chrisvoncsefalvay/vaers-outcomes huggingface dataset:
at 3am on 2/10/21 My arm was extremely sore and it radiated to my back and legs. I had body aches and chills. I had a really bad headache. Symptoms lasted about 10 hours.
Persistent and severe and worsening tinnitus that has not resolved, dental pain, neck pain, fatigue.
Headache 1/2 hour after shot. approximately 12 hours after receiving vaccine blood pressure elevated to 154/108.  Has stayed around that level for 3 days.
Experiencing some side effects; A spontaneous report was received from a Consumer concerning a  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events experiencing some side effects.  The patient's medical history was not provided. No relevant concomitant medications were reported.  No relevant lab data was reported by the reporter.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experiencing some side effects.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, experiencing some side effects was not reported.; Reporter's Comments: Very limited information regarding this event  has been provided at this time.  Further information has been requested.
Pt. found staring into space, mother unable to get pt. attention x 10 min. Later pt. appeared as if just awakened, didn't know where she was, irritable, jerky-Episodes cont. 1-3x day for 1 1/2 wk. lasting 5-30 min. Afebrile during episodes-
POSSIBLE TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned multiple patients.  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: 041A21A, 202A21A, and 205A21A expiry: 21-JUN-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced possible temperature excursion. On 11-MAY-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the possible temperature excursion and out of specification product use was not reported. This report was non-serious.
Information has been received from a registered nurse concerning an elderly patient who on an unspecified date was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of varicell-zoster virus vaccine live (Oka/Merck) (MSD) for Herpes Zoster prevention. Unspecified medical attention was sought. There were no reported problems with the vaccination. There was no product quality complaint involved. It was reported that this was a case of misinterpretation which occurred "on all levels." Additional information received confirmed that no adverse effects or problems were incurred. No further information was provided. Additional information is not expected.
patient received tenivac to early with no reported adverse event; Initial information received on 10-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 64 years old male patient where he received tenivac to early with no reported adverse event while receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac].  The patient's past medical treatment included Tenivac in 2017.  The patient's concomitant medication(s) and family history were not provided.  On 09-Feb-2023, the patient received 0.5 ml daily (QD) dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (batch number- U7189AA and expiration date- 30-Sep-2023) via intramuscular route in the left deltoid (strength: not provided) as Immunization.  On 09-Feb-2023 the patient received tenivac to early with no reported adverse event (inappropriate schedule of product administration) (latency- same day) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult.  Action taken- Not applicable.  It was not reported if the patient received a corrective treatment for the event (inappropriate schedule of product administration).  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.
sz 10 days p/vax neurological work up being done;cont to have sz;
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 24-OCT-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) by a health care provider (HCP) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a HCP at a clinic for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: arm pain and sometime numbness to fingers
High blood pressure heart swelling collapsed lunch headache nausea fluid on heart short of breath fatigue
Had high pitched crying 2-3 hrs p/DTP/HIB/OPV on 30DEC91; mom called MD no tx x/ no pertussis w/next immun;
Pfizer 2 series, dose 1 received in pharmacy, dose 2 received at local pharmacy. Series completed in May 2021. Specific dates and places not known by patient.
dizziness/palpatations/nausea x 48 hours. Tachycardia - pt had symptoms after 1st injection but did not report until same thing after 2nd injection.
MENSTRUAL CHANGES; ACNE; NUMBNESS IN LEGS; ACHINESS AND PAIN IN HER LEGS; FATIGUE; MIGRAINES; HIGH PULSE RATE; SWEATING; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's past medical history included: reaction to flu vaccine, and concurrent conditions included: low pulse rate, non-alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid, and cyanocobalamin. On 07-JUN-2021, the patient experienced high pulse rate. Laboratory data included: Pulse rate (NR: not provided) over 150 bpm. On 07-JUN-2021, the patient experienced sweating. On 07-JUN-2021, the patient experienced migraines. On 07-JUN-2021, the patient experienced fatigue. On 08-JUN-2021, the patient experienced numbness in legs. On 08-JUN-2021, the patient experienced achiness and pain in her legs. On 24-JUN-2021, the patient experienced menstrual changes. On 24-JUN-2021, the patient experienced acne. On 02-JUL-2021, Laboratory data included: X-ray (NR: not provided) Unknown. Laboratory data (dates unspecified) included: Blood test (NR: not provided) exact tests and results were not accessible, and Diagnostic ultrasound (NR: not provided) could not see anything. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraines on 11-JUL-2021, was recovering from fatigue, high pulse rate, and menstrual changes, and the outcome of sweating, numbness in legs, acne and achiness and pain in her legs was not reported. This report was non-serious.
She got hives all over her back and legs. She was very itchy and uncomfortable. We gave her an allergy pill and put hydrocortisone cream on the affected areas. The hives had cleared by morning.
Large deep red welt in shot area about size of 50 cent piece then a secondary lighter red area also swollen and raised about 7 inches long lasted for 3 to 4 days.
