chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came in on 4/6/2022 around 2:30pm. Mom states patient would not sleep last night, very fussy, and started with a itchy rash all over. No fever, but felt hot to touch. Gave Motrin 30 minutes before appointment today. Doctor examined patient and she indeed did have hives on both legs and on abdomen. Flushed face. Not sure which vaccine cause this since rash is all over. Patient is stable otherwise. 3.4ml of Benadryl given and patient sent home with return precautions.
Redness/swelling on left arm -- been taking ibuprofen x3 following vaccination Chills -- ibuprofen x3 following vaccination
Patient received immunizations immediately after leaving room to wait in lobby, pt's mom informed us she was near fainting. Applied ice packs to forehead and base of neck, had pt lay down, elevated legs.  Patient recovered w/in 20 minutes to be able to go home with mother.
9/29/17 vaccination with MMR, VZV, HepA, influenza. 10/19/17 hospitalization with ~7 day history of petechial rash. No illnesses in last several months. Platelets <10. Presumed ITP (immune thrombocytopenia); treated with IVIG (completed 10/20). CBC/manual diff on 10/19/2017 without any atypical lymphocytes. 10/22/17 manual diff showed 4% atypical lymphocytes. 10/24/17 underwent bone marrow aspirate. 10/25/17 developed fever, dry cough; ITP treated with WinRho for persistent thrombocytopenia (platelets improved after this). Mother and father also with upper respiratory infection symptoms around this time. Resp viral panel negative.
Vaccine given 3/22/07, 3/23/07 developed redness at site and itching, seen in office 3/25/07 for redness, tender to touch, warmth R thigh. Treated with Benadryl and Keflex 250 tid X 1 week
1" circle red spot appeared at injection site 12 days after injection, no itching or pain. Irregular edges
This spontaneous report as received from a other health professional refers to a 11 year old female patient. On 08-AUG-2017, the patient was vaccinated with GARDASIL 9 dose 1, .5 ml, intramuscular for prophylaxis. Other suspect therapies included GARDASIL.  On 09-AUG-2017, 2 days after onset of therapy, the patient experienced syncope and head injury.  On an unknown date, the patient experienced interchange of vaccine products. The outcome of head injury, interchange of vaccine products and syncope was unknown.
I had fatigue, headache and muscle aches. Just last night, for a short period of time, I had muscle aches and chills.  I am 34 weeks gestation with a estimated deliver date of 02/10/2021.
Patient came for 1st dose Moderna Vaccine. It was administered by FNP at 1740 Nurse Practitioner was called by  to waiting room at 1755. The PCT stated that the patient voiced he was feeling light headed. I came into waiting room and noted patient sitting in chair, pale and staring. Patient had syncopal episode that lasted 10-15 seconds. Respirations were even and unlabored during the event. No unusual movements noted. Patient woke up and started to get up but encouraged to rest and drink water. He took a few drinks of water and agreed to go back to the patient exam room.  Patient was assisted  by NP and  to exam room one at 1758. The patient became pale and had another syncopal event just past door frame. Patient was lowered to ground by and NP. He verbally responded in about 2 seconds "Am I in the floor?" Patient sat upright in floor and drank some water for nearly a minute. He was then assisted to exam table to lie back. He stated that he feels fine just lightheaded. Patient rested on exam table and called wife on his cell phone to come pick him up. He left the clinic around 1850 with wife. Patient left ambulatory in no distress. Advised patient that adverse event report would be completed on website.
Within several minutes of HPV vaccine administration, pt was in process of sitting up when felt light-headed, then began to shake over whole body according to grandmother. Grandmother called staff to the room and pt was found laying on her side on the exam table. Her mouth was observed to be grimaced to the side and her left arm was extended forcefully to the right. Entire episode was estimated to last less than 10 seconds. Pt was immediately able to answer questions normally and was not observed to be "post-ictal." Stat blood glucose was 99. Pt was observed for another 90 minutes here in clinic without any return of symptoms. Of note, pt fainted following initial HPV vaccine administration so was laying down when this second vaccine was administered.
