chrisvoncsefalvay/vaers-outcomes huggingface dataset:
We did a COVID test on 05/28/2022 and then on 5/30/2022 we administrator a PCR test at Pharmacy and it was positive. Her symptoms was very mild. She had a bad cough and a low grade fever. She handle it really. She had no other symptoms. It really never got her down at all. We caught it early. Thank God that she was vaccinated. Her symptoms was about 2 days. We just quarantine her for about 10 days.
Really bad headache, fatigue, I was throwing up, I was running about 100 fever but it didn't go higher than that. Those symptoms lasted about a week and a half.  Talked to healthcare provider with video chat - put me on bedrest. I had a positive pregnant test about three days after the first dose of COVID vaccine. And went to the Hospital about 1 week and 1/2 after finding out.  I'm due Sept 26, 2021. This is my fourth pregnancy - I had my daughter who is eight years old; an abortion; had my son who is five and he was born pre-term due to lack of fluids in the stomach - 4 lbs 5 oz. and now this pregnancy.  Had the second dose of vaccine, I think of February 9, 2021.
COVID arm; Red spot at injection Site; Itching on spot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red spot at injection Site), VACCINATION SITE PRURITUS (Itching on spot) and RASH (COVID arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red spot at injection Site) and VACCINATION SITE PRURITUS (Itching on spot). On an unknown date, the patient experienced RASH (COVID arm). At the time of the report, VACCINATION SITE ERYTHEMA (Red spot at injection Site) and VACCINATION SITE PRURITUS (Itching on spot) outcome was unknown and RASH (COVID arm) had resolved.            No concomitant medication information was provided, however, it was stated that patient does take other medications.  No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable    Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: follow-up SD received on 10 may 2021 updated with new event(COVID arm) and the information about second vaccination.
I have not had adverse effects. My OBGYN recommended to start a case though so that the CDC and or FDA can get additional info from me in case of future questions.
Sore arm. Evening of 3/20 felt mild stomach discomfort. By 4am 3/21, bad stomach and intestinal cramping, nausea. Back pain. Vomited repeatedly. Dry heaving because there was nothing left to expel. Couldn?t keep water or crackers down. Had to take zofran. Threw it up. Waited awhile and took another. Vomiting subsided around 12:30pm. Cramping continued mildly into the night but has fully subsided today, 3/22.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding the medical history, drug reactions/allergies and concurrent conditions was not reported. On 15-NOV-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (subcutaneously, lot number N013277, expiration date: 28-APR-2019) (dose and site of administration were not reported) for prophylaxis. It was stored in temperature of 6 Fahrenheit degrees (F) to 14 F (7.9 F) for 19 minutes. There was no previous temperature excursion. The call was a result of a reading from a Digital Data Logger. The nurse reported that the diluent (lot number and expiration date were unknown) used to reconstitute the VARIVAX was properly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA002990; US-009507513-1805USA003483; US-009507513-1805USA003481; US-009507513-1805USA003482; US-009507513-1805USA003484.
Injection site sore and muscle swelling. Feet tingling off and on for the past 12 hours.
Myalgia in (L) upper shoulder, with numb hypoesthesia down arm to forearm level, with urticarial-like patches proximal to injection site positive axillary tenderness.
A slightly sharper headache in the early morning around 2:00 A.M.   Not unusual for me to wake up early as I am an early riser as is.   Took Tylenol Acetaminophen for remedy.    Usually I am up early in the morning but was a little more unusually was able to fall back to sleep with some headache awakening before waking up at a (for me) relatively late 6:30 A.M.      It's about 6 P.M. 6/19/21, and unlike other headaches that may have been from just maybe not drinking  enough water during a work day, I felt a couple little pings of a headache.
I got the dry heaves; I got a rash on my arm. it itched; I got a rash on my arm. It was about 6 inches long; I got a rash on my arm. It was red; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (I got the dry heaves), VACCINATION SITE PRURITUS (I got a rash on my arm. it itched), VACCINATION SITE RASH (I got a rash on my arm. It was about 6 inches long) and VACCINATION SITE ERYTHEMA (I got a rash on my arm. It was red) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (I got a rash on my arm. it itched), VACCINATION SITE RASH (I got a rash on my arm. It was about 6 inches long) and VACCINATION SITE ERYTHEMA (I got a rash on my arm. It was red). On 23-Apr-2021, the patient experienced RETCHING (I got the dry heaves). At the time of the report, RETCHING (I got the dry heaves), VACCINATION SITE PRURITUS (I got a rash on my arm. it itched), VACCINATION SITE RASH (I got a rash on my arm. It was about 6 inches long) and VACCINATION SITE ERYTHEMA (I got a rash on my arm. It was red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment medication include calamine lotion.   This case was linked to US-MODERNATX, INC.-MOD-2021-095547, US-MODERNATX, INC.-MOD-2021-095735 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: TCR added. Spoke with husband of the patient. Patient is fine and recovered from reactions she experienced. He declined further Follow-up.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095547:Sister-in-law case US-MODERNATX, INC.-MOD-2021-095735:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 at 18:00 as dose 5 (booster), single (Lot number: GJ6796) at the age of 59 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2 weeks was noted as no. Treatment of COVID-19 was Paxlovid (lot number 00069-0345-30) which started on 18Sep2023 and stopped on 22Sep2023.
