chrisvoncsefalvay/vaers-outcomes huggingface dataset:
weak; hot and cold; Chills; Throat sore; Fatigue; Flu like symptoms; head is hurting; swollen at the site of the injection; Flu like symptoms; head is hurting; weak; hot and cold; Chills; Throat sore; Fatigue was reported as worsened.; a little heat around the injection site area; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Arm Right on 21Jun2021 (at the age of 44 years old) as dose 1, single for COVID-19 immunisation. Medical history included stroke (additional information for other conditions: in 2010 and one in Jan2021), blood pressure measurement (has blood pressure problems and had a stroke in January). The patient's concomitant medications were not reported. The patient experienced head is hurting, swollen at the site of the injection on 21Jun2021, flu like symptoms, weak, hot and cold, chills, throat sore, fatigue on 22Jun2021, flu like symptoms; head is hurting; weak; hot and cold; chills; throat sore; fatigue was reported as worsened, a little heat around the injection site area on an unspecified date on Jun2021. Event reported as, "the patient took the vaccine on monday and then 30 minutes afterwards her head started hurting. Then yesterday the patient symptoms were way worse and today it was worse. Today there was still a little heat around the injection site area. The caller's arm is still swollen a little bit but when the caller moves her arm it is not good, she can feel it still. The caller's throat is sore and she is fatigued. Tuesday is when everything started going down hill. Today the patient is in the bed and missing work because she can't work like this". Outcome of the event flu like symptoms, head is hurting, weak, hot and cold, chills, throat sore, fatigue was not recovered, recovering for swollen at the site of the injection, and unknown for flu like symptoms; head is hurting; weak; hot and cold; chills; throat sore; fatigue was reported as worsened, a little heat around the injection site area.  Information on lot/batch number has been requested.
night sweat; tension in neck; dizziness in the morning; pain on the site of injection; muscle pain; lymph node swollen left more inflamed than right; headache; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweat), NECK PAIN (tension in neck), DIZZINESS (dizziness in the morning), VACCINATION SITE PAIN (pain on the site of injection) and MYALGIA (muscle pain) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced NIGHT SWEATS (night sweat), NECK PAIN (tension in neck), DIZZINESS (dizziness in the morning), VACCINATION SITE PAIN (pain on the site of injection), MYALGIA (muscle pain), LYMPHADENOPATHY (lymph node swollen left more inflamed than right) and HEADACHE (headache). On 04-Feb-2021, HEADACHE (headache) had resolved. At the time of the report, NIGHT SWEATS (night sweat), NECK PAIN (tension in neck), DIZZINESS (dizziness in the morning), VACCINATION SITE PAIN (pain on the site of injection), MYALGIA (muscle pain) and LYMPHADENOPATHY (lymph node swollen left more inflamed than right) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.   Reporter did not allow further contact
69 expired doses administered; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 10-Jan-2022, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that there were a total of 69 administered doses between  January 6, 2022 and January 11, 2022. It was reported that Of these, 68 doses were boosters and 1 dose was a first dose. No concomitant medication information was provided. No treatment medication were provided.
Inejction site looks like a golf ball; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 24th January 2023, the patient received Shingles vaccine. In January 2023, unknown after receiving Shingles vaccine, the patient experienced injection site swelling. The action taken with Shingles vaccine was unknown. On an unknown date, the outcome of the injection site swelling was not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-JAN-2023 Reporter's comments: The case was reported by the patient via interactive digital media. The patient reporter as he/she got a Shingle shot on Tuesday and the site where he/she got the shot looks like a golf ball. The patient asked how long this would go on for. Additional supportive information: The follow-up could not be possible as no contact details were available.
