chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dear Sir or Madam: Writing to you to please refer me to VAERS for possible CVST s/p dose 2 of Moderna I am a retired APRN and just reviewed your article HPI: 57 y/o female  (not obese, no hypothyroidism) H/O travel (February1-March 1 2021) with possible SARS Cov2 exposure; possible long COVID Big supporter of public health and COVID19 vaccine campaign with Moderna dose one 2/14/21 and dose 2 on 3/14/21 Mild to moderate sx after both doses Routine ophthalmology exam 4/8/21 Approximately 4/13/21 left sided facial pain, HA and swelling-self treated for blepharitis with warm compresses 4/15/21 returned to ophthalmologist: forceful lower lid compression applied and diagnosed with pre-septal cellulitis-Rxd Augmentin 875 and steroid dose pack-on return to home experienced severe projectile vomiting x2 and awakened with massive facial edema and ecchymosis-petechial hemorrhages-terrible sinus pain Went back to ophthalmology-they said I had a chalezion and  black eye-referred back to PCP for r/o temporal arteritis. ESR and CRP neg Symptoms progressed to severe headache in left temporal lobe since 4/15/21-severe nausea, changes in speech, problems with word finding photophobia, global malaise, fatigue (seems like migraine) Went to see PCP 5/6/21 and transported via ambulance to ER for severe HA; HTN; neuro deficits, r/o stroke  CBC CMP Etc wnl with CT of Head showing no stroke or aneurysm. Physician did state there may have been Micro thrombi not detected on CT. Neurology consult with plan to treat intractable HA and rxd Zofran and Sumatriptan -I do not recall anyone asking me about COVID19 vaccine timing or side effects. No PL4   As an APRN I would say I have never had migraines-now experience left sided head pain radiating from temporal lobe to jaw; this waxes and wanes; nausea; overall rapid onset of persistent speech deficit and organizational problems also noted by spouse (since dose 2 Moderna)-symptoms poorly controlled with migraine medication  I think this needs further investigation as potential vaccine side effect
I started having flushing and itching on my face twenty-four hours after my vaccination. I was having asthma attacks. I had to use my inhaler six or seven times a day. I had to go see my doctor to insure it wasn't life threatening. The doctor switched up my inhaler medication. I'm still experiencing these issues.
This spontaneous report received from a consumer concerned a 54-year-old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient had no known allergies and concurrent conditions included: diabetic and hypertension. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 22-JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-JAN-2022 (Day of vaccination) the patient felt like his head was hurting (Head pain) that continued for a few days afterwards. He figured it would just pass. On an unknown date within a week (JAN-2022) he was in the hospital and they said he had two strokes (Stroke). The doctors thought he might have had a blood clot in his heart (Cardiac thrombosis) but patient did not want to have a camera go up inside him. After three weeks (FEB-2022) he was sent to rehab where he developed an infection that required him to be sent back to the hospital. He was discharged yesterday (06-APR-2022). Number of days of hospitalization was unknown. He currently had difficulty walking by himself and had absolutely no appetite (Appetite absent). He was suffering from short term memory loss and did not seem to be able to make the right decisions. He kept saying no to everything. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from had two strokes, and lack of appetite, and the outcome of developed an infection, felt like head was hurting and blood clot in heart was not reported. This report was serious (Hospitalization Caused / Prolonged). Sender's Comments: V0. 20220414413-Covid-19 vaccine ad26.cov2.s -blood clot in his heart, developed an infection. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220414413-Covid-19 vaccine ad26.cov2.s - had two strokes. 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 (Diabetes and Hypertension). Therefore, this event(s) is considered not related.
Patient said that she had a lot of pain in her arm, can not move her arm, not feeling good.
I experienced a breakthrough case of COVID-19 with extremely runny nose, I have never had such a runny nose in my life. I had a cough, aches and pains in my joints and a fever of 103 degrees.
