chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red on his entire body; rash is itchy; raised rash on body/bumpy rash; This case was reported by a other health professional via call center representative and described the occurrence of red rash in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced red rash, itchy rash and raised rash. On an unknown date, the outcome of the red rash and itchy rash were not recovered/not resolved and the outcome of the raised rash was unknown.   It was unknown if the reporter considered the red rash, itchy rash and raised rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The reporter had a part-time co-worker that received Shingrix vaccine 10 days ago. He has broken out in a red, bumpy, raised rash over his entire body. He reported that the rash was itchy.  The reporter consented to follow up. The reporter was unable to provide additional information.
Cough & runny nose Bone pain  (intense pain where I literally wanted back shoulder blade removed) Muscle pain Hard swelling & tenderness Fatigue Unable to lift arm  Neck sore.  Can?t turn
I had mild symptoms on first day including fever and fatigue--it happened right after vaccine but I felt fine. Recently on June 24, 2021 I got this blinding pain in the middle of the night around 12/12:30 AM and it was excruciating that I almost passed out --it was in my lower abdomen. What came with the pain was vomiting and I threw up 4-5 times. It was coming and going and it felt almost like a contraction. It felt like I was in labor. It lasted several hours until 2/3 AM when I started feeling better and slept. The next day I went to urgent care at Kaiser Fontana Medical Center and they did CT and some blood work and the tests came back abnormal for fatty liver.  They also wouldn't tell me the cause of my pain because there wasn't anything on CT that showed anything. Everything else was OK except for the enlargement on lymph node on left side and a cyst in vagina that was drained on Monday 07/19/2021.  I had a small procedure on Monday. The cyst could have been there before vaccine. Only thing I'm concerned about is lymph node enlargement and they will do pelvic exam u/s soon and ill see a specialist for lymph nodes. All of these started June 25 and still ongoing.
Child was given vaccines, Hep A, HIB, PCV 7, and VZV. Child immediately had full seizure.
Information has been received from a physician concerning a 2-3 month old pt who in 2006 was vaccinated PO with the first 2.0 ml dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). the physician reported that on approximately 8/31/06, the pt was hospitalized in the ICU with respiratory distress and died. The physician also reported that the pt had tested positive for rotavirus. The physician also considered respiratory distress and rotavirus to be life threatening. The reporting physician, via a follow up telephone call, indicated that she was not the pts physician and did not have any additional information to provide. She did not have the pts name as this was reported to her second hand by an employee at a hospital. No further information is available.
Skin rash all over body, redness, pain, itching, 3 + outbreaks, first outbreak within a week of second dose shot. Many other symptoms lasting a week after both shots, pain in joints, at injection site, fever, irregular period, fatigue, hypersomnia, brain fog. Continuing on for months after vacations loss of taste and smell, frequent headaches.
Diagnosed with sepsis; Diagnosed with acute arthritic response; Felt feverish/fever of 103.8; Unable to walk; Joints were swelling; Felt dizzy; Sore in the knees and joints; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (Diagnosed with sepsis), ARTHRITIS (Diagnosed with acute arthritic response) and PYREXIA (Felt feverish/fever of 103.8) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.  On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced PYREXIA (Felt feverish/fever of 103.8) (seriousness criterion hospitalization), JOINT SWELLING (Joints were swelling), DIZZINESS (Felt dizzy) and ARTHRALGIA (Sore in the knees and joints). On 30-Apr-2021, the patient experienced GAIT INABILITY (Unable to walk). On 03-May-2021, the patient experienced SEPSIS (Diagnosed with sepsis) (seriousness criteria hospitalization and medically significant) and ARTHRITIS (Diagnosed with acute arthritic response) (seriousness criterion hospitalization). The patient was hospitalized on 03-May-2021 due to ARTHRITIS and SEPSIS, and then for 3 days due to PYREXIA. At the time of the report, SEPSIS (Diagnosed with sepsis), ARTHRITIS (Diagnosed with acute arthritic response), PYREXIA (Felt feverish/fever of 103.8), GAIT INABILITY (Unable to walk), JOINT SWELLING (Joints were swelling), DIZZINESS (Felt dizzy) and ARTHRALGIA (Sore in the knees and joints) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 103.8 (High) high.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Concomitant medications were not provided by the reporter. Patient received antibiotics (unspecified) in the hospital for treatment of events.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Very limited information has been provide at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Very limited information has been provide at this time. Further information has been requested.
