chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bump is bigger this time and it doesn't look like it's gonna go away; hardness; redness; swelling; regular pain at the injection site; This spontaneous case was reported by a physician and describes the occurrence of CONDITION AGGRAVATED (bump is bigger this time and it doesn't look like it's gonna go away), VACCINATION SITE INDURATION (hardness), VACCINATION SITE PAIN (regular pain at the injection site), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077K204) for COVID-19 vaccination.     Concomitant products included PANTOPRAZOLE, METFORMIN, CALCIUM, SODIUM CITRATE (CITRATE), ZINC and VITAMINS NOS for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE PAIN (regular pain at the injection site). On 31-Dec-2020, the patient experienced VACCINATION SITE INDURATION (hardness), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling). On 06-Jan-2021, the patient experienced CONDITION AGGRAVATED (bump is bigger this time and it doesn't look like it's gonna go away). At the time of the report, CONDITION AGGRAVATED (bump is bigger this time and it doesn't look like it's gonna go away), VACCINATION SITE INDURATION (hardness), VACCINATION SITE PAIN (regular pain at the injection site), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling) 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.   No treatment medications were reported.; Sender's Comments: This case concerns a 41-year-old female who experienced NS events of unexpected condition aggravated and expected vaccination site pain, vaccination site erythema, vaccination site swelling, vaccination site induration. Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient became dizzy, weak, light headed, sweaty, with coldness of extremities, pale and had visual disturbances due to low blood sugar at time of vaccination and emotional response to "needle" / shot.  After caring for patient in post-immunization waiting area with her mother and father giving her drink and food to bring up her blood sugar to normal range, patient felt better and went home with her mother and father. No signs of allergic reaction were noted by pharmacist. Patient never lost consciousness.
This case was reported by a physician via (Tracking HCP SHINGRIX conversations on social media. Market research programs and described the occurrence of suicide in unspecified number of patients who received Herpes zoster (Hz/su + AS01B) for prophylaxis. On an unknown date, the patient received Hz/su + AS01B. On an unknown date, unknown after receiving Hz/su + AS01B, the patient experienced suicide (serious criteria death and GSK medically significant). On an unknown date, the outcome of the suicide was fatal. The reported cause of death was suicide. It was unknown if the reporter considered the suicide to be related to Hz/su + AS01B. Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, it was so sad about the suicides post vaccination. The consent to follow up was denied. This case is linked with US2021AMR247029 and US2021AMR246983, reported by the same reporter. Note: The narrative seemed to be a generalized statement but as all the posts were related to SHINGRIX vaccination and its side effects, this case was conservatively processed.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR247029: same reporter US-GLAXOSMITHKLINE-US2021AMR246983: Same reporter - 1st dose US-GLAXOSMITHKLINE-US2021AMR246983: Same reporter - 1st dose US-GLAXOSMITHKLINE-US2021AMR247029:Same reporter.; Reported Cause(s) of Death: Suicide.
This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (experienced side effects after vaccination) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication (experienced side effects after vaccination). At the time of the report, vaccination complication (experienced side effects after vaccination) outcome unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant product use and treatment information not provided.
Pain in left arm; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Apr2021 at 14:30 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. On 22Apr2021, the patient experienced pain in left arm. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain in left arm was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient became flaccid, cool to touch, and seizure activity for 3-4 seconds.
she went and got the Covid; she went and got the Covid; Blisters on her feet, there are a few; Super dry skin; Legs hurt; tearful; Both legs are swollen, twice the size; Both feet are swollen; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization.  The patient medical history and concomitant medications were not reported. The patient stated she was having bad reactions. Her legs were extremely swollen, twice the size and both feet were swollen from 23Mar2021 in the morning and were still ongoing and worsen now. She was getting blisters and really dry skin. She clarified she didn't have a lot of blisters but there were a few coming up on her feet. The patient had super dry skin- super, super dry. Her legs hurt. The patient asked should she go to the hospital. She talked to her doctor already. She stated that the doctor, he didn't know anything about the Covid, he was an idiot. And she went and got "the Covid" (as reported). He asked why the patient did that. She was going to try to help herself. The patient was getting a new provider because the doctor didn't do what she asked. She mentioned she was just in the hospital, too, so she could not provided details about the newprovider. The patient was inaudible at times, tearful, made multiple attempts to clarify statements, her phone didn't get good reception in her house. Outcome of the events legs were swollen, feet were swollen was not recovered, of other events was unknown.  Information about Lot/Batch number is requested.
