chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness on Movement 3 weeks after Second Dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness on Movement 3 weeks after Second Dose) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and Unknown) for COVID-19 vaccination.     Concomitant products included CLONAZEPAM (KLONOPIN) for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Dizziness on Movement 3 weeks after Second Dose). At the time of the report, DIZZINESS (Dizziness on Movement 3 weeks after Second Dose) outcome was unknown. Not Provided          No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-080301 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080301:crosslinked
Initially syncope presented to ER. Head CT/labs normal. MRI nornal then EEG workup abnormal during hospitalization. On antiseizure meds. Cause undertermined so far. Neurology involved.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 12-JUL-2010, the patient received improperly stored VARIVAX dose 2, from lot # 666851/0280Z, expiry date 12-FEB-2012 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated the vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
brain bleed; brain surgery; craniotomy; Hematoma; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but Manufacture unknown), for covid-19 immunization. The following information was reported: CEREBRAL HAEMORRHAGE (hospitalization, medically significant), outcome "unknown", described as "brain bleed"; BRAIN OPERATION (hospitalization), outcome "unknown", described as "brain surgery"; CRANIOTOMY (hospitalization), outcome "unknown"; HAEMATOMA (non-serious), outcome "unknown", described as "Hematoma". The events "brain bleed", "brain surgery", "craniotomy" and "hematoma" required emergency room visit. Therapeutic measures were taken as a result of cerebral haemorrhage. Clinical course: Callers husband had brain surgery, hematoma, and brain bleed 6 weeks after booster shot of Covid vaccine. Can he still get another booster shot? They don't know if it was caused by the booster shot, but her husband had the shot 6 weeks before the brain bleed was detected. The doctor in the ER saw old blood and asked them what occurred 6 weeks prior. Caller and her husband couldn't think of anything. Her husband never fell or hurt himself. They had to transfer him from that hospital because they were not qualified or set up to do a brain surgery. They transferred him to [name withheld] Hospital where that is the specialty. Then caller heard from different people that Pfizer's had caused brain bleeds. Caller and her husband believe in science and [name withheld]. Caller and her husband got the shot after comparing shots and deciding to get Pfizer. Then to hear it was causing brain bleeds was astounding. The doctor said there was no proof of that. Caller and her husband didn't know to believe that.  2 days before Christmas in 2021, 23Dec2021, her husband had first brain surgery and had blood drained from brain. Then had to have 2 subsequent surgeries. He developed infection and had to have craniotomy.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fear of needles, syncope. Seizure-like activity for 4 seconds. Alert. Patient states this has happened before.
Pt experienced a seizure in the car on the way home after receiving vaccine. Pt has hx of epilepsy & has had seizures after other injections (not vaccines) possibly triggered by stress of inj. due to mother. Pt's Dr okayed vaccines according to mother.
Patient passed out several minutes after vaccine was administered. She fell off the exam table and sustained a concussion and fractured left clavicle. EKG immediately following showed a borderline long QT which resolved upon reexamination one week later.
Peripheral neuropathy presenting as a mild tingling in ball of big toe on each foot initially, gradually progressing over 3 days to include bottoms of both feet and traveling up calves to knees. It gets worse at night. Also started in fingertips on hands at the same time, gradually progressing over 3 days to include palms and traveling up to elbows. On day 5 tingling and 'fuzziness' is less noticeable in arms and hands. No change in legs and feet. It does make it hard to fall asleep and wakes me up Somme nights.  During the day bottoms of both feet are constantly 'fuzzy' while other areas diminish. There is also a burning ring on scalp at crown on head that follows similar pattern.
Patient came back at about 5 PM complaining that her arm was twitching right by her underarm. She said she doesn't know exactly when it started, but it has gone on for quite some time after the flu shot was administered.