Patient seen for four month well child visit on 6-13-2018, discovered adverse event on 7-25-18 when billing office called inquiring why a KINRIX was ordered on a four month old.  Vaccines due were Dtap,Polio,HIB,PCV and Rotovirus. Patient given KINRIX (Dtap/IPV) combo vaccine vs. Dtap vaccine and IPV vaccine. Immediately verified that this was truly given by reviewing MONTHLY IMMUNIZATION LOG where nursing staff signs out any vaccines given. Consulted with PCP as soon as I was made aware of medication error. Contacted MOC, completed all required reports. Emailed RN Clinic Coordinator with all pertaining information.
took the two doses of the Moderna vaccine 9 days apart; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took the two doses of the Moderna vaccine 9 days apart) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took the two doses of the Moderna vaccine 9 days apart). On 10-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took the two doses of the Moderna vaccine 9 days apart) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Concomitant medications was not provided by the reporter. Treatment information was not provided.
pt had the COVID-19 vaccine on 1/15/21 and then had Bells Palsy after 4 days. No changes to the medication or other immunizations with 1 month and no new diagnoses in that time as well. No previous episodes of bells palsy with any other vaccine but positive for bells palsy in the past.
change is menstruation cycle.  shortened menstruation cycles. Early start of period. Cycle shorted from around 28 days to around 15-18 days.
enlargement of lymph nodes under left axilla; no treatment to date, lumps are still there after 3 weeks
erythema & swelling of lt thigh w/o tenderness 24hr p/vax;mom tried DPh w/o change in appearance;re-exam unchanged;no fever,
After the patient received  his first ever flu vaccine he immediately began to have swelling in his left arm. Immediately the provider was called over and he examined the patient the patient was given  Diphen Diphenhydramine  25 mg capsule and was observed for over 30 minutes the patient swelling began to go down and he was discharged and advised that if he has any other reactions to please go to the emergency room. The patient stated he felt fine and did not feel a thing.
Patient called next day reporting that arm started swelling the evening after receiving the vaccine, was warm to the touch, and was sore to the point that she was unable to lift the arm. Instructed patient that this was a possible side effect of the vaccine and that they could alternate Tylenol and Ibuprofen for the pain and inflammation, and they could use an ice pack on the affected arm as well.
BP spiked today(Oct 5) about 1:30PM, from normal to 185/68; headache; body aches; chills; fever (over102 for about 12 hours, 102.4 at peak); queasy stomach (no vomiting); profuse sweating; feeling woozy-headed; sensitivity to loud/sharp noise,visual sensation of flashing lights.; sensitivity to loud/sharp noise,visual sensation of flashing lights.; general fatigue; dizziness; chest discomfort; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female non pregnant patient received bnt162b2 (COMIRNATY), Left arm on 27Sep2021 11:30 AM at age of 72-year-old DOSE 3 (BOOSTER), SINGLE (Lot number: FC3182) for covid-19 immunisation. Medical history: HPB, SVT, Hypothyroidism (all treated). nausea reactions to anesthesia. No covid prior vaccination. Concomitant medications included flecainide acetate, lisinopril, levothyroxine sodium (SYNTHROID). No other vaccine in four weeks. The patient previously received received bnt162b2 (COMIRNATY) Left arm on 10Feb2021 10:00 AM at age of 71-year-old as DOSE 1, single (lot number: EL9265) for covid-19 immunisation, Right arm on 03Mar2021 10:00 AM as DOSE 2, single (lot number: EN6200) for covid-19 immunisation. Only sore arm and a bit of fatigue with 1st dose, sore arm only for 2nd dose. On 28Sep2021 10:00 AM About 20 hours after 3rd dose the patient developed fever (over102 for about 12 hours, 102.4 at peak), severe headache, body aches, chills, queasy stomach (no vomiting), profuse sweating. The above continued approx 36 hrs., fever lessened after 24 hrs. Post-fever continued feeling woozy-headed, had sensitivity to loud/sharp noise, visual sensation of flashing lights in 2021. At this writing 8 days after 3rd dose the patient still have general fatigue, some dizziness, queasy stomach, some chest discomfort in 2021. Concerned about heart (have SVT). BP spiked today (05Oct2021) about 1:30PM, from normal to 185/68, lasting only a few minutes. No covid tested post vaccination. No treatments received. Outcome of the event queasy stomach (no vomiting), feeling woozy-headed, general fatigue, dizziness, chest discomfort was not recovered. Outcome of the event BP spiked today (Oct 5) about 1:30PM, from normal to 185/68 was recovered. Outcome of the event fever (over102 for about 12 hours, 102.4 at peak) was recovering. Outcome of other events was unknown.