Hard to breath, Light headed, fatigue big time. Still having symptoms having tests run.  Seeing Dr on 03/08/2021.  Have been to Doctor twice already for tests.  Cannot figure what's going on.
shortness of breath; tingling in the right hand; pain in the middle of upper back; pain in the right lower neck and shoulders; pain in the right lower neck and shoulders; fatigue; sleepiness; This is a spontaneous report from a contactable consumer. A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in right arm on 24Mar2021 (Age at vaccination: 66-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history reported as none. Concomitant medication was not reported. It was mentioned that, patient cannot see that good, needs glasses and magnifier to read the COVID patient card. After vaccination maybe about 2-3 days ago on 26Mar2021 patient started getting maybe some pain sort of maybe in the right side of the upper shoulder area, sort of in the middle of back between the shoulder blades it was pretty severe pain and it would come and go. Patient thought it would subside, there was also more drowsiness this time. Patient was not having this before the second dose, said the first dose was fine. Patient was wondering if this seems like it could be a side effect of the vaccine. The outcome of the events back pain, neck pain and arthralgia were not recovered while other events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Patient explained she was very anxious, light headed, flustered, headache - more than 15 mins after the dose. She waited the 15 mins and when heading home, felt sick and returned to the pharmacy where the staff sat with her for an additional 30 mins
pt recv vax & 4 days later had t105.4 in fever, chills, lack of breath & convuls;This was about 730PM; rushed by ambulance to the ER; tx for acute febrile illness, febrile convuls & UTI;
Left arm where i received my 1st Covid19 MODERNA shot has been throbbing and sore since day of shot & is painful . Minor itchy rash.
PT RECEIVED cOVID-19 PFIZER VACCINE 3 MINUTES LATER, FELT WARM AND VOMITTED X2.
felt itchy; nausea; headache; body aches from head to toe; tired/I felt so exhausted; chills; fever; have pain in the arm.; I had sweats and felt cold; I had sweats and felt cold; couldn't even wake up or move/I couldn't even get out of bed; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection , Lot number was not reported), dose 2 via an unspecified route of administration in May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY) as dose 1 for covid-19 immunisation. The patient reported felt itchy, nausea, headache, body aches from head to toe,chills, fever, have pain in the arm , tired/I felt so exhausted, i had sweats and felt cold , couldn't even wake up or move/i couldn't even get out of bed in May2021. It was further stated by the patient that "I received both doses of the Pfizer COVID-19 vaccine. After receiving both shots, I felt itchy. The nurse told me it was normal. When I received the first shot, one hour after I experienced nausea and headache. Towards the end of night, I was having body aches from head to toe and tired. I also had chills with fever. I kept taking Tylenol that's why my temperature was 99. I couldn't even wake up or move. I felt so exhausted. I couldn't even get out of bed. I received the second dose on Tuesday. I have the same symptoms, but my chills lasted longer. I still don't feel great today. I still have pain in the arm. Today I was able to get out of med. This morning I had sweats and felt cold. I still feel nauseas and have a headache". Therapeutic measures were taken as a result of felt itchy, nausea, headache, body aches from head to toe, tired, chills, fever, have pain in the arm, i felt so exhausted, couldn't even wake up or move/i couldn't even get out of bed. Treatment for I had sweats and felt cold was not reported. Patient was asking about booster dose 3.Relevant laboratory tests included body temperature was 99 in May2021. The outcome of the events nausea and headache was not yet recovered. The outcome of the rest of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pityriasis rosea breakout. april 15 had fever of 102, it went away and by the 21st i have developed a rash  that looks exactly like Pityriasis rosea.  started with one big spot and now is breaking into many.
