chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heart inflammation; heart pain; This spontaneous case was reported by a consumer and describes the occurrence of CARDITIS (heart inflammation) and ANGINA PECTORIS (heart pain) 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.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDITIS (heart inflammation) (seriousness criterion medically significant) and ANGINA PECTORIS (heart pain) (seriousness criterion medically significant). At the time of the report, CARDITIS (heart inflammation) and ANGINA PECTORIS (heart pain) outcome was unknown.            No concomitant medication details was provided. No treatment medication details was provided. Company Comment: Vey limited information regarding these events has been provided at this time. Further information has been requested.   This case was linked to MOD-2021-291666 (Patient Link).; Sender's Comments: Vey limited information regarding these events has been provided at this time. Further information has been requested.
7.5 cm x 11.3 w. with redness, warm to touch, itchy to left upper arm. Instructed parent to apply BENADRYL oint. Cool compress 2-3 times per day, TYLENOL every 4 x 8 hours.
Since receiving the Moderna vaccine, I have experience more frequent, more painful, and heavier  menstrual cycles.  I am typically somebody who got my period monthly, with light bleeding and minimal cramping.  I have been bleeding every ~2 weeks since getting my first vaccine, I am experiencing heavier bleeding with significant cramping.
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter  The vials were frozen, shipped in refrigerated temperature and then refroze for storage once arrive at facility. On 1-Dec-2021 vaccine was moved to fridge and vaccine administered post 30 days from the initial storage at 2C to 8C.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site mass (I got a bump and redness on my arm after getting the booster dose) and vaccination site erythema (I got a bump and redness on my arm after getting the booster dose) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date,  patient experienced  vaccination site mass (I got a bump and redness on my arm after getting the booster dose) and vaccination site erythema (I got a bump and redness on my arm after getting the booster dose). At the time of the report, vaccination site mass (I got a bump and redness on my arm after getting the booster dose) and vaccination site erythema (I got a bump and redness on my arm after getting the booster dose) outcome: unknown. No concomitant medications or treatment information provided by the reporter.
rash on arm and shoulder; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on arm and shoulder) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rash on arm and shoulder). At the time of the report, RASH (rash on arm and shoulder) outcome was unknown.            This case was linked to MOD-2021-034817 (Patient Link).
i have mild tinnitus for many years.  maybe 8 to 10 years.  my symptoms worsened after getting the first shot almost immediately.
Left Deltoid: red, rash, hot to the touch, hard at the injection site: states that it's itchy, muscle ache. Area of erythema is estimated to be the size of a half-dollar.
Patient was found on the floor next to his chair facing forward in observation area. When we attended patient alert, awake and oriented x3. Denied any resp distress. No HA. No n/v. Patient has h/o dvt on coumadin. No h/o DM. recommended further evaluation in ER due to patient had syncope, on coumadin, hit his head to ground. But pt declined and signed AMA. patient reported that he will seek emergency if he feels any worsening symptoms.
PATIENT WAS ADMINISTERED VACCINE OUTSIDE GUIDELINE. SHE HAS NO MEDICAL CONDITION AND IS UNDER 65 YEARS OLD
1/14/2005 Varicella Vaccine administered 1/19/2005 Temp 102/shaking /2 minutes unresponisve /staring 1/20/2005 Exam-no focal symptoms for fever?  vaccine Rx. Referred to peds /neuroloyg for flu seizure
Swelling at injection site, spreading throughout left arm, swelling of lymph node in left arm pit. Swelling began 36 hours after injection. Swelling peaked 48 hours after injection.
dizziness/ light headedness; rapid heart rate at 130; irregular heartbeat; This is a spontaneous report from a contactable consumer (Patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 20Feb2021 11:00 (Batch/Lot Number: EL9265) as single dose for covid-19 immunisation. The patient was not pregnant. Medical history included irregular heart beat, controlled hypertension, high chloresterol. Known allergies included sertraline hydrochloride (ZOLOFT). There was no covid prior vaccination. No covid tested post vaccination. There was no other vaccine in four weeks. Other medications in two weeks included ezetimibe taken for an unspecified indication, start and stop date were not reported; duloxetine taken for an unspecified indication, start and stop date were not reported; metoprolol taken for an unspecified indication, start and stop date were not reported and cholesterol medications. The patient had light headedness, dizziness, rapid heart rate at 130, irregular heartbeat; on 20Feb2021 11:30 AM. The patient went to hospital on the 2nd day after vaccine. Events resulted in Emergency room/department or urgent care. Treatment received for the events included fluids and meclizine 25 mg. The outcome of the events was recovering.
Patient received a dose from a vial that had been used on a previous day. The vial used was actually pulled from the fridge and doses were withdrawn on 9/24/22. The vial was not appropriately  disposed of at that time. The technician then thought the vial was pulled for doses to be given on 9/26/22, but it was the vial from 9/24/22. Once this was discovered the patient received a dose from a new vial in his opposite arm's deltoid.
Erythemic area with no tenderness, no decreased range of motion, and patient was in no distress. Area was warm to the touch but painless per patient.
