chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day 1.      After 5 hours So tired could not stay awake but felt fine                    Woke up at 12:30 am burning up, achey, massive headache, swollen vaccination site HOT to touch Day 2.      Slept entire day..same as above Day 3.       Same symptoms, no fever, WEAK, foggy feeling, dizzy, throbbing headache Day 4.       I thought I was feel a bit more energy but then became SO nauseous , vomiting throughout the day and early evening Day 5.     Woke up in a burst of energy, worked out?back to myself ?.by 5pm.. fatigue and massive headache returned Day 6/7.    More energy (not  normal). Foggy head, massive headache, fatigue   *I am very active, exercising 6 days a week, eat vegetarian diet, healthy lifestyle.  Today has been a week and I am just not feeling myself?not comfortable driving due to a foggy/dizzy/headache feeling that has not subsided.   I do not believe that I need doctor or care beyond Advil/Tylenol/hydration but I am not myself.  Could be some bug and timing is exact same but I do not believe so.   Sill grateful to be vaccinated!  I take care of my 86 year old mom and feel  safe together with her!
abdominal pain, tingling, chest pain. Evaluated by EMS-Refusal to transport.
immunocompromised and did not receive a third full dose/He received a half dose instead of the full dose.; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised and did not receive a third full dose/He received a half dose instead of the full dose.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Kidney failure (3rd stage), Autistic disorder and Immunocompromised.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised and did not receive a third full dose/He received a half dose instead of the full dose.). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised and did not receive a third full dose/He received a half dose instead of the full dose.) outcome was unknown.            No concomitant medication information provided. No treatment medication information provided.  The patient received wrong booster dose. He received a half dose instead of the full dose.
administer the High Dose 65+ vaccine to someone 20 years old with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received  via consumer/non-hcp on 15-Sep-2022. Agency number: 01281079  This case involves a 20-year-old and unknown gender patient to whom Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent] the high dose 65+ vaccine was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the 20-year-old patient was administered suspect the high dose 65+ vaccine at (formulation, strength, dose, route, lot number, administration site) for prophylactic vaccination with no reported adverse event (wrong product administered).  Action taken: Not applicable.  At time of reporting, the outcome was Not Recovered.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
25 y/o male ambulates to facility 1 hour after receiving 2nd shot of JEV and 3rd shot of Rabies in right arm. Member felt itchy and took oral Benadryl, after which he presented to Facility. Member presented with hives on arms and chest. Member noted to have runny nose. Member self-reports nausea, dizziness, and unable to stand up. Upper airway noted to be intact without SOB, chest tightness noted in lower chest. Member rushed to restroom and promptly vomited and passed stool. Mild chest tightness resolved following vomiting and passing of stool. No itchiness of lips, tongue or palate, edema of lips, tongue or uvula. No tightness in throat. No dysphagia. Member monitored in Facility for 1.5 hours and told to return should symptoms come back.
On 4/28/00, 4 days post vaccination, pt experienced greater than 20 myoclonic jerks during the day and was hospitalized for 1 day. There was no cyanosis. It was reported that the patient had microcephalopathy and status encephalopathy. Subsequently the pt recovered. The microcephalopathy and status encephalopathy were considered significant medical events. The reporting investigator felt that the events were possibly related to study therapy. No further info is available.
Born at 31 weeks gestation -> discharged 03-15-11 from birth hospital (see hospital admit/discharge notes). Home on cardiac monitor. Office visit at pediatric office 3-17-11 -> received 6 wk shots without complications. Later (8-9 hours post vaccines) patient became "pale/ash color", "not eat right", "heart monitor went off", "he not act right" per mother. She took him to ER per EMS. Diagnosed with anemia. Admitted to hospital 03-17-11 (and as of 03-21-11) he still in hospital but doing "better". Unsure if his episode could be vaccine related due to his prematurity but I thought I'd turn it over to CDC for investigation.
her arm just feels like she bumped into a door; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2 reported as Pfizer-Biontech COVID-19 Vaccine; unknown lot number and expiration date), via an unspecified route of administration on 06Jan2021 at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient reported that she was lucky enough to get the vaccine last night and her arm just feels like she bumped into a door. She mentioned that assuming this vaccine is similar to the flu, she inquired are the symptoms less if you contract covid after getting the vaccine. She inquired as well if it is "consider putting in the fact sheet how long after getting before being protected". The outcome of the event was unknown.  Information on the lot/batch number has been requested.