No second dose after 35 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (No second dose after 35 days) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (No second dose after 35 days). On 01-May-2021, PRODUCT DOSE OMISSION ISSUE (No second dose after 35 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
First shot was fine.  Second shot  on 09/29/2021 I got the reaction. My doctor prescribed an antibiotic. The redness is all the way down my arm and was raised. Had a low grade fever, face was red, headache for two days, Tired, Arm was sore and itched. Bright red. This is the 5th day of reaction and my second day on antibiotics. When I got the flu shot, I couldn't walk. Had GBS. I can walk now but couldn't walk for many months.
local reaction sore, swollen, red lt arm started evening p/vax given;inc over 48hr;
He broke out in a terrible rash all over his entire body.  The rash turned into open sores, especially around his lips and on top of his hands.  They scabbed over.  He had a fever for 3 days and would not eat.  He was miserable.  It took a long time for him to heal.  He STILL has small patches of red bumps 3 months later.
1/13-malaise, mild headache, chills, joint pain, body aches, low grade temp (99.7) 1/14 worsening exhaustion, body aches, head/neck pain, chills, afebrile.
migraine; Fever; Chill; red spot size of a tennis ball on her arm; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), PYREXIA (Fever), CHILLS (Chill) and INJECTION SITE ERYTHEMA (red spot size of a tennis ball on her arm) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced MIGRAINE (migraine), PYREXIA (Fever), CHILLS (Chill) and INJECTION SITE ERYTHEMA (red spot size of a tennis ball on her arm). At the time of the report, MIGRAINE (migraine), PYREXIA (Fever), CHILLS (Chill) and INJECTION SITE ERYTHEMA (red spot size of a tennis ball on her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Red and inflamed arm (including bicep, triceps, deltoid area) entire arm above the elbow. Area is hot to the touch with sharp pain. Patient reported chills and fever of 104 degrees. She has nausea while sitting and walking (laying down she did not have nausea). She has whole body aches. Symptoms started the day after vaccination and became worse each day.
patient that received expired ActHIB vaccine, no AE; Initial information received on 30-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to cases 2020SA271354 and 2020SA271357 (same reporter).  This case involves a patient (age and gender not reported) who received an expired HIB (PRP/T) VACCINE (Box lot UJ055AAA; Diluent lot U6205AC and expiration date: 22-Apr-2020; powder expiration date: 17-Nov-2020) via unknown route in unknown administration site for prophylactic vaccination on 24-Aug-2020 (PT: expired product administered).  The patient's medical history, past treatment, vaccinations, family history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used (same day latency) as the vaccine (diluent) was expired on 22-Apr-2020 and was given on 24-Aug-2020.  No adverse event was reported at the time of reporting.  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 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.
Prior to admission, several episodes stiffening of extremities, rolling eyes for 1 hour lasting 3-5 minutes after fell asleep. A febrile.
Light signs of redness on chest and shoulders began day after vaccination.  Slightly itchy.  Over next few days developed into patches, and then bumps not unlike shingles.  Total of 12 silver dollar size or smaller patches developed over the next week and a half.   Quite painful and somewhat itchy.  Patch locations are on back of right shoulder, chest and neck.  Mitigated with cortisone cream and ibuprofen.  I had chicken pox as a kid.  Do not have shingles vaccine.  Of note:  I had a bad bout of poison ivy last year.   About four or five days ago, i noticed the area on my leg that had had the poison ivy scratches reemerged with red scratches again, but this only lasted for a day.
Sudden onset headache and generalized body aches, without fever, worsening over 1 month to intermittent polymyalgias and arthralgias, tingling in extremeties, and at times severe burning muscle pain and weakness.
This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received 2 years prior to the reporting date). 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 provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient never got the 2nd dose, which led to incomplete course of vaccination. The patient asked to start over. The reporter wanted to know what should a patient do if their second dose of Shingrix was later than six months after receiving the first dose. The reporter reported her pharmacy thought she should start over since first dose was about two years ago.
Day 2 following second vaccine dose  had onset of diarrhea.  After several days of diarrhea, went on BRAT diet with no relief.  Took Pepto-Bismol with no relief.  Took Imodium with no relief.  After two months of chronic diarrhea, discussed problem with NP.  She prescribed CHOLESTYRAMINE with no relief.  Diarrhea is not bloody and does not contain mucus.  No pain but there is occasional cramping.
