chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left arm swelled up at the injection site; left arm red at the injection site; Left arm slightly painful upon pressure at injection site / size had expanded and it was sore; Reaction to that vaccine, Covid Arm; left arm hard at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Reaction to that vaccine, Covid Arm), VACCINATION SITE INDURATION (left arm hard at the injection site), VACCINATION SITE SWELLING (left arm swelled up at the injection site), VACCINATION SITE ERYTHEMA (left arm red at the injection site) and VACCINATION SITE PAIN (Left arm slightly painful upon pressure at injection site / size had expanded and it was sore) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. #032M20A and 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Factor V Leiden mutation, Asthma and Allergy to antibiotic (Allergy to erythromycin.). Concomitant products included SALBUTAMOL (VENTOLIN [SALBUTAMOL]), MONTELUKAST and NATTOKINASE for an unknown indication.   On 09-Mar-2021 at 10:46 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION SITE REACTION (Reaction to that vaccine, Covid Arm). March 2021, the patient experienced VACCINATION SITE INDURATION (left arm hard at the injection site), VACCINATION SITE ERYTHEMA (left arm red at the injection site) and VACCINATION SITE PAIN (Left arm slightly painful upon pressure at injection site / size had expanded and it was sore). On 19-Mar-2021, the patient experienced VACCINATION SITE SWELLING (left arm swelled up at the injection site). On 29-Mar-2021, VACCINATION SITE SWELLING (left arm swelled up at the injection site) had resolved. At the time of the report, VACCINATION SITE REACTION (Reaction to that vaccine, Covid Arm), VACCINATION SITE INDURATION (left arm hard at the injection site), VACCINATION SITE ERYTHEMA (left arm red at the injection site) and VACCINATION SITE PAIN (Left arm slightly painful upon pressure at injection site / size had expanded and it was sore) outcome was unknown. Not Provided          Patient went to an Urgent care and the emergency room, but no treatment information mentioned. It was also reported that patient had no reactions to second shot. Patient was on Pyconogel 200 mg two times a day, indication - blood thinner  Nattokinase - indication - blood thinner.   Most recent FOLLOW-UP information incorporated above includes: On 03-Oct-2021: Updated patient date of birth On 03-Oct-2021: updated patient demographics, past medical history, vaccine details, concomitant medications, events.
Per pt, she got her vaccine at 10:30 am on 04/07. She was fine until later around 4 pm when she developed palpitations, heaviness in chest and pressure in chest. Pt was having heavy breathing. She also had Urticaria itching all over body.  She went to ER and had several tests done including EKG. Everything came back normal. Per ER doctor, it was most likely due to the COVID vaccine she received that day. On 4/9/21 upon following up with pt, pt still complaining of tachycardia. Pt advised to follow up with PCP or return to ER if tachycardia does not resolve.
This spontaneous report was received from a registered nurse referring to a patient of currently 1 year age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) with lot # L009205, expiry date 17-MAR-2017; dose, route of administration and anatomical location not reported). The doses of VARIVAX (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
I know of three people that had the original 2 Pfizer shots and within 90 days contracted the variant.; I know of three people that had the original 2 Pfizer shots and within 90 days contracted the variant; This is a spontaneous report from contactable consumer or other non-health care professional via Escalation team reported for a patient (1 of 3 patients). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiration date: Unknown), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiration date: Unknown), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient received original 2 Pfizer shots and within 90 days contracted the variant. The reporter understand that Pfizer was asking the FDA for 6 months booster for the covid 19 to cover the variant, but reporter know of three people that had the original 2 Pfizer shots and within 90 days contracted the variant and six months was too late. The outcome of the event was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021885398 Same reporter/ drug/ event, different patients.;US-PFIZER INC-2021885397 Same reporter/ drug/ event, different patients.
