chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received her first dose of the Mederna Covid vaccine at the Health unit on 03/10/21.  Her family states she began experiencing nausea and vomiting last night (03/11/2021) and then started having chest pain at around midnight.  This morning (03/12/2021) she was still experiencing vomiting and chest pain.  She collapsed at approximately 07:30 and her family initiated CPR and EMS was called.  She was brought the Hospital via Ambulance at 08:18 in cardiac arrest.  The emergency department was unable to resuscitate her and she was pronounced dead.
Last night I felt some sort of knot and swelling on my neck right above my collarbone on my right side.( I received the janssen shot on my right arm.) It may be my lymphnode.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a first dose of HPV rL1 6 11 16 18 VPL vaccine (yeast) (lot number 660612/0229X) (injection site and route not reported).  Shortly after being vaccinated, the patient passed out in the waiting room.  Unspecified medical attention was sought.  The physician reported that the patient recovered in a short while and went home.  Additional information has been requested.
Chest pain, palpitations, decreased pain with exercise, increased pain with laying down, pain from the middle of the sternum to the left side of the chest wall and from the bottom of the ribs to the sub clavicle area
pt recv vax; screaming almost constantly x 4 1/2 hrs; shaking, limp & pale; T 101; no tx except to cont APAP;
sick; throat was hurting - sore throat; some shortness of breath; both side of my neck where my lymph nodes are were like golf ball size; Lymph nodes hurt; dry cough when I talk; every now and then, I'll get palpitations; hips were really really sore - painful; whole body hurt, not just on the side where I got the shot - my arms hurt; started getting chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), OROPHARYNGEAL PAIN (throat was hurting - sore throat), DYSPNOEA (some shortness of breath), LYMPHADENOPATHY (both side of my neck where my lymph nodes are were like golf ball size) and LYMPH NODE PAIN (Lymph nodes hurt) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced OROPHARYNGEAL PAIN (throat was hurting - sore throat), DYSPNOEA (some shortness of breath), LYMPHADENOPATHY (both side of my neck where my lymph nodes are were like golf ball size), LYMPH NODE PAIN (Lymph nodes hurt), COUGH (dry cough when I talk), PALPITATIONS (every now and then, I'll get palpitations), ARTHRALGIA (hips were really really sore - painful), MYALGIA (whole body hurt, not just on the side where I got the shot - my arms hurt) and CHILLS (started getting chills). On an unknown date, the patient experienced ILLNESS (sick). At the time of the report, ILLNESS (sick), OROPHARYNGEAL PAIN (throat was hurting - sore throat), DYSPNOEA (some shortness of breath), LYMPHADENOPATHY (both side of my neck where my lymph nodes are were like golf ball size), LYMPH NODE PAIN (Lymph nodes hurt), COUGH (dry cough when I talk), PALPITATIONS (every now and then, I'll get palpitations), ARTHRALGIA (hips were really really sore - painful), MYALGIA (whole body hurt, not just on the side where I got the shot - my arms hurt) and CHILLS (started getting chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported  No treatment information was provided
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Undifferentiated connective tissue disease" (unspecified if ongoing); "regurgitation" (unspecified if ongoing); "Raynaud's" (unspecified if ongoing). Concomitant medication(s) included: MYCOPHENOLATE, stop date: 24Jun2022; TADALAFIL oral; PANTOPRAZOLE oral; PREDNISOLONE, start date: 06Jun2022, stop date: 27Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Result; (29Jun2022) Negative, notes: Patient had negative pcr and rapid test on 29Jun; (29Jun2022) Negative, notes: Patient had negative pcr and rapid test on 29Jun; (05Jul2022) Positive, notes: Rapid antigen turned positive on 05Jul. Therapeutic measures were taken because of drug ineffective, covid-19.  Clinical course:  Patient had negative pcr and rapid test on 29Jun. Rapid antigen turned positive on 05Jul. Symptoms began 04Jul. Other medical history Undifferentiated connective tissue disease, regurgitation, raynauds  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product bnt162b2 cannot be ruled out.
