chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got bexsero dose 1 a year ago / never got the 2nd dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (received 1st dose on unknown date, 1 year prior to reporting).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Bexsero, which led to incomplete course of vaccination. The reporter asked if series needed to be restarted. The Vaers details for 1st dose was reported. The reporter consented to follow up.
Erythema and swelling at site, Dorsal portion of Left arm in subcutaneous area. 4 cm round.
Dose =3; Felt unwell.; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 40 year-old female patient (not pregnant) received COVID-19 Vaccine - Manufacturer Unknown, administration date 2021 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization; Moderna (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "Dose =3"; MALAISE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Felt unwell.". It was unknown if therapeutic measures were taken as a result of malaise. Additional information: The facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported as Unknown. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial unsolicited report received from a non-healthcare professional on 12 June 2015. A 37-year -old male patient, whose medical history was none and concomitant medications was not reported, had received a dose of ADACEL (batch number U5213BA and expiry:02-DEC-2017) via unspecified route and site of administration on 11 June 2015. No information about prior exposure to vaccine was provided. It was reported that, on 12 June 2015 (one day after vaccination), the patient experienced twitching of arm and reported twitching in arm occurs three times in a row in an hour and is happening once an hour. Laboratory investigations and corrective treatments were not reported. At the time of this report, the patient outcome from the event was not recovered. Documents held by sender: none.
Fever, violent vomiting (1x at 1030p), SOB, fatigue, rash on belly, vertigo, severe joint pain, serious muscle aches, chills. Sx began @730p & continued until 2p following day.
12 hours after Pediarix, HIB, Prevnar, had episode of prolonged crying, gagged then became limp and pale, unresponsive. Lasted 10 minutes; called 911. Taken to ER and observed overnight.  Nurse follow up on 11/12/04 states: "Gagging, choking, unresponsive."
PT. had ZNC-VZV vacc. in this office at 4 4 08.  Date of first vacc. 5/25/01.  Pt came in my office at 5/21 08 with HO 3 days itchy rash all over body more than 50.  No fever.
This spontaneous case was initially received on 10-Nov-2015. The case report was received from a Health Professional and concerns a female, pregnant patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on unknown dates, Batch no: not provided, Route of administration: intranasal, Dose: 0.5 ml. No additional drugs suspected. On an unknown date, a pregnant patient was administered AFLURIA intranasally. The patient was not experiencing an adverse reaction due to receiving the vaccine intranasally. For relevant test results see appropriate report section.
Pain in arm, feels like stabbing pain, pins and needles, stiff and hurts all the time five weeks later, I postponed the second shot
shivering; fatigue/ very tired; upset stomach; A Fib got worse after 2nd dose; Pain at injection site; very hard and rapid heart pounding; This case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation aggravated in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of atrial fibrillation (received 1st dose in 19th September 2022, on the right arm). Concurrent medical conditions included atrial fibrillation.   On 14th December 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 14th December 2022, less than a day after receiving Shingrix, the patient experienced shivering. In December 2022, the patient experienced atrial fibrillation aggravated (serious criteria GSK medically significant), injection site pain, heart pounding, fatigue and upset stomach. On an unknown date, the outcome of the atrial fibrillation aggravated, injection site pain, heart pounding, fatigue and upset stomach were unknown and the outcome of the shivering was recovered/resolved.   It was unknown if the reporter considered the atrial fibrillation aggravated, injection site pain, heart pounding, shivering, fatigue and upset stomach to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR188512   Additional Information: GSK Receipt Date: 15-DEC-2022 Reporter's Comments: The reporter that a patient with occasionally A Fib. The reporter stated that he had the 1st dose of Shingrix vaccine on 19th September 2022. The patient did not have symptoms at all with the 1st dose.  The patient had the 2nd dose 14th December 2022 at a pharmacy facility at 11 am.  The reporter reported that both vaccines were administered on the right arm.  The reporter reports that he had symptoms of A Fib before getting the 2nd dose but they got worse after the vaccine. At the end of the day the patient was very tired heart pounding very hard, upset stomach, fatigue, shivering, rapid heart pounding, pain at injection site. Not all information was available. Lot and expiration dates of both vaccines were unknown.  The reporter was consented to follow up.; Sender's Comments:  US-GSK-US2022AMR188512:same reporter - 1st dose case
At approx. 1050 pt reported dry mouth, nausea, and feeling need to puke. Pt given emesis bag. Pt dry heaved and reported not eating breakfast. Pt given water and stated she felt better after drinking water.  Pt reported no hx of reaction to prior vaccinations. Pt denied throat irritation, itchiness, and rashes. Vital signs assessed at approx. 1056. BP 110/70 mmHg, PR 75 bpm, spO2 99% RA.  Pt advised to wait 30 minutes for further observation. Vitals reassessed at approx. 1115. BP 120/80 mmHg, PR 75 bpm, spO2 99% RA. Pt reported no throat irritation and stated she felt fine. Pt advised to sign up on CDC V-safe. Pt left facility with steady gait and unlabored breathing at approx. 1120.
