chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Drug ineffective; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 30-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 30 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for influenza immunisation as dose number unknown, single (seqirus). The following information was reported: COVID-19 (medically significant) with onset 13Mar2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 13Mar2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Mar2023) Positive, notes: Nasal Swab. Clinical course: Patient received vaccine at Workplace clinic. Viral sx cough rhinorrhea HA body aches mild 13Mar2023.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccine cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.
On January 18, 2021, vaccine administration site started to itch, then by the next day, there was urticaria throughout the entire body. Patient took benadryl, with little effect. Went to outpatient clinic, was given cetirizine with better results.
Incomplete dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Incomplete dose administered) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Incomplete dose administered). At the time of the report, INCORRECT DOSE ADMINISTERED (Incomplete dose administered) 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.
Patient received an expired dose of the Tenivac single-dose vial today (15 May 2020), as a booster dose/No adverse event; Initial information received on 15-May-2020 regarding an unsolicited valid non-serious case received an other health professional.  This case involves a 49 years old male patient who was administered an expired dose of vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  Medical history, medical treatment, vaccination and family history were not provided. No concomitant medication was given to the patient.   On 15-May-2020, the patient received a booster dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U5854AB) (Expiry date: 25 January 2020) via unknown route at an unknown administration site for immunization.  It was a case of an actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  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
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 31-JUL-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 1200 hours with lowest recorded temperature of 20 Fahrenheit degree. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Administered COVID  vaccine to patient on the  left arm, vaccine was expired on 07/11/22.  Patient waited in office for 20 minutes, no adverse reaction noted. Provider informed parent of expired vaccine and advised parent to call our office if patient has a reaction. mom understood.
diarrhea; cough; vomiting; generalized tiredness; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), COUGH (cough), VOMITING (vomiting) and FATIGUE (generalized tiredness) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21AA) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced DIARRHOEA (diarrhea), COUGH (cough), VOMITING (vomiting) and FATIGUE (generalized tiredness). At the time of the report, DIARRHOEA (diarrhea), COUGH (cough), VOMITING (vomiting) and FATIGUE (generalized tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment medication was reported.
Intense tooth nerve pain on the left side. Intense headache on the left side. Fatigue, tingling on left and right arms
patient reports numbness, pain, and tingling in arm; as well as Nausea and headache.  Nausea and headache lasted 2 days, pain in arm persists.
83-year-old pt with to ED with progressive shortness of breath for the past week 2/8, and was in atrial fibrillation with rapid ventricular response, hypoxic. COVID positive 2/8. 2/10 pt still sob, weak and fatigued. 2/12 pt alert and oriented x 4 denies any cp or sob. No bleeding or hematoma at R groin area. Pt deniesd any distress, medicated for pain as ordered, iv is patent. 2/13 Pt is cold to touch, and it is difficult to get a temperature, increased weakness. 2/14 pt brought to the ICU requiring intubation. Order for propofol started, pt hemodynamically stable, placed on ventilator. 2/15 pt remains on vent, with acute cardiac issues, off pressors. 2/18 pt on minimal sedation, heparin infusing. Pt is aox3-4, on 2L 02NC not in acute distress, with occassional productive cough noted. 2/26 patient is a&o x4, vital signs stable. Patient on O2 via nasal cannula at 4l,spo2 at 97% with no acute distress noted. Pt discharged 2/28.
Have missed 2 doses of the rabies series / been about a week since first dose; This case was reported by a other health professional via other manufacturer and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Rabies NVS (RabAvert) for prophylaxis.  Concurrent medical conditions included animal bite. Concomitant products included Rabies NVS (RabAvert).   On an unknown date, the patient received the 2nd dose of RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable. There were 2- 3 patients who have missed 2 doses of the rabies series. The reporter believed it was up to 3 patients. The patient came into the Emergency Room after being bitten by an animal and received the first dose of the vaccine series.  It has been about a week since the first dose, which led to incomplete course of vaccination. The pharmacist states this was a general question from an emergency room nurse to see what they need to do to complete this series.   On the follow up following internal review it was determined that the initial receipt date (26th August 2020) which is earliar than initially reported.
I got a headache 30 (around 2:45) minutes after the shot. I laid down when I got home and took an hour nap. Follow the nap, the headache was gone. My left arm in the spot of the injection was sore for the next couple of days.
