chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Came into the ER with complaints of sudden-onset palpitations and tachycardia. Received COVID vaccine 3 days ago (2nd Moderna Covid vaccination). Was found to be in AFib with RVR. Was given adenosine 6 mg x 1, then 12 mg x 1 en rote via EmS with no change to heart rate. When in the ER, his heart rate was 189.  He was initially started on Cardizem drip. Admitted to CVU. Cardiology was consulted. An echocardiogram was ordered which did not show any significant abnormalities. No further workup recommended at this time. Hemodynamically stable for discharge. Recommend following up with primary care 2-4 weeks post discharge.
This spontaneous report was received from a Registered Nurse and refers to a multiple patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On unknown dates, multiple patients received doses of improperly stored PNEUMOVAX 23 underwent temperature excursions at 47 Fahrenheit degrees, for unknown time frames. Information about the previous temperature excursions was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports receiving from the same reporter. Additional information has been requested.
Sore/tender arm; headache; This is a spontaneous report from a contactable other hcp (patient). A 67-year-old female patient received bnt162b2 (lot number: ek5730), intramuscularly at left arm, first dose on 18Dec2020 13:45, at single dose, for COVID-19 immunization. Medical history included high blood pressure from an unknown date. No known allergies. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included blood pressure medication. The patient experienced Sore/tender arm and headache the day after the vaccine on 19Dec2020 01:00. The event was reported as non-serious. No treatment received for the adverse event. The patient underwent lab tests and procedures which included blood pressure measurement: high on an unspecified date. The outcome of the events was recovered.
Pt took nap awoke @ 1PM  was stiff-like, difficult to move, screamed high pitch cry; No appetite, kept burping; Taken to MD who felt it was Pertussis rxn & advised DT in the future; No tx; No fever; Crying lessened p/MD visit;
1:30 AM MY ARM WAS THROBING AND I HAD CHILLS VERY BAD  MY ENTIRE BODY ACHE ALL OVER AROUND 10:00 AM THINGS HAD CALM DOWN BY NOON EVERYTHING WAS GONE.
Information has been received from a physician concerning a 15 year old female who received the second dose of GARDASIL and a dose of tetanus shot (manufacturer unspecified) "sometime this week on 17-AUG-2009 and then the next day the patient developed a rash on her trunk. The physician reported that the patient was sent to the emergency room (name, address and phone number unspecified) to have the rash looked at but she was not admitted. The physician reported that they were unsure if the patient would receive the third dose of GARDASIL. "At the time of report the patient was recovering. Additional information has been requested.
Mom called next morning and stated her son was sleeping all day and had blank stare when he woke up and a temp. of 101. She was advised to take him to ER. He was diagnosed w/seizures he did on hospital follow up w/us on 7/21/16.
Balance disorder; Fall; hurt her arm; Bleeding; Blurry vision; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history was not reported   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose.   On 05-Apr-2021, the patient experienced  blurry vision, lost her balance and fell very hard and was bleeding everywhere and hurt her arm.  The patient experienced HAEMORRHAGE (Bleeding) (seriousness criterion medically significant), VISION BLURRED (Blurry vision), FALL (Fall) and PAIN IN EXTREMITY (hurt her arm). On an unknown date, the patient experienced BALANCE DISORDER (Balance disorder). At the time of the report, HAEMORRHAGE (Bleeding), VISION BLURRED (Blurry vision), BALANCE DISORDER (Balance disorder), FALL (Fall) and PAIN IN EXTREMITY (hurt her arm) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant were given No lab details was provided. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-068245 (E2B Linked Report).; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-068245:Husband case
woke up 5am with Arm itching.   Rash Red and very itchy from Elbow to Shoulder.  Injection site red rash around it.   Used Benadryl cream on it .  Rash lasted about 7 days, slowly getting better.   .
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 67-year old female subject who was vaccinated with BOOSTRIX. Concurrent medical conditions included latex allergy. Concurrent medications included unspecified medications. The subject was taking several medications but there were no new medications. On 29 August 2012 at 11:35 the subject received a dose of BOOSTRIX (.5 ml, unknown route, left arm). On 31 August 2012, 2 days after vaccination with BOOSTRIX, the subject experienced injection site redness and injection site warmth. The subject was given antibiotics as treatment. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX. Follow-up information was received on 18 September 2012 via healthcare professional who reported the onset date was 30 August 2012, previously reported as 31 August 2012. At the time of the report the events had improved.
