chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient who received a dose was administered 0.2 mL from the dark pink cap vial; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient who received a dose was administered 0.2 mL from the dark pink cap vial) and NO ADVERSE EVENT (No adverse event) in a 6-month-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.     Relevant medical history or conditions, allergy, concomitant diseases and risk factor were unknown.     On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Patient who received a dose was administered 0.2 mL from the dark pink cap vial) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient who received a dose was administered 0.2 mL from the dark pink cap vial) 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 INCORRECT DOSE ADMINISTERED (Patient who received a dose was administered 0.2 mL from the dark pink cap vial).    It was unknown if the patient was vaccinated with any other vaccinations 4 weeks prior to the COVID-19 vaccine.  Concomitant medication not reported.   Two patients were involved. The facility ordered Bivalent Moderna COVID-19 Vaccines, but they only got the dark pink cap vials. They had two patients, one that was 8 months and 7 days who had not received the dose and one that was 6 months and 2 days who had received a dose. The patient who received a dose was administered 0.2 mL from the dark pink cap vial (lot number 216K22A). Both patients were previously unvaccinated.  Treatment medication not reported.
Back pain; Sore arm; Right side chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Right side chest pain), BACK PAIN (Back pain) and PAIN IN EXTREMITY (Sore arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced CHEST PAIN (Right side chest pain). On an unknown date, the patient experienced BACK PAIN (Back pain) and PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, Back pain and Chest pain, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Right side chest pain), BACK PAIN (Back pain) and PAIN IN EXTREMITY (Sore arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
8 days after injection, have a 3 inch by 1.5 inch red, raised area at injection site. It is feels hot to the touch and is hard. It is not painful, but uncomfortable
ITCHY ARM WHERE THE SHOT WAS TAKEN; SWOLLEN ARM WHERE THE SHOT WAS TAKEN; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sinusitis, anemia, urticaria, and chronic migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 208A21A expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination (series 1). Concomitant medications included iron for anemia, and cetirizine hydrochloride for drug used for unknown indication.  On 09-DEC-2021, the patient experienced itchy arm where the shot was taken. On 09-DEC-2021, the patient experienced swollen arm where the shot was taken. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen arm where the shot was taken, and itchy arm where the shot was taken. This report was non-serious.
Had a mass of tiny blood clots went to his brain and he had a stroke.   He had recovered from this event for months and fell down (while still recovering) re-injuring himself and this led to his eventual death from "unknown" causes.  He had a low lying fever which I have come to believe was the body attempting to reabsorb the blood clots and the hospital admitted him and "Cared for him" to death (they stuck an 82 year old man on an ice sheet because of the low fever and left him like that for a week until he lost all strength and died....he was ALLOWED to come home the day before his passing.
CCL 9/6/2022VAL nstemi/asymptomatic +COVID status severe calcific MVCAD and CA+ ascending aorta and aortic arch. REC: consult with a CT surgeon with regard to the patient's surgical candidacy, with the patient and with an interventional cardiologist and decide if coronary artery bypass, PCI or medical therapy is the best course. Percutaneous coronary intervention would be complex and high risk and should be undertaken at a hub site and perhaps via the transfemoral arterial approach (although with a Destination sheath a transradial approach is feasible). COVID-19 DISEASE.
20 minutes after shot, had muscle pains, headache, nausea, joint pains, 14 Jan had joint pain and fatigue
This spontaneous report as received from a nurse refers to unspecified patients of unknown ages and genders. Since 22-AUG-2017 through 28-AUG-2017 (reported as today), the patients were vaccinated with an improperly stored doses of PNEUMOVAX 23 for prophylaxis. No adverse effects reported. Sender's Comments: US-009507513-1708USA012428: US-009507513-1708USA012501.
Pt stated she had double vision and felt lightheaded and unstable. EMS called pt assessed but refused treatment. Left in private vehicle.
Pt developed redness/swelling/pain at site of injection day after injection. Sought medical attention at urgent care and received ABX. Has pending follow up with physician.
A couple of weeks after the vaccination I started having itching on my upper back where I had a mole and the itching started increasing intensely. I saw my doctor on May 26, the doctor did not know if the itching was related to the vaccine. The doctor removed the mole, and did a biopsy and the results were benign growth. The mole was an inflamed benign mole. Removing the mole resolved the itching. The doctor said it was inflamed which is why it was itching so much. The biopsy site was very slow to heal and it needed further treatment in order for it to heal. The doctor had to use a special dressing called DuoDERM for a couple of weeks, to get the dead tissue off so it could heal. I never had a problem with a wound healing before. It still hasn't fully healed and it's been since May 26, 2021. It slowly healing now. The doctor mentioned that the inflammation could have been caused by the vaccine.
During the process of mixing the Shingrix vaccination, the slip tip needle popped off as I was starting to inject the adjuvant into the antigen component vial. Pressure from pushing the plunger of the syringe down caused the liquid to splash upwards into my eye. Only the adjuvant came in contact with my eye. After rinsing my eye with water and an eye wash, my eye itched for a few minutes, but it resolved on its own. No other adverse events to report.
