chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dizzy/ light heady; Sluggish; began to itch; Hives all over/ broke out in hives from head to toe; flu like symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives all over/ broke out in hives from head to toe), INFLUENZA LIKE ILLNESS (flu like symptoms), DIZZINESS (dizzy/ light heady), SLUGGISHNESS (Sluggish) and PRURITUS (began to itch) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included Back disorder NOS (Improved after surgery) in September 1988, Prostatic disorder NOS (Improved after surgery) on 20-Feb-2018 and Mitral valve prolapse (Improved after surgery) in December 2018. Concurrent medical conditions included Drug allergy (Allergy to codeine), Drug allergy (Allergy to vancomycin), Drug allergy (Allergy to tetracycline), Drug allergy (Allergy to doxycycline) and Barrett's esophagus (Taking medication) in December 1991. Concomitant products included MELOXICAM for Arthritis, OMEPRAZOLE for Barrett's esophagus, ROSUVASTATIN for Cholesterol, LATANOPROST for Glaucoma, PROPRANOLOL for Migraine and Heart disorder, DUTASTERIDE for Prostatic disorder NOS.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On 22-Mar-2021, the patient experienced URTICARIA (Hives all over/ broke out in hives from head to toe). On an unknown date, the patient experienced DIZZINESS (dizzy/ light heady), SLUGGISHNESS (Sluggish) and PRURITUS (began to itch). The patient was treated with HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]) for Adverse event, at a dose of 25 milligram every six hours and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch, at a dose of UNK dosage form, q4h. On 21-Mar-2021, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. On 01-Apr-2021, URTICARIA (Hives all over/ broke out in hives from head to toe) had resolved. At the time of the report, DIZZINESS (dizzy/ light heady) and SLUGGISHNESS (Sluggish) outcome was unknown and PRURITUS (began to itch) had resolved. Not Provided          The patient reported that he visited the primary care physician for the hives and was given a prescription for Vistaril. He reported that he discontinued the medication and took Benadryl for the itch.
Had varicella vaccination on 12/20/2000. On 03/07/2002, the pt developed low grade fever and now has approx. 20-30 pox.
This spontaneous case reported by a consumer, describes the occurrence of oral herpes (cold sore), pain in extremity (sore arm) and fatigue in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 5, 2021, patient experienced oral herpes (cold sore), pain in extremity (sore arm) and fatigue. At the time of the report, oral herpes (cold sore), pain in extremity (sore arm) and fatigue outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
Acute on chronic combined systolic and diastolic heart failure, weakness, shortness of breath. Multiple ED visits and hospital admission within 6 weeks of receiving COVID vaccine.
PATIENT RECEIVED FIRST DOSE ON 06/15/2021 AND CAME BACK  BEFORE 21 DAYS TO GET SECOND DOSE. WAS ADMINISTERED SECOND DOSE BEFORE FILLING OUT CARD AND SEEING DATE.
PATIENT REPORTED TENDER, RED CIRCLE (1" WIDE) AROUND THE INJECTION SITE ACCOMPANIED BY ITCHING AND PAIN. PATIENT ALSO REPORTED 2 RED, SWOLLEN SPOTS WHICH WERE TENDER TO TOUCH AROUND THE WAIST THAT LOOKED LIKE BUG BITES. Patient reported this morning that spot is less red and tender today.  Appears to be getting better at injection site and spots on waist.
A non-serious report of administration of expired FLUMIST to two patients was received from a pharmacist concerning a 43-year-old female. The patient's medical history and concomitant medications were not available. On 06-Jan-2009, the patient received expired FLUMIST (expiration date 30-Dec-2008) at a Pharmacy. The pharmacist states that she did not check the expiration date prior to administration. The patient was doing well. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 09-Apr-2009: product complaint investigation results.
- Had rash and soreness developed on 8/22/09 AM went to the ER in evening as it was spreading - Was put on LEVAQUIN, Prednisone and ATARAX - Was diagnosed with cystitis on Sunday.
Information has been received from an office manager, who on 09-FEB-2007 was vaccinated (arm unspecified) with a 0.5mL first dose of Gardasil. Subsequently, the patient experienced swelling at the injection site. The patient mentioned that the reaction was mild and resolved on its own. After the patient was vaccinated (arm unspecified) with a second dose of Gardasil on 06-APR-2007 she developed "a more severe injection site reaction." The arm swelled up with a "big bubble" at the site. The arm was hardened and red, which lasted for a month. No drainage was noted. The symptom resolved on its own. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Fatigue and "canker sores: in mouth noted between 2nd and 3rd dose of Twinrix which was given on accelerated schedule.
