chrisvoncsefalvay/vaers-outcomes huggingface dataset:
STROKE; This spontaneous report received from a consumer via social media concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total dose, start therapy date were not reported for prophylactic vaccination (dose number series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the reporter stated that the neighbor experienced stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211222253.; Sender's Comments: V0: 20211223284-Covid-19 vaccine ad26.cov2.s-Stroke. This event(s) is considered unassessable. 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).
After DTAP, HAP, IPV, MMR and VZV were administered pt c/o of stomache ache the vomitted moderate amt of breakfast intake.
Three hours after receiving vaccines the patient screamed without stopping for the next four hours. His temperature increased to 100.8F.
pain around lower back/ legs lasted for 3 days, couldn't walk, went to emergency room but nothing was done at the emergency room
Burning in shoulder and across back to spine immediately following injection.  After 24 hours sent to ER for evaluation as vaccine was administered as part of work-related vaccinations available to employees.
At approximately 9 am Pt walked up to PHN and stated he was having chest pain pointing to left chest.  Assisted to cot and PHN attempted to check BP, Pt refused stating he was cold.  PHN explained that would need to call emergency services, called at 9:03 and reported incident.  Pt denies Hx of  cardiovascular disease or being on any medications.  Pt stated he wanted to leave but needed a ride, states he walked to vaccine appt. Advised to wait for ambulance but declines and walked out of waiting area, police officer nearby and went out to talk with Pt, clinical lead also went out to talk with Pt and convinced to come back in and wait for ambulance.  Pt refused to sit down and became agitated trying to leave and saw the ambulance and agreed to sit down.  Paramedic spoke with Pt and he refused care from them,then  ambulated out of clinic on his own volition,  with steady gait   During time here displays being a poor historian and appeared agitated when trying to offer care.
Became very ill that evening and had flu like symptoms for 3 days. I have never received this reaction from the flu vaccination and did not receive a reaction when received in 2019. I did not go back for the shingles booster and also advised by Dr., my doctor at that time. I have developed what I would call an extreme case of pruritus on the arm of the shingles vaccination, so severe it disrupts sleep. I have been applying steroid cream for relief. I also have developed cellulitis. I have never had these issues until after the shingles vaccination. I am a healthy fit 57 year old that takes no prescription medication. I wish I had never received this vaccination. Seborrheic Keratoses Diagnosed by NP and cellulitis on record with NP as well.
Saturday-Tuesday tight chest; Saturday-Tuesday tight chest, should and pectoral muscle; Wednesday- nausea; stomach cramps; watery diarrhea; This is a spontaneous report from a contactable other hcp. A 27-years-old female (non-pregnant) patient received bnt162b2 (Formulation: Solution for injection in pre-filled syringe, Batch/lot number : unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 17Jul2021 14:00 (age at vaccination: 27 years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Hashimotos thyroiditis from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (B12 [CYANOCOBALAMIN]) taken for an unspecified indication, start and stop date were not reported; zinc (ZINC) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid, caffeine (BC [ACETYLSALICYLIC ACID;CAFFEINE]) taken for an unspecified indication, start and stop date were not reported; loratadine (CLARITIN [LORATADINE]) taken for an unspecified indication, start and stop date were not reported.  The patient previously took nickel and experienced allergy to metals.  The patient had covid prior vaccination and covid not tested post vaccination.On 21Jul2021, 08:00 AM Patient experienced, Saturday to tuesday tight chest, shoulder and pectoral muscle, Wednesday nausea, stomach cramps, watery diarrhea (as reported). The outcome of all events reported as not recovered.  Information about lot/batch number has been requested.
Mild skin redness at site of injection. 1 cm circle. Nontender. As of 10/20/2014 the redness has remained constantly without any changes.
pt recv vax & w/in 24hr exp soreness in arm, shoulder & neck & nausea;sx cont;
Patient got her pfizer vaccine 1st dose and was fine.  She went to sit on a chair for observation and was fainted a few minutes after.  After that, the mother called 911 and ambulance came. By the time the ambulance came, patient already regained her consciousness.