After Pfizer booster shot developed tinnitis in both ears.  I noticed it a couple days after the shot.  It got worse for the two weeks following.  The left ear also had a hissing sound in the am after waking up for a while.  It still persists now.  The tinnitus is not severe just very annoying mostly when things are quiet.    I also experienced the typical side effects after the second shot of fever, chills, body aches, vomiting which mostly resolved in by two days after.
allergic reaction to rubber; allergic reaction; This case was reported by a other health professional via sales rep and described the occurrence of rubber sensitivity in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rubber sensitivity.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rubber sensitivity and allergic reaction. On an unknown date, the outcome of the rubber sensitivity and allergic reaction were unknown.   It was unknown if the reporter considered the rubber sensitivity and allergic reaction to be related to Shingrix.     Additional Information: GSK receipt date: 21-FEB-2023 Reporter's comment:  The patient received 1st dose of Shingrix and had allergic reaction, possibly from rubber. The health care professional said the allergic reaction was after the dose was administered.  The patient went to an allergist who said the patient was allergic to rubber.  Health care professional was unsure if this was related to Shingrix.
17 year old given MODERNA covid vaccine: 1st dose given 3/16/21, and given a 2nd dose of MODERNA covid vaccine on 4/13/21
Client was given a 2nd dose of the Covid 19  Pfizer vaccine in his L/deltoid. About 5-10  minutes later the client c/o a scratchy throat and that it felt like it was closing.  I immediately got the epi and prepared it for administration (0.5ml). Client was still able to verbalize and stated that his throat felt funny and was feeling tight. At that point I gave him the epi injection into his Right Lateral thigh/IM. At that point I did take his vitals 122/72,78, 18, O2 99%, 96.9 and followed with a lung and chest auscultation (wheezing heard in chest area)  .Safety was maintained throughout the incident.  The client continued to breath regular and unlabored. 5-10 minutes later the client stated he could breath better and his throat did not have the lump, it  was gone from his throat. After the injection his heart rate increased  ( HR 115bpm).  re-took the vitals 104/62 b/p, 84 p, t,97.0, O2 100%..  Mom was present and the events was explained via her son who remain alert and oriented throughout  the event.  She did express an understanding and I informed her of the importance of following up with the clients primary care doctor. The client continued to recover and vitals remained with normal limits (pulse 64 and O2 100%). No wheezing was heard in chest area on follow up auscultation and client asked for water. So. I assessed his swallowing with a small sip of water and he had no difficulty swallowing. I had him stand and his gait was steady, but I did keep him an extra 30 minute for observation. He remained stable and was discharged to his mom and self ambulated to the vehicle with out incident. On 08/04/21 I called just to follow-up and the client and mom was at the doctors office and he  stated he was okay.
6/27/18 patient received shingles shot. 6/29/18 patient experience redness, pain at site of injection and unable to sleep at night. Patient used TYLENOL and/or ADVIL, and placed ice on site of injection 15 min on and then off 4 times daily. 6/30/18 patient still has redness and pain and she went to see doctor. 6/30/18 doctor prescribed amoxicillin 500 mg 3 times daily for 10 days and told her to wait 6 months for 2nd shingles shot and told she might experience the same reaction again.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, patient received VARIVAX dose 1, (dose, lot # and expiry date unknown). On 30-NOV-2010, patient received second dose of VARIVAX from lot # 666869/0469Z with expiry date of 31-MAR-2012 (dose unknown) which was improperly stored. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Around 1400 on 10-23-18 1 day after injection pt presented to clinic with Headache, chills, fever, nausea, photophobia, stiff neck, weakness, and shortness of breath. DECADRON 10mg was given IM. Pt returns to clinic for follow up on 10-26-18 and has sx's have greatly improved.
In this order: severe sore throat, slight nausea, chills, diarrhea, head-ache when walking. All came within a half hour, the chills being the most severe.
Pfizer 3/19/21 and 4/9/21. Positive on 1/24/22
Patient was nervous prior to vaccine. after vaccine administration, the patient was pale and diaphoretic. She began to feel lightheaded, nauseous, hypertensive, and hypotensive. The patient was observed for an extended period of time with mild improvement in her symptoms. They were offered multiple medications for symptomatic relief, but was reticent to take anything due to her numerous medication allergies. Patient was then discharged to home after resolution.
FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once a total administered, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.8 to 100.2 (units unspecified). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
SM received his primary SPV on 11/27/07.  Never developed Jennerian pustule.  3 weeks post inoculation, he developed a small, red, raised lesion at inoculation site that gradually grew to 3 x 4 cm scaly, erythemtous lesion.
