chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Multiple vesicular lesions on erythematous base with scabbing of other lesions, some on lower legs, no excoriations or burrows, and no lesions on waist band or finger webs. Presented after 14 days. Symptoms consistent with Varicella Rx.
My dad had a cardiac arrest one month after his second vaccine. He had complained of severe indigestion for 6-8 hours within 2 days of his second dose and  refused medical attention for it.  The day he passed he did not verbalize any complaints.
Vaccine given at 2:50pm, employee noted itching, hives by 6:30pm same evening, took Benadryl when arrived home, took Benadryl again next am, came into work at 9pm with some itching, hives, by 5pm covered with hives, sent home, took Benadryl, seen by own MD next am (10/30) given Rx for Atarax and Prednisone.
The first evening was a little uncomfortable. The next day was very uncomfortable--fever, shivers, body ache--no concentration possible; aspirin didn't seem to help;  only a good night's sleep. The next morning was almost normal and by midday completely normal.
No additional adverse events.; on 7/1/2020 an 18 year old patient was inadvertently administered PROQUAD.; This spontaneous report was received from a registered nurse, referring to an 18-year-old male patient.  The patient's pertinent medical history, previous drug reactions, or allergies, were not reported.   On 01-JUL-2020, the adult patient was inadvertently vaccinated with  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, as prophylaxis (strength, dose, vaccination scheme, route of administration, and anatomical site of vaccination were not reported; lot number S012533, which has been verified to be valid, the expiration date was unknown by the reporter, but upon internal review was determined as 20-OCT-2020) (product administered to patient of inappropriate age). As concomitant therapy, sterile diluent (MERCK STERILE DILUENT) was used to reconstitute the vaccine. No additional events were reported.
This spontaneous report as received from a health care worker refers to a 4 months old patient. The patient's pertinent medical history was not reported. On an unknown date the patient was vaccinated with first dose of ROTATEQ SUSPENSION 2 for vaccination at 4 months of age. No adverse effects were reported. The healthcare worker reported that the patient received the first dose of ROTATEQ at another unspecified facility, date unspecified. The outcome of vaccinated with first dose of ROTATEQ for vaccination at 4 months of age and no adverse effect was unknown. Additional information has been requested.
Information has been received from a registered nurse concerning an 11 year old male who on 25-JUL-2007 and 12-SEP-2007 was vaccinated with his first and second (lot# 654813/1088F) 0.5ml doses of varicella virus vaccine live (Oka/Merck). There was no other concomitant medication. On 12-SEP-2007, the patient developed a rash on his face which was mainly on his nose. On that same day medical attention was sought through the health department. At the time of this report the patient was not recovered. There was no product quality complaint. Additional information has been requested.
Anthrax Lot # FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time. Report submitted per milvax direction.
Pfizer- 1st shot- swelling of lips and fatigue- hydrocortisone, benadryl, claritin
Vaccine given at 16 years of age .; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given at 16 years of age .) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included IBUPROFEN for Toothache.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given at 16 years of age .). On 19-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given at 16 years of age .) 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.   Treatment medication was not provided    Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Height, weight, ethnicity, medical history added.
Dizziness; I could hardly walk; This is a spontaneous report received from a contactable consumer (Patient, reported for self).   A 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6198; Expiration date: UNKNOWN), via an unspecified route of administration in Left arm, on an unknown date in Mar2021 as a single dose for COVID-19 immunization. The patient medical history included Atrial fibrillation from an unspecified date and unknown if ongoing. Patient concomitant medications included Atenolol at an unspecified dose from an unspecified date and unknown if ongoing.  The consumer (patient) stated, he was fine he felt a little dizziness right after he got his first injection (Tuesday morning around 11 O clock), it wasnt anything serious. So then patient felt good that night, he felt good on Wednesday, felt good on Thursday went of a walk and then last night (as reported) patient started feeling kind of dizzy and this was like four days into the injection and then this morning (as reported), patient got up and he could hardly walk, he was so dizzy. Patient stated that he was wondering if that was it doesn't sound like it's a common side effect, would that be common side effect, possible side effects of the injection, first injection. No Investigation Assessment reported. The patient has not taken any treatment, he just took an aspirin today (as reported) and been drinking a lot of water. The events, dizziness and could hardly walk were non-serious. Out-come of the events were unknown.  No follow up attempts are possible. No further information is expected
Patient was given a third dose of SHINGRIX, along with seasonal flu vaccine and boostrix vaccine. Patient has already received two doses of SHINGRIX, so this third dose was incorrect. Complaining of body aches, nausea, headache, and painful swelling/inflammation of the left arm.
