chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Weakness; Ache; Headache; Ache; Headache; Weakness; Weakness; Ache; Headache; Nausea / nausea occurred about eight times; Feelings of weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feelings of weakness), the first episode of ASTHENIA (Weakness), the second episode of ASTHENIA (Weakness), the third episode of ASTHENIA (Weakness) and the first episode of PAIN (Ache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   In 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 25-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2020, the patient experienced ASTHENIA (Feelings of weakness) and NAUSEA (Nausea / nausea occurred about eight times). On 25-Jan-2021, the patient experienced the first episode of ASTHENIA (Weakness), the first episode of PAIN (Ache) and the first episode of HEADACHE (Headache). On 22-Feb-2021, the patient experienced the second episode of ASTHENIA (Weakness), the second episode of PAIN (Ache) and the second episode of HEADACHE (Headache). In 2021, the patient experienced the third episode of ASTHENIA (Weakness), the third episode of PAIN (Ache) and the third episode of HEADACHE (Headache). In 2021, last episode of ASTHENIA (Weakness), the last episode of PAIN (Ache) and the last episode of HEADACHE (Headache) had resolved. At the time of the report, ASTHENIA (Feelings of weakness) had resolved and NAUSEA (Nausea / nausea occurred about eight times) was resolving.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication information was provided.  The reporter's causality for the event(s) of FEELING WEAK and NAUSEA OCCURRED ABOUT EIGHT TIMES with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of WEAK onset 25 Jan 2021, WEAK onset 22 Feb 2021, WEAK onset in 2021, ACHES onset 25 Jan 2021, ACHES onset 22 Feb 2021, HEADACHE onset 25 Jan 2021, HEADACHE onset 22 Feb 2021, ACHES onset in 2021 and HEADACHE onset in 2021 with HUMIRA(ADALIMUMAB) was no reasonable possibility.  No treatment medication information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Facial swelling (R) eye swollen shut. Hives on body. Given BENADRYL, Prednisone in ER & given Rx for BENADRYL and Prednisone.
Patient's father called to report that the patient's right arm  is red and swollen. He states that she is having no pain or itching. The symptoms began in the am on 07/21/2020.  Dr, the medical director advised the father to complete a tele health visit. They were referred to clinic since they have no insurance at this time. They were also advised to apply cool compresses and monitor for worsening symptoms.
patient reported red area at injection site - warm to the touch - 1 to 1 1/2 inch around injection site
c/o pain @ inj site x 2 wk,sl redness,no swelling;states pt has pain in both arms & shoulders p/working w/hands;states MD told pt has arthritis;
Patient received her 1st dose of Covid-19 Pfizer vaccine, lot #ER2613, today at 1:19pm at the Vaccination clinic. While waiting in the parking lot, patient got medic's attention and was not feeling well. Patient reported to have a syncopal episode around 1:30pm with low blood pressure and low heart rate. Medics started IV with IV fluids, which stabilized patient's vital signs. Patient was transported to the hospital.
On 10/1/2022 the patient began to have a severe headache, four days later she developed Bell's Palsy on the left, same side as the injection. 3 weeks later she was also diagnosed with carpal tunnel on the left. She has been prescribed gabapentin which doesnt seem to be helping. She is now just starting a course of acupuncture therapy for the palsy and headache.
This spontaneous report as received from a 54 year old male nurse regarding himself. The patient's medical history included migraines. On 30-DEC-2013 the patient was vaccinated with ZOSTAVAX single dose for prevention of shingles. No concomitant medications were reported. On 20-DEC-2013, 1 to 2 hours post vaccination the patient experienced ongoing headache. The outcome of ongoing headache was reported as not recovered/not resolved. Additional information is not expected.
Vaccinated 11/20/18 (L) deltoid with swelling and redness itching on vaccine site yesterday evening. Medicated with BENADRYL 25 m x 3 yesterday evening. Scratched area now with 10 x 12 cm swollen area with small open excoriated area to skin in center of lesion. Hx of skin reactions to flu vaccine but mother says it has never been this bad.
