chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED COVID-19 INFECTION; FELT TERRIBLE; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced felt terrible. On 14-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) POSITIVE. On 15-APR-2021, the subject experienced confirmed covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of felt terrible was not reported. This report was non-serious. This report was associated with product quality complaint: 90000176502. The suspected product quality complaint has been confirmed to be this report indicates a medical adverse event for the patient. while a positive covid test result was received after vaccination, insufficient time (14 days) had elapsed for the patient to achieve immunity therefore this report is not considered a lack of effect. approval to void this record due to no pqc identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Patient states that the night of her vaccine she felt feverish, and had extreme shortness of breath for about 5-6 hours, and she has been exhausted ever since.  She states there has been a few days she has not even been able to get out of bed.
Left upper arm swollen, red, tender, afebrile, CBC, blooc cx. Treatment-Keflex, Ancef IM. The pt is a 4 1/2 years old, who presents to the ED with left arm swelling and erythema. Started this morning. Two days ago she received vaccine in the left upper arm. Left upper arm cellulitis.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On an unknown date in June 2016 (reported as on unspecified date since last week), the patient was vaccinated with one dose of ROTATEQ lot # M014544, expiration date 27-NOV-2017, oral route of administration (dose was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 33.5 degrees Fahrenheit for 28 minutes. Data logger was involved. There was no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
15 minutes after receiving first dose, got up to leave the pharmacy and the room started spinning and the floor felt like it was moving. I almost fell. Since then I have had headache, room spinning, dizziness, nausea, blurred vision, electrical shocks in legs and chest, diarrhea, sweating, heat intolerance, unsteady walking, flushed face, groin pain, body aches, insomnia, vertigo, weakness, canker sores, burning body rash, brain fog.
Headache, Myalgia, arm soreness, chills, nausea Narrative:
Urticarial rash on face & anterior chest appeared in less than five minutes p/DPT/HIB was admnistrered; There were no other problems; Imp: transient urticarial rash;
My once happy baby has been crying for four days. The only time he is not crying is when he is sleeping. There is no fever or anything. He is just completely out of it. He does not seem himself. He is not making eye contact and crying unless asleep.
This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 10-AUG-2015, the patient was vaccinated with the improperly stored dose of PROQUAD (Merck) (lot number L005297 and expiration date 23-SEP-2016; dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
PT'S ARM WAS NOT SORE UNTIL 6 DAYS AFTER RECEIVING SHOT; SHE DEVELOPED A KNOT ON HER ARM AT THE INJECTION SITE AND IT WAS HARD; THE KNOT WAS NOT FEVERISH.
Fever of 101, chills, body aches, headache, nausea, rash all over upper torso
3/4-first vaccine in left arm, only effect was sore arm when I laid on it. 3/25-second vaccine in right arm, arm hurt to lift as well as lay on. Start approx 1515 hrs, severe headache anvil like pressure at back of head  3/26-body aches, some dizziness 3/26-3/28 temperature from 99-102+ with chill, aches, etc 3/28-4/1 extreme fatigue, brain fog.  4/1 to present: random fatigue, headaches, nose bleeds but 4/22 the fatigue brain fog became extreme again.  4/25 spend most of the day in bed sleeping or just laying there  with no motivation or ability to get up and focus on a task  4/26: went to work, but again, extreme fatigue, just want to lay down, no focus
Tingling in both legs wrapping from shin to calf; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 07:30 (Batch/Lot number: unknown) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LITHIUM. The following information was reported: PARAESTHESIA (non-serious) with onset Mar2021, outcome "recovered", described as "Tingling in both legs wrapping from shin to calf". Additional information: Tingling persisted for nearly three days. Upper legs, feet, and ankles did not have any issue. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Concomitant medication also included "hydrozidine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received PENTACEL vaccine on 6/1/09. Leg became red and large amount of swelling on thigh. Very fussy, cried for over an hour.