Body aches; fatigue; joint pain; pain in lymph nodes around breasts; High ANA test result; overactive autoimmune/inflammatory response; overactive autoimmune/inflammatory response; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0158), via an unspecified route of administration in left arm on 09Apr2021 (at the age of 41-year-old) as dose 1, single for COVID-19 immunisation at other facility. The patient medical history was not reported. Concomitant medications included sertraline taken for an unspecified indication, start and stop date were not reported; trazodone taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was unknown if COVID-19 was diagnosed prior to vaccination. The patient had tested for COVID-19 since the vaccination. On 10Apr2021, The patient experienced body aches, fatigue, joint pain, pain in lymph nodes around breasts. High ANA test result, with an overactive autoimmune/inflammatory response that was still lasting with daily pain. The adverse events were resulted in doctor or other healthcare professional office/clinic visit. The adverse events were resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included high antinuclear antibody test result on an unknown date in Apr2021, Vault saliva test (COVID-19) was negative on an unknown date in Feb2021, negative on 05Apr2021 and negative on 14Apr2021. The patient did not receive any treatment for the events. The outcome of the events was reported as not resolved.  Follow-up attempts are completed. No further information is expected.
Discharge Provider: MD  Primary Care Provider : NP    Admission Date: 12/27/2022 Discharge Date: 01/07/2023 COVID positive Date: 12/27/2022 Admitting Diagnoses: COVID-19 virus infection PRESENTING PROBLEM:  Hypoxia [R09.02] COVID-19 virus infection [U07.1] COVID-19 [U07.1]   HOSPITAL COURSE: 84-year-old with medical history of chronic obstructive pulmonary disease on 2-4 L oxygen, recurrent falls, rib fractures, tobacco abuse disorder, hypertension and GERD presenting with flu-like illness that started on 12/26.  Patient found to be hypoxic on presentation to ER 12/27, requiring 6 L nasal cannula oxygen.  Lab work revealed positive COVID infection.  Complete blood count, CMP unremarkable.  Chest x-ray showed bilateral basilar bronchial wall thickening and infiltrates concerning for pneumonia.  She was admitted to hospitalist service for further management.  Patient states that she remembers falling at home and hitting her left shoulder.  She was having discomfort in left shoulder and that is what made her come to hospital. She endorsed having cough at baseline, no worsening recently.  Denies any recent flu-like illness.  Denies any fevers.  Endorses chills.  No nausea or vomiting.  Denies difficulty breathing or chest pain/tightness.  Denies lightheadedness.  When asked about the fall, she stated getting losing her balance and tripping.  Denies any recent change in bowel habits.   Patient was treated with IV remdesivir for 5 days and dexamethasone 6 mg daily for 7 days.  Patient was able to be weaned down from supplemental oxygen to room air and remained on room air for more than 48 hours.  She was evaluated by PT OT and was recommended home health.  Patient's daughter states she will not able to take care of the patient at home and requested placement to long-term care.   1/7 patient underwent evaluation for home oxygenation, found to be maintaining her oxygen saturations with room air on both activity and rest.  She was discharged in a stable condition.
1. Vaccine 8 am (L)/deltoid. 2. Onset stiff neck by 7:30pm. 3. Severe stiff neck (R) 3 days.
Itching, sore throat, nausea, and vomiting 30 minutes after influenza shot. Visited ED and received prednisone 60 mg, Benadryl 50 mg, and famotidine 20 mg all orally. Symptoms resolved.
Patient seemed to be doing well before, during, and immediately following vaccination. About 5 minutes after receiving the vaccine patient fell backwards in his chair and hit the ground. He lost consciousness for a few seconds. I called 911 and stayed with him until EMTs arrived. Patient had started feeling better, was able to get up, drink water etc.  I followed up later in the evening and his parents informed me that he was feeling fine and did not have any additional issues.
Case number PHEH2013US018209, is an initial spontaneous report received from a medical assistant on 26 Aug 2013. This report refers to a 17 years old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: not reported), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 24 Aug 2013. No adverse event was reported following this administration error.
