chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vomiting (15 hrs following vaccine), chills (10 hrs following vaccine), full body muscle ache (10hrs following vaccine), fever of 100.7 (15 hrs following vaccine), weakness (10 hrs following vaccine)
Patient came to pharmacy to discuss adverse events that had occurred a month prior. He actually said he had the same reaction to both SHINGRIX vaccines. Everything he mentioned was on the VIS from which he was counseled. He did not have any serious events but did experience soreness at injection site as well as fever, shivering, and fatigue for over a week. He described the way he felt as flu-like symptoms. He has had no problems since.
Pt developed hives and slight difficulty breathing after receiving vaccines-went to ER for treatment. Treatment: prednisone, BENADRYL, ranitidine.
Blurred vision/focus issues/can't focus visually/couldn't see right; floaters; left arm and leg went numb; Both arms and legs tingly; felt disoriented; cold chills; Legs and arm felt heavy; my eyes are now having esophoria convergence Excess or vergance dysfunction; my eyes are now having esophoria convergence Excess or vergance dysfunction; my eyes are now having esophoria convergence Excess or vergance dysfunction; This is a spontaneous report from a contactable consumer (patient). A 38-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 18Mar2021 11:45 (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included allergies to Penicillin and no other medical history. The patient had no COVID prior vaccination. The patient was no pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID); cetirizine hydrochloride (ALLERTEC); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); ascorbic acid (VITAMIN C); ergocalciferol (VITAMIN D). There was no vaccine in four weeks. The patient stated that right after she drove off, Blurred vision/floaters, left arm and leg went numb. Both arms and legs tingly, felt disoriented, cold chills, had to pull the car over because she couldn't see right. Legs and arm felt heavy. Blurred vision & focus issues had continued and the eye doctor said her eyes were now having esophoria convergence Excess or vergance dysfunction. She still can't focus visually since she drove off from the vaccine. She had to go to the doctor today & they were going to schedule a neurologist appointment to make sure she didn't have a mini stroke. It had been extremely scary since she received it. All events occurred on 18Mar2021 12:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Treatment received for the events and she needed glasses with a prism and neurologist appointment. The patient had no COVID tested post vaccination. The outcome of the events was not recovered.
Non immunocompromised received third full shot; Non immunocompromised received third full shot; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Non immunocompromised received third full shot) and ACCIDENTAL OVERDOSE (Non immunocompromised received third full shot) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0462B21A, 429L21A and 007M20A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN, SPIRONOLACTONE, ESCITALOPRAM, LOSARTAN, TRAVOPROST, ZONISAMIDE and LEVOTHYROXINE for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced OFF LABEL USE (Non immunocompromised received third full shot) and ACCIDENTAL OVERDOSE (Non immunocompromised received third full shot). On 30-Aug-2021, OFF LABEL USE (Non immunocompromised received third full shot) and ACCIDENTAL OVERDOSE (Non immunocompromised received third full shot) had resolved.            Patient's weight was provided as 235 with unspecified units.  Concomitant products included femorol.  No treatment medication was reported.   This case was linked to MOD-2021-406561.
The next day after vaccine, I had a slight fever around 100 with body aches, lethargic, chest congestion and had to use my inhaler. This lasted for 1 week. Then on 4/7/2022 I started getting symptoms of fever, achy, nasal congestion, extreme headaches, exhaustion, and sore throat. I went to urgent care on 4/9/2022 and got COVID-19 test which turned to be positive. Most of the symptoms resided in 2 weeks but I still have congestion to this day. I was prescribed an Amoxicillin. I did have to use my inhaler every 2-3 hours as well.
PATIENT DESCRIBED PAIN AND SWELLING A FEW HOURS AFTER ADMINISTRATION. THE AREA TURNED ITCHY AND WARM TO THE TOUCH. PER PATIENT, THE AREA WAS ALSO SWOLLEN AND HARD. THE FIRST NIGHT SHE WAS NOT ABLE TO MOVE HER ARM BUT ON 12/12/19 SHE WAS ABLE TO GET BETTER RANGE OF MOTION. NOTIFIED PATIENT TO TRY TAKING BENADRYL OR ZYRTEC TO DECREASE THE SYMPTOMS THE LOOK TO BE AN ALLERGIC REACTION AT SITE OF INJECTION. NOTIFIED HER TO SEEK MEDICAL ATTENTION AS SOON AS POSSIBLE IF SYMPTOMS DO NOT RESOLVE OR GET WORSE. WILL CALL PATIENT TO FOLLOW UP TODAY TO SEE HOW SHE IS DOING.
cough, runny nose, congestion, hyperemic throat, scattered papules suggestive of mild chickenpox that did not fully develop;
I was tired a few hours after the shot. Fine for the next few days and then was tired, mild headaches and body aches. I had a lump in my arm the entire week, but at the one week mark, it turned red and began to itch and swell slightly. 2 days later it was bright red. (That was last night).