Patient is a 80 y.o. male patient of MD with a PMHx of CAD s/p CABG, HFpEF, cAF, HTN, HLD, T2DM, GERD presented to hospital for malaise/cough and transferred for elevated troponin.   COVID-19 infection  Acute hypoxemic respiratory failure dt above  P/t hospital with malaise, fatigue, non-productive cough. Transferred for elevated troponin in setting of AKI on CKD. Afebrile on arrival, HDS. No hypoxia Initial CBC without leukocytosis CXR: normal Did not meet criteria for remdesivir/decadron on admission however given interval development of respiratory failure will initiate decadron 6mg daily x 10d  CRP mildly elevated on admission S/p 1x dose IV lasix, resume PO lasix today  Off oxygen, not hypoxemic with exertion today  Discharge home to complete decadron course   Troponinemia, likely type 2 NSTEMI from AKI on CKD CAD s/p CABG, PCI cAF on Eliquis HTN, HLD HFpEF; compensated Denies chest pain or anginal equivalents. Recent normal ischemic work up Initial troponin 66, repeats 56, 54 with negative delta.  Recent stress MPI in 7/2023 without reversible ischemia Recent echo 7/2023 with EF 63%, mod-severe LVH. No WM Repeat EKG unchanged from prior.  Cont home amiodarone, Plavix, statin,Eliquis, Imdur, Toprol AKI on CKD Hx of BPH  Acute urinary retention  Initial Cr 2.1 (recent baseline ~1.7-1.9). Does not appear to follow with nephrology Presumably prerenal from poor PO intake w/ COVID in setting of Lasix/ACEi. Probable underlying diabetic nephropathy Renal/bladder US: multiple cysts on R.  Bladder distended.  PO lasix and lisinopril on hold, will give 1x dose IV lasix today and resume PO lasix in AM   Continue to hold lisinopril for now  Foley placed d/t urinary retention on admission, failed voiding trial.  Foley replaced  Urology referral on discharge for outpatient voiding trial.    Thrombocytopenia  Likely d/t ongoing infectious process, hgb stable, low concern for hemolytic process  Currently 129, CTM closely Transfuse for platelets < 10k    T2DM, poor controlled A1c 8.7%  Home regimen: Levimir 20 units BID, Aspart 10 units qAC with SSI Dose reduce Lantus 16u BID, Aspart 8u qAC with SSI Hypoglycemic protocol. Hold home oral meds
21 year old female presents to ED with complaint of Allergic reaction (PT reports feeling SOB about 10 minutes after getting Moderna Vaccine. PT is a student nurse. States she feels better. NAD skin WNL at themoment)   Patient presenting for possible allergic reaction. She reports that 10 minutes following receiving first dose of Moderna vaccine she felt "flushed" and "fuzziness". She reported mild shortness of breath that has resolved. Symptoms are not progressive, no skin lesions nor pruritus, no nausea, vomiting, throat swelling, stridor. She has a history of nut allergies. She is a history of allergy to ceftriaxone. No active symptoms at present.
Redness, mild swelling and heat that extended about 6 inches out from injection site on day 9 after the injection. I noticed on Monday, 1/18/21 and on 1/19/21 it was worse. I went to an urgent care facility just to be safe. The physician did not find any signs of cellulitis or infection. I did not want any antibiotics. On 1/21/21, I noticed the swelling was almost gone and the redness was going away.
