chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had eaten at a Mexican Restaraunt at 5:00 PM after having received the MMR vaccine at 2:20 PM.  She experienced a feeling of having needles poking at her throat with some difficulty swallowing at 6:30 PM.  She called the Health Nurse line at 7:30 pm and was encouraged to take Diphenhydramine and be seen at an Urgent Care.  She came to the Health Clinic today (4/25/2012) at 2:20 PM after finishing work, but reports having taken Diphenhydramine 25 mg at 8:00 PM last night.  She was treated with Prednisone for safety.  This patient had an appointment for a different matter today and mentioned while here "by the way, after I got my MMR shot yesterday, I started having throat pain like the start of a sore throat later on last evening.  It felt like needles in my throat & I had a little trouble swallowing".  The next box labeled event outcomes is marked as none of the above because the patient would not have come in for the throat symptoms had it not been for an already scheduled appointment.
Patient is a 71 y.o. male patient of DPM with history of HFrEF, pulm hypertension, A-fib on Eliquis, type 2 diabetes, hypothyroidism, GERD, peripheral vascular disease, status post amputation to the right fifth and fifth toe presented to Hospital with septic shock.   Septic shock, POA COVID-19 pneumonia Acute hypoxemic respiratory failure Covid-19 Virus Infection Date of onset of symptoms: 8/30 Symptoms present on admission: Hypoxia Date of covid positive test: 8/31 Vaccination status: vaccinated Imaging: CXR with severe alveolar and interstitial opacities seen bilaterally concerning for severe pulmonary edema.  Some underlying inflammatory infectious pneumonitis would be difficult to exclude.  Cardiomegaly with evidence of CABG.  Right atria, right ventricle and coronary sinus pacing leads redemonstrated.  External cardiac pads overlying the left subhilar region.  No acute osseous abnormality Oxygen requirements on admission: BiPAP Current oxygen requirements: Ventilated Medical therapy: steroids Consultants following: Critical care, infectious disease Anticipated special isolation end date: TBD Critical care managing ventilator and pronating Off NMB  Weaning sedation per critical care Family refusing remdesivir      Status post amputation to right fourth and fifth toe Hold Augmentin Zosyn, changed to  meropenem and vanc as per ID   Elevated troponin Secondary to sepsis, inflammatory mediated Continue heparin for 48 hrs from peak of troponin Appreciated cardiology input     A-fib Continue mexiletine Currently on heparin ggt, hold metoprolol   HFrEF Ejection fraction 36% in 3/2023 Hold medications at this time due to severe sepsis and hypotension AKI on chronic kidney disease Monitor urine output and renal function     Type 2 diabetes uncontrolled Last A1c 6.8 Hold insulin until tube feeds restarted     Hypothyroidism, primary Continue levothyroxine Last TSH 5.24 in November/2022     Neuropathy Continue gabapentin obesity   Obesity Outpatient management following resolution of acute illness    on 9/13 AM Pt experiencing worsening hypotension. Levo required to be increased throughout the night. Also on vasopressin. Remains proned.    After meeting with family , plans to transition to comfort care with a compassionate extubation per the family's wishes.      Condition at Discharge: Expired
started feeling really cold; shivering; fever/had 37; a bit tired right after/Felt beyond exhausted; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: er8729), via an unspecified route of administration in left arm on 05Apr2021 around 15:00 (at the age of 48-year-old) at single dose for COVID-19 immunisation. Medical history included low blood pressure (really low) and mild heart murmur. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications included multivits, herbal supp t-48Hr and muscle relax t-24h. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: en6208) via an unspecified route of administration on 15Mar2021 around 15:00 (at the age of 48-year-old) at single dose for COVID-19 immunisation. Patient received both shots around 15:00, for second shot on 05Apr2021, patient was a bit tired right after, physically tired though mentally ok. On 06Apr2021 at 11:30, patient started feeling really cold, shivering, and felt beyond exhausted. Patient had 37. Patient was still not taking any supplements, vitamins or paracetamol (TYLENOL), she just slept for 90 minutes and now the fever was gone. Though she still felt exhausted. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as result of event fever included slept. It was unknown whether therapeutic measures were taken as a result of the other events. The clinical outcome of the event fever was recovered on 06Apr2021; outcome of events feeling cold and shivering was recovering and feeling exhausted was not recovered.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: patient age and age at vaccination updated to 48, event Exhaustion was removed.
CROWN PUT ON TOOTH; RASH LIKE HIVES ON BACK; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number: 1160299 expiry: UNKNOWN) .4 ml, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis. No concomitant medications were reported. On an unspecified date, the patient experienced crown put on tooth, and rash like hives on back. The action taken with covid-19 vaccine ad26.cov2.s, and adalimumab was not applicable. The outcome of the rash like hives on back and crown put on tooth was not reported. This report was non-serious.
