chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received wrong doses of the Moderna COVID 19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Received wrong doses of the Moderna COVID 19 vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Received wrong doses of the Moderna COVID 19 vaccine). At the time of the report, ACCIDENTAL OVERDOSE (Received wrong doses of the Moderna COVID 19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that five of the seven patients received a 3rd dose instead of the booster dose, while two of the patients received a double dose of the 3rd dose.  No treatment information was reported.
P/receiving vax, pt slept x 2 1/2 hrs; when pt woke up, was irritable & would not nurse; pt exhibited extra irritability for a few hrs & was evn irritable 2 days p/shot, but the mom stated MD did not feel pt should recvd pertussis again;
I had warmth, redness, hard area in the spot where the vaccine was administered that appeared approximately 10 days after the vaccine was administered. I had itching immediately after the vaccine was administered but that wore off about 1 hour later. However, the warmth, redness and hard area on the arm appeared days later.
12 YEAR OLD PATIENT RECEIVED COVID19 PFIZER 10 MCG (5-11 YEAR OLD) VACCINE DOSE INSTEAD OF COVID19 PFIZER 30 MCG VACCINE.
Continued (L) shoulder and upper arm pain 2 weeks post vaccination - flu shot, pain and decreased ROM to (L) shoulder.
Husband described flu-like symptoms (not mild) with a rash.  Stated they were going to reach out to the patient's doctor.
This spontaneous report was received from a medical assistant referring to unknown number of patients of unknown gender and age. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. In September 2016, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L016428, expiration date: 30-JUL-2017) intramuscularly for prophylaxis. No adverse effects noted. No product quality complaint was involved. The medical assistant reported that the vaccine reached 9 C degrees for 8 hours. There were no prior excursions. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004349.
Within 2-3 minutes of receiving 3rd vaccine (ADACEL, MENACTRA, and HPV, pt became lightheaded and fainted for a few seconds. Slightly bradycardic for the first 1-2 min after regaining awareness, but for the next 20 minutes he continued to be pale, dizzy, lightheaded.
It was rapid AFIB (RVR) with classic ACS symptoms: chest pain, anxiety, shortness of breath, generalized weakness.
severe chills, body aches, joint pain, small patch of hives by left shoulder.  Took Tylenol and Advil
Patient called the pharmacy this morning, stating that she experienced chills and inability to move her arm well, several hours after receiving the Pneumovax23 vaccine. She called 911, who offered to come to get her - but she refused. They told her to put heat on the injection site. She said that she had to use her left arm to move her right arm, and that she couldn't sleep on her right side because her arm hurt. She also stated that she felt some heart palpitations, although she could not be sure that they were related to this incident as she has heart disease. The patient states that she has increased mobility of her right arm today. I checked in with the patient several hours later, and she reports that her arm mobility continues to improve.
Symptoms start on day 11: rash starting at hairline and cheeks, then a gradual progression of rash over the torso and back and then waking on the 12th day with rash over entire body. Slight fever at highest of 101, diarrhea on the 11th day. And reduced appetite on the 12th day. After hours nurse called on the 11th day after shot. She suggested being seen the following day. Day 12 pediatrician saw her and dismissed the symptoms as occurring in reaction to the vaccine.
Narrative:  Patient received two Pfizer vaccine doses in Feb/Mar 21 and a 3rd dose on 22 Oct 21. The patient tested positive for COVID 19 on 24 Oct 21 (two days later) and was hospitalized with Sepsis, hypoxia, weakness, headache, and COVID pneumonia. Reported per EUA.
roughly 30 minutes after injection, you started to notice  difficulty swallowing, tongue swelling.  took benadryl  which improved tongue symptoms, but throat still felt different x 3 hrs. back normal 10-12hr after injection.
She got her vaccine, she had headaches since Saturday.  She has had nausea, but she developed swelling underneath her armpit and a lump and typical flu-like symptoms.  The lump is painful when she puts her arm down and puts pressure on it.  She has taken the typical pain regimen and nothing else yet.  Also has a dry cough, itchy throat.  The worst part is the headache, nausea and loss of appetite.    She did not have these symptoms with the 1st two shots other than the usual side effects, but this one is worse.  She is also very sleepy with this one as well, which she did not have with the first two.
More than 2 weeks after shot, sharp moderate pain at injection site, feeling of bruising /soreness in right upper arm muscle
Pt vax w/ HIB. Family DR questioned HIB as a cause of pneumonia. Irritable, cranking, waking frequently during the night. 25MAR90 running temp of 104 starting coughing-dry cough. 26MAR90 clear, runny nose, plus cough. See WORM
Patient received 2nd dose at unknown location on 4/15/2021. Patient presented to emergency room at the Hospital with stroke symptoms. Assessed by neurology and did not receive tPA, of note, also had elevated BG levels at presentation (496). Patient has history of confusion related to hyperglycemic episodes. MRI on day 2 of admission (4/17/21) reported punctate recent or sub-acute infarcts present. Initial symptoms of unilateral weakness is resolved on day 2.
