chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tender arm; hot sweats; chills; headache; feels like a mac truck ran over her; diarrhea; fever up and down; constantly tired; no appetitie; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Tender arm), HYPERHIDROSIS (hot sweats), CHILLS (chills), HEADACHE (headache) and MALAISE (feels like a mac truck ran over her) in a 60-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 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Tender arm), HYPERHIDROSIS (hot sweats), CHILLS (chills), HEADACHE (headache), MALAISE (feels like a mac truck ran over her), DIARRHOEA (diarrhea), PYREXIA (fever up and down), FATIGUE (constantly tired) and DECREASED APPETITE (no appetitie). At the time of the report, PAIN IN EXTREMITY (Tender arm), HYPERHIDROSIS (hot sweats), CHILLS (chills), HEADACHE (headache), MALAISE (feels like a mac truck ran over her), DIARRHOEA (diarrhea), PYREXIA (fever up and down), FATIGUE (constantly tired) and DECREASED APPETITE (no appetitie) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided
Fever 100.9, weakness, body aches, joint pain, muscle pain, nausea, poor appetite, pain at site, chills
BioNtech Covid-19 vaccine EUA Pain at injection site increasing intensity over next several hours then disappeared suddenly and completely about 34 hrs post vacc
At 11;00 pm I had my injection site sore, muscle pain, violent chills, fever, vomiting, diarrhea, headache. This lasted over night and into the next day. I was unable to perform daily functions and was limited to bed rest all day.
Pt recvd Hep B vax on 15JUN90, 17JUL90, 16JAN91; exp inject site soreness, fatigue, arthritic pain, nausea, insomnia; 25FEB91 jaundice appeared & pt dx w/Hep B;
Patient called and said she had her flu shot at 0830 and one minute after receiving the flu shot I left the flu clinic and went down to the clinic where I work and I was red and flushed then felt freezing and my muscles were aching and had a fever of 101 during the night. My throat got constricted and I was having trouble breathing. They gave me BENADRYL 50 mg in the clinic where I work. After the BENADRYL I still had a little trouble breathing but I stayed at work because I am stubborn. She is back to work today with a few muscle aches but I am fine.
Patient presented to the office today for a new patient establishment visit. Patient did not have her COVID vaccine card with her, but informed the provider that she had only had three vaccines. Patient received the Bivalent booster with no side effects. Patient then phoned into the office to report that she looked at her COVID card when she got her and this was actually her fifth vaccine.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 02-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017) (Incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
I experienced intensive shivering, headache, muscle aches, fever of 101 degrees, pain and rash around injection site. I took 2 aspirin and eventually felt better, but I again woke up around 7 am with a fever of 100.4. I took ALEVE and now feel better again.
Migraine started 2.5 hours after receiving shot (2nd dose). Intense migraine with nausea, hand and facial tingling/ numbness, seeing spots. Went away at just about 24 hours after it started. Got the chills just before it went away, no fever. Skin sensitivity and fever set in around 26 hours in - 102. Heart rate jumped from 130-170. Improved to about 150 with Tylenol  and ALOT of fluids as fever improved, remained high until fever was gone around noon the next day. Hip pain, neck pain and back pain throughout. Hip pain first 24 hours. Back pain following that.
Compromised his respiratory system. Developed a moderate respiratory reaction causing shortness of breath that worsened over the following days, caused high fever of 102 for 4 days, moderate to severe abdominal cramping, severe congestion,  back pain as well as panic attacks as he was unable to breathe. Patient was tested for viral infection including covid and strep and all exams were negative. He required urgent care visit which is where the test were ran. He required prescribed steroid medication and an oral suspension for minimum of 5 days. He did require to miss school for 1 week total and he was left with pain in the bony areas such as his knees and suffered from insomnia during and after the events.
I have not seen a doctor yet.   Not where needle went in but on upper arm same arm got vaccine I have itchy bump blister like , red, ooozing, skin broke. not sure what to do.
