chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unable to move; Muscle weakness; Body ache/ pain; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Unable to move), MUSCULAR WEAKNESS (Muscle weakness) and PAIN (Body ache/ pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RUXOLITINIB PHOSPHATE (JAKAFI) for Polycythaemia vera.    Concomitant products included APIXABAN (ELIQUIS), SIMVASTATIN, NADOLOL, FUROSEMIDE, PANTOPRAZOLE and SPIRONOLACTONE for an unknown indication.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) 5 milligram twice a day. On an unknown date, the patient experienced MOBILITY DECREASED (Unable to move), MUSCULAR WEAKNESS (Muscle weakness) and PAIN (Body ache/ pain). At the time of the report, MOBILITY DECREASED (Unable to move), MUSCULAR WEAKNESS (Muscle weakness) and PAIN (Body ache/ pain) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported. Patient had experienced split 10 mg tablets because he ran out of 5 mg, wrong technique in product usage processing regarding jakafi.
24 hours after receiving the vaccine, I passed out while walking.  I do not have any other new medications; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration Arm Left on 13Jan2021 at 08:00 AM as a single dose for COVID-19 immunisation, lot number: EL3249. Medical history included bronchiectasis. Patient had no known allergies. Concomitant medications in two weeks prior to the vaccination included olodaterol hydrochloride, tiotropium bromide monohydrate (STIOLTO RESPIMAT), salbutamol (ALBUTEROL HFA) and multi vitamins. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Jan2021 at 10:00 AM patient passed out while walking, 24 hours after receiving the vaccine, patient did not have any other new medications. Event resulted in emergency room/department or urgent care and hospitalization for one day. Treatments received included cast on hand, computerised tomogram (Ct) scans, electrocardiogram (EKG) and echocardiogram on unknown date with unknown results. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination patient had not been tested for COVID-19. Patient was recovering from the event, at the time of the report.
09/09/22 presents to ED for "extremity weakness". PMHx of "dementia, hypertension, hypothyroidism, skin cancer"
Fever, chills, shaking, body ache hit all at once. Bed bound for about 30 hours. Took 2 extra strength Tylenol about every 4-5 hours for about 24 hours
Fever 101(in the office) ibuprofen, elevated WBC 23600 65% gram. No fussiness, no local swelling/erythema.
A physician reported that a 36 year old female received the vaccine on 10/11/99. On 10/15/99, she developed an injection site reaction characterized by redness and swelling which extended to the elbow. She also developed a low-grade fever of 99.8. The pt was treated with antibiotics and antihistamines. She recovered.
Tired; Dizzy,  lightheaded; Shortness of breath; Neck pain mostly on the right side; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tired, dizzy, lightheaded, neck pain mostly on the right side and had shortness of breath.  The patient's medical history, consumer included cold. Concomitant medications reported included Mucinex (guaifenesin) and some cold medications.  On 03 Feb 2021, prior to the onset of the events tired, dizzy, lightheaded, neck pain mostly on the right side and had shortness of breath, the patient received their first of two planned doses of mRNA-1273 (007M20A) in the left upper part of the arm for prophylaxis of COVID-19 infection.  On an unknown date, after starting treatment with mRNA-1273, the patient experienced tired, dizzy, lightheaded, neck pain mostly on the right side and had shortness of breath.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of events tired, dizzy, lightheaded, neck pain mostly on the right side and had shortness of breath was resolved (feeling better).; Reporter's Comments: This case concerns a 72-year-old male, with history of nasopharyngitis on cold medications, who experienced NS unexpected events of dyspnea, dizziness, neck pain and NS expected event of fatigue.  The events occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes reported as resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Large red upper forearm ,hard to touch, spread down to elbow and under arm slightly itchy started day after injection.Duration 5 days so far. Starting to fade away 5th day.Not necessary to seek medical attention.Took acetaminophen.
left deltoid site very painful during the night, better this morning; nausea, cold sweats, loss of appetite, fatigue  started the next day  Patient took 325mg Aspirin, Sudafed and chlorpheniramine
I was exposed on September eleventh to COVID-19 the next morning woke with shortness of breath which continued until September twenty-first.
Pt recvd vax & exp elevated Gamma Glutamyl Transpeptidase 4 months p/vax;
Had stomach ache, starting 24 hours after vaccination, then diarrhea, then vomiting from 7:00 pm til 2:00 am. Joint pain, 100.0 fever the next day, fatigue.
her father passed away after getting the Pfizer covid-19 vaccine; This is a spontaneous report from a Pfizer sponsored Program Database Support from a non-contactable consumer (patient's child). A male patient of an unspecified age received bnt162b2 (Pfizer covid-19 vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer wanted to know if the Pfizer covid-19 vaccine is FDA approved. Consumer stated on the call that her father passed away after getting the Pfizer covid-19 vaccine. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: her father passed away after getting the Pfizer covid-19 vaccine
Raised red rash, itchy, warm to touch at injection site. Itchy rash on neck.