tested positive; tested positive; This is a spontaneous report received from a contactable reporter Consumer (wife of the patient) from product quality group.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "tested positive". The doctor told her that her husband was positive (unspecified date in 2023) and to go get shots at the hospital and she was told she was negative but then tested positive and they both went and got all the shots and nothing made any difference in terms of testing positive and clarified they both had the Pfizer COVID vaccines that were a series of three vaccines.  Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300078472 same product/event, different patients;
Temperature of 103 consistently even with ibuprofen. Extreme body aches, ringing in ears
20 minutes after injection, I had red face with hives.  I took 50 mg of Benedryl.  Thirty minutes after that my blood pressure elevated to 185/80.  I then took 10 mg Zyrtec.  I remained at clinic with nurse by my side taking blood pressure repeatedly for 2 more hours until blood pressure was 136/70.   Next morning, blood pressure was 140/70.  Later in morning, blood pressure was 120/65.
Clinical Summary Patient is a 82 y.o. male with a history of lung cancer and OSA who presented to hospital 12/1/2022 unresponsive. Required intubation and found to have multifocal PNA. Hospitalist consulted to assume care out of ICU. Course complicated by acute encephalopathy and dysphagia. Care transitioned to DNRCC 12/13/2022. Hospital course complicated by need for insurance application. Patient passed 12/24/2022.    1. GOC: transitioned to comfort care on 12/13/22 with hospice measures. Patient passed 12/24/2022.  2. Acute metabolic encephalopathy:  H/o dementia (on donepezil), but lives independently and performs all ADLs per son. Found unresponsive at home 12/1/22, last known well 11/29/22, GCS 7 on admit. EtOH, UDS, urine cultures, TSH negative. CT imaging on admit non-acute. MRI brain without 12/3/22 non-acute. Patient does not follow commands for neuro exam. Neurology followed.  3. Hypernatremia: Na 156 on 12/4/22. Not further lab work given DNR CC.  4. Community acquired pneumonia: With sepsis on admit. Positive for COVID-19, influenza, and strep pneumoniae on admit. Decadron given 12/1-12/4, stopped d/t worsening mental status. S/p rocephin and tamiflu. Isolation removed 12/12/2022 5. AKI: Baseline creatinine 1.0, creat 2.91 on admit, suspected d/t rhabdomyolysis. Resolved.  6. Hyperkalemia: s/p medical management. No further tx given plan for DNRCC 7. Dysphagia: NGT removed 12/12/2022. Palliative followed 8. Sacral and upper back wounds:  both POA and unstagable pressure ulcers. Wound care followed  9. Cervical stenosis: CT C-spine with severe C3-4 foraminal stenosis. MRI C-spine not tolerated d/t intubation. Trauma followed 10. Parkinson disease: Recent diagnosis. Has right pill rolling tremor.  11. Lung cancer: Completed treatment 2009. S/p left upper lobectomy, chemotherapy and radiation. No history of recurrence. 12. Code status: DNR-CC changed 12/13/2022 per palliative
Headache, Sedation, Mental fogginess, imbalance Narrative: Received 1st dose on 1/28/21 and noted sore arm that day. On 1/29/21 worsened arm pain and itchiness at injection site lasting 24-48 hours. Also on 1/29/21 awoke with fatigue, headache, mental fogginess and dizziness. Symptoms lasted 48 hours. Had history of COVID infection 3/2/20, and positive IgG Ab ~ 4/20.  Other Relevant History:
Had right chest and lower back pain and sweating during night of April 15, 2021. Also had unexplained cough for one month prior to vaccine. Pain was gone by morning. Did regular exercise of walking 4 miles in morning. Same pains came back afternoon of April 16. Went to ER at 4pm on 4/16. D-Dimer and Troponin were elevated and CT scan showed pulmonary embolism in right lung.  Was given Lovenox and was admitted to hospital for 2 days. Was released on Eliquis 2x per day for at least 3 months. Had two plane rides lasting for 2 hours each on 3/21 and 3/31 where I walked to bathroom once so it is unlikely these plane rides caused embolism. I am active and walk about 20 miles per week. Doctors so far have not found likely cause for this event.
Pt called and said she had a "blue circle" at the administration site as well as a "red mark" underneath the area.  She gave no history of when this started.