Inconsolable crying for 3 hours after Pediarix immunization (routine 4 month shot) Didn't respond to 1st dose of Tylenol (given before shots) Resolved 30 minutes after Tylenol dose child fell asleep.
Suspected vaccination failure; Had it twice; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles twice. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
A report was received from a health care professional on 11/17/03 concerning a male vaccinee of unknown age who inadvertently received 1ml Fluvirin on 11/14/03. On 11/14/03, the vaccinee inadvertently received Fluvirin 1ml IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 4/12/04: Further information was received from a health care professional indicating that the vaccinee did not experience any adverse reaction. No follow up pending, no further information available.
Around 7 March 2021 she flew to town from another town and noticed her foot started hurting, she continued to walk through it though the swelling was present (couldn't put on her shoe), and on 12 March 2021 she flew back home from town and her calf felt like a rock at the back of the calf, the swelling of the foot was associated with pain and her leg turning blue with palpable dilated vein along the anterior lower leg  30 March 2021 she had her first Covid vaccine, Pfizer  Due to her leg symptoms not improving despite exercise, she discussed her symptoms with her brother in the medical field, and also noted some significant trouble breathing when trying to chase her niece and she was told to seek medical eval  On 5 April 2021 she had a CT angiogram which showed right lower lobe pulmonary emboli without right heart strain, reactive right axillary lymph nodes which are common if prior Covid vaccine given, the Covid vaccine was given in her right arm, her NuvaRing birth control was stopped and she was started on Eliquis  5 April 2021 a left lower extremity ultrasound showed no evidence of DVT  16 April 2021 transthoracic echocardiogram showed an EF of approximately 60%  20 April 2020 she had her second Covid vaccine Pfizer  CT angio 14 July 2021 showed no evidence of pulmonary embolism, and no evidence of reactive lymphadenopathy likely present on prior scan related to Covid vaccination, thus Eliquis stopped with plans to use only peritravel as prophylaxis  She has had screening mammogram, and does keep her Pap smears up-to-date, there is no family history of blood clots or cancer though her mom had skin cancer but likely nonmelanoma   Hypercoag work-up has shown prothrombin gene mutation negative, beta-2 glycoprotein antibody negative, Antithrombin normal, protein C and S normal, hexagonal lupus anticoagulant negative, DRVVT negative, homocystine normal, though she was noted to be heterozygous for factor V Leiden
HSV-2 Outbreak; lesions; This case was reported by a other health professional via call center representative and described the occurrence of herpes simplex in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced herpes simplex and skin lesion. On an unknown date, the outcome of the herpes simplex and skin lesion were unknown.   The reporter considered the herpes simplex and skin lesion to be related to Shingrix.  Additional details were provided as follows: This case was reported by the Pharmacy Intern. The age at vaccination was not reported. It was reported that a patient had an outbreak of HSV-2 after receiving the 1st dose of Shingrix. The patient later received the 2nd dose of Shingrix and after the HSV outbreak persisted lab testing came back to confirm the etiology of the lesions.  The patient believes there was a relationship between Shingrix and the new medical diagnosis of HSV-2. The patient was consented to follow up. The reporter stated, the event was reported in VAERS but the reporter was fine with receiving a letter from safety.
low grade fever; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2020, the patient received Shingrix. On 4th November 2020, 1 days after receiving Shingrix, the patient experienced low grade fever. On an unknown date, the outcome of the low grade fever was unknown.   It was unknown if the reporter considered the low grade fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Consumer stated that she received a dose of Shingrix and now had a low grade fever. The reporter did not consent to follow-up.; Sender's Comments:  DE-GLAXOSMITHKLINE-DE2020EME219261:Same atient 1st dose
Double pneumonia; Heart attack; was hospitalized was not able to get second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Double pneumonia) and MYOCARDIAL INFARCTION (Heart attack) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced OFF LABEL USE (was hospitalized was not able to get second dose). On an unknown date, the patient experienced PNEUMONIA (Double pneumonia) (seriousness criterion hospitalization) and MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). The patient was hospitalized on 31-Mar-2021 due to PNEUMONIA. On 09-Apr-2021, OFF LABEL USE (was hospitalized was not able to get second dose) had resolved. At the time of the report, PNEUMONIA (Double pneumonia) and MYOCARDIAL INFARCTION (Heart attack) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient wanted to know if she should repeat first dose. It was reported that patient was on "a lot" of concomitant medications but did not specify. The patient was in the intensive care unit. No treatment medication was reported.  Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
