chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 07-Jun-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.) 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 WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.).    No relevant concomitant medications were reported. Route of administration was reported as BI. No treatment medication reported.   This case was linked to MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  MOD-2023-730780:master case
Patient developed motor tics 2 days after getting the Fluvirin vaccine from her PCP. The tics are not definitively related to the vaccine.
Rash on my lower arms and lower legs, my throat was swelling up and my tongue, couldn't really breathe well, and I forgot to mention I had bad diarrhea. I took Benadryl and I used albuteral inhaler from when I had bronchitis a couple years back. The rash went away the next morning and the swelling in my throat and tongue went away to. My throat was still red and itchy the next day didn't take anything for it. I also had a little bit of diarrhea the next day but it got better through the day. On the third day everything went away except me feeling tired and run down.
positive to Covid-19; positive to Covid-19; This is a spontaneous report from a Pfizer sponsored program. A contactable of an unspecified age female consumer (patient) reported that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced positive to covid-19. Patient reported that she was supposed to get the 2nd dose vaccine today however she went positive to Covid-19 and this is her 10th day of quarantine. She wanted to reschedule her appointment and she couldn't find a way to do that. The patient underwent lab tests and procedures which included sars-cov-2 test positive. The outcome of event was unknown.
Team member received MMR vaccine. Complain of difficulty swallowing shortness of breath feeling lightheaded.
Soreness in upper arm where shot was administered. Pain kept accelerating throughout next day - thought I had a joint problem.  Realized it was site of shot.  Bruise, some swelling as well.  Today is 5th day.  Took OTC painkillers last couple of days.  Can't sleep on that side.  Even hurts when I tilt back from keyboard.  Just holding it a certain way helps.
24 hours after receiving the vaccine I had chills and diarrhea which seemed standard. However, a week after the injection, the diarrhea came back for 48 hours and I broke out in full body hives. Since the initial breakout, I have hives that come and go which I treat with an OTC anti-histamine and I have dermatographia.
Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 Patients received bivalent booster with 38 having improvement of symptoms; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure systolic: 200.     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 assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    No concomitant medications were reported.   Reporter stated she has been administering the 65 plus bivalent dose to her patients who have symptoms of long-haul COVID and has seen 88-90% success rate in resolving the symptoms of long-haul COVID.  It was reported that, vaccine was given to patients for long COVID between 21-Mar-2023 and 01-Aug-2023. 42 Patients received bivalent booster with 38 having improvement of symptoms and 50s or more. Patient was treated skin lesions, scary brain, body aches. No adverse reactions occurred. Tachycardia was greater than equal to 150.  No treatment medications were reported.     This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case
MMR/KINRIX 4 days ago in quad then c/o leg pain & sl fever & red blotchy rash. Redness some over 2 days. Alert, happy. (L) quad with red blotchy spots, some muscle induration in area. A) local rxn to DTaP. P) Sx relief. CB if worsens.
Information has been received from a physician concerning an approximately 8 year old (8 or 9) year old male patient who on approximately 25-AUG-2010 (within the last two weeks), was vaccinated with a dose of VARIVAX (Merck) (Lot # not provided). Concomitant therapies included vaccination with a dose of meningococcal vaccine (unspecified) (manufacturer unspecified) (Lot # not provided) and a dose of TDAP (manufacturer unspecified) (Lot # not provided). The physician reported that the patient after receiving a dose of VARIVAX (Merck) experienced syncope in the office and was observed in office for an hour. Patient recovered in office. Follow-up information was received from a medical assistant who clarify that the patient was 11 year old. The medical assistant also stated that the patient never received VARIVAX (Merck) and the physician diagnosed the syncopal episode as being related to anxiety over an injection. Additional information is not expected.
She is 11 weeks pregnant.  On 5/19/2021 began feeling pain in her left groin area.  Didn't think too much about it.  5/20/2021 swelling and pain in left groin area.  Went to urgent care.  scheduled ultrasound.  Blood clot in Left groin detected.  Hospitalized and treated for clot with blood thinners.
Pt exp knot in leg @ site of DTP; stated pt was running & feeling fine; discussed care per protocol; 31MAR94 & mom reports to PHN that pt had shrill high pitched cry for 3-4 days; knot in leg & fever was not carried to MD;
Dizziness, brain fog, weakness, sever indigestion, headaches (lasting more than 3 days)
Information has been received from physician assistant concerning a 16 year old female patient who on unspecified date was vaccinated with 0.5 ml 3 doses of GARDASIL (lot#'s not reported). The three shots were given over the course of the year. Concomitant therapy included DEPO-PROVERA at the time of the first dose. That medication was discontinued before the second dose was given. The patient was taking an unspecified birth control medication at the time of the second dose and that was discontinued before the third shot. The patient was not taking other medication at the time of the third dose. It was reported that about a week after each dose of GARDASIL, the patient complained of severe migraine and numbness in her right arm. The patient was sent to the emergency room and was told she had complex migraines. The patient was not admitted to the hospital. The adverse event went away after a couple hours and there were no residual symptoms. The patient had not had any migraines since the one after the third shot. Each time "the numbness in her arm was the aura before the migraine, and both the numbness and the migraines resolved within a couple hours". The patient had a CT scan performed (results not provided) and was treated with a standard migraine medication. Additional information has been requested.