Fever caused man to convulse; is showing up ill; his arm is so sore he can barely move it; with chills; a sly fever/Fever reached 105.6F; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jan-2022 and was forwarded to Moderna on 04-Jan-2022.    This spontaneous case was reported by a consumer and describes the occurrence of FEBRILE CONVULSION (Fever caused man to convulse), ILLNESS (is showing up ill), PAIN IN EXTREMITY (his arm is so sore he can barely move it), CHILLS (with chills) and PYREXIA (a sly fever/Fever reached 105.6F) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEBRILE CONVULSION (Fever caused man to convulse), ILLNESS (is showing up ill), PAIN IN EXTREMITY (his arm is so sore he can barely move it), CHILLS (with chills) and PYREXIA (a sly fever/Fever reached 105.6F). At the time of the report, FEBRILE CONVULSION (Fever caused man to convulse), ILLNESS (is showing up ill), PAIN IN EXTREMITY (his arm is so sore he can barely move it) and CHILLS (with chills) outcome was unknown and PYREXIA (a sly fever/Fever reached 105.6F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 105.6 (High) Fever reached 105.6F before.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by reporter. No treatment medication was provided by reporter.  Company Comment: This spontaneous case concerns an 88-year-old, male patient with no medical history reported, who experienced the unexpected, non-serious AESI of febrile convulsion and other associated unexpected and expected, non-serious events after administration of an unspecified dose of the Moderna mRNA-1273 vaccine. Treatment information was not provided. However, the event pyrexia had resolved at the time of the report. The outcomes of the other events were unknown at the time of the report. The rechallenge was unknown as the dose number was not provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an 88-year-old, male patient with no medical history reported, who experienced the unexpected, non-serious AESI of febrile convulsion and other associated unexpected and expected, non-serious events after administration of an unspecified dose of the Moderna mRNA-1273 vaccine. Treatment information was not provided. However, the event pyrexia had resolved at the time of the report. The outcomes of the other events were unknown at the time of the report. The rechallenge was unknown as the dose number was not provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
On 4/11/14 Mom called our office around 4:49 pm saying child was having little swelling and little redness on left thigh where child received Polio vaccine. Patient was crying. Dr advised TYLENOL for any pain but to have child seen if swelling increased or pain noted.
Cramps in neck every now and then; Headache when laying down; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramps in neck every now and then) and HEADACHE (Headache when laying down) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced MUSCLE SPASMS (Cramps in neck every now and then) and HEADACHE (Headache when laying down). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Cramps in neck every now and then) and HEADACHE (Headache when laying down) outcome was unknown.            No concomitant medications were mentioned. Treatment medications includes Pain medication along with above mentioned medications.   This case was linked to MOD-2021-139495 (Patient Link).
body aches; Fever, Low grade fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), PYREXIA (Fever, Low grade fever) and FATIGUE (tired) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A, 026L20A and 033F21A) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) tablet for an unknown indication.    The patient's past medical history included Pacemaker syndrome (Pacemaker Passed out and pulse got down to 32) on 12-Jun-2017, Sick sinus syndrome (had sick sinus syndrome, ultimate diagnosis.) on 12-Jun-2017 and Obesity (Obesity Confirmed weight loss of 80 pounds was before Paxlovid). Concomitant products included VITAMIN B [VITAMIN B NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jul-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) three tabs in the morning and three tabs at night. On an unknown date, the patient experienced PAIN (body aches), PYREXIA (Fever, Low grade fever) and FATIGUE (tired). The last dose administered for NIRMATRELVIR, RITONAVIR (PAXLOVID) was on 17-Jul-2022. At the time of the report, PAIN (body aches), PYREXIA (Fever, Low grade fever) and FATIGUE (tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient clarified that first dose was not bad but experienced fever, body aches, low grade fever and tired.  No treatment drug details was reported.   This case was linked to MOD-2022-618147, MOD-2022-618142 (Patient Link).
within 4 hours of shingrix vaccination - noted headache , chills x 48 hours.  fatigue persists.   more recnetly left deltoid (injection site) redness, soreness. had Td (tetanus, diptheria) that same day at same site.
