chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3rd Dose of Heplisav-B was Accidentally Given; Initial Report Received on 12-Oct-2021  A pharmacist in the US (OK) reported that a 58 year-old female (race and ethnicity not provided) received 3 doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 13-Jul-2021, the patient received the first dose of HEPLISAV-B (Lot # 934974, expiration date 29-Apr-2022 and NDC # 43528-003-05) in the left deltoid.  On 29-Aug-2021, the patient received the second dose of HEPLISAV-B (Lot # 934974, expiration date 29-Apr-2022 and NDC # 43528-003-05) intramuscularly in an unknown site.  On 02-Oct-2021, the patient received the third dose of HEPLISAV-B (Lot # 934974, expiration date 29-Apr-2022 and NDC # 43528-003-05) intramuscularly in the right deltoid from a pharmacist. The second dose that was given did not show entered in the system, therefore another dose was given (third dose).  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Pfizer-BioNTech COVID-19 Vaccine EUA She said she felt really dizzy so I had her sit longer than 15 minutes. She started feeling arm heaviness, tingling in hands and feet, heavy legs and head. She moved to another chair in waiting area and had difficulty  I called 911 & monitored her the whole time. Paramedics checked her vitals and all were within range  She didn't want to go to ER and they said they couldn't do anything her for her symptoms and that it was her choice. She wanted to drive home but paramedics and I did not feel comfortable with that so she asked her husband to pick her up
Days 2 and 3 headache, muscle aches, tiredness, upset stomach; Day 2,3,4,5 and continuing, red, swollen, tender arm from  above  elbow to shoulder.
Severe weakness, fever, lethargy, mild nausea, soreness, muscle soreness, joint soreness.
lack of energy; chills; fever; sore muscles; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (lack of energy), CHILLS (chills), PYREXIA (fever) and MYALGIA (sore muscles) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005M21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (COVID-19 prior to getting the 1st dose and stayed at home, mild symptoms). Concurrent medical conditions included Coronary artery disease and Blood cholesterol abnormal. Concomitant products included ATORVASTATIN for Cholesterol, AMLODIPINE for Coronary artery disease, ACETYLSALICYLIC ACID (BABY ASPIRIN), MAGNESIUM, ZINC, COLECALCIFEROL (VIT D [COLECALCIFEROL]) and MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE] for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, the patient experienced ASTHENIA (lack of energy), CHILLS (chills), PYREXIA (fever) and MYALGIA (sore muscles). In April 2022, ASTHENIA (lack of energy), CHILLS (chills), PYREXIA (fever) and MYALGIA (sore muscles) had resolved.            It was reported patient could not read information on the vaccination card. There was a mention of Pfizer being given as a 1st booster dose but could not tell definitely.  It was reported that patient had same reaction with all doses after dose one on 20-Feb-2021 patient experienced chills, fever, sore muscles and lack of energy which recovered on 23-Feb-2021. After second dose patient experienced chills, fever, sore muscles and lack of energy from 20-Mar-2021 to 23-Mar-2021. After first booster patient experienced chills, fever, sore muscles and lack of energy from 02-Sep-2021 to 05-Sep-2021. Patient felt that these side effects are worse than having COVID-19. The patient did not experience a similar event in the past.  No treatment medications were reported.   This case was linked to MOD-2022-649286 (Patient Link).
2 days later developed severe milk allergy/lactose  intolerance. Never had issue before
pain at the injection site (can barely raise my arm, fever of 100.5, mild nausea, headache, muscle aches
After about 18 minutes (patient under observation for 30 minutes) the patient started to complain of itching on face, arms, and swelling feeling in mouth.  she also c/o shortness of breath.  On observation her oxygen saturation and blood pressure remained stable.  she was brought into the office from the waiting area and given 25 mg benadryl IM.  SHe was observed for 15 minutes and vitals were monitored and remained stable.  she subsequently continued to have itching in throat and around mouth and hives were noted on arms and neck.  her lips appeared starting to have edema.  She was given one dose of epipen 0.3mg im in thigh and 911 was called.  she was transported to er for further treatment and observation.  she reported to us several hours later that she remained stable and was discharged on prednisone, famotidine, and cetirizine.
Pt reported feeling ill after returning from lunch, visibly shaking, heart racing, sweating, feeling like something catching in her throat, numbness in fingertips and lips.  Placed in supine position with legs elevated,  administered Benedryl 25mg IM at 1359.  BP 148/96, HR 118, O2 sat 98%.  Dr. in room, checked mouth and throat - noticed redness but no swelling.  Used alcohol under nose, pt did not feel any better and was reporting that she felt like she was spinning.  @1416  BP 140/90 Blood glucose check, 116, HR 101., O2 sat 99%.  Pt observed and remained in supine position.  @1441, pt reported feeling better, BP 128/79, HR 88, skin warm and dry. Assisted to a standing position.  Reported spinning had stopped and was able to ambulate.  Pt sent home to rest with instructions to call if worsening or call EMS.
