chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling on tongue pressure to face weakness to bilateral legs was nervous due to multiple health issues  cleared by NP
Moderna COVID-19 Vaccine EUA: fever 101.5 while alternating ibuprofen and acetaminophen, severe chills, muscle aches, lethargy, moderate loss of appetite, and mild nausea and stomach upset.
Myalgia, HYPERtension,  rash/wheal at injection site; then severe body aches  Narrative:
Incessant crying not relieved by standard dose of Tylenol; resolved with Ibuprofen.
A non-serious spontaneous report of FLUMIST administered to two patients less than 24 months old was received from a health professional concerning a five-month-old female patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received the FLUMIST on 20-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
There are 3 spots on her arm that are itchy; 1 spot feels hard like there is a lump; Red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (There are 3 spots on her arm that are itchy), INDURATION (1 spot feels hard like there is a lump) and ERYTHEMA (Red) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A211A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (There are 3 spots on her arm that are itchy), INDURATION (1 spot feels hard like there is a lump) and ERYTHEMA (Red). At the time of the report, PRURITUS (There are 3 spots on her arm that are itchy), INDURATION (1 spot feels hard like there is a lump) and ERYTHEMA (Red) outcome was unknown.            Concomitant product use was not provided by the reporter.  The patient experienced spots were closer to her armpit and go down to her elbow.  Treatment information was not provided.   the action taken with the drug in response to the events was not applicable.
No adverse event; On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     It was unknown if patient had acute or chronic long-standing health conditions at the time of vaccination.    On 10-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 12-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to .25 milliliter. On 12-May-2023, the patient experienced PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml).    All patients were over the age of 65. No relevant concomitant medications were reported. The vaccine was administered in the deltoid site. On 11 May 2023 26 patients were contacted, on 12 May 2023 18 patients received an additional 0.25ml, 2 patients made appointments to receive the following week and 1 declined to receive the additional 0.25ml dose. A husband and wife pair stated that they would go to the clinic to receive the additional dose but gave no specifics and one patient was mailed a letter as he was not able to be reached by phone. No treatment medication reported.  This case was for the 18th patient out of 27 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-723833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723833:case
Caller mentions he has had 4 Pfizer Covid 19 vaccines and still got Covid.; Caller mentions he has had 4 Pfizer Covid 19 vaccines and still got Covid.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: 6H9694) at the age of 70 years for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes", start date: 2018 (ongoing), notes: Diagnosed 5 years ago. Still takes medication for it. Concomitant medication(s) included: LIPITOR; XANAX; METFORMIN; PHENELZINE; ACIPHEX. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Nov2022, outcome "unknown" and all described as "Caller mentions he has had 4 Pfizer Covid 19 vaccines and still got Covid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Nov2022) Positive; (15Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, took PAXLOVID. Clinical course: Had 5 Pfizer COVID-19 Vaccines total. Two of the primary series shots and 3 boosters. Stated not shocked by that as a lot of people get COVID-19 after vaccination.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
CHIEF COMPLAINT:   sinus congestion,cough loss of taste/smell Onset Monday  Loose stool for 2 days Last night while washing dishes became very hot and had a  brief syncopal episode Is vaccinated No fever Was seen at walk in today sent  here Did not hit head   HISTORY OF PRESENT ILLNESS:     69 years old female with past medical history of anxiety, hypertension, hypercholesterolemia, alcohol use disorder, patient presents to ER with upper respiratory symptoms, including sneezing, cough, nasal congestion, body aches, she denies shortness of breath no fever.  Patient was found to be positive for COVID-19 screen with lower levels of sodium.  She denies chest pain, abdominal pain, diarrhea.  No orthopnea, no lower extremity edema.
Abrupt onset shortness of breath on exertion 11/26. Seen by me for this 11/29, labs ordered, but in next 24 hours, before completion developed painful right leg swelling. Went to urgent care where d-dimer was 7,650, referred to ER for right lower extremity DVT and extensive pulmonary emboli.
