chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Widespread redness, swelling, and feeling hot to the touch and itchy across entire top of thigh.
12 hours after taking the second vax.  her arm was swollen, red and painful.  she some chills, nausea and fever that lasted about 48 hours.  Weeks later these symptoms came back and were more extreme. 4/5/2021 pt has SOB w/ slight exertion.  she developed numbness in her left side of her face including her ear down to her teeth.   4/6/2021 she started violently shaking with chills. her fever was about 102 and she had a severe headache.  She had nausea w/ dry heaving.  She had chest pain from reflux.  She could stand but not walk.  Ambulance was called and she was taken to  ER,  She had CT, Chest XRAY, EKG, Covid TESTs, Antibodies blood test.  Lab work.  O2 level was 98%.  All test were normal/negative.  She was discharged to go home.  On 4/8/2021 her temp was 104.  She had brain fog.  She went back to same ER.  They did the same test. This time the chest x-ray shows small right lower lobe infiltrate.  Pt had no cough.  Her white blood count was normal and was told she had viral pneumonia.  She never had any type of symptom normal to having pneumonia.  She was put on antibiotics and something for nausea.  Her fever and headache finally broke after about 5 days.  She had no strength and was basically laid up sick for almost a month.  She feels like she had a bad reaction to the covid vax since she had a viral lung infection with typical pneumonia symptoms.
This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 08-FEB-2019, the patient was vaccinated with an expired dose of PROQUAD lot # N021725 with expiration date of 06-FEB-2019, for prophylaxis (dose, route of administration, and anatomical location were not disclosed). No adverse effects events were reported.
Pt recvd vax & devel red welts, hives, itching & ear was swollen twice its size;
almost died; Initial information received on 06-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced almost died while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 2011, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, form, dosage, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious almost died (near death experience) (unknown latency) following the administration of INFLUENZA VACCINE. The patient reported that the only time the patient actually almost died was after he/she got a flu shot in 2011. This event was assessed as medically significant and life-threatening.  Final diagnosis was (life-threatening) almost died.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (almost died).  At time of reporting, the outcome was Unknown for the event almost died.; Sender's Comments: Sanofi Company Comment dated 06-Jan-2022:  This case involves a patient of unspecified demographics and it was reported that the patient almost died after receiving the influenza shot. Further information regarding previous vaccination, concomitant medication and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
Four days after (09-22-2021) Patient received his 1st Pfizer vaccine we started noticing personality changes in him. He started complaining about his eyes bothering him; he became withdrawn, anxious, obsessed and paranoid. He progressed to complaining of severe headaches and insomnia. He also had sporadic moments of trouble with balance and movement. He knew there was something not right and wrong with him. He took himself to his Primary care doctor on October 1st, 2021. He was prescribed several medications. His symptoms continued to progress until he ended his own life on November 9th, 2021.
cheeks red, cries when touched; red swollen vax site; upper extremities hot, lower extremities cold; occasional choking, gagging, attempts to vomit, clenched fists, twitching, lethargic, unconsolable crying; fever peaked t104.6 R:
paresthesia along ipsilateral arm (ulnar nerve distribution) a few minutes after vaccination soreness at injection site, mild headache, & lightheadedness 1-2 hours after vaccination chills 4 hours after vaccination (but no fever) * most symptoms improved/resolved 8 hours after vaccination
Day of shot: pain in arm, severe muscle pain in legs, numbness of tongue. Second day:numb tongue, red rash when water applied to face, severe leg pain, sore at injection site.  3 tingling tongue, rash face
EE has a history of anaphylaxis reaction to Latex. EE states she was intubated in Mexico over this in the past. Pfizer-BioNTech vaccine given, 20 minutes later EE c/o dizziness. EE places on cot and starting wheezing and being short of breath. Lungs sound tight and wheezy throughout.   1052- Epi 0.3mg IM given in Right Deltoid 1053- Benadryl 50mg IM given in Left Deltoid   1054- EE getting restless and starts feeling chest tightness. Epi 0.3mg IM given in Right Deltoid   Code Green Team arrived at 1054.   BP 197/126, HR 88, RR 44, blood sugar 109   1058- EE getting wheezing and short of breath again. Epi 0.3mg IM given in Right Deltoid and Benadryl 50mg IM given in Left Deltoid.   1059- EE transferred to ED on stretcher, escorted by ICU RN and ICU MD.  In ED- patient given solumedrol, epi, benadryl, phemodidine, ativan, zofran x 2  and ee sent home with medications as well.
