chrisvoncsefalvay/vaers-outcomes huggingface dataset:
One month, post vax, of his 3rd injection, the pt reportedly experienced liver failure. He was hospitalized for 2 weeks in January, 2000 and discharged. Then, sometime later (nos), he was diagnosed with aplastic anemia (the pt had been having "nose bleeds" and "blood in his urine"). He was hospitalized again for 2 weeks at the end of February, 2000, for the aplastic anemia. According to the reporter, the pt's current status is as follows: pt is out of the hospital but no permitted to go to school due to a decreased white blood cell count. He is not permitted to do any physical activity because of the risk of bleeding. He goes to the hospital about 3 times per week for a blood transfusion "when he bleeds". The mother stated that his "life has been yanked out from underneath him". He is currently on "many medicines" (nos) for treatment of the adverse events, one of which is prednisone. Additional information has been requested. The most recent information received on 4/23/2000, reports the outcome of the adverse events as unknown.
Trigeminal pain on the right side of her face; Nerve pain in left arm; Cognitive word findings; Dizziness / light headedness; Fatigue; Arm soreness; A spontaneous report was received from a heath professional concerning a 56-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, pain in extremity, neuralgia , trigeminal neuralgia, dizziness and cognitive disorder.  The patient's medical history included multiple sclerosis. Concomitant medications were not reported.  On 08 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 5 Feb 2021,  the patient received their second of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 06 Feb 2021, the patient experienced mild reactions as fatigue and arm soreness. On 08 Feb 2021, the patient experienced nerve pain in her left arm, trigeminal pain on the right side of her face, dizziness, light headedness and cognitive word findings that are not visible on her multiple sclerosis symptoms.  Patient notified her neurologist and she was intervened with Steroid pack on 15 Feb 2021, that help for a while not until  27Feb. Left arm nerve pain and trigeminal pain  came back on 28 Feb 2021. She was scheduled on another steroid pack last 1 Mar 2021 however, trigeminal pain came back on 6 Mar 2021. If another Steroid pad will not work, she was planning to undergo on different series of blood works.  Action taken with mRNA-1273 in response to the events was not applicable.  The events, fatigue and arm soreness , were considered resolved on 06 Feb 2021.   The events, nerve pain in her left arm, trigeminal pain on the right side of her face, dizziness / light headedness and cognitive word findings, were considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,  a causal relationship cannot be excluded.
I started having chest pain & some pain up in my jaw area. It was very sporadic & it got worse. It was an irregular beat with pain.
She said that a "little bit" of the vaccine leaked out of the syringe where the needle connects to it because "it was loose"; she didn't get her full dose; Initial information regarding an unsolicited valid non-serious case was received from a physician on 11-Nov-2020.  This case involves a 73 years old female patient who said that a "little bit" of the vaccine leaked out of the syringe where the needle connects to it because "it was loose" (Device connection issue) and she didn't get her full dose (Incorrect dose administered), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitant medication was reported.  On 30-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ536AA and expiration date: unknown) 0.7 ml once via unknown route in unknown administration site for prophylactic vaccination.  On 30-Oct-2020, on the same day the patient said that a "little bit" of the vaccine leaked out of the syringe where the needle connects to it because "it was loose" and she didn't get her full dose". It was actual medication error case due to incomplete dose administered.    Action taken and event outcome were not applicable for both events.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  No further relevant information was reported.
Nausea, dizziness, heart racing, clammy/sweaty palms, vision changes, tingling and hot feeling  face
High fever Headache  Diarrhea  Red, hot large circle about three inches below injection site
POTS; This spontaneous report was received from a lawyer regarding a case in litigation concerning a 15-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. In 2009 following vaccination, the pt experienced Postural orthostatic tachycardia syndrome (POTS). The outcome of the event was not provided. The reporter stated that the event were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had his/her first shot and ended up with shingles.  The patient was due for the second shot. The follow up would not possible as no contact details were available.