The full vaccine was not administered from the syringe for my second Pfizer dose (undetermined amount of liquid was left in syringe).  Could have been up to 50% of vaccine that was not administered.  Nurse determined it was fine, but I've since had zero side effects from vaccination. I had a very sore arm after the first vaccination, and absolutely no sore arm/pressure after the second along with no other side effects.
PANIC; ANXIETY; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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: unknown) dose, start therapy date were not reported 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 subject experienced panic, anxiety, chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the panic, anxiety, chills, fever and headache was not reported. This report was non-serious.
Subsequent to receiving rubella virus vaccine live (second generation), the pt had a Rubella antibody test come out negative, after the original antibody test was positive. No further information is available.
Swollen eyes and tongue; Swollen eyes and tongue; dizzy; weak; This is a spontaneous report from a contactable other hcp. A 34-years-old female patient received second dose bnt162b2 (BNT162B2,Solution for injection,Batch/Lot Number: EL9264), via an unspecified route of administration, administered in Arm Left on 03Feb2021 10:45 as 2ND DOSE, SINGLE for covid-19 immunisation. Patient didn't received another vaccination prior to covid vaccination with in 4 weeks, Patient didn't had Covid prior to vaccination. Medical history included cardiac disorder from an unknown date and unknown if ongoing ,food allergy from an unknown date and unknown if ongoing patient had received first dose bnt162b2 (BNT162B2,Solution for injection, Batch/Lot Number:EK9231), via an unspecified route of administration, administered in Arm Left on 11Jan2021 as 1ST DOSE, SINGLE for covid-19 immunisation. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported, patient didn't got tested prior to post vaccination. On 03Feb2021 11:00 the patient experienced swollen eyes and tongue, dizzy and weak. The outcome of the events swollen eyes and tongue, dizzy, weak was not recovered.  Follow-up attempts are completed. No further information is expected.
Huge circle rash with raised rash, pain and itching, fatigue (possibly cause a fibromyalgia flare, at least those symptoms), joints in my hands hurting enough to effect my coordination
Expired dose was given to a patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose was given to a patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) 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 EXPIRED PRODUCT ADMINISTERED (Expired dose was given to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose was given to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow-up was received on 2-NOV-2021 and contains no new information.
Swelling at the injection site area, inability to raise arm and with a 10 out of 10 pain, temperature of 102 for a 24 hour period of time.
Very severe flu symptoms, drowzy lethargic, could not move limbs due to pain, breasts were severely painful.  Vaccine site was severely swollen and painful
This spontaneous report has been received from a medical assistant referring to a 15 years old patient of unknown gender. No information was provided regarding the patients' medical history, concurrent conditions, drug and allergy history. Concomitant therapies included sterile diluent (MRK). On 22-SEP-2017, the patient were vaccinated with improperly stored doses VARIVAX (lot # N017396, expiration date 07-JUN-2019, dose and route was not provided) for prophylaxis. The doses of VARIVAX were exposed to a temperature excursion of 15 Fahrenheit (F) to 46 F during a time frame of 1 hour and 23 minutes, which was detected by the data logger. There was a previous temperature excursion of 6 F to 14 F for 1 hour and 16 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA003603: US-009507513-1711USA003602: US-009507513-1711USA003604: US-009507513-1709USA011228.
Pt was given an intramuscular injection of Tdap vaccine on 2/21/19 that had expired on 1/21/19. The adminstering RN attempted to contact the patient, but was unable to reach him due to pt's homeless status. Pt returned to clinic 5/2/19 and this RN discussed vaccine with him. Pt denies any adverse reaction and refuses a new Tdap vaccine. Pt states that he does not want to be vaccinated again. Educated patient about tetanus- patient verbalizes understanding and denies questions at this time.
Here is the patient info for the temp excursion/beyond use date excursion; temp excursion/beyond use date excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (temp excursion/beyond use date excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (temp excursion/beyond use date excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (temp excursion/beyond use date excursion) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Treatment medications was not provided.
Lost voice x 2 days. Chills (intermittent and minor). Shoulder and neck pain. Pt says she felt fine after 2 days.
