chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Adult patients received pediatric doses 6 years to 11 years doses  of the Moderna COVID 19 vaccine instead of bivalent booster doses by accident; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Adult patients received pediatric doses 6 years to 11 years doses  of the Moderna COVID 19 vaccine instead of bivalent booster doses by accident) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Adult patients received pediatric doses 6 years to 11 years doses  of the Moderna COVID 19 vaccine instead of bivalent booster doses by accident). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Adult patients received pediatric doses 6 years to 11 years doses  of the Moderna COVID 19 vaccine instead of bivalent booster doses by accident) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Adult patients received pediatric doses 6 years to 11 years doses  of the Moderna COVID 19 vaccine instead of bivalent booster doses by accident).    No concomitant drug was reported. No treatment drug was reported. This case contains information for the 1st of 4 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-651022, US-MODERNATX, INC.-MOD-2022-651023, US-MODERNATX, INC.-MOD-2022-651024 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-651022:This case pertains to Adult 2 US-MODERNATX, INC.-MOD-2022-651023:This case pertains to Adult 3 US-MODERNATX, INC.-MOD-2022-651024:This case pertains to Adult 4
ARM SWELLING, RED, ITCHY WITHIN HOURS OF ADMINISTRATION. 3 DAYS LATER, SINUS SYMPTOMS X3 DAYS, THEN ASTHMA SYMPTOMS. ASTHMA EXACERBATED SEVERELY. ADMITTED TO HOSPITAL 10/7-10/9.
10-11-10 c/o back of left hand swelled & itched started in AM & increased severity in the PM 10-12-10. Left foot swelled up & itching the hand swelling decreased. 10-13-10 - Patient called-said her Dr said not to get another flu shot.
Stomach cramps from 4 a.m. - 10:30 p.m. on 5/13. The cramps worsened after eating each meal, and reminded me of having endometreosis cramping in my 40's. Also woke up with a large canker sore on the right side of my lower lip on the morning of 5/13. I typically get a canker sore when I'm very stressed, and I had been feeling fine prior to the receiving the shot, so this reaction surprised me. I did not seek medical attention for either issue, and both problems were gone when I woke up on 5/14.
My arm turned bright red and began to swell.  I experienced severe body aches and fatigue for 2 weeks.  My injection site continues to swell and is now about 6 inches across, red with yellowing in the center,, swollen, hot and itchy.  Saw my Dr. on day 15 and he said it was the worst vaccine reaction he has seen.  He recommended I report it.
Moderate pain to right side on 08/11-12, 2021.  Severe swelling of right side of face requiring Emergence room treatment on 08/13/2021 with follow-up at Primary Physician on 08/16/2021.
Severe muscle ache; Fatigue; High fever (103); Chills; Restless leg; Joint pain; Persistent headache; Mild cough; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 27Mar2021 at 12:00 (at the age of 24-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 03Mar2021 at 15:00 (at the age of 24-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On 27Mar2021 at 23:00, the patient experienced severe muscle aches, fatigue, fever (103 units unspecified), chills, restless leg, joint pain, persistent headache and mild cough. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for muscle ache, fatigue, fever, chills, restless leg, joint pain, headache and cough. The clinical outcomes of the events muscle ache, fatigue, fever, chills, restless leg, joint pain, headache and cough were resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Lack of efficacyCovid + on 1/4; Lack of efficacyCovid + on 1/4; Inappropriate age at vaccine administration; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 8 year-old male patient received bnt162b2 (BNT162B2), administered in leg right, administration date 26Nov2021 10:30 (Lot number: FK-5127) at the age of 8 years 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 Number: 1, Batch/Lot No: FK-5127, Vaccine Administration Time: 10:00 AM), administration date: 06Nov2021, when the patient was 8 years old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "recovering" and all described as "Lack of efficacyCovid + on 1/4"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 26-NOV-2021 10:30, outcome "unknown", described as "Inappropriate age at vaccine administration". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19, product administered to patient of inappropriate age. The patient did not receive other vaccine in four weeks and did not have Covid prior vaccination.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the serious events and the suspect BNT162B2 cannot be excluded.