Hives starting at base of scalp within 24 hours wide spread. Went to PCP next day and started a course of steriods x 7 days. Hives went away, developed dermatographia. Within a month figured out this was made worse by certain foods; nuts, gluten, dairy. Adjusted diet w sole improvement. Was taking Zyrtec twice daily, making me fatigued. Went to see allergist switched to Allegra and Pepcid in the am and Zyrtec and Pepcid at night. Slowly having improvement down to only am Pepcid and can tolerate dairy and very little gluten. Migraines have gotten worse, but I switched meds thinking med might have caused the hives. Have now switched back without any hives
Fatigue; Dizziness; Discomfort in my head; Headaches; Grogginess; Mood swings; Nausea; Weakness; It got to the point where I couldn't go into work It affected me doing day to day things; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), DIZZINESS (Dizziness), HEAD DISCOMFORT (Discomfort in my head), HEADACHE (Headaches) and SOMNOLENCE (Grogginess) in a 33-year-old male 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 was provided by the reporter.     On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue), DIZZINESS (Dizziness), HEAD DISCOMFORT (Discomfort in my head), HEADACHE (Headaches), SOMNOLENCE (Grogginess), MOOD SWINGS (Mood swings), NAUSEA (Nausea), ASTHENIA (Weakness) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (It got to the point where I couldn't go into work It affected me doing day to day things). At the time of the report, FATIGUE (Fatigue), DIZZINESS (Dizziness), HEAD DISCOMFORT (Discomfort in my head), HEADACHE (Headaches), SOMNOLENCE (Grogginess), MOOD SWINGS (Mood swings), NAUSEA (Nausea), ASTHENIA (Weakness) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (It got to the point where I couldn't go into work It affected me doing day to day things) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt recvd vax; on 10aug95 exp fever up to 103;weak & tired;events resolved in 3 days; pt had strep throat infect shortly p/ these sxs; tx w/ atb;
This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), SNEEZING (Sneezing like crazy), RASH (Rash on Stomach that is spreading), HEADACHE (Headache) and NAUSEA (Nauseous) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032620A) for COVID-19 vaccination. The patient's past medical history included UTI (Had culture and took anti-biotics). On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), SNEEZING (Sneezing like crazy), RASH (Rash on Stomach that is spreading), HEADACHE (Headache) and NAUSEA (Nauseous). The patient was treated with HYDROCORTISONE for Rash, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), SNEEZING (Sneezing like crazy), RASH (Rash on Stomach that is spreading), HEADACHE (Headache) and NAUSEA (Nauseous) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: Event outcome was updated into recovered from unknown.Event listedness recalculated
Irregular heart beat, heart palpitations, weakness, dizziness. Had two episodes that lasted 1 hour.   No treatment, went to bed. Still feel off, not normal.  Other symptoms were the normal ones-fever, chills, sweating, extreme achiness.  By the 3rd day had the adverse events.  Continue to feel weak and tired, and like heart is racing if I do too much.
Fever with seizure several hours after receiving vaccine. Family did not seek medical attention at an ER, they did call helpline told to give BENADRYL.
diaphoretic, sweaty, lightheaded  Vitals: 1355 HR 60, RR 18, BP 121/76 (94), O2 97% 1400 HR 62, RR 18, BP 124/78 (96), O2 96% 1405 HR 62, RR 18, BP 123/81 (101), O2 97%
C/o itching, redness, swelling at injection site next day at 10 am right arm 1 1/2 inch x 1 1/4 inch area upper arm.
precipitated continuous menstruation; This is a spontaneous report from a non-contactable consumer. A non-pregnant 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration on 15May2021 as dose 1, single and on 05Jun2021 as dose 2, single both for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, it was unknown if the patient has been diagnosed with COVID-19 and post vaccination, it was unknown if the patient has been tested for COVID-19. On an unspecified date of 2021, the patient experienced precipitated continuous menstruation. It was reported that it started from the first dose and still ongoing at the time of report. The event resulted to doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event included patient was prescribed oral contraceptive. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's medical history included spinal cord injury. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot# reported as H016823, expiry date and route not reported). No concomitant medications were reported. On an unknown date the patient experienced local swelling at the injection site, malaise, fever and was also hospitalized in an intensive care unit (ICU). The name of hospital and dates of hospitalization were unknown. The patient received unspecified treatment in the hospital. The outcome of local swelling at the injection site, malaise and fever was unknown. This one of several reports received from the same reporter. Additional information has been requested.
I have Hyperosmia and so my sense of smell is extremely developed and My sense of smell was returning gradually from my COVID infection in February 2021. The morning after my vaccine shot, ALL the remaining smells that had not yet returned came back at once but were not their correct smells, they were all the same smell and it was a horrible smell. In addition, plant based smells (to include pollen and blooming plants) took on a terrible sour smell, mint especially smells (and tastes) like sour milk. These new tastes and smells described are hard to explain since they are new and are not anything I have experienced before. They are persistent to-date and affect my ability to enjoy anything involving smells or tastes; pretty much most activities all day long, i.e. brushing teeth with sour milk toothpaste each morning. Also, my own body odor has taken on a terrible smell to me (not others that I am aware of) as well as feces and urine of humans and animals (different from the normal terrible smell). This condition hasn't shown any sign of going away at this time.