This spontaneous report as received from a registered nurse refers to 2 patients of unknown age and gender. On an unknown date, the 2 patients was vaccinated with RECOMBIVAX HB (dose, and lot # not reported) which was improperly stored, intramuscularly. The 2 patients received an intramuscular dose in accordance with the prescribing information. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Did you/the patient previously receive a COVID-19 Vaccine?: Yes; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL3249), in right arm, on 16Feb2021 as dose 2, single (Lot number: EN6200), in right arm and on 25Aug2021 as dose 3 (booster), single (Lot number: EW0165) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypogammaglobulinemia" (unspecified if ongoing); "ANA positive but no activity" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "high blood pressure well with meds" (unspecified if ongoing), notes: high blood pressure well controlled with meds. Concomitant medication(s) included: SIMVASTATIN, start date: 05May2021, stop date: 26Apr2022; LOSARTAN, start date: Dec2019, stop date: 01Aug2022; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: May2011, stop date: 01Aug2022; NASACORT, start date: May2011, stop date: 01Aug2022; CALCIUM CITRATE, start date: Dec2019, stop date: 01Aug2022; D3, start date: Dec2019, stop date: 01Aug2022; ALIGN, start date: Dec2019, stop date: 01Aug2022. Past drug history included: Fentanyl, reaction(s): "known allergies: fentanyl (post surgery, got hives)". The following information was reported: COVID-19 (medically significant) with onset 26Apr2022, outcome "not recovered", described as "COVID 19 Treatment"; VACCINATION FAILURE (medically significant) with onset 26Apr2022, outcome "not recovered", described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01May2022) Negative, notes: tested negative on day 6; (06May2022) Positive, notes: next tested on day 11 and was positive;; (07May2022) Positive, notes: positive also on subsequent tests (days 12, 13, 15, 16 and 19);; (08May2022) Positive, notes: positive also on subsequent tests (days 12, 13, 15, 16 and 19);; (10May2022) Positive, notes: positive also on subsequent tests (days 12, 13, 15, 16 and 19);; (11May2022) Positive, notes: positive also on subsequent tests (days 12, 13, 15, 16 and 19);; (14May2022) Positive, notes: positive also on subsequent tests (days 12, 13, 15, 16 and 19);; (26Apr2022) Positive, notes: except also tested positive on PCR test on 26Apr2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Contracted COVID-19 26Apr2022 and started paxlovid for 5 days; tested negative on day 6; next tested on day 11 and was positive; positive also on subsequent tests (days 12, 13, 15, 16 and 19); stopped testing after day 19 so don't know if would have tested positive longer (I have Hypogammaglobulinemia but am not receiving IgG infusions); all of above tests were antigen tests (except also tested positive on PCR test on 26Apr2022)
apr 4,2021- after first dose: only pain and soreness in right arm april 25/26, 2021- (most symptoms on the day after) after second dose: pain/soreness in left arm and whole body, migraine, feverish (dont have a thermometer to check temperature), chills, pain in neck, sharp pain in inner ears (maybe a part of the migraine not sure but it hurts worse than the migraine)
For about a week I had a red spot that was about the size of a baseball, and my arm itched. Recently I had a  sinusitis Dx. However I prior to going to the doctor I had difficulty breathing, coughing, sneezing and  runny nose. I have not been this sick in several years, since getting the pneumonia shot. I got my most recent one in October, 2021.
Pt received Johnson and Johnson vaccine at about 145 pm. About 10 - 15 minutes later the pt was feeling light headed, nauseous, sweaty, and felt like he was going to faint. I attended to the patient, laid him on the ground bein case he fainted (which he did not), put his feet up, and asked him how he was feeling. The pt stated he felt better after laying down for a couple minutes and sat back up in his chair. I gave the pt the pt water and Gatorade and told the pt he would need to hang out for about 15 minutes longer. Pt stated he felt fine and 100% and requested to leave.