Patient was given Fluzone HD, he had experienced lightheadness but said he was fine and a baidaid was paced on his arm by pharmacist and turned to give his wife her immunization and after going back and forth with her as to which arm she wanted she noticed him getting red in the face and looked like he was having trouble breathing and was losing conscientiousness. The wife was asked if she ever experienced him like this before and she said no. Pharmacist went to call 911 and other staff got him a bottle of water and he came around and started to drink the water and looked fine at that point. EMTs arrived shortly and administered to the patient. They transported him to the hospital.
Started breaking out 07/13/02 light rash. 7/14/02 Blisters on back in AM. By 4 hours later, down trunk. 7/15/02 Blisters on back, face, head, and mouth. Went to MD on 07/15/02. MD called in medicine this AM which is Valtrex and Tylenol with Codeine. On 7/15/02, too to ER due to child crying and restlessness.
Pt began to have tingling in her tongue within minutes of receiving vaccine.  Pt reports allergy to topical benadryl, so benadryl was not administered and two RN's observed patient with Epi on hand should it be needed. BP up to 212/90, HR 126 and 99% on RA. Pt observed by RN's approximately one hour until symptoms resolved and pt returned to baseline.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2006, the patient was vaccinated with a dose of ZOSTAVAX (exact dose, route of administration, anatomical localization, lot # and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles (onset date unspecified). As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of vaccination failure and herpes zoster was unknown. The reporter considered vaccination failure and herpes zoster to be related to ZOSTAVAX.
I got sick; my arm/feet/ legs hurts; Neck pain; Eye pain; Back pain; Knee pain; I feel so weak; tooth pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old patient received bnt162b2 (BNT162B2), administered in arm right (Lot number: 3014SDA) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "take' them for my headache" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN] taken for headache. The following information was reported: ILLNESS (non-serious), outcome "not recovered", described as "I got sick"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "my arm/feet/ legs hurts"; NECK PAIN (non-serious), outcome "not recovered", described as "Neck pain"; EYE PAIN (non-serious), outcome "not recovered", described as "Eye pain"; BACK PAIN (non-serious), outcome "not recovered", described as "Back pain"; ARTHRALGIA (non-serious), outcome "not recovered", described as "Knee pain"; ASTHENIA (non-serious), outcome "not recovered", described as "I feel so weak"; TOOTHACHE (non-serious), outcome "not recovered", described as "tooth pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of illness, pain in extremity, neck pain, eye pain, back pain, arthralgia, asthenia, toothache.  No follow-up attempts are possible. No further information is expected.
Severe flu like symptoms Severe dizziness (lasted 4 days) Severe headache (lasted 4 days) Bilateral lower extremity weakness (2 days)
sensitivity to cold; dizziness; sweats; severe chills; fatigue; muscle pain in his arm and throughout his body; low grade fever; a little tired; arm was slightly sore; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (sensitivity to cold), DIZZINESS (dizziness), HYPERHIDROSIS (sweats), PAIN IN EXTREMITY (arm was slightly sore) and CHILLS (severe chills) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was slightly sore) and FATIGUE (a little tired). On 18-Feb-2021, the patient experienced DIZZINESS (dizziness), HYPERHIDROSIS (sweats), CHILLS (severe chills), FATIGUE (fatigue), MYALGIA (muscle pain in his arm and throughout his body) and PYREXIA (low grade fever). On 22-Feb-2021, the patient experienced FEELING COLD (sensitivity to cold). On 11-Feb-2021, PAIN IN EXTREMITY (arm was slightly sore) and FATIGUE (a little tired) had resolved. On 18-Feb-2021, FATIGUE (fatigue) had resolved. On 22-Feb-2021, DIZZINESS (dizziness), HYPERHIDROSIS (sweats), CHILLS (severe chills), MYALGIA (muscle pain in his arm and throughout his body) and PYREXIA (low grade fever) had resolved. At the time of the report, FEELING COLD (sensitivity to cold) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported. Treatment information included Aleve.
