chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Feb2021 at 12:00 as dose 1, single (Lot number: EN 6205), in left arm, on 20Mar2021 at 15:00 as dose 2, single (Lot number: EP 7534), in right arm and on 20Oct2021 at 12:00 as dose 3 (booster), single (Lot number: EWD173) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing); "Axial Spondylarthritis" (unspecified if ongoing); "Herpes" (unspecified if ongoing); "latex" (unspecified if ongoing); "gluten" (unspecified if ongoing); "capers/mango" (unspecified if ongoing); "pistachios/cashews" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Doxycycline, reaction(s): "Known allergies: Doxycycline"; Formaldehyde, reaction(s): "Known allergies: formaldehyde"; Beta interferon (avonex), reaction(s): "Known allergies: beta interferon (avonex)". The following information was reported: COVID-19 (medically significant) with onset 18May2022 at 16:00, outcome "unknown", VACCINATION FAILURE (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) Positive; (13May2022) Negative; SARS-CoV-2 test positive: (unspecified date) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment medication was not provided. Action taken with mRNA-1273 in response to the events was not Applicable.     This case was linked to MOD-2021-027635 (Patient Link).
States received 5 doses of Pfizer BioNTech COVID-19 vaccine and has become infected with COVID-19 Mar2023; States received 5 doses of Pfizer BioNTech COVID-19 vaccine and has become infected with COVID-19 Mar2023; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Mar2023, outcome "unknown" and all described as "States received 5 doses of Pfizer BioNTech COVID-19 vaccine and has become infected with COVID-19 Mar2023". It was reported that, event took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, there is a reasonable possibility of a causal  association between the reported adverse events COVID-19, drug ineffective and the suspect  product BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5).
Discharge Provider: MD Primary Care Provider: MD Admission Date: 6/22/2022 Discharge Date: Jul 2, 2022  PRESENTING PROBLEM: Gait instability [R26.81] COPD exacerbation [J44.1] Acute and chronic respiratory failure with hypoxia[J96.21] Injury of head, initial encounter [S09.90XA] Stage 3b chronic kidney disease [N18.32]   HOSPITAL COURSE: Patient is a 79 year old women admitted to the hospital after coming in for right sided headache, blurred vision in her right eye and weakness after falling and hitting her head 2 weeks prior to presentation. She has baseline right sided weakness in her right arm from a stroke in the past. She had a CT head in the ED which was negative for any acute changes. She has been having some shortness of breath with exertion over this 2 week period as well. She was wheezing and diagnosed with a COPD exacerbation. She normally uses 2L nc of oxygen and was requiring more than this during her stay but then weaned down to her home supplemental oxygen. She was treated with steroids and duo-nebs. She received a course of azithromycin for her COPD. She was evaluated by PT/OT who recommended SAR. She was screened for COVID-19 prior to be accepted to SAR but tested positive. Placement then took several more days. During her stay she complained of continued headache. She also felt that her right eye was burning and the vision was blurred in it. Her intraocular pressure was 18.5mmHg (normal). She had slight conjunctival injection. She at baseline has no vision in her left eye since an injury in childhood. A referral to ophthalmology was placed at discharge.
Vaccine administered, within a few minutes child began to cough, c/o sore throat and vomited. He was pale and sleepy.  Blood pressure and HR lower than at start of visit  examined by physician, rested and monitored in office, popsicle given
Blood Clots in left  leg. Removed. from Dr. from Health Services on Thursday, August 19, 2021.  Left groin area down to foot.  Was communicated and recommended I have a stent put in the groin area within a week or two  to prevent it from happening  again. No history in my family. No. Smoker, not on Birth control.