ASSESSMENT/PLAN:   1. Injection site reaction, initial encounter New problem to me. Discussed with patient that it is possible that she may have cellulitis of her left arm vs injection site reaction. Since she has had some improvement in symptoms over the past 2 days patient is going to monitor over the next 24 hours and if she still has pain, swelling, redness, or increased warmth she will start antibiotic as discussed.  Medication side effects were discussed with patient in detail. Patient voiced understanding without any questions or concerns.   Continue to use a warm compress, Motrin, and tylenol as discussed. Return to the office for persistent or worsening symptoms.  Patient advised and voiced understanding of instructions.     - cephalexin (KEFLEX) 500 MG capsule; Take 1 capsule by mouth 3 (three) times daily for 7 days.  Dispense: 21 capsule; Refill: 0      Patient is a 19 y.o. female    Today's visit was done via Telemedicine.     Patient presents today for possible immunization reaction. She had flu and pneumonia shot in her left arm on 10/28/20 and has had redness, swelling, increased warmth, and soreness at the injection site. Patient has had a fever up to 102.2 on Saturday but has not had another fever since that time. No abscess or drainage per patient. She states that her arm pain, swelling, and erythema have been slowing improving. She has been using Tylenol, Motrin, and cold compress with some improvement.    Patient's past medical, surgical, social and family histories as well as medications and allergies were reviewed and updated as appropriate
This spontaneous report was received from registered referring to a 64 year old female patient. On 29-SEP-2014 the patient was vaccinated with PROQUAD (Lot# was reported as K002481, expired on 08-AUG-2015), 0.5 ml, subcutaneous, which was instead of ZOSTAVAX. The nurse states that the error occurred because she had rearranged the contents of the freezer, and she grabbed the wrong vaccine. She states that there was no confusion over the labeling of the PROQUAD and the ZOSTAVAX; she didn't check the vaccine before she administered the dose of PROQUAD to the patient in error. No adverse effects have been observed or reported. The outcome of event was unknown. Additional information has been requested.
I was confused by the survey questions asked.   After the October vaccination, I came down with Covid-19 in December.   There were no adverse effects to the injection.   My doctor proscribed  a five day course of Paxlovid.   I had no adverse  effects to the Paxlovid.
This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 23-NOV-2015, the patient was vaccinated with improperly stored GARDASIL, lot # K011562, expiration date 08-APR-2017, (dose, dose number, route and anatomical location were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: lips tingling and radiate to left arm and right arm-Medium, Additional Details: at first she felt lips tingling, we gave her a benadryl and let her sit for the other 15 minutes. after that, she felt tingling more on her right arm and left arm, warmness on her neck and her chest, a little redness. she did not have any trouble breathing, no shortness of breath.
Suspected vaccination failure; still got shingles and battering shingles now; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles and battering shingles now). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   The reporter considered the vaccination failure and shingles to be possibly related to Shingrix.     The company considered the vaccination failure and shingles to be possibly related to Shingrix.   Additional Information: GSK receipt date: 09-MAY-2023 The case was received from the patient interactive digital media. The patient had the shots and four or five years ago and battering shingles now (at the time of reporting). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
3rd dose of the vaccine; 3rd dose of the vaccine; Ringing and hypersensitivity of left ear; Ringing and hypersensitivity of left ear; This is a spontaneous report from a contactable nurse, the patient. A 30-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 24Aug2021 at 11:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included Crohn's disease and chronic immunosupressive therapy. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included azathioprine (MANUFACTURER UNKNOWN) and cyanocobalamin (Vitamin b-12), and unspecified prenatal medication; all for unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of COVID-19 VACCINE (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and also second dose of COVID-19 VACCINE (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 26Aug2021, the patient had ringing and hypersensitivity of her left ear which was began in the same week of her injection. It occurred frequently and had faded. The patient had not noticed the problem at the time of report. It was reported that, this was her third dose of the vaccine about 7 months after her second dose series. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events ringing and hypersensitivity of left ear was resolved on an unknown date in 2021.
Information has been received from a healthcare professional, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # R002344, expiration date on 16-NOV-2011, intramuscularly (anatomical location and dose number were not reported) for prophylaxis. No adverse effects were reported.
Patient had extreme pain in her arm that escalated to her chest for a day or 2. Patient went to urgent care where she was given some pain killer and got relief after 2 days. Now her arm is fine.
Patient was administered with vaccine past the BUD (17-Feb-2023); No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)) and NO ADVERSE EVENT (No adverse event) in an adult 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. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history or conditions, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis). The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)).    No concomitant medications were provided. The vaccines were administered between 13-Mar-2023 to 05-Jun-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. No treatment medication was provided. This case contains information for the 2nd of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master case
mom reports pt rt leg 1 1/2 x 2x large than lt leg, warm, hard & swollen;mom denies child having fever & reports activity as nl;mom report MD felt rxn d/t pertussis & ordered APAP as needed & apply ice;
Pt recvd vax on 25JUL92 & that day exp sore arm, nausea, tiredness, malaise, which lasted approx 12 to 24 hrs;