chrisvoncsefalvay/vaers-outcomes huggingface dataset:
75-year-old woman who presented to the emergency room 2 days after vaccination with chest tightness, fatigue and was found to have pericardial effusion without tamponade.  It was noted that patient has had intermittent syncope since August of 2020 and clinical interpretation is likely that pericardial effusion pre dated vaccination.  In her workup for dizziness and syncope she had not previously undergone EKG, chest x-ray or echocardiogram therefore pericardial effusion could have been missed.  I elected to report the  pericardial effusion to be on the side of caution.
Incorrect monovalent Covid-19 formulation given to child. Covid-19 monovalent (5-11YR) formulation given to child age 4 YR.  Follow-up has been done and family report child has had no adverse reactions or side effects after vaccination.
This spontaneous report as received from a registered nurse refers to a 41 year old patient. On 26-NOV-2014 (also reported as today) the patient was vaccinated with PROQUAD (lot # K000710, expiration date 16-JUL-2015, 0.5 ml dose, subcutaneously in the left arm) rather than M-M-R II. The patient had not experienced any adverse effects. Additional information has been requested.
Left shoulder pain and loss of motion. Migrated to right shoulder. PCP diagnosed as Adhesive Capsulitis. Started physical therapy. No progress so referred to Orthopedic surgeon. On 6/30/21 had manipulation under anesthesia on both arms. Ongoing physical therapy as of 8/24/2021.
Beginning at about 4 pm I began to feel warm and like I could no longer lift my arm. By 6 pm I had a fever of 99.8 and an extreme headache. My body was also becoming increasingly painful with the pain radiating from my injection arm through my chest, arms, and down to my legs. At 8 pm I took 1 aspirin after continuing to have my previous symptoms get worse and now also throwing up. By 3 am, my fever was at 102, breathing was difficult and I no longer could swallow.   After taking 800mg Motrin every 8 hours. My fever finally broke on the 21st at 2 am. Symptoms slowly started to improve after the fever broke. As of October 22nd, my body is still in immense pain and I can not lift my injection arm.
No additional AE reported; Customer called for a temperature excursion and reported PROQUAD that had undergone temperature excursion was administered to patients before calling. No additional AE reported. No PQC reported. No patient demographics was provided. No further i; This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patients were vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number W019628, expiration date 19-DEC-2023 (dose and route of administration) for prophylaxis (product storage error). No adverse event was reported.  No information about the temperature excursion was provided.  Follow up information has been received on 10-MAR-2023.  Varicella virus vaccine live (Oka/Merck) (VARIVAX) (Lot numberW018828 expiration date 14-JUN-2024), and Lot number W006412 expiration date 23-FEB-2024) (dose and route of administration) for prophylaxis (product storage error), and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number W019627, expiration date 19-DEC-2023) (product storage error).    This is a non-valid case due to the lack of patient identifiers.  Follow up information has been received from an other healthcare professional on 18-APR-2023. The reporter specified the patient's information. Therefore, this valid case was split from original case 2303USA002114. This spontaneous report was regarding a 4-year-old female patient. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported. On 09-JAN-2023, the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) (lot number W019628, expiration date 19-DEC-2023) underwent temperature excursion for 30 minutes from 22:30 to 23:30. The digital data logger was involved in recording excursion details. On 10-JAN-2023, the patient was vaccinated with the improperly stored vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) (lot number W019628, expiration date 19-DEC-2023, strength and dose were not reported) intramuscularly (IM) at right thigh for prophylaxis at private doctor's office/hospital.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA002114: US-009507513-2304USA007837:MSD US-009507513-2304USA007931:
mom states on 5MAY92 pt recvd vax & started w/fever that MP; cont w/fever & on 7MAY92 fever to 104-unable to dec temp w/APAP & sponge bath; took pt to ER; ER could not find any others problem w/pt poss rxn to DTP;
I went shopping 7-8 hours after receiving my Pfizer booster shot, and when I went to leave the store, I started to not feel well, and then I got tunnel vision. I had my boyfriend pull the car around to the front of the store, and went I got into the car, everything went black, and I couldn?t hear anything. After I got home, every time I stood up I got the same lightheaded feeling.
Vaccine at age 17; Invalid dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine at age 17) and INCORRECT DOSE ADMINISTERED (Invalid dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01120A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine at age 17) and INCORRECT DOSE ADMINISTERED (Invalid dose). On 16-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine at age 17) and INCORRECT DOSE ADMINISTERED (Invalid dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.  This report refers to a case of product administered to patient of inappropriate age 17-year-old  and incorrect dose administered for mRNA-1273 (lot number unknown) with no associated AEs reported.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Follow-up information received on 31-MAR-2021. Updated event - Vaccine at 17 years.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age 17-year-old  and incorrect dose administered for mRNA-1273 (lot number unknown) with no associated AEs reported.