I got my shot 2 weeks ago today and i have metallic taste in my mouth.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 76-years-old female patient received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Mar2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced I got my shot 2 weeks ago today and i have metallic taste in my mouth. It started about 1 week ago. Is that a side effect. The clinical outcome of the events was reported as unknown.  Follow-up attempts completed. No further information expected.
pt terminally ill with hepatocellular carcinoma; had a positive COVID test on 1/24/22; admitted to hospital on 2/1/22; tachycardia, fever, dyspnea; O2 supplementation; hospice GIP due to terminal disease process; hospice addressing sx; Fentanyl patch, Keppra, Ativan and Morphine given; pt passed away in the hospital
Pt. rec'd 11 yr imm. at WCE in office on 8/07/17. On 8/10/17 s/s=HA/blurry vision; 8/12=(+) diplopia. 8/13=O.D. turned inward. Pt. to ER and admitted x 2 days. Dx with "idiopathic intracranial hypertension". Tx'd with DIAMOX 250mg PO BID x3d; then 500mg.
See attached Abdominal pains, myalgias. Patient reports 2 dose of Moderna COIVD 19 Vaccine, 3/6/21, 4/3/21, and after each vaccine, elevated temperature, chills, sweats, sever muscle aches, headaches, abdominal pain, intestinal distress. Patient had to stay in bed after each injection for 2 days. She did not go to ER. As of today, 12/15/21, patient still feels intestinal distress, abdominal pains on a daily basis. She declines a 3rd dose of Moderna booster. Now requiring daily Protonix for gastric distress. Will pursue Gastroenterology Endoscopy at some point.
Arm ached for first 2 days.  On 5/10/19, I threw up for no reason. On 6/2/19 at 9:30 PM, I found myself on the floor and so debilitated with vertigo that I had to call an ambulance to take me to the hospital where I stayed until 6/5/19 This date, 7/5/19, I am functioning at 90%. I could not drive until 7/1/19. My balance is still a little shakey and I'm still taking meclizine 3x per day. Between 5/10 - 6/2/19 I was overly tired and achey. I have since found out that Shingrex can cause 1/100 to get vertigo. I'm really healthy and and until now have never had a reaction to any shot or medication. I get a cold once a year and never have headaches or earaches. The last time I threw up, before this event, was 45 years ago and the result of food poisoning. I still can't believe that I got vertigo so badly that I had to be hospitalized It will be six weeks on Sunday and I'm still not well.
This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 44-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number YR7AA) for prophylaxis.   On 10-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 14-Apr-2023 The patient received unstable vaccines after a temperature excursion, which led incorrect storage of drug. The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Information has been received from a physician concerning a 19 week old male patient who on 30-AUG-2011 was vaccinated with his second dose of ROTATEQ (dose two lot # 669764/0776AA) (date of dose #1 unavailable) and died suddenly two weeks later. No problems were reported to the office after administration, child was not symptomatic. On 09-SEP-2011, the child was discovered "unresponsive, at daycare". The child was life-flighted to hospital. On 14-SEP-2011, the child died. Autopsy revealed child was positive for rotavirus. Death certificate stated "positive for rotavirus". "Unresponsive, at daycare" and "positive for rotavirus" and "died suddenly" were considered to be immediately life-threatening. Follow-up information has been received from the physician concerning the patient received concomitantly on 30-AUG-2011 the following vaccinations: PENTACEL and PREVNAR 13. The physician also stated that he had not spoken with the patient's parents. The patient had been taken from day care to the hospital. He indicated he would send any additional information that he receives concerning the patient. A lot check has been initiated. Additional information has been requested.
Extreme shooting pains left side of head. Tenderness above ear. Left eye pain. Lethargic. Neck pain. Muscle pain.
Information has been received from a certified medical assistant concerning an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. Since an unspecified date in 2015, an unspecified number of patients were vaccinated with VARIVAX (Merck), subcutaneously (lot# reported as K005427, dose, strength and frequency were not provided) which underwent supported temperature excursions (Incorrect product storage). Co-suspect or concomitant therapies were not provided. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a nurse practitioner concerning a 5 year old female pt with no relevant medical history and no known drug allergies who on 13Oct2000 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. An illness at the time of vaccination was urinary frequency with a negative culture. There was no concomitant medication. On 22Apr2003 the pt developed a fever of 104 degrees and chickenpox described as a mild rash that began on the forehead and spread to the neck, back and abdomen with 20 lesions, papules and vesicles. It was noted that there were no other symptoms. There was no relevant laboratory data. Unspecified medical attention was sought. She was treated with acetaminophen (Tylenol) and diphenhydramine HC1 (Benadryl). Subsequently, the pt recovered. No other information is expected.