the booster shot is weakening her system; has anxiety; not feeling well; coming from somewhere what's making her sick; after the booster was suffering a horrendous rash/the rash was very uncomfortable to work/rash was been there for almost 3 days; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (the booster shot is weakening her system), ANXIETY (has anxiety), FEELING ABNORMAL (not feeling well), ILLNESS (coming from somewhere what's making her sick) and RASH (after the booster was suffering a horrendous rash/the rash was very uncomfortable to work/rash was been there for almost 3 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (the booster shot is weakening her system), ANXIETY (has anxiety), FEELING ABNORMAL (not feeling well), ILLNESS (coming from somewhere what's making her sick) and RASH (after the booster was suffering a horrendous rash/the rash was very uncomfortable to work/rash was been there for almost 3 days). At the time of the report, ASTHENIA (the booster shot is weakening her system), ANXIETY (has anxiety), FEELING ABNORMAL (not feeling well) and ILLNESS (coming from somewhere what's making her sick) outcome was unknown and RASH (after the booster was suffering a horrendous rash/the rash was very uncomfortable to work/rash was been there for almost 3 days) had not resolved.            No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-413742 (Patient Link).
Patient reports that started Sunday afternoon her right arm lost a muscle control that she had a hard time moving and  area of injection was swollen and painful.  She states that symptoms  that she experienced were gone on Wednesday afternoon and her arm function came back as normal.
Pt reported to post vaccination waiting area as instructed after vaccine administration. Pt began to feel "dizzy" and notified staff. While with patient, pt started to have tightness in chest, difficulty breathing. tingling in throat, and "tight airway".  Vitals signs were obtain at 1400 178/110. At 1402 EPI 0.3 mg given in the Right Thigh and 1405 50 mg Benadryl IM to Left deltoid. After EPI administration vitals were obtained, 1406 148/82, SpO2 99%, HR 95. Vitals at 1409  164/100 HR 118 SpO2 98%. EMS was called at 1357 and arrived to site at 1410.
Headache, chills, nausea, arm pain severe, tired. stared 24 hrs after Vaccination, Day after just pain in Rt Arm.
pt recv vax;pt had been coughing & v;T 102;apap given;v again p/apap given ;fever of 104.6;began to stare & body jerking then became listless & non responsive;to hosp er;apap supp used pt taking fluids,fussy,talking,eating;dx febrile sz;
Patient received Pfizer COVID vaccine on 3/22/21 and 4/12/21. On 10/8/21, patient was admitted to our facility with acute respiratory failure with hypoxia due to COVID-19 pneumonia. Patient received remdesivir and dexamethasone. On 10/11/21, patient was transferred due to needing maximum setting high flow  and currently still there as of today (10/12/21).
Four days after receiving MMR vaccine, the pt developed pain, swelling, redness at left testicle. Mother gave Tylenol with some relief from pain, but it became worse on 03/19/2002. Seen by family physician, referred to ER on 03/20/2002 and was seen by urologist; taking doxycycline 100 mg at this time.
Pt accidently received a third dose of the Hepatitis A vaccine. No adverse effects. pt mother was notified about the injection. No harm expected for the patient in receiving an extra dose per PCP.
Information has been received from a physician concerning a patient who was vaccinated with ZOSTAVAX and developed shingles. A product quality complaint was not reported. Additional information was not available.
Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication and treatment medications were reported.  The patient was in good physical shape and worked out regularly in a gym.  Company comment:  This case concerns a 36-year-old male patient with no medical history provided, who died after he had received the mRNA-1273 vaccine (serious unexpected event of Death). The cause of death remained unknown at the time of this report and it is also unknown whether an autopsy was performed. The dose of the vaccine was not disclosed and temporal relationship between Death and vaccination remained unknown since no dates were provided. As per source document, it was stated that the patient had been in good physical shape. Limited information precludes a meaningful medical assessment. The re-challenge is not applicable, having in mind that the patient died. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-445819, MOD-2022-445817 (Patient Link).; Sender's Comments: This case concerns a 36-year-old male patient with no medical history provided, who died after he had received the mRNA-1273 vaccine (serious unexpected event of Death). The cause of death remained unknown at the time of this report and it is also unknown whether an autopsy was performed. The dose of the vaccine was not disclosed and temporal relationship between Death and vaccination remained unknown since no dates were provided. As per source document, it was stated that the patient had been in good physical shape. Limited information precludes a meaningful medical assessment. The re-challenge is not applicable, having in mind that the patient died. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
pt recv vax & had hives w/itching;took DPH every 4hr x 2 days p/calling nurse;denies SOB, dyspnea;
Swollen left shoulder, arm and elbow w/i 24 hours erythematous. Ice, Motrin PO ABX, F/U 24 hours.
Localized vaccine injection reaction - onset in hours - pain, redness, itching. Given symptomatic treatment.
Within 15 min after receiving vaccine, child became frightened and scared. Child requested to stay in nurse office. Vaccine given at school. Within 1 hour child became pale. Glassy eyes. Temp 104: mother took child to emergency room at 3:15PM-- stayed in ER till 9:00 PM and diagnosed with UTI.
SKIN AROUND IT COLD; VERY PAINFUL AT INJECTION SITE; HOTSPOT AT INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 30-AUG-2021, the patient experienced hotspot at injection site. On 30-AUG-2021, the patient experienced very painful at injection site. On an unspecified date, the patient experienced skin around it cold. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from hotspot at injection site, very painful at injection site, and skin around it cold. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Knee surgery; Ulcerative Colitis; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4317616-00.  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (cf) for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COLITIS ULCERATIVE (medically significant) with onset 2021, outcome "recovering", described as "Ulcerative Colitis"; JOINT INJURY (medically significant) with onset 2022, outcome "recovered" (2022), described as "Knee surgery". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of joint injury.  Clinical course was reported as, Patient experienced events of Knee surgery and COVID shot triggered the symptoms of Ulcerative Colitis. Patient reported she did not know that she had Ulcerative Colitis until she had the COVID shot. It triggered the symptoms. In 2022, patient had surgery on knee. She needed a knee replacement and instead they put gel under her knee cap, but since she started the Humira her knee felt brand new now. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for (Adalimumab) HUMIRA: The reporter's causality for the event(s) of Knee surgery and COVID shot triggered the symptoms of Ulcerative Colitis with Humira (Adalimumab) was a reasonable possibility.  Causality for BNT162B2: The reporter considered "ulcerative colitis" related to bnt162b2 (reported as Probable), The reporters assessment of the causal relationship of the event Knee surgery NOS (Knee operation) with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment..  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
On day 2 of the second dose, had  soreness, pain and swelling to injection site, also fever of 100.3, chills, body aches and weakness On day 4 after second dose had severe back pain, painful to walk, despite taking Motrin.  Went to doctor and had MRI done.      Then by early February started having insomnia, hard time falling asleep and staying asleep . I feel the second dose of vaccine might have caused my immune system to become over active.  The back is now ok after rest and physical therapy but the insomnia still persist.
Evening following vaccine, developed temperature of 100, burning of feet and hips, nausea, headache, felt sluggish, itching on legs. Symptoms improved but did not resolve. On 7/16/04 became disoriented, weak, nausea, dizzy, increased BP. Numbness, pain generalized but increased leg/hip involvement; to ER. Diagnosis: Neuropathy, Guillain Barre and Neurotin. Continues under Rx at this time.
