chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain started after vaccination, after 2-3 days not better, went to MD, was given Rx to help relax the muscles. Returned to MD after a couple weeks of no improvement, x-ray was done was told the nerve was affected due to the shot. He currently states he has pain night and day all the time.
A Week after my first dose ~ I had a rash all over my body 14 hours after my second dose.  I awoke to a very painful cramp about an inch below my left rib on my left side that lasted for almost 2 hours.  The more I moved, the worse it became.  I could not go to the bath room  and when I drank water, the cramp intensified.  Worse pain that I had ever experienced.  I sweated profusely.  Felt like I got kicked in the side.  I was not nauseous, a little dizzy for a moment.  My mouth was dry only because of my heavy breathing.     My second episode happened the following Saturday morning,  I don't think that it was as intense, but it felt like it was only because my left side was sour from Friday mornings episode.     My third and final episode happened again early Sunday morning.  This one was not as intense, but still woke me up and made me struggle.   I did not experience another episode on the 4 the night from my second dose.  At this time, my left side feels bruised internally and I have to change the speed of my walk.  It hurts to walk fast
Immediately after receiving vaccine my blood pressured dropped considerably (it was measured at 77 by medical staff), I started sweating profusely, and briefly was unable to speak because I felt dizzy and felt as if I had no energy. After a few minutes, I recovered and my blood pressure resumed to normal (114). As this was happening, my partner-- who was with me when I experienced the allergic reaction--observed that my face suddenly became red and flushed (a minute after getting vaccination).  Medical staff did not  need to administer an Epipen. They had me lie down and breathe. After about 15-20 minutes I felt normal. Medical staff had me wait a total of 30 minutes before releasing me.
After the shot patient complained of pain at the site, redness, swelling & warmth. Treatment AUGMENTIN oral tab 875 mg BID two days after injection when seen again in office.
Little bit sore; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 89 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 2021 (Batch/Lot number: unknown) at the age of 89 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Time: 14:00, First dose was in her left arm), administration date: 22Feb2021, for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Little bit sore"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fatigue".  Additional information: The patient received the second dose of the vaccine either in  Mar2021 or the beginning of Apr2021. Time of Vaccination for the second dose: 14:00. The second one she was a little bit sore but nothing with the first one. The reporter stated that the soreness ended sometime in Mar2021 or beginning of Apr2021 since by the next day it was all gone and it did not last more than a day. Patient also had fatigue. She recovered completely from this. Vaccination Facility Type was Other. Vaccine was not administered at Facility. No additional vaccines administered. No prior vaccination within 4 weeks. Investigation assessment was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Myalgia, Arthralgia, Rash, Diarrhea, fatigue, swollen axillary glands Narrative:
This spontaneous report as received from a 67 year old female patient via company representative refers herself. In 2009 the patient was vaccinated with an unspecified dose of ZOSTAVAX (route, lot number not reported). On an unspecified date of 2016, the patient had a mild case of shingles. The patient did not seek medical attention. No treatment was given for the event. At time of this reporting, the patient was recovered from the shingles. Additional information is not expected as there is no consent to contact the physician.
arm pain from area of injection to the shoulder.  Pain was significant for the first week. Continues to this day, 3 weeks later, some days less pain than others. Can be very painful to move arm and at time with just ache/throb.
Patient was given Moderna vaccine at approximately 16:30 hrs. Patient began to feel nauseous, but did not vomit.
pt states 3 days p/vax swelling, tenderness, itching lt arm-redness (6SEP96) was away from area till 9SEP96 which was seen by PA;FBS 250 given med;11SEP96 infect resolving seen by PA;
11/14/21 presents to EC ED for "fatigue, rectal bleeding x 3 days" PMHx "kidney transplant 2018, HTN, AS s/p TAVR, prostate CA s/p XRT w/ subsequent radiation proctitis"
The day after vaccination, I started having swelling in my left ankle and discomfort going up the lower left leg. I went to the doctor on 2-23-2021 and I was sent to the Hospital for leg scan/ultrasound the same day. They told me at the time of the scan that I had a superficial blood clot. They called the doctor and he put me on a baby aspirin and my symptoms resolved 4-5 days later.
