chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Booster; Sore arm; Cardiolipin antibodies went up after the COVID booster higher than normal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. A 80-year-old female patient received bnt162b2 (BNT162B2), administration date 22Sep2021 (Batch/Lot number: unknown) at the age of 80 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Positive cardiolipin antibodies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Single), administration date: 08Feb2021, when the patient was 79 years old, for COVID-19 Immunisation, reaction(s): "Sore arm"; Bnt162b2 (Dose 2, Single), administration date: 08Feb2021, when the patient was 79 years old, reaction(s): "At that time her Cardiolipin level was about 40"; Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Sore arm"; CARDIOLIPIN ANTIBODY POSITIVE (non-serious) with onset 2021, outcome "unknown", described as "Cardiolipin antibodies went up after the COVID booster higher than normal"; IMMUNISATION (non-serious) with onset 22Sep2021, outcome "unknown", described as "Booster". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She has a history of positive cardiolipin antibodies. Reason for no lot number of COVID vaccine was caller unwilling to complete the report. Expiry Date of COVID vaccine was not provided. Other products, patient history and investigation assessment were not provided. Additional Context: She was calling to report that her cardiolipin antibodies went up after the COVID booster higher than normal. She was taking blood test after the second dose, and booster dose. After the booster dose, her cardiolipin went up high. She also mentioned a sore arm. She did not really say when she got the sore arm. She said it was a minimal condition. This did not occur after the second COVID dose. Her second dose was 08Feb2021. She states that she got her cardiolipin antibodies tested on 05Mar2021 and she had a 40 result. At that time her Cardiolipin level was about 40, AbigM. Then, on 22Sep2021 she had her booster dose. After the booster dose, she got tested again on 27Oct2021 and her cardiolipin IgM levels 102.1 which was quite high. Normally her cardiolipin was antibody positive with IgM, and somewhat with IgA also. It was a little higher which was concerning to her. She knows cardiolipins can be a problem with blood clotting. She has to leave at a quarter to two. She does not have time to do this. Her physician told her not to worry. Reporter seriousness for elevated cardiolipin antibodies and sore arm was unspecified.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
2 days after the vaccine began feeling some itchiness in the middle of the back. Three days after the vaccine begin to feel itchiness on the arms and torso with a rash beginning to appear. Four days after the vaccine the rash spread over the entire body. Visited urgent care and received a steroid shot and a steroid dose pack.
Inflammatory Marker Increased; This spontaneous case was reported by a non-health professional and describes the occurrence of INFLAMMATORY MARKER INCREASED (Inflammatory Marker Increased) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No medical history was provided.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, 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 ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, received first dose of ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced INFLAMMATORY MARKER INCREASED (Inflammatory Marker Increased). At the time of the report, INFLAMMATORY MARKER INCREASED (Inflammatory Marker Increased) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Blood test: (High) Inflammatory markers high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.
Office visit 11/3/05 c/o fatigue, sore throat, chills, aches, progressed over 2-3 weeks to significant bilateral upper extremity and joint weakness and pain.  11/7/05 saw her Rheumatalogist-viral syndrome. 11/30/05 saw neurologist ordered EMG/nerve conduction study.  12/13/05 neurologist again-patient recovered-? post vaccinal syndrome
FELT WORSE AND WORSE; DID NOT WANTED TO MOVE, EVERYTHING HURT; WHEN WANTED TO GO TO SLEEP, SUDDENLY STARTED SWEATING FOR NO REASON WITH CESSATION; FREEZING ENDLESSLY IN AN ATTIC APARTMENT AT 25 DEGREES; ARM STILL HURTS A BIT; WHEN TRIED TO SHOWER FELT LIKE THERE WAS 1000 TINY NEEDLES STICKING; SLIGHT HEADACHE; HOT FLASHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 24-SEP-2021 08:00 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On SEP-2021, the patient experienced hot flashes. On SEP-2021, the patient experienced arm still hurts a bit. On SEP-2021, the patient experienced when tried to shower felt like there was 1000 tiny needles sticking. On SEP-2021, the patient experienced slight headache. On 24-SEP-2021, the patient experienced felt worse and worse. On 24-SEP-2021, the patient experienced did not wanted to move, everything hurt. On 24-SEP-2021, the patient experienced when wanted to go to sleep, suddenly started sweating for no reason with cessation. On 24-SEP-2021, the patient experienced freezing endlessly in an attic apartment at 25 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt worse and worse, did not wanted to move, everything hurt, when wanted to go to sleep, suddenly started sweating for no reason with cessation, and freezing endlessly in an attic apartment at 25 degrees on 27-SEP-2021, and when tried to shower felt like there was 1000 tiny needles sticking on SEP-2021, and had not recovered from slight headache, arm still hurts a bit, and hot flashes. This report was non-serious.