Patient was given a expired dose of the Pfizer Covid-19 vaccine for ages 5-11.
intense pain all over body with numbness and tingling in hands and feet. Has a bad headache, chills, feels like she has a fever and has dizziness.
This case was reported by a nurse via call center representative and described the occurrence of injection site hives in a patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced injection site hives. On an unknown date, the outcome of the injection site hives was unknown. It was unknown if the reporter considered the injection site hives to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient received FLUARIX QUADRIVALENT on left arm and presented hives on same arm. The reporter declined to proceed with Safety report.
Patient broke out with hives all over his left arm, then his face, then they would go away. The next morning he had them on his legs, face, and arms.  This allergic reaction to the RotaTeq, unknown if further issues will develop or if hives will continue to develop. First day clear of hives was 5/5/19.
Pt had intensified wrist, finger and ankle joint pains. Her upper arm was swollen and so painful that it required ice packs. She could not lift or turn her arm or sleep (even with Dalmane and Advil) for 72 hours. Ten days post vax, her arm still hurt when she turned it and at injection site.
Received H1N1 LAIV 11/16/09,as reported by parent had onset of fever 100.4 with body aches on 11/18/2009, returned to school on 11/20/09, well.
swelling UNDER arm started a few hours after vaccine.  Now size of another DD bra cup. Very dizzy.  Falling asleep ALOT.  Like in the parking lot in my car after a quick trip into grocery shopping. Some afib and high heart (over 135) rate on pulse O2 meter. Mild headache first 48 hours.
Staff complained of itching  mild redness to neck, arm and back  after Flu vaccine was given- referred to urgent care was given bemadryl and breathing treatment
Plunger malfunctioned. No dose given on initial vaccine. Once removed from arm, plunger was able to move with increased force. Second syringe worked properly and dose administered.
Shortness of breath, facial swelling, slight throat swelling, difficulty swallowing, heart palpitations, fatigue, vision changes, headache
pt recvd vax & was limp, difficult to arouse, breathing shallowly; returned to clinic about 245PM, pink, high pitched cry elicited while undressing, had inc muscle tone;
Patient woke up in the morning and around 9am had a swollen upper lip. This progressed to a swollen face and a swollen tongue. Patient self administered 50mg of diphenhydramine. She did not have trouble swallowing or breathing.
Right eye droop noticeable next day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 02Feb2022 18:15 (Lot number: F55603) at the age of 15 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Lupus" (unspecified if ongoing). No Known allergies. No Covid prior vaccination, no Covid tested post vaccination. No other vaccine in four weeks. Concomitant medication(s) included: PREDNISONE. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot Number: EWO173, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 13Aug2021, when the patient was 15 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, Batch/Lot Number: EWO173, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 23Jul2021, when the patient was 15 years old, for COVID-19 immunization. The following information was reported: EYELID PTOSIS (disability) with onset 03Feb2022 23:45, outcome "not recovered", described as "Right eye droop noticeable next day". Therapeutic measures were not taken as a result of eyelid ptosis.  No follow-up attempts are possible. No further information is expected.
Per the clinical lead the Hepatitis A vaccine was transported to clinic in the brown portable cooler. A vaccine excursion occurred with the brown portable cooler. The temperature on the data logger attached to the brown portable cooler went out of range according to Havrix manufacturer recommendations. The portable cooler was reconditioned and the Hepatitis A vaccine was administered to the patient. Manufacturer contacted by Health Department representative. Per the Health Department Bureau of Immunization they were advised by GlaxoSmithKline that the Hepatitis A vaccine was not viable and the patient needed to be re-vaccinated.