This spontaneous report was received from a nurse practitioner referring to a 21 year old female patient. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with the first and second dose of GARDASIL 9 for prophylaxis (strength, dosage schedule, lot number and expiration date were not reported). On an unknown date, the patient was evaluated in an unspecified emergency room for a urinary tract infection; additionally, the patient had a pregnancy test and it was negative. On 24-SEP-2018, the patient was seen in the office for a follow-up visit and was vaccinated intramuscularly with the third dose of GARDASIL 9 lot number: R0002345, expiration date: 16-OCT-2020. On the same day, the patient informed that she had not had her period in a while and a pregnancy test was performed resulting positive. The last menstrual period (LMP), date of conception and estimated date of delivery (EDD) were unknown and could not be calculated. The pregnancy and fetal outcome were unknown. The outcome of urinary tract infection and was also unknown. Causality assessment was not provided. Lot number R0002345 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine.
high blood pressure; itchy at injection site; puffy at injection site; red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure), VACCINATION SITE PRURITUS (itchy at injection site), VACCINATION SITE SWELLING (puffy at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (carries an EpiPen).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HYPERTENSION (high blood pressure), VACCINATION SITE PRURITUS (itchy at injection site), VACCINATION SITE SWELLING (puffy at injection site) and VACCINATION SITE ERYTHEMA (red at injection site). At the time of the report, HYPERTENSION (high blood pressure) and VACCINATION SITE PRURITUS (itchy at injection site) outcome was unknown and VACCINATION SITE SWELLING (puffy at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood pressure measurement: 90 to 150 (abnormal) blood pressure went from  90 to 150..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. Treatment information was not provided.     This case was linked to MOD-2021-210107 (Patient Link).
This case was reported by a nurse via sales rep and described the occurrence of difficulty breathing in a 18-year-old female patient who received BEXSERO (batch number 16A401, expiry date January 2019). On 8th February 2018 09:00, the patient received the 1st dose of BEXSERO .5 ml. On 8th February 2018, 3 hrs after receiving BEXSERO, the patient experienced difficulty breathing, skin discoloration and pale. On an unknown date, the outcome of the difficulty breathing, skin discoloration and pale were unknown. It was unknown if the reporter considered the difficulty breathing, skin discoloration and pale to be related to BEXSERO. Additional details were provided as follows: The patient received the vaccine in the left deltoid. About 3 to 4 hours after the patient received dose of BEXSERO, the patient experienced trouble breathing, turned purple, and then pale. The patient was taken to the emergency department by an ambulance called from her mother. Health care professional did not think this was due to the BEXSERO, stated that patient was fine when she was leaving the office.
thinks that  received a 1ml   instead of the 0.25 ml for their Moderna COVID 19 booster; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (thinks that  received a 1ml   instead of the 0.25 ml for their Moderna COVID 19 booster) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 milliliter. On 14-Feb-2022, the patient experienced ACCIDENTAL OVERDOSE (thinks that  received a 1ml   instead of the 0.25 ml for their Moderna COVID 19 booster). At the time of the report, ACCIDENTAL OVERDOSE (thinks that  received a 1ml   instead of the 0.25 ml for their Moderna COVID 19 booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Rx Number was 802441.  No concomitant medications were reported.  The pharmacist reported about the administration of expired Moderna vaccine that were given as booster shot to the patients around 490 to 500 on the last date 20-OCT-2021 to 29-NOV-2021. The Lot number of vaccines were as 006C21A (10-OCT-2021), 026B21A (17-SEP-2021), 031B21A (22-SEP-2021). It was reported that the vaccines were stored in freezer, took out one to two vials and place in fridge each day as needed.  No treatment medication was provided to the patient.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/16/2022 ANEMIA OF CHRONIC DISEASE R09.02 HYPOXIA 2/25/2022 ANEMIA OF CHRONIC DISEASE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/16/2022 CHRONIC LYMPHOID LEUKEMIA R09.02 HYPOXIA 2/25/2022 CHRONIC LYMPHOID LEUKEMIA
Achy upper arm muscle (from both shots) Sore & tender Lymph nodes.  So far it's lasted a week, altho the intensity has lessened.