On March 25, 2021 the 1st dose was administered. And the only reaction was swelling at the injection site of approximately 2.25" diameter with a raised irregular border that lasted more than 4 days, with mild pain to the touch and constant soreness. On 2nd dose within 4 hours of injection a similar swelling occurred, within 5 hours pain along the right clavicle  that affects both bone and muscles, slowly extended to lower arm. Wednesday 4/21, moderate fever developed overnight that lasted 2-3 hours. Pain has now radiated to right upper-back quadrant to include the right scapula and right shoulder. Pain continues to this moment.
pt recv vax 29APR98 & 10min post vax pt devel possible anaphylaxis w/apnea & arm rigidity;pt transferred from the nursery to a neonatal unit or administered oxygen;
Doctor received a phone call from the patient's brother on 01/03/22, to report that she went home after her booster on 12/15/21 and passed away later that night.  She was not a patient of our clinic and was only here to receive her booster shot of Moderna. She gave us a copy of her vaccination card and filled out the pre-vaccination checklist from the CDC. She also waited the recommended 15-30 minutes post-vaccination and left without issue.  She and the circumstances of her death are otherwise unknown to us.
Itching bumps on the lower back, later developed itching burning 2 in rash on left side of waist.
5-1cm subcutaneous atrophy at injection site.  No obvious muscular antibody.
hives all over body within 1 hour of vaccines. NO wheezing or shortness of breath. Benadryl given.
This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 08-FEB-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N013279, expiration date 28-APR-2019, for prophylaxis (Strength, dose, route and frequency were not reported). The M-M-R II was reconstituted with a properly stored sterile diluent (MERCK) (lot # and expiration date were not reported). The temperature excursion was of 9°C to 25°C, during 8 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA007574: US-009507513-1802USA006448: US-009507513-1802USA007576: US-009507513-1802USA007577: US-009507513-1802USA007578: US-009507513-1802USA007579: US-009507513-1802USA007573: US-009507513-1802USA007572: US-009507513-1802USA007575.
Pt was discharged  stable after covid-19 vaccine. Pt went home and came back complaining of Rt arm rash and SOB: Dr  and RN for   triage the patient.
Within about 30 minutes after the vaccine I developed muscles aches and didn't feel well. Later that night a fever and chills developed and I was very fatigued. My muscles ached, I developed a cough but by later that day my body hurt so bad it felt as if I had got run over by a truck. My PCP advised I get a COVID test which was negative and that next day I went to work but got sent home because I still had a fever and wasn't feeling well. I loss my sense smell. Over the weekend, the SOB and the fever continued and got worse so I saw my PCP who advised if the symptoms got worse to see him again. I was taken off work for a week because my symptoms didn't get better and finally after a week or so I was able to return back to work. I also had a headache during this entire time as well. I still deal with the SOB to date and my immune system now seems to be all out of whack since the vaccine.
Fever to 102.9, rigors, joint pain, nausea lasting 24 hrs
Pt had 3 shots of Lymerix; 10/99, 11/99, 4/00 with follow-up after 2nd and 3rd. 10 days later, had numbness of left lower extremity and 2 months later, LLE and RLE was numb as well as upper BL, LS spine and hip pain, balance and vision affected.
I got both shots yesterday in the same arm and it hurts; I got both shots yesterday in the same arm and it hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 16-SEP-2023, the patient received the 1st dose of RSV vaccine (unknown arm) and the 2nd dose of RSV vaccine (unknown arm). In SEP-2023, an unknown time after receiving RSV vaccine and RSV vaccine, the patient experienced pain in arm (Verbatim: I got both shots yesterday in the same arm and it hurts). On 16-SEP-2023, the patient experienced overdose (Verbatim: I got both shots yesterday in the same arm and it hurts).  The outcome of the pain in arm was not reported and the outcome of the overdose was unknown.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine and RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine and RSV vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 The case was received from the patient via interactive digital media. The patient received both the RSV shots in same arm which hurted like a heck. The patient also got his/her pharmacy. The patient received both the RSV shots in same arm on same day which led to overdose. The follow-up would not required per process.
