chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received my second Moderna booster for COVID-19 on 4/28/2022. On 7/7/2022, I woke up with reddening of the skin on the right side of my neck. There was itching and burning, and it progressively got worse. I  went to a walk-in clinic on 7/11/2022. I was given prescriptions for Bactrim and prednisone. At this point, they were unable to give me a diagnosis, so they asked me to come back on 7/13/2022, which I did. By the time I returned, the symptoms were much worse. At this point, I was diagnosed with cellulitis and sent to the ER to receive intravenous antibiotics. At the ER, I also underwent a CAT scan, which verified the cellulitis diagnosis. I was then given a prescription for Cleocin capsules. I also underwent bloodwork, which showed that my white blood cell count was elevated. I was asked to return to the ER on 7/15/2022 to get checked again. More bloodwork was done, and it showed that the white blood cell count had decreased. They advised me to finish taking the Cleocin and to follow up with my PCP.  I saw my PCP on 7/26/2022, and he gave me a 10-day supply of Cleocin, since I had finished the prescription I had been given by the ER. He also put me on Augmentin for 10 days. The PCP also gave me an injection of an antibiotic, though I don't remember the name of it. At the time of this writing, I am still taking the Cleocin and the Augmentin. The cellulitis has improved a great deal. There is no longer any itching or burning, but there is still some redness on the right side of my neck, although it has decreased significantly.
Seen 9/27/19 for (L) distal arm weakness. Noted to have decreased pulses & cool (L) hand. Doppler showed thrombus (L) brachial/ulnar/radial artery thrombus. Now known family history known of emboli/thrombi.
This spontaneous report as received from a licensed practical nurse refers to 8 unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L019835 exp date 23-MAR-2017) (dose and route not reported) that were exposed to 11 degrees C for 38.5 hours and 0 degrees C for 269.16 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
She got her vaccine, had no reaction on the day of the vaccine.  She woke up fever of a little over 101 and body aches, and a sore arm.   She is still having these symptoms at this time.
Vaccine given in wrong site. Per his spouse, his vaccine was administered approximately 2 inches below his Deltoid muscle. She sent a picture of his right arm with band-aid intact below his Deltoid into Health department. She is an employee of Medical Center. Per phone conversation with his spouse on 3/25/21, she stated that he currently was not experiencing adverse effects since receiving the vaccine on 3/24/21.
red lump at injection site; raised lump that's hot.; Injection site raised; Injection site redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number KR7G2, expiry date 2nd June 2021) for prophylaxis.   On 26th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 27th June 2019, 1 days after receiving Shingrix, the patient experienced injection site lump, injection site warmth, injection site swelling and injection site erythema. On 1st July 2019, the outcome of the injection site lump, injection site warmth, injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site lump, injection site warmth, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right deltoid. The patient experienced raised red lump that was hot at the injection site.
I work 3rd shift Started with chills about 11pm same day as shot, then by 3am my heart rate dropped to 48 bpm and extreme shivering.  (My normal resting rate is about 80 bpm). Heart rate came back up shortly but still below my normal bpm. When I got home at 7am was very weak and chilled, and on both hands my fingers turned completely white like they wasn?t getting circulation and were very cold.. I went to bed feeling horrible hoping it wasn?t serious and after I slept more than normal, I feel good now.  Can?t say my heart rate going that low wasn?t kinda scary.
Patient was given ADACEL in (R) delt. When patient went to leave she walked out of the exam room and to the front office where she fell had LOC for about 30 secs. When she came to she was alert and oriented. We sent to ER to evaluate head.
Immediate discomfort. Pain increased through the night to a level 8/10. ROM reduced, unable to adduct, reach behind back, lift affected arm above 45 degree.