While pt was sitting in waiting area about 10 minutes after vaccine, pt's head dropped, she turned grayish, and became unresponsive. After several seconds, she lifted her head and responded to my questions and asked for cold water. I asked for someone to call 911 and an ambulance was dispatched. A technician brought her cold water. She sat for a few minutes, then expressed an urgent need to use the restroom. Her son took her to the restroom. I checked on her a moment later. She said she was doing ok. She came back to the waiting area to wait for the EMTs. The EMTs assessed her and advised her of their recommendations and her options. She was going to go home with her son as the driver. As the EMTs turned to leave, she dropped the open bottle of water, her head fell back and she became unresponsive for a short time. The EMT expressed that this looked like seizure activity. They loaded her on a gurney and headed for the emergency room.
BUMP ON THE SIDE OF LEFT EYE FILLED WITH PUS; This spontaneous report received from a patient concerned a male of unspecified age. 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: 1805020, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced bump on the side of left eye filled with pus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bump on the side of left eye filled with pus. This report was non-serious.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
high cholesterol; could not breathe well; did not feel well; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH, COVID-19, solution for injection, Lot number and expiration date: Not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated she received first dose. She wanted to know what will happen if she did not get second dose. She had high cholesterol. She could not breathe well and did not feel well with first dose. She was afraid to feel worse with second dose. The patient underwent lab tests and procedures which included blood cholesterol: high on an unspecified date. The clinical outcome of the events was unknown at the time of report.  No Follow-up attempts are needed. Information on lot/batch number cannot be obtained.
temperature of 101; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (temperature of 101) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (temperature of 101). At the time of the report, PYREXIA (temperature of 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2021, Body temperature: 101 (Inconclusive) temperature of 101. On 28-May-2021, Heart rate: 129 (High) rapid heart beat of 129.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
p/vax c/o SOB; T103 on & off x24hr; temp continued x3day on & off up to 101; no redness or swelling at inj site
Pt received vaccine at 3:14pm.  She started having a reaction at 3:27pm and flagged the nurse down.  She stated she was having a tachy cardia episode and hot flashes.  We gave her some water and she took off her beanie and the provider on site was asked to come over.  Provider came in and started asked her reaction question.  Pt denied any itching, SOB, chest pain/tightness and throat swelling/closing.  Pt did indicate her heart rate jumped on her fit bit, doctor asked for a set of vitals  180/100, 130 pulse and 97%.  At this point we took patient back into exam room. The patient was given Epi and Benadryl 3:34p 911 called  Vitals checked: 3:37 168/88, 132, 98% Pt was monitored until ambulance showed up.  Pt was transferred to MCR
severe myalgias, joint pain, bone pain, chills - lasting from hour 15 after vaccination till hour 45;   associated with severe fatigue . slept all day on 12/24.   took tylenol and ibuprofen every 4-5 hours.  80 % resolution of symptoms by hour 48.  complete  resolution of symptoms in 72 hours.
Information has been received from a physician concerning a 4 year old patient who on 29-JAN-2004 was vaccinated with a first 0.5 ml dose of Varivax (Merck). Subsequently the patient experienced breakthrough. The lesions had lasted approximately three weeks and the patient was still experiencing breakouts. It was unknown how many lesions the child experienced. At the time of the report the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested. Additional information has been received from the physician who reported that the patient had pityriasis lichenoides et varioliformis acuta(PLEVA) and not varicella. No further information is available.
body pain especially in back and knees; body pain especially in back and knees; body pain especially in back and knees; arm pain; chills; swelling and pain in breast and lymph nodes; swelling and pain in breast and lymph nodes; swelling and pain in breast and lymph nodes; swelling and pain in breast and lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 34-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (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 complete, Unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "arm pain"; PAIN (non-serious), BACK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset Nov2021, outcome "unknown" and all described as "body pain especially in back and knees"; CHILLS (non-serious) with onset Nov2021, outcome "unknown"; BREAST SWELLING (non-serious), BREAST PAIN (non-serious), LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset Nov2021, outcome "unknown" and all described as "swelling and pain in breast and lymph nodes". Relevant laboratory tests and procedures are available in the appropriate section. Description of Event: 34 year old female, heavy weight received booster abs experienced body pain especially in back and knees within first 24 hrs of shot, along with the arm pain and chills. Within 36hrs of shot, developed swelling and pain in breast and lymph nodes on same side where received shot  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a Registered Nurse concerning a female who on an unspecified date was vaccinated with GARDASIL and experienced arthritis and alopecia. It was unsure if it was the office patient or not. At the time of reporting the patient's outcome was unspecified. No further information is available.
Swelling in BOTH calves and ankles to double the size about 3 hours after injection. Swelling still persists 1 day after vaccination.
