chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Noted: Left Clavicular Lymph Node swelling approximately (3) days prior to vaccine #2. Saw PCP on 2/11/21, who encouraged completion of series and ordered ultrasound of neck and chest, and basic blood work.  Took vaccine #2 on 2/12/21 at @ 3pm. Approximately 13 hours thereafter, fever spiked to 104.9, delirium, fatigue, muscle pain, chilling, neck and upper arm pain, limited ROM in neck, systemic lymph tenderness and edema, sore throat and headache. Reported symptoms to PCP.  Encouraged to take Tylenol. 2/18/21, developed dysphasia, dizziness when extending neck, laughing or coughing, pressure on esophagus, and food getting stuck when swallowing/choking. 3/01/21, ultrasound neck and chest revealed lymphadenopathy. PCP ordered CT Chest, abdomen, and pelvis. 3/3/21, symptoms continued to exacerbate. Consult with internal medicine physician who added CT of the neck, CXR, blood and urine. 3/7/21, CT of neck, chest, abdomen, and pelvis. CT of neck revealed 3.6 cm mass on thyroid. PCP ordered ultrasound of thyroid for 3/15/21.
Expired vaccine administered  beyond 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.  The vial was initially stored in the refrigerator 29 Nov 2021.On 30 Nov 2021 at 8:21am vial was first punctured. The vial stored post puncture at room temperature. Total amount of time the vial was exposed to room temperature range (8 to 25 degree Celsius or 46 to 77 degree Fahrenheit) is 14 hours.
h/a, nausea, rt arm numbness, vomiting 1/2hr to 1hr post vax;
Pericarditis, diagnosed by history EKG changes- Diffuse ST segment elevation; within 24 hrs of symptoms; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 47 year-old female patient (patient was not pregnant at the time of vaccination) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Jan2022 (Lot number: BD33030) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Generalized anxiety disorder" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) the patient received within 2 weeks of vaccination included: BUSPIRONE; CLONAZEPAM; NORTREL [LEVONORGESTREL]. Past drug history included: Avelox, reaction(s): "Known Allergies: Avelox"; Ranitidine, reaction(s): "Known Allergies: Ranitidine". Vaccination history included: Bnt162b2 (Dose 1, Lot number: Ek5730, Location of injection: Arm left, Route of administration: Intramuscular), administration date: 18Dec2020, when the patient was 46 years old, for COVID-19 immunization; Bnt162b2 (Dose 2, Lot number: EK4176, Location of injection: Arm left, Route of administration: Intramuscular), administration date: 08Jan2021, when the patient was 46 years old, for COVID-19 immunization. The following information was reported: PERICARDITIS (medically significant) with onset 20Jan2022 18:00, outcome "not recovered", described as "Pericarditis, diagnosed by history EKG changes- Diffuse ST segment elevation; within 24 hrs of symptoms". The event "pericarditis, diagnosed by history ekg changes- diffuse st segment elevation; within 24 hrs of symptoms" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: electrocardiogram st segment: diffuse st segment elevation. Therapeutic measures were taken as a result of pericarditis which included Indomethacin, colchicine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The device date was reported as 21Jan2022.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and PERICARDITIS cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Started after RSV vaccine with nausea, no vomiting, slight fever (99). Then aches and pains, chills. This continued. She is not sleeping well. The more she drinks, the more she urinates.   Reports started with sneezing. She would start having to blow nose after drinking, but nose spray has been helping.  She now has a deep cough and shortness of breath increased. She was given azithromycin and might of noticed improvement, but she continues with exhaustion and both eyes "feel heavy".   Denies fever.  Appetite has been "ok". She eats to eat.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 5 days after receiving SHINGRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was not recovered/not resolved. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per SHINGRIX indication. The patient received the 2nd shot and 5 days later, they had an injection site reaction. The injection site reaction was not resolved. Pharmacist reported that, they had no data because the patient left the pharmacy.
Developed frequent isolated ectopic beats for 36 hours after an episode of vigorous exercise 2 weeks and 1 day after second Covid vaccination.. No runs of tachycardia.
