chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Period has been delayed for a week; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Sep2021 at 11:00 (at the age of 35-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Oct2021 at 11:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included pulmonary stenosis, mitral valve prolapse and hypothyroidism. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 01Oct2021 at 15:45, the patient had her period been delayed for a week now (at the time of this report) and had timely periods for the past 5 years. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of event. Since the vaccination, the patient had been tested for COVID-19. On 05Oct2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the event period had been delayed for a week was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Could not walk for 3 days, screaming in pain lasting hours and even in her sleep, huge red bump at site of vaccination.
who was first admin MMR II in MAY Of 2020 when she was 18 years of age; This spontaneous report was received from a certified medial assistant and refers to an 18-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date in May 2020, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (exact dose, site and route of administration, lot# and expiration date were not reported) for prophylaxis. The patient, who was then 19 years old, came back to get her second dose. The reporter wanted to confirm if they should start the doses over of just complete the series.
Patient is a 79 y.o. female admitted to the hospital on 12/25/2022 for with fever, intermittent confusion, cough, and positive COVID test. Symptoms improved with fluids and supportive therapy. Briefly placed on 2L O2 however likely did not need this. Received 1 dose of dexamethasone. Discharge home with no changes to meds. Considered paxlovid however avoided due to interaction with home eliquis.   Discharge Diagnosis and Hospital Course   Comments/Problems to be Addressed After Discharge - Follow up with PCP in 1 week for hospital follow up. Isolate for 5 days post symptoms onset and wear a mask around people for 10 days post symptom onset. Advised patient to monitor O2 levels at home.    COVID-19 - Symptom onset 12/21 with cough, sore throat, congestion, fever, and confusion when febrile. Positive test 12/24. Vaccinated and boosted. Received 4 total shots with last in April 2022.  - CXR on admit w/ few areas of interstitial changes but overall unremarkable. - Briefly on 1-2L. Received 1 dose dexamethasone.  - Does not qualify for remdesivir. Considered paxlovid on discharge however concern for significant interaction with eliquis.  - Weaned off O2 and no need for home O2. Follow up with PCP in 1 week.    Acute encephalopathy, resolved - In setting of parkinson's disease and likely metabolic with hyponatremia contributing. Reported periods of confusion when she was febrile PTA, would improve as fever resolved. - CT head on admission unremarkable. - Alert and oriented on exam this morning without focal neurological deficits.   Hyponatremia - Likely in setting of PO intake. Sodium 126 on admission. Was started on LR infusion for about ~1.5 L in. - Urine sodium of 46. Osmolality 275. - Improved to 130 s/p fluids.    Permanent Atrial Fibrillation - With single-chamber pacemaker.  Follows with Dr.  - Continue home Eliquis and Coreg.  Parkinson's disease - Follows with Dr. in movement clinic and on carbidopa/levodopa and midodrine for orthostasis. - Continue home dosing of carbidopa/levodopa. Patient has follow up scheduled with neurology.   Hypertension with history of orthostatic hypotension - Continue home carvedilol 12.5 mg daily and midodrine with carbidopa/levodopa orthostasis. - Can tolerate some supine hypertension if needed.   Hypothyroidism - Continue home Armour Thyroid 60 mg daily.   Depression and anxiety - Continue home paroxetine
3 days after the 2nd dose, I was getting ready for bed when all of sudden my heart rate raced up to almost 160/minute. I heard clearly my heart beat like thunder. I felt nausea and both sides of my head above the ears were feeling like going to explode. I sweated and couldn't stand or sit. Fortunately I was sitting on the bed and managed to lay down. Then I lost conscious. The next morning when I woke up I was feeling okay. But ever since, my heart rate goes up easily with mild activities. I also can't lay on my left side because this position pressed my heart feel and make it aching and I will have a hard time to breath.
once the person recieved the vaccine within a minute he felt dizzy, dry mouth, blurred vision, kept sweating he asked for water but he lost control of his muscle and the water spilled on his pants. We called 911, then after about 6 minutes he felt ok even before 911 arrived.