This case was reported by a physician via call center representative and described the occurrence of injection site hyperpigmentation in a 2-month-old patient who received HIBERIX (batch  number 4294M, expiry date 20th January 2018). On 4th April 2017, the patient received HIBERIX .5 ml. On 4th April 2017, immediately after receiving HIBERIX, the patient experienced injection site hyperpigmentation. On an unknown date, the outcome of the injection site hyperpigmentation was unknown. It was unknown if the reporter considered the injection site hyperpigmentation to be related to HIBERIX. Additional details were provided as follows: The patient had a black dot being left at the injection site of HIBERIX and had not faded by the date of the next dose. On an unknown date, the patient received 2nd dose of HIBERIX 0.5ml (Batch number: 4B745, Expiry date: 23 February 2018). This was purely cosmetic and no additional adverse events were reported. This was one of the two cases reported by the same reporter.
Rash around knee on left leg,; Itchy skin; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 07May2021 at 12:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included loratadine (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 14Apr2021 at 08:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. On 10May2021 at 16:00, the patient experienced rash around knee on left leg, itchy skin. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash around knee on left leg, itchy skin was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium
Subject in pneumococcal vaccine trial (not blinded) was diagnosed with gastric cancer. This is an SAE in our trial because it is 'New Cancer'. Relationship to study treatment is 'None'. The only further information we might obtain about this event would be the biopsy results.  Vaccination took place on 10/5/07 and diagnosis was made on 11/2/07.  We would be happy to forward the Study's SAE form upon request.  11/27/07 Reviewed study SAE form which reveals patient diagnosed w/gastric cancer on 11/2/07. FINAL DX: gastric cancer.
Monday on 02/21/2022 at night I took a COVID-19 test it was negative. I had cough, fever, and nasal congestion through the night. Thursday morning on 02/24/2022 I took a COVID-19 test again it was negative but the staff kept my COVID-19 few more minutes since I had symptoms of COVID-19 just to make sure the result was accurate. On 02/24/2022 after 15 minutes of my COVID-19 test it turned out to be positive. I called my doctor but I wasn't able to see him so I was sent to the urgent care because COVID-19 set inside my bronchiole which made it harder for me to breath. At the urgent care they prescribed me antibiotics and few inhalers.
PATIENT COMPLAINED OF CONTINUED PAIN ON THE ARM AFTER THE VACCINE WAS ADMINISTERED ON 07/16/2023
Local erythema and edema 4in x 2in, no warmth or discharge noted. Happened directly after administration to left sub-q tissue.
Onset of redness at injection site, SQ L upper arm noted by pt on 10/23/03 at 7pm with feeling of heaviness in calf carm, chest tightness and wheezing and fever. Reported on 10/24/03 at 3pm with 30mm x 50mm redness to L arm with 30mm wheal. No wheezing /t-97.0 BP: 165/118 P 74. Ref to hospital for evaluation. By 10/26/03 at7pm treated. BP was monitored x 2 days. Return to normal reading by 10/26/03. Pt states was symptom free by 10/26/03 at 7pm. Treated at hospital with Ventolin inhaler, ice pack to injection site.
TIINGLING IN LEFT ARM FROM INJECTION SITE DOWN, CRAMPING OF LEFT WRIST AND HAND
Patient was given Influenza vaccine that was not requested. Patient reported no adverse reaction after 15-20  minutes under observation. This was not the first time patient has received the flu vaccine.
