chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious report of "child received two doses" was received from a registered nurse concerning a five-year-old patient of unknown sex. The patient's medical history was not reported. On 27-Oct-2009, the patient received two doses of H1N1 within hours. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Ttiredness; Diizziness when patient stands; Sleepiness; Lack of energy; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Ttiredness), DIZZINESS (Diizziness when patient stands), SOMNOLENCE (Sleepiness) and ASTHENIA (Lack of energy) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced FATIGUE (Ttiredness), DIZZINESS (Diizziness when patient stands), SOMNOLENCE (Sleepiness) and ASTHENIA (Lack of energy). At the time of the report, FATIGUE (Ttiredness), DIZZINESS (Diizziness when patient stands), SOMNOLENCE (Sleepiness) and ASTHENIA (Lack of energy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
No Additional AE; The PROQUAD also suffered from a non supported temperature excursion; HCP called to report that the patient was given PROQUAD instead of MMR II.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information on patient medical history, current conditions and concomitant medications was provided.     On 26-JUN-2023 the patient vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W029552 and expiration date 14-MAR-2024, for prophylaxis (exact dose, dose number, route and site of administration were not provided) instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (wrong product administered, no adverse event and product storage error).
Increased Nausea; Constipation; Headache; Loss of Appetite; Chills, Fever 1 Week After Injection; Initial Report Received on 23-Sep-2019 and 24-Sep-2019   A pharmacist reported that a 64-year-old female patient (unknown race) was administered with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced increased nausea, constipation, headache, no appetite, and "chills, and fever for 1 week after injection".    Relevant medical history included liver cirrhosis. The patient has an allergy to penicillin.   Concomitant medications were not provided.     On 11-Sep-2019, the patient received a dose of HEPLISAV-B (lot # 933842, expiration date: 30-May-2021, and NDC # not reported) via a prefilled syringe. It was reported that the patient received HEPLISAV-B at the direction of her healthcare provider.   On 19-Sep-2019, the patient called the pharmacist stating that she was experiencing an increase of nausea, constipation, headache, loss of appetite, and "chills and fever for a week" following administration of HEPLISAV-B. The pharmacist instructed the patient to report this to her healthcare provider and to go to the emergency department if the symptoms did not improve. No further information was provided.   At the time of the report, the outcome of all events was not reported.    The reporter did not provide a serious assessment for the event.   Company comment: The company assessed the events of nausea, constipation, headache, loss of appetite and chills, fever as non-serious. The events of nausea, constipation and loss of appetite are unlisted and the events of headache and chills, fever are listed per HEPLISAV-B.; Sender's Comments: The company assessed the events ofnausea, constipation, headache, loss of appetite and chills, fever  as non-serious. The events of nausea, constipation and loss of appetite are unlisted and the events of headache and chills, fever are listed per HEPLISAV-B.
within 24 hours- Large "golf ball size" lump. Hard, hot to touch, red from injection site down to elbow. after 36 hours swelling had gone down, redness had moved all the way from the injection site to wrist. No pain noted, skin temperature was back to normal.
woke during the night with chills, body aches, and migraines, hurts to walk
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in May 2018, refer case US2019035155). In July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm, pustular skin eruption, erythema, rash hemorrhagic and local swelling. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the pustular skin eruption, erythema and rash hemorrhagic were not recovered/not resolved and the outcome of the local swelling was unknown. It was unknown if the reporter considered the pain in arm, pustular skin eruption, erythema, rash hemorrhagic and local swelling to be related to SHINGRIX. Additional details were provided as follows: The patient had the second dose in July 2018. She reported that her arm hurt for a couple of weeks after shot. She also had a lump in her arm after the second shot. She could not remember which arm. Her face broke out with little pustules 2 to 3 weeks after receiving the shot. At first she thought it was acne but it was not. It resolved and then came back. The pustules presented again the previous week before the date of reporting and were still present. The break out was worse after the 2nd shot. She still had a red mark on my one cheek that bled. The reporter consented to follow up.
Patient complained about chills and malaise. Advised patient to take APAP or ibuprofen and to seek medical attention if last longer than 3 days.
