chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm broke out / arm red; Arm broke out / arm itches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Arm broke out / arm itches) and RASH ERYTHEMATOUS (Arm broke out / arm red) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), ATORVASTATIN, CLOPIDOGREL BISULFATE, PANTOPRAZOLE SODIUM and LISINOPRIL for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced RASH PRURITIC (Arm broke out / arm itches). On 31-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Arm broke out / arm red). On 31-Jan-2021, RASH PRURITIC (Arm broke out / arm itches) had resolved. At the time of the report, RASH ERYTHEMATOUS (Arm broke out / arm red) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Breakthrough case admission after three doses Moderna 4/19/21 Lot# 040B21A Moderna 5/17/21 Lot# 040B21A Moderna 1/17/22 Lot# 069H21A
Patient visited physician on 12/30/2020 due to an allergic reaction to the COVID vaccine. Patient has large red area, that is swollen, and puffy the size of a grapefruit, it is also hot and itchy. Lymph nodes in underarm of left arm and swollen and painful. Physician prescribed steroids. Redness continues to grow.
PATIENT PRESENTED ON 10/20/2017 AT 5:15 PM WITH LEFT ARM SWELLING AND RASH/REDNESS AROUND THE BICEP AND INNER ARM AT ELBOW. REACTION PRESENTED WELL BELOW INJECTION SITE. PATIENT DID COMPLAIN OF SORENESS OF THE ENTIRE ARM AND ESPECIALLY AT INJECTION SITE. PATIENT SAW DOCTOR AND RECEIVED STEROIDS AS PER PATIENT.
Covid19 breakthrough.  1st Vaccine on 03/18/2021.  88 y/o with pmhx-HTN, Asthma, leukemia and malignant neoplasm of glottis presents to ED with lower back pain from fall.  Daugher found pt of floor after 6 hours and brought to ED for eval.  Pt also presents with cough x2 days.  Denies Sob, fever, chills or CP.  Room air sat 91%.  Started on IV steroids and Remdesivir.
Bilateral upper arm pain and weakness with decreased strength.  Onset symptoms 2 days after Adacel administration.  On exam decreased strength abduction after 180 degrees both UE's.
Date of Admission: 1/9/2022   Date of Discharge: 1/14/2022   Issues to be Addressed at Follow-up:   Acute Hypoxic Respiratory Failure iso covid-19, IGG-4 related ILD - self-isolate for total of 20 days from sx onset (12/28) - s/p remdesivir x5d, decadron 6mg PO x4d  - cefepime/azithro (1/9-1/12) -- > levaquin 750mg PO q24hr (1/12-1/16) to cover for superimposed bacterial pna - 0LPM O2 at rest, 2-4L w/ exertion 77yo male hx of IgG4 related ILD (not on home O2, on chronic pirfenidone, Cellcept), with recent PFTs (2/2021) showing restrictive ventillatory defect, normal TLC,DLCO (improved from prior). Flu-like symptom onset 12/28, +COVID. Symptoms initially improved, however 3 days prior to admission had worsening SOB. Met sepsis criteria (fever, tachypnea, hypoxia to 84% w/ exertion, requiring 2L NC) on admission. No leukocytosis, however, patient on immunosuppressive therapy.  CXR showed diffuse patchy and interstitial opacifications as well as consolidation of medial L lung base. CT Chest w/ new patchy multifocal infiltrates and L medial lobe infiltrate, no PE. Etiology of AHRF suspected from COVID vs component of ILD flare. Concern for superimposed pna given immunosuppressed status. Started on remdesivir 1/10, decadron 1/11 (d/w Dr.) for covid, cefepime/azithro -- > levaquin for superimposed bacterial pna. Continued pirfenidone/cellcept for ILD. Also noted to have +legionella Ab 1:256, though unclear if current vs prior infection. Prior to discharge, trialed ambulation in room, desatted to 85%, although patient reported feeling better than recent baseline prior to covid infection. Stable for discharge home w/ home O2 2-4L.    Primary Procedures:  None   Secondary Procedures: None   Reason for Hospital Admission (Admitting Diagnosis):  Severe sepsis wo acute organ dysfunction due to covid pna
Right before the second shot she got Covid and had antibodies in the hospital; Right before the second shot she got Covid and had antibodies in the hospital; This is a spontaneous report received from a contactable pharmacist. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received a dose of the vaccine on 27Feb2021. Right before the second shot, on an unspecified date in 2021, she got Covid and had antibodies in the hospital. The doctor told her to go ahead and get her second shot. It had been almost 4 months since the first dose. The pharmacist asked if it will be going to be effective and if it should be given to her. The seriousness of event was reported as non-serious by the reporter. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive. The outcome of events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on known Vaccine safety profile and as patient received only one shot of vaccine there is reasonable possibility of drug ineffective for Covid-19.
