chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After consenting and answering "no" to all pre-screening checklist items, patient  received the 1st Pfizer COVID-19 vaccine on 4/28/2021. Upon trying to enter the vaccination information, it was discovered that patient previously received both doses of Moderna COVID-19 vaccine.  -2/12/2021 Moderna 032L20A -3/17/2021 Moderna 013A21A   No adverse reactions noted.
Itching after vaccine. Now itching with rash that won't go away on back and arms. Doctors didn't know what it was.
Approximately 10-15 minutes after vaccine administered, pt passed out while sitting in a chair, slow slurred speech and unalert upon waking up. EMS called, pt refused hospital transport.
I began getting aching in my right ankle. I was concerned that I had a blood clot. I went to the doctor, and they sent me to the hospital to have a doppler done to tell whether there was one. That was negative. There was aching and numbness in the right calf, from the foot to knee has numbness in it. The doctor recommended a neurologist. There was right leg from the foot to knee has numbness in it. I went to the doctor and was referred to a neurologist. They did not find neuropathy. Since it was negative, I did not see the neurologist again. I am still having pain and numbness in my leg and foot. Sometimes are better than other but it's still not gone. I plan to mention this to the doctor on my annual visit.
This spontaneous case was reported by an other health care professional and describes the occurrence of SYNCOPE (like I was going to faint), ILLNESS (Felt really sick), HOT FLUSH (Hot and cold flashes), PAIN (Aching) and HYPERHIDROSIS (Sweating) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 011L20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient experienced SYNCOPE (like I was going to faint), ILLNESS (Felt really sick), HOT FLUSH (Hot and cold flashes), PAIN (Aching), HYPERHIDROSIS (Sweating), FEELING ABNORMAL (It was awful), DIZZINESS (Very dizzy), PYREXIA (Had a little fever), CHILLS (Chills) and EXPIRED PRODUCT ADMINISTERED (Vaccine had expired or was left out of the fridge too long). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Incorrect product storage). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine had expired or was left out of the fridge too long) had resolved. On 16-Dec-2021, SYNCOPE (like I was going to faint), ILLNESS (Felt really sick), HOT FLUSH (Hot and cold flashes), PAIN (Aching), HYPERHIDROSIS (Sweating), FEELING ABNORMAL (It was awful), DIZZINESS (Very dizzy), PYREXIA (Had a little fever) and CHILLS (Chills) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Incorrect product storage) outcome 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 received the booster dose of the vaccine at 2:00 AM and by 4:30 AM she felt really sick, very dizzy, like she was going to faint, and she had a little fever.  She took ibuprofen for symptoms and they resolved within 24 hours.  Also after receiving the booster dose of the vaccine, she was told that the vaccine had been stored improperly prior to administration. She believed that the vaccine had expired or was left out of the refrigerator for longer than it was supposed to.   This case was linked to MOD-2022-448411 (Patient Link).
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 24-NOV-2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles and other complications. On or about 11-DEC-2015 the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The patient has been prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
pt recvd vax; exp rash just like previous vax;rash was itchy per mom;
This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L023588, expiry date: 26-JUN-2017). Medical assistant reported that the vaccine underwent temperature excursion on unknown dates with following details: lot # L023588 (exposed at 10 degree Fahrenheit for an unknown time frame and for 300 hours, respectively). No adverse effects were reported. This is one of the four reports received from the same reporter. Additional information has been requested.
welts, looks like mosquito bites; skin rash on legs and buttocks; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (welts, looks like mosquito bites) and RASH (skin rash on legs and buttocks) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 031A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METHENAMINE HIPPURATE and HYDROCHLOROTHIAZIDE for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced URTICARIA (welts, looks like mosquito bites) and RASH (skin rash on legs and buttocks). On 14-Mar-2021, URTICARIA (welts, looks like mosquito bites) and RASH (skin rash on legs and buttocks) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient's Teladoc prescribed Hydroxyzine, Benadryl, Triamcinolone ointment as treatment and symptoms resolved the following day.