Error occurred when administering a dose of Pediatric Pfizer Bivalent vaccine. Clinic staff did not dilute vaccine vial prior to administration and so patient received concentrated vaccine. Estimated dose administered ~28 mcg rather than intended 10 mcg.   Patient/caregiver did not report any adverse event.
10-15 minutes after injection, pt. felt weak, dizzy and about to pass out.  Went to plant nurse. B/P 80/50. pt was transported via nurse to ER.  Blood work done with UA. Started D51/2 NS with Kt. Pt. was released around 12 noon.  MD stated this was an allergic reaction to the flu shot. When speaking with plant nurse, Nurse stated pt had similar event about 2 weeks ago.
3/23/21. I stayed at the pharmacy for 30 minutes after the shot. Itching started right before I left. I other symptoms occurred while on my way home.  Sought medical attention, transported to ER  Itching on the left side of my neck. Tingling/ numbness on my left cheek, lips, tongue and throat. Felt like I was trying to swallow around a golf ball. Burning in my chest. General body itching.   Vitals checked and monitored. Hospital administered Benadryl and monitored for approximately 3 hours.
Friday night 9/19/14 swelling started. Get worse Saturday 9/20/14. Swelling, warm at injection site to elbow. Sunday 9/21/14 swelling improves per wife statement. No fever. Wife gave ice to affected area. Pt on blood thinner so RPH told to give TYLENOL for pain and follow up w/PCP on Monday 9/22/14. Follow-up call on 9/22/14 and pt said swelling went down and didn't want us to follow-up with doctor.
COVID arm appeared exactly 1 week after first shot, large red rash on inside of arm, not at injection site.  Plus is was very warm to the touch, no ring around it.  Lasted about 3 days.
Redness, warmth, swelling, tenderness. Venous Doppler ordered, negative results. Antibiotics & steroid given if symptoms got worse.
Mother took pt to the ER for questionable fever of 103 and chills. ER assessed the baby to be at normal temp. Blood and urine tested results were negative. Questionable chills vs. seizure. Temp taken at home was axillary.
About 30 minutes after shot, patient experienced tightness in her chest and shortness of breath. She was at home at this time and just waited to see if it got worse. It lasted about 2 hours and then went away. Later that night, she experienced the same symptoms for about 1 hour. I talked to her the next day and she has not had anymore episodes,  She did not receive any treatment.
Received dose 3 on 22Oct2021; Soreness at the injection site; This is a spontaneous report from a contactable consumer (Patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 42-year-old female patient(not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0188), via an unspecified route of administration, administered in left arm on 22Oct2021 15:45 (at age of 42-year-old)as dose 3 (BOOSTER), single for covid-19 immunization in hospital. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine and she was not diagnosed with COVID-19 prior to vaccination. On 12Mar2021(at age of 41-year-old), the patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN6206), via an unspecified route of administration, administered in left arm  as dose 2, single for Covid-19 immunization and experienced sore arm and Low-grade fever (100.2). On 22Feb2021(at age of 41-year-old), the patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL9266), via an unspecified route of administration, administered in left arm as dose 1, single for Covid-19 immunization and experienced soreness at injection site. Medical history included asthma and overweight and the known allergies were Penicillin, possibly aspartame. Concomitant medications in 2 weeks included ibuprofen (ADVIL), probiotics and tocopherol (VITAMIN E). The patient experienced soreness at the injection site on 22Oct2021. The patient underwent lab tests and procedures which included body temperature: 100.2 fahrenheit on 13Mar2021. The outcome of soreness at the injection site was recovering with treatment including paracetamol(Tylenol). Since the vaccination, the patient has not been tested for COVID-19.  No Follow-up attempts are needed. No further information is expected.
Headache, Sedation, Myalgia, Fever, First felt somewhat lethargic, then this morning chills,  body aches, headaches; some relief with Tylenol Narrative:  Other Relevant History:
Vaccine administered on 4/08/2022 expired on 4/06/2022
ENTIRE LEFT ARM IS FEELING ACHEY; MUSCLE ACHE AT INJECTION SITE; This spontaneous report received from a patient concerned a male of unspecified age. 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: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 17-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-JUL-2021, the subject experienced entire left arm is feeling achey. On 22-JUL-2021, the subject experienced muscle ache at injection site. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from entire left arm is feeling achey, and muscle ache at injection site. This report was non-serious.