Pt recv vax on 9/23/97; on 9/24/97 pt exp red, swollen, sore vax site
6/14 18y.o.  male who presented to the emergency center with a chief complaint of blood in vomit.
Information was received from a nurse referring to an unknown number of unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates, the patients were administered doses of improperly stored ROTATEQ injection (Lot# M041184, expiration date 31-MAY-2018; Lot# M044724, expiration date 13-JUN-2018) (Strength, dose, frequency, anatomical location and route were not reported) for prophylaxis. The vaccines were exposed to 47 to 77 Fahrenheit degree (F) for 2 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects was reported. This is one of several reports received from the same reporter. Lot number (M044724) has been verified to be a valid lot number for ROTATEQ. Sender's Comments: US-009507513-1707USA012152: US-009507513-1707USA012415: US-009507513-1707USA012417: US-009507513-1707USA012418: US-009507513-1707USA012419.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in arm left, administration date 30Oct2021 10:15 (Batch/Lot number: unknown) at the age of 66 years as dose 3 (booster), single for covid-19 immunization; influenza vaccine (FLU VACCINE VII), administered in arm right, administration date 30Oct2021 (Batch/Lot number: unknown) as dose 1, single. Relevant medical history included: "Blood pressure meds" (unspecified if ongoing); "cholesterol meds" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. I am the patient, Location of injection: Arm Left), administration date: 21Feb2020, when the patient was 66 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. I am the patient, Location of injection: Arm Left), administration date: 28Jan2021, when the patient was 66 years old, for COVID-19 Immunization. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Other medications in two weeks were Diuretic, vitamins. Patient had not been tested for COVID-19 since the vaccination. The following information was reported: blood pressure abnormal (non-serious) with onset 04nov2021, outcome "not recovered", described as "erratic blood pressure"; nausea (non-serious) with onset 04nov2021, outcome "not recovered", described as "nausea"; diarrhea (non-serious) with onset 04nov2021, outcome "not recovered", described as "diarrhea"; immunization (non-serious) with onset 30oct2021, outcome "unknown", described as "since the booster shot". The events "erratic blood pressure", "nausea" and "diarrhea" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood pressure abnormal, nausea, diarrhea. The lot number for bnt162b2 was not provided and will be requested during follow up.
pt recvd vax & c/o being hot, rt arm burning, hand burning, nausea, palpitations, dizzy, lightheaded, insomnia, weakness, tinnitus; 1 wk p/dose 2 c/o visual distrubances in addition to other sx;
No adverse events listed - patient was exposed and tested positive for COVID 4/13/21 0145  COVID-19 (SARS CoV-2,RNA Molecular Amplification)  Collected: 04/12/21 1552 | Final result | Specimen: Swab from Nasopharynx   COVID-19 SARS-CoV-2 Overall Result DetectedCritical
Patient called Monday Morning 11/01/2022 complaining about severe pain in her. right shoulder, having difficulty moving it It started in both arms but left as better right is still hurting Tried Tylenol, Advil, no improvement
Narrative: Hospice pt with multiple underlying conditions died 8/3/21, had received 2nd dose of Moderna on 4/25/21.
Two hours after immunization pt developed flu symptoms with fever. Went to see PMD 7 days later who diagnosed Otitis Media 2 hours to hepatitis vaccine (Pt allergic to yeast).
felt "violently seek"; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (felt "violently seek") and DIARRHOEA (diarrhea) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced VOMITING (felt "violently seek") and DIARRHOEA (diarrhea). At the time of the report, VOMITING (felt "violently seek") and DIARRHOEA (diarrhea) outcome was unknown.            No concomitant medications were provided No treatment medications were provided   Reporter did not allow further contact
Area -> 3 in length 3 in width red, swollen, hot to touch area.
