chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore throat; Light-headed; Injection site pain; A spontaneous report was received from a consumer concerning a 46-years-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced some injection site pain, sore throat and was light-headed.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 06 Jan 2021, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (batch unknown) intramuscularly in the deltoid muscle of the left arm for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the patient had some injection site pain, sore throat and was light-headed which lasted for a couple of days. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.   Outcome of the events of injection site pain, sore throat and was light-headed was recovered/resolved on 08 Jan 2021.; Reporter's Comments: This case concerns a 46-year-old male who had NS events of unexpected oropharyngeal pain, dizziness and expected injection site pain. Event onset the same day as the first dose of mRNA-1273. Treatment not reported. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Swelling and rash near injection site appeared/felt within 7 hours  of injection, and continued  for 60+ hours.  Within 36 hours of injection I experienced intermittent, mild to moderate dizziness.  48 hours after injection, dizziness increased  to point where I wasn?t sure I should drive and go to work (teaching at university).  Did go, dizziness  continued for about an hour, subsided for about  3-1/2 hours,  then resumed, stronger,  and continued intermittently until bedtime.
after giving the flu shot the boy complained about dizziness after 3-5 minutes and according to the mother he got seizure. he was pale and don't remember what happened. he started responding to the questions in about 1-2 minutes and he was pale. called 911 and they took him in the ambulance to the hospital.
No adverse event; Patient received in total 3 doses of the monovalent vaccine and received 2 doses of bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received in total 3 doses of the monovalent vaccine and received 2 doses of bivalent booster) and NO ADVERSE EVENT (No adverse event) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (Dose 1,monovalent,lot# 042L20A) on 29-Jan-2021, Moderna COVID-19 Vaccine (Dose 2,monovalent,lot # 010M20A) on 26-Feb-2021, Moderna COVID-19 Vaccine (Dose 3,monovalent,lot # 037A22B) on 14-Jun-2022, MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (Dos4,DAVESOMERAN,First bivalent booster andlot #061F22A) on 15-Nov-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 20-Feb-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (Patient received in total 3 doses of the monovalent vaccine and received 2 doses of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient received in total 3 doses of the monovalent vaccine and received 2 doses of bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Patient received in total 3 doses of the monovalent vaccine and received 2 doses of bivalent booster).    Concomitant medication was not provided.   Patient received in total 3 doses of the monovalent vaccine and received 2 doses of bivalent booster.  Treatment information was not provided.   Reporter did not allow further contact
Information has been received from a physician concerning an 18 year old female who on 07-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 659055/1522U) and also with varicella virus vaccine live (Oka/Merck) in her arm. Concomitant therapy included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). The physician reported that the patient experienced pain and weakness in her arm after receiving GARDASIL vaccine (yeast) (Lot # 659055/1522U) and varicella virus vaccine live (Oka/Merck). The vaccines were administered in the same arm on the same day and the symptoms are being experienced in the same arm that the vaccines were administered. The patient's pain and weakness in her arm persisted. No further information was provided. The patient sought medical attention, seen by the physician. Additional information has been requested.
12FEB unusually sleepy p/inj, inj site red & swollen, fever 103.6, vomiting & diarrhea, high pitched screaming for short time x 2;
Bowel issues. After vaccination all of her medical conditions became worse. (type 2 diabetes, high blood pressure, and throat cancer was no longer in remission.)
SERIOUSNESS CRITERIA: OTHER-MEDICALLY SIGNIFICANT. Initial report was received 12 September 2008 from another manufacturer who received the report from a health care professional. A female infant experienced a seizure an unspecified amount of time after she had received a pertussis vaccine (lot number, date, route/site of administration not reported). The event occurred approximately 13 years ago and the manufacturer of the vaccine was unknown. The reporter had no other information available at the time of the report.
observed for 30 min, flushing and/ or skin edema. Given 25mg Benadryl pill, felt better
PT BECAME PALE, LETHARGIC. VOMITED.  PT STATED THROAT FEELS FUNNY.  EPI PEN JR.
