chrisvoncsefalvay/vaers-outcomes huggingface dataset:
don´t feel well today; kept at room temperature / was only administered an hour after the preparation; 1st: Saturday (7NOV) / 2nd: Monday (9NOV); This case was reported by a consumer via licensee and described the occurrence of malaise in a female patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included rabies vaccine needle device (Rabavert Needle Device) injection needle for prophylaxis and rabies vaccine pre-filled syringe device (Rabavert Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Rabies NVS (RabAvert).   On 9th November 2020, the patient received the 2nd dose of RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device. On 9th November 2020, unknown after receiving RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device, the patient experienced product storage error and drug dose administration interval too short. On 10th November 2020, the patient experienced malaise. On an unknown date, the outcome of the malaise, product storage error and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the malaise to be related to RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. On 9th November 2020, the patient received the RabAvert. On 10th November 2020, the patient experienced not feeling well. The vaccine was prepared, kept at room temperature and was only administered an hour after the preparation, which led to shortening of the vaccination schedule, product storage error.
PATIENT RECEIVED MODERNA 1ST DOSE LOT 003C21A AT 2:35PM 4/26/2021 IN THE LEFT DELTOID. 5 MINUTES LATER, HE PRESENTED TO PHARMACY COUNTER WITH DIZZINESS AND SUBSEQUENTLY LOST CONSCIOUSNESS FOR APPROXIMATELY 30 SECONDS BEFORE REGAINING CONSCIOUSNESS. HE STATED FEELING LIGHTHEADED AND HAVING SHORTNESS OF BREATH. WE RETRIEVED THE EPIPEN AND WAS ABOUT TO ADMNISTER TO HIM WHEN HE STATED THAT HE FELT BETTER AND THAT HE WAS NO LONGER EXPERIENCING ANY SHORTNESS OF BREATH AND THAT HE WAS FEELING BETTER IN GENERAL. EMS CAME TO THE SCENE AND UPON EVALUATION RECOMMENDED HIM TO GO TO THE HOSPITAL DUE TO HIS BRIEF LOSS OF CONSCIOUSNESS. EMS CHECKED VITALS AND DID NOT STATE ANY ABNORMALITIES TO OUR KNOWLEDGE. HE DECLINED HOSPITAL CARE AFTER REPEATED RECOMMENDATIONS. PHARMACY STAFF OBSERVED HIM FOR AN ADDITIONAL 20-25 MINUTES DURING WHICH PERIOD HE DID NOT SHOW ANY WORSENING SYMPTOMS. PATIENT WAS TRANSPORTED HOME BY A FRIEND.
PATIENT SIGNED UP AND CAME IN FOR COVID VACCINATION.   DID NOT CATCH UNTIL AFTER THE VACCINATION THAT PATIENT WAS 17.   MODERNA RECOMNENDED AGE IS 18.   NO ADVERSE EVENTS REPORTED TO ME AT THIS TIME .  STILL TRYING TO CONTACT PATIENT
Some of the dose ran down the patient's elbow; dose running down patient's elbow; A spontaneous report (UNITED STATES) was received from a pharmacist concerning of a 27 years old, female patient, who received Moderna's COVID-19 vaccine, and who experienced dose of vaccine running down patient's elbow (accidental underdose) (exposure via skin contact).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 15 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot number 010M20A) intramuscularly for COVID-19 prophylaxis. During the administration, the vaccine ran down the patient's elbow, and the patient experienced accidental underdose and exposure via skin contact.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event was resolved on 15 Feb 2021.; Reporter's Comments: This report refers to a case of accidental underdose and exposure via skin for mRNA-1273 with no associated AEs.
Information has been received from a physician concerning a pt who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt experienced mild break through varicella. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Patient sitting in waiting area states her legs feel cold and shaky. Patient diaphoretic and pale. Patient layed down on stretcher. VSS, O2 sats 99, BP stable, HR 66.
Signs/symptoms: Abdominal cramps, diarrhea, nausea, clammy feeling. Time course: occurred the day of vaccine administration. Treatment: Hydration and rest.