Patient still don't feel great, was sick all night and was sicker, almost think patient was sicker than when patient had Covid; patient still very very nauseous; patient still had a headache and still had a lot of nausea; patient was like incapacitated; patient felt better patient felt awful, patient felt physically awful, that didn't made patient felt any better; This is a spontaneous report from a contactable consumer (the patient, reported for self). An unspecified age and gender patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date were not reported), via unspecified route of administration, on 02Apr2021, as single dose, for COVID-19 immunization. The patient's medical history included I had Covid back in December on an unspecified date in Dec2020 and mononuclear infusion. Concomitant medications were not reported. Patient still don't feel great, was sick all night and was sicker, almost think patient was sicker than when patient had Covid, patient still very nauseous, patient still had a headache and still had a lot of nausea, patient was like incapacitated, that doesn't made patient felt better patient felt awful, patient felt physically awful, that didn't made patient felt any better and all were on an unknown date on an unspecified date in 2021. Patient stated that I got the Pfizer vaccine yesterday (02Apr2021) and I do have a couple of questions I am an intern I did call my doctor on another phone but I just wanted to know because I had Covid back in December and also had Mononuclear infusion so I waited for 90 days to get my Pfizer but I would I still don't feel great I was sick all night, I was sicker I almost think I was sicker than when I had Covid and I am still very nauseous, I mean I don't have any respiratory I don't have anything I need to go an ER for but I still had a headache and I still have a lot of nausea. Patient stated, I don't need to say you one more you are sorry because that doesn't make me feel better I feel awful, I feel physically awful, that doesn't make me feel any better. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a physician assistant concerning a patient who on 08-JAN-2008 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) by accident instead of zoster vaccine live (Oka/Merck) due to computer error. The patient was not experiencing any known symptoms. No further information was available. There was no product quality complaint. Additional information has been requested.
Skin rash on upper arm near injection wrapping around the arm ; raised skin, hot, itchy, arm ache 13 days after vaccine
Head ache equal to a migraine in severity Jittery  woke up feeling as though I had too much caffeine  or when I am nervous.  Settled down by 1pm today Tightness in chest and lungs feels as if I've taken a deep breath on a really cold day. Been there since I woke this morning.  Breathing is not hampered at all and remains normal. Very tired, feels like I could sleep all day.  Tried to do normal activity and became tired quickly.  Have been resting at home all day.  No plans to leave house. Joint and muscle aches throughout the day.
20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; 20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; receiving doses from vials affected by a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range), PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion) in a 39-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 049l21a and 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-May-2022 at 10:30 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Jun-2022 at 11:56 AM, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2022 at 11:56 AM,  after starting mRNA-1273 (Spikevax), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range). At the time of the report, PRODUCT STORAGE ERROR (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range), PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range. Patient received 2 full doses. It was reported that no adverse event occurred at time of administration or were reported thereafter. Treatment medications were not reported.
Sore at injection sight (mild)  next day.     Nothing noticeable until 24 Apr 21   Pounding headache, fatigue, sleepy long periods , mild sore throat, blood pressure lower than usual .  Temperature  with in normal limits .      I have been resting a lot , waiting for  conditions to improve, however,  as of this writing nothing has changed.  Thus I decided to file this report.  my  I have not seen my healthcare provider yet but will make contact tomorrow
Headache, Myalgia, Nausea Vomiting,  fatigue, chills, nausea without vomitting  Narrative:
Given tdap and menactra in the left then HPV in the Right arm 1:15pm pale, shaking and passed out. 1:25pm vomited. 1:29 BP 93/57. Mother states he had not eaten anything but 1 doughnut and some chips. 1:50 Feeling 'fine'-left to go eat lunch.
Had a patchy scattered psoriasiform eruption starting 50 hr & after GARDASIL vaccination 7/20/2012. Reportedly largely faded 8/14/12.
On 3/27/09 Mom reports to IM clinic at 2nd shot visit, that patient developed projectile vomiting & abd. pain about 24 hours after his 1st set of shots.  Several MD office visits were done & patient referred to surgeon.  3 visits made to surgeon & on 12/3/08 exploratory surgery was done & was negative.  Both Mom and MD report no intusseption.  As noted by nutritionist Mom reports change in bowel habits after switching from exclusive breast feeding after 7 weeks to bottle (from several stools a day to once per day with straining).   Mom reports the child developed what appeared to be a hernia on his penis after straining.  She says the doctor was watching this possible condition.  Mom was putting a drop of Karo syrup in patient's Formula. The nutritionist charted that Mom didn't want to stop the Karo and planned to ask physician about other ways to deal with constipation. 4/10/09-records received for DOS 12/10/08-laparoscopy no inguinal hernia, colon normal.  Presented with history of growing mass visualized by caregivers. Admitted with abdominal pain and large right groin swelling screaming episodes.