Her parents got COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Her parents got COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced COVID-19 (Her parents got COVID). At the time of the report, COVID-19 (Her parents got COVID) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information included Monoclonal antibody treatment on 11-Feb-2021.   This case was linked to MOD21-083916 (Linked Report).; Sender's Comments:  MOD21-083916:
pt recv vax OCT97 & NOV97 pt exp pain & numbness in entire arm;
Developed a cold a few days ago, then parents noticed 2 spots on chest on Sat, 5 more by Sunday, and a large amount today. Inchal spots are scabbed Sat parents not see any blisters. Today there were macules, papules and scabbed spots.
Patient experienced a tingling and numbness for about 30 minutes from her shoulder to her fingers after getting the shot.
Subsequently the pt developed a rash on her left deltoid, site of administration. This is 1 of 2 patients from this facility who experienced an adverse event following receipt of Acel-Imune lot 467474.
I had pain in my urinary track which I thought was a UTI which became severe after drinking lots of water & cranberry juice, called a telehealth professional for antibiotics,  then went to an emergency care which they gave me an injection for UTI and lastly went to my OBGYN who informed me the urine culture was negative for a UTI & they need not treat me for a UTI but to look for where else this pain is coming from which through ultrasound & testing they found nothing & recommended I see a urogynocologist.  Pain persisted through out the day & night for almost 3 wks which is when it completely subsided.   I went for my 2nd covid vaccine & was informed other women have complained of urinary track & bladder pain after getting the vaccine & was informed to take Benadryl prior to receiving the 2nd vaccine.
I started having symptoms on 01/21/23 after being exposed toCOVID-19 when my wife tested positive. I took a home test for the COVID-19 that came back positive. I went to the local urgent care that confirmed that I was indeed positive for COVID-19. I was given a prescription of PAXLOVID, it did help clear up COVID-19, I did get rebound COVID-19.
Right Ischemic Occipital CVA with Left Sided Paresthesia and visual field deficit
Information has been received from a pharmacist concerning a 71 year old male with a latex allergy to "latex"  who on 05-NOV-2008 was vaccinated with ZOSTAVAX (lot #663198/1419X), 0.65ml, subcutaneously into the left arm.  3-4 days after vaccination the patient developed pain in his left leg and difficulty walking.  The patient's pain in left leg and difficulty walking persisted.  Unspecified medical attention was sought.  Pain in left leg and difficulty walking were considered by the reporter to be disabling.  Additional information has been requested.
He developed weakness and could not raise his right arm without assistance from his left arm. He has passive rom and was evaluated by Dr. who advised a course of PT.
Patient breaks out in hives around his neck, under his axilla, and groin, chest, thigh, back. Patient described this reaction as occurring any time his body temperature rises due to illness. Occurs with each Anthrax vaccine.
Patient received Moderna 0.5 mL IM x 1 as his first dose.
About 12 hours after injection started experiencing injection site pain, headache, chills and then a slight fever. All symptoms cleared by the next day.  Note: I had previously tested positive for COVID19 on 1/25/2021 with no symptoms.