Within 3-4 hrs of injection,Pt (who is morbidly obese) felt dizzy, vision blurred, was acting strange (per mom) and was starting to developed swollen, warm injections site. Also had headache.
Myalgia, Arthralgia, chills and fever, left arm pain Narrative:
feeling shaky; fast heart rate; This spontaneous case was reported by a patient and describes the occurrence of NERVOUSNESS (feeling shaky) and HEART RATE INCREASED (fast heart rate) in a patient of an unknown age and gender 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 NERVOUSNESS (feeling shaky) and HEART RATE INCREASED (fast heart rate). At the time of the report, NERVOUSNESS (feeling shaky) and HEART RATE INCREASED (fast heart rate) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported.
Pt w/ allergies/intolerances to Codeine (nausea and vomiting), Gabapentin (paresthesias and numbness), ACEI (Cough), Ibuprofen (abdominal disorder).  PMH significant for Thyroid disease, Herpes, Osteoarthritis, Obesity, Insomnia, HTN, GERD, Fibroid, Endometriosis, Depression.  PSH of Gastric bypass, Oophretomy, myometomy, hysterectomy, emdometriosis fulguration, and appendectomy.  Pt vaccintated at 15:50, and adverse reaction started at 16:05. After the vaccination patient c/o feeling weak, lethargic, and left side numbness (leg),lips numbness and left side of the face. Easy to arouse/ ambulate to w/c with steady gait.  On exam left side weaker than right. Patient denies exertional chest pain or chest pain at rest, no exertional dyspnea. Patient denies palpitations, lightheadedness, presyncope or syncope. No rash noted. No angioedema. No sob.  As per patient she had same previous reaction after Covid vaccination and as per her PCP Dr. she can take 2nd vaccination. Patient c/o only feeling sleepy and weak.  VS @16:05 BP 177/115FS, HR 89 -- > @16:20 168/104, 89, 98% RA, POCT Gluc 82. Patient speak full sentences but speech delayed  Called 911 @ 16:16 and RRT arrived at 16:25.  Sent patient to ER via gurney @16:30 due to stroke like symptoms. Grandson with her. Nurse called family and someone will come to pick up her grandson. Pt observed in ED and released @~8pm.  Current Medications: APAP 500mg 2tabs PO Q6hr PRN Pain Ca-VitD3 500mg(1250mg) 1tab PO BID Premarin 0.5g vaginally Daily PRN Diazepam 5mg PO Q8hrs PRN Anxiety Colace 100mg PO Daily Duloxetine 30mg PO Daily ergocalceiferol 1250mcg PO Qwk Flonase 1 spray each nostril daily levothyroxine 112mcg PO daily on empty stomach before breakfast Omeprazole 20mg PO BID Senna 8.6mg PO daily Tramadol 50mg PO daily Triamcinolone 0.1% cream apply to affected area BID Vitamin B complex 1tab PO daily
Heart rate got up to 214 five hours after the vaccine. Called 911 and they came to get me. When I got there, they had me rear down and my heart rate decreased and they took me to the hospital. The hospital ran test and everything was normal. They discharged me after the IV fluid bag was done.   I followed up with my cardiologist 2 weeks later and had a stress test and ekg. All tests were normal.   The doctor thinks it was an adverse reactions to the vaccine.
My symptoms started 30 minutes after the injection. My throat and tongue started to get very itchy and scratchy.  I had to keep clearing my throat. My throat felt thick with secretions.
Right after I had the vaccine I did not feel well so I stayed home for a couple of days. On the Wednesday after the vaccine I thought I was well enough to go to work but I started feeling dizzy and passed out. I was transported to the emergency room by ambulance. They ran a CT Scan, Ultrasound and complete blood work up, results came back inconclusive. I passed out again on Thursday in the shower, I went to a different hospital. There they determined that from the second COVID-19 vaccine dose that had caused a ruptured aneurysm I was still having problems.
Hospitalization 12/26/21 2nd COVID shot 3/27/21, Pfizer, EN6203, IM/LD
After having little or no initial reaction, 2 1/2 weeks after the vaccine I developed a softball size lump, redness, erythema, and pain at the injection site.