Got vaccine at 12:30am, was home asleep by 2:30. Head was insanely stuffy when I woke up around 8:30, my ears hurt on the inside and I couldn?t hear well. My lungs felt kind of funny, as if I?d taken too much asthma medication. By noon my lungs were burning with every breath, my eyes were hot and weepy, the fever and muscle/joint aches had gotten really bad, and I had pain in my neck under my jaw between chin and ears.
Headache Joint pain Chills Nausea Fatigue  Loss of appetite (Just the first day that the symptoms started )  I Just took acetaminophen for 2 days
Elevated heart rate 100-117 for almost 24 hours, fever 102, chills, body aches, asthma attacks. Still having daily cough and asthma attacks that I did not have until I received the second dose.
Chills; body aches; exhaustion; ha (headache); This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on an unknown date for Covid-19 immunisation and had no adverse event. On an unspecified date, after the second dose, the patient experienced chills, body aches, exhaustion, and ha (headache) that lasted for 24 hours. Outcome of the events was recovered.    No follow-up attempts are possible. No further information is expected.
Date started (or best estimated period): 24Jan2021, 10Feb2021; sore arm; fever; chills; headache; hot flashes; This is a spontaneous report from a contactable consumer reported in response to Non-HCP letter sent in a cross-reference case. A 37-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9269) via an unspecified route of administration in left arm on 10Feb2021 at 10:30 (at the age of 37-year-old) as single dose for COVID-19 immunization at Hospital. Medical history included bad reaction to eggs. Concomitant medications of the patient were not reported. Patient previously had MMR vaccine in 1999 that resulted in facial swelling and blotches on her face. When she was admitted to the hospital, the MD told her to never receive a flu vaccine because she had a bad reaction to eggs. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9262) via an unspecified route of administration in left arm on 24Jan2021 at 12:00 as single dose for COVID-19 immunization and experienced only a sore arm. On an unspecified date in 2021, after receiving second dose of vaccination patient experienced sore arm, fever, chills, headache, and hot flashes. Outcome of the events were resolved as events were gone within 24 hours on an unspecified date in 2021 and patient was fine now.  Follow-up attempts completed. No further information expected.
got vaccine 6 months later 2nd vaccine booster. 2 yrs later i had internal shingles/ Suspected vaccination failure; Internal shingles/Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine and 2 years 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got vaccine 6 months later 2nd vaccine booster. 2 yrs later i had internal shingles/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Internal shingles/Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 31-March-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received both doses of shingles vaccine 6 months apart and 2 years later experienced internal shingles. The patient stated that do not get the vaccine. This case was considered as suspected vaccination failure as laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Patient received second Varicella Vaccine early. First dose was given 8/27/2021 and second dose given 7/28/22
Raynauds of the R index finger.  Resolved with warmth after 15 minutes.
terrible arrhythmia; atrial fibrillation; tachycardia; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1 Batch/Lot No: Unknown.), for COVID-19 immunization. The following information was reported: ARRHYTHMIA (medically significant), outcome "not recovered", described as "terrible arrhythmia"; ATRIAL FIBRILLATION (medically significant), outcome "not recovered", described as "atrial fibrillation"; TACHYCARDIA (medically significant), outcome "not recovered", described as "tachycardia". The events "terrible arrhythmia", "atrial fibrillation" and "tachycardia" were evaluated at the physician office visit. Therapeutic measures were taken as a result of arrhythmia, atrial fibrillation, tachycardia which includes treatment with Metoprolol. Additional information: The patient did not receive other vaccine in four weeks. No COVID prior to vaccination and not tested for COVID post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
possibly frozen product was administered on accident with no adverse event; Initial information was received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via Global Medical information (GMI under reference number - 00815021).  This case is linked to case 2021SA345065(CLUSTER).  This case involves 81-years-old female patient who was accidently vaccinated with possibly frozen suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no reported adverse event (product storage error).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On 27-Sep-2021, the patient received a 0.7ml {total} dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number UJ716AA expiry date 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was reported "the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment."  It was case of an actual medication error due to product storage error temperature too low (latency was on same day)  At the time of report, no adverse event was reported.  Event outcome was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a registered nurse concerning a 38 year old female with a sulfonamide allergy and an allergy to REMICADE and no medical history who on 07-NOV-2006 was vaccinated subcutaneously with a 0.5 ml dose of Pneumovax 23 (lot #655500/1005F) in the right deltoid. Concomitant therapy included Fluvirin (manufacturer Novarits, lot #71926), PAXIL and "sodium chloride injection". On 08-NOV-2006, the patient called the office and reported that the injection site arm was swollen, red and painful. The patient complained of her arm hurting. The patient was directed to use cold compresses and take TYLENOL as needed. No lab studies were performed. On an unspecified date, the symptoms went away and the patient recovered from the events. No product quality complaint was involved. Additional information is not expected.
Injection site at left deltoid had a firm nodule 1cm X 1cm in tissue/muscle with mild swelling and erythematous area 4cm X 4cm. This developed 1 week after injection.
Pt. presented with (R) arm swollen, red & warm to touch around site of vaccine. Had shot day before presenting. Rest exam was normal. Pt. given cephalexin 250 mg. 1 tab. 3x daily. Pt to return if conditions worsen.