RECIEVED TDAP, GARDISIL, MENINGOCOCCAL INJECTION, TOLERATED WELL, WALKED OUT OF EXAM ROOM AND PASSED OUT (5 -7 MINUTES AFTER INJECTIONS)  6/10/09 Hospital records received DOS 6/3/09 to 6/4/09. FINAL DIAGNOSIS: Syncope, closed head injury. Post vaccination patient passed out, hit back of head, had brief jerking activity. Emotional, crying, headache, left hand numbness. Nausea, visual changes, lightheaded. Tenderness, swelling over occiput.  7/16/09 ICD-9 Codes: 780.2, 959.01, 784.0, 780.4
Narrative:  70yo male pt died at home on 09/25/2021. See pt's problem list below. PROBLEM LAST MOD PROVIDER Obstructive sleep apnea of adult (SCT 03/27/2018 1101000119103) (ICD-10-CM G47.30) Atrial fibrillation (SCT 49436004) (ICD-10-CM 01/29/2018 I48.0) Cardiomyopathy (SCT 85898001) (ICD-10-CM I42.9) 11/28/2017 Osteoarthritis of knee (SCT 239873007) 07/14/2016 (ICD-10-CM M17.0) Benign hypertension (SCT 10725009) (ICD-10-CM 12/01/2015 I10.) Diabetes mellitus (SCT 73211009) (ICD-10-CM 12/01/2015 E11.9) Hyperlipidemia (SCT 55822004) (ICD-10-CM E78.5) 12/01/2015 Chronic obstructive lung disease (SCT 13645005) 12/01/2015 (ICD-10-CM J44.9) Knee pain (SCT 30989003) (ICD-10-CM M25.569) 12/01/2015 Gout (SCT 90560007) (ICD-10-CM M10.9) 12/01/2015 Gastroesophageal reflux disease (SCT 235595009) 12/01/2015 (ICD-10-CM K21.9) Hyperuricemia (SCT 35885006) (ICD-10-CM E79.0) 12/01/2015 (ICD-9-CM 272.2); Mixed Hyperlipidemia 12/05/2012 (ICD-9-CM 600.20); Benign Localized Hyperplasia 12/15/2010 of Prostate without Urinary obstruction (ICD-9-CM 6 (ICD-9-CM 477.9); Allergic Rhinitis 01/14/2010 (ICD-9-CM 274.9); Gout * (ICD-9-CM 274.9) 09/04/2009 (ICD-9-CM 144.9); Malignant neoplasm of floor of 05/06/2009 mouth (ICD-9-CM 144.9) (ICD-9-CM 272.0); Hypercholesterolemia, Pure 02/12/2008 (ICD-9-CM 496.); COPD * (ICD-9-CM 496.) 01/08/2007 (ICD-9-CM 303.90); Alcohol Dependence * 06/22/2011 (ICD-9-CM 303.90/303.91) In remission (ICD-9-CM 719.46); Knee: arthralgia * (ICD-9-CM 12/17/2004 719.46) (ICD-9-CM 278.00; Obesity * (ICD-9-CM 278.00) 10/22/2003 (ICD-9-CM 530.81); ESOPHAGEAL REFLUX 03/03/2003 (ICD-9-CM 786.09); Sleep Apnea (ICD-9-CM 786.09) 05/23/2001 Family History of Malignant Neoplasm of 02/07/2013 Gastrointestinal Tract (ICD-9-CM V16.0) 1. Colonoscopy 11/07 - no adenomatous polyps 2. Scope 1/13- tics, hemorr., no polyps Diabetes Mellitus Type II or unspecified 05/09/2000 (ICD-9-CM 250.00) Essential Hypertension (ICD-9-CM 401.9) 03/14/2000 Tobacco Use Disorder (ICD-9-CM 305.1) 04/06/2007 In remission This death is likely not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration.
Patient states he was feeling light headed and had a headache and around 7pm started having chest pains. He states he coded at the hospital. He was admitted to the hospital, tests done and observation until the next afternoon before being discharged. They were unable to determine a cause so he was told probably a reaction to the vaccine.
