arm on a different site/ on his inside bicep area/it's not real severe/it hasn't gone away yet), TENDERNESS (it feels like a tenderness/like when you work the muscle too much) and MYALGIA (he had a sore arm from the next day which lasted for a couple of days) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced PAIN IN EXTREMITY (another ache in the same arm on a different site/ on his inside bicep area/it's not real severe/it hasn't gone away yet), TENDERNESS (it feels like a tenderness/like when you work the muscle too much) and MYALGIA (he had a sore arm from the next day which lasted for a couple of days). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (another ache in the same arm on a different site/ on his inside bicep area/it's not real severe/it hasn't gone away yet) had not resolved, TENDERNESS (it feels like a tenderness/like when you work the muscle too much) outcome was unknown and MYALGIA (he had a sore arm from the next day which lasted for a couple of days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported
Moderna COVID-19 Vaccine EUA Pt found unresponsive with seizure at her skilled nursing facility.  Pt had first dose of vaccine earlier in the afternoon prior to being found unresponsive and seizing.
GOT SICK; IT WAS LIKE THE FLU; This spontaneous report received from a consumer concerned an 18 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, (dose number in series 1), start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, 10 hours after he got the vaccine (during night) the patient got sick and it was like the flu for 8 hours (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient additionally received covid-19 vaccine ad26. cov2.s. (manufacturer not specified) (suspension for injection, route of admin, batch number and expiry date not reported), (dose number in series 2) 01 in total, administered dose was not reported for prophylactic vaccination. No adverse events were reported following vaccination with covid-19 vaccine ad26. cov2. s (dose number in series 2). The patient recovered from got sick, and it was like the flu. This report was non-serious. This case, from the same reporter is linked to 20220110608, 20211265856 and 20220110776.
Pt developed 3"x4" erythema with swelling and tenderness over the site of the DTaP on right deltoid. Pt able to take swimming lessons but swelling did spread to under arm but improved with ice and Advil.
Patient turned cyanotic and passed out approx. 1 minute post shot while sitting on a chair. He could not speak or respond for a minute. . Pharmacy staff were called upon and pt responded initially to the pharmacist, then almost immediately appeared cyanotic, We thought patient may have had a syncope and then an absence seizure. Pt was helped to the ground while 911 was called. We had Epipen to use, but patient began responding.  He was oriented to time x2  and place.  He was alert for the remainder of the time and through paramedics examination.
Patient brought to the ED with worsening weakness and congestion.  Patient admitted to the hospital with Covid and treated with remdesivir.
I had my two initial [Pfizer] vaccines and three boosters/ I did get Covid; I had my two initial [Pfizer] vaccines and three boosters/ I did get Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Feb2023, outcome "recovered" and all described as "I had my two initial [Pfizer] vaccines and three boosters/ I did get Covid". Clinical course: Patient felt that it was important to be vaccinated against Covid so had two initial Pfizer vaccines and three boosters. Patient got Covid in February and because she was fully vaccinated, she only dealt with Covid for two days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pretty significant rash all over her body that look like underlying diffused erythema with a multiforma look.; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date in Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation and the patient experienced a few small red spots on her body. The patient experienced pretty significant rash all over her body that look like underlying diffused erythema with a multiforma look on an unspecified date. The outcome of the event was unknown. The 2nd dose, which she received last week (in Apr2021), blew her up with a pretty significant rash all over her body that look like underlying diffused erythema with a multiforma look. She mentioned that she was already given steroids at a fairly moderate amount without improvement. She is considering on giving her a high dose of steroids. She is asking if there have been any reports on this and for any input on the situation. Response: Was going to offer information on the reports of allergic reactions but caller clarified that what happened to the patient was not histamine-mediated. Mentioned to caller that there was no specific data on non-histamine-mediated skin reactions. Offered data on use with immunosuppressive therapy to address higher steroid dose issue but caller mentioned that it will not be helpful. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Considering the plausible temporal association, the reasonable possibility that the event reported as ' Diffused erythema with a multiforma look' (Erythema multiforme) is related to BNT162B2 vaccine cannot be excluded. No alternative explanations were reported.   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 agency, as appropriate.