This spontaneous report was received from a registered nurse, and refers to an adult patient of unknown age and gender. Concurrent conditions, medical history, historical or concomitant drugs were not reported. The registered nurse informed that on an unknown date, the patient may have been vaccinated with a pediatric dose of VAQTA Injection, for prophylaxis (strength, dose, dose number, route, anatomical location, lot # and expiration date were not reported). No adverse effects were reported.
during administration of Shingrix half of the dose leaked out of the needle; during administration of Shingrix half of the dose leaked out of the needle and down the patients arm; during administration of Shingrix half of the dose leaked out of the needle and down the patients arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number 2Z9N3, expiry date 26-SEP-2025) for prophylaxis.   On 27-SEP-2023, the patient received Shingrix. On 27-SEP-2023, an unknown time after receiving Shingrix, the patient experienced accidental underdose (Verbatim: during administration of Shingrix half of the dose leaked out of the needle), exposure via skin contact (Verbatim: during administration of Shingrix half of the dose leaked out of the needle and down the patients arm) and inadvertent exposure to vaccine (Verbatim: during administration of Shingrix half of the dose leaked out of the needle and down the patients arm).  The outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.   Additional Information: GSK Receipt Date: 28-SEP-2023 Pharmacist reports during administration of Shingrix half of the dose leaked out of the needle and down the patients arm, which led to accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. The reporter consented to follow up.
Small rash, swelling in armpit into breast, swelling had come back and tender after 3 weeks.
on 10/28/2022 I had the above patient on the injection schedule for an HPV vaccine injection.  When prepping her chart - it was documented that she had her last injection on 6/10/22 and the immunizations were not reconciled.  When I reconciled them,  I found that she had completed her series of HPV injections as follow:  4/5/13, 12/7/12, 10/5/12.  When the patient arrived, I reviewed her immunization history and reassured her that her receiving an additional HPV vaccine in June will not harm her and that she has completed the series.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. No medical history, concomitant therapies, drug reactions and allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX (lot # was either M023380, expiry date 11-MAY-2018 or M028549, expiry date 07-JUN-2018 (the reporter was unable to specify which one was administered)), dose and injection route and site were not reported). Data logger was involved. On an unknown date, the vaccine was stored at temperature of 11.5F (also reported as 12 F), time frame was reported as 18 days and 19 hours. There was no previous temperature excursions. No adverse events were reported. Additional information has been requested.
Got the second dose at 3pm 10/13. Around 12am 10/14 my temperature spiked and I couldn't get warm. I felt faint and dizzy. I did an Blood oxygen reading and it read 73% on three measurements. I did a blood sugar test and it read 68. My Blood pressure also dropped to dangerous levels but I did not have the strength to record the numbers by that time. From 10/14 to 10/22 I had registered fevers ranging from 101.8 to 104.1 alongside not being able to eat due to pain in my stomach and chest. Back at 10/12 my weight was 315 pounds, and by this time I was 285 pounds. On 10/23 I suffered from a crippling migraine for 36 hours. My joints ached and my muscles cramped endlessly. On 10/24 my migraine broke at 11:45am. When I blew my nose I saw what looked like Blood clots in the tissue. I couldn't walk 10 feet without crippling exhaustion and profusely sweating, as well as swelling tonsils. And that continued from 10/24 until 11/3. From 11/3 to 11/11 I have slowly been getting my strength back.
Patient developed a fever of 101.6 F with erythema and pain at the injection site.  On 11/5/12 there is documentation that the "RUE extremity appears to hve grown larger in size, noted redness, pain and heat".  The patient is being treated as if she has a cellulis around the injection site.
The lump in my arm and the redness and swelling seemed to be gone after about the 4-5 day. There was no pain. Then on day 9, I noticed that my arm was again red, swollen and sore to the touch and itchy.  But I didn?t feel bad just the arm lump and swelling again. After a few days the swelling and itchiness/burning  went away. The red spot is still there but pretty light now. I didn?t say anthing to anyone because I was fine. Then I started thinking that I should report it for the records.
This was an 8 year old who came thru drive thru COVID vaccination site accompanied by his father. He received Pfizer pediatric dosage in left deltoid around 915 am. While being observed in holding area, he started to state he felt warm, had headache and was nauseated. He had no other symptoms. No shortness of breath, chest pain, tingling, itching or swelling.  He was not tachycardic. No diaphoresis or sweating. No hives.  He was given an ice pack to his neck and observed for an additional 30 minutes. He was offered Acetominophen but his symptoms of feeling warm and headache resolved. The episode was about 10 minutes. He still had some nausea but improved significantly (50% improvement). After observation period, his father felt comfortable taking him home and observing for any worsening or recurring symptoms. He was instructed to immediately seek medical care if symptoms returned or worsened or did not resolve.