Swelling, warm sensation, red mark around injection site, headache, joint pain, muscle pain, congestion, itching of ears/neck, night sweats, severe headache, shaking and freezing/feeling cold.
Received a dose of the Moderna vaccine more than 30 days on the fridge.; Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Received a dose of the Moderna vaccine more than 30 days on the fridge.) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received a dose of the Moderna vaccine more than 30 days on the fridge.) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, PRODUCT STORAGE ERROR (Received a dose of the Moderna vaccine more than 30 days on the fridge.) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Follow-up received contains description of the event. Updated the event description in the I-narrative. Deleted previously captured  event Expired vaccine used.
loss of taste; his back throat hurts; felt there's a needle under his ear; This is a spontaneous report from a Pfizer Sponsored Program  Support. A contactable male consumer of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on 16Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. He reported that he never got a schedule for the second dose because his vaccination card was switched with a different card. On an unspecified date in Feb2021, the patient experienced loss of taste, his back throat hurts and felt there's a needle under his ear. The events accessed as a non serious. The outcome of the events were unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Vomiting; It was awful after the first vaccine too; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 54-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 01Jun2021 (at the age of 54-years-old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation.  Medical history included covid-19 prior to vaccination from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that It was awful after the first vaccine too, including a day of vomiting and being in bed on 23Jun2021. Patient did not receive any other vaccines within 4 weeks prior and other medications 2 weeks prior to the COVID vaccine. Since the vaccination, patient not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in 2021.  Information on the lot/batch number has been requested.
Shot received 2/19 Muscle felt firm 2-27 and 2-28 3/2 noticed slight pink space while showering 3/3 area is darker in color and larger; occasionally feels like it itches.
Parent was given link to 9/15/22 clinic, as that was appropriate date for the third and final vaccine in the series. She erroneously registered for the clinic for 9/9/22, and the vaccine was therefore administered one week earlier than recommended.
Came in on 5/14/08 to have injection site of left arm examined.  Is red, hot and complained of soreness area measures 3" x 1 1/2".
Chills, Nausea, Fever, Headache, Vomiting, Brain Fogg, Body Aches started around 1 am Friday morning.  Bright red, hot, swollen rash from elbow to shoulder.  Fever broke Saturday night.  Sunday feeling much better - no change in rash. Monday rash is not as hot/swollen - itchier and is spreading under/down arm.
Information has been received from a consumer her 24-month-old daughter with no allergies or medical history who on 12-Dec-2005 was vaccinated SC in the left thigh with a first dose of measles virus vaccine live (lot#647584/1146P). There was no concomitant medication. Illness at the time of vaccination with 12 to 10 lesions on her torso. The lesions were pink and were turning pale. The patient's mother called her daughter's physician. No diagnostic laboratory tests were performed. At the time of the report, the patient was recovering. A product quality complaint was not involved. Follow-up information was received from a physician's office which indicated that on 12-Dec-2005, the patient had a rash on her torso and groin. She subsequently recovered. The patient had no adverse events following prior vaccination. No further information is expected.
an altered sense of taste and smell for many foods; an altered sense of taste and smell for many foods; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 03Jan2022 as dose number unknown (booster), 0.3 ml single (Lot number: 33036BD) at the age of 63 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, 1st dose Pfizer COVID-19 Vaccine: , Route of Administration: Intramuscular , Batch/Lot number: ER8735), administration date: 30Mar2021, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, 2nd dose Pfizer COVID-19 Vaccine:, Route of Administration: Intramuscular , Lot number: ER8731), administration date: 20Apr2021, when the patient was 62-year-old, for COVID-19 Immunization; Flu shot (She got the flu shot but doesnt know if last year or year before but thinks 2021), administration date: 2021, when the patient was 62 years old, for immunization. The following information was reported: TASTE DISORDER (non-serious), PAROSMIA (non-serious) all with onset Jan2022, outcome "not recovered" and all described as "an altered sense of taste and smell for many foods".  Additional information: Patient took Over the counter vitamin supplements as concomitant.
Narrative:  Admission Date: Sep 9,2021 Discharge Date: Sep 17,2021 Admission diagnosis: acute hypoxic respiratory failure secondary to COVID Condition of patient at discharge: stable 83yo male with past medical history of HTN, hyperlipidemia, type 2 diabetes, CKD III, prostate cancer in surveillance, hypothyroidism, dementia who presented as transfer from another hospital with DKA and acute hypercapnic respiratory failure (AHRF) secondary to COVID on 9/9/2021. AHRF secondary to COVID pneumonia: Patient noted to be hypoxic at Emergency Room to low 80s. Septic on admission. O2 sats stable initially stable at 92% on 7L oxymizer, though increased to high flow nasal cannula. Patient is fully vaccination with Moderna COVID vaccine on 2/26/2021 and 3/23/2021. CXR with patchy bilateral infiltrates. CT c/w multifocal pneumonia and emphysema. Eventually weaned down to RA with 2L O2 on exertion. Home O2 ordered. Procal elevated at 1.5 on admission, completed CAP coverage (rocephin, azithro, Levaquin given renal fx) Completed remdesivir x5 days and given Tocilizumab on 9/10. Give dexamethasone 6mg daily 9/9 x10 days (end date 09/18). Albuterol inh 2 puffs q6h. Inflammatory markers downtrending at discharge.