swollen red tender at injection site, fever 101.7, chills, headache, tired, body aches
Tiredness; Weakness; Diagnosed with Shingles / Shingles spread from his torso to chest to waist and to right side of back to the center of spine; Pain in the middle of chest and waist on the ride side of the body / soreness and pain; Itching; Bumps; Soreness on the arm; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bone marrow transplant (with T cells 3 years before the date of reporting).   On 17th March 2020, the patient received the 1st dose of Shingrix (intramuscular). In March 2020, 4 days after receiving Shingrix, the patient experienced shingles, pain in arm, pain, pruritus and papular rash. On an unknown date, the patient experienced tiredness and weakness. On an unknown date, the outcome of the shingles, pain, papular rash, tiredness and weakness were not recovered/not resolved and the outcome of the pain in arm and pruritus were recovered/resolved.   It was unknown if the reporter considered the shingles, pain in arm, pain, pruritus, papular rash, tiredness and weakness to be related to Shingrix.  Additional details were provided as follows: The patient's wife reported this case.  The patient received Shingrix in the left arm at his oncologist office. Less than a week after vaccination, the patient experienced soreness on the arm that lasted for a day. About 4 days after vaccination, the patient started experiencing pain, itching and bumps in the middle of chest and waist on the ride side of the body. Due to this, the patient went to emergency room on 23rd March 2020. The patient was diagnosed with shingles and was discharged in one hour. Few days later, shingles spread from his torso to chest to waist and to right side of back to the center of spine. Less than a month after vaccination, the patient experienced tiredness and weakness. The shingles were on the right side of the body and were associated with soreness and pain. The patient was still experiencing all of this side effects. The patient had shingles on his forehead, but they had disappeared. The patient also had a virtual visit with his primary care physician and it was confirmed that he had shingles. No further details were provided. The reporter consented to follow up.
Patient developed a severe kidney infection (Pyelonephritis) within 12 days of receiving the Menomune vaccine on 8/11/03. This infection resulted in a 3 day hospital stay during which she was on IV antibiotic Ciprofloxacin.  She left to attend freshman year at college four days after leaving the hospital. She will be getting recommended follow up tests for kidney function when she returns home next month. 8/11/03 AM Patient receives Menomune vaccine. 8/23/03 PM Patient complains of joint stiffness, back pain, extreme fatigue. 8/24/03 Symptoms worsen throughout the day: headache/stiffness/fever between 8 PM and 4 AM. Fever ranged from 101 to 1043 degrees. 8/25/03 AM Fever is still above 100 degrees. Symptoms: Stiff neck, eyes extremely sensitive to light, vomiting. AM Is seen by physicians at healthcare office. They recommend that she go immediately to an ER. AM Patient is seen at hospital. AM-PM ER does blood and urine tests. Diagnosis is Pyelonephritis. Patient is put on IV Ciprofloxacin and admitted overnight. 8/26/03 Patient continues on IV Cipro; still has unexplained stiff neck. 8/27/03 PM Patient continues on IV Cipro. Ultrasound is done to see if any structural abnormality of her urinary tract could have precipitated the kidney infection. Ultrasound shows no structural abnormalities. PM Release from hospital with 10 day prescription for oral Cipro.
Left arm at site of shot it got red and swollen.  10 days after the shot. Also was itchy. I looked it up on internet and it was just like COVID arm description.
Migraine; Vitamin D low; Flu; Itchy; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), VITAMIN D DECREASED (Vitamin D low), INFLUENZA (Flu), PRURITUS (Itchy) and VACCINATION SITE PAIN (Vaccination site pain) in a 43-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced MIGRAINE (Migraine), VITAMIN D DECREASED (Vitamin D low), INFLUENZA (Flu), PRURITUS (Itchy) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, MIGRAINE (Migraine), VITAMIN D DECREASED (Vitamin D low), INFLUENZA (Flu), PRURITUS (Itchy) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vitamin D: Low.         Concomitant Drugs Not Reported  The reporter's causality with Humira for the event(s) of migraine, low vitamin d, vaccination site sore, flu and vaccination site itchy was not provided.  Treatment Drugs Not Reported.  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
Patient received her first Moderna vaccine 1/25/21 at hospital. Today patient came in for Moderna vaccine #2 but was given a Pfizer vaccine instead.  No adverse affects. Per  Dr. recommendation, there is no need to get a third vaccine.  This will complete her series.