Pt came in for flu shot. After receiving the shot pt was asked to wait for 15 min. As soon as he went to waiting room he fainted. Pt was put in supine position: his legs were raised his vital signs were checked. He was coherent within 5 minutes. No EPI PEN was used. No allergic symptoms were noted rash, hives, etc. Pt left w/ parent. Followed up the next day and was fine. BP 77/54. BP 102/70 Pulse 41. BP 100/62. BP 110/65 Pulse 52. BP ?14/67 Pulse 52.
No reaction when given. Next day patient presented with redness and soreness. Provider advised to wait and have PCP observe on next day. Seen PCP on 12/15 and diagnosed with cellulitis. Patient was due to have procedure and received second opinion and diagnosed as cellulitis. Prescribed Keflex. Pharmacist reviewed literature- suspect that it is a cellulitis-like reaction- doubtful that is is a secondary infection.
This case was reported by a nurse and described the occurrence of fever in a 4 month old female patient who received DTaP , hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix). On 19JULY2004, the patient received a dose of Pediarix. On 19JULY2004, the patient also received injections of 7 valent pneumococcal conjugate vaccine and Hib conjugate vaccine. Approximately one day following the administration of Pediarix on 20JULY2004, the patient experienced a fever of 100.3 degrees Fahrenheit and screaming. The patient was seen at a physician's office and was treated with ibuprofen. The outcome of the events was unknown at the time of the initial reporting. Report received via manufacturer.
Swollen eyes, redness, itchy, Major pain, burryness  Started in one eye and has continued into the second  These symptoms are current and on going.
On 4/5/2021, arrived to the vaccine clinic via ambulance. was registered into the system and was asked a series of standard questions from our staff and our vaccinator.  The system did not have any record or notes regarding a previous vaccination.  The questions asked included whether this was his first or second COVID vaccination which was replied to as his first.  Additionally, there was no previous vaccine card presented to the vaccine clinic staff.    After administration of the Pfizer vaccine, the patient noted that this dose was given in the same arm as the previous dose.  Upon further questioning, the staff suggested that the dose was the patients first dose.  The clinic contacted and spoke to the nurse who additionally stated that she had no records of a first dose.  The call was then transferred.  This is when it was confirmed that the patient has receive a Moderna vaccine in March.
said it felt like he had drank a fifth of Captain (name); flu; feeling drained/completely wiped out/ exhausted; felt like he was run over by a tractor trailer; He's been sleeping 10-12-14-16 hours a day and feels completely out of it; lightheaded/ dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Aug2021 (Lot number: FA7485) at the age of 69 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, LOT- EW0196, administered on left arm), administration date: 11Jul2021, when the patient was 69 years old, for COVID-19 immunisation. The following information was reported: MALAISE (non-serious) with onset 03Aug2021, outcome "unknown", described as "felt like he was run over by a tractor trailer"; HYPERSOMNIA (non-serious) with onset 03Aug2021, outcome "unknown", described as "He's been sleeping 10-12-14-16 hours a day and feels completely out of it"; DIZZINESS (non-serious) with onset 03Aug2021, outcome "not recovered", described as "lightheaded/ dizzy"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "said it felt like he had drank a fifth of Captain (name)"; INFLUENZA (non-serious), outcome "unknown", described as "flu"; FATIGUE (non-serious) with onset 03Aug2021, outcome "not recovered", described as "feeling drained/completely wiped out/ exhausted".  Additional information: Patient does not received any other vaccines on same date of the pfizer vaccine. Patient does not received any other vaccine prior to COVID-19 vaccine within 4 weeks. Relevant Tests and Family Medical History Relevant to AE was None. Patient received his second dose of the Pfizer BioNTech Covid 19 vaccine on Sunday. On Sunday and Monday he felt fine but then on Tuesday he felt like he was run over by a tractor trailer. He's been sleeping 10-12-14-16 hours a day and feels completely out of it. He's felt lightheaded and dizzy.  After he gets off the phone he wants to go back to sleep.  Yesterday he attempted to get gas but he was so lightheaded he said after a few blocks he turned back around and went home.  He said it felt like he had drank a fifth of Captain (name withheld) and didn't feel safe driving. Adverse events does not require patient to visit emergency room or physician office.  No follow-up attempts are possible. No further information is expected.
12/30/14 (R) leg knot, red, swollen: MOTRIN/TYLENOL given; Cool compress applied; Consulted dr.; Increased fluids; Fu with private MR or ER 12/31/15 mom states 3 knots now; cranky; afebrile per dr control with MOTRIN and compresses; F/U with ER or MD prn.
