chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 12;45 pt received vaccine, she says her left arm felt numb but didn't verbalize reaction until 1pm. Vital signs B/P 125/80, resp 16, pulse 80, and reporting feeling dizzy. Pt says her left arm feels numb from the elbow to shoulder. Pt denied wanting to go to ER, refusing further treatment despite multiple education attempts. B/P 128/74 on last recheck, pt refusing continued treatment. Signed adverse reaction by patient.
could hardly breathe/hurts me to breath; Right side of chest hurt/pain on right side of the chest like muscle pulled; two weeks ago had dysentery; This spontaneous case was reported by a consumer and describes the occurrence of DYSENTERY (two weeks ago had dysentery) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes mellitus and Blood pressure high.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced DYSENTERY (two weeks ago had dysentery) (seriousness criterion medically significant). On 31-Mar-2021, the patient experienced DYSPNOEA (could hardly breathe/hurts me to breath) and CHEST PAIN (Right side of chest hurt/pain on right side of the chest like muscle pulled). At the time of the report, DYSENTERY (two weeks ago had dysentery), DYSPNOEA (could hardly breathe/hurts me to breath) and CHEST PAIN (Right side of chest hurt/pain on right side of the chest like muscle pulled) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       At first she didn't feel bad but last night 31Mar2021, she could hardly breathe, right side of chest hurt, hurts me to breathe, pain on right side of chest like I pulled a muscle, two weeks ago had dysentery. Treatment included ointment. Patient didn't want to call doctor as her doctor would just tell her to go to the hospital. Doctor told her to get tested for COVID.  Based on the known etiology of dysentery as being if infective origin, causality with mRNA-1273 is assessed as unlikely.  Although a temporal association exist, it is not enough to assess the other reported events as related to the administration of mRNA-1273.  Additional information has been requested as causality is cofounded by the patient's concurrent history of diabetes.; Sender's Comments: Based on the known etiology of dysentery as being if infective origin, causality with mRNA-1273 is assessed as unlikely.  Although a temporal association exist, it is not enough to assess the other reported events as related to the administration of mRNA-1273.  Additional information has been requested as causality is cofounded by the patient's concurrent history of diabetes.
Slight dizziness within 10 minutes after injection.  Dizziness continues daily for brief periods with slight nausea.   Low body temp - 95.8F average
Began with soreness at injection site, progressed to joint soreness, fever and convulsions (from around 6 pm to 1 AM 9 Dec 2014). Continue to have headache, joint stiffness, fatigue and fever. Had I been able to drive at that point I would have gone to an emergency room.
This spontaneous report as received from a registered nurse refers to a 6 month old patient of an unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 25-OCT-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M031802 with expiry date: 09-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014706.
Patient presented to ER on 3/22/23 with SOB. Admitted for Acute Respiratory Failure. Cough started 3-4 days prior to admission. Dose, Site, Route, Manufacturer, Lot not available on our charting system, only date given.
Small wheel appeared under injection within 5 minutes of injection. Treated with 1/2 tsp of BENADRYL. Parents and pt left within another 5 minutes of treatment of BENADRYL.
This spontaneous report was received from a 76 years old female patient regarding herself. Patient had no medical history or drug reactions/allergies. On an unknown date in 1998, the patient received ZOSTAVAX 19400 PFU (dosing details not reported). Patient was not on any concomitant medications. The patient stated that she had been experiencing shingles like pain on and off since being vaccinated. The pain has been consistently in her right eye and has recently been on her stomach. No lab diagnostic tests were performed. The administrating physician was unknown. Patient did not receive any treatment for the events. Outcome of the event was reported as not recovered. Causality of the events was not reported. No product quality complaint was involved. Additional information is not expected.
Covid breakthrough care  I received my 2nd booster shot on 04/26/2022. My adverse event started on 05/11/2022 in the morning when i woke up i had fever , bad headache, and runny nose that day. I  took a COVID test which was negative. The next day 05/12/2022 I had fever, cough, headache, fever, and runny nose. The next day on 05/13/2022 i had body ache, fever, cough, runny nose and a headache. I took a COVID test which was positive. The same i called my doctor through tele health he prescribed me benzonatate ( cough) capsules 3 times a day. He also prescribed me paxlovid for 5 days . Yesterday 05/18/2022 i finished  paxloid.  I still have the COVID symptoms which I started with but  its not severe as before.