Patient was accidentally administered PEDIARIX (instead of PENTACEL) et Hepatitis B resulting in an extra dose of Hepatitis B given. Patient was called et informed (patient's parents). Denied any problems at this time.
Three days and continuing since onset Fevers of above 100(Tylenol sometimes controls fever) 2 every 6 hours Muscle aches Extreme fatigue  Dizziness  Shivering /hot and cold flashes Loss of strength Mental confusion  Coughing  Shallow breathing  Loss of taste and smell  Loss of appetite  Nausea  Sensitive skin(pins and needles)
Patient reports that her chronic migraine headaches worsened and were more severe after receiving each dose of the Pfizer Biontech Covid-19 vaccine.; Patient reports that her chronic migraine headaches worsened and were more severe after receiving each dose of the Pfizer Biontech Covid-19 vaccine.; Patient reports that her chronic migraine headaches worsened and were more severe after receiving each dose of the Pfizer Biontech Covid-19 vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraine headaches" (unspecified if ongoing), notes: Other medical history: Migraine headaches. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Single, Lot number- UNKNOWN), for Covid-19 immunization, reaction(s): "Condition worsened", "Headache", "Migraine"; Bnt162b2 (Dose 1, Single, Lot number- UNKNOWN), for Covid-19 immunization, reaction(s): "Condition worsened", "Headache", "Migraine". The following information was reported: MIGRAINE (non-serious), CONDITION AGGRAVATED (non-serious), HEADACHE (non-serious), outcome "recovered with sequelae" and all described as "Patient reports that her chronic migraine headaches worsened and were more severe after receiving each dose of the Pfizer Biontech Covid-19 vaccine.". The events "patient reports that her chronic migraine headaches worsened and were more severe after receiving each dose of the pfizer biontech covid-19 vaccine." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of migraine, condition aggravated, headache. Additional information: Patient was not pregnant at the time of vaccination. Patient medical history included Migraine headaches. It was unknown if patient had any known allergies. It was unknown if patient received any other vaccines in four weeks. It was unknown if patient received any other medications in two weeks. Patient reported that her chronic migraine headaches worsened and were more severe after receiving each dose of the Pfizer BioNTech Covid-19 vaccine. As a result, she is hesitant to receive a second booster/fourth dose but she also suspected there may be other factors affecting her migraine(s) and planned to discuss with her doctor. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if patient received any treatment for the adverse events. Patient did not have COVID-19 prior to vaccination. Patient was tested with COVID-19 post vaccination with results as unknown.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Skin rash on both arms, one day after the first dose by mouth typhoid vaccine, "like big blisters" using topical BENADRYL spray.
Rash appeared 8 days after injection. Patient came in 2 days after she first noticed rash.
gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021; gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) and EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) had resolved. At the time of the report, PRODUCT STORAGE ERROR (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
6 x 8 cm indurated, warm, erythematous, itchy, non tender, no fever.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 09-MAR-2016, the patient was vaccinated an improperly stored dose of VARIVAX (Merck) (Lot number L037563, expiration date (exp) 29-SEP-2016), dose, route and anatomical location were not provided. The patient's concomitant medications were not reported. The reporting nurse stated that unspecified doses in VARIVAX (Merck) immunization series were improperly stored in a temperature of -5.9 degrees C, the time frame was 15 hours and 38 minutes. There was previous temperature excursion, data was cumulative since 04-MAR-2016. The vaccines involved included VARIVAX (Merck) private stock: Lot #L035124 exp 14-SEP-2017 and VARIVAX (Merck) VFC stock: Lot 3 L037563 exp 29-SEP-2017. No adverse effects were reported, no product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