The roof of my mouth shedded (was raw) and bleed for a few days; The roof of my mouth shedded (was raw) and bleed for a few days; I felt like I was having a heart attack; This is a spontaneous report from a contactable other healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), intramuscularly on 29Jan2021 at 09:30 AM at a single dose for COVID-19 immunisation. The patient's medical history included asthma and known allergies to medication. Concomitant medications included paracetamol (TYLENOL) and metoprolol, which were reported as medications in two weeks. It was reported that other vaccines in four weeks were prescribed. On 31Jan2021 at 09:00 AM, the patient experienced the roof of her mouth shedded (was raw) and bled for a few days. A few days later (2021), she felt like she was having a heart attack. There was no treatment for the events. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The outcome of the events was recovered on 2021.  Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event myocardial infarction cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Jan2023 at 11:30 as dose 5 (booster), single (Lot number: GL0446) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6199), on 02Apr2021 as dose 2, single (Lot number: EW0150), on 11Jan2022 as dose 3 (booster), single (Lot number: FL3198) and on 18Aug2022 as dose 4 (booster), single (Lot number: FP7137), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "GERD" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: nsaids, reaction(s): "Known allergies: NSAIDs". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Treatment was Paxlovid. Treatment start date was 26Aug2023 and treatment stop date was 30Aug2023. Lot number was GF7893.
7-23-99 530/p.m (Fri) had DTaP Rt deltoid on 7-22-99 presented to clinic now w/erythema & swelling to upper half of rt lateral upper arm. Swelling was noted this AM at bath time. Has good movement and mother states it doesn't seem to bother her. Instructed to use ice intermittently & continue to observe. F/u Mon AM 7/26 - mom states child doing fine.
Onset of period the next morning. The heaviest and most painful of my life.  ONGOING: Scull splitting headache, Sinus cavity congestion and contribution to headache, Chills to sweats back and forth. Extreme fatigue, muscle and joint pain
FEVER, CHILLS, Rigors, Chest pain, weakness. Not relieved by OTC pain relievers (APAP, iBU)
Would not walk on R leg/painful.  No redness or swelling noted.  No fever noted.
Pfizer-BioNTech COVID-19 Vaccine EUA  Chills/temp 38 (starting 2200 1/10-1/12) Moderate nausea (1/10-still present as of 1/15) Mild-mod headache (1/11-1/13) Tachycardia (at rest 105-138 1/10-1/13) Moderate muscle/joint pain - same side as injection from shoulder/collar bone into neck (1/11-still present as of 1/15) Moderate-severe fatigue (1/10-1/14)  Dizziness (1/12-1/14)   Used ibuprofen and Bengay for soreness w/ mild/fair effect.
red non-tender, non-pruritic, hot to touch; large arm, inject administered @ lower border of muscle insertion; no tx;
lymph level is extremely high/Elevated Lymph levels on blood work; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient (unknown age) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 04Apr2021 as SINGLE DOSE for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On an unspecified date patient had her lab work done and her lymph level was extremely high. Elevated Lymph levels on blood work. The response which the patient received included a review of the prescribing Information for Pfizer Covid Vaccine did not find information regarding elevated lymph. As the Prescribing Information did not include all adverse reactions that have been reported or that may occur, the patient was advised to consult with her doctor/healthcare provider about what she had experienced/experiencing. Because her doctor/healthcare provider is most familiar with her medical condition, clinical history, how her treatment has been conducted and any relevant information to her specific case, her doctor/healthcare provider was in the best position to advise her about the appropriate action to take. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
other is pregnant approximately 30 weeks and delivered the baby early; other is pregnant approximately 30 weeks and delivered the baby early; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) was exposed to bnt162b2 (BNT162B2), transplacental (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The mother's relevant medical history and concomitant medications were not reported. The following information was reported: PREMATURE BABY (medically significant), MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown" and all described as "other is pregnant approximately 30 weeks and delivered the baby early".  The lot number for bnt162b2 was not provided and will be requested during follow up.  Follow-up (14Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.  Follow-up attempts have been completed and no further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event "Premature Baby" and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101408376 Same reporter, event, product/ mother, fetus
This spontaneous report was received from a registered nurse referring to a 17 weeks old patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 17-JUL-2017, when the patient was 17 weeks and 4 days old, was vaccinated with the first dose of ROTATEQ, orally, lot # N003396 and expiration date on 21-OCT-2018 (dose was not provided) for prophylaxis. No adverse effects were reported.
Evening after vaccine. Right leg. Right leg swollen and red and warm form knee to groin. Walking okay. Not tender. Lasted four days.