Fever, pain, feeling ill  went to ER. Diagnosed with Cellulitis, treated with Antibiotics. No further information available.
pt recv vax & devel hives;muscle tone changed;no longer meets appropriate devel milestones;dx infantile spasms;
bleeding; urticarial rash for almost three months; all four limbs very itchy; causes bleeding because I scratch it when I am sleeping; fatigue; vasculitis where I have had my fingers turned purple; My heel turned purple; bruising; This is a spontaneous report from a contactable physician (Patient). A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EH9899 and Expiry date: Unknown), via an intramuscular, administered in Deltoid Right on an unspecified date, at the age of 52-years-old as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced bleeding, urticarial rash for almost three months, all four limbs very itchy, causes bleeding because i scratch it when i am sleeping, fatigue, vasculitis where i have had my fingers turned purple, my heel turned purple, bruising, i think i had a re-infection from covid. The patient stated that "I did not retest myself until I had an adequate amount of time to treat what I thought was a COVID Infection just because I need to get back to work and I can't go back to work if test positive for COVID my health department at the hospital advised me to continue therapy and then to retest late last week. Actually, today is Saturday so I tested out on Thursday and it came back negative." The patient underwent 27 different lab tests this past week those results are pending. The patient underwent lab tests and procedures which included Covid-19 swab test: negative on an unspecified date. Therapeutic measures were taken as a result of the events. Treatment currently taking immunosuppressant doses of PREDNISONE and taking IVERMECTIN. The outcome of event was unknown. Regarding causality, the patient stated, "That is my suspicion. Yes. That's just the only thing I can think of." The reporter provided the causality as related.
This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 84-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included chronic sinusitis, postnasal drip and cough. Concomitant products included dTpa vaccine, levofloxacin and PNEUMOVAX. On 30th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 10th August 2018, 11 days after receiving SHINGRIX, the patient experienced pneumonia (serious criteria hospitalization and GSK medically significant). In August 2018, the patient experienced immunoglobulin G decreased (serious criteria hospitalization). The patient was treated with antibiotics nos. On an unknown date, the outcome of the pneumonia was recovered/resolved and the outcome of the immunoglobulin G decreased was unknown. It was unknown if the reporter considered the pneumonia and immunoglobulin G decreased to be related to SHINGRIX. Additional details were provided as follows: The patient saw her pulmonologist the morning of her SHINGRIX vaccine for a standing 6 month appointment for chronic sinusitis with cough and postnasal drip which was a condition she has had for many years. The patient received the dose of SHINGRIX on the left arm around 1:40 PM and that she was not planning on getting her second dose after her reaction. The patient was recommended that she get the Tdap vaccine and PNEUMOVAX. The patient received PNEUMOVAX vaccine in August 2018. The patient claimed that she was admitted to the hospital on 10th August 2018 with pneumonia and she was discharged on 12th August 2018. Her pneumonia resolved after high doses of antibiotics with an intravenous and other antibiotic after her release from the hospital. She was diagnosed with Immunoglobulin G deficiency after blood work in August 2018. On 31st October 2018, the patient was recommended that she see an infectious disease doctor and they put her on an antibiotic Levofloxacin and her cough resolved. She had the cough with postnasal drip for months but it never amounted to anything. This was an ongoing condition that she has been treated for many years ago. The patient received the Tdap vaccine in September or October 2018. The patient had provided contact details of her treating physician.
Mom reported that on day of vaccines and for one day afterward, child would have single jerks involving right eye area and right upper and lower extremities, would happen about every 10 sec (x20). Then subside and reoccurred later in the day. In between these movements child happy awake smiling, mom described movement looking , cold, chills, shudders, by 10/05, movements had disappeared. reported to physician on visit of 10/14/05.