6/9 - received vaccine. 6/13 - pain (L) back/breast/upper arm. 6/17 - doctor appt. 6/19 - rash started on (L) breast. 6/23 - rash started on (L) upper back. 7/7/11 - rash healing - pain resolved - still sensitive.
6/10/08 Headache, sore throat, fever, fatigue, vomiting.
Covid Arm on day 2-4,  just below injection site.  Urinary issues... similar to UTI (urgency at first then not wanting to go, just pain) but not the same pain feeling for 4+ days.  Feverish and bad headache on day 5.
I spiked a 104 fever and violent shaking. That made my muscles tense up so badly I had trouble breathing. I also had the worst headache I?ve ever experienced along with nausea and vomiting. The worst part was my bones all felt like someone was trying to crush them all at one time. The pain had me on the floor unable to move and I couldn?t rest.
syncopal episode after 2nd shot approx about 1 minute after shot - tonic/clonic movements approx 2 minutes. stopped on their own
Intermittent headache especially at right temple, shivering including torso/teeth/hands/arms, body feeling very cold (especially hands and feet) despite multiple layers of clothing and blankets, body temperature at 10:00pm was 97.3 (low for me). Feeling a bit cold began about 5:00pm and continued/worsened for about 6 hours when I fell asleep; was most significant with shaking for about 1 hour+ from 10-11:00pm. I fell asleep with someone closely monitoring me. I woke at 2:30am and removed a second pair of pajamas and socks, and a pair of socks I wore on my hands.  Started feeling better.  Stayed in bed much of the following day.  Feel well now.
antibiotic taken at time of ssecond shot; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (antibiotic taken at time of ssecond shot) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (antibiotic taken at time of ssecond shot). At the time of the report, ADVERSE EVENT (antibiotic taken at time of ssecond shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided.
I contracted COVID about a month after the vaccine. The symptoms were mild, I did not have a temperature. I did have strong fatigue, congestion and a cough. The doctor gave me PAXLOVID where I felt immediate improvement for about a week, but the cough and the congestion felt consistent. I went back to the doctor and was diagnosed with a respiratory infection. I was given antibiotics and everything cleared up in about a week.
client received 1st Moderna COVID-19 Vaccine. Client was leaving observation room after fifteen mins when he informed RN he was feeling dizzy. RN had client sit down and began taking vitals. 15:52 vitals: blood pressure 142/84; pulse 64; oxygen 98%. Per client had only an orange all day and no water. RN gave client water. Client informed he would stay an additional 30 mins for observation, client agreed. PHN  arrived, client sitting in chair, alert and oriented. Per client no relevant medical history, no medications and no history of allergies. Per client does not follow up with provider and unsure if he has history of high blood pressure. 1557 vitals: blood pressure 138/96, pulse 73, oxygen 98%. Per client starting to feel better. 1602 vitals: blood pressure 141/88. pulse 74, oxygen 98%. Client denied chest pain, shortness of breath, blurry vision, or headache. Client aware blood pressure high. Vitals: blood pressure 146/85, pulse 62, oxygen 98%. Per client headache, pain 1/10. PHN advised to get primary doctor to follow up on high blood pressure. ER precautions also given. Vitals at 1624: blood pressure 143/78, pulse 63, oxygen 98%. No complaints. Last vitals at 1637: blood pressure 139/77, pulse 64. Client left facility with steady gait at 1640.
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of 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. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.