The pt experienced joint pain, swelling, fever, and headaches. The pt had a rash after the shot the next day.
Patient called in to the office at 11:15 am and reviewed health history and discussed vaccines to be administered. Immunizations administered at 11:20 am. Minor and parent continues to be in the office for approximately 10 minutes after administration discussing additional vaccinations due per immunization record. Parent declined and stated he only wish for daughter to receive what school was  requesting. Once conversation was completed; client was referred to observation area for the remaining time. Minor was asked if feeling okay before exiting office; she replied yes.  Front desk contacted clinical staff for assistance when minor fainted while in lobby. NP evaluated minor at that time and suggested cleared to leave clinic.
About 5 minutes after patient came back out into the waiting room she waved the technician over saying she was not feeling well.  RPh went out to her and she reported feeling light headed and having trouble breathing.  Her breathing did not sound labored and she had no swelling anywhere.  We asked her if she wanted us to call an ambulance and she declined.  She reported that she had not ate or drank anything all day so we gave her some OJ and a granola bar.  She sat in the waiting room under RPh and technician supervision for about another 20 minutes until she eventually felt ok enough to leave and drive.
Fever of 103F night and 1st day after injection.  Nausea/vomiting night & 1st day after injection, puffiness at site.
Pt's (L) leg became swollen from thigh to below the knee, red, hot and sore to touch. Patient took three BENADRYL the evening of 4/9/13. Today, it is better, but still swollen.
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 54 years old female patient who experienced a generalized papular/macular, itchy, rash while she received vaccine FLUBLOK QIV. The patient's past medical history included Parotid abscess with 3-4 week prior to the immunization. Received antibiotics and steroids to treat. The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was also reported that she had no known drug allergies. Concomitant medication was none. Reported as no other medications at the time of the immunizations. On 11-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot LQFAA1825 expiry date: 16-Jun-2019 via intramuscular route in the right deltoid. On an unknown date, the patient developed a non-serious a generalized papular/macular, itchy, rash 2 hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. On an unknown date, the patient developed a non-serious a generalized papular/macular, itchy, rash 2 hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. (Other relevant tests included No lab data). Final diagnosis was a generalized papular/macular, itchy, rash and a generalized papular/macular, itchy, rash. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for a generalized papular/macular, itchy, rash and as Unknown for a generalized papular/macular, itchy, rash. List of documents held by sender: none.
severe arm pain, dizziness (spins) anytime I woke in the middle of the night starting at 12am on 01/01/2020,  when trying to get out of bed at 0800 on 01/01/2020 I continued to have severe dizziness to the point I couldn't walk, vomitting, in ability to keep anything down by mouth,  muscle pain,  severe arm pain in arm vaccine was given. At 2pm I was still having moderate dizziness, nausea, and began to have a headache. For a week I continued to have mild dizziness, headache, extreme fatigue, brain fog,  and swollen lymph node pain in the armpit of the arm I received the vaccine in (right side).  I continue to have mild brain fog and headache.
2 days after patient received a flu shot, she developed a 3"x3" red, hot, hard area at injection site. Patient also developed redness below her D.D. and right breast. Family was instructed to call physician.
I started feeling like I had a sinus infection or cold. I was so tired and run down and had body aches. I had headache and sore throat as well. A lot of sneezing as well as a small fever. The next day I was worse. I thought it was due to stress. I slept for 24 hours and still wasn't feeling good. Some family members texted me that they were COVID-19 positive. I tested, took an at home test, and was positive. I went to the health department and had them retest, which was definitely positive. I was so sick with coughing so I called my doctor and got PAXLOVID. I lost my taste and smell but had an awful taste with this medication so I didn't take it. It took a couple of weeks to run it's course.
OFF LABEL DOSING FREQUENCY; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient concerned a female of an unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: alpha tryptasemia (causes allergic reaction to many things). The patient was previously received Moderna covid 19 vaccine (elasomeran) (Dose number in series 1) (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on 2021 for covid-19 prophylaxis.  On an unspecified date in 2021, the patient experienced reactions (Dose number in series 1). The outcome of reactions was not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 01 total, administered on 10-APR-2021 for covid-19 prophylaxis which was associated with off label dosing frequency (off label use) and revaccination with different covid-19 vaccine (Dose number in series 2). The batch number was not reported and has been requested. No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label dosing frequency and revaccination with different covid-19 vaccine was not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 01 total, administered on 29-OCT-2021 for covid-19 prophylaxis. The patient did not experienced any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 3). This report was non-serious.