Pt vaccinated with DTP/OPV developed fever 102-104.6, rash on scalp, face, chest & back.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jul2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma/ Seizures" (unspecified if ongoing); "Asthma/ Seizures" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing); "capers allergy" (unspecified if ongoing). There were no concomitant medications.   The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti viral therapy of paxlovid was given from 01Aug2022 to 04Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 3 mins after Janssen vaccine was given, pt was very white and faintish.  I rushed out of pharmacy and had a tech call 911.  As I was running to him pt started slipping out of his chair, as a women, who I later found out was his mother and I helped keep pt in chair as he fainted and then seized for about 2 seconds and then gained consciousness. Upon awakening pt said , what  just happened?" The mother answered "oh you just had a little seizure, you're fine." To my surprise, I asked the mother is this has happened before and she said yes when he sees needles/get shots.  I told them the ambulance was on it's why and the mother asked "why?!" I told her because your son just fainted/had a seizure and we want to make sure he is ok.  The pt refused to go to the hospital.  I did go back out there and mentioned to them that it is very important to answer questions truthfully any time they are asked as they failed to honestly answer our questions about ever feeling faint after receiving a vaccine. His blood pressure normalized and once the paramedics left so did they.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 10-MAY-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L035276 and expiration date 09-JUN-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
headache; runny nose; nausea; soreness around the injection site/ 3 to 4 inches below the injection site; pain seems to be getting worse; he can touch his arm and it doesn't feel sensitive at the location.; a constant ache deep in his arm, like in the bone; This is a spontaneous report from a contactable consumer (patient).   A 72-years-old male patient received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown) via an unspecified route of administration in unspecified arm at single dose for covid-19 immunization at the mall. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer Covid-19 vaccine on 06Apr2021 and received the second dose on 27Apr2021. He reported experiencing several side effects for 36 days after administration of the vaccine such as headache, runny nose, soreness around the injection site that was described to be 3 to 4 inches below the injection site, and nausea. He was not sure if the nausea he was experiencing was related to the vaccine. He could touch his arm and it does not feel sensitive at the location. He described a constant ache deep in his arm, like in the bone, and stated the pain was most evident when he raises his elbow to shoulder height. The pain he was experiencing was in the administration arm and described the pain to be in the middle of his arm that has lasted 36 days. He stated if the pain gets any worse than it was then, he will consult with his doctor. That pain seems to be getting worse. He does not believe a needle broke off in his arm. He once experienced a needle break off in his foot during a lidocaine injection between his big toes. He was hoping to find more in-depth information. The outcome of event headache, runny nose, nausea, bone pain and sensation loss were unknown and vaccination site pain and condition aggravated was not recovered.  Information on the lot/batch number and Additional information has been requested.
Localized swelling on superior shoulder of right side, approx size of quarter along trapezius, approximately 3 finger widths from AC joint.
On Monday 01/24/2022, I woke with backache, headache and nauseas, It went away by the afternoon. The next morning the body ache started getting worse and got a low grade fever 99.5 and that continue until Wednesday as well. 12/26/2022 Sinus pressure and headaches started, as of yesterday and today I have a sore throat. I went to the clinic on 01/26/2022 to get tested for Flu and covid they both came back negative. I have been taking Dayquil and ibuprofen.
Pt states received vaccine 11/11/13. She went camping that day and was camping for few days. Her arm hurt night of 11/11/13. Then starting 11/13 - arm hurts, goes up into shoulder and numbness in thumb. Area around vaccine site not red, hot, no sign of infection. Counseled her to see MD, states will wait another week. She is not sure if vaccine related or something from.
Approx 10 minutes after vaccination. Pt complained of dizziness. She briefly lost consciousness and upper extremities jerked and were drawn toward her chest for approx 5-10 sec. She regained consciousness and complained of nausea. She was diaphoretic. Pt was observed for 30 mins. Bp 90/60, HR 72 talked with pt on telephone 2 hours after incident. Still complained of nausea.
pt recvd vax 12SEP95 AM & was given APAP prior to clinic visit;awoke from afternoon nap w/shrill scream or screeching for 1 1/2hrs; & occurred intermittently for total of 5hrs;APAP given q 3 1/2hrs;pt burning up-mom did not take temp;
developed symptoms 11/17/2021 of lethargy and shortness of breath. ADmitted to the Hospital on 11/18/2021 and discharged 11/22/2021.
This spontaneous report as received from a pharmacist refers to a 55 year old patient of unknown patient. On 07-NOV-2013 the patient was vaccinated with MMR II dose 1. The patient received the second dose on 20-NOV-2013. Dose, lot and expiry date for both doses were not reported. No adverse effects were reported. Additional information is not expected.
1554 Dizziness.BP 104/65, HR 66, sats 99%, Resp 16. Drank water, laid down. 1600 Symptoms resolved. 1609 Left ambulating for home. Second Vaccine
vaccine on 1/20/21. Fatigue, confusion on morning of 1/21/21. Pt's family concerned could be due to vaccine vs infection vs dementia.