On 8/7/13 RN was notified by employee that one day after starting oral typhoid she experienced bodyaches, generalized malaise, slight nausea, diarrhea, and a low grade fever. Symptoms ceased approx 2 days after completing vaccine. The day after completing the vaccine she went to a work physical and it was noted she had an increased WBC, AST, ALT labs.
about two weeks after my son developed a rash that started behind his neck, the next morning it had spread across his back onto his head and face. about a week later the rash moved to his arms and legs. hes had the rash about three weeks now with no signs of it getting any better. its getting worse.
pt had flu vax 530PM 19OCT95 for the first time; @11PM had shaking chills, sclera very bloodshot, temp elevation (102);transported to hosp ER by amb;MD in ER treated BP elevation but other test neg;tx APAP
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/14/22. When error discovered facility contacted CDC for course of action. At direction of the CDC, patient contacted regarding occurrence to offer re-vaccination of dose. No adverse side effects or event as result of dose.
Had an outbreak of COVID after being fully vaccinated and having the booster dose. I had the antibody infusion on 09/26/2021
Woke up with a 101.4F Fever; Woke up with chills; Woke up with muscle aches; Woke up with sore throat; Woke up with slight headache on right side; Woke up with sore arm; This is a spontaneous report from a contactable Consumer (patient)  A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 10Mar2021 13:45 (Batch/Lot Number: Lot# EL3248) (at vaccition age of 62 years)  as single DOSE, SINGLE for covid-19 immunisation  .  The patient received the first dose of BNT162B2 at age of 62 years on 17 feb2021 at 01:45 PM  Lot# EM 9810 on right arm for covid-19 immunization.No other vaccine in four weeks  .Medical history included breast cancer Concomitant medication(s) included tamoxifen (TAMOXIFEN, 20mg) taken for an unspecified indication, start and stop date were not reported; ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported.  The patient experienced woke up with a 101.4f fever (non-serious) on 11Mar2021 07:30 with outcome of unknown , woke up with chills (non-serious) on 11Mar2021 07:30 with outcome of unknown , woke up with muscle aches (non-serious) on 11Mar2021 07:30 with outcome of unknown , woke up with sore throat (non-serious) on 11Mar2021 07:30 with outcome of unknown , woke up with slight headache on right side (non-serious) on 11Mar2021 07:30 with outcome of unknown , woke up with sore arm (non-serious) on 11Mar2021 07:30 with outcome of unknown.  The patient underwent lab tests and procedures which included body temperature: 101.4f  on 11Mar2021; body temperature: 100.5 fahrenheit on 13Mar2021   , body temperature: 98.5 fahrenheit on 13Mar2021  .  The clinical course was reported as follows:Adverse event Woke up on 11Mar2021 with chills, muscle aches, sore throat and a slight headache on right side, sore arm and a 101.4F fever. Took Ibuprofen before bed that night, fever broke, but came back that evening with chills, nausea and cough. 13Mar2021 up and  down temps: 12:49am 100.5F temp down to 98.5F at 9:00am.Event sore arm and fever were treated while no received treatment for  the other ones .Additional information included:No covid prior vaccination;No covid tested post vaccination  No follow up attempts are Possible. No further information is expected.
Dizziness, Fever, Palpitations, Tachycardia, fatigue, Narrative:
Patient received vaccination on Friday. Started developing symptoms Saturday at around 5pm.  ADR: lost all muscle control, unable to stand, lost control of bowels and bladder (urinary incontinence). Developed irregular heartbeat.   Patient received fluid in ambulance
12/10/2004 Pt reported reddened, blotchy, swollen, hot area at site vaccine placed and further down her arm. Seen by physician 12/10/04. Pt reports on 12/14/04 her physician told her it looked like an infection and gave her antibiotics. By 12/14/04, pt reports no redness or swelling or pain.
Severe Vertigo ( extreme dizziness, nausea, headache) after the 2nd vaccine 1st vaccine: 02-26-2021 2nd vaccine:  03-19-2021 Vertigo occurred after the 2nd vaccine. ( 2 episodes) I have never experienced Vertigo prior to the Vaccines