Adverse: 1. Injection site bruising 2. The area of the skin where the injection was administered has sunk. It was indented.
8 hours after vaccine, extreme chills, fever chest pain  8-12 hours after extreme exhaustion  8-24 hours nausea, shooting pains in extremities, aching in joints
my leg muscles got extremely weak; i had great difficulty standing without my knee's buckling; i had great difficulty standing without my knee's buckling; severe neuro/muscular issues; severe neuro/muscular issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "idiopathic peripheral neuropathy" (unspecified if ongoing); "Charcot Marie Tooth disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Primary Immunization series, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, Primary Immunization series, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious), 2 weeks after the suspect product(s) administration, outcome "unknown", described as "my leg muscles got extremely weak"; DYSSTASIA (non-serious), JOINT INSTABILITY (non-serious), all with latency 2 weeks after the suspect product(s) administration, outcome "unknown" and all described as "i had great difficulty standing without my knee's buckling"; NERVOUS SYSTEM DISORDER (non-serious), MUSCLE DISORDER (non-serious), outcome "unknown" and all described as "severe neuro/muscular issues". The events "my leg muscles got extremely weak", "i had great difficulty standing without my knee's buckling" and "severe neuro/muscular issues" required physician office visit.  Additional information: Reporter wanted to ask if any patients who took the Covid booster experienced severe muscle pain in the legs. Patient had 3rd booster in Dec2021 and about two weeks later leg muscles got extremely weak and had great difficulty standing without knee's buckling. Patient had severe neuro/muscular issues. Patient had idiopathic peripheral neuropathy and Charcot Marie Tooth disease. Patient's neurologist told that other patients also experienced muscle pains.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
16 month with tactile fever, took ibuprofen, then febrile seizure. Diagnosed in ER setting at Hospital. Seizure lasted 2 minutes. Seizure was 9 days after immunizations, and a few days of decreased solid intake. On PE TM's not visible in ER T max 103.
lost appetite; Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lost appetite) and VACCINATION SITE PAIN (Soreness in arm) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, LOSARTAN and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness in arm). On 24-Jan-2021, the patient experienced DECREASED APPETITE (lost appetite). At the time of the report, DECREASED APPETITE (lost appetite) and VACCINATION SITE PAIN (Soreness in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Patient denied to identify herself and refused further FU
The pt came in to  the pharmacy requesting her first dose of the Covid-19  vaccine. She was given the immunization in the  IM  in left arm .  We asked her to wait in the store for 15 min  to  make sure she didn't  have any adverse reaction.  Ten minutes later the husband called out to say his wife was feeling really dizzy and  laid  down on the couch . We immediately called 911. The patient did not lose conscientiousness.  She looked pale.  EMS came 5 minutes later and transported her to the hospital.
This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 29-MAY-2014, the patient was vaccinated with RECOMBIVAX HB 2.5/0.5, lot# 1106AA; Secondary and concomitant therapies were not reported. Pharmacy technician reported that the patient received an expire dose of RECOMBIVAX HB on 29-MAY-2014 (reported as 29-MAY-2013). Pharmacy technician reported that the RECOMBIVAX HB did not have any previous temperature excursion. No adverse symptoms reported. Additional information has been requested.
Information has been received from a registered nurse concerning two female patients (ages unknown), who, on unspecified dates, were vaccinated with doses of GARDASIL. Subsequently, the patient fainted in the office post vaccination. At the time of the report, the patients had recovered. No product quality complaint was involved.  Follow-up information received 4/16/2008. This is one of two reports from the same source. Additional information has been requested.
I was having a sore throat which I woke up with.  By Tuesday it was worse, and I was having a cough and it just got worse. I took a COVID-19 Home Test on that Wednesday, and it was negative, but I was still really sick. I was having body aches and just feeling terrible. This was still happening, and it had been about a week by that point and I reached out to my healthcare provider, and they got me on a zpack. By the next day I was doing so much better and on the mend.
pain in joint of rt elbow 1 hr p/inj & cont to get worse for a wk;spread to lt elbow for 3 days;rt elbow appear to be improving slowly but still painful
Shingles (Herpes zoster without complication).  Pain developed on right shoulder blade with two hours of injection.  I could not see the rash so I did not know what was wrong, and associated it with my frozen shoulder.  Took acetaminophen and naproxen for the pain; neither pain-killer alone was effective.  On 4/15  my doctor identified the rash on my shoulder and took a photo.  The pain had begun to subside on 4/13, but is still painful enough to require the painkillers.