Received vaccine at 08:15 and by 08:25 I had a red rash on bilateral arms. My throat and tongue felt as if it was starting to swell. I was given Benadryl 25mg by mouth and escorted to the ER by administration.  While in the ER I was given anther Benadryl 25mg, Prednisone 40mg by mouth and epinephrine 0.3 mg injection. After about an hour I was discharged home with a prescription of prednisone 20mg to take for 10 days. I have been taking the prednisone and Benadryl 25-50 mg every 8 hours since the reaction occurred. I still have a rash on my body today and some red dots on body today also.
Tooth extracted; Tooth starting hurting/tooth infection; Area was warm; Area where she got the shot from the bottom and down arm was red; Area where she got the shot from the bottom and down arm was itchy; Tooth starting hurting/tooth infection; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), TOOTH INFECTION (Tooth starting hurting/tooth infection), TOOTHACHE (Tooth starting hurting/tooth infection), TOOTH EXTRACTION (Tooth extracted) and VACCINATION SITE WARMTH (Area was warm) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Tooth infection and Allergy. Concomitant products included AZITHROMYCIN for Tooth infection.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 13-May-2021, the patient experienced TOOTHACHE (Tooth starting hurting/tooth infection). On 16-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (Area where she got the shot from the bottom and down arm was red) and VACCINATION SITE PRURITUS (Area where she got the shot from the bottom and down arm was itchy). On 17-May-2021, the patient experienced VACCINATION SITE WARMTH (Area was warm). On an unknown date, the patient experienced TOOTH INFECTION (Tooth starting hurting/tooth infection) and TOOTH EXTRACTION (Tooth extracted). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 14-May-2021, PAIN IN EXTREMITY (Arm was sore) had resolved. At the time of the report, TOOTH INFECTION (Tooth starting hurting/tooth infection), TOOTH EXTRACTION (Tooth extracted), VACCINATION SITE WARMTH (Area was warm), VACCINATION SITE ERYTHEMA (Area where she got the shot from the bottom and down arm was red) and VACCINATION SITE PRURITUS (Area where she got the shot from the bottom and down arm was itchy) outcome was unknown and TOOTHACHE (Tooth starting hurting/tooth infection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Benadryl cream.
big old bruise on her shoulder, where the shot was giving, the size of a tennis ball, a big bruise; This spontaneous case was reported by a patient and describes the occurrence of ADMINISTRATION SITE BRUISE (big old bruise on her shoulder, where the shot was giving, the size of a tennis ball, a big bruise) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M204 and 013M204) for COVID-19 vaccination.     Patient never had COVID positive test or diagnosis. Patient was not given any vaccines within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose number).  Concurrent medical conditions included Drug allergy (Cotrimoxa, motrin, naproxen, trazodone Hydrochloride.) and Allergy to antibiotic (clindamycin).   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2022, the patient experienced ADMINISTRATION SITE BRUISE (big old bruise on her shoulder, where the shot was giving, the size of a tennis ball, a big bruise). At the time of the report, ADMINISTRATION SITE BRUISE (big old bruise on her shoulder, where the shot was giving, the size of a tennis ball, a big bruise) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication reported as diabetes medication.  It was also reported that the patient did not had any symptoms.  AE did not cause patient to seek medical care. The patient did not experience a similar event in the past.  No treatment details reported.
8 pm - arm pain 3/4/15. 3/5/15 Cant move arm well - started fever up to 101.8 at 9:00 pm arm red raised rash. 3/6/15 100 degree temp in a.m. 99 degrees PM. Arm sore. 3/7/15 fever gone.
This case involves an unknown demographic patient (unknown age and unknown gender) who received only the liquid portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] was administered (product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to product preparation issue (latency: same day).  At time of reporting, no adverse event.  There will be no information available on the batch number for this case.  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.
Has not gotten second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not gotten second vaccine) 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 PRODUCT DOSE OMISSION ISSUE (Has not gotten second vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not gotten second vaccine) had resolved.            No concomitant medications were reported. No treatment medications were reported.
June 6, 2022: Initial Shingrix vaccination August 1, 2022: CoViD Infection, treated with Paxlovid, normal infection course of about 5 days of symptoms September 2022: Unusual shortness of breath during exertion October 24-31, 2022: Back pain October 31, 2022: Diagnosis, ER and Hospitalization for Pulmonary Embolisms
Inappropriate schedule of vaccine/2nd dose was given at 6 weeks; This non-serious case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Inappropriate schedule of vaccine/2nd dose was given at 6 weeks).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 28-SEP-2023 The reporter informed that patient received 2nd dose of Shingrix before 2 months and 2nd dose was given at 6 weeks. The patient received 2nd dose of Shingrix, earlier than the recommended interval, which led to shortening of vaccination schedule. No additional information available. It was unknown if follow up was permissible. This case had been linked with US2023135142 and US2023135132 due to same reporter.; Sender's Comments:  US-GSK-US2023135142:Same reporter US-GSK-US2023135132:Same reporter
Pt seen at ER complained of red, swollen left arm with pain that evening and saw MD in our office in follow up on 11/12/2001.
Fever of 101.7°F; very bad body aches especially in arms; legs burning; tingling of feet numb tingling fingers; nausia; several minutes after the shot my tongue went numb at the tip with tingling; Body aches total weakness; Extreme shaking could not stop shaking; Severe migraine lasting two days now; Today extreme sweating and weakness; The sickest I have been in many years it appears I may be getting better somewhat today; A 65-years-old female patient received second dose of bnt162b2 (Solution injection; Batch/Lot Number: EN6203), via an unspecified route of administration, administered in Arm Left on 27Feb2021 at 15:30 as single dose for covid-19 immunisation. The patient previously took first dose of bnt162b2 (Solution injection; Batch/Lot Number: Em9809), via an unspecified route of administration, administered in Arm Left on 06Feb2021 at 16:30 (Batch/Lot Number: EN6203) as single dose for covid-19 immunization. Medical history included hereditary haemorrhagic telangiectasia. Patient had no known allergies. Concomitant medications included oxycodone hydrochloride, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE; PARACETAMOL]), propanol (PROPANOL), furosemide (LASIX [FUROSEMIDE]), alprazolam (XANAX), calcium, colecalciferol (CALCIUM & VITAMIN D [CALCIUM;COLECALCIFEROL]) and ergocalciferol (VITAMIN D [ERGOCALCIFEROL]). Patient was not diagnosed with COVID prior to vaccination. The patient was not tested for COVID post vaccination. On 28Feb2021, the patient experienced fever of 101.7°F, very bad body aches especially in arms, legs burning and tingling of feet numb tingling fingers nausea, several minutes after the shot her tongue went numb at the tip with tingling. Patient had body aches total weakness. She had extreme shaking and she could not stop shaking. She had severe migraine lasting two days now. After 24 hours temperature was down to 99 her normal temp was usually 97.5 still have body aches shakes and tremors legs feel like they want to give out. Today extreme sweating and weakness. Patient stated that it was the sickest she have been in many years it appears she may be getting better somewhat today. Therapeutic measures were taken due to the events and she was advised to take percocet and drink plenty of water. The patient underwent lab tests and procedures which included body temperature which was 101.7 fahrenheit. The outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
This spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown age and gender. Approximately on an unknown date in May 2013 (reported as throughout May and June), as unspecified number of patients were vaccinated with an unspecified number of unsupported doses of GARDASIL (lot number and expiry date reported as 0555AE and 14-DEC-2014 respectively, dose and route unspecified) which was exposed to as low as minus 1 degrees Celsius (C) for approximately 13 hours. No concomitant medications were reported. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
At 10:55 AM the child complained of not feeling well. This was after receiving the H1N1 Nasal spray. The childs temp was taken by the school nurse and was 100.1 F. The child then stated that she didn't feel well this morning. The mother was notified to come and pick the child up. She was instruced to give Tylenol as directed by her pediatrician and watch for further symptoms.