4 weeks after my third covid vacinnation shot I started experiencing extreme itching all over my body. This ithching is accompanied by hives that can be found all over my body. I first reported this to my PCP and they did a virtual exam and then referred me to an allergist. I saw the allergist several times and had blood work drawn to figure out what I'm allergic to and everything on the list I was mildy allergic to and have since stopped eating these things. It has been over two months since I've stopped eating the things that I am mildly allergic to and I am still experiencing the itching and hives. The only relief I get is when i take an OTC allergy pill named Zyrtec. After i take zyrtec the itching and hives go away for about 2 days and then they come right back. Therefore every few days i have to take zyrtech whereas before i only had to take this a few times a year during seasons like the spring. If i try to go days without taking zyrtec i can make it to about day 4 and then the itching and hives become too intense and so i need to tak zyrtec to get relief. this has never happened before in my life and only started 4 weeks after my third covid shot.
The patient reports swelling and redness at and around the site of injection. It started shortly after the injection. The "welt" is about the size of her hand and is painful and itchy. She says it is less painful this morning than last night but is no smaller in size.
This spontaneous prospective pregnancy report was received from a consumer referring herself as a 22 year old female patient. The patient's concurrent conditions were not reported. The patient had no known medical history, drug reactions and allergies. The patient was not receiving any concomitant medications at the time of report. On an unknown date in 2011, reported as when she was 15 years old, the patient was vaccinated with GARDASIL (dose, units and frequency not reported) (lot# and expiration date not reported) intramuscularly. On an unknown date in 2015, reported as 3 years ago, pap smear test was performed to the patient which resulted negative for human papilloma virus. On an unknown date, patient reported that, she was eleven and a half weeks pregnant (Exposure during pregnancy). On 10-APR-2018 (also reported as last week), pap smear test was performed to the patient, which resulted positive for human papilloma virus (papilloma viral infection). The patient planned to follow-up with her physician. The patient was not recovered from the events. The reporter did not provide causal relationship for the events with suspect therapy GARDASIL. No product quality complaint was involved.
Migraine with black spots in eye on day vaccine was given  Since that day she has had daily headaches, vision problems to include black spots, waves in the eye and temporary blindness) and numbness in her limbs
side effects; This case was reported by a consumer and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had side effects. The reporter asked how long could the side effects last from the Shingrix.
Mild Rash started from arms to chest legs and face.  No treatment. Symptoms resolving.
Mom stated that patient reported she did not feel well about 6:30 pm (the same evening). She then sat down, eyes rolled back in her head, speech was slurred and finally, became unresponsive for about 10 seconds. She was sweating uncontrollably, had a temperature of 99.1 F. afterwards. After she came to, she reported that she couldn't hear, eyesight became blurry just prior to incident. Mom stated that she was a little confused. Had some bottled water and felt better. Mom states that today (6/10), she is feeling better. She did not take any medications at that time. (The vaccine clinic was held as a drive-through, with people remaining in their cars). The weather was very warm. Unknown what activities patient was engaging in the rest of the day.
At 4:30am, I experienced Extreme nausea, and intense malaise and profuse sweating. I could but stand up without help and I was close to fainting.   At approximately 7:30am I was struck again with extreme nausea, hot flashes and a feeling of blacking out/fainting.   I was able to cool off with cold towels and water. After taking tylenol, ginger, peppermint and ginger ale I was able to keep toast down.
1 week after receiving shingles vaccine I came down with shingles and still have them after 3 weeks. (Right thigh area).
Cold sweat at 2am  Achy all over and especially upper joints Injection site sore Cannot  get warm Slight intestinal discomfort
approx 27hr p/vax pt devel bright red rash over face, trunk & extremities;sl puffiness around eyes;no urticarial lesions;no fever no wheezing;sl erythema;no induration @ inj site;sx resolved in 24hr;
18 y/o female presents diffuse rash, which started 2 wks ago after she received a  series of immunizations, which got worse over last 2 days. reports subjective fever and reports rash is intermittently itchy. denies recent travels.  Exam rash is blanching, erthematous and diffusely over body. confluence to her lower extremities. patient reports she has never been vaccinated before.