Little bit of arm soreness; 8 days after vaccine I experienced swollen lymph nodes under arm; Swelling and pain of injection site; Swelling and pain of injection site; Fever; Chills; 3 by 5 inch red circle and swelling around injection site/arm turned red; This is a spontaneous report from a contactable other healthcare professional (medical receptionist -patient). A 47-years-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number, EL3246, expiration date unknown), via an unspecified route of administration on the left arm on 20Jan2021 at 17:30 at the age of 47 years old at a single dose for COVID- 19 immunisation in the hospital. Medical history included mitral valve prolapse, gallstones , hypertension and crab allergy. Concomitant medications included lisinopril and  hydrochlorothiazide. The patient did not receive vaccines in four weeks. On 28Jan2021 at 07:00 AM,  the patient had a little bit of arm soreness initially. The patient experienced swollen lymph nodes under arm, swelling and pain of injection site, fever and chills. On the 9th day after vaccine (29Jan2021), patient had a 3 by 5 inch red circle and swelling around injection site. It was also reported that the arm and lymph nodes swelled. The patient had fever and chills. Then her arm turned red. As of 05Feb2021, the swollen mark which is about 5x4 inches is swelling again. The patient's next dose is scheduled for 10Feb2021. She is really concerned about getting the second dose.  The events were assessed as non-serious by the reporter. It was unknown if the patient received a treatment in response to the events. The patient was not diagnosed with COVID-19 prior t vaccination and was not tested for COVID-19 post vaccination. The outcome of the event was unknown.
Pfizer / BioNTech 06/Apr/2022 / COVID 19 Treatment; Pfizer / BioNTech 06/Apr/2022 / COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2022 as dose 4 (booster), single (Lot number: FM698) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "Pfizer / BioNTech 06/Apr/2022 / COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: testing positive again on rapid antigen; (06May2022) negative, notes: Tested negative starting Day 3 of taking Paxlovid (06May2022); (unspecified date) negative, notes: continued to test negative on rapid antigen; (15May2022) positive, notes: 15May2022 (7 days after finishing Paxlovid / 12 days after first testing positive for COVD. Therapeutic measures were taken as a result of covid-19. No follow-up attempts are possible. No further information is expected.
PATIENT DEVELOPED SWELLING, REDNESS AT INJECTION SITE. TENDER TO TOUCH. ROUND WELT AND GETTING LARGER. POSSIBLY CELLULITIS. ADVISED PATIENT TO SEE DOCTOR FOR FURTHER TREATMENT.
Adverse event: I had an unusual feeling in front of my neck, I went to see a doctor and they did electro, but it was normal due to my condition of previous heart attack. Outcome: Unknown.
Patient is saying he has red streaks going down his arm to his elbow, just started today.   No fever, patient doesn't feel well.
3APR96 pt recv vax & was fussy & inconsolable immed p/vax; 1 to 2 hr later @ home had limp spell x 5mins, no apnea, cyanosis or sz activity but color pale & extremely diff to arouse;mom called 911;pt transported by amb to ER;
Developed left inframammary rash, I'm not sure of the exact date it started.  I first thought it was bug bites, but it is an unlikely location for bug bites, and then another day I saw it had spread.  It was itchy and irritating.  I kept wondering about it.  I developed mild upper respiratory symptoms after a bit less than a week.  I realized my symptoms were very similar to when I had shingles in the past, about 12 years earlier, with the rash starting in the exact same location.  I currently had possible tingles on the back; last time the back part of the rash developed later.  Conducted video visit on 10/10/22.  Doctor observed via video, per notes, "Left inferior to breast - red patches with superimposed papules and vesicles."  Doctor prescribed Valacyclovir for seven days.  I developed a bad cold over the course of treatment.  The rash faded slowly.  Currently, after more than one month, the bump parts are faintly visible, and can be felt as raised bumps, but are not causing irritation.  (Previously had three doses of Moderna Covid vaccine, this was first Pfizer - Pfizer bivalent and flu shot.)
the first day (1/16/21) following the first dose of the  vaccine, i began experiencing nausea. the third day (1/18/21) i vomited that morning once but then not again throughout that day.  after that for about two weeks, i was just generally nauseous and also had no appetite. food tasted off to me. this went away after two weeks, but then i got my second dose on 2/12/21. on 2/13/21, i spent about 12 vomiting very consistently, about every 10-15 minutes. i also had chills alternating with profuse sweating and hot flashes, but did not ever have a fever. other symptoms included headache, extreme fatigue, dizziness, body aches, shortness of breath, and chest pains. the next day, i was fine aside from some slight lingering nausea but no vomiting. since then, i have experienced nausea intermittently every day, and have vomited on more than a dozen of those days. i have no appetite, and have now lost ten pounds since getting the second dose. i realized that my main food aversion is to meat, i will vomit every single time i eat meat now. i?m not sure if this is my reaction to the texture and taste like i think it is, or if it?s actually more like an allergic response by my stomach. i also still struggle with shortness of breath and feeling like my chest is tight, as well as dizziness and a nagging cough.