Typical side effects of fever, chills, injection site pain began 12 hours after the shot.  24 hours after the shot, my breathing got gradually worse. It was like an asthma attack, but normally my asthma attacks are caused by a sinus infection. This was just shortness of breath and gasping for air.  I used my rescue inhaler with increasing frequency over the course of the following week. By March 12, I had to use my nebulizer. I used the nebulizer once on March 12, twice on March 13, twice on March 14, and I finally went to urgent care on March 15 when the nebulizer stopped helping. Urgent care was unable to help due to covid protocols, so they put me on oxygen for 5 minutes and transferred me to the ER.  At the ER, by the time I got to the ER, my breathing had normalized. I was given prednisone on site, as well as a prescription for 5 days. I had a chest xray done that returned completely normal.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 70 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 06Mar2021 as dose 2, single (Lot number: EN6205), in left arm and on 26Sep2021 as dose 3 (booster), single (Lot number: FF8839), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 01Sep2023 to 06Sep2023.
This spontaneous report as received from a pharmacist via a company representative, and refers to an approximately 70 year old female patient. The patient has no medical history or concurrent conditions. On 11-JAN-2017, the patient was vaccinated with a dose of PNEUMOVAX23 injection (route of administration, anatomical location, lot number and expiration date were not reported)  for "vaccination".  Concomitant therapies included bupropion hydrochloride(WELLBUTRIN). On an unspecified date in January 2017, after receiving the vaccine, the injection site was very swollen. On an unspecified date in January 2017, the patient called to the pharmacy for medical attention, however no treatment was given for the adverse event. There were no laboratory diagnostic studies performed. On 14-JAN-2017, the patient had recovered from the event. Causality assessment was not provided. Additional information is not expected because there was no consent for follow up.
Day 1, slight nausea and fatigue, Day 2, ankle and wrist aches, Day 3 Histamine like redness in both arms and chest--no swelling, just redness.
COMPLETELY UNRESPONSIVE; PROMINENT VEINS IN HANDS; WEAK; TIRED; COLD; SHIVERING; BEGAN A PERIOD THE DAY SHE GOT THE INJECTION, THEN IT STOPPED AD BEGAN AGAIN; This spontaneous report received from a consumer concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included menopause, and other pre-existing medical conditions included the patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021 about 10 hours after receiving the vaccine, the patient was cold and shivering (cold on the inside) and later became completely unresponsive, began a period the day she got the injection, then it stopped ad began again. At 1: 15 a.m. (date unspecified) she was sent to hospital. She received lab testing and imaging and she woke up within 5-6 hours. The results were inconclusive. On 11-APR-2021, the patient experienced feeling weak and tired, her veins were prominent in hands. She received unknown medication while in the hospital. She has not followed up with primary care physician nor has she been back to the hospital since. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from completely unresponsive, and cold and shivering on 11-APR-2021, and began a period the day she got the injection, then it stopped ad began again on 14-APR-2021, was recovering from weak and tired, and the outcome of prominent veins in hands was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:-covid-19 vaccine ad26.cov2.s -completely unresponsive,  began a period the day she got the injection, then it stopped ad began again. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
I started thinking that I was having bad seasonal allergies. I was sneezing, had a runny nose with congestion. Thursday it was worse and by Friday I was having a cough that was coming from like a tickle in my throat but it was intermittent. I did a home test and it was positive. By Saturday the fatigue had set in and I ended up going in for a PCR test and to get the Paxlovid. I am doing a little better but have been very tired and just felt like its a bad allergy season aside from the cough which is not constant or productive.
p/vax pt exp 3'' redness&hardness arm; unable to move lt arm about shoulder; pain @inj site;
No additional AE reported; Nurse reported administration of 1 dose of V ARIV AX that was involved in temperature excursion; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender.      There was not information about patient's concurrent conditions, medical history or concomitant medications.  On 20-AUG-2020, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S022758 with expiration date of 22-JUL-2021) that was involved in temperature excursion at 7.8 °F during 45 minutes, for prophylaxis (dose and route of administration were not reported). There was not previous temperature excursion and it was called because of a data logger. No adverse events were reported.
No adverse symptoms or event. Pt while receiving GARDASIL series, was administered CERVARIX for 2nd shot instead of GARDASIL. This was noted when pt. presented for 3rd shot. Pt. was told to follow up 1 month to rec'v 3rd GARDASIL.