Waited in lobby "after sometime we left and as soon as we left she got real dizzy couldn't walk or talk" Child was taken to ER and was told child has vertigo and happens to 1 of 10 kids vaccinated. Child was monitored in ER then released home.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Mar2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left 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 included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (Oct2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Positive; (Oct2023) Negative; (Oct2023) Negative; (Oct2023) Negative; (Oct2023) Negative; (Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment from 16Oct2023 to 21Oct2023.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Myalgia, Arthralgia, Fever, NauseaVomiting, Poor sleep Received 1st dose 12/31/20 - 8 days later developed a red welt at the site which lasted x 2 days. Received 2nd dose on 1/26/21. Noted mild tenderness at injection site that evening, as well as nausea, arthralgias/myalgias. She had poor sleep that night and awoke in the morning drenched in sweat. Nausea and arthralgias/myalgias worsened as the day went on. Fever with temp up to 101.7. Still noted mild nausea and headache on 1/28/21. Also with left axillary swelling for 5 days after injection. Missed work x 1 day. No known prior COVID infection.  Other Relevant History:
Nausea, vomiting, diarrhea, trembling, confusion, feeling as if going to pass out.
Patient was given monovalent Pfizer grey 12+ vaccine as a booster dose (shot #3). Patient should have received bivalent dose, Patient is not immunocompromised.
Tachycardia, dizziness, prurititis, after receiving  vaccine.  Resolved on its own minutes later.
Client contacted health dept. on 4/27/18 to report reaction to vaccine. Client stating she experienced severe shaking, chills, and trembling several hours after receiving vaccine. Advised client to see PCP if symptoms persist. Should hives or airway closure occur see emergency dept.
After receiving the second dose of the Moderna COVID vaccine I have felt on several occasions SOB, winded, heart racing, palpitations  and body aches(2 occasions)
Unable to awaken, became unresponsive to verbal stimuli, pulse weak. Sent to ER, recovered completely, kept for observation over night.
Chest Pain for 1 week leading up to event that got worse the day after 2nd vaccination. EKG with elevated ST levels from PCP same day - sent to ER same day.
Diarrhea/loose stool; abdominal cramping; This is a spontaneous report from a contactable consumer (patient herself). A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: FA6780, expiry date not reported) via an unspecified route of administration, administered in left arm on 21Jul2021 11:00 (at the age of 48 years old) as dose 1, single for covid-19 immunisation. Medical history included allergies, deficiency (Vitamin D), supplement, and pain. The patient had no covid prior vaccination and was not tested for covid post vaccination. The patient was not pregnant at the time of the report and vaccination. Concomitant medications included loratadine (CLARITIN) taken for allergies from an unspecified start date and ongoing, orally at 10mg, unknown frequency; vitamin d [vitamin d nos] taken for deficiency (Vitamin D) from an unspecified start date and ongoing, orally at 5000 iU, unknown frequency; multivitamins [vitamins nos] taken as supplement orally from an unspecified start date and ongoing; and oral ibuprofen taken for pain at 400 mg, unknown frequency from an unspecified start date and ongoing. The patient had no other vaccine in four weeks. On 24Jul2021 at 09:00 AM, patient experienced diarrhea/loose stool and abdominal cramping. On 31Jul2021, it was reported that diarrhea had a seriousness criterion of persistent/significant disability/incapacity. Patient had colonoscopy on 17Sep2021, and patient was still waiting for biopsy results. Treatment was received in response to the event diarrhea while no treatment was received for abdominal cramping. The outcome of the events was not recovered. Patient had dose 2 of BNT162B2 (Batch/Lot number: FC8486) on 11Aug2021, at 16:00, administered in the left arm.   No follow-up attempts are possible. No further information is expected
My left eye has been "twitching"/ spasming intermittently since the day after the vaccine
Constant muscle pain in the neck, shoulder arm, collar bone, back elbow; Low blood pressure. fatigue, headache, balance. Injection site swelling, redness, pain. Symptoms still exist today went to visit rheumatologist performed blood tests, MRI. X-ray from primary physician. Treatment - Meloxicam 15 mg.
Severe headache, nausea, body aches, orthostatic BP, fever of 101, arm swollen, in bed for several days.  Had covid in 2020, tested in December again after exposure to son but tested negative.