Patient received Fluarix Quad by GSK she stated had normal soreness, but when it lasted more than 24 hours she realized her arm was red, swollen, and hot. Now over 1 month later and still swollen and she has a huge bump in injection site area
mild chest tightness, cough, feeling anxious and lightheaded minutes after receiving the shot  pt received:  Benadryl 25 mg iv push  Solumedrol125mg iv push   Normal saline 1000ml IVpb
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On 21-SEP-2018, the patient was vaccinated with PROQUAD, subcutaneously for prophylaxis (lot#, expiration date, dose, strength and frequency were unknown). On the same date, the patient was vaccinated with Oka/Merck VARIVAX subcutaneously for prophylaxis (lot#, expiration date, dose, strength and frequency were unknown). On 21-SEP-2018, the event was considered to be an inappropriate schedule of drug administration, no adverse effects were reported.
9APR94 reddened & small hard area @ site; reddened area became larger on 12APR93 showed larger hot, red area to MD; area kept inc in size & became itchy;
Information has been received from a health professional concerning a 13 month old male with no known medical history or allergies who on 08/02/2004 was vaccinated with a dose of varicella virus vaccine live.  Concomitant therapy included sulfamethoxazole/trimethoprim and pimecrolimus.  On 09/23/2004 the patient developed a chickenpox like rash with papular and some vesicular lesions over his body.  The patient was afebrile.  It was reported that some spots appeared off and on for two weeks prior to this date.  Unspecified medical attention was sought.  Subsequently on 09/23/2004, a titer for IgG and IgM were negative.  The patient was treated with diphenhydramine hydrochloride.  There was no product quality complaint involved.  Additional information has been requested.
Patient woke up this morning and it was noted that her R arm was red, inflamed, and hot to the touch. A "hard knot" was felt at injection site. She c/o itching at the site. No fever noted. L arm was just red at injection site but no other symptoms. Parents took patient to pediatrician's office and was told to administer Benadryl or Claritin to child along with IBUprofen for discomfort. Also to place ice on area of reaction. No other treatment was advised. Parent reports patient has complained minimally of pain and had no reaction noticed until this AM.
HYPOXIA ANGIOEDEMA, INIT ANGIOEDEMA, SUBSEQ
Stated on lots of meds, 3 days after injection she developed hives all over. Her doctor said that hives are of unknown etiology. Going to allergists.
pt recvd vax 6NOV95 early AM hrs of 7NOV95;pt crying for approx 5 seconds, then began sz activity, stopped breathing;EMS responded, resuscitated;pt hospitalized
Infants parents speak very little English. When asked about vaccines they provided a shot record showing patient had only had Hep B at birth. 2 Month vaccines were administered. When putting vaccines into NCIR we found patient had received vaccines on 6-5-07 at PHD.
body shaking; chest pain; pain in throat; muscle aches; joint aches; headache; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (COVID arm), TREMOR (body shaking), CHEST PAIN (chest pain), OROPHARYNGEAL PAIN (pain in throat) and MYALGIA (muscle aches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (COVID arm). On 15-Feb-2021, the patient experienced TREMOR (body shaking), CHEST PAIN (chest pain), OROPHARYNGEAL PAIN (pain in throat), MYALGIA (muscle aches), ARTHRALGIA (joint aches) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (COVID arm), TREMOR (body shaking), CHEST PAIN (chest pain), OROPHARYNGEAL PAIN (pain in throat), MYALGIA (muscle aches), ARTHRALGIA (joint aches) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not provided. Treatment details included Tylenol.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 09Jan2021 as dose 2, single (Lot number: EL0142), in left arm and on 12Nov2021 as dose 3 (booster), single (Lot number: 320308D) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies allergic to penicillin" (unspecified if ongoing); "known allergies allergic to sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Vicodin, reaction(s): "known allergies vicodin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The causal association between the events and suspect vaccine cannot be excluded based on known safety profile. Case will be reassessed on receipt of more information.