SEVERE headache that will not go away.; Chills; Fever; Body aches; Lethargy; Lymph node swelling and pain; Lymph node swelling and pain; Rash on face; painful sores on scalp; painful sores on scalp; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 42-year-old female patient received BNT162b2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration in right arm on 19Apr2021 as dose 2, single (at the age of 42-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient medical history was reported as none. Patient had no known allergies. The concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration in left arm on 28Mar2021 15:00 as dose 1, single for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medication within two weeks. The patient experienced severe headache that will not go away, chills, fever, body aches, lethargy, lymph node swelling and pain, rash on face, painful sores on scalp, on 20Apr2021. The patient did not receive any treatment for the events. Facility type vaccine was Pharmacy or drug store. The outcome of the events was resolved with sequelae on an unspecified date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Flu like symptoms with severe stabbing chest pain. Started to feel achy and a twinge in chest around 12:30 am, went to sleep, woke up at 2 am with severe stabbing pains in chest that would come and go. Took some Advil around 3:15am and within a half hour flu like symptoms stopped but not chest pains. The chest pain were less severe. Continues to feel a  slight twinge and slight aching in chest 4 days later.
On Friday July 16,Patient was wrongly administered 0.5ml of Pfizer Vaccine Intramuscular instead of 0.3ml by the Medical  Volunteer Vaccinator. Management was informed ,Incident report filed and patients are being notified by medical staff.
Pericarditis; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: PERICARDITIS (medically significant), outcome "recovered". Clinical course: Complainant did not have the product with them at the time of call. Pfizer employee was at a hospital previous day for a meeting and had a pharmacist ask about pericarditis she had after having her Bivalent Booster Shot and was wondering if it was ok to get the next shot in the series. Pharmacist had pericarditis after the bivalent shot for about 5 months. Pfizer employee sent the pharmacist the information for medical vaccine information. Pharmacist was the reporter and patient. He didn't have time to get the pharmacists information previous day but he did get it that day to file the report. He didn't directly get the reporter's consent to contact but did have some contact information. End Date: Unknown but thought it resolved fairly recently. Pericarditis must have happened in the last 8 months since the Bivalent Vaccine released.  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.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information. 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
Approximately 10 hours after the vaccine my son started to feel shaky and very cold. He laid in bed to try and keep warm and I decided to take his temperature. It was 104.3. F. He didn't feel to sick just cold and tired. He's not the complaining type at all. I took his temperature at half hour intervals and at one point it reached 106.3 F. I called the hospital ER and asked if we should bring him in. They said since he wasn't feeling too too badly to just give him Tylenol. For the next few hours until about 2:30 A.M. his fever fluctuated between 104-105.8. It broke at that point down to 99 degrees F. He woke up this morning feeling OK but just tired. I and my husband both tracked our temperatures so we would know our thermometer is accurate, and we both consistently showed 97 and 98 degrees which is our normal temperature.
Client received one dose of Pfizer vaccine on 1/14/2023.  RN discussed restarted the vaccine series since the client never received her 2nd dose of the series.  The client agreed to restart the series however the RN administered the bivalent vaccine instead of the monovalent vaccine.  She immediately called me to report this error.  The client was informed of the vaccine she received by the nurse soon after vaccine administration. I consulted with Dr., the Mobile team Medical Director.  Dr. advised that no additional vaccine were needed for this client, since she received the bivalent vaccine. A call was made on 1/19/23 with the site contact, (client), Mobile Team Program Director, and myself (NP).  All questions and concerns were addressed with the client.