Hives for 4 days. My doctor prescribed Hydroxyzine HCL 25mg tb. 1 tablet every 8 hrs.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 at 07:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 81 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jul2022, outcome "recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19, drug ineffective. Patient received Paxlovid as COVID 19 treatment from 26Jul2022 to 30Jul2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
By Friday afternoon, I became overwhelmingly fatigued.  Unable to walk in store after walking from the parking lot.  Needed a w/c.  Went to bed early and by Saturday AM continued to be so weak could not walk upstairs.  Had to lean against walls to walk to bathroom.  Temp was 102.0 on Sat. AM.  2 hours later it was 102.9.  Took Aleve.  Recheck 102.8.  Pushed fluids, bedrested.  Alternated Tylenol and Aleve Sat. and Sunday.  Temp. returned to normal by Monday AM.  Vaccine site was red, hot, swollen and painful. All down to mild pain by Mon.
RIGHT THIGH: redness, swelling and warmth. swelling diameter: 5-6cm.  LEFT THIGH: redness.
SEPSIS; This spontaneous report received from a physician concerned a 68 year old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient had no allergies and no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980 and expiry: 04-AUG-2021) .5 ml, 1 total administered in left deltoid, on 10-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced sepsis, and was hospitalized (date unspecified). The number of days of hospitalization was not reported and it was unsure the patient discharged from the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sepsis was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This case, involving the same patient is linked to 20220316804.; Sender's Comments: 20220435730 -COVID-19 VACCINE Ad26.COV2.S- Sepsis. The event(s) has a unknown/unclear 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.
Having Ehlers Danlos and Mast Cell Degranulation as well as Dysautonomia... Anaphylaxis is often referred to as slow roll and without the typical face swelling and rash. It is more subtle and can be harder to detect.  And that was my experience: as follows: I became faint and briefly passed out within 2 minutes of injection. I stabilized quickly within a 30 minute hold although developed increasing nausea, I and med tech was satisfied that it might just be my dysautanomia. I spent the evening with severe headache vomiting as passed out again. I experienced throat tightening but not full closure. The next day I had flue like symptoms that I assume were normaland vaccine related. When this passed in the evening I again suffered nausea and dizziness, vomiting and throat tightening when I tried to eat.  These symptoms were not similar to the flush feelings earlier in the day. The symptoms ebbed and waned for 2 days with increased frequency as I took chromalyn , Benadryl with some effect at first and ate with great care as not to introduce more allergens.  I had increased chest pain,  sweating, fainting, throat tightening became severe Benadryl was not effective. I was having trouble swallowing. I was forced to us an epi pen and call 911. This  is a typical anaphylactic response for EDS< Mast Cell patients. It became clear that I could not get past this on my own and the symptoms were increasing. I started to shake with chills and feared shock as my chest pains increased. The epi pen injection and hospital visit via ambulance occurred Monday 1/25-1/26. I became very faint during the Ems intake with the techs having to hold me up to check vitals etc.. My HR dropped despite the EPi. At the ER I was given IV steroids,  IV Benedryl and Potassium,  tablets and fluids throughout the night, admitted for evaluation.
Nausea 1/15 and 1/16, developed blotchy rash on back and abdomen, numbness/tingling in left arm. Patient awoke vomiting on 17th.
Extreme fatigue on day dose was received.  10/23/2021 began having severe stomach cramping and fatigue 10/24/2021 stomach cramping and fatigue continues with constipation 10/25/2021 stomach cramping and fatigue continue with diarrhea and hot flashes 10/27/2021 symptoms that began 10/25 still occurring with no improvement
BAD HEADACHES; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (BAD HEADACHES) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (BAD HEADACHES). At the time of the report, HEADACHE (BAD HEADACHES) was resolving.     Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event of bad headaches with Humira (Adalimumab) was a reasonable possibility.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Presented with SOB x 4 days, hypoxic in ED; SpO2 39% improved with NRB mask ; Covid + in ED; Admit 9/15 to ICU with Covid PNA; tx with 9/15 Baricitinib, maxipime, remdesivir, steroids, doxycycline, LMWH, singulair, zinc started 9/16 Vanc started; O2: intially on HF O2 via NRB and Bipap; intubated 9/16 100% FiO2; pt progressed to ARDS and Multiorgan failure with inability to wean from vent; Comfort Care on 9/30; Died @ 14:50 9/30
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022; No adverse event; Patient administered the vaccine after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022).    No concomitant product use was reported. Reportedly, Patient received half dose. Vial did not undergo any temperature excursions. No treatment information was provided.
Patient came to the pharmacy to receive a flu shot.  I followed all the required criteria as per the corporate immunization protocol.  After I administered the vaccination, I noticed that the syringe used (BD Integra Syringe with Retracting BD PrecisionGlide Needle) did not have the needle attached to the syringe.  I assumed that the needle had been dislodged into his left arm.  I recommended that he be checked out via an emergency provider.  Patient was checked out and discovered that in fact the needle was NOT in his arm at all.  Apparently, the syringe must have fallen off of the syringe before the injection was initiated.