Moderate pain and soreness to left arm at injection site somewhat immediately, same evening mild fatigue and difficultly sleeping.  During night restless difficultly sleeping, severe headache, moderate body aches, muscle pain. Next day severe headache, moderate fatigue and weakness, general malaise, loss appetite and mild nausea.  24 hours after injection symptoms including headache, began to subside somewhat.  36 hours after injection pt just feeling mild fatigue at this time.
Unknowingly administered expired quadrivalent flu vaccine. Given IM in the left deltoid
Reports after injection given 07/14/03, had welt 3x2 inch, raised in which increased size day 1, then day 6.  Took advil, cold compress.  Cephelgra occurred 1.2 days then resolved. 01/14/2003: Premed OTC claritine and acetaminophen.  Base BP 90/60.  Proceed with injection #5.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm 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: "Lupus" (unspecified if ongoing), notes: Other medical history: Lupus; "fibromyalgia" (unspecified if ongoing), notes: Other medical history: fibromyalgia; "celiacs disease" (unspecified if ongoing), notes: Other medical history: celiacs disease. The patient took concomitant medications. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine", notes: Known allergies: Morphine. 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: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was not pregnant at the time of vaccination. Other medication in 2weeks was reported as yes. Therapeutic measures included Anti-viral details: Product: COVID 19 Treatment, Brand: Pfizer, Treatment started on 12Jan2023 and stopped on 12Jan2023, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2, BNT162b2 omi ba.4-5, and the reported events covid -19, drug ineffective cannot be excluded.
I underwent routine screening mammogram at age forty and I was diagnosed with DCIS of the right breast requiring surgery and radiation.
CONSTANT RINGING IN MY EAR, CONSTANTLY,ALL DAY ALL NITE,24/7
Patient was given adult dose of Havrix. No adverse event. Patient contacted and informed of error. Denies having any issues at this time.
improperly stored; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 23-NOV-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally, for prophylaxis (lot number 1684163 was verified to be valid, expiration date reported and established as 26-JUN-2021), (dose, strength and frequency were not provided).  The administered dose of vaccine previously experienced a temperature excursion of 0.92 and 13.36 Celsius degrees for the time frame of 43 hours and 45 minutes. There was no previous temperature excursion. Digital Data Logger was not involved.
2 days post Flu vaccination, redness at site, swelling, warmth and painful to touch.
1 hour past 2nd shot, I felt fatigue, dizziness, brain fog and mild nausea.  Possibly 12 hours past the shot, I awoke with a massive headache, achy joints & muscles from head to toe, chills, sweating, congestion, sore throat, increased dizziness and weakness.  This was similar, but not as severe, as the onset of Covid-19 symptoms I experienced on January 5, 2021.  30 hours past the 2nd shot, I am still experiencing aches, pains, dizziness, fatigue, and a headache I cannot alleviate with Ibuprofen.
4/20: Vaccine 2nd dose 4/23: Face and neck pustules / rash 4/24: Betamethosone topical cream prescription 4/25: doxycycline oral prescription (10 days) 5/12: Tinnitus onset 5/14: Ear fullness onset (right ear) 5/17:  Ear flush by doctor 5/17: Prednisone 40mg (5 days) 5/20: blurred eye and floaters onset (right eye)  As of 6/25, tinnitus, ear fullness and blurred eye remain.
Arm pain 2 weeks after getting the vaccine, the pain radiates down through my entire arm and wrist, hurts to move/this is the arm I received the vaccine on; Arm pain 2 weeks after getting the vaccine, the pain radiates down through my entire arm and wrist, hurts to move/this is the arm I received the vaccine on; Arm pain 2 weeks after getting the vaccine, the pain radiates down through my entire arm and wrist, hurts to move/this is the arm I received the vaccine on; feels like a burning sensation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 19:00 (Lot number: FA7485) at the age of 29 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 13Aug2021, outcome "not recovered" and all described as "Arm pain 2 weeks after getting the vaccine, the pain radiates down through my entire arm and wrist, hurts to move/this is the arm I received the vaccine on"; BURNING SENSATION (non-serious) with onset 13Aug2021, outcome "not recovered", described as "feels like a burning sensation". Therapeutic measures were not taken as a result of pain in extremity, pain, arthralgia, burning sensation.  Additional information: it happens every few days. The patient did not have covid prior vaccination. The patient did not have covid test post vaccination. The patient did not had known allergies.  No follow-up attempts are possible. No further information is expected.
Rash, sweats, fever, sore lymph nodes. Sent to local walk in clinic for evaluation.