I am a medical doctor and have shown to a colleague in my office, but no formal office visit. Have had skin rash since the first COVID-19 vaccine (May 3rd). Symptoms started approximately 7-10 days after the first injection. Started on my chest.  I have had dry erythematous scaly and flaky areas (8) measuring approximately 3 mm, 4mm, 6mm, 10mm , 20 cm,  8cm,  4cm, 18cm. Located on abdomen, left upper extremity near , both lower extremities approximately lateral and superior to the greater trochanter.  Lateral thorax just posterior and inferior to the axilla. Each side of the chest. Symptoms worsened after the 2nd Injection (May 21st). Approximately 5 days after 2nd injection symptoms worsened to the areas listed above.
Pt. experienced redness and swelling at the site of injection as well as down left arm. Symptoms began the day after the injection. Patient came to the office on 07/31/17 to show nurses her arm.  She was instructed to use ice/heat/OTC pain relievers/Benadryl and return to the clinic if symptoms get worse.
The patient was given inactivated polio vaccine injection today by certified pharmacist immunizer. Within 10 to 15 minutes of taking the vaccine, patient started to complain of "feeling like throat was tightening up". The pharmacy technician alerted pharmacist of the patient's complaint.  Pharmacist instructed pharmacy  technician to call EMS immediately and proceeded to retrieve epipen injection from patient care room. Pharmacist spoke with patient who said "I am not feeling well, I feel flush". Pharmacist asked patient if he still felt as though throat was closing, then explained that epinephrine would be injected in outer thigh to help relieve the symptoms. After consulting with patient, epinephrine was not given but epipen was kept nearby patient in the event symptoms worsened. The patient alerted pharmacist again  that he was not feeling well, and felt as though he was "going to pass out". Pharmacy technician assisted patient to the lay on the floor, and the pharmacist put a cool towel on the patient's forehead. The patient was then assessed and examined by EMS immediately upon their arrival to the pharmacy. Per EMS findings, the patient experienced a "vagal response" after receiving the vaccine., which included tingling/tightness in the throat, dry mouth, feeling flush, etc. The patient was cleard by EMS to leave the pharmacy.
severe stiffness and pain in arm, shooting pain down arm, burning at injection site, abdominal pain and weakness, welts formed on left arm
This spontaneous report was received from a medical assistant referring to a 13 months old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 13-SEP-2016, the patient received improperly stored dose of VARIVAX injection, lot # M009768, expiration date: 23-FEB-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes on 29-AUG-2016. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received; Sender's Comments:  US-009507513-1610USA011133:
This spontaneous report as received from a provider office representative via a company representative refers to a 20 year old female patient. The reporter stated that the patient was "perfectly healthy", no information regarding her medical history was provided. In approximately August 2015 (reported as "about a month ago"), the patient was vaccinated with the first dose of GARDASIL 9, intramuscularly (dose, anatomical location, lot # and expiration date were not reported). Concomitant therapies were not reported. On an unknown date, approximately in 2015, the patient experienced severe injection site pain and she returned to the reporter's office on an unspecified date (reported as 'recently"). There was no swelling or bruising just pain. The outcome of severe injection site pain was reported as not recovered. The relatedness between GARDASIL 9 and the adverse event was not reported. Additional information has been requested.
Information has been received from a physician concerning a male baby was born to a 23 year old female patient who on 11-JAN-2010 was vaccinated with the third dose of GARDASIL (lot # 662299/1099Y). It was reported that the baby was a healthy male, with a clubfoot. At the time of the report, the outcome was unknown. The reporting physician stated that "the clubfoot had nothing to do with GARDASIL". It was unknown if the patient sought medical attention. The mother's experience was previously reported in WAES 1002USA01532. Additional information has been requested.
74 y/o male, BMI 34, PMHx of CHF, CKD, DM, hyperlipidemia, HTN, Cdiff, and MRSA, admitted for leukocytosis on 4/1/21. Pt received 1 dose of 2 g IV Rocephin, then ID recommended holding further abx. Pt placed on PO vanco for Cdiff. Pt discharged on 4/4/21.
This spontaneous report was received from a physician assistant and refers to a 23 year old female patient with dyslipidaemia and anaemia. No concomitant medications or drug reactions/allergies were reported. On 13-SEP-2013, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX (lot # J006109, expiration date 21-MAY-2015, dose not provided) administered subcutaneously. On 14-OCT-2013, the patient was vaccinated with th second dose of (Oka/Merck) VARIVAX (lot # J0082289-this lot was confirmed twice with the reporter who stated it may have been documented incorrectly, expiration date 12-JUL-2015, dose not provided), administered subcutanenously. The patient had titers drawn on 14-NOV-2013 and on 31-MAR-2015 and both showed she was negative for immunity to varicella. No treatment was given for the adverse event. No additional information was provided. The outcome of the adverse event was reported as not recovered/not resolved. The relatedness between the adverse event and the suspect vaccine was not provided. Additional information has been requested.