This spontaneous report as received from a physician refers to a currently 73 years old female patient with allergy to CIPRO and penicillin, advanced osteoarthritis, mitral valve prolapse. Grave's disease and hypothyroidism secondary to Grave's disease. In 2012, "sometime last year", the patient was vaccinated with a dose of ZOSTAVAX (route and lot # not reported). Concomitant therapies included SYNTHROID. The physician reported that on an unknown date, she experienced negative titers: IgM 0.90 for varicella antibody. The patient did not receive treatment for the adverse event and did not seek medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
I felt very tired after receiving the vaccine for a day.  I tested positive for COVID-19 on 12/30/2022. I had sinus pressure and a tickle. I contacted my doctor, and they did not recommend taking Paxlovid. I took Advil for one day to help me with my symptoms. It took thirteen days to test negative for COVID-19, but I finally tested negative on 01/13/2023.
5 hours after vaccination: body aches and light headache, left arm soreness, cramps and numbness for 2 days. Feeling well and resolved except arm numbness.
Pounding Headache 6 out of 7 days since 2nd vaccine administered that is constant and almost debilitating
Arm was sore and swelled. It was examined by a doctor and told it was infected.
mom claims on last visit of 20DEC95 pt had vax on 17OCT95 & was well till that evening when notified shaking spell x 1 that lasted only 5seconds;no high fever;mom did not report immed;
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 07-NOV-2017, the patient was vaccinated with an expired dose of M-M-R II (albumin status was not provided) lot # L043704 with an expiration date 04-NOV-2017 for prophylaxis (route of administration was not reported) which was reconstituted with sterile diluent (strength, dose, frequency, lot# and expiration date were not reported). There was no side effects reported.
pt recv vax & same noc @ 10PM took Celexa & @ 2AM 6/10/99 pt was unable to move or speak;also noticed had hives;event was considered life threatening by reporter;
Did not feel right; This is a spontaneous case from a contactable consumer (on behalf of a patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, at an unknown anatomical location, on an unknown date and time at a single dose for covid-19 immunisation (age at the vaccination was unknown). Medical history and concomitant medication were not reported. On an unknown date, the patient did not feel right and is currently in the hospital awaiting MRI results. The treatment received for the adverse event was unknown. This case was reported as serious. The outcome of the event was unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
This spontaneous report as received from a nurse practitioner via a company representative refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was given an additional (the third one) dose of M-M-R II (0.5 ml; route, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Bad headache Dehydration Significant fatigue (I slept 17 hours) Short term memory loss
Patient received ZOSTAVAX 7/14/17. She reported having muscle pain starting 7/14 evening. She also had nausea and vomiting twice 7/15. She did had 1 drink 7/15. Her pain has eased after taking a pain pill.
there is still a large, light purplish discolored patch at injection site; there is still a large, light purplish discolored patch at injection site; raised temperature; Pain radiated into underarm and left side of chest; developed 6" by 4" painful, raised, hot, red welt at site of vaccine; developed 6" by 4" painful, raised, hot, red welt at site of vaccine; developed 6" by 4" painful, raised, hot, red welt at site of vaccine; developed 6" by 4" painful, raised, hot, red welt at site of vaccine; developed 6" by 4" painful, raised, hot, red welt at site of vaccine; vaccine with 2" x 2" large hard lump in center; Pain radiated into underarm and left side of chest; This is a spontaneous report from a contactable consumer. A 65-year-old non pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported), dose 3 via an unspecified route of administration, administered in the left arm on 25Oct2021 13:30 (at the age of 65 years old) as dose 3 (booster), single for COVID-19 immunisation at pharmacy or drug store. The patient was not pregnant at the time of vaccination. Medical history included gallstones from an unknown date and unknown if ongoing. Patient had no known allergies. There were no concomitant medications. The patient previously received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in the left arm on 26Mar2021 11:00 (at the age of 65 years old) as dose 1, single and bnt162b2 (BNT162B2, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration, administered in the left arm on 23Apr2021 11:00 (at the age of 65 years old) as dose 2, single for COVID-19 immunisation. No other vaccines were given within 4 weeks. No other medications were given within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 26Oct2021 08:00, the patient experienced developed 6 by 4 painful, raised, hot, red welt at site of vaccine, vaccine with 2" x 2" large hard lump in centre, pain radiated into underarm and left side of chest. On Nov2021, patient had there is still a large, light purplish discoloured patch at injection site, there is still a large, light purplish discoloured patch at injection site, raised temperature. The patient underwent lab tests and procedures which included body temperature resulted slightly raised temperature on 26Oct2021. No treatment was received. All the events resulted in physician room visit. The clinical outcome of the events was reported as not recovered.  The lot number for (BNT162B2), was not provided and will be requested during follow-up.