The patient turned very pale and fainted within  a minute or two of the vaccination. She was out for a second and then came right back to.
TD and MMR given 6/28/05 in L deltoid. Swelling developed between L shoulder and neck area on 6/30/05. Slight pain upon palpation of area. No fever. No redness.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination. No Medical History information was reported. On 04-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. The vial did not undergo any temperature excursions. The vial was initially stored in the refrigerator on 04-May-2022. No treatment information was provided by the reporter.
Pt received adult 12+ Pfizer bivalent instead of Peds Pfizer 5-11 bivalent
Sore R upper arm within an hour of injection;  sudden onset of nausea, vomiting, diarrhea, fatigue and severe headache 12 hours after injection;  slept from 8pm on Friday 2/12/21 through till  1:30pm on Sunday 2/14/21 (except for going to the bathroom to throw up and defecate);  Took promethazine, which had NO effect on the nausea.  N/V/D subsided  about 60 hours after onset.  Headache (severe, like a vise was on my temples) subsided about  4-5 days after onset.  Persistent fatigue lasted for 6 days total.  I had stopped my daily tylenol and ibuprofen and zyrtec 48 hours before the injection, and did not restart them till 3 days after the injection.  Tylenol and ibuprofen had NO effect on the headache, but did relieve my chronic bilateral  hip-replacement leg pain.
This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 08-JUL-2016 and 10-APR-2017, the patient was Oka/Merck VARIVAX (lot # L035124, expiry date: 14-SEP-2017) for prophylaxis (dose and route was not reported), which was stored improperly(reported as vaccine temperature excursion) (Product storage error).
CHEST REDNESS; EYE ACHE; ELEVATED PULSE; DIZZINESS; DRY SKIN; EXCESSIVE THIRST; ITCHY RASH; HEADACHE; FACE FLUSH/ FACE WAS RED AND BUMPY; TOO HOT OR COLD/ INTERMITTENT FEELING EXTRA COLD(HEAD FEELS HOT AND REST OF BODY FEELS COLD); TINGLY FINGER; FELT LOUSY; BLOOD PRESSURE FLUCTUATION; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced blood pressure fluctuation. On 12-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 150/84 mmHg. On 15-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 125/85 mmHg. On 16-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 137/91 mmHg, 156/90 mmHg, 142/92 mmHg. On 17-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 137/88 mmHg, 140/92 mmHg. On 18-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 143/89 mmHg. On 23-MAR-2021, the subject experienced felt lousy. On 24-MAR-2021, the subject experienced tingly finger. On 27-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 156/96 mmHg. On an unspecified date, the subject experienced chest redness, eye ache, elevated pulse, dizziness, dry skin, excessive thirst, itchy rash, headache, face flush/ face was red and bumpy, and too hot or cold/ intermittent feeling extra cold (head feels hot and rest of body feels cold). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood pressure fluctuation, and the outcome of headache, chest redness, eye ache, elevated pulse, dizziness, dry skin, excessive thirst, itchy rash, face flush/ face was red and bumpy, too hot or cold/ intermittent feeling extra cold(head feels hot and rest of body feels cold), felt lousy and tingly finger was not reported. This report was non-serious. This case, from the same reporter is linked to 20210408073.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
pt recv vax;48 hrs later,exp photophobia&aching joints;sx lasted approx 1 wk;
1.5 in by 1 in indurated, warm, erythematous region of left upper arm; no discharge. No treatment, no fever.
Received shot at 11:00 AM, approx 4:30 PM patient began feeling short of breath a little, with a lump in the base of my throat, kind of dizzy, arm was achy and sore in antecubital area. These sx slightly improved around 6 and by 7:30 PM were gone. Approx 10 PM pt. was hit with the typical flu sx: shivering/chills, extremely achy, weak, headache, tired. Pt. went to bed and in AM was fine.
received 3rd full dose of Moderna (not a booster, due to being on a biologic medication)  Within 14 hours experienced severe fatigue, sore arm, joint pain, chills/fever (for approx. 6 hours). Fatigued lingered for 36 hours; the other symptoms resolved after approx. 24 hours.
pt recv vax 14SPE96 & 15SEP96 pt exp joint pain in wrist & fever of 101 @ noc;pt had pain in rt thigh which was hard;16SEP96 leg pain resolved;joint pain in wrist, fever & painful, hard, right thigh persists as of 16SEP96;
Information has been received from a nurse concerning a 6.5 year-old white male who on 14-Jan-1998 was vaccinated with a dose of varicella virus vaccine live (lot #623130/0568E). The reporter indicated that on 20-May-2003 the patient developed a generalized rash with less than 50 lesions. It was noted that the rash was documented and evaluated by a physician. The patient also developed a fever which had a duration of three days. The highest temperature was 100. It was indicated that the patient did not have a cough. Additional information has been requested.