It started every time I would sit up, I would feel faint and blackout, I would go from normal to a high heart rate higher 130s, I went to ER then they did EKG, EKG showed Wolff Parkinson White heart rhythm. They had given medication in the ER that should have brought my heart rate down but did not work. I had a sinus tachycardia. I'm being medically discharged because of this heart condition that developed after my vaccine.  I was sent to a cardiologist to confirm what was going on with my heart. I still get lightheaded and faint. I'm not allowed to work out or be in the heat now. If I sit up too quickly I blackout.
Patient was administered PNEUMOVAX 23 with AFLURIA on her Left arm 09/12. A rash spread on her left arm the next day. She went to the urgent care 09/14, and MD put her on KEFLEX 500mg, 1 capsule 3 times a day for 7 days. She started to feel better on 09/15.
Fever 37.3 C and 37.6 C Muscle pain Chills Headache Pain in the left arm at the site of injection Symptoms started 12 hours after the injection. They last about 12-14 hours. I took aspirin, ibuprofen and Tylenol.
about one week after moderna 2nd shot started explosive diaherra for about 1 month.  Also started noticing an irregular heartbeat.  My pulse started skipping beats.  Diaherra cleared up after about 2 months.  Lab tests showed blood in stool.  Still experiencing irregular heartbeat
Left shoulder pain (initially 8/10), swelling and muscle fatigue that began immediately at the injection site AVA #1 on 15 Sep 2010. These symptoms persist, but have improved. She has no numbness or tingling. She has taken MOTRIN, performed PT and was seen on 08 Oct with diagnosis of adhesive capsulitis.
Information has been received from a physician concerning a 12 month old female with no known pertinent medical history or drug reactions/allergies who on 16-AUG-2008 was vaccinated with a first dose of VARIVAX (Oka/Merck) (lot# 659740/0165X) 0.5 ml SQ. There was no concomitant medication. On 18-AUG-2008 the patient developed 6 scattered vesicular lesions with an erythematous base. The patient sought medical attention via an office exam. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center and was released. This is one of several reports from the same source. No further information is available.
Nine days later parents were concern about the large red area on (R) upper thigh, father states PREVNAR and varicella were admin. in the (R) thigh 10/17/08. Mother noticed limbs jerking (arms and legs) on 10/17/2008 one time for one minute.
Patient was complaint of feeling itchy to chest and right arm following administration of vaccine. No redness was seen to chest and only redness to right arm was where there were two red scratch lines to arm. Denied any shortness of breath or edema.  After a few minutes patient stated that she was starting to feel better.  Patient wanted to go home on own and did not want further medical assessment.
itching right where she got injected; arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching right where she got injected) and PAIN IN EXTREMITY (arm is sore) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced INJECTION SITE PRURITUS (itching right where she got injected). In March 2021, the patient experienced PAIN IN EXTREMITY (arm is sore). At the time of the report, INJECTION SITE PRURITUS (itching right where she got injected) and PAIN IN EXTREMITY (arm is sore) outcome was unknown.            Reporter did not allow further contact
2 weeks after receiving the vaccine I developed a reaction in the spot of vaccination.  There is redness, heat, and itching.
heart attack; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2 NOS), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 2023, outcome "unknown", described as "heart attack". The patient underwent the following laboratory tests and procedures: heart tests: Unknown results.Clinical course: Patient had heart attack after getting the shot. It was reported that patient had 1 shot and 1 booster and he was in perfect health, 179 pounds and nothing wrong with him before getting shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain in arm at the injection site; This is a spontaneous case, initially received from pharmacist via Med Communication (reference number: SEQ20-00086) on 07-Jan-2020, concerning a 39-year-old, male patient.   The patient's relevant medical history was not reported.  The patient's concomitant medications were not reported.  On 03-Dec-2019, the patient was administered with Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number: 261234, expiration date: 30-Jun-2020, anatomical location: arm, route of administration: not reported] for influenza prophylaxis.  On the same day, after receiving the vaccine, the patient developed pain in arm at the injection site.  At the time of this report, the patient did not recover from the event of pain in arm at the injection site.  The reporter did not provide causality assessment to Flucelvax Quadrivalent.  Company comment: The event of pain in arm at the injection site was considered as related to Flucelvax Quadrivalent.; Sender's Comments: The event of pain in arm at the injection site was considered as related to Flucelvax Quadrivalent.