Pt received the moderna covid vaccine on Aug. 5th andbegan having symptoms that day and was sent home from work. Had COVID test that day and was negative.  Shot was given early afternoon and symptoms began in the middle of the night. His left arm wouldn't move, left side of his body wouldn't move, hurt and was tingling, had to move it with his right arm. He went back to sleep and woke up in the morning and couldn't get out of bed. Left arm hurt and it wouldn't work and tingled. The tingling lasted 2 days. "Felt like my arm was dead"  Stayed in bed until 1:30 in the afternoon, got up and still felt bad, sluggish, went and had dinner, slept that night and then felt better the next day. Still didn't feel like himself. Came home for 3 days. Felt ok while he was home, but still not "normal", Went back on the 9th and to work on the 10th. Sent home from work was sicker, hot, tired, foggy headed. Diarrhea started the day after the shot then again on the 10th,   Pt had diarrhea , loss of appetite, nausea and extreme fatigue.  Pt states he felt like he had the flu with body aches.  Pt is unsure if he had fever or not.   Pt is still having loss of appetite . Pt is due to get his second shot on sept 2nd.   Has lost 15#.    Moderna, 052E21A  8/5/2021.   2nd shot due 9/2/2021      Today 8/18/2021, he is still fatigued, has mild body aches, no appetite, mild headache. Denies SHOB or CP. Denies GI complaints, Has his smell and taste.  Has not been able to go back to work since the date of vaccine, except the attempts noted in which he was sent home.
vaginal bleeding; knee pain; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (vaginal bleeding) and ARTHRALGIA (knee pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Vaginal bleeding.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VAGINAL HAEMORRHAGE (vaginal bleeding) and ARTHRALGIA (knee pain). At the time of the report, VAGINAL HAEMORRHAGE (vaginal bleeding) and ARTHRALGIA (knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Reporter did not allow further contact
Overall skin ache, slight fever (highest reading 99), fatigue, head/chest congestion, very sore injection arm restricting movement, chills on the first overnight. Continued eating and drinking fluids. I cancelled all other activities. I have not fully recovered but approximately 45 hours after the injection, the symptoms subsided.
PATIENT FELT LIKE HER THROAT WAS GETTING ITCHY AND HER TONGUE WAS SWELLING,  WITHIN 5 MINS OF RECEIVING VACCINE ,  PT WAS GIVEN 25MG BENEDRYL BY MOUTH, WITH NO SIGNS OF IMPROVEMENT, PT WAS  GIVEN 75MG OF SLOUMEDROL BY IV,  10 MINS LATER SHE WAS GIVEN 50MG OF BENADRYL BY IV.  HER SYMPTOMS DID APPROVE AFTER 30 MINS OF OBSERVATION PT WAS ABLE TO LEAVE.  PATIENT'S CAREGIVER CALLED  THE OFFICE AT 2:14PM STATING THAT THE PATIENT'S SYMPTOMS HAVE RETURNED AND THEY HAVE GOTTEN WORSE PT WAS TOLD TO GO THE ER. PATIENT WAS ADMITTED TO HOSPITAL
Hard; swollen arm; Extremely itchy arm; A big red spot on arm; Warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (Hard), PERIPHERAL SWELLING (swollen arm), PRURITUS (Extremely itchy arm), SKIN MASS (A big red spot on arm) and SKIN WARM (Warm to touch) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy (Allergic to sulfa drugs) and Drug allergy (Allergic to Amoxicillin). Concomitant products included CETIRIZINE for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INDURATION (Hard), PERIPHERAL SWELLING (swollen arm), PRURITUS (Extremely itchy arm), SKIN MASS (A big red spot on arm) and SKIN WARM (Warm to touch). At the time of the report, INDURATION (Hard), PERIPHERAL SWELLING (swollen arm), PRURITUS (Extremely itchy arm), SKIN MASS (A big red spot on arm) and SKIN WARM (Warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Flushed Cheeks; Sweating; Chills; Fatigue; Aches; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushed Cheeks), HYPERHIDROSIS (Sweating), PAIN (Aches), VACCINATION SITE PAIN (Sore Arm) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 05-Mar-2021, the patient experienced PAIN (Aches) and VACCINATION SITE PAIN (Sore Arm). On 19-Mar-2021, the patient experienced FLUSHING (Flushed Cheeks), HYPERHIDROSIS (Sweating), CHILLS (Chills) and FATIGUE (Fatigue). On 07-Mar-2021, PAIN (Aches) and VACCINATION SITE PAIN (Sore Arm) had resolved.  At the time of the report, FLUSHING (Flushed Cheeks), HYPERHIDROSIS (Sweating), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.      No treatment information was provided. The patient received both scheduled doses of mRNA 1273 before the events, therefore Action taken with mRNA-1273 in response to the events was not applicable.