The Pt.'s left upper arm developed exuberent local reaction with erthyema, warmth, tenderness with systemic fatigue, fever.
legs were hurting as if she had restless leg syndrome; legs were hurting as if she had restless leg syndrome; could not get out of bed; sore arm; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PAIN IN EXTREMITY (legs were hurting as if she had restless leg syndrome), the second episode of PAIN IN EXTREMITY (legs were hurting as if she had restless leg syndrome), MOBILITY DECREASED (could not get out of bed), MYALGIA (sore arm) and FATIGUE (tiredness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Concomitant medications were provided by the reporter.     On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced the first episode of PAIN IN EXTREMITY (legs were hurting as if she had restless leg syndrome), the second episode of PAIN IN EXTREMITY (legs were hurting as if she had restless leg syndrome), MOBILITY DECREASED (could not get out of bed), MYALGIA (sore arm) and FATIGUE (tiredness). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency and MELOXICAM for Adverse event, at a dose of 15 milligram. At the time of the report, last episode of PAIN IN EXTREMITY (legs were hurting as if she had restless leg syndrome), MOBILITY DECREASED (could not get out of bed), MYALGIA (sore arm) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.   This case was linked to MOD-2021-295607, MOD-2021-295431 (Patient Link).
Patient was feeling "hot"  immediately after vaccination.  Sitting in waiting area/  Put head down on knees.  Feels room is "too close".  Pulse and BP normal.  Reports anxiety in past.  Encouraged slow deep breathing.  Relaxes after conversing about normal symptoms.  Gave literature on symptoms, v-safe.  Encouraged V-safe enrollment.  Gave bottled water.  Encouraged plenty of fluids and rest today.   C/o "tightness" in shoulders and back.  Encouraged relaxation and rest.  Symptoms present:  Lightheadedness. Anxiety.  Orientation x 3, Back and shoulders were achy.  "Hot" right after shot, then resolved.
Patient reported developing  skin itching with rash, mouth itching and SOB/bronchospasm with wheezing. She developed the symptoms immediately after vaccination. She went to the nearest ED where she was given IM Epinephrine.  She was also treated with IV methylprednisone, IV famotidine, Albuterol, Benadryl.  Vital signs were stable throughout her ED visit. She continues to complain of cough, shortness of breath, and rash several weeks post vaccination.
Rash on back, arms, legs x 1 month Hydrocortisone 2.5% cream - apply to affected areas BID.
03/15/2021: Presented to the emergency department with abdominal pain. The patient was admitted with acute appendicitis with focal peritonitis, and underwent surgical intervention. The patient was discharged the subsequent day.
very hot temp was 99 at 2PM; slightly achy; minor chill; minor headache; swelling over eyes; sense of heat; dryness in throat; dryness in chest; This is a spontaneous report from a contactable consumer or other non hcp. A 75-year-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6201; Expiration Date: unknown), via an unspecified route of administration, administered in left arm on 20Feb2021 14:00 1st dose, single for COVID-19 immunization.  Medical history included allergy to metronidazole, sulfonamides, penicillin, cephalosporins, back pain from 1982 to 1989, chronic low back pain/4 surgeries, hemorrhage intracranial from 2015 to an unknown date, endometrial cancer from 2015, had surgery only. Concomitant medication(s) included meloxicam for unknown indication, hydrocodone bitartrate, paracetamol (NORCO) taken for back pain, levetiracetam, verapamil, atorvastatin, taken for an unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 25Feb2021, the patient stated that she experienced "a sense of heat and dryness in throat and chest. Today tired with same sense of dryness, very hot, temp was 99 at 2PM and has gone down and up since then. (First time I have elevated temp since vaccine on 20Feb.) I feel slightly achy, minor chill, minor headache swelling over eyes, like flu. (I had flu shot 5 months ago.) Too tired to go out or do housework Is this a delayed reaction to the vaccine. She asked: Will the meloxicam weaken the shot and "My next Pfizer Covid-19 shot will be on 13Mar2021. I am worried about the shots working well (considering the drugs I've ben taking) and if this is just a normal reaction to the vaccine, or something else. The patient underwent lab tests and procedures which included body temperature increased: 99 Fahrenheit on 20Feb2021 temp was 99 at 2PM and has gone down and up since then (First time I have elevated temp since vaccine on Feb2020). The clinical outcome of the events was not recovered.
Pt reported "blisters" on back after receiving vaccine the day prior 7/27/21. Pt was scheduled an urgent care visit with provider on  7/29/21