Pt called to say she developed "tightness" under the arm of injection and aching in armpit. She stated there was no redness or swelling at site of injection. Instructed to put ice on it and observe. Phoned on 11/20/00, states arm is fine; no pain or redness.
The pt experienced transverse myelitis in cervical region versus Guillain-Barre. Lumbar puncture showed increased myelin, evolving symptoms, some of which have improved. Persistent paresthesia to the left upper extremity. Cervical lesion on MRI. No hx of MS.
Horrible pain in lungs; Gasping for air; Wheezing; This is a spontaneous report from a contactable consumer (patient, self-reported). This 47-year-old non-pregnant female patient bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration, administered in left arm on 01Feb2021 at 09:30, single for COVID-19 immunization at hospital. The patient medical history included that she was allergic to pollen and dust. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have other medications in two weeks. On 01Feb2021 at 21:00 in the evening, the patient had a horrible pain in her lungs and was gasping for air and she could not stop gasping and wheezing so she went to the Emergency room. The patient treated with inhaler. The patient underwent lab tests and procedures which included blood test and unknown results and had COVID-19 SARS-coV-2 test (nasal swab) was negative on 10Feb2021. Outcome of the events were recovered on an unknown date in Feb2021.  Information about lot/ batch number has been requested.
Information has been received from a physician concerning a 12 month old female who on 01-MAY-2007 was vaccinated with "one dose" Proquad. On 11-MAY-2007 the patient developed a rash on her forehead. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.  10/06/2007 This is in follor-up to report(s) previously submitted on 7/6/2007. Follow up information was received from a physician who reported "not sure if it was a vaccine reaction. No case". Additional information is not expected.  Follow up information was received from a physician who reported "not sure if it was a vaccine reaction. No case. Follow up information was received from a health care provider who indicated "we do not have any patient, you are wrong", previously reported as a 12 month old female. No further information is expected.
Diffuse erythematous rash, chiefly on trunk; Referred to MD;
Discharge Provider: Private, DO Primary Care Provider at Discharge: Private, MD Admission Date: 7/30/2022 Discharge Date: 8/1/2022 HOSPITAL COURSE: Patient is a 19 y.o. woman with a history significant for chronic lung disease of infancy, Moebius syndrome, Pierre Robin sequence, and adrenal insufficiency who presented to ED on 7/30/22 with 1 day history of sore throat, nonproductive cough, body aches, SOB and a positive home COVID test. In the ED, she was tachycardiac with HR 120, tachypnea > 30 and afebrile. EKG was insignificant and chest X-ray showed no acute cardiopulmonary abnormalities. She was given fluids, one dose of remdesivir in the ED, and started on hydrocortisone 15 mg q6h as part of her stress dosing regimen for adrenal insufficiency. She was admitted and management was continued on the medicine floors. Admission remained uncomplicated and patient's respiratory status improved. Two doses of remdesivir were administered during admission. Patient and mother were informed that the course of monoclonal antibodies could be completed in outpatient infusion clinics if needed. On 8/1/22, patient was medically and vitally stable for discharge.
Polymyalgia rheumatica symptoms onset within days of receiving vaccination. Resulted in MD visit, elevated C-reactive enzymes and steroid therapy for pain.
This spontaneous report was received from a pharmacist via a company representative and refers to a female patient. The patient had no concomitant medications, pertinent medical history, drug reactions nor allergies. On 25-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX injection, in arm, lot# reported as M036296, expiry date 14-NOV-2014 (dose and route of administration were not reported) for shingles prevention. On the same date, the patient experienced an injection site reaction: she developed an itchy rash and bumps on the arm vaccinated. The pharmacist advised the patient to follow up with her primary physician however it was not known if the patient contacted her physician for treatment or not. At the time of the report, no treatment was given for the events. Additional information has been requested.
after administration VARIVAX SQ in R arm pt immediately had redness & swelling @ site of injection. There was approximately 3x5 cm redness and 1x1 cm induration. Gave 2 tsp of Zyrtec here in office
Pt given FLU-MIST 10-1-15. When he returned for booster 4 wks later patient and siblings and dad*so it is probably not a vaccine reaction had upper resp symptoms. On exam patient had wheezing; he had not even wheezed before.