33 y/o female G1P0 and COVID ~ 1 month ago.  She presented to the hospital with intractable nausea/vomiting that has been going on for the last week.  Was seen at an Urgent Care about 2 days ago for dysuria and urinary frequency.  Diagnosed with UTI and started on Keflex.  She came to the Urgent Care due to persistent nausea/vomiting.  D/c home with outpatient OB follow-up.
No additional AE reported; patient was administered the first dose of ROTATEQ on 04-AUG-2021 and received the second dose today, 20-AUG-2021; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  The patient was administered the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number, expiration date and route of administration not provided) 2 mL on 04-AUG-2021 and received the second dose on 20-AUG-2021 (inappropriate schedule of vaccine administered). No adverse event was reported.
Initial information regarding this clinically sponsored solicited case was received on 07-Mar-2016 from the non-health care professional via a Patient support program Study. This case involves 62-year-old female patient who presented with heart rate was 145 beats/minute (heart rate increased), patient came down with fever that lasted one day, unknown duration after and she underwent right eye cataract removal, left eye cataract removed (cataract removal), 49 days after starting treatment with alirocumab (Praluent) and unknown duration after starting influenza vaccine. On an unknown date, patient received influenza vaccine (Dose, form, route, frequency, lot/ batch number and expiration date: unknown). On 13-Jan-2016, the patient received subcutaneous alirocumab at the dose of 150 mg every other week (Form, lot/ batch number and expiry date: unknown) via alirocumab prefilled pen for other hyperlipidemia. The patient went in for a Right eye Cataract removal on 02-Mar-2016 (Latency: 49 days after receiving alirocumab and unknown duration after receiving influenza vaccine) and on an unknown date (Latency: unknown) the patient's heart rate was 145 beats per minute (while on alirocumab). The patient was then transferred to the emergency room (ER) and admitted. Patient was discharged on 03-Mar-2016 and her heart rate was managed and within patient's normal range. On February 3 or 4th 2016, the patient had her left eye cataract removed without complication (while on alirocumab). The patient received a Flu and pneumonia shot on 03-Mar-2016 and on an unknown date (Latency: unknown) the patient experienced fever that lasted one day (while on alirocumab). No action was taken with therapy of alirocumab and unknown for influenza vaccine. Corrective treatment: Not reported. Outcome: Resolved for heart rate increased and fever. Reporter causality: Unknown. Company causality: Not associated. Seriousness Criteria: Hospitalization for heart rate was 145 beats/minute and important medical event for right eye cataract removal, left eye cataract removed.
Fever, red, swollen, hot, and tender right thigh, 7cm with edema. 10cm with erythema for 1 day, post vax. Treated with Zithromax, Benadryl and cool compresses.
pt had apparently forgotten hx of Td allergy when sched appt for Td booster on 20OCT92; pt exp itchy rash w/small bumps on face & neck only; pt had no other sxs of an adverse reaction following the above; pt was advised to take DPH;
Twenty four hours after vaccine administration patient had extreme fatigue, moderate to severe midline back of the neck pain (wouldn't move neck on own but I was able to passively flex it). Forty eight hours after vaccine pain spread down both arms. Seventy two hours after vaccine administration positive L'Hermitte's sign when pulling up pants. Since that event has had "feeling like she bumped her funny bones" bilateral upper extremities left>right. No weakness. Pain waxes and wanes but still present fourteen days after injection. Exhaustion continues.
dizziness; nausea; rapid heart rate; This is a spontaneous report from a contactable consumer (patient himself). A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: EN5318, expiry date: unknown) via unspecified route of administration in left arm on 20-Feb2021 09:00 as dose 1, single (age at vaccination: 46-years) for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medications included Advair, Combivent, Zyrtec, daily multi vitamins, taken for unspecified indication, start and stop date not reported, taken in two weeks. Patient had no known allergies. No other vaccines in four weeks were administered. On 20Feb2021 09:30, after 25 minutes after receiving the shot, patient began to have dizziness, nausea, rapid heart rate. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No treatment was given as a result of the adverse events. The outcome of events was unknown.   Follow-up attempts completed. No further information expected.
Patient was needing her first COVID  vaccine primary series. At the time when I was coming back from lunch I was helping MA and I grabbed the Pfizer COVID Bivalent vial instead of the Pfizer COVID Monovalent vial. When I double verified with MA; we didn't realize that patient was needing the COVID Monovalent because we were worried about making sure to reconstitute the immunization correctly before the vaccine was administered.   Per facility when I called to notify if patient was okay, the patient was doing good no adverse reactions. Per facility "she was crabby over the weekend". Facility was later on notified via phone call and a voicemail had been left that per CDC recommendations and the providers recommendations, that there was no need to administer any further COVID vaccines.
