chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Strong headache; Rash all over her body; going up to her face now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (unknown if pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose number unknown), for COVID-19 immunization.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; HEADACHE (non-serious), outcome "unknown", described as "Strong headache"; RASH (non-serious), outcome "unknown", described as "Rash all over her body; going up to her face now".  Additional information: The patient had the Pfizer, the latest vaccine, the third one (Clarified as Pfizer COVID-19 Vaccine) and they were wondering that maybe what she have are the side effects of that one but it almost a week now, in the past she always had the Moderna and the patient had no reactions. The reporter just called the pharmacy and they said no, this time they gave her the Pfizer. So, the reporter  was wondering because the side effects that she is getting, rash all over her body, fever, strong headache and she has been having almost for a week for now with that and the rash is all over her body and it's going up to her face now. The reporter was wondering if that probably the side effects.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
screaming for 6hr p/vax rt leg swollen given APAP q 4hr;phone f/u 23JUL97 doing better this AM;
L leg rash-red, raised x 2 days. Torso rash, erythematous maculopapular rash, few with slight vesicular appearance.
This case was reported by a consumer via call center representative and described the occurrence of pain in a 60-year-old female patient who received FLUARIX QUADRIVALENT. The patient's past medical history included cold (prior to receiving the vaccine the patient felt like she was coming down with a cold). Concomitant products included PROLIA. On 11th December 2017, the patient received FLUARIX QUADRIVALENT (intramuscular). On 11th December 2017, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced pain, fever and worn out. In December 2017, the outcome of the pain, fever and worn out were recovered/resolved. It was unknown if the reporter considered the pain, fever and worn out to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The reporter was not sure which flu vaccine the patient received. In the evening of the same day of vaccination, the patient experienced aches, pain, low grade fever and feeling wipe out. The patient recovered in approximately 2 days. The patient was not running a fever prior to receiving the flu shot and they were not sure if she was coming down with a cold anyway or if it was the flu vaccine that caused these events. The caller was reporting adverse events on behalf of his wife (patient).
is experiencing a rash after getting the second dose of the Pfizer COVID-19 vaccine; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information Team. A 64-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8736) via an unspecified route of administration in right arm on 22May2021 12:00 as 2nd dose, single dose (at the age of 64-years-old) for COVID-19 immunization. Vaccine was not administered at military facility. Patient did not receive any prior vaccinations within 4 weeks. Patient medical history included blood pressure, diabetes, anxiety all of which were ongoing. The concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EH0150) via an unspecified route of administration in right arm on 01May2021 12:00 as 1st dose, single dose for COVID-19 immunization. On 22May2021, patient was experiencing a rash after getting the second dose of the Pfizer COVID-19 vaccine. She is trying to see if it could be a reaction to the vaccine and what she should do for the rash. Rash was reported as worsened. Patient states she started noticing it in the evening on 22May2021 then she really started to notice it more that 24May2021, like where it was getting kind of bad and stuff. Patient states she received the vaccine on the 22May2021 and so right now she was experiencing a rash and so she was trying to see if the rash was part of could be a symptom of an outbreak or adverse reaction to it. She states because on her arm, it started on her right arm, where she did have the vaccine at, and now it was on her chest and on her neck and everything. She states so she was trying to see if it was related. The adverse events did not result in emergency room or physician office visit. The treatment for the adverse event included use of Hydrocortisone cream by the patient. The outcome of the event was not recovered.   Follow-up attempts are possible, additional information has been requested.