Itchy horribly; Red spots; Scaly; Injection site itchy; Injection site is red; Injection site swollen; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (Itchy horribly), RASH PAPULAR (Red spots), SKIN EXFOLIATION (Scaly), VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE ERYTHEMA (Injection site is red) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disease, unspecified since 2010 and Blood pressure high since 2010. Concomitant products included IRBESARTAN from 2019 to an unknown date, HYDRALAZINE from 2020 to an unknown date, ROSUVASTATIN, AMLODIPINE from 2018 to an unknown date, CARVEDILOL from 2019 to an unknown date, ACETYLSALICYLIC ACID (BABY ASPIRIN) and ASA from 2010 to an unknown date for an unknown indication.    On 04-Feb-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021 at 11:00 PM, the patient experienced PRURITUS (Itchy horribly), RASH PAPULAR (Red spots), SKIN EXFOLIATION (Scaly), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Injection site swollen). At the time of the report, PRURITUS (Itchy horribly), RASH PAPULAR (Red spots), SKIN EXFOLIATION (Scaly), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Injection site swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PRURITUS (Itchy horribly), RASH PAPULAR (Red spots), SKIN EXFOLIATION (Scaly), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Injection site swollen) to be not related.    Treatment information was not provided.  There were 25- 30 red itchy swelling spots that are pealing on the knees, ankles, a couple on up the leg, on his Rt Hip, Left upper shoulder, wrists on top. The injection site is red and swollen, itchy.   This case was linked to MOD-2021-271504 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up information received contains updated patient details, new concurrent conditions (heart disease and high BP), new event (injection site itchy, Injection site swollen, Injection site rash) added, events (Itchy horribly, Red spots and Scaly) outcome updated to not recovered from unknown and causality updated from not provided to not related.
Rec'd Hep B #1 at approx 2:00PM, 11/2/04. Reports had rash to fever at 8:00PM same day, went to ER rec'd Benadryl, steroid shot.
A couple of hours after first shot, my left knee (which I've had 9 surgeries on, synvisk injection, and is arthritic) swelled up very large and constantly for 5 days straight and was unresponsive to wrapping, icing, electrodes, elevation. With my previous surgeries, my knee rarely swelled if ever believe it or not!
Post vax, child was anorexic. During the night, she became very restless and uncomfortable. Mom couldn't detect a fever. The next morning, leg was swollen and tight at injection site, warm to touch though not red. Child awoke crying and remained extremely irritable all day long. She complained of pain and was unable to bend her leg or walk on it. She cried the greater part of the day and was not interested in eating. That evening, she showed interest in food. The next day, she continued to complain of pain and was unable to bend her leg. By 8/9/01, she began to bear weight on leg and by 8/10/01, she seemed to be completely recovered.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The information regarding medical history, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # N013504, expiration date: 08-DEC-2019 (dose and route of administration were not reported). No adverse effects were reported. The vaccine was stored in temperature of 32 Fahrenheit degrees (F) to 35 F (35.4 F) for 8 hours. The call was not because of a data logger.
History of Present Illness:  13y/o male with no significant past medical history or allergies reports nausea following receipt of first dose Pfizer vaccine today. He reports associated pre-syncopal sensation, palpitations and minimal difficulty with swallowing. He denies shortness of breath, chest pain, swelling/numbness of the lips and tongue, vomiting, injection site pain/redness or rash.   Physical Exam:  VS- HR ~110  VS #2: taken by paramedic reportedly within normal limits and normal sinus rhythm  Inspection: no redness, swelling or pain at injection site; no rashes. No tongue/lip swelling.  Heart: increased rate, regular rhythm; radial pulse strong with increased rate  Lungs: clear to auscultation bilaterally without adventitious sounds  Plan: Patient was also evaluated by paramedics. After ~30min, the patient reported cessation of symptoms and was feeling much better. Paramedic informed patient and mother that he can be transported by ambulance to hospital or decline services. The mother and patient elected to decline transportation via ambulance to hospital as he was feeling much better. Patient and family left the site after his symptoms resolved.
Received the first dose of covid vaccine on 2/11.  About 2/25, started to develop a sun rash on elbows and arms.  Gradually, rash extended to hands and was quite severe.  Applied a salve prescribed by physician which was somewhat effective and skin gradually cleared.  Now, whenever arms or legs are exposed to sunlight, burning and itching effect the exposed area (but, so far, no rash).
This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. The patient pertinent medical history and drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX. Concomitant therapy information was not provided. On an unknown date, the patient experienced rash vesicular described as in appearance a varicella like rash over his entire body. The patient sought medical attention by an office visit. At the time of the report, the outcome of rash vesicular was unknown. Additional information has been requested.
Body aches; Fatigue; Fever; Chills; Headache; Sweats; Coughing; This is a spontaneous report from a contactable consumer Patient reported that. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced body aches, fatigue, fever, chills, headache, sweats and coughing. The event outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report as received from a physician refers to a 26 year old male patient who on 22-JAN-2013, was intended to receive PPD skin test, was inadvertently vaccinated with PNEUMOVAX 23 dose 1, subcutaneous. No concomitant medications were reported. The physician stated that on 22-JAN-2013, the patient developed a 5-6 cm area of redness, swelling, induration, and heat at the injection site. The patient was treated with KEFLEX and MEDROL dose pack and has recovered. No further information provided. The relatedness adverse events was unknown for PNEUMOVAX 23. This is one of several reports from same source. Additional information has been requested.
Patient complained of feeling dizzy and possibly passing out. Patient diaphoretic with brief moment of loss of consciousness and the woke on her own. Patient alert and oriented. BP 104/70, HR 71, O2 sat 98%. Patient assess by physician.
hard spot at the injection site; itchy red bumps at the injection site; itchy red bumps at the injection site; itchy red bumps at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hard spot at the injection site), VACCINATION SITE PRURITUS (itchy red bumps at the injection site), VACCINATION SITE URTICARIA (itchy red bumps at the injection site) and VACCINATION SITE ERYTHEMA (itchy red bumps at the injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia (chronic nerve and muscle pain). Concomitant products included CANNABIDIOL and MARIJUANA for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (hard spot at the injection site), VACCINATION SITE PRURITUS (itchy red bumps at the injection site), VACCINATION SITE URTICARIA (itchy red bumps at the injection site) and VACCINATION SITE ERYTHEMA (itchy red bumps at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (hard spot at the injection site), VACCINATION SITE PRURITUS (itchy red bumps at the injection site), VACCINATION SITE URTICARIA (itchy red bumps at the injection site) and VACCINATION SITE ERYTHEMA (itchy red bumps at the injection site) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable Patient stated she was on opiates for 4 years   This case was linked to MOD-2021-229938 (Patient Link).
Large red area around injection site, warm to touch swollen, nausea, painful upon touching area.
I got it after getting the shingles vaccine / suspected vaccination failure; got it after shingles vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The patient reported case for himself or herself. The age at vaccination was not reported. The patient got shingles after getting the shingles vaccine. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.