Manager came to pharmacy to report that a customer was not feeling well after her booster shot. Went up front and found her slumped in a chair and nonresponsive.  Family member stated that she complained of an upset stomach right before collapsing. Paramedics were called, and patient started to respond a little. Every time she tried to sit up she would fall over again though. Her vitals seemed ok, but she had great difficulty walking to the bathroom. Paramedics advised that she be transported to the hospital, but she opted to return home with a family member.
11/22/21 ID physician Dr.'s note: "Impression: 1. COVID 19 pneumonia in vaccinated host w/ Pfizer 1/25, 2/15 2021 - presenting 3 days into his sx; high O2 req's; s/p one dose dexamethasone in ED 11/21. 2. Acute respiratory failure - 60% on RA; placed on BIPAP, then OPTF/NRB 100%/60 lpm sats 93-95% 3. AKI on admission w/ prob dehydration, ?retention; denies urinary sx 4. Troponin leak". 11/22/21 Pulmonology physician Dr.'s note: "Assessment: Acute hypoxic respiratory failure associated with COVID 19- Bilateral COVID 19 Pneumonia-HTN-DM-Hx cholelithiasis-GER-BPH Recommendation: Decadron ,Remdesivir, Proning ,F/U inflammatory markers ,F/U oxygenation". 11/23/21 Dr.'s note H and P: "Patient is a 89 y.o. male with history as noted below who presents with groin pain and dysuria. Pt was in USOH until 1 day ago when he developed dysuria, inability to urinate.  Per chart review, he lives with his daughter who noticed that he was uncomfortable and his son brought him to the ED where a Foley catheter was placed which resolved the abdominal discomfort.  He was noted to be coughing and was mildly short of breath in the ED and was treated with BiPAP, subsequently weaned off to high flow nasal cannula.  On the floor he desaturated to 90 to 91% and was switched to a nonrebreather mask with OptiFlow.  Per his discussion with RN he wanted to kill himself 3 months ago which was notified to Dr. who recommended 1:1 sitter for safety. A rapid and PCR COVID-19 test was positive. He desaturated and his respiratory failure progressed rapidly and an ICU eval was called. He was seen lethargic, minimally responsive and on 15L oxygen by NRB and optiflow. Vitals included: temp 96.6, pusle 84, RR 40 and BP 95/52. Will obtain a CT angio chest and transfer him to the ICU for close monitoring".
This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # L036823 and expiration date 24-DEC-2016, lot # M0017445 and expiration date 07-APR-2017; exact doses and route of administration were not provided). No previous temperature excursion was reported. Digital Data Logger was not involved. At the time of report, the temperature was back in range. No adverse effects were reported. Additional information has been requested.
Pneumococcal pneumonia. 102 degrees fever hospitalized for IV antibiotic treatment. Blood in stool and urine.
Narrative:  Patient received Moderna Covid vaccine #1 on 5/14/21. He had two follow up visits with behavioral health on 5/18/21 and 5/19/21. In those notes, he did not report any medical concerns. He was followed by mental health for anxiety, PTSD, alcohol abuse and panic disorder. On 6/11/21, the Covid clinic attempted to contact patient regarding his second vaccine and they were informed by his mother that he had passed away and only information given was that he was found in his truck. Date of death is recorded as 5/29/21, no autopsy reports available. There were 15 days from time of vaccine to date of death.
RECTAL ITCHING AND PERI AREA ITCHING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced rectal itching and peri area itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rectal itching and peri area itching. This report was non-serious.
LEFT ARM SWELLING; This spontaneous report received from a consumer concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced left arm swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm swelling. This report was non-serious.
p/vax pt exp lt arm inj site very sore; blister; redness & swelling of upper arm; 8/22 blister dissipating; 8/23 redness;swelling gone
AFFECTED KIDNEY FUNCTION; CAUSED MY BLOOD PRESSURE TO GET REALLY HIGH; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, sex, 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) dose was not reported, 1 total, start therapy date was 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 an unspecified date it was reported that "Don't take it caused my blood pressure to get really high and affected my kidney function." Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the caused blood pressure to get really high and affected kidney function was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220233866 -COVID-19 VACCINE AD26.COV2.S- Affected kidney function. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Chills Body aches (all over, even my fingers) Fever (did not surpass 100.2) Headache Heavy chest  Most everything gone by 10:00 am following day, so less than 24 hours.