26APR96 recv vax & couple hr later started screaming cry lasted 48hr & t102 R not relieved by APAP q 6hr & motrin q 4hr;MD contacted & told to cont rx;29APR96 pt OK;1MAY96 to MD ear infect;MD advised not to immunize
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING HOT (Arm became hot), ERYTHEMA (red, like a big red blob), PERIPHERAL SWELLING (swollen like a big blob) and MALAISE (did not feel 100%) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 028A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Nov-2021, the patient experienced PAIN IN EXTREMITY (sore arm), FEELING HOT (Arm became hot), PERIPHERAL SWELLING (swollen like a big blob) and MALAISE (did not feel 100%). 13-Nov-2021, the patient experienced ERYTHEMA (red, like a big red blob). On 14-Nov-2021, the patient experienced MOBILITY DECREASED (tough time playing music, hurt moving my left arm). 14-Nov-2021, the patient experienced FATIGUE (so wiped out). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), FEELING HOT (Arm became hot), ERYTHEMA (red, like a big red blob), PERIPHERAL SWELLING (swollen like a big blob), MALAISE (did not feel 100%), MOBILITY DECREASED (tough time playing music, hurt moving my left arm) and FATIGUE (so wiped out) was resolving. No concomitant medications were reported.This case was linked to MOD-2021-388704, MOD-2021-388689 (Patient Link).
Night chills; Muscle soreness; Slight fever; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old female patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Batch/lot number: EH9899) via an unspecified route of administration on 05Jan2021 in left arm as single dose for COVID-19 immunization. The patient's medical history was reported as none and concomitant medications were not reported. The same day (on 05Jan2021) the patient experienced night chills, muscle soreness and slight fever. The patient received her second dose of COVID Vaccine (Lot number: E19262, NDC number and Expiry Date: unknown) on 26Jan2021 in left arm. She did not have issues with the second dose, but she had issues with the first dose. On an unknown date in Jan2021 she had a rapid COVID test, and the result was negative. On 06Jan2021, all the events recovered. Investigation Assessment: No.  Follow-up attempts completed. No further information expected.
Injection site of upper right arm was very sore later that evening. She rubbed the area and applied cold compress. By the next day she could barely lift up her arm. She then took some ibuprofen and continued stretching and icing the arm. She went to her chiropractic doctor and he said she had a knot of scar tissue at the site of injection. The chiropractor initiated "Star" therapy to break up the area and will do 2 to 3 treatments. The patient stated that this does seem to help.
Discharge Physician: MD Primary Care Clinician at Discharge: MD  Admission Date: 6/23/2022 Discharge Date: 6/26/2022  PRESENTING PROBLEM: Hypoxia [R09.02] Acute cystitis without hematuria [N30.00] COVID-19 [U07.1] Acute respiratory failure with hypoxia [J96.01]   HOSPITAL COURSE: Patient is a 84 y.o. female with a past medical history of autoimmune hepatitis, type 2 diabetes, hyperlipidemia, and hypothyroidism who presents today with sore and cough.  In the emergency department patient was febrile with temperature of 101.1° F, she was tachycardic and tachypneic.  Patient also was hypoxic and required 6 L by nasal cannula supplemental oxygen.  Pertinent lab findings include a white blood cell count within normal limits at 7.28.  Lactic acid within normal limits at 1.8.  COVID testing was positive.  Chest x-ray showed mild bibasilar infiltrates and/or atelectasis.  Suspect small right pleural effusion.  She was admitted to the medical service for treatment of COVID-19 pneumonia.  She was started on dexamethasone.  Azathioprine for autoimmune hepatitis was held due to viral infection.  Oxygen support was titrated down to room air.  She was afebrile and hemodynamically stable.  On 06/26/2022 she was discharged home to continue immunosuppressive medications and with follow-up with her primary care physician.
fever , upset stomach , swollen lymph nodes in armpits , stiff neck , migraine.   the migraine and stiff neck has lasted for 4 days so far. tylenol doesn?t seem to be helping
Patient with 2 dose Moderna series admitted to hospital with COVID PCR pos 4/14/22
pt recvd vax;devel large localized rxn consisting of erythema, swelling, tenderness approx 7 hrs after vax; cbc revealed wbc of 18.1; hosp 2 days;rx ancef;MD rept not a case of cellulitis but possibly arthus rxn;had been immun w/ ppv in 93;
This spontaneous report as received from two nurses' conversation refers to a 65 years old patient with fever at vaccination time. The patient was vaccinated with PNEUMOVAX23. Lot#, date and route were unspecified. It was reported that PNEUMOVAX23 gave the patient reaction of swelling in the arm on 31-AUG-2012. The outcome of swelling in the arm was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source (MARRS 1209USA001828). Additional information is not expected.
Presented to ED w c/o nausea, fatigue x 2 days; COVID+ 1/6 but Z-pak, steroids & Tessalon Perles ineffective; admitted for acute resp failure w/hypoxemia d/t COVID-19 pna; tx w/steroids, zinc, remdesivir, O2; weaned to RA prior to dc.