Received 2nd Moderna shot on 4/21 at 1pm (it is currently almost 60 hours later). I was pretty out of it just a few hours after injection, so while I dont have specific times, here are some of the side effects I've been experiencing. Note: I had a pretty significant reaction to the first shot so expected to have the same with the second.  Arm pain - pain radiated from injection site to fingers and fluctuated from uncomfortable to almost unbearable off and on throughout the next 48 hours. Felt better if I slept with pressure on the arm itself, but once I took it off, it throbbed relentlessly. Still have swelling, redness, and tenderness almost 60 hours later.   Fever - consistent low grade fever; spiked to 103.8 and plateaued between 99 and 101 for some time. Broke after 36 hours, but returned after 48.  Brain fog and confusion - consistent for first 24 hours.   Nausea/vomiting - was not able to keep most foods down, but alleviated after 24 hours. Returned after 48 hours and continued on to 60 hours.  Swollen foot - unsure if this is direct result of vaccine, but important enough to note. Left foot was very swollen after 48 hours (same side of injection). This was after returning to work and being on my feet.  Kidney pain - experienced pain similar to passing a stone in lower left kidney area a few hours after the shot. Continued until about 24 hours after.  Joint pain - all joints tender for the first 24 hours (all knuckles, elbows, knees, ankles, wrists). I experienced this with the 1st shot as well.   Itching - whole body, moderate level itching for almost 24 hours. No rash, just sensation. Returned at 60 hour mark.  General flu like symptoms- have carried over past 48 hour mark 60 hour mark.  39/F
redness and pain at the injection site with redness spreading down the arm; stated it was very sensitive and felt warm to the touch; no treatment has been sought at this time
PATIENT STATES SWELLING IN ARM AND HAND, UNABLE TO MOVE OR ROTATE ARM.  SYMPTOMS ARE RESOLVING AS OF SUNDAY 4/25/2021 AT ABOUT 12 NOON.
Information has been received from a physician concerning a 66 year old white female with seasonal allergies, allergies to penicillin, DEMEROL, codeine and "fluoroquinolones", hyperlipidemia, hypothyroidism, anxiety disorder and glucose intolerance who was vaccinated SC in the left upper extremity with a first dose of Zostavax (lot # 652965/0622F). Concomitant therapy included hydrochlorothiazide, SYNTHROID, ZOLOFT, montelukast sodium and ezetimibe. There was no illness at the time of vaccination. Within 24 hours of vaccination the patient developed a rash which was persisted. The rash covers her face, both arms, the trunk of her body and the lower limbs. The physician mentioned that the patient complains of a little itching, but no pain was noted. The patient went to see a dermatologist and an endocrinologist. The dermatologist performed a biopsy on 24-JAN-2007 which a diagnosis of granuloma annulare was determined. The endocrinologist performed various tests including fasting blood sugar and glucose tolerance testing in regards to possible diabetes that were all negative. As of 11-JUN-2007, the patient was recovering. Additional information from the physician indicated that on 14-NOV-2006, in the am, the patient developed a diffuse erythematous palpable macular rash in the bilateral axilla, torso and bilateral groin with pruritus. The patient had a biopsy of the left inner thigh and right cheek. The left inner thigh biopsy showed granuloma annulare. At the time of the report, the patient had not recovered. The physician reported that another office administered the vaccine. It was reported that the patient had no adverse events following prior vaccinations. The physician considered the patient's experiences to be disabling. Additional information has been requested.
Heavy mensural bleeding for over 28 days; low BP; tachycardia; nausea; migraines; Fatigue; Chills; hot flashes; This is a spontaneous report from a non-contactable nurse (patient). A 39-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 02Aug2021 at 16:00 (Lot Number: Ew0196) at the age of 39-year-old as single dose for COVID-19 immunization. Medical history included Na. The patient didn't receive other vaccine in four weeks. COVID prior vaccination was none. COVID tested was performed post vaccination. On 13Aug2021, the patient performed COVID test (Nasal Swab) post vaccination and result was negative. Known Allergy was none. Concomitant medication was not reported. On 02Aug2021 at 18:00, the patient experienced heavy mensural bleeding for over 28 days, low BP, tachycardia, nausea, migraines and excessive fatigue chills hot flashes. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment was received for events included Zofran. The outcome of events was not recovered.  No Follow-up attempts are possible. No Further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Heavy menstrual bleeding" and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sore arm in the beginning; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm in the beginning) 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 02-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm in the beginning). At the time of the report, PAIN IN EXTREMITY (Sore arm in the beginning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  No relevant concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-138584 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-138584:Husband case
Rash and other nonspecific skin eruption (swollen, tender left deltoid area).
Pain at injection site, Arm soreness starting at time of injection    , elevated temp 99F with mild chills, fatigue and malaise starting the following morning lasting about 8 hours.