Hospitalization 5/3/22-5/5/22 Nausea, vomiting, diarrhea, weakness, DKA, afib,
On Monday, May 31, 2021 at 1:20am pt. woke up with intense chest pain and labored breathing.  He was able to fall back to sleep and woke up two hours later (3am) with the pain escalating.  He did fall back to sleep again and once again woke up at 9am only to learn the pain was even worse and was barely able to breathe.  He called me, his mother, and I raced him home and straight to our local Emergency Room.  The ER originally thought it was a collapsed lung.  After the x-ray came back negative for a pneumothorax, they continued testing.  The very last test they did showed extremely elevated Troponin numbers at 1.05 and C-reactive Protein (CRP) numbers at 5.42.  We were transferred by EMS/ambulance to the hospital 40 minutes away and checked into the Pediatric Intensive Care Unit (PICU). Pt was admitted in the afternoon of May 31st and was released on June 3rd at 1:30pm.  June 1st his Troponin was 0.26 and CRP was 6.10.  June 2nd Troponin was .45 and CRP was 3.54.  The day he was released from the PICU (June 3rd ), his Troponin was .45, and the CRP was down to  1.83.  Pt received daily EKGs, 24-hour heart monitoring, constant blood pressure tests, as well as blood oxygen levels.  Once released from the hospital, Pt will be on light duty for at least a week, if not more.  First follow-up Cardiologist appointment was June 8th at 10:30am.  Echocardiogram, EKG, and blood work was ?normal.? Pt was put on a 72 hour heart monitor on June 8th and will be removed June 11th.  Will start weaning off Ibuprofen and acid reducer, Pantoprazole, the next three weeks.  Will continue to take Colchicine for three months, as well as light movement and exercise, nothing strenuous (swimming, running, etc.).  Follow-up with cardiologist in one month (beginning of July).
Left arm is sore; This case was reported by a consumer and described the occurrence of pain in arm in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2019, the patient received the 2nd dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and asked could I exercise. The reported stated that there are no contraindications to exercising after receiving the Shingrix vaccine. The patient stated that even though the patient left arm was sore at the time of reporting, and can work out with arm weights. The reporter stated they did not had any contraindications to exercise as I said but it was always good to check with your healthcare provider as we are unable to give medical advice
Was sitting on exam table. Medical Asst. noticed child looked white and sweaty. Laid patient down on exam table. Patient recovered fully after a few minutes.
pt recvd vax & reported stomach ache & fever of 102 the eve p/ vax; pt did not become ill the next day;
Pt received the flu vaccine on 9/20/10 and presented to ER with Bell's Palsy the next day. No other history of viral infection or illness that would cause this.
Caller's son received the 1st dose of the Moderna vaccine on April, never received the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Caller's son received the 1st dose of the Moderna vaccine on April, never received the 2nd dose) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Caller's son received the 1st dose of the Moderna vaccine on April, never received the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Caller's son received the 1st dose of the Moderna vaccine on April, never received the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Sudden onset of sinus drainage from 10:00 PM to bedtime and again the next morning.  The event was minor and similar to annual hay fever alergic reaction and lasted 12 hours
fever, swollen lymph nodes, fluid filled vesicles .Fever 3 days ago, vesicles x1 day
Dizziness, tremors, fast heartbeat, strong tingling in fingers.  Symptoms onset 30 minutes after vaccine was administered and subsided about 2 hours later.  Primary care physician suggested that skipping breakfast may have been a contributing factor (I sometimes skip breakfast; I had not eaten for about 14.5 hours at the time the vaccine was administered).
Sudden hearing loss on left ear accompanied by fullness in the left ear and muffled sounds.
Covid-19; Mild chills; a little bit sore Arm; A spontaneous report was received from a health care provider regarding a 54-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, a little bit sore arm and a positive COVID-19 test.  The patient's medical history as provided by the reporter included a positive COVID-19 test. No concomitant medications were reported.    On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 03 Jan 2021, the patient experienced mild chills, a little bit sore arm. A few days later,  on an unknown date, she tested positive for COVID-19.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The event, chills, a little bit sore arm and a positive COVID-19 test was considered to have an unknown outcome.  The reporter did not provide causality for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events chills and pain arm, a causal relationship cannot be excluded. The causality for the event COVID-19 is assessed as unlikely, based on its known causative agent. It is likely that the patient was already infected with the virus but was asymptomatic before being administered with the mRNA-1273 vaccine.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 11-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10 PK SD-PFS LLok w Tip", 0.5 ml lot # L007720 with expiration date: 08-JUL-2016 (strength, route of administration were not reported). No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the longest reported temperature excursion lasted 168 hours, with a lowest recorded temperature of 1 F (also reported as 1 Celsius degree). There was also another excursion on an unknown date which lasted 96 hours with a lowest recorded temperature of -1 F (also reported as -1 Celsius degree). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases received from the same reporter. Additional information has been requested.