I started with a sore throat the next day I had body ache and extreme tiredness with extreme body aches and tested positive with a rapid COVID19 test PAXLOVID was prescribed as well as Z-PAK.
low heart rate 30 beats per minute; extreme weakness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (extreme weakness) and HEART RATE DECREASED (low heart rate 30 beats per minute) in a male 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 an unknown date, the patient experienced ASTHENIA (extreme weakness) and HEART RATE DECREASED (low heart rate 30 beats per minute). At the time of the report, ASTHENIA (extreme weakness) had resolved and HEART RATE DECREASED (low heart rate 30 beats per minute) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 30 (Low) 30 beats per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Symptoms: rash - diffuse, full body rash (trunk and extremities), from the neck down to the toes, red, circular, flat and raised, itches, warm, rash is slowly improving, (9-14-15 - less red and itching). Treatment: Benadryl, Calamine Lotion, Medrol Steroid Dose Pack.
1. Period cramping daily (when on my period and off my period).  This is abnormal for me.  I never experience cramping when I have my period 2. Heavier periods than normal.  I typically have very light bleeding and the last two periods have been heavy bleeding.   3. Longer periods than normal.  Mine typically last 1-2 days.  I have had my period twice since my last shot and each period has been about 5-6 days.   4. During the months of Oct and Nov I was spotting between my periods.   5. I typically get a migraine every month during my period.  My migraine in November was the worst Migraine I have ever had it lasted from 11/24-11/27.  I was throwing up (I have only done that one other time in the past with a migraine)  6.  Extremely lethargic every day  I have been feeling better since my last period.  I am heading into my 3rd cycle since my last shot and will monitor the symptoms.
appeared some trembling in the body, sometimes on a hand, some other times in the whole bodypatient said she does not know if the trembling are like chills or due to the weakness in her wholebody she is experiencing; Weakness in  her whole body; sweated that night; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (appeared some trembling in the body, sometimes on a hand, some other times in the whole bodypatient said she does not know if the trembling are like chills or due to the weakness in her wholebody she is experiencing), ASTHENIA (Weakness in  her whole body), NIGHT SWEATS (sweated that night), PYREXIA (Fever) and CHILLS (Chills) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced TREMOR (appeared some trembling in the body, sometimes on a hand, some other times in the whole bodypatient said she does not know if the trembling are like chills or due to the weakness in her wholebody she is experiencing), ASTHENIA (Weakness in  her whole body), NIGHT SWEATS (sweated that night), PYREXIA (Fever) and CHILLS (Chills). On 21-Mar-2021, NIGHT SWEATS (sweated that night) and PYREXIA (Fever) had resolved. At the time of the report, TREMOR (appeared some trembling in the body, sometimes on a hand, some other times in the whole bodypatient said she does not know if the trembling are like chills or due to the weakness in her wholebody she is experiencing), ASTHENIA (Weakness in  her whole body) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment drug included TYLENOL from 21-MAR-2021 to 22-MAR-2021   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: The patient denied any further follow ups.
0.5ML DRAWN UP AT PROVIDERS ORDER AND GIVEN, CORRECT BOOSTER DOSE FOR VIAL IS 0.3ML
Eight days after I got my blood work and it showed an increase in liver levels. ALT AFT Alkaline Phosphatase those three levels were increased. I had it taken and then they told me to retake it in two or three weeks roughly. So I had the bloodwork levels taken again and they were still increased. So they had an ultrasound of my live done, nothing abnormal came back. That didn't come back with any findings. So then Dr. asked me to follow up with my primary care physician. They took it about a month later and it was still increased. Then they wanted to re-check it in a month but two weeks later my endocrinologist also checked it when he was doing his bloodwork and they were elevated there. My primary care physician took them again on 5/7 and they were still increased. He said to still remain well hydrate until now.
Client fainted, lost consciousness for approximately 20 seconds. Was pale and diaphoretic. He had not eaten and was very nervous about receiving this or any shot. We wiped his forehead with a wet cloth, gave chocolate, water, and a lollipop. He was talking and moving. Reported he still felt dizzy. No nausea, no vomiting. Colored returned to face but still dizzy and sleepy. Sent client home with mother and siblings. Advised feed him, let him rest and not to leave him unattended. Advised that fainting is  common side-effect.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB, (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information had been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 6 months old patient of unknown gender. On 12-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported), lot#J016188, expiration date: 02-OCT-2016 that was improperly stored. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
Chills; Fever (100,2°F); Little Headache; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills), PYREXIA (Fever (100,2°F)) and HEADACHE (Little Headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21H) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever (100,2°F)) and HEADACHE (Little Headache). At the time of the report, CHILLS (Chills), PYREXIA (Fever (100,2°F)) and HEADACHE (Little Headache) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable No concomitant medication was provided.  No treatment information provided.   This case was linked to MOD-2021-031782 (Patient Link).
The pt received the vaccines in his left deltoid. The site bled slightly. The pt's wife called the next day with a pt complaint of fever, achiness and fatigue. Denied swelling or redness at the site. Later that evening, it became warm to touch. The pt was hospitalized but is recovering. According to the pt's doctor, the pt was found to have underlying strept infection. Cultures performed on vaccinee came back negative in 72 hours. Pt was released from the hospital and is doing fine.