Patient had Moderna as first dose at another facility.  Patient received Pfizer as the second dose.  Per CDC guidelines, dose was  not repeated and patient was counseled that there wasn't any intervention necessary.
had a major seizure on day 8 of dose one despite nearly no history of seizures; I was tired after the first dose (26Feb2021) on days 2-3; This is a spontaneous report from a contactable consumer (patient).  A 27-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in arm left on 26Feb2021 15:00 (Batch/Lot Number: EN6204) as SINGLE DOSE for COVID-19 immunization at doctor's office/urgent care. Medical history included atypical trigeminal neuralgia since 2009, complex regional pain syndrome (CRPS), attention deficit hyperactivity disorder (ADD), anxiety, depression, asthma, Epilepsy-prone and many more. The patient also had orthopedic knee surgery on 26Aug2020 which she had pain after surgery. She also had known allergies with Cephalosporins and elemental nickel. Concomitant medications included tapentadol (TAPENTADOL), amphetamine (AMPHETAMINE), and candesartan cilexetil, hydrochlorothiazide (CANDESARTAN HCTZ) all taken for unknown dates and indications. The patient stated that she was tired after the first dose (26Feb2021) on days 2-3 (Feb2021). She also had had a major seizure on day 8 of dose one (07Mar2021) despite nearly no history of seizures which require emergency room/department or urgent care visit. The seizure has been attributed to other issues by her doctor. The patient had no COVID-19 prior vaccination and was not tested post vaccination. The events were considered life threatening. The patient did not receive any treatments for the events. The patient recovered on unknown date in 2021.
adverse experience; Temperature excursion involving GARDASIL 9; This spontaneous report has been received from a medical assistant (also reported as a nurse), concerning 14-year-old of male patient. The patient's concurrent condition, medical history and concomitant therapy were not reported.   On 27-DEC-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T039467, expiration date: 20-MAY-2023, which have been verified to be valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) administered in left deltoid (strength, exact dose and route of administration was not provided) for prophylaxis. The vaccine was exposed to a temperature excursion of below 36°F (30.4°F) for 0 hours 35 minutes on 08-DEC-2021. Digital data logger was involved. On an unknown date, the patient experienced unspecified adverse reaction (ill-defined disorder). The patient's parents agreed to revaccination. The outcome of the event of ill-defined disorder was reported as resolved on an unknown date.   The causality assessment between the event of ill-defined disorder and suspect vaccine was considered as unknown.  The reporter considered the event of ill-defined disorder to be important medical event (medically significant).  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2201USA000582:
Local reaction Left Arm 13 Sept 07, Swelling,Redness, Warm to touch, Had fever on 12 Sept. C/O fatigue. Given Anthrax 4 11 Sept 2007
Patient was administered 0.3 mL of un-reconstituted Pfizer without dilution around 9:30 am. Upon discovery after dose had been given, pharmacist reached out to patient to see if any side effects had occurred. As of 12:30 pm that same day, patient stated none at this time so pharmacist counseled patient to monitor for any adverse effects such as excess soreness, flu-like symptoms, headache, fatigue, etc. Pharmacist encouraged patient to seek medical attention if any of those symptoms occur.
Client stated she discovered a reddened area that is warm to the touch and non tender 5-6 inches below the site of her flu vaccination. Client states the reddened area is the size of a deck of playing cards. Client denies any redness, swelling, warmth or tenderness at injection site.
had fainting episode likely vasovagal rxn;treated w/02 initially, monitored, pulse ox, BP w/full recovery;
Client called  3/4/20 to report symptoms after receiving Tdap vaccine.  Client states her arm was sore and "felt like dead weight" all day.  She says it did not get red or swollen.  She states she had chills and slept for several hours over the next 2 days, and that she had called into work sick.  Says she took her temperature, but never ran a fever. She reports loss of appetite during this time.  States she did not take medication or do any type of intervention for the symptoms.  Client states she has never had any type of reaction to any vaccine in the past.  States she has not notified her PCP.  States her arm is better today and getting better each hour.  Advised client to notify PCP of events.  Advised her to get further management recommendations from her PCP if arm does not get better or gets worse.  Advised her to keep health department apprised of any additional interventions or if condition does not get better or worsens.  Alert placed in client''s chart. Client called back on 3/11/20 advising her arm continued to be painful until 3/10/20, but is not painful today (3/11/20).  Client did not advise of any additional comfort measures or medical treatments received since vaccination.