Pt exp generalized tonic clonic sz lasting about 1 min w/in 1st 24hrs of immun; Pt has hx of sz in neonatal period;
Security notified this writer patient was feeling "light headed" post 1st dose of Pfizer covid vaccine.  Patient seated in auditorium seating. Writer approached patient. Patient stated she was light headed.  Assessed patient, noted sweating, pale skin and dilated pupils. Patient then went unconscious for approximately 30-60 seconds with seizure like activity. Increased diaphoresis noted.  Upon regaining consciousness patient declined any medical history including DM or seizures.  Rapid was called, arrived within minutes.  VSS were noted to be HR of 43, BP of 68/42.   Legs were elevated in seating.  When attempted to move patient to gurney patient went unconscious again.  Fireman lifted to cart, elevated legs.  No seizure activity noted with second unconscious event. patient placed on left side with legs elevated. Return of consciousness noted.  Moved to alcove with Rapid team.  IV placed, fluids started. Monitored vitals prior to transport to ED. Patient's manager made aware and returned to unit.  --Hospital
Patient called the pharmacy on 12/30/17 at 9:10 AM. Patient reports his hands will not stop shaking. I referred patient to contact MD. Patient states he refuses to go to hospital where he can seek medical attention. I informed patient that I am not sure of other options for medical attention, but repeated that I recommend you speak to a physician.
Associate c/o cough, sweating, chills, fatigue, headache, body ache, severe itching
shot caught up with me; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced feeling unwell. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter reported that same here 2nd shot caught up with him/her the next day. The patient took 2 Motrin and slept for 6 hrs all was well and worth it for sure. The follow-up could not be possible as no contact details were available.
24 hrs after receiving PPV23 (pneumovax)0.5 ml vaccination in left posterioir upper arm sucutaneously, patient has reddened 10 cm by 6 cm warm, indurated, non-itching area on posterior left upper arm.  No hives, no itching, no dyspnea or other signs of reaction systemically.  This was the patient's SECOND PPV23, had first one approximately 13 years ago per patient statement. Denies histroy of any reaction to the first vaccination.  No treatment given for present reaction, observation only.
Information has been received from a physician concerning a female who was vaccinated with her third dose of Gardasil. Subsequently the patient experienced "hot-cold fever" and lower back pain. The physician believed these symptoms to be related to a urinary tract infection. Additional information has been requested.
Information has been received from a consumer concerning his daughter, with no past medical history or allergies, who in approximately May 1998, was vaccinated with MMR (date of vaccination and lot number not reported). There was no concomitant medication. The reporter stated that his daughter was vaccinated with MMR when she was 14 to 18 months old and the next day she would not talk or look at him. There were no physical changes noted and there were no other vaccinations or medications administered. The patient was diagnosed with autism and received special education including speech and psychological therapies five days a week for years. She was not treated with medications. At the time of this report the patient was now 7 years old; she had shown improvement. She was able to read on a 6th grade level but not recovered 100%. Doctors are now stating that the patient does not have autism. There was no product quality complaint involved. The reporter considered autism to be disabling. Additional information has been requested.  Follow up on 08/04/04 states: "Follow up information from a physician stated that the pt "was not a pt at this office when (MMRII) was administered." It was also reported that the pt "did have significant autistic-like behaviors as a toddler" which were reported as improving. The reporter considered autism to be disabling. Additional information has been requested."
Mom describes about 2 1/2 hours after vaccination child with problems breathing, whistling in throat, shaking, trembling, crying a lot. Both legs hot. No color change or swelling at site per mom. Seen in ER discharged 9am 11/09 still fussy. Decreased sleep, crying, very sweaty, vomiting, flaccid, limp went to clinic hospitalized.  Information received from parents on the 60 day follow-up states that parent reports child is not as active as prior to vaccintions. Father feels child speaks slowly, sleeps more. Doctor has told parents that increase sleeping is normal.
Office drew up all doses from a vial and did not run a double check. They used a sticky note w/bivalent NDC, lot and expiration as source of data to enter all info into EMR. At some point the office realized that on some days they had pulled monovalent vials and administered instead of the intended bivalent booster
Patient received a dose of Pfizer COVID-19 Vaccine (PEDS) pediatric formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9% NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL, 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.
Hospitalization: 10/18/22 - 10/22/22 Presentation to the ED: acute encephalopathy and generalized weakness. COVID + date: 10/19/22, With PMH of testing positive on 10/5/22.  Treatment: "no indication for therapy for COVID nor abx." Discharge to: SNF.
Diarrhea, nausea, itching to both arms, redness and swelling to both sites
Patient was accidentally given a dose of HPV vaccine instead of Prevnar13 vaccine due to similar packaging on vaccine vials. "Patient erroneously got an HPV/Gardasil vaccine instead of the Prevnar today.  Once the error was recognized, I called poison control.  Talk to the pharmacist there and of course there is no data in this age group with this particular vaccine.  We reviewed the type of vaccine. Protein subunit type - it's not a live attenuated vaccine, so should not be dangerous to him, other than inflammatory reaction.  soreness, fever, redness.  I called mom, and explained the error, conveyed sincere apologies, and recommend they watch him closely tonight, and come into the clinic tomorrow anytime for a quick recheck to see how he is doing.  She will do that. If any concerns during the night, can always come to ER if serious appearing reaction. Also gave mom phone number for poison control, in case they want to call and speak with someone there as well.  .................................................................... MD  October  4, 2021 5:40 PM"