Given expired vaccine--expiry date 11/28/2022 and given on 12-01-2022
Sometime in November 2021 I had significant amounts of blood in my urine. When I went to see a doctor, they didn't find anything. A month later that happened again so I went back to see a doctor. I had multiple tests did, but the doctors still couldn't find anything. One day I noticed a small lump on the side of my neck. When I went to the doctors for it, they said it was malignant. They said that the malignancy came from my left kidney. I was diagnosed with Upper Tract Urothelial Carcinoma. When I caught COVID in October 2021 I was running a high fever of 103 degrees for 4 days, and I was out of work for 3 weeks.
Fever up to 101.6 F the following day and continuing at around 99 or 100 degrees for 3 to 4 days. Questionable jaundice on 6/30/17. Child was taken to walk-in clinic on 6/30/17. Vitals and CMP values were normal. There was increased sleepiness the following day, then irritability, increased cruising for no reason for about 7 to 8 days. On day 3 or 4 a light rash appeared on the head and followed to neck and torso over 24 to 48 hrs then gradually disappeared. This lasted a total of about 3 days.
101f Fever, full body severe aches and pains, cough, Headache , severe pain radiating from injection sure to under arm, back and chest and neck, dizzy
10/17 Vaccine given in left deltoid.  Within hours the left arm from shoulder to fingertips were red and edemoutous.  Pt. c/o extreme itching and whelps visible.  Prednisone 20mg. PO given imediately.  Hydoxyzine 25mg. PO taken at bed time to relieve the itching.  10/18 Seen in the ER c/o increasing pain in arm and in joints from the hip to neck.  The left arm had increase in swelling.  Pt. took Tylenol, Ibuprofen and Excedrin to relieve pain with not results.  Medrol dose pack and Toradol given to pt. i
pt recvd vax;approx 12 hrs later, pt exp ha & chills which which resolved in about  12 hrs;
On March 2nd and 3rd I had a very sore, feverish, harden lump at the site of injection. I even checked the temp with my infrared thermometer and I was at 97.6 while the spot was over 100.4. It sometimes felt like someone was putting a stick into my arm,, sometimes it was throbbing but it was very sore and feverish the whole 2 days.  It was about a 10 cm circular area (my husband took pictures) I left it alone hoping it would get better. It has pretty much gone away now although it is still warm and feels like an old bruise.
allergic to VARIVAX; This spontaneous report was received from a consumer referring to a male patient of unknown age. On unknown previous dates, the patient was administered and had experienced separate allergic reactions to amoxicillin, pneumococcal vaccine conj 13v (CRM197) (PREVNAR 13) and hib vaccine conj (tet tox) (ACTHIB). The patient's pertinent medical history and concomitant medication were not reported.    On an unknown date, reporter was unable to confirm if patient was administered varicella virus vaccine live (oka/merck) (VARIVAX) (dose, strength, route, batch/lot# and expiration date were not reported) for prophylaxis or if patient had experienced an allergic reaction to varicella virus vaccine live (oka/merck) (VARIVAX) at call time.   Reporter was requesting information on if varicella virus vaccine live (oka/merck) (VARIVAX) had shared the same inactive ingredients as amoxicillin, pneumococcal vaccine conj 13v (CRM197) (PREVNAR 13) and hib vaccine conj (tet tox) (ACTHIB) at call time. Outcome of allergic reaction was unknown. The causality assessment between allergic reaction and varicella virus vaccine live (oka/merck) (VARIVAX) was related.
Sever headache a few hours after injection. Chills, body aches, muscle and joint aches, fatigue, nausea, cold sweats, fever. All of these lasted about 24-36 hours. Once those subsided I noticed strong tinnitus in my left ear and a feeling of fullness or stuffyness in left ear, as well as brain fog, mild vertigo and an upset stomach. Stomach doesnt quite feel like nausea but more like sour stomach like from too much alcohol (I Have not had any). These symptoms have continued every day since then. Today I woke up with slight sore throat and fatigue as well
It seems like a blister but it's not a blister; at the injection site had pain and tenderness / It was sore/ it hurts when moved hand; swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (It seems like a blister but it's not a blister), VACCINATION SITE PAIN (at the injection site had pain and tenderness / It was sore/ it hurts when moved hand) and VACCINATION SITE SWELLING (swelling) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A-B, 002B21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (It seems like a blister but it's not a blister), VACCINATION SITE PAIN (at the injection site had pain and tenderness / It was sore/ it hurts when moved hand) and VACCINATION SITE SWELLING (swelling). At the time of the report, VACCINATION SITE REACTION (It seems like a blister but it's not a blister), VACCINATION SITE PAIN (at the injection site had pain and tenderness / It was sore/ it hurts when moved hand) and VACCINATION SITE SWELLING (swelling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included Pressure pills, Cholesterol pills, Bladder pills and Eye drops. No treatment medication was reported.   This case was linked to MOD-2021-224785 (Patient Link).
Moderna vaccine was mistakenly administered to a 15 years old patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine was mistakenly administered to a 15 years old patient) in a 15-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine was mistakenly administered to a 15 years old patient). On 21-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine was mistakenly administered to a 15 years old patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown. The patient had not reported any adverse reaction to the vaccine so far.