This spontaneous report as received from a medical assistant refers to a 2-month-old patient of unknown gender. No information on the patient's concomitant medications, pertinent medical history, drug reactions or allergies was reported. On 22-SEP-2017, the patient was vaccinated with a dose of VAQTA injection (lot # N005274 with expiration date on 03-APR-2018; exact dose and route of administration were not reported) for prophylaxis. This administration of the vaccine was outside the recommendations per the VAQTA prescribing information. No adverse effects were reported. No product quality complaint was involved.
Flu like, fatigue, lymph node swelling beginning on left side underarm, traveling to right side neck, under jaw
8 days after shot I noticed a large (6 inches in diameter) round red rash on the arm I had the injection. It was warm, a little puffy, and itchy. I put Eucerin cream on the area to help with the itchiness. It lasted about 8 days.
SOME SMALL BLOOD VESSELS IN BRAIN HAD DIED; STARTED FALLING; FELT LIKE GOING TO PASS OUT/DIZZY; COVID MILD CASE; This spontaneous report received from a patient via a social media and by a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin and batch number were not reported, and expiry: Unknown) dose was not reported, 1 total, first dose administered on an unspecified date for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series: 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin and batch number were not reported, and expiry: Unknown) dose was not reported, 1 total, second dose administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date following vaccination with second dose of covid-19 vaccine ad26.cov2.s, the patient started falling and was dizzy, and felt like going to pass out (Dose number in series: 2). On an unspecified date, the patient was found that some small blood vessels in brain had died (Dose number in series: 2). The patient also experienced covid mild case (date unspecified) (Dose number in series: 2). It was reported that "I took the first two shots of Covid. After the second one, I started falling was dizzy, felt like I was going to pass out. Come to find out some small blood vessels in my brain had died. I had Covid later on but it was a mild case" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the started falling, felt like going to pass out/dizzy, some small blood vessels in brain had died and covid mild case was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000263914 and 90000263913.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious
Extreme flu-like symptoms, extreme dizziness, crown headache; weakness in arms then legs, numbness in hands, difficulty breathing. Follow up on 11/20/2003: "Vaccine recipient did not recover from the adverse events that were reported for this vaccination.  I still have nerve damage especially in my upper body.  The symptoms are gradually improving with every passing month.  My prayer is that my body will be able to heal itself over a period of time.  Some clinics are still confused thinking they need to give "booster" shots for Hep B.  I think letters should be mailed to doctors and clinics to remind them that people should be tested before booster are recommended or even needed."
This spontaneous report was received from a pharmacy technician refers to unspecified patients of unknown ages and genders. On an unknown dates unspecified patients were vaccinated with ZOSTAVAX (Lot # unspecified) (dose, frequency and route unspecified). The pharmacy technician stated that unspecified patients that received ZOSTAVAX on unspecified dates experienced injection site reactions that involved "a big red bump the size of a lemon that itched" at injections site on unspecified dates. Outcome of the events were unknown. Additional information is not expected.
A consumer report  has been received. The report concerns a female consumer, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. The patient experienced dizziness. The outcome of the event of dizziness is unknown. The report was considered to be non-serious.
PER PATIENT REPORT IN ABOUT THE 12TH HOUR MARK AFTER RECEIVING THE VACCINE PT WAS CONFUSED, LOOKED PALE, WAS NON VERBAL, UNRESPONSIVE, FAINTED AND PASSED OUT FOR ABOUT 10 MINUTES. HIS WIFE USED TO BE A REGISTERED NURSE AND SHE MENTIONED SHE HEARD HIS LUNGS AND THEY HAD FLUID WHICH RESOLVED LATER ON.
Immunization on 1/27/21 Client developed a red, itchy rash on her neck on 1/30/21. Rash is still present 2/1/21 but is resolving.