After less then 48 hours I woke up with diarrhea. Then I started throwing up followed by severe chills & body aches, a fever & a headache
This case was reported by a consumer via call center representative and described the occurrence of dizziness in a male patient who received RABAVERT. On an unknown date, the patient received the 1st dose of RABAVERT. On an unknown date, 1 days after receiving RABAVERT, the patient experienced dizziness, ear congestion and auditory disorder. On an unknown date, the outcome of the dizziness, ear congestion and auditory disorder were unknown. It was unknown if the reporter considered the dizziness, ear congestion and auditory disorder were unknown. It was unknown if the reporter considered the dizziness, ear congestion and auditory disorder to be related to RABAVERT. Additional details were provided as follows. This case was reported by the patient himself. The reporter said that he had two doses of the RABAVERT. The reporter said on the 2nd day of his 1st dose (1 day after vaccination), he experienced a little dizziness which was very subtle and he believed that it may have been congestion. He also said that his hearing was different.
Hives all over body beginning about 8 hours after vaccine treated with BENADRYL-would clear up then come back after BENADRYL wore off. Cleared up completely 1/2/16.
patient had an adverse reaction to the Imovax; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) via Medical Information (Reference number- 00395404) and transmitted to Sanofi on 16-Dec-2020.  This case involves female patient with an unknown age who had an adverse reaction to the imovax (adverse reaction), while she received RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect RABIES (HDC) VACCINE (lot number unknown) via an unknown route in an unknown site for prophylactic vaccination.  On an unknown date either in the fall of 2011 or spring of 2012, patient stated that she had an adverse reaction to the RABIES (HDC) VACCINE (adverse reaction). Patient wanted to know what is in the RABIES (HDC) VACCINE because, with the new Covid vaccine coming out, she wanted to make sure that the Covid vaccine doesn't have the same ingredients.   No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for adverse reaction.  There will be no information regarding the batch number for the case.
soreness; tiny knot under arm that dissolved within 2 weeks.; This case was reported by a other health professional via sales rep and described the occurrence of pain in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number ABX749AA, expiry date unknown) for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On 9th July 2019, the patient received the 2nd dose of Bexsero. In July 2019, less than a month after receiving Bexsero, the patient experienced pain and axillary lump. On an unknown date, the outcome of the pain and axillary lump were recovered/resolved.   It was unknown if the reporter considered the pain and axillary lump to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero and experienced soreness, tiny knot under arm which dissolved within 2 weeks.
PATIENT PRESENTS TO PHARMACY DEPARTMENT ON 11/17/20  STATING THAT HE RECEIVED A FLU VACCINE ABOUT 2 MONTHS AGO IN HIS RIGHT ARM AND IS CURRENTLY EXPERIENCING  PAIN IN THAT ARM AND HAS LIMITED RANGE OF MOTION. PATIENT STATES THE PAIN STARTED ABOUT A WEEK AFTER RECEIVING FLU VACCINE. PATIENT WAS  ADVISED TO FOLLOW-UP WITH HIS PRIMARY PHYSICIAN FOR FURTHER EVALUATION. AS OF 11/20/20 PATIENT STATES HE HAS NOT BEEN SEEN BY A MEDICAL DOCTOR FOR THIS ISSUE.
A few hours after my vaccination I had small headaches and felt a little lightheaded and woozy, like many people.  The day after my vaccine injection my stomach felt like I had swallowed a rock.  It became hard internally.  I felt this feeling that can only be described as a rock or blockage for 2 weeks and 2 days.  The blockage or rock feeling moved through my digestive system like bad food and I felt it slowly travel down my body, manifesting in back pain that also moved down my back.  It sat lodged in my lower back/abdomen for a few days and then finally dissipated.  It was a terrible two weeks with little sleep and I felt crappy the entire time.  I am concerned about receiving my second dose.
20may90 pt vax hepta B. pt ex profuse n/v. unable to work for 1 day.