Nausea for 10 days and continuing  - vomiting several times, unable to eat, fatigue
pt recv vax 2APR97 & 7APR97 pt devel a chickenpox-like rash;15APR97 pt was seen in MD office w/chickenpox & mild cellulitis;
Vaccine 06 10 21 was fine the whole day woke up Friday was fine until 2:00 in the afternoon start feeling chills, had a headach got a fever of 101 the symptoms lasted 48hrs. During this time I took Tylenol and drank lits of fluids .
Headache started night of vaccine, continue for next two days. Had chill that night only. Nauseous x1.  Stuffy nose x 2 days. Feeling cold and fatigue for 3 days. Injection site was firm and slight raised.  Rash started next day, it was red and spread medically, still continue on day 5.
Child had fever of 103. Broke out in rash on torso. Was told to alternate between Tylenol and Ibuprofen and if fever did not subside to go to ER. Went in next day so Doctor could check rash.
Fever (103 degrees) treatment with TYLENOL and MOTRIN. No further treatment or fever.
First I had two bumps size of half a dollar on my upper left arm and, like, a mass or swelling about the size of a silver dollar on my left arm right above my right wrist on the upper side. The two bumps on my upper arm have gone away, but the mass or swelling above my wrist is still there.
Vaccine given on 10/5/22, Vaccine expiration date 9/30/22.
Deceased 3/28/21 "natural causes" Narrative: Per notes "Pathologist was informed that he died of natural causes". PCP indicated that death cert will only show HTN as cause of death.
3CM RED AREA AROUND INJECTION SITE.  NO PAIN, ITCHING OR OTHER COMPLICATIONS OBSERVED.  PT WILL RETURN MON. 6/12/06 FOR MONITORING.
Patient received her second dose of moderna on 4-22-21.  On 4-25-21, patient states she began to experience chest pain when she took deep breaths. On 4-28-21, patient states she went to the emergency room.  She states the hospital did a chest x-ray, a scan, and a heart echo.  She was diagnosed with a lung clot.  Patient states she was put on a blood thinner.  On 4-29-21, the patient was discharged with a prescription of Eliquis.
Patient had a seizure (hypertonic, extension); had normal EEG, normal CT. Sepsis work up negative, although unable to obtain CSF for 2 hours. Numerous unsuccessful LP's even under fluoro). Patient did not have seizure gain but did have twitching during sleep similar to benign sleep myoclonus. Otherwise patient well. The hospital record confirms diagnosis of seizures.
Information has been received from a physician concerning a 11 year old male patient who on 27-JAN-2000 was vaccinated the first dose of with MMR II and on 17-AUG-2004, was vaccinated with the second dose of MMR II. On 09-JAN-2010, the patient experienced mumps that was diagnosed on 11-JAN-2010. The patient had left parotitis and did not experience other symptoms. On 11-JAN-2010, the following labs were taken: serum immunoglobulin M test which showed <1:10; serum immunoglobulin G test which showed 8.2 and serum amylase test which showed 1281. The outcome from mumps was not reported. No further information is available.
Pt showed to clinic 2 days after vaccine administration (for TST reading), left arm bruised and swollen at injection site, redness below the site. Pt states entire arm is numb, unable to lift arm above shoulder, body aches, fatigue, low grade fever. Therefore assessed site, referred to PCP if no improvement tomorrow.
This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDAIL 9 (lot # L045711, expiry date: 08-MAY-2017; lot # L048237, expiry date: 08-MAY-2017; lot # L048237, expiry date: 08-MAY-2017 or lot # L016429, expiry date: 08-AUG-2017). Medical assistant reported that the vaccine underwent temperature excursion on unknown dates with following details: lot # L045711 (exposed at 49 degree Fahrenheit (F) for an unknown time frame), lot # L048237 (48 F for 100 hours and 31 F for 340 hours,  respectively), lot # L045711 (49 F for 720 hours and 30 F for 720 hours, respectively), lot # L016429 (31 F for 1420 hours and 49 F for 700 hours, respectively) and lot # L048237 (34 F for 40 hours). No adverse effects were reported. This is one of the four reports received from the same reporter. Additional information has been requested.
Mom noticed redness, swelling of left upper arm the afternoon of vax. Redness and swelling had spread down arm to wrist, up arm to neck and had heat to touch. Treatment Benadryl and antibiotic.
pt recv vax 11JUN96 & on 8AUG96 pt devel sx of varicella;pt devel a mosquito-bite-like rash on face, arms, & diaper area, & fever 101;