Patient has been having intermittent headaches since the evening of flu shot for more than 5 days. Patient has been taking Ibuprofen for h/a.
Tachycardia 130 BPM at 1 pm.  102 BPM at 1:05 pm and 80 BPM at 1:10 pm.  Patient observed for 30 minutes and given juice and crackers. Felt better. Advised to go to dr if symptoms returned.
Redness at the site started developing within 5 minutes of receiving the vaccine. Also reported feeling like the site was itchy and lips began tingling.
Per client's mother - 8/28 - Bilateral arm pain. 9/1/14 - Palpitations and chest pain.
Swollen lymph nodes cervical and axillary on the left side - where Tdap (Adacel) and Pneumovax 23 were given.  10/29-10/31 mild generalized swelling and discomfort entire left arm, nodes remain swollen.  No reaction in right arm where seasonal flu shot given; last year flu shot given left arm and cervical lymph node swollen X 1 week
This is a spontaneous report from a contactable consumer, reporting for his daughter. This female patient of an unspecified age, race and ethnicity received a single dose of TRUMENBA via an unspecified route of administration on 22Sep2016 for immunization. The patient medical history and concomitant medications were not reported. On 22Sep2016 the patient was feeling very heavy and she experienced sore at the injection site, on 23Sep2016 she was lethargic, very tired, she had headache and she could not breathe. Outcome of events was unknown.
had only pain @ inject site until sz; no fever until sz; pt had sz @ the dinner table; eyes rolled back; shoulders clenched, body started trembling; face turned blue; sx lasted 3 mins; breathing stopped but resumed; t104.7 R; no eye contact
vaginal bleeding; This is a spontaneous report from a contactable consumer (patient reported for herself). A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Right on 04Mar2021 at 09:00 (Batch/Lot Number: EN6202) as dose 2, single for covid-19 immunization (at the age of 58-years-old). The patient medical history included hysterectomy 4 years ago. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: EL9267) via an unspecified route of administration in right arm on 13Feb2021 at 11:00 Am (at the age of 58 years old) as dose 1, single for COVID-19 immunization. The patient stated she had her second Pfizer vaccine a little over a month ago and she had a hysterectomy about 4 years ago. On 12Apr2021, the patient stated that she went to the bathroom this afternoon and she saw blood and she should not be having a period because she had a hysterectomy, Patient confirmed this was vaginal bleeding. It was stated that she knows there had been reports of this being a possible side effect of the vaccine. Patient queried if this was a side effect of the vaccine and how long this may last. No other additional vaccines administered on same date of the Pfizer vaccine. The patient did not visit emergency room and physician office due to the event. The outcome of the event was not recovered.  No follow-up attempts were needed. No further information was expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021403456 same reporter/drug/AE, different patients
itching at my injection site and noticed a red dot  that is 2 1/2 inches in diameter; itching at my injection site and noticed a red dot  that is 2 1/2 inches in diameter; it has slight burn; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Mar2021 (Lot number: EN6502, EN6205) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EL9267 or EL9269, Anatomical Location: Right arm), administration date: 13Feb2021, when the patient was 71 years old, for COVID-19 immunisation, reaction(s): "sore arm"; Flu vaccine, reaction(s): "sore arm". The following information was reported: VACCINATION SITE MACULE (non-serious) with onset 09Mar2021, outcome "not recovered", VACCINATION SITE PRURITUS (non-serious) with onset Mar2021, outcome "unknown" and all described as "itching at my injection site and noticed a red dot  that is 2 1/2 inches in diameter"; VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "it has slight burn". Therapeutic measures were taken as a result of vaccination site macule, vaccination site pruritus, vaccination site pain.  Additional information: The patient stated that the lot number for dose 2 listed on card was EN6502, but she received an email from the health Department that listed the Lot number as EN6205. She reported she received the vaccine between 15:30 and 16:00. The patient reported that she received the second dose of vaccine on Saturday, 06Mar2021. She stated that Sunday 07Mar2021 and Monday 08Mar2021 she was fine she had hardly any pain in her arm or nothing. On the afternoon of Tuesday 09Mar2021, she noticed a big red spot just below and to the right of injection site. She reported that it measures 2.5 inches in diameter, that it is not painful, it is sometimes itchy, and that it has slight burn. She stated that on a scale of one to ten (10 being the worst), she would rate the burning sensation at maybe a 2. The patient was treating the red spot with cold compresses. Additional administered vaccines were none. AE(s) did not require a visit to emergency room nor physician office visit. Family medical history relevant to ae(s) was no.  No follow-up attempts are possible. No further information is expected.