I have been continually dizzy every since the 2nd vaccine I got last Thursday.  I am still experiencing slight headache as well. The dizziness is severe and new to me since taking the 2nd dose Maderna vaccine.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a male patient who received BOOSTRIX (batch number TB2R2, expiry date 2nd December 2019). On 6th February 2018, the patient received BOOSTRIX. On 6th February 2018, unknown after receiving BOOSTRIX, the patient experienced wrong vaccine administered. In February 2018, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm and wrong vaccine administered were unknown. It was unknown if the reporter considered the pain in arm to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. According to pharmacist, the patient's wife believed that she did not receive the BOOSTRIX vaccine on 6th February 2018. On that day her husband (patient) received PNEUMOVAX and she received BOOSTRIX, according to pharmacist. However, the patient's arm hurt afterward and hers did not, and this males the wife believe the vaccines were switched. Thus, the patient received BOOSTRIX instead of PNEUMOVAX, which led to wrong vaccine administered. On February 2018, less than a week after receiving BOOSTRIX, the patient experienced pain in arm. The patient did not receive any GSK vaccine as per pharmacist. The wife wanted to receive another dose of BOOSTRIX but had not yet received it.
Bloody nose in the evening after the vaccine, followed by subsequent bloody noses every evening for 5 days.
itchy, swelling w/redness; 1" x 2" wheal on rt deltoid;
pt recvd vax 20MAY93 on evening of 21MAy93 devel swelling & pain in both ankles & purpuric rash on both lower extremities;
Stress response from the vaccine; Vertigo; Tachycardia; Dizziness; Weakness; This spontaneous case was reported by a physician and describes the occurrence of TACHYCARDIA (Tachycardia), DIZZINESS (Dizziness), ASTHENIA (Weakness), VERTIGO (Vertigo) and STRESS (Stress response from the vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced TACHYCARDIA (Tachycardia), DIZZINESS (Dizziness) and ASTHENIA (Weakness). On 28-Mar-2021, the patient experienced VERTIGO (Vertigo). On an unknown date, the patient experienced STRESS (Stress response from the vaccine). At the time of the report, TACHYCARDIA (Tachycardia), DIZZINESS (Dizziness), ASTHENIA (Weakness), VERTIGO (Vertigo) and STRESS (Stress response from the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Products known to have been used by the patient, within two weeks prior to the event, included steroid dose.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up information received on contains non-significant information.
FEVER WITH TEMPERATURE OF 100.4 DEGREE FAHRENHEIT; SLIGHT DIZZINESS; CHILLS; HEADACHE; MUSCLE ACHES; FATIGUE; This spontaneous report received from a patient concerned a 19 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 13-AUG-2021 10:15 for prophylactic vaccination. No concomitant medications were reported. On 13-AUG-2021, the patient experienced slight dizziness. On 13-AUG-2021, the patient experienced chills. On 13-AUG-2021, the patient experienced headache. On 13-AUG-2021, the patient experienced muscle aches. On 13-AUG-2021, the patient experienced fatigue. Treatment medications included: ibuprofen, and paracetamol. On 14-AUG-2021, the patient experienced fever with temperature of 100.4 degree fahrenheit. Laboratory data included: Body temperature (NR: not provided) 100.4 F, 99.5 F, and Pain scale (NR: not provided) 4/10. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever with temperature of 100.4 degree fahrenheit on 15-AUG-2021, and was recovering from headache, chills, muscle aches, slight dizziness, and fatigue. This report was non-serious.
Tenderness at injection site, 100.6°F fever developing overnight after vaccine administration, headache, muscle soreness, fatigue
The pt developed a 7cm erythematous patch with vesicles and crust at site of injection.