I experienced a flushing, an increase in pain and erythema in the pelvic area where I had received radiation therapy approximately 5 hours after administration of the vaccine.  The following 2 days, the lymph nodes in my groin (also previously radiated) were swollen and tender, this was unexpected.  My right arm was sore at the site of the injection (which I expected).  Today, Thursday Nov. 11th, mild pelvic skin erythema and tenderness persist, but have not gotten worse.   Left groin lymph node still feels tender, is no longer swollen or palpable.
Pt. mom reported swelling with redness at injection site. She noticed this 2 days after vaccine administered.
This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder Pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced ARTHRALGIA (Shoulder Pain). At the time of the report, ARTHRALGIA (Shoulder Pain) outcome was unknown.            No concomitant and treatment medication details were reported.
Restless sleep. After taking shower, felt very dizzy, head buzzing, while drying my hair I fell to the floor but did not actually lose consciousness; took my temperature 99.4 (as the day progressed to went up to as much as 100.7 using an ear thermometer); felt "other-worldly," was unable to go through my normal daily routine and activities; slept from 9 to 11am and from 1-3pm. Called doctor's office and was advised that it probably was a virus, and an episode of hypoglycemia? not a reaction. Told to take 1 TYLENOL, which I did, but fever remained, and increased towards evening. Able to eat dinner normally. No fever the following morning. No dizziness. No buzzing in my head. Restful sleep. Able to go about my usual routine on 3/8/18.
Father started complaining about his right leg after first dose of Vaccine.  After second dose on Feb 12, 2021, Father started complaining much more about his leg.  On Feb 23, 2021 it was diagnosed Father had a Blood Clot in his leg.
Adverse event information provided in this submission, is per a report received by the Health Department from a submitting facility. Covid-19 vaccination information is from the Registry. Pfizer 1/26/2021 LOT # EL0142;  Pfizer 2/16/2021 LOT # EN5318;  Pfizer 9/27/2021 LOT # 301558A;  Pfizer 5/2/2022 FK9894  Pfizer BvlntBstr 12+  9/27/2022 LOT # GH9702 Per note submitted. ?Patient present to ED 11/13/2022 positive for COVID-19. Patient?s chief complaint is shortness of breath that has been getting worse since the past few days. Of note, the patient was also seen in the ED yesterday during which he was found to be confused but eventually returned to his baseline, vitals were stable and hence he was discharged back to his nursing home. Patient stated that he developed symptoms of cough productive of sputum, shortness of breath and generalized weakness a few days ago 11/9. He took a COVID test at home that came back positive. States that his symptoms have persisted without any improvement despite symptomatic management and has decided to come to ED for further evaluation. He denies s any chest pain, lightheadedness, dizziness etc. Ambulates using assistance. States to be compliant with his home medications. Review of systems is negative for any other findings. Upon examination of the bedside patient was lying in the bed in no apparent distress. He was awake and alert, AO x3. His vitals are notable for T-max of 99.6, heart rate in the 90s, respirate rate of 22 blood pressure was 114/59 and he was saturating 93% on 2 L nasal cannula. Patient on admission had a saturation of 89% on room air. Chemistry was unremarkable. Patient had elevated CRP of 7.63 and proBNP was 486. Troponin within normal limits. CBC showed MCV of 102.5. Patient also had elevated D-dimer of 469. Digoxin le vel was subtherapeutic 1.2. Chest x-ray showed bilateral interstitial thickening. EKG showed sinus tachycardia. CTA chest was ordered and patient will be admitted to hospital for further management. Patient admitted to Hospital 11/13/2022. ?  PUBLIC HEALTH HAS NO FURTHER INFORMATION ON THIS PATIENT NOR ON THIS PATIENT OUTCOME. PLEASE CONTACT HOSPITAL FOP ANY ADDITIONAL INFORMATION.
I was pregnant at the time of my booster shot, approximately 8.5 weeks pregnant (estimated date of delivery June 4, 2022). Two days after my COVID booster I began experiencing spotting. The spotting continued and at a doctor's appointment on Nov 4 I learned there was no longer a fetal heartbeat. I am aware this miscarriage happening after my vaccination is likely just a coincidence but given the timing I felt I should report this.