Vaccine administered to a 12 year old patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 12 year old patient) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 12 year old patient). On 05-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 12 year old patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided Patient had not experienced any symptoms
Lymph nodes seam swollen under the right arm; At the injection site it is red; At the injection site it is warm; At the injection site it is swollen; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes seam swollen under the right arm), VACCINATION SITE ERYTHEMA (At the injection site it is red), VACCINATION SITE WARMTH (At the injection site it is warm) and VACCINATION SITE SWELLING (At the injection site it is swollen) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 14-Jan-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes seam swollen under the right arm), VACCINATION SITE ERYTHEMA (At the injection site it is red), VACCINATION SITE WARMTH (At the injection site it is warm) and VACCINATION SITE SWELLING (At the injection site it is swollen). At the time of the report, LYMPHADENOPATHY (Lymph nodes seam swollen under the right arm), VACCINATION SITE ERYTHEMA (At the injection site it is red), VACCINATION SITE WARMTH (At the injection site it is warm) and VACCINATION SITE SWELLING (At the injection site it is swollen) 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. Concomitant medication was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a pharmacist refers to a 60 year old male patient. The patient's pertinent medical history and drug reactions/allergies were not reported. On 06-AUG-2014 the patient was vaccinated with a dose of expired ZOSTAVAX (dose and route not reported) lot# H019420 expiration date 23-APR-2014. No adverse effects reported at this time. Additional information has been requested.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from an other Health Care Professional (medical assistant) in the United States. This case involves 54 patients of an  unknown demographics who received an expired dose of vaccine FLUZONE HIGH DOSE which was passed the two day shipment time frame. The patient's past medical history and concomitant medications were not provided. On an unknown date (Date range would have been from August when shipment received to 10-Oct-2018), the patient received a 0.5 ml single dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, lot UJ0048AB via unknown route. It was a case of actual medication error due to incorrect product storage and expired vaccine used. It was reported that there had been approximately 54 people that have received the vaccine. According to the MA they received their vaccines back in August and they were unaware that they were not received within the two-day shipping limit. MA stated that the vaccines were shipped on a Thursday and they did not receive the vaccines until a Monday. MA stated that they have not gone through the records to which patients received the invalid dose at that time. No adverse event was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sore arm and fatigue for 1 day after 1st vaccine.  Exactly 1 week after 1st vaccine, I have a raised red bump at injection site and severe itching in area.
5 minutes after KINRIX & MMRV given, moc came out of room and stated "patient has a rash starting". When asked by R.N. where, moc lifted shirt. Small fine red rash on area of underpants waist, upper thighs, and 3-4 10 cent size red raised blotches on back. Sl. small area fine rash on arms. Dr. saw this. Pt. advised to wait 10 min & leave after staff d/c them.
Generalized papules, too numerous to count, scattered on face, trunk & extremities, appeared 10 days after vaccine administered. Papules stayed x 4 days except at injection site which stayed for 6 days.
five year old female patient received doses of Ipol,and Kinrix; This case was reported by a pharmacist via other manufacturer and described the occurrence of overdose in a 5-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and POLIOMYELITIS VACCINE (IPOL) for prophylaxis.   On 9th August 2021, the patient received Kinrix .5 ml, Kinrix Pre-Filled Syringe Device and IPOL .5 ml. On 9th August 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose 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 details were provided as follows: The patient received doses of Ipol and Kinrix (not produced by Sanofi Pasteur) vaccines via an unknown route at unknown administration site with no reported adverse event. Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. It was a case of actual medication error due to overdose (Ipol and Kinrix latency on same day). It was reported that the reporter asks what to do about the patient receiving a double dose of the polio vaccine and what side effects that a 5 year of age patient might expect. Unable to find this information in the standards or PI (prescription information). At the time of report, no adverse event was reported. There would be no information available on the Ipol and Kinrix vaccine batch number for this case.
Initial report received from a consumer, (patient) on 28 Jan 2010; The patient was vaccinated with FLUVIRIN (batch no: unknown), (unknown dose), intramuscular on 04 Jan 2010. On 04 Jan 2010 in evening the patient experienced head spinning, throwing up, lightness, nausea, dizziness and faintness. The patient received a shot for nausea on the next day which helped, but the other symptoms persisted. Outcome of the event was reported as condition unchanged.
Pfizer-BioNTech COVID-19 Vaccine EUA: Patient stated "About 5 minutes after I received the vaccine, I got up to use the bathroom. After I got out of the bathroom, I started having problems breathing. It felt like my throat was swelling shut. I felt like I couldn't breath." Patient stated she notified staff and on-site EMS "stayed with me for about 15-20 minutes" States after that, she left clinic site on her own. Stated she felt fine and went home without any breathing difficulty. States "I just called you today to report that it happened. States no more episodes of breathing difficulty or other side effects from vaccine.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Additional Details: he was fainted right after the shot. my tech called 911 and i stayed with him. after 1 minute he was responding but still needed medical attention. i waited with him until paramedics come.
pt reportedly screamed for 12 hr & exp swelling & redness @ the inj site;some time later pt was dx w/pervasive developmental disorder not otherwise specified;pt abn EEG & had problem w/development;slept 12 hr;dx hypogammaglobulinemia;