1.Bronchitis 2. Insomnia 3. High Blood Pressure 4. Agitation, Anxiety, Depression 5. Joints and Muscles Aches 6. Abdominal pain/burning sensation 7. Conjunctivitis 8. Asthma 9. Constipation and Diarrhea 10. Hemorrhoids, Rectal bleeding 11. Angry, Irritable Mood 12. Pain on my groin, knees and hip, lower back, legs 13. Cysts developed 14. Blurred Vision, pain eye 15. Walking with difficulty 16. Numbness and tingling on legs and arms 17. Trouble remembering recent information, bad memory 18. Unable to perform multiple tasks simultaneously, confusion, disorientation 19. Inappropriately sweating 20. Respiratory problems
1/21/21 5:00 AM chills and body aches, no fever  12:00 PM chills, fatigued  4:00 PM fever 101.3 1/22/21 AM chills, body aches, fatigued, fever 101.1 1/21/21 PM no fever  1/23/21 body aches, swelling noted and tenderness to right armpit
Bell's Palsy. Paralysis to left side of face, lip, and eye-lid on left eye
pregnant /no AE; Initial information was received on 03-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional and physician.  This case involves a (unknown age) female patient who was exposed to vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (exposure during pregnancy).   Data regarding this pregnancy were received prospectively, that is before pregnancy outcome was known.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient's medical treatments, vaccinations, concomitant medication and family history were not provided.  The patient had no medical history, concomitant disease or risk factor.   The information regarding the patient's previous pregnancy/ies was not reported.  On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiry date not reported) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of vaccine exposure during pregnancy (same day latency).  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  There will be no information on the batch number for this case.
Showed the common signs of redness and swelling around the varicella vaccination site already the day afterwards, but around 72 hours later, my tongue became swollen enough that in talking I was chewing on my tongue.  Developed canker sores on the bottom of my tongue and it was dry and sticky no matter the volume of water consumed.  This lasted for about 48 hours.  MD did not advise follow-up other than reporting incedent as other symptoms did not arise.
Swelling, redness, moderate itching at injection site Mild numbness, burning, raw feeling with mild feeling of swelling of tongue and lips, coughing, tightness in chest, flushed cheeks,  Red rash under left arm pit, temp of 100.4. Body aches.
pt recv vax 24APR97 & 25APR97 pt devel rash which was seen while giving pt a bath;f/u recv from MD indicated no reaction occurred;
This spontaneous report was received from a registered nurse and refers to an 11-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 20-DEC-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # 1586752, expiration date 16-FEB-2021 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient).; Sender's Comments: US-009507513-1901USA000071:
Febrile seizure on 13JUN91; Also dx as having a viral infection; t104;
improperly stored VARIVAX were administered to patients.; no additional adverse events were reported; This spontaneous report was received from an Office Manager referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapy and drug reactions or allergies were provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # W039294 and expiration date: 11-DEC-2024 (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis. No adverse event reported.  The temperature excursion was 17.4°F during 2 hours 0 minutes 0 seconds and there was no previous temperature excursion.
Information has been received from a physician concerning a 5 year old patient who on 5/18/99 was vaccinated with a dose of Varicella virus vaccine live (lot # 630034/0313J). The week of 3/29/04 the patient came to the physician's office with a moderate varicella rash with 20-30 lesions on the trunk and back. There was no fever. No product quality complaint was involved. Additional information has been requested.
Body aches; Body pain; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PAIN (Body pain) and DIARRHOEA (Diarrhea) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided). Concomitant products included TRAMADOL, Diazepam as needed and DULOXETINE for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN (Body aches), PAIN (Body pain) and DIARRHOEA (Diarrhea). At the time of the report, PAIN (Body aches), PAIN (Body pain) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient didn't receive any treatment her symptoms subsided.
Fever began Friday, 7/3  ranging from 100.5 - 102 (at this point, currently 100.5 on 7/7) chills sweats extreme fatigue low appetite skin sensitivity
Pt called today concerned that the left upper arm is red and itchy. Redness is spreading but it does not hurt. She is to apply a cool compress as needed to relieve itching or discomfort.
Patient developed symptoms of covid around 8/14 including shortness of breath and cough, then presented to Emergency Center on 8/28 where he tested positive for COVID-19 despite being previously vaccinated. He is currently on high-flow oxygen 15L ( as of 8/30/21)
After 3rd booster, I started experiencing chronic hives that shift from place to place all over my body. In conjunction with the hives, I am also experiencing nerve irritation/sensations (like icy-hot) that rotates all over my body in the same places that the hives happen to be. When I am having a bad flare-up, then I also start experiencing tightness in my chest and difficulty breathing. These symptoms get worse when my hormones are fluctuating.