Soreness in the arm; very tired/fatigue; fever - was 100 up to 101; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever - was 100 up to 101), FATIGUE (very tired/fatigue) and VACCINATION SITE PAIN (Soreness in the arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PYREXIA (fever - was 100 up to 101). On 15-Jan-2021, the patient experienced FATIGUE (very tired/fatigue). On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness in the arm). At the time of the report, PYREXIA (fever - was 100 up to 101) and FATIGUE (very tired/fatigue) had not resolved and VACCINATION SITE PAIN (Soreness in the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Patient started having fever started on 14-Jan-2021, fever was 100 up to 101, it drops periodically but still hanged in there. Patient reports that he had fever today (at the time of reporting) and has fatigue as well. He reported that soreness in the arm had gone.  Patient took Tylenol and Aspirin for treatment.    Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Patient was dizziness, with problem to be stand up. He was pale and said that there was flash light in his eyes. He felt cramps in his hands and hot flashes in the head. We called EMS and an ambulance take him to the hospital. In the hospital he was diagnosed with vagal vessel. All symptoms occurred 15 minutes after Covid vaccine
pt recv vax 7SEP95 & 15DEC97 pt devel a clear rash;mom noted that rash was past the contagious stage;
Given MMR and Varicella SQ. Rt thigh had immediate swelling and redness. Ice pack applied. BENADRYL 25 ml given swelling did not persist. Discharged home with instructions.
Woke up feel extremely nauseated, dizzy, and overheated, went to the bathroom and couldn't get up off the toilet, she then blacked out she isn't sure for how long. Everytime she tries to get up she starts to feel sick and dizzy, and hot and cold chills and has a bad headache. She does have soreness at injection site.
Site: Swelling at Injection Site-Mild, Systemic: Bleeding from penis for 3 to 4 days 2 weeks after vaccine-Medium, Additional Details: Patient said that he was bleeding from his penis for 3 to 4 days and he says that it has to be from the covid vaccine even though was 2 weeks after the vaccine. He will follow up with provider to check whats the reason for the bleeding from the penis. He wanted me to report this anyways because he is almost sure it was the vaccine.
Received immunizations on 5-6-08/5-7-08 his left leg was swollen, sore & red.  He told me it hurt to walk or try to bring his knee up to chest.  5-8-08 worse took to medical center.
a lot of pain on my second vaccine like throughout my leg that was like a shooting pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 -old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 (Lot number: EN6207) at the age of 58 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 (1st dose of covid vaccine, The LOT number was EN6202, Anatomical Site: Consumer stated, "It was on the Left arm, both times), administration date: 20Feb2021, when the patient was 58 years old, for COVID-19 Immunization, reaction(s): "brain zaps", "brain fog", "there was a doctor that gave me some medication for vertigo which seems like it made it wors", "Dizziness", "I have ringing in my ears now", "brain dash / headache", "light headedness". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "a lot of pain on my second vaccine like throughout my leg that was like a shooting pain. The patient underwent the following laboratory tests and procedures: blood cholesterol: unknown results. Therapeutic measures were taken as a result of pain in extremity.  Additional information: Reporter stated that she received both doses of Pfizer BioNtech Covid19 Vaccine the first primary series. She said that after exactly 2 weeks after she got the first dose. So, the reason for her call to ask his if she could get a half of her dose or a dose of a Pediatric vaccine as a booster to lessen the chance or her having additional side effects. So, she said she is rather a small person that does not do well on medication. She said she heard that doses being administered into a vein could be so many people are having side effects and that is the main complaint that she has so I thought, I need to get over to Report her side effects from her first and second doses. She got lot of pain on her second vaccine like throughout her leg that was like a shooting pain that was probably just couple of night, couple of days that not went away but the brain and light headedness has not gone away. She does not feel as healthy as she used to because of this side effects unfortunately. It is good that they know the side effects. She took treatment with Meclizine (expiry date:30Nov2022).  Follow-up attempts are completed. No further information is expected.