Discharge Diagnoses and Associated Hospital Course:   Patient is a 78 y.o. male with history of HTN, HLD, DM, prior SBOs managed conservatively (11/2019), L CVA with residual deficit (7/14/22) who presented to hospital as transfer on 12/12/2022 with concern for SBO 2/2 internal hernia & strangulated small bowel.    Admitted with these risk variables:Encephalopathy, Acute Kidney Injury, Chronic Kidney Disease, and Acidosis. Please see assessment and plan for further details.   CT A/P IV Contrast (12/12): SBO w/ incarceration & strangulation 2/2 internal mesenteric hernia in R abdomen & pelvis. Suspicious for small bowel ischemia.    SBO w/ concern for strangulated small bowel Lactic Acidosis, resolved  AKI on CKD, resolved  Hyperglycemia, resolved COVID Positive - s/p reduction of small bowel volvulus, LOA on 12/13/2022 - kept intubated post-op; extubated 12/13 to HHFNC; now on RA  - NGT removed 12/15 - Postoperatively, the patient had slow return of bowel function, his diet and activity were advanced cautiously.  He was maintained on DVT prophylaxis throughout his hospitalization.  Please refer to daily progress notes for detailed clinical progression.   COVID-19 infection tested positive 12/12/2022, unsure symptoms due to encephalopathy however noted hypoxia on presentation with bilateral infiltrates. Decadron started 12/13/22, stopped 12/19/22. Patient on RA as of 12/17/22.   Acute respiratory failure with hypoxia CXR with mild opacities in lung base, possibly sec to aspiration vs COVID 19. required O2 prior to surgery. Remained intubated postoperatively 12/13/22 extubated to HHFNC. Required 60L HHFNC with fiO2 50% 12/14/22. Resolved.   Acute Metabolic encephalopathy noted on admit. Unclear baseline, suspect sec to above. Management as noted. Remains intermittently confused as of 12/18/22   AKI on CKD stage 3  baseline Cr 1.5-2. On admission 4.39. S/p IVF. Resolved. Monitored.  PAF or PSVT EKG in ED showed afib with RVR rate 150's. No history of a fib, +history of SVT, rate back to 110's spontaneously. Repeat EKGs with sinus tachycardia. S/p scheduled IV metoprolol, transitioned to home metoprolol. Continue telemetry monitoring. Recommended outpatient follow-up with cardiology.   DM2 hold oral medications, SSI.    HTN  continue home amlodipine. Held home hydrochlorothiazide, lisinopril for soft BP. Restart as tolerated.
Arm was in pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was in pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (her lymph nodes were removed from right side).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm was in pain). On 10-Feb-2021, VACCINATION SITE PAIN (Arm was in pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication provided no treatment given
Moderna Covid-19 Vaccine EUA Fatigue 9:30pm1-17-21 to current time (10:00am) Chills 11:00pm 1-17-21 to 1:00am 1-18-21 Migraine 1:00am 1-18-21 to current time (10:00am)
12Apr- Developed full body rash with extreme itching from scalp to soles of feet and palms of hands. - took Claritin and applied Benadryl cream in AM, used Aveno Lotion and took Benadryl in PM.  13 Apr- rash worsened - continued at-home remedies with no relief. Saw PCM and received prescription for prednisone and steroid cream.  Unable to get prescription filled and rash worsened. Saw Urgent care in the evening and received steroid injection and advised to continue with PCM instructions when I received prescription.  14 Apr- Rash continued to worsen, lips swollen and blistered, sores/blisters inside mouth and on tongue.  Picked up prescription prednisone and cream and used them with no relief yet. Returning to doctor or ER on 15 Apr if it continues.
Information has been received from a health professional concerning a 16 year old female who on 07-MAR-2007, was vaccinated with Gardasil (Lot# 654535/0960F). There was no local site reaction but on 07-MAR-2007, the patient became dizzy and pale. The patient had to wait 20 minutes in the waiting room before she was fine (recovered). Additional information has been requested.
Fever (103.3), Chills, loss of smell, headache, nasal congestion, persistent coughing, sneezing and fatigue.
an hour after my injection I had tingling and numb sensation on my face. I checked in the mirror to see if i was having a stroke but I was fine. I was still numb and tingly so I went to the ER (03/8/21) a few days later. its now been 2 weeks and I get the numbness and tingling off and on. Doctors say to just keep an eye on it and make sure I don't get any drooping. I can still feel myself touch my face but it still has a tingly numb sensation.