Approx 1 month after first vaccine, she began experiencing syncope, rapid heart rate, chest pain, dizziness, palpitations, headache, shortness of breath, wheezing and nausea. She has not experienced these symptoms before and was not ill at the time of vaccination or within the month prior. The first time she passed out (01Jun2018), she was transported to the hospital by ambulance and treated with oxygen, IV fluids, aspirin, ZOFRAN, TORADOL, and albuterol breathing treatment. She was diagnosed with postural orthostatic tachycardia syndrome in May2018. She was started on 1000 mg salt tablets twice a day and increased oral fluids. On June 8th she started treatment with midodrine, which is still continuing. She may also need to be treated with fludrocortisone if her symptoms do not improve.
Hives on arms. Stomach. Lower back. Lasted for 24 hours. Did not take anything. Was not itchy. No shortness of breath. Usually happens when I get sick.
bleeding problem/issues with bleeding; bleeding in her eyeball; bruising on her legs; Prothrombin Time (PTT) was elevated; This is a spontaneous report from a contactable consumer (patient's daughter) via Medical information team and via Pfizer- Sponsored Program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced some issues with bleeding and bruising, that there was "bruising in the leg, and bleeding in her eyeball". The patient's prothrombin time (PTT) was elevated. The patient's daughter wanted to ask if it is possible that the spike protein would damage her mother's vascular system and made her mother's veins leak? But upon transfer, the patient's daughter pushed on "what doctor" does her mother need to see?. The patient's daughter mentioned that their Doctor and Hematologist both mentioned that this is not related to the vaccine, but the patient's daughter asked for more information since this happened after the vaccination. The patient has developed a bleeding problem after getting the COVID 19 vaccine. The patient has gone to the regular doctor. Her regular doctor said it is nothing to do with the vaccine. The patient had an elevated PTT. The patient has bruising on her legs, and her keeps bruising for no reason. The patient went to the doctor because of the bruising. The bruising started after the vaccine. The patient never had an issue with bruising before. The doctor sent her to the hematologist. That doctor keeps taking blood work. He says the patient's blood work is getting more normal, but this is going on three months since the second shot. They also sent her mother to the eye doctor. They found that the patient was bleeding in her eyeball. They gave her an injection in her eyeball to stop the bleeding. The caller is worried that her mother is going to bleed in her brain and have a stroke. Just like the regular doctor said, the eye doctor says the bleeding has nothing to do with the vaccine. The patient has seen a hematologist, and her blood levels are more normal. The PTT is only slightly elevated it is not 60-70 and platelets are normal. The doctors cannot explain why this could be happening. The outcome of the events was unknown.  Information about lot/batch number has been requested.
pt reported fever, body aches, swollen glands, rash;exam +adenopathy, diffuse red maculo papular rash face, arms, trunk, legs;referred to PCP for tx & eval by MD;pt devel h/a, felt achy, sore throat;viral illness;
pt recvd flu vax & devel wheezing, coughing, & excess phlegm; pt has been treated w/tetracycline, theophylline, Proventil inhaler, Pred, alupent, & cipro; pt is getting worse;
HEART PALPITATIONS, HEADACHES, VERTIGO,  SLIGHT NAUSEA, LIGHTHEADED/SLIGHT DIZZINESS  IM VERY CONCERNED ABOUT RECEIVING THE 2ND DOSE DUE TO THE PALPITATIONS.  I WOULD APPRECIATE SOMEONE CONTACTING ME OR REFERING ME TO A SITE WHERE I CAN GET A CLEARER UNDERSTAND ON THIS CONCERN.
Patient received vaccine 13:06, at 13:11 patient reporting some tingling to hands and feeling anxious. Observed for 5 minutes, patient then reports circumoral tingling, and throat tingling. 13:36: Patient reports burning to throat. Call for EMS assistance. HR 90. Color is pink, BP 130/80. No lip or tongue swelling, no urticaria, no chest pain or shortness of breathe. 13:38: Patient reports feeling better, tingling is improving. EMS arrived. Patient reports symptoms almost completely resolved. EMS Paramedic over to assess. Patient refuses EMS transport, states she feels completely recovered. 13:55: Patient discharged, daughter able to drive home.
Patient developed symptoms of muscle weakness after 3 days from flu vaccination. Pt. was hospitalized and diagnosed as GBS (Guillain Barre Syndrome).