Patient received shots Dec. 29th, seizures started that weekend following, progressed into 5-10 daily, mostly rt. sided jerking turning blue and eyes gazing off occuring mostly when tired or stimulated by light, loss of motor skills on rt. side, neurological problems, breathing and swallowing problems. Developing normal until this time. Can no longer roll over, laugh, smile, decreased muscle tone and all over function. Physical therapy currently. On Keppra and Topamax and just discontinued Trileptal. Due to meds she is lethargic and requires constant daily care. Being treated by Dr. neurology. They have little hope for meds because they have not controlled her seizures at all. We have lost the daughter we had and her wonderful personality. We have no doubt her immunizations have changed our lives forever. I have not worked for over 1 month due to seizure activity. No seizures disorders on either side of family, normal pregnancy c-section at 38 1/2 weeks. 4 EEGs spinal tap, MRI performed with no known cause.  4/6/09 ER record received for DOS 1/31/09 with dx: possible focal seizures. Pt presented with increased intesity and length of shaking/jerking episodes of the R arm which pt has been experiencing. Began at age 5 weeks. PE WNL with jerking of the R arm noted. D/C for outpt f/u. Lab 4/24/09 MR received for ER visit 2/3/09 and admission DOS 3/4-6/2009 with D/C DX:  Seizures. Pt with increasing frequency and severity of seizures which began 1/4/09. Mainly R-sided jerking with post-ictal tiredness.  11 seizures day prior to admission. PE (+) for hypotonia and decreased movement orn R side. D/C to f/u as outpt. Follow-up: Being investigated now. Seizures following DTaP--PENTACEL vaccine. She is delayed, physically, socially and speech delays. Received Occupational, Physical and speech therapy. Could write pages on the hell we've been through. Has been confirmed her vaccines caused her seizures. Call if any questions, no time to write everything that I need to say.
Gave ZOSTAVAX 0.5 mL (L) arm. Client not 60 years of age.
This spontaneous report was received from a licensed practical nurse (LPN) and refers to a patient of unknown age and gender. Information regarding the pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On 15-AUG-2017, the patient was vaccinated with improperly stored PROQUAD, Lot # N008825 with expiry date 12-SEP-2018 (dose, route and anatomical location not reported), that was reconstituted with sterile diluent (MRK INJ) for prophylaxis. No adverse effects were reported. The administered vaccine underwent a temperature excursion between -9 °Centigrade (C) to 8 °C for a time frame of 4 hours and 43 minutes. Previous temperature excursion was between -9 °C to 8 °C for 57 hours and 40 minutes and between -14 °C to -10 °C for 23 hours and 57 minutes. The call was not because of a data logger. No product quality compliant (PQC) was involved. The nurse stated that she decline to give patient specific data with this report. This is one of the four reports received from the same reporter. Sender's Comments: US-009507513-1708USA010551: US-009507513-1708USA009081: US-009507513-1709USA012931.
Pt recvd MMR vax 17SEP91; 28SEP91 pt exp tenderness in rt submandibular lymph node & cervical lymph nodes; pt exp back stiffness, joint ache, nausea & sore throat; pt devel swelling & joint aches; seen by MD 21OCT91 sore throat infect;
Missed dose; Muscles felt weak; Legs felt weak; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Muscles felt weak), ASTHENIA (Legs felt weak) and PRODUCT DOSE OMISSION ISSUE (Missed dose) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced MUSCULAR WEAKNESS (Muscles felt weak) and ASTHENIA (Legs felt weak). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, MUSCULAR WEAKNESS (Muscles felt weak) and ASTHENIA (Legs felt weak) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: went up (High) went up. On an unknown date, Heart rate: rapid heartbeat (High) Rapid heartbeat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received included reporter contact details, patient age updated, lab details added, event details updated.
nerve damage; Leg went numb; burning sensation; Initial information was received on 14-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves adult patient (unknown gender) who experienced nerve damage (nerve injury), leg went numb (hypoaesthesia) and burning sensation, after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious nerve damage (nerve injury), leg went numb (hypoaesthesia) and burning sensation(unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  It was reported "enabled me to walk properly."  At time of reporting, the outcome was unknown for the events.  There will be no information available on the batch number for this case.