Blister on left upper arm reaction from flu shot (11mm - clear water like blister noted) 2 1/2 inch area of redness to deltoid area of same arm; ? swelling.
Within 10 minutes of receiving GARDASIL, patient passed out, regained consciousness. Since that time - 2 episodes of similar symptoms with loss of vision for a few seconds and feels dizzy.  3/9/09 Received PCP medical records of 12/30/08. FINAL DX: syncope Records reveal patient experienced back pain, knot at left hip, fleeting dizziness, dimming vision beginning w/HPV vaccine & had since had episodes of passing out.  Examination revealed orthostatic blood pressure & referred to cardio for tilt table test.  Also referred  MRI of left hip.  3/9/09 Received Cardiology records of 1/16/2009. FINAL DX: neurocardiogenic syncope Records reveal patient experienced daily episodes of blacking out, seeing stars, HA & blurred vision x 9 mo.  Instructed to increase fluid intake, add salt to diet & exercise to strengthen legs & augment venous return to heart.
Patient states the day of vaccine he developed a headache shortly after the vaccine. He has had hives reaction/itching all over body, sparing face. Patient with rash on palms of hands and feet as well.
Case number PHEH2016US029305 is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to 85 year old male patient. Medical history and concomitant medication was not reported. The nurse stated that first temperature excursion of FLUCELVAX Quadrivalent on 18 Oct 2016 at 52 Fahrenheit (F) for 1 hour, second excursion of FLUCELVAX Quadrivalent on 23 Oct 2016 dropped low 6 times to 34 Fahrenheit (F) and lasted 30 minutes each time, it was unknown if vaccine was frozen. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml intramuscularly on 25 Oct 2016. Third excursion on 02 Nov 2016 down to 32 Fahrenheit (F) 3 times over the course of 12 hour. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date.; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date.) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2022 at 1:56 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In December 2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date.). On 05-Mar-2022 at 1:56 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Patient received booster dose.  This vaccine was administered up until its manufacturer expiry date of 04-Apr-2022.  No treatment information was provided.
Breakthrough case admission after 3 vaccines THIS IS THE INFORMATION AS LISTED IN THE STATE DATABASE Pfizer 3/10/21 NO LOT # recorded;  Pfizer 3/31/21 NO LOT # RECORDED;  Pfizer 12/11/21 Lot# 33130BA
Initial information received on 25-Sep-2018 regarding an unsolicited non-serious case received from other health professional (physician's assistant). This case is related to case- 2018SA274507, 2018SA274519, 2018SA274520, 2018SA274521, 2018SA274522, 2018SA274523, 2018SA274524, 2018SA274525. This case involves 66 years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot number: UI993AB), expiry date 18 Mar 2019 via intramuscular route that were not considered valid due to prolonged shipping and unknown temperatures on 21 Sep 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to deteriorated drug administered because of prolonged shipping. It was reported that Vaxserve delivered FLUZONE HD 0.5mL the week of 09 Aug 2018 and it took 3 days to deliver, was told by Vaxserve that doses were viable at that time and temp indicator in shipping container did not show a change in temp, then received call from Vaxserve on 25 Sep 2018 stating that doses were not viable from shipping excursion, doses were given to nine patients. It was not reported whether the patient experienced any adverse event following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. Follow up information received from other health professional (physician's assistant) on 27-Sep-2018. Individual patients were identified. Narrative updated accordingly. List of documents held by sender- none.