No adverse effects reported; One patien received one dose of improperly stored ROTATEQ; This spontaneous report was received from the office manager (also reported as "health care business professional) referring to a patient of unknown age and gender. The medical history, his historical medication, current conditions, allergies and drug reactions were not reported.    On 08-JUL-2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) Lot # R025713 with expiration date on 20-JUN-2020; one dose was administered orally, for prophylaxis, which was discovered through the digital data logger that it was improperly stored with lowest temperature below 36 degrees Fahrenheit (°F) (33.9F) for 40 minutes (previously reported 20 minutes) time frame. There was a previous temperature excursion with total time and lowest temperature below 36°F (30.5F) for 1 hour 45 minutes and total time and lowest temperature below 36°F (35.2F) for 2 hours 5 minutes. No adverse effects were reported. No additional doses were administered.
fever.  redness, heat, swelling at vaccination site.  Pustule with drainage.  Seen 9/17.  Right leg swollen, measuring 2" more in diameter then left leg.  dx with cellulitis.  Rx clindamycin.  Later that evening redness and swelling progressing to below knee.  Advised to go to ER.  Benadryl given in ER.  Follow up phone call to parent on 9/26 parent stating improving, swelling resolved.
8-1-10 glands swollen, slight fever. 8-2-10 pain and tenderness at lower right abdomen. 8-3-10 pain, tenderness lower right abdomen and right back. 8-3-10 PM - rash noted at right back and abdomen. 8-4-10 AM - MD appt. dx'd with shingles. Anti-viral med. and pain med given.
Client reports arm became red, itchy, with "bag of water" on inner aspect of the arm approximately 1 inch above the elbow.
Patient given expiration date 12/7/06. Also additional Varicella immunization given. ProQuad thought to only be MMR.
Running a high fever from 10/14 pm to 10/15  Fever went down in the afternoon and stayed down then on 10/16 in early afternoon started running a low fever again and started with runny nose Would not eat & drink on 10/15 Called doctor in am on 10/15 and was told to give him tylenol and pedialyte And was told this was not caused by the flu shot but I think otherwise, he was absolutely fine until a few hours after the shot.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age (gender unspecified). It was reported that the patient was vaccinated with GARDASIL doses on the following dates: 19-DEC-2011 and 19-FEB-2013. Lot# and administration route was unspecified. No adverse effect reported. It was unspecified if the patient sought medical attention or not. Additional information has been requested.
Starting mid-day on the Day 2 following administration, my lymph nodes in the upper left side of my body got larger and became very sensitive to the touch. Being listed among the common side effects, I did not think much of it. On Day 3, the inflammation got a bit worse and so uncomfortable that I had to hold my pectoral muscle on the left side during a morning run. The pain and swelling reduced about 50% on Day 4, and is almost (but not completely) gone by mid day  Day 5.
Extreme fatigue, headache, body aches, swollen red arm, pain at injection site.
On 1/31/2023, I had a temperature of 104, and I was feeling unsteady on my feet. I didn't fall or anything, but I was weaving. I also had a runny nose. I took two home antigen tests, and I had a positive result on both. I went an urgent care on 2/2/2023. At the urgent care, I was prescribed Paxlovid and benzonatate. When I took the medicines, the temperature went down, and so did the unsteadiness. I began to feel better. I took another home antigen test on 2/8/2023 and got a negative result. I felt fine, but on 2/21/2023, I began having sinus congestion, and my ears were clogged and roaring. I didn't experience pain. I went to the pharmacist, who recommended that I take decongestant and nasal spray, so I got triamcinolone acetonide nasal spray and pseudoephedrine loratadine. After I began taking them, the congestion continued. On 2/22/2023, I went back to urgent care. I was given a prescription for azithromycin. They told me that the combination of azithromycin and the OTC medicines would help clear up my sinuses over a period of anywhere between 3-4 weeks to five months. They also told me that I had the symptoms of long COVID-19. I felt better, but the congestion continued, and on 3/15/2023, I went to the doctor. I was administered a pulmonary test. They referred me to a pulmonologist, whom I saw on 3/27/2023. The pulmonologist prescribed me Trelegy and azelastine hydrochloride nasal spray. He wanted me to undergo a chest CT scan, which I underwent earlier today. I should get the results in the very near future.
Patient insists that ever since he got the H1N1 he is belching & burping ever since.
no adverse event; VARIVAX had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 30-AUG-2023, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # reported as W039699) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  Lot # W039699 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA006884: US-009507513-2309USA009905: US-009507513-2309USA009906: US-009507513-2309USA009907: US-009507513-2309USA009908: US-009507513-2309USA009909: US-009507513-2309USA009910: US-009507513-2309USA009911: US-009507513-2309USA009913: US-009507513-2309USA009914: US-009507513-2309USA009915: US-009507513-2309USA009927: US-009507513-2309USA009928: US-009507513-2309USA009929: US-009507513-2309USA009930: