chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At about 1030 patient started feeling light headed & dizzy. Had patient tip down & elevated feet. Staff checked heart rate (within normal), O2 with pulse ox (within normal) and blood pressure (elevated - 160/112). Patient at first stated started to feel better, but around 1050 blood pressure became more elevated 200/105). Instructed patient to go DR/ER treatment/outcome unknown once patient got to ER.
Past the 42 days and has not received second dose; Back pain; Muscle spasms in back; Back knots; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced, back pain, muscle spasms in back, back knots and past the 42 days had not received second dose.  The patient's medical history was not provided. No relevant concomitant medications were provided.  On 18 Jan 2021, prior to the onset of events, the patient received their first of the two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 18 Jan 2021, on the day of vaccination, the patient developed back pain and muscle spasm in back and back knots for three weeks.   In addition, the patient had not received his second dose yet and was past the 42 days for receiving it.  No Laboratory investigations were provided. No Treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcomes of the events, back pain, muscle spasms in back and back knots, were resolved.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events (back pain, muscle spasms in back, and back knots), a causal relationship cannot be excluded.
about 48hr p/vax noticed some itching which persisted for 3 days;on 5th day post vax had some breathing difficulty in afternoon;6th dasy post vax awoke w/swollen face;did not seek treatment for diff breathing or swelling in face;
Severe abdominal pain, chest and back.     Pain was the worse I ever had.    When pain persisted through the next days,  I went to hospital and was admitted with acute pancreatitis.  This happened in September and then flared up in October, resulting in another trip to ER and another hospital stay
PATIENT PRESENTED TO ER ON 1/8/21 @ 6AM WITH STROKE SYMPTOMS INCLUDING (R) SIDE WEAKNESS
4 hours later after My daughter got 2nd COVID vaccine Small round red rashes on the face .
Strong nausea and feeling like throwing up all day and night. I had headache and muscle aches that subsided 4 hours after. The nausea and feeling like throwing up subsided around 9pm.
approx 3mos p/vax pt devel intussusception, treated w/barium enema;
This is the second shot.  My first Phizer shot was 3/27/21 Lot ER8732.  The first shot I was just ending my period.  Right after the first shot I started getting heavy cramps and experienced flooding, clotting, and cramping for the next 3 weeks.  After this second shot I was not having my period (having ended about 1 week before the second shot).  3 days later I again got heavy cramps and heavy bleeding.  I have not experienced the clotting as much this time - but I am bleeding MUCH heavier and experiencing uncomfortable cramps to the point I had to take some time off from work yesterday.
Pt had soreness and had trouble moving her arm 2 to 3 hours later.
On Saturday, that evening, I began having a headache and I noticed that when I took my shoes off that my feet were swelling.  The next day (yesterday), I woke up with my entire face and eyes swollen, feet and ankles swollen, fingers swollen, and I had a bad case of diarrhea.
pt recv vax & had welts x 3 on back of lt calf welts ranges from 1" diameter to 2 1/2" diameter;pt denied any SOB of diff swallowing;parent advised to observe child & return if sx worsen;
approx. 1 hr after vaccination developed rash L shoulder, back, chest.  Had Benadryl before ed evaluation, at time of my evaluation rash was not raised but mother describes as initially hives like.  no swelling mouth or face, no rash to face, no resp symptoms.
SLE; Death; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 2, single (Lot number: EP7534) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Enlarged Prostrate" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6200, Location of injection: Arm Left), administration date: 20Feb2021, when the patient was 69-year-old, for Covid-19 Immunization. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (hospitalization, disability, life threatening) with onset 17Mar2021, outcome "not recovered", described as "SLE"; DEATH (death), outcome "fatal". The patient was hospitalized for systemic lupus erythematosus (hospitalization duration: 60 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Nov2021) unknown. Therapeutic measures were taken as a result of death, systemic lupus erythematosus. The date and cause of death for the patient were unknown. Patient had not received any other vaccine in four weeks. Patient not had covid prior vaccination and was tested to covid post vaccination. Treatment of events was reported as multiple. Patient had no known allergies.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Reported Cause(s) of Death: unknown cause of death
10 hours after Hep-B #1 given, child developed hives on back and torso. Neck became red and hot; left hand became swollen, red, purple and hot.
I have been having burning tongue since the end of January. The pain travels around my mouth and cheeks. I was treated twice for thrush using the antifungal but that did not help. The day I stopped taking the antifungal, I started having a pain in my tooth. The dentist put me on clindamycin for 2 weeks which resolved the issue with pain in the tooth but the tongue still hurts. I went to my primary care doctor today and she drew blood to test for B12 and folate deficiency to rule out. I have also aspirated a few times in the middle of the night, This has happened before and my doctor doubled the dose of my omeprazole but I still have since aspirated in the middle of the night.
Urticaria and red erythematous, hot and blotchy rash all over body.  Hot , swollen tense forearms.  Chest tightness.  Seen 4/13/21.  Treated with Prednisone.  Given 20 mg bid (prescribed for 5 days).  Pt only took 3 days as rash resolved.  Also advised pt to increase Pepcid to 20 mg BID and continue Zyrtec 10 mg he had taken for a few days.  Rash completely resolved by followup visit 4/21/21.
Expired booster dose administered (> 12 hours post puncture); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered (> 12 hours post puncture)) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078J21A, 005C21A and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021 at 11:51 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021 at 11:51 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered (> 12 hours post puncture)). On 20-Dec-2021 at 11:51 AM, EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered (> 12 hours post puncture)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.  Reporter stated that date the vial was initially stored in the refrigerator was 18-Dec-2021 and vial was first punctured at 8:54 AM on 18-Dec-2021. And the vial did not undergo any temperature excursions Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) is approximately 29 hours.
MENSTRUAL PROBLEMS - SEVERE MENSTRUAL PAIN (THE PAIN COULD COMPARE TO LABOR PAIN) , IRREGULAR PERIOD, BLEEDING BETWEEN CYCLE. CONSTANT HEADACHE , CONSTANT ABDOMINAL PAIN
8 days after vaccine my arm is swollen, red, itchy and very sore. More sore than when the vaccine was administered. I have a welp about 2 inches around at site of vaccine
major urticaria all over my body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (major urticaria all over my body) 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 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced URTICARIA (major urticaria all over my body). The patient was treated with BILASTINE for Urticaria, at an unspecified dose and frequency. At the time of the report, URTICARIA (major urticaria all over my body) outcome was unknown.            No concomitant medications was provided by the reporter.   Reporter did not allow further contact
received her first Shingrix vaccine a year ago and never got the second vaccine; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of 0.5 ml by intramuscular route received 1 year ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was reported by the patient's for herself. The age at vaccination was not applicable for this report. She reported that, the patient never got the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Acute pain 2nd and 3rd day after vaccination.After a week red spot in arm, swollen, no pain. I think it will be get better.
began 6JUL98 w/papular vesicular rash on face;extremities, upper torso-non pruritic;afeb;
Just over 48 hours after vaccination left armpit areaswollen; Just over 48 hours after vaccination left armpit areaswollen and slightly tender; Chills; Tiredness that lasted approximately 12 hours beginning approximately 15 hours after vaccination; Soreness at injection site still present 61 hours after vaccination.; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PC3182) via an unspecified route of administration in the left arm on 27Aug2021 at 17:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 06Aug2021 at 09:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient previously received ciprofloxacin (CIPRO) on unknown date for unspecified indication and experienced drug allergy. On 27Aug2021 at 20:00. the patient experienced soreness at injection site which was still present 61 hours after vaccination. On 28Aug2021, beginning approximately 15 hours after vaccination, the patient experienced chills and tiredness that lasted approximately 12 hours. On 29Aug2021, just over 48 hours after vaccination, the patient experienced left armpit area swollen and slightly tender. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events chills and tiredness was resolved on an unknown date in Aug2021, whereas the outcome for the events soreness at injection site which was still present 61 hours after vaccination, left armpit area swollen and slightly tender was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Generalized muscle pain, stomach pain, red face on the 3rd day after vaccination. Spoke with patient via phone on 03/09/2021 and all side effects currently resolved.
Information has been received from a RN concerning a female pt with a history of chickenpox who in approximately 2003 was vaccinated with a dose of varicella virus vaccine live (Lot # not provided). The pt subsequently developed shingles. It was not known what treatment was provided or if the pt recovered. Unspecified medical attention was sought.  There was no product quality complaint involved. The reporter indicated a similar experience with another pt (WAES # 0308USA01976). No further information is available.
nausea; sore throat/ throat hurt; feeling unwell; fatigue/extra tired; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EI1686; expiry date: unknown) intramuscular in the right arm, on 04Jan2021 at 12:00 at a single dose, for COVID-19 immunization. Medical history included diabetic/ diabetes diagnosed in 2015, high blood pressure, and high cholesterol, all prior vaccination. The patient has no relevant family history. The patient has no concomitant medications. Patient has no previous immunization with the Pfizer vaccine. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient received the first shot of the vaccine 04Jan2021 at 12:00, and she started feeling unwell during the weekend (Saturday; 09Jan2021). She's still experiencing these symptoms: fatigue, nausea, sore throat, and she's feeling worse. She called the COVID hotline because she was having fatigue and nausea. They told her to call her PCP and call Pfizer to report. After first dose on 04Jan2021, she felt ok over the weekend. She was just fatigued last night and had nausea and her throat hurts. She wanted to know about getting her second shot that is scheduled for 26Jan2021, if it is recommended or not. There was no prescriber. She received the vaccine through work clinic. She was extra tired this weekend, so Saturday would have been the start for that. She went to bed early and that was when the nausea started. It woke her up. Her throat hurt off and on through winter. But last night, it was worse than it has been. It comes and goes without any medication or anything. She was sure it was given in the muscle. NO emergency room (ER) or physician's office required. She called COVID hotline and they are making her go to the doctor before she can return to work. She has not gone yet. Outcome of the events was not recovered.
Patient had an angry, red rash appear at one of the injection sites. 10 days after the immunizations, he was suffering from a high fever that ranged from 101.5 to 103.6 degrees. He was taken to the emergency room.
This is a spontaneous report from a contactable consumer (patient). A 26-year-old (non-pregnant) female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), at the age of 27, via an unspecified route of administration, in left arm, on Apr 27, 2021, 08:15, single dose, for COVID-19 immunization. The patient's medical history not reported. Concomitant medications included Nexplanon and testosterone. The patient previously took sesame oil and experienced drug hypersensitivity. Reportedly, patient did not receive any other vaccine in four weeks. The patient did not have COVID-19 prior to vaccination, nor  tested post vaccination. On May 1, 2021, at 12:00 (patient reported 10 days post vaccine), she still has a lump at vaccination site, arm soreness, headaches almost every day and nausea. The patient did not receive any treatment for the events. At the time of report, the outcome: not recovered from the events. No follow-up attempts possible. Information about batch/lot cannot be obtained. No further information expected.
This patient is currently hospitalized for "possible" Guillian-barre Syndrome and received J&J vaccine on 3/13.
Pt's deltoid immediately swelled 1/2 in x 2 in circle raised lump. Pt stated he did not feel well and had a vasovagal response. EMS came. His blood sugar was 66. Other vitals 118/72, HR= 84, PO: 98%.
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 60-year-old male patient who received SHINGRIX (batch number ER5ZB, expiry date 9th June 2021) for prophylaxis. On 19th March 2019, the patient received SHINGRIX. On 19th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the injection site pain, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX vaccine in the right deltoid. Nurse practitioner reported that the patient received SHINGRIX diluent which was reconstituted with another SHINGRIX diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient presented with soreness at the injection site afterwards.
My period has been affected since receiving the first of the covid 19 vaccines. After the first  C-19 vaccine that I received, my period was affect/ altered and it was very heavy then reduced to spotting. After my last C-19 vaccine injection: the bivalent booster in 9/3/22, my period has now all together ceased. I no longer have periods. I experience the pain/ cramps/pms with no blood. After visiting my Gyno, ultra sound, in December 2022, my period in January 2023 was brown blood only when wiping and 2 small blood clots.  Also, when receiving the vary first vaccine for C-19 in 2021, after my 2nd shot, I believed that I was going to die. I did not call the ambulance. I sat at the edge of my bed and began bouncing up and down, praying, chanting, talking to God asking for help. It was my heart, it felt...not good. I called my sons regional center and told them I was going to bed, it was 5am. I was worried about my health I said as I am having an adverse reaction to the C-19 vaccine.
By 30OCT pt c/o h/a,; 3NOV joint pain; 4NOV difficulty standing; 5NOV loss of balance; 6NOV ER visit dx w/bladder infect sent home, 7NOV taken by ambulance to hosp w/convuls;
Started with chills during night "may have had fever" around 7 am, on 07/22/2006 she was going to pass out, felt dizzy most of that day.  Also felt tired and had loss of appetite.  Felt better on Sunday.  Reports having taken a pill called on Saturday for dizziness.
Patient moved from exam table to chair post vaccine administration.  While sitting in chair, patient began shaking for approximately "2 seconds" as reported by administering LPN and patient's mother. Patient experienced near syncopal episode for approximately 20 minutes post administration. Patient assisted to supine position and provided with ice packs and water. LPN remained with patient until she was well enough to walk safely.
3/18/07 went to Hospital ER for vomiting and bloody diarrhea. Diagnosed with intussusception. Treated with reduction twice. Hospitalized 3/18-3/20/07. 04/02/07-ER and Diagnostic records received from facility. US:Instussusception identified in left upper quadrant of abdomen. Reduction with therapeutic enema. Recurrance seen on US in small ileocolic intussusception at level of cecum. Second therapeutic enema.  Presented with abdominal pain positive bloody stools, nonbilious emesis. Labs: WNL.
She didn't receive the full dose; Red patch, is hot; It can be itchy; Arm is still red and swollen; Arm is still red and swollen; A spontaneous report (United States) was received from a consumer concerning a 64-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm has a big red patch/erythema, was hot/feeling hot, swollen/swelling, it can be itchy/pruritis and did not receive full dose/accidental underdose.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 27 Jan 2021, prior to the onset of the events, the patient received their dose of mRNA-1273 (Batch Number: 028L20a) for prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced the events big red patch, red patch was hot and swollen. The patient stated big red patch can be itchy. The doctor was concerned that some of the band aid went into arm or the patient did not received full dose.  Treatment details included cephalexin and a topical cream fluocinonide.  Action taken with mRNA-1273 with respect to the events was not reported.  The outcome of the event, accidental underdose was considered as resolved. The outcome of the events,  big red patch, red patch was hot and swollen and itchy was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the se events, a causal relationship cannot be excluded.
Soon after: fatigue, soreness at site (more than usual), headache 10:00PM  throughout entire night: significant muscle cramping in both feet and lower legs, unable to sleep most of night and had to walk up & down stairs numerous times all night to relive cramping.