Td vaccine given on 7/11/23 as part of patient's annual work physical. Call received on 8/4/23 from patient's employer stating patient has been experiencing arm pain and slight impairment to range of motion since the vaccination.  Contacted provider for treatment recommendations. Provider suspects inflammation reaction and recommends  OTC ibuprofen or aleve for 7-10 days and applying ice for swelling.  Attempted to contact patient to convey treatment recommendations. Left voicemail and sent message through EHR.  Patient states she has been taking ibuprofen daily since the vaccination with no improvement.  Provider recommends follow-up with primary care provider or urgent care.
INJECTION SITE SORENESS, EXTREME FATIGUE, CHILLS, NUMBNESS IN FEET AND HANDS FOR COUPLE OF HOURS AND STILL HAVING "SHOCK" LIKE FEELING IN HER FINGERS.
Patient presented for second vaccine.  Approximately 10 minutes after administration, rash appeared on right arm and right side of her back.  Pt states that she has had this happen before but feels that it might be "in her head" as well.  Pt has significant list of medication allergies, none present in Moderna COVID vaccine.  Pt continually monitored, rash continues to spread.  Decision made to transport patient to hospital by ambulance.  Pt begins to report that he lips are numb and that she feels her throat is closing.   Pt transported by  Ambulance to hospital.
missed the appointment for the second dose and wants to receive the second dose now, more than 42 days after the first one; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed the appointment for the second dose and wants to receive the second dose now, more than 42 days after the first one) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed the appointment for the second dose and wants to receive the second dose now, more than 42 days after the first one). In 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed the appointment for the second dose and wants to receive the second dose now, more than 42 days after the first one) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
COVID vaccine was administered afterthe 6 hour administration window from being mixed.              Lot # 030B21A    Vial Exp-9/30/2021
I had started coughing and that lasted for about two days and the second day I had low grade fever with lethargy. That all got worse and I ended up going into the Doctor and had COVID-19 PCR test which came back as positive. I was given Paxlovid which I started taking on the 28th in the afternoon and by the time I went to bed the symptoms had improved. I did the isolation period of the ten days and I tested negative on the 6th of July. On the 9th I tested positive again and the symptoms had started again which was coughing and a fever. This time my symptoms were more mild than the first time around. I did another ten days of isolating and then tested negative again.
1.5 inch x 1.5 inch red, swollen, hard, and warm area located about 2 inches from injection site. Area was noticed at 3:00pm 7 days from vaccine date as it was itching - a new symptom.
01/13/2023 I started having a fever, sore throat and flue like symptoms. After reaching out to my doctor I was diagnosed with Covid. I was prescribed Paxlovid. Symptoms lasted a week.
Red, raised rash to trunk, arms and legs. Pt c/o pruritus only. No fever. Mom stated pt has had appt. to see physician tomorrow. Instructed mom to give pt Children's Benadryl. As of today, 6/9/06, pt's mom reports that the pt has been seen by a pediatrician who does not feel the rash is vaccine related. A cream prescription has made a slight improvement to rash. Physician may refer pt to a dermatologist.
Within 12 hours after receiving the vaccine, I developed hives. It started on my torso, back and sides.  I sent a message to my doctor, and I started treating myself. For dose 4 I took two Allegra and Pepcid AC to prevent developing hives again and it worked.  I started using allergy medication and calamine lotion. I have also had cardiac issues for two years. I noticed it more when I was active like exercising and going up stairs. I was diagnosed with AFIB in 12/2022. As of today, I have not had any more hive breakouts.
swelling and redness around the injection site around 6 cm by 2 cm. Fever & chills 10/4 PM.  right side neck stiffness 10/5
macular lesions on R and L arms/forearm (volar aspect), back, R lower leg
Pt received DTAP vaccine in his leg. Dad called next AM stating leg was swollen and red at injection site.  MD told parent put lukewarm compresses and Motrin for pain.  Swelling subsided and went away after 2 days.