This spontaneous report as received from a health care worker refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with RECOMBIVAX HB. Dose, route, lot number and expiration date were not reported. The health care worker reported that RECOMBIVAX HB was improperly stored and administered to unspecified number of patients on unspecified dates. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
COVID Break through case. Was very stuffed up, runny nose, coughing like a maniac, very achy, very short of breath, very fatigued. Memory loss, where you go to look for something and you go back and it was right in front of you the entire time.
She was feeling really cold; shivering; Pain in the arm,complaining aches and pain; fever of 102degF; started sweating; feet were numb; heart was racing; breathing was heavy; even complained of chest pain; lower back was hurting; shoulder were hurting too in the middle of the night; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (She was feeling really cold), CHILLS (shivering), PAIN IN EXTREMITY (Pain in the arm,complaining aches and pain), PYREXIA (fever of 102degF) and HYPERHIDROSIS (started sweating) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced FEELING COLD (She was feeling really cold), CHILLS (shivering), PAIN IN EXTREMITY (Pain in the arm,complaining aches and pain), PYREXIA (fever of 102degF), HYPERHIDROSIS (started sweating), HYPOAESTHESIA (feet were numb), HEART RATE INCREASED (heart was racing), DYSPNOEA (breathing was heavy), CHEST PAIN (even complained of chest pain), BACK PAIN (lower back was hurting) and ARTHRALGIA (shoulder were hurting too in the middle of the night). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, FEELING COLD (She was feeling really cold), CHILLS (shivering), PAIN IN EXTREMITY (Pain in the arm,complaining aches and pain), PYREXIA (fever of 102degF), HYPERHIDROSIS (started sweating), HYPOAESTHESIA (feet were numb), HEART RATE INCREASED (heart was racing), DYSPNOEA (breathing was heavy), CHEST PAIN (even complained of chest pain), BACK PAIN (lower back was hurting) and ARTHRALGIA (shoulder were hurting too in the middle of the night) outcome was unknown. Not Provided      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.   Concomitant medications were not provided by reporter.
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "86 yo female, with PMH significant for OSA on CPAP, asthma, bipolar depression, HTN, who presented from nursing home to the ED today due to decreased responsiveness and fevers   Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) treated in intensive care unit setting initially for urosepsis, E coli bacteremia, NSTEMI 1/7 Transferred to general floor   1/8 Underwent nuclear cardiac stress tests-ischemia of the lateral wall, mild   1/ 10 Seen by Cardiology, started on beta-blocker   1/11 Planned discharge to SNF on hold due to rising leukocytosis, leukocytosis improved down to 14 K the time of discharge     Altered mental status, Improving gradually, most likely due to urosepsis Has significantly improved   History of bipolar depression Continue with Tegretol and Cymbalta   History of asthma Oxygen p.r.n., albuterol inhalers   History of OSA On CPAP   NSTEMI Appreciate cardiology consultation, echo showed normal LVEF of 55-60%, mild AS Giving IV heparin for 48 hours On aspirin, beta-blocker  nuclear stress test,1/ 9 , as Cardiology, mild reversible defect, in the lateral wall consistent with mild ischemia, Cardiology recommended to treated medically , with beta-blocker, patient already on aspirin Urosepsis with E coli bacteremia Was on Levophed in intensive care unit setting Weaned of Levophed On ceftriaxone from 01/05, anticipate total course of antibiotic of 10 days at least Leukocytosis improving, has normalized 1/11 significant rise in leukocytosis to 19 K, planned discharge to SNF on hold  No fever, patient does not look toxic, currently on IV Rocephin Has anion gap acidosis with bicarb of 15, check lactic acid, do sepsis workup, including blood culture   History of hypertension PTA antihypertensives on hold   Acute kidney injury, solitary right kidney, status post left nephrectomy Due to urosepsis, improving renal function   Possible cognition impairment, move Moca scoring by speech, checked  vitamin B12.  