The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 31-JUL-2014 was vaccinated with (Oka/Merck) PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and does schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a licensed practical nurse referring to a 1 year old male patient. No concurrent condition, medical history or concomitant therapy was provided. On 13-JAN-2016 at 15:46, the patient was subcutaneously vaccinated in the right thigh with the first dose of VARIVAX (Merck) (lot # L0252047, expiration date on 07-JUL-2017, dose unknown). No adverse effects were reported. All telephone attempts to obtain follow up information had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested.
after 15 minutes of observation headache, hot flash and vomiting  after 50 minutes now cold.
Pt received pneumo vaccine in (R) deltoid and returned next day w/ complaint of pain/stiffness in (R) arm.
The pt experienced hives, dizziness, hoarsness, felt like something was caught in throat, and fatigue.
she is experiencing sore arms; she can take medications like Aspirin/Advil for her shoulder injury; This is a spontaneous report from a Pfizer sponsored program . A contactable consumer (patient reported herself) reported that a female patient of an unspecified age received first dose of (Pfizer Covid-19 Vaccine, Formulation: Solution for injection) via an unspecified route of administration on 12Feb2021 at single dose for Covid-19 immunization. The patient's medical history included sinus (she took sinus pill in the morning before her first dose). Concomitant medications were not reported. Caller received her first dose yesterday 12Feb2021 stated she was experiencing sore arms, consulting if she could take medications like ASPIRIN/ADVIL for her shoulder injury and concerned if she could take medications that would not interfere with the vaccine and the sinus pill she took in the morning before her first dose. Outcome of the events was unknown.  Information about lot/batch number has been requested.
8 hours after receiving the injection on 1/14/21 I had (as expected) extreme soreness of the injection site and could not move my arm much or touch directly over the site.  This was mostly resolved within 48 hours.  72 hours after the injection I had a silver dollar sized area of redness, erythema and itching. This resolved over the course of the next two days.  I had daily headaches for around 7 days.   11 days after receiving  the injection I developed a large area of redness, erythema, itchiness and hives over the injection site (around 3 inches in diameter). I have not noticed any other systemic symptoms besides that.
patient said the day after her vaccination she got flu like symptoms, chills and night sweats. Those effects only lasted one day then she was fine.
Severe headache - after 2 PM, 10/11/15 - to present off and on. Severe faint feeling, severe dizziness - after 2 PM, 10/11/15 - to present - off and on daily. Severe nausea - after 2 PM, 10/11/15 - to present - off and on. Severe weakness - after 2 PM, 10/11/15. Palpitation - on and off, started 10/12/15 AM to present - slow to very slow off and on daily. Severe pains and tingling - feet, toes, limbs, ankle, legs, arms, hands, fingers, back, torso, lower bodice - to present - off and on, daily. Shaking and tremors - 2 days after - to present, off and on.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Apr-2021, Body temperature: 99.9 degrees fahrenheit (High) High.         No concomitant medication provided.    Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up received on 24-MAY-2021.TCR: email obtained
Called patient to follow up to see when they wanted to get 2nd series of shingrix vaccination. Patient says they remember me giving the shot and arm is still in pain for over 2 months. Patient said she will come in this week to get the 2nd shingrix vaccination.   I did not question about Signs and symptoms, patient seemed upset about the vaccination.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-AUG-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 suspension ten 0.5 ml single-dose vial (SDV) (lot # M005714, expiration date 03-OCT-2017, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 144 hours with the highest recorded temperature of 12 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Nausea, Vomiting, Diarrhea, Headaches, and Muscle aches. Vomiting lasted 3 to 4 hours, Nausea was 2 to 3 days, and headaches was 2 days.
Information has been received from a physician concerning a male in his "early 60s" who, on 05-JAN-2007 at 12:30PM, was vaccinated into the right arm with a dose of Pneumovax 23 (Lot# 651318/1006P).  Concomitant suspect vaccination on the same day at 12:40PM included a first dose of Varivax (Oka/Merck) (MSD), administered into the left arm.  Shortly after vaccination, at 5:00PM, the patient's arm (unspecified) became swollen, red and painful.  The physician instructed the patient to go to the emergency room.  It was also noted that the patient was not admitted to the hospital.  The patient may have had bronchitis at the time of vaccination.  The physician reported in follow up that the patient was treated with BENADRYL and TYLENOL.  The symptoms were reported to have lasted 4-5 days.  The physician reported that the patient recovered 5 days later (09-JAN-2007).  Additional information is not expected.
patient had 2nd vaccine on 2/26/21. she called the office on 3/1/21 and stated that she had hives/welts with extreme itching.   she states she had diarrhea and was nauseous. she was taking Benadryl and Caladryl lotion for the itchiness. she stated at that time she was feeling better as the day went on. she called back the office on 3/3/21 and stated that she still had the hives and itching and that the Benadryl helped. she also stated that she was not willing to leave the house to go out to the pharmacy for any meds that might have been prescribed.