Softball sized raised lump at injection site that was red, hot, itchy, sore, and hard. Painful to the touch.; Softball sized raised lump at injection site that was red, hot, itchy, sore, and hard. Painful to the touch.; Softball sized raised lump at injection site that was red, hot, itchy, sore, and hard. Painful to the touch.; This is a spontaneous report from a contactable other health care professional (Patient).    A 36-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0151 and expiration date was not re-ported), via an unspecified route of administration, administered in Arm Right on 22Apr2021 13:30 (at the age of 36 years), as single for covid-19 immunization. Medical history included depression, anxiety, low back pain, known allergies: Latex, adhesive, Strattera, Wellbutrin. Concomitant medi-cations included metoprolol tartrate, hydrochlorothiazide, esomeprazole sodium (NEXIUM), ven-lafaxine hydrochloride (EFFEXOR SR) taken for an unspecified indication, start and stop date were not reported taken in two weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and unknown if covid tested post vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6217 and expiration date was not re-ported), first dose an unspecified route of administration, administered in Arm Right on 01Apr2021 15:30 (at the age of 36 years), as single for covid-19 immunization. On 23Apr2021 02:00, the pa-tient experienced Softball sized raised lump at injection site that was red, hot, itchy, sore, and hard. Painful to the touch. The outcome of the events was reported as resolving.    No follow-up attempts were possible. No further information was expected.
3 DAYS POST VACCINATION PATIENT BROKE OUT INTO A CHICKEN POX LIKE RASH ALL OVER TRUNK AND EXTREMITIES SUPER ITCHY RED BUMPS, WAS NOT EXPOSED TO ANYTHING ELSE, NOR HAD IT BEFORE. NO OTHER ALLERGENS OR IRRITANT EXPOSURE
day p/vax pt broke out w/6 pox then covered w/pox by 6/13. temp 101f. will not eat or drink due to pain in mouth & throat.
2 inch diameter rash at site with rough red skin, Aching large joints, muscle soreness/stiffness
Pt presenting for several days of ascending weakness and paraesthesias without SOB or difficulty swallowing. Pt had been recovering well from surgery however starting last weekend started experiencing numbness and tingling of the distal b/l UE/LE. By 10/27 he was having difficulty ambulating due to weakness in the lower extremities and experienced a fall without injury. By 10/29 he was experiencing facial/tongue/lip parasthesias although not affecting his speech or ability to eat or drink. o Risk factors: recent surgery (L hip TR) on 10/8 and received flu shot during that admission   Workup: o LP - sent WBC, RBC, gram stain, glucose, protein, Lyme, and ME panel    History examination are compatible with AIDP, at this point more affecting sensory than overt motor pathways.  CSF analysis consistent.  Unclear if his complaints of pain today are related to the IVIG or another manifestation of his neuropathy. Different diagnosis might include Lyme disease, though that seems less likely, laboratory investigation pending. Recommendations as detailed below.  Continue with IVIG, add p.r.n. Muscle relaxant, consider gabapentin. Does not require MRI imaging in my opinion. No indication of any respiratory distress, RT to monitor NIF/vital capacity daily Plan: o Will follow up on pending results of LP  o If results are suggestive of GBS will start IVIG
Late on April 8th injection sight swelled and got red and hot to touch. Lymph node pain in left armpit sore. On April pain in lymph node lessened but injection site still swollen and hot to touch. Woke up at 3am and was very itchy and developed red itchy blotches on both breast, ride side of rib cage and right side of groin area. Took Benadryl and itchiness lessened. Woke up with red blotches on the same areas that were itchy . Just took more Benadryl at 10:30am on April 10 to control itchiness on torso and injection site.
Both eyes swelled shut, still dry and itchy. Right arm swelled to size of football. Red band extended from back to front of arm. Hard knot in bicep, very sore, very hot.
Hand Numbness and tingly. Wednesday Small symptoms kept going on. Blood flow to hands deteriorated. Couldn?t move feet, Feet became dusky. This all happened Thursday after symptoms became worse.  Blood pressure elevated 175/100. Usually 110/70. Heart rate 170s generally  65-70.  I was at work as a nurse and I about coded. Was taken to er.
Shot received 2:45 pm pain and swelling around 6 pm bruuse approximatrly 8 pm soreness also by bedtime - 10 pm.