Normal     Condition at the time of discharge-   Vss  Constitutional:  No distress, elderly, 2 liters/minute HENT:  Normocephalic, Atraumatic, Pupils Reactive, Normal oropharynx, Nose normal.  Cardiovascular:  Normal heart rate, Normal rhythm, No murmurs, No rubs, No gallops.  Respiratory:  Normal breath sounds, No respiratory distress, No wheezing, No chest tenderness.  GI:  Bowel sounds normal, Soft, No tenderness, No masses, No pulsatile masses.  Extremities:  Intact distal pulses, No edema, No tenderness, No cyanosis, No clubbing.  Neurologic:  Alert & oriented x 2 , confused at times,  No focal deficits noted. Skin:  Warm and dry   Issues Requiring Follow Up: (Who, what, when, and how communicated?)  Losartan & Aldactone are on hold  till f/u BMP & CBC , renal function improvement To follow-up on tolerance and efficacy of Augmentin"
Expired vaccine used; Second dose was improperly stored; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Second dose was improperly stored) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PRODUCT STORAGE ERROR (Second dose was improperly stored). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, PRODUCT STORAGE ERROR (Second dose was improperly stored) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications and treatment information was not provided.   This case was linked to MOD-2021-163363, MOD-2021-163751, MOD-2021-163459, MOD-2021-163974, MOD-2021-163302 (E2B Linked Report).; Sender's Comments:  MOD-2021-163363:Same reporter MOD-2021-163751:Same reporter MOD-2021-163459:Same reporter MOD-2021-163974:Same reporter MOD-2021-163302:Same reporter
Patient describes a very large rash developing following vaccine and encompassing the entirety of his back, parts of his chest and the area around the vaccine site, as well as some of the typical soreness associated with an IM vaccination. Patient not extremely distressed or in pain due to reaction, however did wish to report it.
chest pain (dull/pressure) - pain severity 3/4 out 10; intermittent daily pain started on 01-Sept-2021 (day following 2nd dose) by 5-Sept-2021 length of pain was lasting longer and by 6-Sept-2021 pain was constant albeit still dull/pressure feeling. Went to ER the evening of 6-Sept-2021.
After the vaccine was given which was at 5:45 pm and it passed 15 minutes of waiting time, I start it getting  dizzy, drowsy, my heart accelerated, anxious. I told the nurse on stand by, what I was feeling and she said to seat down because she was going to check my blood pressure. She checked by BP and it was on 160/80's ranges, was checked 3 times and they were the same  ranges. I don't suffer from high blood pressure I told her. So she gave me cranberry juice and water and I stayed for another 30-45 minutes. She rechecked my BP and it went down to 138/70's. I was told if I want it to go to the ER to get check, I told her that I felt much better that the dizziness went away and my accelerated heart had lessen. I feel much better today and BP it's back to normal ranges.
Redness to right arm injection site, warm to touch, itchy, tender. Treated with oral prednisone.
Delay in receipt of 2nd dose was due to pandemic COVID-19; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose 5 months ago from 2nd dose).   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, unknown after receiving Twinrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The patient had been administered with Twinrix vaccine on month 0 and the second dose had been given 5 months later.  The reporter asked regarding of how to proceed on the 3rd dose. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthtening of vaccination schedule. The reporter consented to follow up.   Follow-up information received from nurse on 23rd April 2020 : The patient's demographics were updated. On 18th February 2020, the patient received 1st dose, intramuscularly, from batch 75C72 with expiry date 13th June 2022. On 10th July 2020, the patient received 2nd dose, intramuscularly, from batch 9RT94 with expiry date 24th May 2022. The patient received 2nd dose of vaccine late because of pandemic covid 19 situation. The physicina waiting recipient to meet face to face. Third dose was planned 5 months from 2nd dose administration as per CSC guidelines. The VAERS details were updated.