Dizzy, vertigo, difficulty breathing immediately after shot. Dizziness subsided after a few hours, typical arm pain at the injection site a few days after. Fatigue and difficulty breathing increased over the next few days. On the third day after injection, experienced cognitive difficulty using words, vertigo. Went to emergency for possible stroke symptoms. Cognitive testing, Brain CT scan w/contrast, MRI, Echocardiogram, 24 hour in patient observation. All negative. Still experiencing shortness of breath and anxiety a week after injection.
Extremely itchy hives scalp, neck, ears, forearms, ankles and lower legs, abdomen/severe case of hives; Occasional wheezy cough; sore throat; runny nose; Occasional wheezy cough; This is a spontaneous report from a contactable consumer, the patient.  A 73-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL9269), via an unspecified route of administration, administered in Arm Left on 11Feb2021 at  15:30 (at the age of 73 years old) as SINGLE DOSE for covid-19 immunization;  chlorphenamine maleate, dextromethorphan hydrobromide, paracetamol, phenylephrine hydrochloride (ALKA SELTZER PLUS COLD &COUGH FORMULA, Lot number not provided), (reported as 'Alka Seltzer Plus Severe Cough, Mucous, Congestion') orally on 24Feb2021 at 22:00 1 DF single dose  (LIQUID GEL CAP) for sore throat runny nose and wheezy cough.   Medical history included hypothyroidism, osteoporosis, drug hypersensitivity (Allergy to: Penicillin). Concomitant medication(s) included levothyroxine (LEVOTHYROXINE); atorvastatin (ATORVASTATIN); alendronate sodium (ALENDRONATE).  No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 24Feb2021 the patient experienced occasional wheezy cough, sore throat, runny nose.  On 25Feb2021 The patient experienced extremely itchy hives scalp, neck, ears, forearms, ankles and lower legs, abdomen/severe case of hives. The clinical course as reported by patient is as follows experienced Extremely itchy hives scalp, neck, ears, forearms, ankles and lower legs, abdomen. Possibly reacted to combination of vaccine and 1 gel capsule of Alka Seltzer Plus Severe Cough, Mucous, Congestion Liquid Gel which I took for a sore throat, runny nose and cough. Have never had hives before. Have never had reaction to gel cap. Had NO reaction to vaccine first 13 days. Yesterday had a wheezy cough, runny nose, sore throat. Didn't think due to vaccine. Took gel cap about 10pm 24Feb2021. Within 2 hours had severe case of hives still present over 12 hours later, though lessened. Occasional wheezy cough. New symptom last 2 days. Not sure if linkage.  Treatment was given as a result of occasional wheezy cough, sore throat and runny nose. No Treatment was given for hives. The clinical outcome of the hives was recovering while the remaining events wheezy cough, sore throat and runny nose were not recovered.
Initial misuse report received from a health care professional on 17 January 2014 and at GPV on 21 March 2014. A 35-year-old patient of unknown gender had received FLUZONE HD. The patient received FLUZONE HD at an incorrect age. No adverse event was reported. The list of documents held by sender: none
Expired vaccine is stored and then administered; doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. No temperature excursion and no adverse event was reported. Vaccine was placed in refrigerator on 22-Sep-2021. Treatment details were not given.
Nausea; Lethargic; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 18Mar2021 at 09:00 (at the age of 40 years) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not tested positive for COVID-19 after vaccination. On 19Mar2021, the patient experienced nausea and lethargy. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events nausea and lethargy was reported as not recovered.  Information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information include in patient tab, patient name updated , for event lethargic no treatment  was received. Final sentence should be updated to no follow-up attempts are possible; information about lot/batch number cannot be obtained. Relevant history none added since not provided, pending PSSR review.
Started having massive headaches to the point of not thinking "straight", and feeling tired all of the time.  Was not having this until after the vaccine.