Child was given injectable H1N1 in addition to intranasal H1N1 vaccine and other scheduled vaccinations
Top of arm red all the way around, swollen, hot to touch, painful. Started day after injection. (has lasted 3 days with no improvement so far)
Initially headache, fever, chills, bodyaches, vomiting, and diarrhea with soreness at injection site.  This started within 13 hours after receiving my second dose and these symptoms lasted approximately 72 hours.  I had increasing redness and pain at the injection site on day 3 so I went to the Clinic to rule out cellulitis.  I was told that it was an adverse reaction and they labeled it as a rash with bruising that continued to go down my arm for approximately 6 days in total.  The rash seems to be resolving now and all other symptoms have subsided.
Felt warm, "shaking" all over x 5 min & turned blue; t102 when seen in ER;
Tenderness in left upper deltoid area, site is 12.5 cm x 10.5 cm with erythema and swelling, warm to touch, raised, patient febrile.
Brought to ED due to altered mental status.  EMS called d/t patient found to be confused.  EMS found patient to be hypoglycemic and given half a bag of D10 then an amp of D50.  Patient was just recently discharged after being evaluated for bilateral lower extremity weakness/edema.  Up arrival to ED Upon arrival to the ER labs showed WBC 2.6, lactic acid 8.9, H&H 9.4/27.9, platelet 105, Sodium 129, K 5.9, creatinine 1.47, glucose 209, AST 164, ALT 150, creatinine kinase 1637, troponin 0.171, UA negative for UTI, and COVID 19+. Chest x-ray showed bilateral patchy infiltrates consistent with pneumonia. Vitals show HR 124, BP 79/49, temp 95.2 rectal, and currently 98% on nonrebreather mask. Patient given IVF bolus, IV steroids, Azithromycin, Narcan, started on Levophed gtt, and placed on bair hugger. Was admitted to the ICU for further workup/management.  She was intubated and placed on IV antibiotics, she required pressor support, and was increased up to 3 pressor for blood pressor support.  Family opted for withdrawal of care.
Uncontrollable shaking in entire body from 1:30 am until 3:30 am after receiving my vaccine at 10:45 am the previous day. I had these same symptoms when I received the shingles shot. I had these same symptoms after the c-section birth of my two daughters.
egg shaped lump in muscle; Noticed slightly tender 3"x1.5" egg shaped lump in muscle under left armpit this morning while showering.; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Dec2021 10:15 (Lot number: FF2589) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "blood pressure" (unspecified if ongoing), notes: Have been under treatment for blood pressure. Concomitant medication(s) included: FENOFIBRAT; EDARBYCLOR; ROSUVASTATIN CALCIUM; EZETIMIBA; ASPRIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM, Route of Administration: Intramuscular), administration date: 15Mar2021, when the patient was 59 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: El3247, Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM, Route of Administration: Intramuscular), administration date: 22Feb2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021 10:15, outcome "unknown", described as "booster"; MASS (non-serious) with onset 15Dec2021, outcome "not recovered", described as "egg shaped lump in muscle"; TENDERNESS (non-serious) with onset 15Dec2021, outcome "not recovered", described as "Noticed slightly tender 3"x1.5" egg shaped lump in muscle under left armpit this morning while showering.". Therapeutic measures were not taken as a result of mass, tenderness.  Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was patient was diagnosed with covid, Since the vaccination, patient has been tested for covid.
Blood squirting out of the injection site immediately after the needle was removed from the deltoid. I applied pressure to the site and bleeding stopped. Patient was observed in the waiting area for 30 minutes. She said that she felt sore and throbbing at the injection site. I advised her to apply ice and take Tylenol when she gets home.
TRANSIENT ISCHAEMIC ATTACK; This spontaneous report received from a consumer concerned a 99 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: transient ischemic attacks (TIA's) but it was less often, it was perhaps once a year and concurrent conditions included: cancer that has metastasized, has 24 hours around the clock care and frail. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. It was reported that, the patient had TIA's occurred in JUN-2021, AUG-2021, SEP-2021 and NOV-2021. She was uncertain if it could be related to the vaccine since she was 99 turning 100. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of transient ischaemic attack was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211116517-Covid-19 vaccine ad26.cov2.s- Transient ischemic attack. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Mar2021 at 09:45 as dose 1, single (Batch/Lot number: unknown), in left arm and on 17Apr2021 at 09:45 as dose 2, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Nov2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 06May2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "VFib" (unspecified if ongoing); "SCA caused by vasospasm" (unspecified if ongoing); "vasospasm" (unspecified if ongoing). Concomitant medication(s) included: SUDAFED, start date: 25May2022, stop date: 06Jun2022; NORVASC, start date: 03Dec2019. Past drug history included: Known allergies: quinolones, reaction(s): "Known allergies: Quinolones". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical Course: Antiviral details: Product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 07Jun2022, Treatment stop date: 12Jun2022, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt recv vax on 7/31/93; on 4/9/99 pt exp chicken pox w/ scabbing, fever, body aches of arms, shoulders, hips & head
Initial pain of upper arm (shoulder) - progressed to swelling of (R) shoulder and bruise at site of injection. Cold applications used with lotions. Medical office visit - refer to orthopedist - who took x-rays - injection of steroid - no help - pain continuous - radiating to hand.