Started in the right face facial numbness and paralysis, mouth uneven, swelling, difficult to speech, swelling and numbness around my mouth, problems to swallow, breathing problems, difficult to walk. Hours after been hospitalized the paralysis affected the left side and stays there. The vision problems due swelling , pain and unable to close the left eye.
Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: vomiting-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
Patient began to experience side effects the day after vaccine (4/1): shortness of breath, severe nausea and vomiting, abdominal pain, and constipation. Pt was unable to hold down water and was send to the hospital to help with hydration, pain, and shortness of breath. Pt reports she is not starting to get back to her normal breathing and eating habits almost 4 weeks later.
a registered nurse at the vaccination site was stuck with a used needle to her left hand as she was trying to pull back the plunger to activate the safety component. She washed her hands wit soap and water and as soon as she notified the clinical lead she was sent to Hospital for evaluation
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient's husband). This is the 2nd of 2 reports. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) dose 1 (lot number: EL9262) on 28Jan2021 at 15:30 and dose 2 (lot number: EN6201) on 18Feb2021 at 15:30, both via an unspecified route of administration and both as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies and was not diagnosed with COVID-19 prior to vaccination. Concomitant medications (other medications in two weeks) were reported as yes. The patient did not receive another vaccine within 4 weeks prior to the COVID-19 vaccination. The patient experienced COVID-19 confirmed by positive COVID-19 test on 17Apr2021 at 14:00 (as reported). The clinical course was reported as follows: "My wife and I have both been fully vaccinated since 18Feb2021 at 3:30 pm. We both have since tested positive with COVID-19 on 22Apr2021. Our 15month old daughter and her daycare provider are the people who exposed us." It was reported that the event required a physician office visit and no treatment was received for the event. The patient tested positive for COVID-19 via nasal swab, COVID test name: Innovative care, on 22Apr2021. The clinical outcome of the event COVID-19 confirmed by positive COVID-19 test was recovering/resolving.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021456777 same reporter/drug/AE, different patients.
24 hrs after vaccine-severe aching x 24-36 hrs 36hr after vaccine-slept for 2 days RTC, then continued increased sleepiness until sx'g gone at 1 wk. (+) mental confusion, HA
1 1/2" hard, hot, red, puffy circle at injection site. Very itchy. Feels like a giant mosquito bite.
9 bouts of diarrhea; Abdominal cramps; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (COVID-19 MRNA VACCINE BIONTECH; Lot number: ER8732), via an unspecified route of administration in the right arm on 24Mar2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder, insomnia, some spinal compression, some arthritis due to chronic Achilles rupture, chronic sore in nose, tongue was too big for mouth, dust mites allergy and elm pollen allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included lorazepam (MANUFACTURER UNKNOWN), zolpidem (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN), topiramate (MANUFACTURER UNKNOWN) and lamotrigine (LAMICTAL), all for unknown indications from unknown dates. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Mar2021 at 12:40, about 40 minutes after the shot, the patient experienced abdominal cramps and on 25Mar2021 (reported as today), the patient experienced 9 bouts of diarrhea between 09:00 to 15:00. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received treatment with OTC anti-diarrheal medications for the event's abdominal cramps, 9 bouts of diarrhea and zoom was scheduled for 18:00 on 25Mar2021. The clinical outcomes of the event's abdominal cramps and 9 bouts of diarrhea were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
received the first dose of the / vaccine 9 months ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 9 months ago from the date of reporting, on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not have information about the patient at the time of the report. The reporter consented to follow up. The VAERS details were reported for 1st dose of Shingrix. The case was linked with case US2021168359, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021168359:Same reporter