Severe neuropathy extending down from injection site (left deltoid) into left fingers and up into left shoulder.
Patients left arm became red, swollen and warm to the touch. Diagnosed with Cellulitis. Treated with Sulfamethoxazole-Trimethoprim 800-160 mg.  Returned to clinic on 10/31/19 with intermittent left arm pain around the injection site.
Pt experienced a 10 cm area of pain, tenderness, induration and erythema around injection site.
Every time I get a Covid injection I have a flare up of pyoderma Gangernosum.  I treat it myself with a steroid ointment and I have been able to keep the wound from growing. The wound usually last a few days to a couple of weeks. This was my 4th injection and it has happened every single time.
Starting 12 hours after dose: Rotating between fever and chills Fever of 103+ Numbness / loss of feeling in tips of fingers / thumb Tinnitus  Lower back pain Lack of focus / irritable Overall random shots of pain through body Diarrhea  legs and feet turned purple Constant frontal headache Lack of appetite/ nausea  Some foods taste metallic
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 24-MAY-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L035276 and expiration date 09-JUN-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
Severe abdominal pain; cramping with constipation; cramping with constipation; lymphadenopathy; breast swelling; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 10:00 as dose 4 (booster), single (Lot number: G32525610123) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Yes-I have predicatable immune responses to all vaccines" (unspecified if ongoing), notes: Yes- I have predicatable immune responses to all, vaccines. This is different. Environmental; "Environmental" (unspecified if ongoing), notes: Yes- I have predicatable immune responses to all, vaccines. This is different. Environmental. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 10Oct2022; ZOCOR. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: FH8028212822), administration date: 29Nov2021, when the patient was 55-year-old, for Covid-19 immunization, reaction(s): "breast swelling"; BNT162b2 (DOSE 2, SINGLE, Lot number: EL3248), administration date: 12Jan2021, when the patient was 55-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 1, SINGLE, Lot number: EJ1685), administration date: 22Dec2020, for COVID-19 Immunization. The following information was reported: ABDOMINAL PAIN (non-serious) with onset 21Oct2022 at 03:00, outcome "recovering", described as "Severe abdominal pain"; BREAST SWELLING (non-serious) with onset 21Oct2022 at 03:00, outcome "recovering"; MUSCLE SPASMS (non-serious), CONSTIPATION (non-serious) all with onset 21Oct2022 at 03:00, outcome "recovering" and all described as "cramping with constipation"; LYMPHADENOPATHY (non-serious) with onset 21Oct2022 at 03:00, outcome "recovering". Therapeutic measures were not taken as a result of abdominal pain, muscle spasms, constipation, lymphadenopathy, breast swelling.  Follow-up (26Oct2022): Follow-up attempts are completed. No further information is expected.
Very swollen, red, hot, itchy and extremely painful.   This is more than 48 hours after initial injection.
chills; headache; nausea; fatigue; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     It was unknown if patient received any other vaccines within 1 month prior to Moderna COVID-19 vaccine. It was unknown if patient had ever tested or diagnosed for COVID-19. It was unknown if patient had allergy. It was unknown if patient had acute and Chronic illnesses at the time of vaccination.     In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced CHILLS (chills), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue). In March 2021, CHILLS (chills), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that with 1st dose symptoms lasted might be for 1 day. Patient was taking Tylenol, Aspirin and another medication but it was not clear if it was regular medication or the treatment given for her symptoms.   This case was linked to MOD-2022-664696, MOD-2022-664687 (Patient Link).