Patient was given the  Pfizer Bivalent Booster for 5-11 year olds instead of the Pfizer Bivalent booster for 12 years and older.  Family was notified.  Per guidance, the dose was repeated, during same clinic, with the correct dose for 12 years and older.
mild fatigue (same day); sore left arm at the injection site; This is a spontaneous report from a contactable consumer (patient herself). A 44-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection and Lot Number: EL9261) via an unspecified route of administration in left arm on 22Jan2021 15:30 (age at Vaccination 44 years) as a single dose for COVID-19 immunization. Medical history included blood pressure and heart burn. Concomitant medications included she took medications in two weeks for blood pressure and heart burn. No other vaccine in four weeks, no COVID prior vaccination, no tested COVID post vaccination and none known allergies were reported. Patient stated that after the first dose she experienced with mild fatigue (same day) and sore left arm at the injection site. No treatment was received for the events. The outcome events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Within 35-40 minutes after vaccination; lips became a little swollen and tingly.  Benadryl taken within 10-15 min and s/s subsided.
Nausea , headaches, dizziness, vertigo, fatigue,facial neuralgia,, abdominal pain,   All day, every day for over 6 weeks continues
Horrible pains for several days, went to doctor and was diagnosed w shingles. Two weeks later now, still in horrible pain. Worst experience of my life, would rather have had covid again.
Arm pain 1 hour after vaccine. Most severe (to touch to move and at rest) 6 hours post shot.  Seemed that when noticed my fever around 7pm after the vaccination that morning and began drinking more water, the water spread the arm pain throughout my body.  Fever onset 8 hours post vaccine.  Fever range beginning at 100.9 and holding steady at 101-102 for 48 hours.  Height of fever 09/10/2 pm at 102.7  Body pain onset 12 hours post vaccine. Worst in legs. Unable to walk due to pain in body and head.  Headache onset with fever and remained in sync until offset  Drunk feeling in head during entire onset of symptoms  9/12/21 onset of a different feeling headache entirety of day; partial loss of taste and smell
accidentally gave expired IPOL with no reported adverse event; Initial information received on 06-Jul-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 20 years old male patient who was accidentally given expired IPV (VERO) [IPOL] with no reported adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine INACT, hepatitis B vaccine RHBSAG (yeast) (Twinrix) for prophylactic vaccination; and measles vaccine, mumps vaccine, rubella vaccine (MMR) for prophylactic vaccination.  On 06-Jul-2023, the patient accidentally received a standard expired dose of suspect IPV (VERO) Suspension for injection at a dose of 0.5 mL (lot U1C571N, expiry date- 17-JUN-2023) via intramuscular route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency- same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
brother in law who has been mentally ill for years/He later became mentally unstable; Passed the 35 days for receiving the second dose; This spontaneous case was reported by an other caregiver and describes the occurrence of MENTAL DISORDER (brother in law who has been mentally ill for years/He later became mentally unstable) and PRODUCT DOSE OMISSION ISSUE (Passed the 35 days for receiving the second dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Mental retardation.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MENTAL DISORDER (brother in law who has been mentally ill for years/He later became mentally unstable) and PRODUCT DOSE OMISSION ISSUE (Passed the 35 days for receiving the second dose). At the time of the report, MENTAL DISORDER (brother in law who has been mentally ill for years/He later became mentally unstable) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Passed the 35 days for receiving the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug was not reported.  Treatment medication was not reported.
Information has been received from a physician referring to a five month old male infant. The patient's concurrent condition included transposition of the great arteries, hypothyroidism, dysphagia, cerebrovascular accident with abnormal electroencephalogram (EEG), left ventricular dysfunction, blood clot in neck vein, lack of normal development and chylothorax. The patient's medical history included G-tube insertion for dysphagia. The patient was vaccinated with ROTATEQ (dose, lot# and route were unknown) on 31-JAN-2015 and 20-MAY-2015 (inappropriate schedule of vaccine administered). On 18-FEB-2016, the patient was vaccinated with VARIVAX (Merck) (dose, lot# and route were unknown). Concomitant therapies included acyclovir, furosemide (manufacturer unknown), zinc sulfate, aspirin (manufacturer unknown), spironolactone, benzocaine (manufacturer unknown), diazepam (manufacturer unknown), levothyroxine sodium (manufacturer unknown), simethicone, acetaminophen (manufacturer unknown), milrinone and lansoprazole. On 25-FEB-2016, the patient had a polymerase chain reaction (PCR) test which tested the patient's stool and the results were positive for rotavirus. From 26-FEB-2016 through 08-MAR-2016, the patient had diarrhea. On 15-MAR-2016, the patient developed chicken pox. The reporter stated that at time of report, the patient was hospitalization in the hospital and was waiting for a cardiac transplant. The patient had sought medical attention on an unknown date. The patient had not recovered from the events. The causality between the events and ROTATEQ and VARIVAX (Merck) was not provided. Additional information has been requested.