12/2/13 Fever 103.7 and had tonic/clonic seizure event. Taken to the ED for full evaluation. Has concomitant croup illness, but also 12 days after MMR vaccine given.
approximately  one hour later at 14:00 my teeth were so sore as if all had been in hot or cold water. then about 16:00 or so when i had been on the floor to water the new bought Christmas tree my knees were so sore I needed help to get up from the floor.  next morning my right leg was very painful to bend and I had some swelling around the knee and the pain was up and down the leg. the 16th of December i could barely bend my right leg due to pain when i tried to get into my car to drive to the store. my right leg is still very painful at this day the 19th of December and I plan to contact my primary provider
Difficulty breathing. Erratic and rapid heart, dizziness, swelling of throat. Went to the ER. Was placed on gurney and given EKG. Heart rate was 179. They administered Cardizem also did Basic Metabolic Panel, CBC with Differential, ECG 12 Lead, Troponin 1. My heart was in Aortal Fibrillation and took over two hours to get back to normal heart beat. Spent 3 hours there.
Runny nose, clear yellow from left nostril; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL3249 and expiration dates were not reported), via an unspecified route of administration in arm left on 26Jan2021 at 12:30 as 1st dose, single for COVID-19 immunisation. Medical history included obesity, hypertension, coronary artery disease and atrial fibrillation. The patient previously took daptomycin and experienced drug hypersensitivity. The patient experienced runny nose, clear yellow from left nostril on 03Feb2021. The patient did not receive any treatment for the event. Facility type vaccine: Hospital. No COVID prior vaccination and No COVID tested post vaccination. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Redness, itching, and tenderness at vaccination site starting on day 7 after shot #1
This spontaneous report as received from a Registered Nurse refers to multiple patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored improperly stored RECOMBIVAX HB,  lot # M036156, expiry date: 23-FEB-2019 for prophylaxis (Incorrect product storage). Dosing details and route of administration were not reported. No concomitant medications were reported. No adverse effects were reported. On an unknown date, the vaccine was exposed to temperature of -1°C or colder (-1°C) for 11 hours 29 minutes. No previous temperature excursion were reported. This case was reported because of a data logger. No product quality complaint (PQC) was reported. No further information was provided. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA005593: US-009507513-1708USA006090: US-009507513-1708USA006089: US-009507513-1708USA006091:
The patient started describing left-sided hemiparesis roughly 14 minutes after vaccination. The symptoms remained stable. It was strongly suggested that I call EMS to have her evaluated for a stroke. She then stated she had a history of a TIA. I asked if she had a PCP, she stated she did not have a doctor. She did not want medical attention and was going to leave. I advised against this and she declined my advise. I called to check on her and ask her how she was doing, she stated the tingling had spread. She was experiencing blurred vision in the left eye, she also stated her sister said her left eye seemed "sleepy." I again urged her to seek medical attention, she thanked me and declined.
11 days post vaccine a red square approx  2 in by 2in appeared on my upper right arm approx 2 inches from the injection site. Injection site had no redness. Now 13 days post vaccine the square is growing and now there is redness at the injection site. The redness is warm to the touch but does not hurt or itch. On day 13 it measures approx 6m x 7cm with some outlying splotches.
10/6 Temperature 101 degrees F. 10/6 Body aches. 10/6 Rash on face. 10/10 Developed secondary ear infection. Treatment of Tamiflu 10/6/14 thru 10/10/14.
pt experienced slurred speech, confusion, weakness, trembing directly after immunization; continuing for a hour after, before slowly subsiding
The same patient received both Boostrix and Menveo(1 vial) in the office yesterday on 10/4/23; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 54CP2, expiry date 11-JAN-2026) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number 52X45, expiry date 31-DEC-2024) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX) and MENVEO.   On 04-OCT-2023, the patient received Boostrix and Menveo. On 04-OCT-2023, an unknown time after receiving Boostrix and Menveo, the patient experienced extra dose administered (Verbatim: The same patient received both Boostrix and Menveo(1 vial) in the office yesterday on 10/4/23).The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 05-OCT-2023 The RN (registered nurse) reported a 11-year-old patient received Boostrix and Menveo (2 vial) back on 29-AUG-2023. The same patient received both Boostrix and Menveo (1 vial) in the office yesterday (day before reporting), which led to extra dose administered. The reporter called to inquire and asked was there any information available and how to proceed. The reporter did not consent to follow-up.
Client verbalized that her right arm developed severe swelling, red area from elbow to shoulder with stiffness of neck area for 1 week after vaccine was given.