DEVELOPMENT OF SEBORRHEA ON NECK, ARMS AND LEGS USED HYDROCORITIZONE CREAM.  DEVELOPMENT OF ECZEMA ON LEGS THEN ON ARMS AND IS NOW ON 95% OF LEGS AND ARMS. SKINS LOOKS LIKE ALLIGATOR SKIN AND IS VERY DARK IN SOME PLACES.
She received her first covid vaccine on 1/16/2021. She said the next day she had body aches, fever, stuffy nose which she said you did prepare her for. However, she said she "felt like she was hit by a truck" and since the vaccine, she said her fatigue and L hip pain has not subsided, it even feels like it might be getting worse. She said she has not had any injury to that L side, she is generally an active person w/o any issues other than some routine joint soreness as the weather changes but she said this is much different.
9 days after receiving vaccine, site of inject has a round rash which is warm, red and itches.   Tender to touch and hard at site.   Lotion applied.      At time of this report, rash is ongoing.  V-Safe check in has already ended, so unable to report this avenue.
Mother brought in patient for flu vaccine and 2nd dose of Trumenba. Mother called in the afternoon concerned for son. Mother states that he has malaise, joint pain specifically to knees and ankles. Has trouble walking because they ache.
Two major side effects. 1. Breast feeding baby developed severe hives and face rash the day after second shot (I breast fed him after the shot) he was <2 mos old. Stopped breastfeeding and the rash went away. Doctor agreed it was likely the vaccine   2. My periods have become incredibly heavy and painful. Has not resolved in over 4 cycles now. I used to have very regular and predictable menstrual cycles. My cycle is still regular but about 5-6times heavier and painful. OTC meds don?t work anymore
rheumatoid arthritis flare up; hands started hurting/Hand pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4218960-00 (Agency).  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 26Feb2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single and intramuscular, administration date 26Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; prednisone (PREDNISONE) (Batch/Lot number: unknown); adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a covid-19 vaccine trial. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "rheumatoid arthritis flare up"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "hands started hurting/Hand pain". The action taken for prednisone and adalimumab was unknown.  The reporter's assessment of the causal relationship of the events (Hand pain, Rheumatoid arthritis flare up) with the suspect products Humira (Adalimumab) and Prednisone was Not Reported.  The reporter's assessment of the causal relationship of the events (Hand pain, Rheumatoid arthritis flare up) with the suspect product PFIZER BIONTECH COVID-19 VACCINE was Probable.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Rheumatoid arthritis, Pain in extremity and the suspect drug BNT162B2.
left face was swollen; left eye was swollen; was hoarse; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (left face was swollen), EYE SWELLING (left eye was swollen), DYSPHONIA (was hoarse), CHILLS (chills) and MYALGIA (body aches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (Patient reported she has 27 allergies and her body chemistry's just crazy) and Vascular disorder (left leg vascular problems).    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced SWELLING FACE (left face was swollen), EYE SWELLING (left eye was swollen), DYSPHONIA (was hoarse), CHILLS (chills) and MYALGIA (body aches). At the time of the report, SWELLING FACE (left face was swollen), EYE SWELLING (left eye was swollen), DYSPHONIA (was hoarse), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information, if any, was not provided by the reporter.  Treatment information, if any, was not provided.
Patient's mother says that her daughter used to have regular periods. After getting her vaccination she did not have a period for at least 3 months. She then had a couple of periods. Now she goes many months without a period.
Pt reported experiencing blurred vision and some lightheadedness. However symptoms resolved with time. Vitals signs stable. Pt AAOx4 with no other complaints. Sent home in stable condition. Advised to have eat upon departure. Accompanied by family.
Post injection, Immediate wave of dizziness while I waited for 15 minutes. It subsided and I drove home. Within two hours I was feeling extremely drowsy and achy.  The drowsiness felt like I had been given a heavy sedative.  I felt this for 48 hours post shot. I have continued to feel extreme fatigue and headache since the shot. Headache worsened today April 7th.  I have also been having nausea.
Pt reported tingling sensation in tongue/ lower mouth area initially and stated that she is having to exert a little more energy talking than she should due to her tongue. observation and pt refused treatment or transport AMA