This is a spontaneous report from a contactable physician through Pfizer Vaccine Representative. This physician reported for a 8 year old (unknown gender) patient who received a dose of PREVNAR 13 on unknown date. Relevant medical history and concomitant medication were unknown. It was reported that on an unknown date the patient had streptococcus pneumonia and meningitis. Therapeutic measures taken, if any, were unknown. The patient had not recovered from the reported events and passed away on an unknown date in Feb2013 due to streptococcus pneumonia and meningitis. At the time of reporting, it was unknown if autopsy was performed.
Sinus infection, bilateral ear infections, vertigo, dizziness, nausea, heart palpitations
Local skin vaccine reaction, delayed. 4 cm x 5 cm. Started day 8 after vaccination and worsened on day 10.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Hypertension-Medium, Systemic: Shakiness-Medium
1st shot 1/13/21, 2nd shot 2/3/21 0830 am 1st dose pfizer # EK 9231, 2nd dose pfizer# EL8982  shivers, heart pounding, bp 153/86 elevated for her, congestion
This case was reported by a healthcare professional and described the occurrence of injection site pruritis in a 68-year-old female subject who was vaccinated with FLULAVAL. On 13 October 2008, the subject received unspecified dose of FLULAVAL (.5ml, unknown, left arm). On 13 October 2008, within minutes of vaccination with FLULAVAL, the subject experienced injection site pruritis and injection site redness; 30 minutes later, she experienced a lump at injection site and injection site pain. The subject was treated with BENADRYL and antibiotics for five days. The subject has not reported any further problems. At the time of reporting the outcome of the events were unspecified. Follow-up information was received on 24 November 2008, via healthcare professional. No new information was provided.
However about 16 hours after my booster I also had chest pain and heart palpitations, which I have never had from a vaccine before; However about 16 hours after my booster I also had chest pain and heart palpitations, which I have never had from a vaccine before; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jan2022 10:30 (Lot number: FL3209) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "IBS" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE; FLUOXETINE. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer/ Biontech, prev dose brand unknown: False, prev dose lot number: FE3380, prev dose lot unknown: False, prev dose administration date: 11Aug2021, prev dose administration time: 02:00 PM , prev dose dose number: 2, prev dose vaccine location: Left arm), administration date: 11Aug2021, when the patient was 28 years old, for covid 19 immunization, reaction(s): "For the first two doses I had a sore arm, which I expected"; Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer/Biontech, prev dose brand unknown: False, prev dose lot number: FA1027, prev dose lot unknown: False, prev dose administration date: 16Jun2021, prev dose administration time: 08:45 AM , prev dose dose number: 1, prev dose vaccine location: Left arm), administration date: 16Jun2021, when the patient was 28 years old, for covid 19 immunization, reaction(s): "For the first two doses I had a sore arm, which I expected". The following information was reported: PALPITATIONS (non-serious), CHEST PAIN (non-serious) all with onset 09Jan2022 02:00, outcome "recovered" and all described as "However about 16 hours after my booster I also had chest pain and heart palpitations, which I have never had from a vaccine before". Therapeutic measures were not taken as a result of palpitations, chest pain. There were no other vaccine in four weeks. There was no covid prior vaccination. Covid was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
No other AE reported; a temperature excursion involving PNEUMOVAX23; This spontaneous report as received from a "HBP" refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 22-DEC-2020, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, lot # T007790, expiration date: 03-DEC-2021 (anatomical location and route of administration were not reported), for prophylaxis.  Administered dose of vaccine underwent the temperature excursion of 31.2 degrees Fahrenheit for 30 minutes. Digital data logger was involved. There were no previous excursions reported. No adverse event was reported.   This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007790; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2101USA010281: US-009507513-2101USA010448:
Coughing about 15 minutes after vaccine, eacalated  to asthma exacerbation; given benadryl, used albuterol 2 puffs, no response.  Taken to ED and given 2 duo-nebs, 40 mg prednisone, chest xray. Dischargedbhome
Pain in left arm for 4 days; fatigue; flu-like symptoms; rash with warmth in area.
At approximately 2:50 pm, two minutes after receiving vaccination, patient complaining of heart racing and feeling lightheaded. HR 88, oxygen 97%-100% on room air,  BP123/84. Denies SOB or chest pain. Given glass of water, symptoms improving at 3:10 pm. Monitored in room for 30 minutes and discharged to home at 3:20 pm. Symptoms much improved.