Patient reported feeling dizzy and was not verbally responsive for 10 seconds after receiving vaccine, and then vomited. Patient's pulse was faint, but became palpable once patient started talking again. Patient was breathing spontaneously. Patient reports last meal at 10am (7-8 hours prior vaccine administration), and anxiety to needles. Mother reports that patient faints with vaccine administration. Patient was taken to a cot to lay for 15 minutes and instructed to slowly drink sips of water in case of vomiting. Patient's symptoms resolved 15 minutes after laying supine. Instructed patient to go to ED if symptoms worsen.
arm was sore; swollen; can't move it; hot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), PERIPHERAL SWELLING (swollen), MOBILITY DECREASED (can't move it) and FEELING HOT (hot) 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 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), PERIPHERAL SWELLING (swollen), MOBILITY DECREASED (can't move it) and FEELING HOT (hot). The patient was treated with ACRIVASTINE (BENADRYL ALLERGY RELIEF) at a dose of 1 dosage form twice a day. At the time of the report, PAIN IN EXTREMITY (arm was sore), PERIPHERAL SWELLING (swollen), MOBILITY DECREASED (can't move it) and FEELING HOT (hot) outcome was unknown.            No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: TCR attached: NNi
2 1/2 weeks after administration of vaccine, Moderna had episode of severe leg pain bilaterally, 'scared' patient.' Hurt to stand, hurt to sit'. Has Post-Polio syndrome concerned this could be reaction from vaccination of Moderna, wants to receive next shot but 'afraid of repeat episode and that it could be worse.'
This spontaneous report as received from a certified medical assistant, refers to a 44 years old female patient. The patient's medical history included cough caused by unspecified ACE inhibitor. On 13-FEB-2015, the patient was vaccinated with dose of PNEUMOVAX 23 lot # K010466, expiration date: 23-MAR-2016, (dose, route and anatomical location were not reported). Concomitant therapies included CYMBALTA, BYDUREON, LIPITOR, metoprolol, hydrochlorothiazide (manufacturer unknown), losartan potassium (manufacturer unknown), metformin, diazepam (manufacturer unknown) and omeprazole (manufacturer unknown). In February 2015, the patient experienced redness all down her left arm associated with a fever of 104.5 grades Fahrenheit (F). In February 2015, the patient was admitted to the hospital and was given unspecified intravenous antibiotics. The fever and redness down her arm subsided in February 2015, but after that, the patient was experiencing significant pain down her arm and a large "knot" under the arm. At the time of this report, the patient was still in the hospital. The outcome of the events of "redness all down her left arm associated with a fever of 104.5 F" was reported as recovered/resolved. The outcome of the events of "the patient was experiencing significant pain down her arm" and "a large "knot" under the arm" was unknown. The relatedness between the events and the vaccination with PNEUMOVAX 23 was not provided. Upon internal review the event of "the patient was experiencing significant pain down her arm" was considered medically significant. Additional information has been requested.
Per ER report: 6 days after vaccine, he had a rash reported to have started, 1 day after Hep-B vaccine. Rash had blisters. Had hives and some vesicles and had pharyngitis with cough. He was treated with Benadryl.
severe, continuous status migraine daily March 31-May 17th. Not responsive to any medications or "migraine cocktail" in ER. Interrupted by nerve block injection but returned May 25th through present. Lymph nodes in neck are also still swollen and painful since March 24th.
This dose was given as a booster to a first dose J&J. . 0.5 ml given instead of 0.25ml. Pt fell into category for full dose due to active cancer treatment, but his first dose was J & J not moderna.
Information has been received from a 70 year old male consumer concerning himself with no medical history who in approximately 2006 (two years ago) was vaccinated with ZOSTER vaccine (lot# was unspecified). At the time of reporting, the patient experienced shingles. He contacted with the physician, and had no lab and diagnostic tests. At the reporting time, the patient's shingles persisted. No further information was available from the consumer. This is one of several reports received from the same source. Additional information has been requested.
Left deltoid region w/ 7x7 cm round, well circumscribed erythema.  Are defined by rash is tender & indurated.  Dx cellulitis + abscess Keflex 500 mg one tablet three times a day x 10 days.