PATIENT WAS GIVEN MODERNA VACCINE AS 2ND DOSE, BUT WAS GIVEN PFIZER AS 1ST DOSE
Extreme swelling and pain in both hands; Extreme swelling and pain in both hands; numbness; Left eyelid swelling; Hives on head and stomach; not feeling well; headache; This is spontaneous report received from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0150), via an unspecified route of administration, administered in Arm Left on an unspecified date in 2021 (pending clarification) as 2ND DOSE, SINGLE for Covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient has no medical history. Concomitant medication included birth control (unspecified). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extreme swelling and pain in both hands, and numbness. The patient also experienced left eyelid swelling, hives on head and stomach, generally not feeling well, and non-stop headache. The event onset date was not reported (pending clarification). There was no treatment received for the adverse event. The adverse events resulted in disability or permanent damage. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered.  Information on lot/batch number was available. Additional information has been requested.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
two weeks after the second vaccination I started to feel profoundly unwell. Over the course of the next 2 weeks symptoms progressed to the point I was barely functioning.  Symptoms included: rapid weight loss, extreme hunger, shakiness, hand tremors, cognitive fogginess, inability to problem solve and think critically, muscle and joint aches, exhaustion, fatigue, headache, and weakness. I saw my GP and she did a full blood lab work up. Blood labs revealed very high liver function and hyperthyroid. I then saw an endocronologist and  had a radioactive uptake test to confirm Grave's Disease. I was put on beta blockers and after two weeks when my liver levels started to come down, I was put on 15 mg of Methimazole.  I reacted well to the Methimazole, had no side effects and my thyroid functions began to come down. I am now on 5 mg of Methimazole once a day and my throid functions are normal. Auto-immune tighters are still high, but are half of what they were when first tested.
Diarrhea; Stomach cramping; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramping) and NAUSEA (Nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramping) and NAUSEA (Nausea). The patient was treated with CALCIUM CARBONATE, MAGNESIUM HYDROXIDE (ROLAIDS [CALCIUM CARBONATE;MAGNESIUM HYDROXIDE]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) at an unspecified dose and frequency. On 12-Mar-2021, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramping) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Second dose scheduled on 09-APR-2021.
Arm is red and warm approximately 3X5? area beginning about 24 hrs after injection and continues as of today (1 week) so far
I got my COVID vaccine booster (Moderna). This was 7 months after completing my first 2 doses of the Pfizer COVID vaccine. After 12 hrs I started feeling extreme fatigue, muscle aches, headache and my left arm (site of injection) was tingling. I basically slept the entire day after the vaccine which wasn't restful because I was experiencing very vivid dreams. The extreme fatigue ended after approximately 24 hrs but the muscle aches continued for 48-72 hrs. Additionally, 36 hours after vaccination there was swelling in my left arm pit, likely lymph nodes, which is still persisting. Also, I experienced a lot of night sweating the second night after my vaccine; I woke up completely drenched in sweat.
Within hrs of vaccine child developed urticaria, eyes shut swollen-Benadryl given
SYMPTOM OF COVID; This spontaneous report received from a patient concerned a 37 year old male. 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: 1808986, expiry: 01-MAR-2022) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. Age at time of vaccination 37 years old. No concomitant medications were reported. On an unspecified date, the patient experienced symptom of covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of symptom of covid was not reported. This report was non-serious.
Patient reports "seizure-like symptoms", being "paralyzed many times", stiff muscles, severe headache, difficulty speaking, fatigue, body pain and ringing in the ears.  States she did not actually have a seizure.  She did not seek medical attention.  Onset of symptoms occurred one hour after vaccine administration and resolved three days after.
On February 4, 2021, patient woke up at 3 a:m, left eye kept opening and closing, vision was blurry, and left side of face numb by lips and jaw. She took 2 Benadryl and took a nap Thursday afternoon. She went to the ED later and was told it may be Bells' Palsy but was referred to PCP. She is on 5 mg Prednisone but rheumatologist increased dose and put on 5 day regimen. She saw PCP and he told her she had Bell's Palsy and just to follow regiment prescribed by rheumatologist.
STUFFY NOSE; SORE THROAT; DARK GREEN MUCOUS; VOCAL CHORDS ARE AFFECTED; SUSPECTED COVID 19; TERRIBLE COUGH; DIZZY; This spontaneous report received from a consumer concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-MAR-2021 14:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAR-2021, the subject experienced dizzy. On an unspecified date, the subject experienced terrible cough, stuffy nose, sore throat, dark green mucous, vocal chords are affected, and suspected COVID 19. Treatment medications (dates unspecified) included: fluticasone propionate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, had not recovered from stuffy nose, sore throat, terrible cough, dark green mucous, and vocal chords are affected, and the outcome of suspected COVID 19 was not reported. This report was non-serious.