Sudden paralysis of hands and arms on July 10 2021. Sudden paralysis of hands and arms on August 1 2021.
Patient is a 65 y.o. male patient of local MD with history of COPD with chronic hypoxic respiratory failure (on 3-4L NC), DM2, chronic venous stasis with chronic BLE wounds, OSA noncompliant with CPAP who presents with AMS and hypoxia, COVID positive    Acute on chronic hypoxic hypercapneic respiratory failure COVID-19 Acute COPD exacerbation H/O left upper lobectomy  Found to be confused at his PCP office, hypoxic on RA (wasn't wearing his baseline O2 of 4L), bradycardic to 30s, and hypotensive to 70s. Semi-emergently intubated in ER due to worsening responsiveness.  Pulmonology consult appreciated Intubated Completed 10 day course of IV Decadron  Hold IV Lasix due to hypotension DuoNebs   VAP Chest x-ray-retrocardiac consolidations noted, sputum cultures MSSA and haemophilus influenza MRSA probe is positive, blood cultures negative Due to worsening hypoxia, antibiotics broadened to vancomycin and ceftriaxone on 11/4 Sputum culture positive for MRSA and Haemophilus Influenzae  MRSA DNA probe positive Abx stopped on 11/09/22 due to palliative extubation and changing to DNRCC Blood cultures negative Pulmonary consulted.    Bilateral chronic venous stasis Noted right lower extremity purplish discoloration and cold Bilateral ABI-mild peripheral artery disease noted Monitor   Shock  Unlikely Cardiogenic as per Cardio ECHO- preserved LVEF, with right ventricular systolic dysfunction CTPE- no p.e, probable Pulmonary HTN Likely due to hypovolemia and sedatives Initially required pressors but weaned off Hypotension on 11/8/22 and not responsive to fluid boluses Family wanted to hold off on additional IVF boluses and/or pressor Covid-19 Virus Infection Date of onset of symptoms: 10/25/22 Symptoms present on admission: lethargy Date of covid positive test: 10/27/22 Vaccination status: unvaccinated (according to brother POA) Imaging: CXR with left whiteout, CHF Oxygen requirements on admission: up to 15L NRB, intubated 10/27/22 Medical therapy: Finished course of steroids.  CRP <75 Consultants following: pulm critical care Anticipated special isolation end date: TBD    Metabolic Encephalopathy Delirium Due to polypharmacy, recent start of Marijuana, on Flexeril and Gabapentin CT head on admission- normal On delirium protocol, up titrated Seroquel to 25 mg 3 times daily   T2DM Home RX: lantus 20 units at bedtime, SSI. Recent A1C 7.8% in June 2022. On decreased dose of lantus to 10 units given relative normoglycemia, continue SSI Blood sugar stable    Nutrition Received TF Add free water 300 every 6 hours Bowel regimen   Goals of Care Palliative Care consulted.  Palliative extubated on 11/09/22 and pronounced deceased at  1310 DNRCC
Patient Received a non viable vaccine on 04/18/2023 with Immunization System expiration date of 03/31/2023 and BUD expiration date of 04/25/2023. No harm was cause to patient. Patient will return to complete series with Bivalent Covid vaccine.
This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 79-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FK49894F), in right arm for covid-19 immunisation. The patient's relevant medical history included: "POTTS" (unspecified if ongoing), notes: POTTS. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Left), administration date: 12Jan2021, when the patient was 77-year-old, for COVID-19 immunization, reaction(s): "1st-5th doses mild flulike: HA, SLcough, fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough, fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs"; BNT162b2 (Dose Number: 2, Batch/Lot No: N9581, Location of injection: Arm Left), administration date: 02Feb2021, when the patient was 77-year-old, for COVID-19 immunization, reaction(s): "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), HEADACHE (non-serious), COUGH (non-serious), FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs".  Additional Information: COVID prior vaccination reported as No. COVID tested post vaccination reported as yes. COVID test post vaccination, test date 30Nov2021. result positive. Known allergy reported as unknown. Device Date : 17Dec2022.; Sender's Comments: Linked Report(s) : PFIZER INC-202201380992 same patient and different drug dose/events.;