19MAR93 mom called clinic & stated inc fever no response w/APAP; rash, irritable & crying, vomiting, shaking, pale color; sz;
While in waiting lot after receiving vaccine, pt reported to attendant that she felt dizzy and light-headed. RN responded.  Pt reported hx of POTS and sees cardiologist at times.    VS @ 1205: BP 80/60, HR 88, R 14. RN instructed pt to recline and elevate legs.  Gave water to drink.  BP @ 1215: 100/80.  Pt reported feeling better.    RN advised parent who was with pt to contact cardiologist for guidance prior to receiving 2nd dose of the vaccine.  RN spoke with pt by phone on 3/4/21 @ 0845.  Pt states she recovered fully and has had no further adverse effects at this point.
PATIENT INDICATES SHE HAS A LOT OF NAUSEAS AFETR RECEIVING THE FIRST DOSE. SHE CAME TO THE DOCTOR AND HE ORDERS SOME STUDIES. PX DOES NOT KNOW THE NAMES OF THE STUDIES
Fever 101.5.  Profound lethargy, headache, runny nose, muscle aches, fatigue. Some improvement by this report 10/22/18.
After 2nd dose, woke up at 1 am (roughly 12 hours after receiving the 2nd shot on 3/31/21) with chills, muscle cramps, 101.7 degree fever and nauseous. Drank some water and immediately threw it up & had diarrhea. Took an extra strength Tylenol and felt slightly better. For the next 24 hrs continued with muscle cramps, headache & fever. Woke up the following morning & felt back to normal.
more significant swelling near the injection site; Initial information was received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a physician.  This case is linked to case 2020SA267987 (same reporter).  This case involves a patient (age and gender unspecified) who had more significant swelling near the injection site (vaccination site swelling), when received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported, form: pre-filled syringe) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed more significant swelling near the injection site (vaccination site swelling) within the last few weeks following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No laboratory data was reported.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on lot number.
p/vax pt devel T101; eye lids swollen; vomiting; hard breathing; felt tired; no tx
Patient stated his shoulder began hurting the next day after the vaccination. His arm is weak, he has been taking Tylenol, Has used ice a few times, but he said ice makes it hurts more, so he likes to use warmth on his arm. . as of 5/23/22, his arm is still hurting. He has not seen a MD or medical provider, but will see one if this pain continues past this week.
Patient requested a flu vaccination and the vaccine checklist was completed with the patient prior to administration. After the vaccinator had administered the influenza vaccine the patient then informed her that she remembered she had already received one.  Patient was asked to wait at the clinic which she did for approximately 30 minutes. Staff contact the state health department for any further instruction.  Patient was informed that she may have an increased likelihood of symptoms and if so to contact us with any concerns. Patient said she felt fine and left on her own accord. Phone follow up with patient on 11/3. Patient said did feel soreness in her arm but took tylenol and was fine. No further discomfort of symptoms.
After normal fatigue and general aches the day of the vaccine, today I developed a random nosebleed which took approximately 15 minutes to stop with pressure.; After normal fatigue and general aches the day of the vaccine, today I developed a random nosebleed which took approximately 15 minutes to stop with pressure.; After normal fatigue and general aches the day of the vaccine, today I developed a random nosebleed which took approximately 15 minutes to stop with pressure.; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 36-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 30Mar2021 02:15 PM (Lot Number: EP6955) at single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was in hospital. The patient's medical history and concomitant medications were none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine or other medications within 2 weeks of vaccination. The patient previously received the first dose of bnt162b2 (lot number: EN6206), on 13Mar2021, 02:30 PM in right arm for covid-19 immunization. After normal fatigue and general aches the day of the vaccine, today patient developed a random nosebleed which took approximately 15 minutes to stop with pressure. Adverse events started from 31Mar2021 01:00 PM. No treatment was received for the events. Since the vaccination, the patient had not been tested for COVID-19. The patient had recovered from the events. Seriousness criteria was reported as non-serious.  No follow-up attempts are needed. No further information is expected.
Grandmother reports child's left leg with red circular area approximately 2 inches in diameter. She states child had temp from Saturday afternoon thru Sunday afternoon. She did not take temperature. Child was warm to touch. The grandmother has not noticed if the leg was tender to touch. She states the child does not seem to be bothered by the condition. Given Tylenol on Saturday and Sunday. Grandmother reports redness cleared up by 06/04/02.
vomting, collapsing, dizzy, couldn't feel hands, speech impaired, small stroke