COVID arm - rash on my left arm. Started out as a splotchy, small rash on the same day of the injection. The day after injection, the rash was no longer splotchy and was a complete circular/blob. It was still fairly small. It is 4/15 and the rash is quite large (larger then my hand, almost wrapping around completely above the elbow part of my arm). The rash is hot to the touch but not too itchy.
Patient is 63 y.o. year-old female status post receipt of first dose of Pfizer Covid vaccine. Patient walked into triage area at the vaccine clinic 30 minutes after receipt of vaccine. Pt stated she felt itching on the arm she received the vaccine( left) immediately after receiving the vaccine which is resolved soon. Then while sitting in the observation area she felt warm in chest, then tightness. After coming to triage area vital signs were checked which is wnl and given below. She reported of ER visit 3 weeks ago for anaphylaxis after kissing her granddaughter who had consumed shrimp.She was evaluated in allergy clinic after her ER visit. She also reported about an asthma attack a week later the ER visit which is resolved by using albuterol inhaler at home, not evaluated by healthcare provider at that time.    While in triage room patient she took two puffs of her albuterol inhaler and she her chest tightness resolved after some time. Then she felt something in her throat as if she can feel more when she swallows, also started feeling tip of tongue numb/tingling. Then she started feeling congestion in head/nose and voice becomes husky. Patient has similar symptoms with her previous anaphylaxis.  Due to persistence of feeling congested and feeling of tongue swelling and previous hx of anaphylaxis patient sent to hospital via EMS personnel for further observation. Patient also preferred to be observed longer given her persistence of sx  Pt is instructed to check with ER physician or allergy specialist regarding the safety of second dose of the Covid vaccine before coming for the second dose.
I experienced tachycardia all night long. Heart rate stayed at 120-130 while resting and would elevate to 150-160 if I stood up. Went to Emergency room where I was admitted. I was given a medication to lower heart rate along with fluids, but my heart rate seemed to be coming down around the same time my other (more typical) vaccine side effects subsided. These effects included body aches, fever and nausea. My resting heart rate returned to a more normal rate during the daytime on Thursday.
This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 06-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 30-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 06-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 06-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 06-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 (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 06-Jul-2022). No concomitant medications were reported. The vial was initially stored in the refrigerator on 04-Jun-2022. Patient received half dose. The vial did not undergo any temperature excursions. No treatment medications were reported.
having hand pain; sedimentation rate is high; knees being bad; Product use error; This is a spontaneous report from a Specialty Pharmacy reported on behalf of a 55-years-old female (patient) reported that: A 55-Year-old female patient of an age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration  (at the age of 56-year-old) on an unspecified date at for COVID-19 immunisation; tofacitinib citrate (XELJANZ XR), at 11 mg, orally, daily from an unspecified date (Batch/Lot number was not reported) to an unspecified date for rheumatoid arthritis.  Medical history included overweight from an unknown date and unknown if ongoing. The patient reported that her cholesterol levels are normal. The patient's concomitant medications were not reported. The patient experienced having hand pain, sedimentation rate is high and knees being bad. The Patient reported that she had been off of xeljanz for over a month due to taking the COVID vaccine Pfizer and being on antibiotics (previously reported adverse event 20Jan2021). The patient reported having hand pain while off of xeljanz, but was not in complete pain (patient did not clarify complete pain). The patient reported that the sedimentation rate is high, knees being bad (patient did not clarify knees being bad), and took knees x-ray. No exact dates or further details were reported. The patient re started the xeljanz on 21Apr2021. The patient reported before xeljanz being upset and cried, was in too much pain, had to take prednisone. The action taken in response to the events for tofacitinib citrate was unknown.  No follow-up attempts are needed. Information of lot/batch number can not be obtained.