Nausea, dizziness, pale, chills ~ 1 hr. then resolved spontaneously.
localized swelling, tenderness, redness at the injection site. no systemic symptoms such as fever. advised patient that this is a commonly reported side effect and to monitor. if it worsens, seek care and contact PCP tomorrow.
flu; Initial information received on 07-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (patient) via social media.  This case involves Adult patient who experienced flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, unknown latency after vaccination, the patient developed a non-serious flu (influenza).  Final diagnosis was flu.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  No further information was reported.
Information has been received from a licensed practical nurse concerning a 10 year old male with amoxicillin allergy who on 27-APR-1998 was vaccinated with a 0.5 mL SC first and second dose of Varivax on 27-APR-1998 (lot # 625128/0062H) and 30-APR-2007 (lot # 654527/1043F in left arm). There was no concomitant medication. There were no development of symptoms after the first dose. On 01-MAY-2007 the patient experienced a significant local reaction with symptoms described as red, swollen left arm which was "hot to the touch". The patient could not raise his arm, Ibuprofen and warm soaks were ordered for the symptoms. The patients reaction was considered to be disabling. There was no product quality complaint involved. A lot check was requested. Additional information has been requested.
pt recvd vax;had fever;t 102-103;was crying & very fussy;unable to dec T w/ apap & tepid baths;to MD,felt fever related to shots;mom also stated was having a difficulty time getting pt to take apap;tx w/ apap;pt now calm & resting;
Arm/shoulder pain, fever 101, chills, mild nausea, extreme fatigue, pain/tenderness under left armpit--lasted until Sunday, then diminishing. Fever gone on Monday though still feeling feverish.
Had cellulitis over left thigh, unresponsive to oral abx. Required IV antibiotics and 2 ED visits. Recovered without complication.
Patient was given the Moderna vaccine and she is not 18 years old yet.  This was discovered after she received the vaccine.  She has had no adverse effects from the vaccine.  This was a medication error.
1 day after vaccination, redness, tenderness, heat around injection site and down the arm about 6 inches.
increased heart rate that continued to occur intermittently over the next 24 hours; Injection site redness; Injection site swelling; Injection site heat; This is a spontaneous report from a contactable nurse, the patient. A 50-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0173), via an unspecified route of administration in the arm left on 11Jun2021 09:45 as dose 1, single (at the age of 50-years-old) for covid-19 immunization. Medical history was not reported. Concomitant medications included ergocalciferol (VITAMIN D), cetirizine hydrochloride (ZYRTEC), multivitamins and tocopherol (VITAMIN E). The patient previously took demerol and experienced hallucination. On 11Jun2021 15.30, the patient experienced increased heart rate that continued to occur intermittently over the next 24 hours, injection site redness, injection site swelling and injection site heat. The patient did not received the treatment for the events. The patient had tested positive for the covid prior to the vaccination but not tested for post vaccination. The patient did not received the any other vaccine in four weeks. The outcome of the events was unknown.  Follow-up attempts were completed. No further information was expected.
Sunday, I started having severe chills and headache. I never get headaches. I started coughing. I was really tired. I work 12 hour shifts. I'm a nurse. When I got home, I was so tired that I went straight to bed. I coughed all night long. The next morning, I called my PCP because I thought I was having a flare up on my asthma. We had a Telehealth appointment. My nose was running. My chest was tight. Since I have heart problems history, my PCP wanted me to get an MRI, but I didn't want to get exposed to Covid at the ER. We have had 3 patients at work that tested positive for Covid. My PCP set up a Covid test, but said that it may not be accurate because it was too soon. I went up to the hospital and got a test, then I came home. That's how it all started. I have lost 10lbs in the last week or so. My throat is sore today. I also have an ear ache. Things don't taste right. I can taste, but it's like a metallic taste.
Covid19 breakthrough. Vaccine received on 05/17/2021.  66 y/o PMHx HTN, T2DM, Stage 4 liver cancer presents to ED with c/o of severe RUQ pain and increasing abdominal girth.  Pt was recently discharged from hospital where was treated for Bacteremia and GIB.  Pt afebrile, Room air sats 95% and CXR- unchanged with patchy opacities.  Per ID no specific treatment for Covid at this time, monitoring.