Information has been received from a registered nurse concerning a 2 year old female with an allergy to cefprozil who on 09/23/2003 was vaccinated with a first dose of varicella virus vaccine live.  On approximately 09/24/2003, a few days post vaccination, the patient had broken out in spotty rash and fever.  On 09/23/2004, it was reported that the child is still having problems with lesions on her body, arms, legs, torso.  It was noted that they look like individual little lesions, some fluid filled and some are not fluid filled.  The nurse indicated that the child has had multiple treatments which included: cetirizine hydrochloride 5mg, prednisone, triamcinolone, and different creams and salves.  The child was also tested for scabies, which was negative.  The child was referred to a dermatology specialist who has tired various therapies including pulmonary tests and some type of biopsy.  The nurse stated that the family has even bug sprayed and bombed their house for insects, and given up family pets, to rule out other factors.  The outcome was reported as not recovered.  There was no product quality complaint.  Additional information has been requested.
Expired dose given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-year-old female patient who received DTPa (Infanrix) (batch number 23T73, expiry date 30-APR-2023) for prophylaxis.   On 15-MAY-2023, the patient received Infanrix. On 15-MAY-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-May-2023  HCP called in to report that an expired dose of Infanrix was accidentally administered, providing the vaccine, patient and event information. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter.
complained of seeing floaters and having headaches within days of 2nd dose. Optometrist visit revealed optic nerve swelling and hemorrhaging behind eyes.
Patient reported no discomfort or pain at time of vaccination or for a week.  No swelling or tenderness was associated with the vaccination site. Patient said that about a week after the vaccination she started feeling ache in the arm were the vaccine was administered.  She is having difficulty doing activities of daily life like driving
12/22/2020 08:00 AM Nausea, chills, slight headache, sore arm; 12/23/2020 symptoms have slightly relieved
Muscle stiffness through out the body, headach/migraine, sore area at injection site with tenderness. All of this was after the second dose.
The same night I began experiencing extreme soreness in the injection site.  By the next morning it had gown to the size of a baseball and was hot, raised and very painful.  It continued to get worse through Sunday 1/31/21, growing to a size larger than my hand (and I am 5'10").  As of 2/1 the swelling had gone and it isnt as red, but is still very tender and having clothing on it does irritate it.
pt felt lightheaded and vomited and anxious bp 100/69 p 72 SA02 99 r-18  lungs clear pt laid down 30 minutes, felt better, and released to mother to go home
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-JUN-2015, the patient was administered a dose of improperly stored MMR II, subcutaneous (dose, injection site, lot number and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Despite all the vaccine and boosters, we did finally catch it; Despite all the vaccine and boosters, we did finally catch it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Despite all the vaccine and boosters, we did finally catch it". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid. The symptoms were mild.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
States had dizziness, loss of peripheral vision, nausea, headache lasting for 24 hours
Narrative: COVID infection following COVID vaccine series 03/03, Moderna , dose #1 03/31, Moderna, dose #2 09/08 pt cc: chills, cough, fatigue, myalgias, fever, loss of taste or smell, diarrhea, headache nausea, rhinorrhea exposure: unknown 09/21 COVID swab, result: detected 09/21 SARS-COV-2 Variant Sequencing result: pending
large aggravation of pre-existing neuropathic pain, especially in feet  slight appearance of rash on index finger, right hand
Red Spots (Injection Site); Swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Red Spots (Injection Site)) and VACCINATION SITE SWELLING (Swollen) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE RASH (Red Spots (Injection Site)) and VACCINATION SITE SWELLING (Swollen). At the time of the report, VACCINATION SITE RASH (Red Spots (Injection Site)) and VACCINATION SITE SWELLING (Swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-063831 (E2B Linked Report).
pt rcvd vax; pt stopped talking after 15mo; dx: questionable autism/pervasive developmental disorder;
Symptoms began with headache immediately after received shot. A few hours after, experienced fatigue and fogginess. The next day headache, fatigue, fogginess was worse. That night noticed slight muscle tremors, especially in legs. Also, woke up with night sweats. Although headache, fatigue and fogginess seemed to lessen significantly by day 4, muscle tremors increasing, especially at night. Also, night sweats remained. On day 6, muscle tremors worse.
Left Arm very sore within 2 hours same day, joint and muscle aching the next day and today. Extreme fatigue.
Parents went into pt's room around 5:30pm, noticed face red and swollen. Called on-call MD. No medical attention needed. This was reported to us 1 week after vaccine.
Patients mother notice rash on 04/06/11 2 days after vaccine was given.
severe muscle aches; This is a spontaneous report from a non-contactable consumer (Patient). A 59-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 at 08:15 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included estradiol (ESTROGEN); Progesterone; Rizatriptan; Nortriptyline. Patient did not receive any other vaccines in 4 weeks. Patient did not have Covid prior vaccination. Patient did not tested Covid post vaccination. Patient did not have allergies. The patient experienced severe muscle aches on 06Apr2021. AE resulted in doctor or other healthcare professional office. Patient received Fluconazole, Nystatin as a result of adverse event. Patient received dose 2 on 02Apr2021, at 08:15 AM, Vaccine location: Left arm, Dose number=2, Lot number: EP6955, for Covid-19 immunization. 1 & 2nd doses had severe muscle aches on day 2 post shot. The outcome of the event was not recovered.  No Follow-up attempts are possible. No Further information is expected.
Patient complaining of pain at injection site. Area warm to touch. No signs of infection. Pt received diphenhydramine.