Fever; Body aches; Nausea; Vomiting; Diarrhea; Headache; This is a spontaneous report from a contactable physician, consumer and healthcare professional. These contactable physician, consumer and healthcare professional reported similar events for two patients. This is the second of the two reports.  A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA, Lot number: AR9309; Expiration date: Feb2021), via an unspecified route of administration on an unspecified date at single dose for immunization. On an unspecified date, the patient had fever, body aches, nausea, vomiting, diarrhea and headache. The outcome of the events, fever, body aches, nausea, vomiting, diarrhea and headache, was unknown. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019303263 same reporter/drug, different patient, similar event
PATIENT IN OBS AREA FOR 10 MIN WHE SHE BEGAN TO FEEL"PANICKY WITH HEART RACING. HR 144 BP 148/88.   REDIRECTION AND REFOCUS ATTEMPTED WITH GOOD EFFECT AS NOTED BY HR DECREASE TO 88-103 AND BP 130/88 100%  PATIENT DENIED SOB AND CHEST PAIN. MARKED DECREASE IN SYMPTOMS WHEN CALM, HOWEVER, DIFFICULT TO KEEP HER CALM AND SHE WAS CONVINCED THE VACCINE WAS THE CAUSE OF THE SYMPTOMS. DECISION MADE TO TAKE PATIENT TO THE ER     FOR EVALUATION. VS ON D/C 98- 138/73 100%; REPORT GIVEN TO RN ER CHARGE
Began with headache and felt real hot. It was a sudden onset. Began getting dizzy and starting having aching pain in both shoulders. Dr. On call was notified and IM benadryl was given x 1. Vital signs and oxygen remained normal limits. Felt drained and had nausea. Did not vomit. Remained approximately 45 minutes after symptoms began. Still felt tired and achy at that time. No respiratory issues, no shortness of breath, no fever, no rash. Was driven home and laid down and slept. Adult children woke her up every couple of hours. Remained tired, achy, with headache on Tuesday. Woke up feeling better on Wednesday. Contacted personal physician by phone. Was instructed to take OTC tylenol and rest. Called off work WednesWednesday. Will likely not be at work Friday and start fresh on Monday. At the time of reaction, she recieved 25mg. of IM benadryl and 650mg of Tylenol.
Monkeypox despite the completion of Jynneos vaccination; Case reference number US-BN-2022-004174 is a spontaneous case report initially received on 21-Oct-22 from physician via Bavarian Nordic (reference: BN_2022_02594) and concerns a patient of unknown age or gender.  The patient's medical history and concomitant medications details were not provided.  On an unspecified date, as reported in August, the patient was vaccinated with a first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at a dose reported as 'first full dose', through unknown route of administration, at unknown anatomical location, for unknown indication.  On an unspecified date, as reported in September, the patient was vaccinated with a second dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at a dose reported as 'second microdose', through unknown route of administration, at unknown anatomical location, for unknown indication.  On an unspecified date, the patient developed monkeypox despite completion of Jynneos vaccination.  As reported, the patient developed more severe symptoms.  The reporter did not provide a seriousness criteria or a causality assessment.  This case is linked with the case US-BN-2022-004175 (same reporter).  No further information was provided.; Reporter's Comments: A patient of unknown age and gender developed monkeypox (patient developed more severe symptoms) despite completion of Jynneos vaccination. Monkeypox are unlisted and unexpected according to CCDS v1 and USPI. Vaccination with Jynneos may not protect all recipients and may not result in protection in all cases. The outcome was unknown. The patient's medical history and concomitant medications details were not provided. Causality is therefore assessed as not related to suspect product but to environmental factors. The case is serious due to medical significance.; Sender's Comments: A patient of unknown age and gender developed monkeypox (patient developed more severe symptoms) despite completion of Jynneos vaccination. Monkeypox are unlisted and unexpected according to CCDS v1 and USPI. Vaccination with Jynneos may not protect all recipients and may not result in protection in all cases. The outcome was unknown. The patient's medical history and concomitant medications details were not provided. Causality is therefore assessed as not related to suspect product but to environmental factors. The case is serious due to medical significance.
Patient received a Pediatric vaccine that had wrong expiration date on the label but the actual expiration date was 09/30/2022. They received the vaccine on 10/09/2022. I have not heard any complaint from the parent
Patient report that she a burning sensation on the inside of her skin, also her face felt numb, headaches, and stomach pains and sore throat