This spontaneous prospective pregnancy report as received from a physician refers to a 42 year old female patient. The patients pertinent medical history and drug allergies were none. On 16-APR-2014 the patient was vaccinated with VARIVAX (lot# H015557, expiry date: 16-AUG-2014, dose: 0.5 milliliter (ml), subcutaneous for titer immunoglobulin G (IgG) was equivocal. Concomitant Medication were none. The patient became pregnant with LMP of 14-APR-2014 and EDD of 19-JAN-2015. Initial exposure to varicella VARIVAX was at week 0 week(s).The pregnancy outcome unknown. On 16-APR-2014, the patient received VARIVAX during early pregnancy. The patient learned of pregnancy on 22-MAY-2014. Lab Diagnostics Studies Performed were none. No adverse event was reported. The outcome of received varicella VARIVAX during early pregnancy and no adverse event was unknown. The patient did no sought medical attention. Additional information has been requested.
Approximatley 24 hours after being given Prevnar 13 patient had fever up to 103.5, body aches, screamed and held head multiple times for about 48 hours. This was the patient's last Prevnar.
COVID arm. Large swollen area from injection site down to elbow. Itchy, red, warm to touch.  Lasted about a week then went away.   Heavier more painful periods. Passing large clots. Occurred next period after vaccine and ongoing still
BACK PAIN; FEVER; LITTLE HEADACHE; EYES HURTING; SINUS PAIN FOREHEAD AND EYES; LITTLE PAIN IN HER RIGHT LEG; This spontaneous report received from a consumer concerned a female of unspecified age. 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: Unk) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced sinus pain forehead and eyes. On JUN-2021, the subject experienced little pain in her right leg. Treatment medications included: ibuprofen, and paracetamol. On 17-JUN-2021, the subject experienced eyes hurting. On 17-JUN-2021, the subject experienced fever. On 17-JUN-2021, the subject experienced little headache. On 18-JUN-2021, the subject experienced back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sinus pain forehead and eyes, and little pain in her right leg, and the outcome of fever, eyes hurting, little headache and back pain was not reported. This report was non-serious.
PNEUMONIA; INJECTION SITE ITCHINESS; RASH AT INJECTION SITE; This spontaneous report received from a consumer concerned a 97 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: Unknown) dose was not reported, 1 total dose administered on 07-APR-2021 in left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient developed an itchy rash at the site of the vaccine, 5 days after receiving the vaccine. Her husband did not said anything and it had started to dry up. Consumer said her husband picked up pneumonia about 3 weeks after the vaccine on 27-APR-2021 and was hospitalized. He was on antibiotics for a long time. might be 2 weeks or more. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pneumonia, injection site itchiness, and rash at injection site. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 - 20210557955-covid-19 vaccine ad26.cov2.s-Pneumonia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient developed seizures that were caused by streptococcal meningitis, 19A.
The employee complained of extreme lethargy and headache, nausea and vomiting, photophobia after taking hepatitis B vaccine.
Initially with large immune response (rigors, chills, sweats, fatigue, nausea, anorexia, headache), resolving in 48 hours, with lingering chest pressure, increased shortness of breath, and fatigue for 2 weeks.  Ibuprofen 400mg taken after 48  hours with no relief to chest pain, left sided.  Constant dull ache, with occasional 'pings' radiating toward the left.
tested positive for Covid 19; tested positive for Covid 19; This is a spontaneous report from a contactable consumer (patient).    59-year-old feAmale patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on Feb2021 as DOSE 2, SINGLE, and first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on Jan2021 as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive for covid 19 on 30Oct2021. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 30Oct2021. The outcome of the event Covid-19 was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Pt received Pneumovax SQ notl arm. Sxs of red and swelling started 12 hrs post receiving injections. Pt states that redness and swelling was 2-3" width. Started antibiotics. Within 24 hrs and sxs started to improving. Pt states sxs cleared.
40 patients administered with vaccines that have undergone temperature excursion; Patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  No patients have reported any adverse events to date.  Vaccines were thawed on 28-Jan-2022.  It was reported Maximum or minimum temperatures reached as applicable (specify temp is in C or F) on 28-Jan-2022 temp range positive 34.7F to positive 41.2F, on 30-Jan-2022 temp range positive 34.7F to positive 41.2F which occurred for 48 hours; on 31-Jan-2022 temp range positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range positive 35.2F to positive 41.7F for 12 hours.  Treatment information was not reported.   This case was linked to MOD-2022-539815 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2022: Follow-up information received: Added patient Information and dosage information.
Papular rash on left thigh, confluent near injection site and more sparse on rest of thigh. Few papules on right arm and chin, also. No fever.
Had a mild reaction 10-15 min after vaccine. My throat felt tight and uncomfortable as I left vaccination clinic. I took an Aler-Tec pill and felt better 20 minutes after. My arm was sore for 2 days after and couldn?t sleep on Right side, arm hurt. Injection site was purple and bruised one week later but no pain.