RN was administering a booster dose of the Covid19 Moderna vaccine (Lot#011F21A) to client at 14:20 when she noticed the vaccine running down the client?s arm.  RN immediately removed the syringe with attached needle from the client?s arm, safely re-capped the needle, and called the Lead RN for assistance.  The RN then explained to the Lead RN that the client has a very thin and small arm, therefore, she did not want to inject the full length of the needle into the client?s arm.  The RN believed she may not have injected the needle far enough into the client?s tissue and based on her observation, most (more than 50%) of the vaccine appeared to leak out of the needle and drip down the client?s arm.  The Lead RN did observe what appeared to be a very small attempt at a puncture on the client?s right arm.  Additionally, the client stated she did not feel a needle puncture.  This information was shared with the client and the client agreed to receive another booster shot of the Covid19 Moderna vaccine (Lot#011F21A).  The shot was administered at 14:30 in accordance with COVID19 vaccine administration protocols.  RN educated the client on both the potential side effects and adverse effects of the vaccine, when to seek medical attention, and ER precautions.  After being vaccinated, the client walked to the observation area to sit for a 15-minute observation.  No further interventions were needed.
This spontaneous report was received from a physician, via a company representative, referring to a female patient of unknown age. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported). On an unknown date, the patient was hysterical following the administration of the vaccine, because her arm was painful at the injection site. The physician mentioned the patient also started vomiting. Additionally, the physician sent the patient to the emergency room for treatment. The outcome of hysterical, vomiting and injection site pain was reported as recovered. Causality assessment was not provided.
passed out; bad stomach ache; Tired; not normal; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received second dose of BNT162B2 (brand=Pfizer), lot no. EN60207, via an unspecified route of administration (left arm) on 19Mar2021 10:15 at a single dose for COVID-19 immunisation. The patient had no relevant medical history. She had no known allergies. No covid prior vaccination. Concomitant medications included levothyroxine, simvastatin, calcium, and multivimi (as reported). Historical vaccine included first dose of BNT162B2 (brand=Pfizer, lot no EN6203) on 26Feb2021 10:15 AM, left arm at age of 59 years. No other vaccine in four weeks. On 20Mar2021, the patient got up to go to bathroom at 4:00am Saturday and passed out. Bad stomach ache Saturday (20Mar2021), Sunday (21Mar2021). On Mar2021, tired and not normal til Thursday. No treatment for the events. No covid test post vaccination. The patient recovered from bad stomach ache on 21Mar2021 and from other events on Mar2021.
Her son was a few days late receiving his 3rd GARDASIL-9 vaccination; This spontaneous report as received from a patient's mother regarding a male patient of unknown age. The patient's medical history, concomitant medications and drug reactiosn or allergies were not provided.  On an unspecified date, the patient was a few days late to be vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, frequency, route, lot # and expiration date were not provided).
pt described an egg-size swelling w/in hr of vax;felt heat @ site, but no redness;cont for several months;then egg-sized swelling has persisted;aches mildly almost all the time, pain radiates down lt arm to forearm;can't sleep on lt arm;
large local reaction with the first immunization; Not feeling good; This case was reported by a physician via sales rep and described the occurrence of local reaction in a 59-year-old male 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 local reaction and feeling unwell. On an unknown date, the outcome of the local reaction was unknown and the outcome of the feeling unwell was recovered/resolved.   The reporter considered the local reaction and feeling unwell to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR160058   Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: Reporter was the patient. He reported not feeling good for 1 to 2 days after immunization with Shingrix. He had a large local reaction with the immunization. The patient asked if reported since he was a vaccine expert, he stated that he had not and these events were expected with Shingrix vaccine. The reporter did not consent to follow up. Additional supportive information: For the tolerance of the 2nd dose, refer linked case US2022AMR160058.; Sender's Comments:  US-GSK-US2022AMR160058:same patient, 2nd dose
After the initial Moderna shot, my husband began having light headaches every day. He is healthy, doesn't have any conditions, isn't taking any prescription drugs, but ever since that first shot, he's complained of a headache every single day. It gets worse when he bends over with blood flow. He has since had his second shot and headaches have continued.
Woke up to use the bathroom and was extremely dizzy - almost fell down.  I never have dizziness spells.  I am still somewhat dizzy at 8:30 AM on 10/17/12 and am developing a headache.