Systemic: heart pounding and extremely anxious-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: patient repoted with heart pounding and shakiness after receiving the 2nd dose of covid vaccine. patient appeared visibly anxious and patient requested ambulance to be called. patient never experienced difficulty breathing and towards the end stated she could have just been having panic attack. ambulance escorted the patient to further evaluate.
Child is under 4 years of age and was given the vaccine "Kinrix" which is licensed for 4 years through 6 years of age.
Provider discharge summary "These were her acute medical issues addressed this hospitalization:   1. Hypoxia, resp insufficiency likely due to both CHF and COVID infection. -- received 5 days of Remdesivir. Daily Decadron. -- O2 requirement remained stable at 3-4 L nasal canula. -- at discharge, ambulated without significant O2 desaturation while on 3 L. -- not felt to have any superimposed bacterial infection. -- vaccinated patient   2. HFpEF. 3. Group 2 pHTN. -- continued daily Lasix.   4. HTN. -- BP well controlled.   5. PAF -- Rate controlled. Not on any AC due to history of severe epistaxis.   6. COVID infection in vaccinated patient. 7. Facial bruising due to fall at home a week ago.   8. Chronic leukocytosis due to PV. -- cont daily Hydrea.   DC home today 1/22 with home O2 (3L).  homecare and therapies set up."
Had severe headache which lasted for one week then off and on for 3 weeks total. Reported it to employee health. Sent to ER for follow up. CT and MRI done with contrast revealing 1 cm area of demyelination in the posterior right frontal lobe. Follow up with neurosurgeon and follow up MRI in Dec 2009, no worse but not improving. Headaches are gone. MD said it is not an old lesion but does not think it was caused by the H1N1 vaccine. I am still questioning that point. Have a follow up MRI in March 2010. Have to follow up with neurologist.
Woke up w/red swollen eyes.  After shower began scratching and notices raised skin.
Pt. was scheduled for booster of Moderna 0.25ml and received immune comprimised dose 0.5ml. Pt. informed immediately when occurance recognized.   Pt. monitored thoughout remaining of shift here at clinic, instructions given to go to dr post hours and to report any adverse side effects, pt. reported upon return to work on following Tuesday, no adverse reactions, felt fine.
AFTER RECEIVING VACCINE SHE COMPLAINED OF HEADACHE AND LIGHT HEADEDNESS. GLUCOSE 69, BP 156/96  HR 68  100% O2 ON ROOM AIR SHE WAS TREATED WITH ORAL GLUCOSE WAITED 15 MINUTES RECHECKED GLUCOSE  WAS 75MG/DL AND SHE FELT BETTER. SHE WAS RELEASED TO HOME, WITH A RECOMENDATION TO GET SOMETHING TO EAT.
Patient received vaccine approximately 8:30pm, monitored for 20 minutes and returned at 9:15pm with the following symptoms: redness on his face and upper extremities and itching throughout his back. No signs or symptoms of labored breathing and given diphenhydramine to decrease the swelling.
UTI; Dropped bladder; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A female patient of unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Feb2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced UTI (urinary tract infection) but she had a dropped bladder and she do get frequent UTI's. Therapeutic measures were taken and She was on Keflex for a UTI and scheduled Thursday for her second dose and inquired Is it ok to get the vaccine while taking Keflex. The outcome of the events was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Severe heart palpitations, weight loss, and a recent diagnosis of Graves Disease.  Starting methimicil and currently on atenolol.  No symptoms prior to vaccine.  Thyroid was checked a year or so ago and was fine.
pt woke p/noc sleep; went into bathroom had diarrhea; became very weak, diaphoretic, dizzy; once back in bed, had nausea w/vomiting; devel a severe h/a & lumbar back pain immed; APAP for h/a & low grade fever 98.8;
This spontaneous report as received from licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not provided. On 03-FEB-2015, the patient was vaccinated with a dose of M-M-R II (dose, lot number and expiry date were not provided) and a dose of VAQTA (dose, lot number and expiry date were not provided) that underwent a temperature excursion. The VAQTA dose was supported while the M-M-R II dose was not supported. No adverse experiences were reported. Additional information has been requested.