Information has been received from a physician concerning a 7 year old white male with no known medical history or allergies who was vaccinated IM in the right thigh with a first 0.5 mL dose of Varivax. On 20-FEB-2006 the patient developed singles at the injection site. A doctor's visit was required. A CBC was performed which showed a high white blood cell count (11.7 K/uL) and an high lymphocyte count (4.3). The patient was treated with acyclovir (ZOVIRAX). The patient's outcome was not reported. There was no product quality complaint involved. Additional information is not expected.
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, chills Narrative:
C/O dizziness, nausea, stomach ache, increased heart rate 120'S.
Swelling, redness, pain, itching at injection site; malaise, muscle aches, low fever
I went to donate blood and my heart rate was at 220 beats per minute. We waited it out and I eventually ended up donating blood. I followed up with my physician on 04/28/2021. She referred me to a cardiologist. I saw the cardiologist on 06/16/2021. They set me up with an event recorder, which I wore for 28 days. I went for a stress echocardiogram which was negative. The event recorder showed tachycardia, SCT, and ventricular tachycardia. They advised that I repeat the event recorder in another year, which indicated that I was still having episodes of SCT and ventricular tachycardia. I had a loop recorder implanted for further monitoring. During this time, they also noticed that my blood sugar was elevated, and I am now taking a medication to lower that.
15 years old was vaccinated with Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 years old was vaccinated with Moderna vaccine) in a 15-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 years old was vaccinated with Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 years old was vaccinated with Moderna vaccine) had resolved. Not Provided      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.   Relevant concomitant medications were not reported.  Treatment medication was not provided.
No adverse event occurred.  This is being reported because the incorrect booster dosage of 0.25 ml was administered rather than the initial vaccine dosage of 0.5 ml.  Pharmacy and physician recommends giving the additional 0.25 ml of vaccine to equal the complete dose of the initial vaccine.
Caregiver experienced severe symptoms after the second dose including a huge headache, Nausea/Vomiting, and severe malaise. Caregiver had to miss work due to vaccine reaction symptoms.
Narrative: COVID infection following COVID vaccine series 12/21/2020 , Pfizer, dose# 1 01/11/2021, Pfizer, dose #2 08/05 COVID swab, result: detected 08/05 pt cc: pt non verbal exposure: wife COVID+ 08/05 COVID swab, result: detected Severe bilateral lower lobe bronchitis without convincing bronchopneumonia. No pleural effusion. 08/10 SARS-COV-2 IgG result: 2.92 08/12 SARS-COVI-2 LINEAGE result: pending 08/12 SARS-COV-2 clade result: pending 08/12 SARS-COV-2 mutations result: pending 08/16 clinically resolved
Fully vaccinated with Moderna with second dose given on 6/24/2021. Tested positive for covid on 12/01/2021 and admitted to Medical Center on 12/01/2021. Case expired on 12/12/2021 while still admitted to hospital.
Constant headaches.  Sinus drainage, especially in AM.  Tired an.d can?t do exercise due being out of breath in short period of time
Narrative: Patient tested positive for COVID-19 and was hospitalized despite full vaccination (Pfizer 1,2, and 1st booster ) and 2nd booster of Pfizer vaccine.
Diarrhea, nauseous, vomiting, weak/tired, slight headache, temperature 100.5.  Didn't feel well at 3:00 am.  At 5:45 am diarrhea and nauseous.  6:30 am vomiting.  Diarrhea all day and evening.  Temp began around 11:30 am.  Slept most of day.  Treated as if stomach bug.  Small drinks of water.  Sleep.  Returned to work today, 01/13/21.  No fever, mainly aches, tired, no diarrhea, stomach little nauseous.
Won't be getting the second; This case was reported by a consumer via  interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse reaction (1st dose received on an unknown date and had a terrible reaction).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 case was reported by the consumer for herself/himself. The age at vaccination was not applicable to this report. Till the time reporting, the patient did not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
Seizure and pallid breath holding spells.  First ever episode was within 15 min of receiving DTaP shot.