chickenpox p/vax;acyclovir et stress steroids (20-10-10)
Upper arm pain; Headache; Intense fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Upper arm pain), HEADACHE (Headache) and FATIGUE (Intense fatigue) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Vaccination adverse reaction (Patient always had problems with vaccines ).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Upper arm pain), HEADACHE (Headache) and FATIGUE (Intense fatigue). On 04-Mar-2021, HEADACHE (Headache) had resolved. On 05-Mar-2021, FATIGUE (Intense fatigue) had resolved. In March 2021, PAIN IN EXTREMITY (Upper arm pain) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications provided. On 01-Mar-2021, the patient Tylenol as treatment for her headache.   This case was linked to MOD-2021-068421 (Patient Link).
feels tired; Today he is having intestine issues/ tummy issues; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL DISORDER (Today he is having intestine issues/ tummy issues) and FATIGUE (feels tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced GASTROINTESTINAL DISORDER (Today he is having intestine issues/ tummy issues). On an unknown date, the patient experienced FATIGUE (feels tired). At the time of the report, GASTROINTESTINAL DISORDER (Today he is having intestine issues/ tummy issues) and FATIGUE (feels tired) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
12/31/2021: Event occurred after 2nd vaccine.   75-year-old female past medical history COPD not on home O2, hypertension, diabetes, CAD presenting for shortness of breath.  Patient states for the past 3 days she has developed some rhinorrhea mild cough and some body aches.  She states that she has had shortness of breath that is progressively worsening.  States that she does not feel as though she has had fevers.  Respiratory: +shortness of breath, +cough. GI: No abdominal pain, no nausea, no vomiting, no diarrhea.
had local reaction to hep B;erythema 10x12cm in lateral aspect lt arm;swollen & warm-fine, pinpoint vesicles in the area;
Swollen lip.  Dr decided it was my blood pressure medicine and not the vaccine.  Said no swollen lips were being reported from the vaccine.  Prescribed prednisone which I didn?t take.
sore throat; body pain; felt miserable; received first Comirnaty vaccine on 12Aug2021 and a week later tested positive for Covid-19 on 20Aug2021; This is a Follow-up spontaneous report from a program. This contactable male consumer (patient) reported that, a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on 12Aug2021 as a DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced received first comirnaty vaccine on 12Aug2021 and a week later tested positive for covid-19 on 20Aug2021. On an unspecified date the patient had, sore throat, body pain and felt miserable. It was reported that, the patient received first Comirnaty vaccine on 12Aug2021 and a week later tested positive for Covid-19 on 20Aug2021. He went to the hospital for his covid infection and complained of sore throat, body pain, and felt miserable for 3-4 days. He was scheduled for a 2nd dose of the Comirnaty vaccine and wanted to see if it's ok to get the second dose. The patient asked, how long do isolate after being infected with COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test that was positive on 20Aug2021. Outcome of all the events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Contracted COVID 19 6/21/22. Cough, feverish (no measurable fever), runny nose, scratch throat, myalgias
Pt has "chronic neuropathy" of hands X 2 years. This morning reported numbness, pain and trembling of hands "is much worse than ever before since taking Recombivax yesterday.
injection site pain; headache; vomited; nauseous; achy; chills; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sales Representative.   A 65-year-old female patient started to receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose, and influenza vaccine (INFLUENZA VACCINE), both via an unspecified route of administration on 22Oct2019 for immunisation at a pharmacy.  The patient medical history and concomitant medications were not reported.  The patient experienced injection site pain, headache, vomited, nauseous and achy chills. The outcome of headache was not recovered and of all other events was unknown. Course of events: She had injection site pain at time of the Prevnar vaccine. She then texted her daughter, a colleague, on 23Oct2019 asking if she should take acetaminophen or naproxen for headache since she just got that pneumococcal shot on 22Oct2019. She reported to have experienced to have "vomited, was nauseous, headache now, achy, chills last night."  Information on the lot/batch number has been requested.