Sore arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-064106 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up received on 12 May 2021 included no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-064106:Mother case
After the 2nd dose of Covid, I gradually started to feel some pain in my right shoulder and got really bad after a couple months.  I went to see an Orthopedic and was under his care starting in September, not sure of the exact date at this time.   But he told me I had cold shoulder but I wasnt aware it may have had anything to do with the Covid shots.   I was seeing him for a couple months and I quit because the therapist gave me some wrong advise and I cant afford it.  Cost is way too high.  Already spend over $1000.     It wasnt till I seen my gynecologist  and she told me she had read articles where people had the same effect. And yesterday on 12.17.21 when I went to get my Covid booster shot, they asked me which shoulder I would like and I said left please because I have cold shoulder due to the covid shot they gave me.    They too said they heard of that side effect as well.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for dyslipidemia, edema, barrett's esophagus, vitamin d3 deficiency, solitary nodule of lung, chronic airway obstruction, HTN, obesity, b12 deficiency, nondependent alcohol abuse, peripheral nerve disease. Per note 5/11, patient found deceased in apartment as a result of cardiac arrest. No cause of death listed or any other information.
heart rate 130; Pretty ill; Stomach upset; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (heart rate 130), ILLNESS (Pretty ill), ABDOMINAL DISCOMFORT (Stomach upset) and PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included RA. Concomitant products included TOFACITINIB CITRATE (XELJANZ) for RA.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (heart rate 130), ILLNESS (Pretty ill), ABDOMINAL DISCOMFORT (Stomach upset) and PYREXIA (Fever). At the time of the report, TACHYCARDIA (heart rate 130), ILLNESS (Pretty ill), ABDOMINAL DISCOMFORT (Stomach upset) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 130 resting (Inconclusive) 130 resting.         This case was linked to -MODERNATX, INC.-MOD-2021-075625 (E2B Linked Report).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-075625:Dose 1 case
C/O itching at injection site, and chest tightness: No wheezing or hives: Arm swollen. Benadryl 50mgm IM given left deltoid. ER Tx STeroids, Histamine Blocker (Zantac), NEB Tx  in hospital for 5 days
48 hours after getting the 2nd COVID vaccine my mom (the patient) had a reaction (anaphylaxis) to the vaccine. She started with having itchy hands, then began getting a rash to her upper thighs, arms, and abdomen. She then began having angioedema, redness in the face,  facial and lip swelling. She took an antihistamine. The rash continued and she began having residual abdominal pain and cramping. The rash continued to spread and then after 1-2 hours after taking the antihistamine the symptoms began to subside.
Chills, about 1.30a-3.30a, again about10a-2p. Fever, nausea, numbness in fingers of arm that was vaccinated. Weakness, hot flashes.
06/20/2002 sustained sunburn while out commercial fishing with family. 06/22/2002 went to ER with C/O HA, vomiting, weakness especially in lower extremities. MD suspected Guillain Barre. Med-vacted to another hospital. Received 5 days Immuoglobuin responded very well. Neurologist stated to mother that he felt this was due to Hep B immunization received 2 months prior. Other neurologist were not committed. Pt has fully recovered per mom. She still receives intermedient p.t. for hip weakness. The discharge summary states GBS.
This was a mixed series dosage. Patient did not disclose she had already received a Moderna vaccine on 2/26/2021. Provider administered a Pfizer vaccine on 3/19/2021 - on day 21. Once vaccine was given, she disclosed that she received a Moderna dose previously.
pain at the the injection site; pain in his shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the the injection site) and ARTHRALGIA (pain in his shoulder) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain at the the injection site) and ARTHRALGIA (pain in his shoulder). At the time of the report, VACCINATION SITE PAIN (pain at the the injection site) and ARTHRALGIA (pain in his shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment taken.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-085837:Husband case
This spontaneous report was received from a 30 year old female patient who is a registered nurse regarding herself. On an unknown date, the patient was vaccinated with 2 doses of MMR II when she was child. On an unknown date she had received a third dose of MMR II when she was 30 years of age because one or both of her doses of MMR II when administered as a child could not be verified. No adverse effect reported with the third dose of MMR II. This is one of several reports received from the same reporter. Additional information is not expected.