Patient reports about 3 hours post-vaccination, she started having lower back pain. As the days progressed, she also reported shoulder pain and couldn't lift her arm. The back pain moved from lower back to mid-back. She also is now experiencing waves of nausea that come and go.
Rash red, raised tender area at the injection site Narrative: ice and benadryl
Based on readings of my smart watch, my heart rate bpm was almost double the normal value for 2 days after the injection. Normal for me in the average resting range is 60-75 bpm (based on over 2 years of daily readings) and after the injection, the rate was 77-101 the first day after injection and 67-99 the 2nd day after injection and is still higher than normal today, the 3rd day after. Is this something to be expected? It is not noted in the adverse reactions information provided with the injection, nor could I find any info about this via a web search.
4/10/14 (R) arm  - swollen lump at site of VARIVAX injection. Size of 25 cent piece. Slight rash on back of neck up to ear for past 48 hours. Afebrile til 4/16 evening. T 100.5. 4/11/14 Seen in office. Hands  and feet swollen, red. T98, SpO2 96%. Rash on neck. Recom. BENADRYL.
awoke next day following flu vax w/severe h/a;no other sx;recv partial relief w/advil;slept most of day;
The shot hurt immediately, burning through my arm in a way I've not experienced before. My headache onset was also on my drive home, which I hadn't experienced. Two days later (the adverse event timing I've put here), I had noticeable reddening, swelling, and itching at the site of the injection. Over the next several days, the reddening, swelling, and itching had spread around my arm. One week after my booster (6/13), I showed a pharmacist the red spot and she suggested I start taking Benadryl at bedtime. Although even today (12/23) my arm is still slightly itchy, it's no longer swollen or red. The booster I'm reporting is Moderna, my previous two doses were Pfizer.
pain and redness at injection site, low grade fever, chills, body aches, arm pit pain, dizziness
Headache, body aches, nausea, chills, fever - 48 hours
Loss of appetite; arm pain; Fatigue; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), PAIN IN EXTREMITY (arm pain), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included DILTIAZEM, ESCITALOPRAM, ATORVASTATIN, CHONDROITIN SULFATE SODIUM, GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (GLUCOSAMINE + CHONDROITIN [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE SULFATE POTASSIUM CHLORIDE]), CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN C [ASCORBIC ACID] and FISH OIL.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DECREASED APPETITE (Loss of appetite), PAIN IN EXTREMITY (arm pain), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache). On 09-Mar-2021, PAIN IN EXTREMITY (arm pain) had resolved. At the time of the report, DECREASED APPETITE (Loss of appetite), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment information not provided.
diarrhea; Chest pain; Diaphragmatic pain; upset stomach; Nausea; red dots around injection site; dizziness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), DIZZINESS (dizziness), DIARRHOEA (diarrhea), CHEST PAIN (Chest pain) and DIAPHRAGMALGIA (Diaphragmatic pain) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), DIZZINESS (dizziness), DIARRHOEA (diarrhea), CHEST PAIN (Chest pain), DIAPHRAGMALGIA (Diaphragmatic pain), NAUSEA (Nausea) and VACCINATION SITE ERYTHEMA (red dots around injection site). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 07-Aug-2021, HEADACHE (Headache) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), DIZZINESS (dizziness), DIARRHOEA (diarrhea), CHEST PAIN (Chest pain), DIAPHRAGMALGIA (Diaphragmatic pain), NAUSEA (Nausea) and VACCINATION SITE ERYTHEMA (red dots around injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  Took tylenol for symptoms, patient states that only helped with headache but other symptoms do not go away.
Symptom onset started the day after the injection (Sunday), she complained of severe arm pain with some associated joint pain in the shoulder. She was instructed to take Naproxen OTC 2 tablets to start then 1 every 12 hours until feeling better, take TYLENOL 500 mg, 2 tablets every 6 hours (max 4000 mg /24 hours) and to ice the injection site. This was started on Sunday in the evening. Patient was called Monday for follow up and stated she was feeling better, but still sore, followed up on Thursday, and stated that she was still feeling better, but still sore.