No adverse event; Mixed COVID-19 primary series administered to patient/Patinet received 1st dose of Pfizer COVID-19 vaccine; Patinet received the Pfizer COVID-19 vaccine and then Moderna vaccine given as 2nd dose after 1st dose of Pfizer; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 IMMUNISATION (Mixed COVID-19 primary series administered to patient/Patinet received 1st dose of Pfizer COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Patinet received the Pfizer COVID-19 vaccine and then Moderna vaccine given as 2nd dose after 1st dose of Pfizer) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 03-Aug-2022, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 30-Aug-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2022, the patient experienced COVID-19 IMMUNISATION (Mixed COVID-19 primary series administered to patient/Patinet received 1st dose of Pfizer COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Patinet received the Pfizer COVID-19 vaccine and then Moderna vaccine given as 2nd dose after 1st dose of Pfizer). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, COVID-19 IMMUNISATION (Mixed COVID-19 primary series administered to patient/Patinet received 1st dose of Pfizer COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Patinet received the Pfizer COVID-19 vaccine and then Moderna vaccine given as 2nd dose after 1st dose of Pfizer) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for COVID-19 IMMUNISATION (Mixed COVID-19 primary series administered to patient/Patinet received 1st dose of Pfizer COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Patinet received the Pfizer COVID-19 vaccine and then Moderna vaccine given as 2nd dose after 1st dose of Pfizer).    Concomitant product use was not provided by the reporter. Patient was five and a half years old. Patient was watched for 15 minutes and no adverse reactions were reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2022: Live Follow-up has been appended
Pt complained of nausea around 12:14.  By 12:38 had hypotension and lightheadedness.  Required 2 doses of epi and IV fluid to raise BP back to normal limits.  Taken by 9-1-1 to ED at that time.  Never lost consciousness.
pain and swelling at injection site, redness~ 4 inches diameter; fever (100 F), chills, body ache, headache, palpitations, weakness
56 y.o. female received YF vaccine on 2/25/11 developed floaters & flashes in (L) eye on 2/26/11. Eval by ER on 2/26/11 referred to ophthalmologist  monitoring for progression. YF injection site - indurated, eryth, warm spot.
Mild swelling, redness 4 x 2 1/2 cm, warmth, pruritus, limited to mid triceps vaccination location.
localized rxn lt inj site 12cm diameter cellulitis/warm to touch (4 days);T95.7 ax;DPH & ice;
2 fingers same arm are hurting; Arm is hurting especially under her armpit; arthritis and wrist carpel tunnel flares up; wrist carpal tunnel flares up; Arm has been swollen; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (arthritis and wrist carpel tunnel flares up), CARPAL TUNNEL SYNDROME (wrist carpal tunnel flares up), PERIPHERAL SWELLING (Arm has been swollen), PAIN IN EXTREMITY (2 fingers same arm are hurting) and AXILLARY PAIN (Arm is hurting especially under her armpit) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Carpal tunnel syndrome. Concomitant products included SIMVASTATIN, LISINOPRIL, LEVOTHYROXINE SODIUM (LEVOTHROID), AMLODIPINE and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced ARTHRITIS (arthritis and wrist carpel tunnel flares up), CARPAL TUNNEL SYNDROME (wrist carpal tunnel flares up) and PERIPHERAL SWELLING (Arm has been swollen). On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (2 fingers same arm are hurting) and AXILLARY PAIN (Arm is hurting especially under her armpit). The patient was treated with PARACETAMOL (TYLENOL) for Arthritis, at an unspecified dose and frequency. At the time of the report, ARTHRITIS (arthritis and wrist carpel tunnel flares up), CARPAL TUNNEL SYNDROME (wrist carpal tunnel flares up) and PERIPHERAL SWELLING (Arm has been swollen) had resolved and PAIN IN EXTREMITY (2 fingers same arm are hurting) and AXILLARY PAIN (Arm is hurting especially under her armpit) outcome was unknown.            This case was linked to MOD-2021-044397, MOD-2021-044397 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Updated Event Outcome and Patient denied additional Follow up
She got her J & J vaccine around 4:30 on April 7th ,2021.  She was feeling fine up until around 10:00 that night when she began to have some of the regular side effects in addition to some unusual ones that were more concerning.  She had chills was feverish and nauseous with flu like symptoms of her body aching.  However, at around 10:30 that night she reported having difficulty breathing and having chest pains with pain when she would take breaths. She noticeably was taking very small but frequent breaths due to the pain. She described a pressure on her chest as if there was a bowling ball sitting on top of her chest. She was crying from the pain and her difficulty breathing. She also reported that her throat felt like it was smaller/ constricted.    At that time, she was given Acetaminophen and later around 12:00 she was given Benadryl.  When she went to bed that night, she was in pain but she also reported that her heart was racing and her resting pulse at the time was 110 bpm. She had the flu like symptoms into Thursday evening but by Friday she looked a lot better except for her difficulty breathing with complaints of chest pain when she breaths with continued pressure on her chest.  She rested in bed for most of Friday and on Saturday she got dressed in the afternoon and took a walk around half a mile at which time she was exhausted and felt out of breath.  When she walked back from her destination about a half mile, she needed to rest in bed to recuperate.  The pain while breathing lasted into Sunday. Monday morning, she attempted to run and became winded from running a short distance of ¼ of the block and could not catch her breath having difficulty breathing and throwing up with a lot of subsequent chest pain that day. She was taken to the doctor by 10:00 that morning to run lab tests and get an examination.  She is slowly getting better and taking it easy but Tuesday she still had some pain and by Thursday she is reporting that while the chest pain is still there it is more of a discomfort that she feels when breathing as compared to pain.  She continues to report the discomfort when breathing till today 4/16/21 and is still limiting her physical activity but going about her daily routine.