Mother reports child began having rash 7/15/09 which progressed to include neck, back, shoulders, abdomen, (R) hip to (R) leg and calf, both feet. Pt. c/o itching, BENADRYL 12.5 mg adm every 5 hours until 7/17/09. Was seen by PCP who also tested for strep throat. PCP felt Rx to Hep A but would decide with culture results. Mother was instructed to call clinic. Rash is resolving 7/17/09.
had both doses, shingles/suspected Vaccination failure; breakthrough shingles; rash, left side of face, forehead, eyelid; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On 23rd July 2018, the patient received the 1st dose of Shingrix (intramuscular). In July 2021, more than 2 years after receiving Shingrix and 3 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and rash were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported for 2nd dose. The patient got both doses Shingrix in 2018. At the end of July 2021, patient had a breakthrough case of shingles and developed rash on the left side of face, forehead and left eyelid.  The patient mentioned the rash lasted for 3 weeks and then cleared up. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up.
Started feeling dizzy. Dizziness lasted about 3 weeks. Was able to still walk and complete activities of daily living with dizziness.
My right arm was so very painful that I couldn't even move it for 4 wks. Couldn't lift it to comb my hair, couldn't sleep for over a week because of the pain. Had a fever for almost a week from it. Took 650 mg of aspirin every 4 hrs. and it didn't take pain away! From Oct 25th 2015 to after Nov. 25th before I could lift my arm. Still had pain in the arm where shot was given over 2 months later.
Right red in streak across though approx 1/3" x 2" starting at point of injection with knot.
Pt stated she had pain the day of shot and redness and swollenness. Monday 11/5/18 she had a visit with MD. He stated cellulitis - prescribed - AUGMENTIN.
12/28 @ 0745 - Moderna Shot  1800 - Shot site sore, tired/exhausted  1900 - Chills and achy  2107 - Achy, cold, 99.4 fever; took cold and flu medicine to combat s&s  12/29 @ 0207 - 100.3, achy, sweaty  12/29 @ 0630 - 100.2, achy, sweaty  12/29 @ 0900 - 99.5, joint pain, achy, sweaty  12/29 @ 11:50 - 99.0, achy   12/29 to Present - shot site tender, hot to touch, red. Palpable area slightly larger than golf ball.
PATIENT DEVELOPED RED WELT AT INJECTION SITE THAT LATER WAS DIAGNOSED AT AN URGENT CARE FACILITY.   PATIENT WAS GIVEN AN ANTIBIOTIC KEFLEX
The day after I received my booster in the morning I started having racing heart palpitations that came and went throughout the day. It lasted one day.  I was 28 weeks pregnant at the time of the booster shot. I am now 30 weeks pregnant and baby is healthy and active.  I also experienced this after my second dose in the same way. I was not pregnant during the second vaccine but was 2 months post miscarriage.  When I became pregnant after receiving the second dose I also had a flare up of heart palpitations. They went away following one acupuncture session.  After the booster shot the palpitations went away after a day on their own. My baby is due February 27, 2022
low T-Tylenol, vomiting - 3 days - gave Pedialyte, 3rd day-some diarrhea then resolved
Pt received both doses of the Pfizer COVID-19 vaccine, on 2/18/2021 and 3/10/2021.  On 7/12/2021, pt presented to our ED for "feeling crumy" with a decline in ADLs.  Pt tested positive for COVID 19 via PCR.  Chest Xray positive for pneumonia, suspected UTI also contributing.  Pt admitted to inpatient due to weakness and suspected underlying infection.
This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a adolescent female patient who received BEXSERO for prophylaxis. Previously administered products included BEXSERO with an associated reaction of injection site pain (For tolerance of 1st dose refer case US2018GSK230218). On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain. Rechallenge with BEXSERO was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: The age of vaccination was not reported. The patient experienced injection site pain which persisted for approximately one week. This case has been linked to the cases US2018GSK164861, US2018GSK164860 and US2018GSK091195.
Reacted with tachycardia to first Moderna shot; This spontaneous case was reported by a patient and describes the occurrence of TACHYCARDIA (Reacted with tachycardia to first Moderna shot) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Altitude sickness (suffers from symptoms of altitude sickness with changes in elevation less than 1850).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TACHYCARDIA (Reacted with tachycardia to first Moderna shot). At the time of the report, TACHYCARDIA (Reacted with tachycardia to first Moderna shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient's race was reported as (withheld).  No concomitant medications were reported.  The patient developed tachycardia within 5 minutes of taking the first shot of Moderna vaccine.  No treatment information was reported.   This case was linked to MOD-2022-598342 (Patient Link).
later that day, i felf flu like symptoms like body ache, very tired, chills, low grade fever (99.7), abd x1 episode of diarrhea in the morning. took tylenol and low grade fever resolved but still felt very tired.
Arm soreness; Terrible headache; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old unspecified gender patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 13Mar2021 at 15:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, fibromyalgia, chronic fatigue, chronic pain, migraine, depression, anxiety, insomnia, high cholesterol, obesity, post-traumatic stress disorder. The patient has known allergy to sulfa, seafood, bee stings, corn, pollen, dust and ragweed. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrocodone (MANUFACTURER UNKNOWN), cyclobenzaprine (MANUFACTURER UNKNOWN), duloxetine hydrochloride (CYMBALTA), levocetirizine dihydrochloride (XYZAL) and ambroxol hydrochloride (AMB); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Mar2021 the next morning woke up at 07:00, the patient experienced arm soreness and terrible headache. The patient tried many methods to relieve the pain and nothing helped. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm soreness and terrible headache was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient seen in the ED on 11/27/22 with shortness of breath. Patient reports chronic intermittent shortness of breath with associated wheezing, however over the last 3 days has had increased shortness of breath, wheezing, and chest pain during coughing. Also reports intermittent fever, chills, and headache.  In the ED, patient was started on BiPAP. COVID PCR test done in the ED on 11/27 resulted positive. Patient admitted 11/27/22 - 11/30/22 for acute hypercapnic respiratory failure, COVID-19 pneumonia, acute asthma exacerbation, and asthma-COPD overlap syndrome.
patient is experiencing muscle aches and joint stiffness since receiving the vaccine on 11/05.  patient also experienced a pinched nerve about a week after the flu vaccine and didn't know if it was because of the vaccine.
Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 81 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 22-JUL-2013, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, unit, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for the event. The outcome of the event was not reported.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Doctor ordered Tdap vaccine. Pt was given DTaP vaccine in error. MD was informed. Parent was informed. No known adverse reactions. (No need to repeat a Tdap vaccine per MMRW).
Pt recvd vax in 1990 & in 1992; a rubeola IgG was neg; No further details were provided;
pt recv vax & that same day devel h/a, aches, legs became weak; took 2 APAP, chills; Today got out of bed-hard to stand on legs, along w/soreness;
Seen 9/15/06 developed 9/13/06 mild papulovesicular lesions on perineum, fingers, feet, some near perineum are crusted (+) itching, no fever.  Aveeno bath and ZYRTEC 1/2 teaspoon by mouth daily.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm from the first two doses.) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History information was reported. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced PAIN IN EXTREMITY (sore arm from the first two doses.). At the time of the report, PAIN IN EXTREMITY (sore arm from the first two doses.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. This case was linked to MOD-2021-400075, MOD-2021-400094 (Patient Link).
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: had redness and itching on right arm. also watery eyes and was sweating-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: She confirmed she usually has such a reaction of itching and redness after vaccination and after the 2 doses of moderna. she was given 20ml benadryl and symptoms subsided in about 5 minutes. she was observed for another 15 minutes and she felt fine and said she was okay to leave. her husband was with her.