Nausea, diarrhea, severe stomach  pain, sweating, vomiting, no appetite, fatigue.
Information has been received from a physician, concerning an 18 year old female who on 23-JUL-2007 was vaccinated IM in the right arm with the first dose of Gardasil (lot #657737/0522U), and with a dose of PPD (manufacturer unspecified).  There was no concomitant medication.  Following the vaccinations, she reported she "didn't feel well," and spent 1 day in bed.  On 24-SEP-2007 the patient was vaccinated IM in the right arm with the second dose of Gardasil (lot #658560/1062U), and within 4 hours her right eyelid became itchy and swollen.  On 26-SEP-2007, she was seen in the office.  Treatment included a nonspecified steroid dosepak, BENADRYL and ice.  At the time of this report, the patient had not recovered from the swollen and itching eyelid.  Additional information has been requested.
Student standing at table to receive juice student started falling, this nurse grabbed him under both arms, holding student up asked for help and parent volunteer took students legs and we lowered  him to floor on his side-student legs stiff and head jerked a few times before waking.
60 hours after receiving the first Moderna dose I woke up with acute GI bleeding. I am very healthy, athletic, in good shape and rarely get sick. I was transported via ambulance because I passed out in my bathroom. It took 5 days and 4 blood transfusions before they found the bleed, a GIST in my small intestine. My hgb dropped below 7 four different times warranting 4 blood transfusions while they tried to find the cause of the acute bleed. Small bowel resection surgery to remove the gastrointestinal stromal tumor.  Either the vaccine caused the GIST but most likely it stimulated a change in the DNA to start the bleed.
After the second dose I began to have joint pain and face break outs. Joint pain is in my ankles and in my knees as well as my shoulders, elbows and neck. Doctor stated it was probably arthritis. But allergy doctor did allergy tests to check to see if it was allergy related. I began to have a vitamin D deficiency after 2nd shot. I began to have diarrhea in July through September 2021 and was diagnosed with Colitis. Two colds since 2nd dose, congestion and sinus pressure with cough. I had COVID-19 in March of 2020 and lasted about one month.
6PM fussiness, crankiness, felt warm;7PM t100 ax-lt leg started to swell-cold compress applied;14JUN96 AM t99 ax, leg still swollen;took to sitter-sitter called mom 12noon t103 ax, legs trembled, eyes rolled back in head;high pitched scream
11 days after the 1st dose, I got sick with Covid. Muscle aches, sore throat and positive PCR.
Sore arm and mild chills 5 hours after injection. Moderate chills, fatigue, headache, sore arm 20 hrs after injection. Went to bed and slept 2 hrs, started feeling better 26-36 hours after injection. Completely recovered by 48 hrs.
Burning prickling pain in hands on November 14. Second week of December I had three tests done- emg, blood work. And mri of cervical spine. December 15 - burning pain and prickling felt in feet.  Beginning in end of December  - widespread muscle  and joint pain along with involuntary twitching and jerking.  Current treatment for pain is not relieving symptoms leading to significant reduction in quality of life.
Headache and body aches beginning the day after the second dose of the vaccine.  The body aches were mild and subsided within 24 hours, but the headache persisted for more than a month.
Chills, weakens, and high fever for 36 hours. Temp ran from 101 to over 103 for 36 hours.T emp perked  at over 103 for 5 hours. Took tylenol for this.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown ages and genders. There was no information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies provided. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (lot # M041184 with the expiration date of 31-MAY-2018; dose number and exact dose were not reported), orally, for prophylaxis. No adverse effects were reported. The administered doses of vaccine experienced a temperature excursion of 51 Fahrenheit degrees for 15 minutes. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA002664: