chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9 days post booster, developed uticaria, dermatographia, extreme itchy if scalp. Any applied pressure or tight clothing can cause symptoms to flare.  I am taking Zyrtec 10 mg QID, Singulair 10 mg QHS. Took 5 day Prednisone tape  with some relief.  Have been off steroid for 5 days and back to where I started.
Herpes zoster; Information has been received from a lawyer regarding a case in litigation, concerning a currently 79-year-old patient (pt) of unknown gender. The pt's medical history, concurrent conditions, and concomitant medications were not reported.   On or about 10-JUN-2015, the pt was administered zoster vaccine live (ZOSTAVAX) by a pharmacist, for the long-term prevention of shingles and herpes zoster-related conditions (dose, route of administration, anatomical location, lot number and expiration date were not reported).   On an unspecified date (reported as "subsequently"), the pt was treated by a health care provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX) vaccine: herpes zoster. The pt claimed damages as a result of injury to themselves, loss of consortium, loss of services and economic losses. The outcome of the event was unknown. The reporter considered herpes zoster to be related to the suspect vaccine.
A raised painful red papule surrounded by inflamed purple tissue on the dorsal surface of the tongue anteriorly along with greatly diminished taste; a raised painful red papule surrounded by inflamed purple tissue on the dorsal surface of the tongue anteriorly along with greatly diminished taste; a raised painful red papule surrounded by inflamed purple tissue on the dorsal surface of the tongue anteriorly along with greatly diminished taste; a raised painful red papule surrounded by inflamed purple tissue on the dorsal surface of the tongue anteriorly along with greatly diminished taste; This is a spontaneous report from a contactable physician. A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9265), intramuscularly, administered in Arm Right on 05Feb2021 at 12:00 (at the age of 76-year-old at vaccination) as a Dose 2, single for COVID-19 immunization. The patient was non-pregnant during vaccination. The patient' medical history included ablation for atrial fibrillation (AFib) from Mar2020, Hypertension, Hypothyroidism, Lymphoedema, Anaphylactic reactions to mango, pistachio, shellfish, glossitis and Glossitis to Sulfa drugs and the patient was inserted with Dual-chamber pacemaker May2021 for 3rd degree heart block. The patient' concomitant medication(s) included cyanocobalamin [B12], bioflavonoids NOS, lecithin, quercetin, ubidecarenone (CO-Q-10 PLUS), colecalciferol (D3), diltiazem, disopyramide, azilsartan kamedoxomil (EDARBI), furosemide (LASIX), levothyroxine sodium (SYNTHROID), hydrochlorothiazide, triamterene (TRIAMTERENE/HCTZ), rivaroxaban (XARELTO) within two weeks covid-19 vaccination. The patient's past medications included levofloxacin (LOVENOX) and Arixtra. The patient had bleeding and swelling because of Lovenox and Arixtra use and allergic to both the drugs. Vaccination facility type was reported as Clinic. The patient was not infected with Covid prior vaccination. The patient was not on any other vaccine in four weeks prior to Covid-19 vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3248) via unspecified route, administered in Arm Right on 11Jan2021 at 15:30 (at the age of 76-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. On 07Feb2021 at 08:30 PM, the patient had a raised painful red papule surrounded by inflamed purple tissue on the dorsal surface of the tongue anteriorly along with greatly diminished taste. Symptoms started about 55-60 hours after 2nd Covid-19 vaccine injection. Both papule and diminished taste are present and unchanged 72 hours after vaccination. The AE resulted the patient to visit Doctor or other healthcare professional office/clinic visit. The patient was not covid tested post vaccination. The patient had not received any treatment medications for the resulted events. The outcome of the events was not recovered. Follow-up attempts completed. No further information expected.
Patient was scheduled to receive MMR vaccine.  HPV was accidentally ordered and administered to patient.   There have been no complaints, side effects reported so far.
Pain at the injection site & tiredness; Pain at the injection site & tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Lot number: GH9694) at the age of 34 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: VACCINATION SITE PAIN (non-serious), FATIGUE (non-serious) all with onset 22Sep2022, outcome "recovering" and all described as "Pain at the injection site & tiredness". Therapeutic measures were not taken as a result of vaccination site pain, fatigue. Additional Information: It was also reported as Dose 1, administration time 06:15PM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
pt recv vax 1JUN95 & 1MAR96 lab eval revealed the pt had failed to seroconvert;no further details were provided;
After receiving the 2nd dose for a short period of time, I start having rash and bumps and itching all over my body.  It happens almost every day or every other day.  If it happens at night , it?s difficult to breathe.
Pt returned to clinic 3 days after receiving ZOSTAVAX. c/o redness, swelling, & mild itching at injection site, site erythematous & mildly warm & tender to the touch, approx 3-4 cm diameter. No treatment.
Patient went to observation area, after receiving third dose of Pfizer vaccine and reports feeling tachycardia. Head nurse is notified at 1:00pm and called Dr. who indicated to reposition patient on Trendelenburg position and to keep patient in observation for 30 minutes and then reevaluated. At 1:48pm patient is reevaluated and head nurse notified Dr. and discharged patient.
Exhaustion for 48 hours. Lightheadedness/dizziness from date of 2nd dose to present (16 days).
I?m having terrible nauseous. I am throwing up anything I eat. Super hot then cold and then I get the chills.
Pt received vaccine in the morning and returned after completing her shift to report chest tightness. She was sent to ED for evaluation  She was  worked up to rule vaccine adverse event  She was not treated with medication discharged home wt 1700 with diagnosis of costochondritis
Clinical Summary Patient is a 88 y.o. male with a history of HFpEF, HTN  who presented to RMH 11/20/2022 after fall and fever. Labs on admission  BNP 5181, COVID +. Imaging on admission including CXR with mild cardiomegaly. CT head and C spine non acute. ECG atrial fib with RVR.  Family requested to discharge back to assisted living with hospice.  Patient was evaluated by nursing supervisor from AL and recommended rehab prior to going back to AL.      1. Sepsis: Secondary to COVID infection. Treated with Zosyn, end date 11/24/22.  Bcx on 11/21/2022-No growth, UC-negative, and MRSA-negative.  Resolved 2. Atrial Fibrillation with RVR: noted on admission,  possibly incited in the setting of above.  Treated with Cardizem gtt. stopped due to lack of IV access, continued po Cardizem.   Discussed with family, who refused cardioversion.  Started on amiodarone, increased to twice daily on 11/26/22.  Taper to 200 mg daily starting from 12/3/22.  3. Hypernatremia: Most likely from poor oral intake secondary to confusion. Improved with supportive care. 4. COVID Infection: incidently noted on admission with hypoxia as below. Treated with decadron in the ED continued on admission for 3 days, end date 11/24/22. Continued scheduled and PRN SABA. Special isolation through 11/30/22 per Health protocol.   5. Acute Hypoxic Respiratory Failure: suspect multifactorial in the setting of above requiring 15L non rebreather in ED but weaned to 2L NC on admission.  Improved to room air on 11/22/22. 6. Abnormal UA: UA with many bacteria, trace esterase, 10 WBC. Empiric antibiotics as above. UC not significant.  7. Lactic Acidosis: LA 4.4 on admission suspect in the setting of above. Resolved with supportive care   8. Concern for Dysphagia: noted on admission per ED staff. S/P MBS on 11/21/22 reported risk for aspiration. Started on puréed diet after repeat MBS on 11/23/22 9. Fall: Unclear story, patient reportedly found on ground. Suspect related to above as well as dementia. Imaging on admission including CXR with mild cardiomegaly. CT head and C spine non acute. PT/OT followed 10. HFpEF: per history. Has had dual lead ICD placed. TTE 9/19/22 with EF 55-60% with mild diastolic dysfunction noted. Labs on admission with BNP 5181 with prior noted to be around 6.5k. Patient euvolemic during admission. Held home Lasix while receiving gentile IVF with sepsis/COVID as above.  Resumed home diuretic on 11/22/22 11. CAD: per history s/p stent placement to LAD in 2017. Does not appear to be on AP per AL documentation. Continued home statin.  12. Dementia/Anxiety/Depression: per history. Continued home namenda, Aricept, and SSRI.  13. Code status/GOC: DNRCC
J&J Dose 8/4/21 (203A21A) COVID Positive 1/11/22  1/11/22: Patient is a 50-year-old male with no significant past medical history.  He denies taking any medications at home.  He denies any history of surgeries.  He started having it a tickle in his throat and cough approximately 1 week ago.  His symptoms have progressed.  He tested himself with an at home COVID test and was found to be positive. He has been quarantine a at home and checking his pulse ox regularly.  This morning, he began feeling more short of breath.  He was satting in the upper 70s on room air at home.  He therefore presented emergency department where he was satting 84% on room air.  His O2 sats improved with administration of O2 at 2 L via nasal cannula.  Other symptoms include fevers, chills, sweats, muscle aches, generalized weakness, and fatigue.  He otherwise denies chest pain or pain in his lower extremities.  He was vaccinated with a Johnson and Johnson vaccine.  He did not receive monoclonal antibodies as an outpatient.  He denies any alcohol use, tobacco use, or illicit drug use.  He denies any environmental exposures that may have predisposed him to lung disease.  Family history is noncontributory.  1/15/22: Patient is a 50-year-old male who presented on 01/11/2022 with chief complaint of shortness of breath.  He had previously been struggling with 1 week of cough at home.  He did do a an at home COVID test and was found to be positive.  He was checking his oxygen saturation at home and was noted to be in the upper 70s on room air.  He therefore presented to the emergency department.  He was placed on supplemental oxygen and admitted to the hospital. He was monitored supplemental oxygen as needed as well as standard COVID-19 cares.  He did receive Actemra due to elevated CRP.  He declined remdesivir.  He completed a course of antibiotics with Levaquin.  On 01/15/2022, the patient's oxygen requirements were significantly decreased. He was requiring O2 at 2 L via nasal cannula with exertion. He did not require any O2 at rest.  He was therefore discharged home on oxygen.  He was instructed to follow-up with his primary care provider as an outpatient.
metallic taste in mouth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSGEUSIA (metallic taste in mouth) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and FAMOTIDINE for an unknown indication.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced DYSGEUSIA (metallic taste in mouth). At the time of the report, DYSGEUSIA (metallic taste in mouth) outcome was unknown.            Treatment : Mouth rinse from dentist
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 3/18/2021 and 4/14/2021. Patient presented on 8/14/21 via EMS with shortness of breath and AMS. Per EMS, patient was found unresponsive and short of breath by family member for an unknown duration. EMS was called, with SpO2 of approximately 50%. EMS reports administering 20L O2 by NC and nonrebreather which improved SpO2 to 94% with improved mental status. Per chart review patient symptoms began around 8/5/21 and she tested positive 8/11/21. On admission, patient knew name, responded to pain, and followed commands- otherwise, was unable to communicate. MRI revealed Bilateral globus pallidi infarcts probably related to hypoxic ischemic injury, possibly due to hypoxia from COVID pneumonia. Based on irreversible state of mental status, patient was recommended to hospice team. Patient was transferred to inpatient hospice care on 8/19/21. Patient expired on 8/20/21.
Patient fainted and believes he had a brief seizure.  He was unconscious for about 20 seconds.  He woke with no apparent lingering issues.
Swelling, warm to touch, inflamed (L) arm. Painful. Started the night the vaccine was given.
puffy left side; eyes hurting; sinus headaches; eyelids swollen and hurting behind her eyes; This spontaneous case was reported by a consumer and describes the occurrence of PERIORBITAL SWELLING (puffy left side), EYE PAIN (eyes hurting), SINUS HEADACHE (sinus headaches) and SWELLING OF EYELID (eyelids swollen and hurting behind her eyes) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIORBITAL SWELLING (puffy left side), EYE PAIN (eyes hurting), SINUS HEADACHE (sinus headaches) and SWELLING OF EYELID (eyelids swollen and hurting behind her eyes). At the time of the report, PERIORBITAL SWELLING (puffy left side), EYE PAIN (eyes hurting), SINUS HEADACHE (sinus headaches) and SWELLING OF EYELID (eyelids swollen and hurting behind her eyes) outcome was unknown.            No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Patient reported hearing loss. Patient had significant decline of hearing ability between 4/21/22 and 11/28/22. He started feeling his hearing loss around June 2022. The condition has persisted with no improvement.
brain fog; it triggered my brain to dissociate.DP/DR disorder; DP/DR disorder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 02Jun2021 (Batch/Lot number: unknown) at the age of 25 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Hydrocodone, reaction(s): "allergy". The following information was reported: FEELING ABNORMAL (non-serious), outcome "not recovered", described as "brain fog"; DISSOCIATION (non-serious), outcome "not recovered", described as "it triggered my brain to dissociate.DP/DR disorder"; DEPERSONALISATION/DEREALISATION DISORDER (non-serious), outcome "not recovered", described as "DP/DR disorder". Therapeutic measures were not taken as a result of feeling abnormal, dissociation, depersonalisation/derealisation disorder.  Additional information: The patient did not receive other vaccine in four weeks. The patient did not have covid prior vaccination. The patient did not get covid tested post vaccination. The patient had really bad 'Vax-fog' or 'brain fog' as people are calling it (which was fine it's a normal side effect), but it triggered her brain to dissociate. DP/DR disorder (Depersonalization/derealization disorder). The patient got the first dose on 02Jun2021, never got the second dose because it was so bad. It's been over 3 months and it hasn't gone away. The patient had never had DP/DR in her life so it was 100% from the brain fog. The patient don't know where the vax-fog ended and where the dissociation started.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : 202101198459 Same drug/reporter/patient, different dose
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. Concurrent condition, medical history and concomitant medications were not provided. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck) Lot # J012378, expiry 03-OCT-2015, (dose, frequency, route of administration and indication were not provided). No adverse experiences reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
consistent shortness of breath, chest pain and nasal congestion starting 5 days after his 2nd injection
sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 74-year-old patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included FLU SHOT (INFLUENZA VACCINE) NO FURTHER INFORMATION AVAILABLE. (FLU SHOT (INFLUENZA VACCINE) NO FURTHER INFORMATION AVAILABLE) for prophylaxis.   On an unknown date, the patient received RSV vaccine and FLU SHOT (INFLUENZA VACCINE) NO FURTHER INFORMATION AVAILABLE. On an unknown date, several days after receiving RSV vaccine and an unknown time after receiving FLU SHOT (INFLUENZA VACCINE) NO FURTHER INFORMATION AVAILABLE, the patient experienced pain in arm (Verbatim: sore arm).  The outcome of the pain in arm was resolved.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 The case was received from the patient via interactive digital media. The patient received flu and RSV shot and for couple of days had soreness in arm.
pt became faint, nauseous & lethargic; sx persisted throughout noc; following morning, pt still nauseous but other sx resolved;
Patient was given a 12+ Bivalent Booster of Pfizer when it should have been Peds Bivalent Pfizer (5-11yrs). Patients parents were called and notified of mistake and cleared that the only symptom he had was tiredness.
29DEC98 SOB, loose productive cough, elevated T;30DEC98 same, chest x-ray;5JAN99 expired @ hosp;no autopsy;
pt came in 08/10/2021 stating he has had, inner tricep inflammation/ warmth. Under arm pain. Also for 3 days following immunization he had limited mobility, and could not move his arm
I had a huge almost quarter-sized allergic reaction on the middle of my chest.; This is a spontaneous report from a contactable consumer (Patient). A 20-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0161, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 16Apr2021 (age at vaccination: 20years-old) as dose 1, single for COVID-19 immunisation. Medical history included polycystic ovaries, asthma and food allergy to Peanuts and nuts. Concomitant medications included sertraline; spironolactone; drospirenone, ethinylestradiol (LORYNA) and alprazolam. Patient was not pregnant at the time of vaccination. The patient was not tested positive for covid 19 prior to vaccination and had been tested post vaccination. On 16Apr2021, the patient experienced "I had a huge almost quarter-sized allergic reaction on the middle of my chest." It was reported that after receiving the shot, less than an hour later, she had a huge almost quarter-sized allergic reaction on the middle of her chest. It went away later in the day, but it was irritated and took almost the entire day to disappear. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 16Apr2021, 19Apr2021, 21Apr2021 and 24Apr2021 Other. No treatment received for the event. This case was reported as non-serious. The outcome of the event was recovered on 17Apr2021.  No follow-up attempts are needed. No further information is expected
fatigue, body ache, fever (101 F); pain/sensitivity in left arm pit, left shoulder
Right leg swollen and reddened down into knee area since the shot - mother states.  He initially came down with a fever of 103 degrees at 1AM 12/14/2002, then on 12/15/2002 @7:30 PM the swelling in the leg was noted.  I was notified on Monday 12/16/2002 at 4:45 PM - I referred the patient to their PMD and mother made an appt. for 12/17/2002 at 4PM
Pt recieved tetanus in left arm on 4/6/10. Pt stated that the next day injection site was red and warm just around the site and has now spread down to the elbow.
Upon discussing pt's due vaccines today she states she is only here for her MCV4 booster and becomes tearful. She tells me she does not like needles. Her respirations begin to increase. MCV4 vaccine quickly drawn up and given to (R) deltoid site. Ice applied before and after administration. Within a minute of administering vaccine pt begins to cry heavily, hyperventilate and perspire. She is lying down on the exam table. She then states she is feeling nauseas and feels like she needs to vomit. After a couple of minutes she states this does pass. Her complexion is pale. Pt c/o both arms going numb. She denies any pain at the injection site. Encouraged slow, deep breaths. Her wrists begin to flex and tense up. She states she is unable to move her hands or wrists. When this worker grabs her hands she is able to lightly grasp my hands. When talking she tells me her upper lip feels tingly and numb and this scares her. She begins to hyperventilate again. Encouraged slow, deep breaths. Applied ice to nape of neck. BP checked at 115/60 and P 72. When encouraged pt go to ER, she refuses. She declines to call any family members. She states she has to drive back to get to class at noon. She states she would just like to sit here until she feels better. Pt's condition gradually improves. After 55 minutes, she states she is feeling back to "normal" except for her (L) handle occasionally trembling. Encouraged pt to have family drive her. She states she will call her Grandma before she leaves and once she gets as well. She does drink about 8 oz of water, declines any crackers. Her breathing is regular and normal. Her complexion has returned to normal. She is no longer perspiring. Encouraged pt to seek emergent care should s/s return. Pt verbalizes understanding.