Body aches started on 8/18. Woke up 8/19 feeling severely nauseous, experienced diarrhea and severe headache
Initially tenderness at injection site (left deltoid), then focal erythema and mild swelling at site. Progressed to pain/tenderness in left armpit due to lymph node swelling, some dull aching pain left biceps/shoulder. Fever, moderate fatigue.
Persistent cough with breathing issues. I received breathing treatments from hospital, prednisone injections/medications, antibiotics.  The symptoms never completely go away.  I might receive some relief from hot tea/coffee or over counter medications, I also purchased a nebulizer and portable nebulizer that I have to take with me everywhere.  I receive temporary relief from nebulizers , but the symptoms always return and I feel I have no choice but to live with this.
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot number FD0809. The Regulatory Authority, per guidance from the Regulatory Authority, Centers for Disease Control and Prevention (CDC), and Pfizer have determined that the dose of vaccine that you received is valid.
Client came to receive influenza vaccination at school based flu clinic. Client was inadvertently given high-dose flu vaccine for 65 and older and client was only 54 years of age. Client was notified about the inadvertent vaccine administration.
Swelling & redness & warm to both injection sites. Mild tenderness to touch. (L) arm 8 cm area erythematous (R) arm 17 cm.
Patient called on Tuesday with complaints of left swollen painful, itchy  warm to the touch arm.
Pt vaccinated with DTP/OPV became hypotonic, hyporesponsive, pale, bluish.
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Jun2021 (Lot number: EW0177) at the age of 15 years as dose 2, single and intramuscular, administered in arm left, administration date 13Mar2021 (Lot number: EW0168) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 01Jan2022, outcome "recovered", COVID-19 (medically significant) with onset 01Jan2022, outcome "recovered" and all described as "tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test (Nasal swab): (01Jan2022) positive, notes: QuickView at Home COVID Test. Therapeutic measures were not taken as a result of covid-19.
Immediate itchy throat and reddening of entire arm. Sent to employee health then immediately to Emergency Room where counter active IV's where administered.
TIREDNESS; SORE ARM & NECK, CHILLS AND FEVER,  HEADACHE
Pt describes "debilitating pain" similar to a "dislocated shoulder". Pain 7/10 started 1-2 hours after injection. Decreased strength (90%) unable to lift arm. Swollen glands in neck & axillary region. Sx lasted 3 days then intermittent.
myocarditis; chest pain; This is a literature report.  A new trend of myocarditis among young adults who received mRNA vaccines for COVID-19 is emerging. The authors presented the case of a young adult who presented with chest pain 3 days after the second dose of Pfizer-BioNTech COVID-19 vaccine. He had elevated troponin I and C-reactive protein levels at the time of admission. Electrocardiogram (ECG) and echocardiogram findings were unremarkable. The patient improved with conservative management and was discharged home the next day.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events myocarditis and chest pain cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Have so much pain; All my muscles hurt; Arm so hurt; Fever; Couldnt get out off bed; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Have so much pain), muscle pain (Verbatim: All my muscles hurt), pain in arm (Verbatim: Arm so hurt), fever (Verbatim: Fever) and bedridden (Verbatim: Couldnt get out off bed). The outcome of the pain, muscle pain, pain in arm, fever and bedridden were not reported.   It was unknown if the reporter considered the pain, muscle pain, pain in arm, fever and bedridden to be related to Shingles vaccine.     It was unknown if the company considered the pain, muscle pain, pain in arm, fever and bedridden to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-JUN-2023 This case was reported by consumer via interactive digital media. The patient reported that he or she had so much pain with the shingles vaccine. The patient's arm was so hurt and his/her muscles hurt and had fever and could not get out off bed. The patient was so hurt that he or she was not looking forward for the second dose which was on 11th September 2023.