3/12 Moderna and had a stroke with a clot 3/26 Moderna 6/2 and then had seizures 6/17 while in the facility  she is in a facility COVID Vaccine ADRs  Patient name: PRIVATE Patient gender: F Patient age: 71 yr Patient DOB: 5/25/1950 Patient weight: Patient race: Patient ethnicity: Patient occupation: Patient residence type (home, congregate): Patient pregnant? If yes week of pregnancy N/A Patient prior COVID infection? N/A Patient date of COVID diagnosis? N/A Vaccine brand: Moderna Vaccine lot if known: first shot has no lot, second one 026B21A Vaccination number (1st or 2nd shot): 1st and 2nd Time/date of vaccine: 3/12 and 6/2 Administration facility: Pharmacy/inside rehab facility Allergy history: chronic diseases: obesity, HTN, type 1 diabetes ADR experienced:  had a stroke with a clot 3/26  then had seizures 6/17 while in the facility Pre-dose therapies: Post-dose therapies: anticonvulsants Onset of reaction: 2 weeks Has ADR resolved? no Duration of ADR so 9+ months  Unclear if related, many comorbitities.  Would not recommend booster.  Will report to VAERS
Five minutes after receiving vaccination patient off from his chair. he was diaphoresis & hypotensive.  RN checked VS( BP 56/30)
2nd dose was administered 1 month after the 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional information was provided as follows:  The age at vaccination was not reported. The patient received 2nd dose of Shingrix, less than the recommended interval, which led to shortening of vaccination schedule. The patient received 2nd dose 1 month after the 1st dose. No further details were reported at the time of call. No lot number or expiration date nor patients details were provided. The reporter consented to follow up.
eyes swelled shut @ 230PM 2AUG95;no fever, no vomiting, no diarrhea;rx Suprax PO, eye drops;3AUG95 swelling dec
Information has been received from a physician concerning a 5 year old female who at 15 months of age, in approximately 2002, was vaccinated with a dose of varicella virus vaccine live. On 01-MAR-2006 (14 days prior to the report) the patient was diagnosed with encephalitis and was hospitalized. On 05-MAR-2006 (10 days prior to the report) the patient developed vesicular lesions that may be chickenpox. It was reported that sample was taken for VZV analysis. There was no information regarding outcome. No product quality complaint was involved. Additional information has been requested.
1-2 weeks post injection: localized left deltoid pain and weakness.  2 weeks post injection:  vesicular rash on nose, bilateral forehead that itch.  Now clearing.  plantar surface (arches) of both feet - to toes.  Feet burn and hurt. Rash started as blisters; now is scaly, red and tender.  widespread maculopapular eruptions of both legs that are itchy.
Client complains of itching, burning, redness, swelling, warm to the touch at injection site. State he has used ibuprofen, benedryl, and ice pack to relieve symptoms. No improvement since started yesterday, but reports he is at work today and is not able to treat symptoms regularly. He will continue current treatment of symptoms and report any improvement/worsening over the next few days. He has been advised to seek emergency care if he should have worsening symptoms and/or has any difficulty breathing. He also reports he gets annual flu vaccines and was in the military and has not had reactions to vaccines like this in the past.
Has metallic taste in her mouth; Cough; "This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3247), via an unspecified route of administration in right arm on 23Jan2021 (at the age of 76-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took historical vaccine, first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL1284) in left arm on 03Jan2021, (at the age of 76-years-old) as a single dose for Covid-19 immunisation. The patient experienced cough on 29Jan2021, and has metallic taste in her mouth on an unknown date in Jan2021. The patient was hospitalised for the event has metallic taste in her mouth on an unknown date in 2021. The patient did not receive any treatment for the events. The outcome of the event Cough was not recovered and Has metallic taste in her mouth was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected."
No additional AEs or PQC reported; vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current condition, previous drug reaction or allergy, and concomitant medication were not reported.  On 07-JUN-2022, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection (strength, anatomical site of vaccination were not reported, 0.5 ml, lot number U034712, expiration date reported and validated as 30-Jul-2023) intramuscular (IM) for prophylaxis (product storage error). The vaccine was exposed to the temperature excursions: 34.2 degrees Fahrenheit for 12 hours. There was no previous temperature excursion. No additional adverse events.