Information has been received from a medical assistant referring to a 15 months old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K016153 with expiration date 24-SEP-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Instant tension headache where it felt like a band tightened around the crown of my head for several hours. Soreness like associated with a TB shot but it lasted for 5 days. Fist sized bruise on 4th day at injection site. Fatigue set in the day after the shot and lasted for at least a week even though I got regular sleep of 8-9 hours a night and did my regular work out each morning and ate well. The fatigue was concerning as I am normally very energetic and upbeat and don't usually feel like taking a nap in the middle  of my shift as a police officer. This negatively affected my job.
According to the patient.  He received his dose on May 4th and had a stroke on July 4th.
10/27/2021 the very next day, I woke up feeling really, sick. My left arm- I could not lift it up. I could not get my shirt on and off. I had a little bit of a migraine. I took the Ubrelvy to stop it from getting worse. I only take that on a as needed bases. My temperature was 100.2 very low-grade fever for most of the day. I drank lots of water and ate a plant-based breakfast, oatmeal, and took it easy and tele-worked. The next day,10/28/2021, my temperature came down to 99.8 in the morning and then went back to normal. My arm was not as sore. I was able to lift my shirt on and off. When I woke up on 10/28/2021I could tell I felt a little bit better, but I kept having the extreme exhaustion. and fatigue. and just a little bit of the aches, but not as bad as 10/27/2021. On 11/23/2021- I went to get my physical and to tell my NP, I was having extreme exhaustion and fatigue since I had the vaccination. I also told her that I was having blood vessels rupturing and bursting on my arms and on my legs. The blood vessels in my arms and legs started bursting since after the 1st Dose and Dose2 of Moderna. I started to have more of the blood vessels bursting on both my arms and legs after the 3rd dose of the Moderna. The blood test showed my thyroid was going toward hyperthyroid. I have always had hypothyroid, Hashimoto for 13 or 14 years, since 2009. I have not recovered from the AEs. I still have extreme exhaustion and fatigue and I am still having my blood vessels bursting.
This spontaneous report as received from a pharmacist (who learned of the event from another unspecified pharmacist), refers to two unspecified patients of unknown age and gender. The concurrent conditions, medical history and drug reactions/allergies of the patients were not reported. On an unknown date, the patients was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU) (dose and route of administration were unknown. The lot number was M0159326 with expiration date of 28-JUN-2017. There were no concomitant therapies reported. The reporter stated that, ion an unknown date, the patients experienced injection site adverse effects, severe pain, localized swelling and tenderness. The pharmacist was requesting a lot check to be done. No product quality complaint was involved. The outcome of injection site pain and injection site swelling was unknown. The causality between ZOSTAVAX and the events was not provided. Additional information has been requested.
My legs throb down the back side of each leg. They ache and hurt walking and sitting. The only relief I get is where they are elevated and I put heat on them.  Ive never had problems with my legs.  It started two days after the first shot, ive received my second shot and they are just as bad. I will see my Dr on the 9th of this month ( march).
The day of I was really tired and fatigued. The day after I was dizzy. I couldn't sit up or walk. I was seen by what is called a telenurse.
Mild rash that included the injection site down the inner arm toward the elbow. Presented to the pharmacy 2/2/18 but unsure when the reaction occurred between time of injection and now. She said it wasn't bothersome now, but I recommended BENADRYL cream to apply if itching.
My hands are blood red; my finger tips are blood red; Like a rash but it is like a red and white all over my body; My whole arm is killing me, I am in so much pain; taste of foul fish in mouth and I drink and eat taste like nasty salmon; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number, expiry date not reported) via an unspecified route of administration, on 01Mar2021, at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced the hands and finger tips are blood red, like a rash but it is like red and white all over the body, the whole arm is killing with so much of pain on previous day night (02Mar2021) and taste of foul fish in mouth; when drink and eat taste like nasty salmon on Mar2021. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shingles 15 days later; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles 15 days later) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Cancer. Concomitant products included CALCIUM and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced HERPES ZOSTER (Shingles 15 days later). The patient was treated with VALACYCLOVIR [VALACICLOVIR] at a dose of UNK dosage form and PREDNISONE at a dose of UNK dosage form. At the time of the report, HERPES ZOSTER (Shingles 15 days later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitants reflamin.