she got COVID; she got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 86-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in arm and as dose 4 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in arm and as dose 2, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she got COVID". The patient underwent the following laboratory tests and procedures: Full blood count: Unknown results; SARS-CoV-2 test: Positive; Positive. Clinical course: It was reported that the patient has had both vaccinations shot and then each of the booster shot she had a breakthrough case about a month ago. The patient takes a lot of medications. It was also reported that the patient experienced cold symptoms. The reporter (patient's child) will have to look at the list. Not at this time, the reporter has to look at that. For the lab tests, it was reported that yes, they run all kinds of test and the patient just got diagnosed with cancer not that long ago and then she got COVID. There was about 20 different tests she has been going through. You just want blood test or, because they did like a complete CBC they did all kind of thing because they were getting ready to treat her for cancer.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300155487 same patient/drug, different drug dose/event;US-PFIZER INC-202300155299 same patient/drug/event, different drug dose;
Had the shot, now have shingles/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 12th December 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had the shingles shot and now he/she had shingles. The reporter had friend who suffered from shingles.  The pain they described sounded unbearable.  They had to put their lives on hold because of this painful, blistering rash caused by shingles, and she wanted to make sure that, never happened to her.  The patient educated herself about the risks and what she could do for prevention. The people 50 years or older are at risk for shingles. The reporter thought that, the event might had been related to the drug. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. This case has been linked to the case US2022AMR155249, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR155249: Additional safety information
This case was reported by a health professional on 05 September 2007.  An 11-year-old female patient, with a history of ADHD (attention deficit / hyperactivity disorder) and acne, received an intramuscular deltoid injection of Menactra (lot number U2386BA) on 21 August 2007.  Concomitant medications included Adderall XR and Duac Gel.  On 31 August 2007, ten days post-vaccination, the patient experienced "open sores in several areas".  She was seen by her physician on 04 September 2007, at which time the rash was noted to be on the stomach and legs.  Herpes C/S was negative, and the patient was referred to a dermatologist for follow-up.  At the time of the report, the event was resolving.  Follow-up information received from a health care provider on 23 October 2007.  On 20 July 2007, the patient received deltoid injection of Boostrix, lot number AC52B018AB, manufactured by GSK.  It was determined by the dermatologist that the open sores and rash experienced by the patient were not adverse reactions to Menactra.  The patient was evaluated by her physician on 31 August 2007.  Physical examination revealed open sores in several areas.  They were nickel sized areas of redness with vesiculation and some clear fluid in it with no induration.  The patient also complained of left knee pain when she twitched it medially.  Ceftin 250 was prescribed and the open sores cultured.  The patient returned to see the physician on 04 September 2007.  Physical examination determined that the open sores did get better over the weekend but not a whole lot better.  The patient had five to six open sores remaining, scattered around.  She also had a little maculopapular mildly vesicular rash on the side of her abdomen and the inside of her legs.  The physician noted the dermatitis was puzzling.  Impression: believed it may be an Ecthyma kind of illness but it had gotten a lot better on the Ceftin.  The patient was referred to a dermatologist for follow-up.  The patient was evaluated by the dermatologist on 10 September 2007, Lidex had been prescribed for contact dermatitis secondary to impetigo.  Office visit notes dated 20 September 2007 indicated, "Previous treatment: BX - Bite reaction, Lidex; improved.  The patient was reported as recovered from the event and no further information was provided.  Documents held by sender: Doctors notes.
Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 21 Feb 2022; Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 21 Feb 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 21 Feb 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 21 Feb 2022) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022 at 2:19 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Feb-2022 at 2:19 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 21 Feb 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 21 Feb 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 21 Feb 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 21 Feb 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.    Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021, this vaccine was administered up until its manufacturing expiry date of 4 April 2022.  No treatment medication was reported by reporter.   This case was linked to MOD-2022-542869.
Area around vaccine is warm, hard, and red. Area is about 3 inches wide all around. Chills and not feeling right as well.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The agency consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The agency is working with the public health dept on a compliance improvement plan and has been reinstated vaccination privileges.
Initial report received from a nurse on 14 March 2007. A 5 year old, female patient (with a medical history of no known allergies; asthma and eczema) who was bitten by a dog, developed a fever of 102F and complained of nausea vomiting and soreness at the injection site after she received IMOVAX (lot number Z0905-1) intramuscularly in the right deltoid and IMOGAM (lot number, route and site of administration not reported) on 13 March 2007. There was no local reaction noted. She denied any illness at the time of vaccinations and not on any medications. The patient was treated with Motrin and at the time of the report, she had not recovered. Follow-up information received on 06 June 2007 from a health care professional. The patient had fully recovered and had received "all vaccines of the series without complication." Follow-up information received on 06 September 2007 from a health care professional. The patient made a full recovery and experienced no further adverse events.
low grade fever, sore throat, chills, leg aches, minor headache,  moderate arm pain (injection arm).
Information has been received from a health professional concerning a patient (age and gender unknown) with diabetes who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included "Other vaccines within the same visit". Subsequently the patient experienced elevated blood sugars. Unspecified medical attention was sought. No product quality complaint. Follow-up information received from the registered nurse indicating that the patient is a 12 year old Asian female with Type II Diabetes Mellitus. The mother reported that blood sugars were more out of control than normal approximately 1 week (15-Nov-2007) after receiving the following immunizations: On 09-NOV-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 658964/1466U) subcutaneously in the left arm and diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL) (lot# AC5280210B) intramuscularly in the right arm. On 06-Nov-2007, the patient received meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (lot# U2540AA) intramuscularly in the right arm, influenza virus whole virion 3v vaccine inactivated (FLUZONE (influenza virus whole virion 3v vaccine inactivated)(lot# U2448AA) intramuscularly in the left arm and tuberculin purified protein derivative (TUBERSOL) (lot# C2805AA) intradermally. She wondered if there was a correlation. No illness at the time of vaccination. The patient recovered on an unknown date. No further information is expected.
My arm was sore and the rash started. It has been present since 01/07/2021 and it is not going away. The only thing different is the vaccine.  I've had IV antibiotics twice that seems to help so that it's not quiet as bad. It has never gone away.