Patient experiencing pain and weakness in arm area of vaccination that has not improved after 4 weeks. Patient had not been treated at this point.
chills; fever; This spontaneous case was reported by a pharmacist and describes the occurrence of CHILLS (chills) and PYREXIA (fever) 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 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 CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown.        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.   No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
certain degree of anxiety that occurs with symptoms aside from the usual sore arm; I can walk without a limp now; certain degree of anxiety that occurs with symptoms aside from the usual sore arm.; Chills; grade 2 left ankle arthralgia/extending from the dorsal aspect circumferentially including the soft tissue around the Achilles area; pain and swelling of increasing intensity around my left ankle; Erythema; edema; throbbing ache/pain and swelling of increasing intensity around my left ankle; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (pain and swelling of increasing intensity around my left ankle), ERYTHEMA (Erythema), OEDEMA (edema), PAIN (throbbing ache/pain and swelling of increasing intensity around my left ankle) and ANXIETY (certain degree of anxiety that occurs with symptoms aside from the usual sore arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2022, the patient experienced JOINT SWELLING (pain and swelling of increasing intensity around my left ankle), ERYTHEMA (Erythema), OEDEMA (edema), PAIN (throbbing ache/pain and swelling of increasing intensity around my left ankle), PAIN IN EXTREMITY (certain degree of anxiety that occurs with symptoms aside from the usual sore arm.), CHILLS (Chills) and ARTHRALGIA (grade 2 left ankle arthralgia/extending from the dorsal aspect circumferentially including the soft tissue around the Achilles area). On an unknown date, the patient experienced ANXIETY (certain degree of anxiety that occurs with symptoms aside from the usual sore arm) and GAIT DISTURBANCE (I can walk without a limp now). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 600 microgram. At the time of the report, JOINT SWELLING (pain and swelling of increasing intensity around my left ankle), ERYTHEMA (Erythema), OEDEMA (edema), PAIN (throbbing ache/pain and swelling of increasing intensity around my left ankle), GAIT DISTURBANCE (I can walk without a limp now), CHILLS (Chills) and ARTHRALGIA (grade 2 left ankle arthralgia/extending from the dorsal aspect circumferentially including the soft tissue around the Achilles area) was resolving and ANXIETY (certain degree of anxiety that occurs with symptoms aside from the usual sore arm) and PAIN IN EXTREMITY (certain degree of anxiety that occurs with symptoms aside from the usual sore arm.) outcome was unknown.            No concomitant medication was reported.  Symptoms are still present 10 days after booster dose, but are slowly waning, was reported. Weanig off Advil was reported.
This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding an 8 months old male patient who experienced ear infection, drug ineffective and vaccine stored below the recommended temperature range. At 8 months of age, the patient received a dose on 09 Apr 2010. The patient also received a dose of PEDIARIX (GlaxoSmithKline) and a dose of HIB (manufacturer unknown) on 09 Apr 2010. Relevant  medical history was not provided. Indication for PREVNAR was immunization. Product was administered on 09 Apr 2010. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. Patient received PREVNAR therapy on 09 Apr 2010. On an unspecified date (approximately 2.5 months after receiving vaccine in 2010), the patient experienced an ear infection and it was noted that the vaccine had been stored below the recommended temperature range. Patient had reportedly recovered. No further information was provided.
Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: Patient fainted immediately after receiving vaccination. Patient was asked to lie down on floor with feet up for 10 minutes. Pt was monitored for signs of allergy or distress. Blood pressure and heart rate were normal. Mother declined any other medical intervention.
got the worst flu that he has ever had; Initial information received on 04-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 72 years old male patient who got the worst flu that he has ever had while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Latex allergy and allergic reactions to Thimerosal and Sulfa in the past.  On an unknown date, the patient received a unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, formulation, strength was unknown) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient got the worst flu that he has ever had (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Patient said she was feeling "weird". Her tongue was numb and had sudden sore gums. Nurse gave her a 25mg chewable Benadryl at 1601. Patient stated that the numbness was not getting worse but was moving up her face and now by her cheeks. Another 25mg chewable Benadryl was given at 1610. Patent stated that it was moving up by her temples. Patient stated that this happened after her first dose of Moderna but happened hours after the vaccine was administered. Patient stated that these same symptoms lasted a couple of hours after her first dose. At 1648 patient's symptoms had not worsened and she declined any EMT help and drove to her closest friend's house. She was alert and oriented x3 with no SOB or tachycardia. When nurse called to check on her 1713 she stated that symptoms were still there but had not gotten any worse.
Developed covid 19; Developed covid 19; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as unknown dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient developed COVID-19 and drug ineffective on an unspecified date. These events took place after the use of product. The outcome of these events was unknown at the time of report.   The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Intense chest pain that woke me in the middle of the night. Felt like I was being stabbed through the heart. Felt it in my upper left back as well as my upper right chest. Leaning forward helped it feel better. I went to the emergency room twice for the same pain. They gave antacids, Tylenol, and lidocaine patches. Nothing seemed to ease the pain except for time. It took 4ish hours for the pain to subside to manageable and another 2ish hours for the pain to go away completely for the day.
Patient had came into the office on 9/25/23 and the patient father had a form form the school stating the patient needed Men B.  We did not have the vaccine in stock at the visit. On 10/30/2023 the patient returned with his father and Men B (Bexsero) was administered.  On 11/14/23 patient and his father returned to clinic to receive MenQuadFi.
Patient states shooting pain "worse than labor pains" started in left outer thigh and moved down front of left calf about 6 times on Saturday 10/25. Never felt this type of pain before. Patient describes it as excruciating. No pain in arm, just sore, like previous years flu-vaccine. Pain occurred again on Sunday 10/26 in the am. Has improved since, no pain yet today 10/27. Patient took ibuprofen, did not seek medical care.
Pt came into office + reported vaccine site was red, raised + warm to touch.  Presently abscent disappeared on its own.  Zero intervention needed.
HIVES; This spontaneous report received from a health care professional concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: idiopathic urticaria. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 26-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hives was not reported. This report was non-serious.
19MAR Td given; 20AMR temp 99.9- sl chills - inc pain about site - warm to touch w/erythema 3cm around site ? cellulitis put on Ceftin; 22MAR91 erythema & induration inc to 10cm;
Employee vaccine clinic given at Central Office. Employee/Pt seen by post-vaccine observation RN, . Pt c/o dizziness w/HA within minutes after 2nd Dose Moderna. This is same reaction pt had after 1st dose at an earlier employee clinic. Per, RN: Pt was Monitored and  VS taken q 10 minutes and over approx. 45 minutes. HR, Resp and temp WNL. BP elevated beginning at 142/85 -155/100 over course of observation. Pt given 25 mg Benadryl. Both HA and dizziness resolved after 30 minutes of observation. Pt sent home from work instructed to take another 25 mg Benadryl and to continue monitoring BP as pt states she has a self-monitor cuff at home from another family member. Instructed to notify RN once arrived safely at home which she did at 1255 pm indicating that all adverse symptoms had subsided. Pt instructed to see PCP asap for F/U  and HTN eval. Pt verbalized understanding.  Physical copy of VAERS completed by RN and scanned in to EPIC, Pts's EHR.
Patient got dyspnea after received the vaccine at 11:00. Had syncopal symptoms with admin of vaccine then dyspnea/ throat tightness on the ride home.