Rash on torso mainly on front with a few on back. Mom describes as "welts in groups". Mom gave BENADRYL. No itching with rash. Mom states pt had same reaction the last time he received immun at H. Dept (10/6/10). She reported this last time to pts previous phys who recommended BENADRYL. This is the 1st time immuns. were given at this office. Pt est at this visit.
pt states on 4/1/2021 when he woke up his mouth was crooked and face was dropping.  He thought he was having a stroke Pt went to Hospital ER.  They gave him a CT, Blood test, X-RAYS.  pt was transported to another hospital  to have the MRI which showed no sign of stroke.  He was brought back to hospital where he was admitted for observation.  He was released after 3 days.  His DX was Bells Palsy.  He was prescribed valacyclovir 1mg bds and prednisone.  He has to wear a patch of his left since he cant close it and he has no control of the tear ducts in this eye.   The left side of this face is still drooping and he cant use the left side of his mouth and he bites his tongue when he is eating.  He wishes he had not taken the shot.
ADVERSE EVENT:  POSSIBILITY OF VACCINE STORED IN UNAPPROVED FREEZER TREATMENT:            NONE OUTCOME:                NO ADVERSE SIGNS OR SYMPTOMS WHATSOEVER
headache; painful throat; back pain; weak eyes; At times I feel so weak and my head seem heavy on me; head seem heavy on me; This is a spontaneous report from a contactable consumer or other non hcp.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EWO180),  via an unspecified route of administration on 01Jun2021, as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had received the first doses of the vaccine (batch number: EWO163) in 16May2021. In Jun2021, the patient stated that, took 2 doses of the covid-19 vaccine 1st dose on 16May2021 Pfitzer EWO163 2nd dose 01Jun2021 Pfitzer EWO180. Since I took 2nd dose I had been having headache, painful throat, back pain & weak eyes. At times I feel so weak and my head seem heavy on me. These were symptoms and issues I never had before now. I visited my primary care doctor and he gave medication which I took for four days and there was no change, I just came back from the Emergency room and have been sent to the withheld for more. Treatment was given for the events. Outcome of the events were not recovered.    Additional information has been requested.
Headache tinnitus and photophobia Narrative:  employee with h/o TBI and migraines.
Woke up at 5am to take some Motrin for joint.  Was up for about 10 minutes and passed out. Hit my head on the floor and was out for a few minutes while my husband tried to wake me. Lost 2 teeth and have split lips and facial bruising
Recipient reported that his heart was "pounding hard" and "trying to work harder" -- several times over the course of the morning.
Pain in arm day after vaccine. Lasted about 24 hours  6 days after vaccine - red rash and itchiness around vaccine site on arm
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 04Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 05Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "IBS" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "migraines" (unspecified if ongoing); "known allergies: Shellfish" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative after 9 days of initial illness; Positive, notes: Then tested positive after 4 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had all 4 doses of the vaccine prescribed and took Paxlovid from 23Nov2022 to 27Nov2022, for treatment of COVID-19.  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.
A physician reported the occurrence of Stevens Johnson syndrome in a 6 month old female who was vaccinated with Infanrix for prophylaxis. The subject's medical history and concurrent conditions were not reported. The subject began a 7 day course of Amoxil therapy for an unspecified indication 10 days prior to Infanrix administration. On 12/3/02, the subject received an injection of Infanrix; it was not known if the subject had received previous injections of Infanrix. later that day, the subject developed skin rashes. She was seen by the physician, who made a diagnosis of Stevens Johnson syndrome. As of 12/9/02, the event persisted. The reporting physician considered the event to be possibly realted to both Infanrix and amoxil administration. Stevens Johnson syndrome is considered medically serious (OMIC).
Fever 101-102 within 24 hours of vaccine administration. No other sxs initially, then fussy and not same activity level for next 2 days.
Patient received TDAP & PNEUMOCOCCAL on 3-16-09.  Presented to office on 3-19-09 with a 4 1/4 X 2 1/2" red, raw, hard area, painful.
fever & rash w/tightening of throat 30min p/4th dose in post exposure series;
Reconstituted Hiberix with sterile water; Reconstituted Hiberix with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-month-old female patient who received Hib (Hiberix) (batch number FL53S, expiry date 29th December 2022) for prophylaxis.   On 25th April 2022, the patient received Hiberix. On 25th April 2022, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-MAY-2022 Reporter's comment: The patient received Hiberix on left vastus lateralis. The clinical director called in to inquire if the dose was valid. The clinic director reported they reconstituted Hiberix lyophilized powder with sterile water and inadvertently administered to a patient.  The reporter did not consent to follow up. Additional supportive information: The patient received Hiberix for which lyophilized powder was reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.