We gave a 10 yr old 0.5mL of Moderna Covid-19 vaccine, Bivalent; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (We gave a 10 yr old 0.5mL of Moderna Covid-19 vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in a 10-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (We gave a 10 yr old 0.5mL of Moderna Covid-19 vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (We gave a 10 yr old 0.5mL of Moderna Covid-19 vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (We gave a 10 yr old 0.5mL of Moderna Covid-19 vaccine, Bivalent).    Concomitant product information was not provided by the reporter.   Treatment information was not provided.
The patinet got very pale; Shaky/shakiness; The patient started projectile vomiting; She was feeling queasy/queasiness; This spontaneous case was received on 18-Sep-2020 from other non-health professional (consumer) via agency (reference number: SEQW20-01986) and concerned an adult, female patient.  The patient's medical history and concomitant medications were not reported.  On 18-Sep-2020 around noon, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: right or left arm and route of administration: not reported) for protection against seasonal influenza. The batch reported was 276562 and expiry date was 30-Jun-2021.  On the same day, about five to seven minutes after receiving Flucelvax Quadrivalent, the patient got very pale, shaky, was feeling queasy, and started projectile vomiting. The vomiting episode only occurred once. The shakiness also went away.   On the same day, four hours after receiving Flucelvax Quadrivalent, the queasiness was still occurring. The patient was able to eat a piece of toast about four hours after the incident.   At the time of initial reporting on 18-Sep-2020, the patient was recovering from the event of 'feeling queasy' and 'pale'.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  This case is linked with case 202004562 (the same patient).  Company comment: The patient developed pallor, tremor, vomiting projectile and nausea on the same day after receiving the suspect product, Flucelvax Quadrivalent. Chronology is suggestive. No information about concomitant medications and medical history was provided. Based on provided information, causal relationship for all events is assessed as possibly related. (defaults to ''related' in the safety database for reporting purposes).; Sender's Comments: The patient developed pallor, tremor, vomiting projectile and nausea on the same day after receiving the suspect product, Flucelvax Quadrivalent. Chronology is suggestive. No information about concomitant medications and medical history was provided. Based on provided information, causal relationship for all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
On the evening of 04/29/2022 I lost my voice. I thought that really strange. By the end of Saturday I was exhausted. I haven't had a lot of coughing but my nose has been more runnier than usual. I was really exhausted. I took two at-home tests that one was Neg and the other Positive. I called Emergency care Saturday night. They prescribed Paxlovid on 04/30/2022 and I started 05/01/2022. It wasn't a dramatic shift but I did start to feel better. I am not sure how to report that as working or not or if I would have been worse without it. My PCP contacted me on 04/30/2022 and advised me what to do if my symptoms or my O2 under 84 or less or short of breath to go to Urgent Care or ER. I was just told to Isolate and suggested I stop taking my OTL medicines and that I could take Tylenol.
Watery diarrhea, multiple bouts of vomiting, and tenderness of the left thigh began approximately 5 hours after vaccines were administered.
Woke up day after with VERY sore arm; more so thanin past. By noon the day after vaccine, pain increased and a hard, medium sized ball  (i.e., just smaller than a gall ball) formed at injection site. By 10pm the evening after vaccine, the hard ball shape had grown to just smaller than a baseball. Very intense pain without even touching. Had a video ER visit aound 11pm. No signs of infection per se; however, certaintly a REACTION. The pain has subsided; however, the hard "ball" is still on left arm. Has reduced in size to that of a grape and is remaining contstant.  In addition, three days ago, I began to have short (i.e., ~one second) stabbing pains in the left side of my chest near my heart. The stabbing sensations have continued peroidically with no accompanying symtoms (e.g., shortness of breath, arm tingling, etc.).  I am very concerned.  NOTE:  COMIRNATY VACCINE - no side effects with previus Pfizer C19 vaccines.