Patient received the rotavirus vaccine on 9-11-09 approx. 4pm.  The next morning he developed a fever and it became high (103.5 degrees F)and the fever lasted 5 days.  He became extremely fussy and wouldn't sleep (and prior to this he was an "angel baby" and sleeping through the entire night since 4 weeks of age.)  He was uncomfortable and felt horrible.  We had to give tylenol every 4 hours round the clock for five days.
consumer wants to know if neck pain is a normal after getting the shot a few hours later; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 21Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NECK PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "consumer wants to know if neck pain is a normal after getting the shot a few hours later".  Additional information: The patient wasn't sure if it was stress or the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
hoarseness, much mucous, sore sinuses;rx amoxicillin, DPH, zyrtec;seen in ER 27APR97;
Heart palpitations, pain, stiffness & swelling of joints (knees, elbows, & fingers) skin rashes & itchy eyes. Treatment: Prednisone & Loratadine.
w/in 24hr of vax pt exp swelling under the rt arm w/severe pain & tenderness;individual went to civilian MD & was placed on ATB & pain med;
Almost immediately after injection started to experience a bitter metallic taste that has gradually gotten stronger. Writing this roughly 3 hours after injection and still experiencing the strong taste.
I experienced hives erupting all over my body for 2 months gradually lessening in severity. They could be brought on by heat or abrasion, but not necessarily so. At the beginning I also experienced minor swelling in my throat for a couple of days, but it did not prevent breathing or eating, just minor difficulty swallowing.  Went to urgent care twice at the beginning. OTC anti-histamines provided little relief.
My whole body itched. I changed into silky pajamas and took 2 over-the-counter benadryl, laid down and took a nap for 2 hours. When I woke up, my body no longer itched. I kept pajamas on for the rest of the day.
Pt was given an expired dose of the Anthrax vaccine on 11Sep2020 vaccination expires 10Aug2020. No adverse signs or symptoms presented themselves at or after the time of injection.
Patient had red hard bumb on left posterior arm. Doctor note: "The symptoms began 3 days ago and generally last 3 days. She states the symptoms are acute."
Still struggling with muscle spasming and some skin sensitivity a week after second shot.; Still struggling with muscle spasming and some skin sensitivity a week after second shot.; Still struggling with muscle spasming and some skin sensitivity a week after second shot.; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 35 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 13Apr2021 (Lot number: ER8733) at the age of 35 years as dose 2, single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medications included: MULTIVITAMIN [ASCORBIC ACID;CALCIUM PANTOTHENATE;COLECALCIFEROL;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]; FISH OIL; PROBIOTICS; ADVIL [IBUPROFEN]; PEPCID [FAMOTIDINE]. Vaccination history included: BNT162B2 (Dose 1, Lot number: EN6202, Anatomical location: Left arm, Administration time: 03:45 PM), administration date: 23Mar2021, when the patient was 35 years old, for covid-19 immunization, reactions: "I got painful skin sensitivity" and "found a large muscle knot nearby". The following information was reported: MUSCLE SPASMS (non-serious), SENSITIVE SKIN (non-serious), DISEASE RECURRENCE (non-serious) all with onset Apr2021, outcome "unknown" and all described as "Still struggling with muscle spasming and some skin sensitivity a week after second shot.". The event "still struggling with muscle spasming and some skin sensitivity a week after second shot." was evaluated at the physician office visit. Therapeutic measures were taken as a result of muscle spasms, sensitive skin and disease recurrence.  Additional information: Treatment received were muscle relaxers, advil, massage, heat, and waiting. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient was not allergic to any medications, food or other products and was not diagnosed with other illness, medical history and chronic health conditions.  No follow-up attempts are possible. No further information is expected.
Headache, body aches, fever, fatigue, pain in arm (where vaccinated) - started 12 hours post vaccine, lasted for 48 hours  Anxiety - started 40 hours post vaccine, lasted for 24 hours Dizziness - started 12 hours post vaccine, continued and intensified for 168 hours after (It's been almost 7 days and I'm still dizzy.  It's gotten worse in the last two days)
Patient woke up approximately 38 hours post injection with partial loss of vision in the right eye.  Patient's daughters took her to the Emergency Department.  BP was extremely elevated (no prior history of hypertension).  CT was inconclusive regarding symptoms but MRI of the head indicated small CVA in the temporal lobe.
swollen,itchy red site where the injection went in. started looking like a mosquito bite but over night it swelled and is hot to the touch and itches.