Information has been received from a physician concerning a 8 week old male on 22-MAR-2007 was vaccinated with 2 ml dose of Rotateq. On 01-APR-2007, the patient experienced blood in the stool. The patient sought unspecified medical attention. Subsequently, the patient recovered from blood in the stool. Upon internal review blood in stool was determined to be an other important medical event. Additional information has been requested.
Swelling and redness on right arm pain going up right side of neck stiffness of neck at night. Could not lift arm - very painful.
admitted 9/13/2021 for fever, SOB, cough, vomiting and Urinary TRact INfection
7 days after getting Moderna vaccine (my first shot) my arm at injection site started itching.
.        patient reports has been having pain in the left arm at the spot twhere he was vaccinated ,pain started right after the shot and has been present since then ,feels pain when tries to lift something heavy and also feels weakness and decreased strength since the 2nd shot in the arm   did had a previous history of paresthesias in left arm few years ago which resolved on its own but now symptoms reappeared after the shot.
Had varivax 3 years ago.  Broke out with chickenpox 11/18/2003.
Father with positive shingles X 20d. Positive chicken pox at school. 20-30 erythematous lesions over trunk, head, scalp- no crusting. pt. now 7.6y.
Patient had an allergic reaction.  Onsite EMS was called vitals BP 108/70   97% 02 room air      HR 100.  Patient refused evaluation/care and released against medical advice.
Patient received a 0.5 ml first dose after beyond 12 hours after first vial puncture  it was open on 06/08/2022 @1:10pm expires @ 1:10Am on 06./09/2022
12/9/13 lethargy, vomiting began 15-30 minutes after vaccines given.
In May of 2023 I woke up with a wave of dizziness when I tried to get out of bed.  I tried again and I still had it but this time I was able to get out of bed.  I had the dizziness throughout the morning.  I also had nausea throughout the week.  The next several days I still had it.  On day 6, May 14th, I was unable to shake the dizziness and went urgent care. After running some tests, I was diagnosed with vertigo.
Patient received first Moderna vaccine this morning. Immediately after walking to the waiting room, patient fainted, fell backwards to the floor and hit his head on the corner of a desk and trash can. Patient came to, and shortly after loss consciousness again. When patient came to, this RN kept him talking and moving his feet. Patient reported he has fainted from giving blood before. Patient taken back to private room with code team. He was then taken to a higher level of care.
shingles; This is a spontaneous report from a non-contactable consumer via medical information team. A patient of unknown demographics received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unknown route on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The seriousness was non-serious with seriousness criteria results in death/life threating/caused or prolonged hospitalization/ Disabling/Incapacitating/Congenital anomaly/birth defect all reported as no. There was no PQC present. On an unknown date, the patient had shingles. Reporter asked should a person who got shingles 2 1/2 weeks after first dose of Pfizer, delay getting second dose which was scheduled 4 weeks after first dose. The outcome of the events was unknown.   No follow-up attempts are needed. Information on lot/batch number cannot be obtained.
Pt recvd a series of 3 Engerix-B vax on 18SEP90, 25OCT90, & 26MAR91 & 29APR91 titer was neg; Pt recvd 2 Engerix-B doses on 06MAY91 & 11JUN91 & 09JUL91 titer was neg;
both of us were deathley sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (both of us were deathley sick) in a 68-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (both of us were deathley sick). At the time of the report, ILLNESS (both of us were deathley sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-263840 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-263840:wife case
Systemic: Nausea-Medium, Systemic: flushing; symptoms lasted 1 day