chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine given approximately 4pm, Friday April 30th.  Insomnia (cannot sleep at all during the night). Approximately 5am, begin to feel aches and malaise.  Approximately 6am, aware of faster heartbeat and anxiety. Begin to feel dizzy and sit up in bed. Nausea begins. 6:10am vomit. Feel better after vomiting though achey, weak, shakey. Further dizzy spells throughout the next 6-8 hours, every time I get out of bed, but no further vomiting. At 10:55am, blood pressure is 86/58 with pulse at 94.  Headache throughout the day.  Abnormal fatigue lasts approximately 72 hours. Left arm is, of course, very sore at site of injection for approximately 36 hours.  Treatment: rest and hydration (Gatorade & water). Ice at injection site for sore arm.  Outcome: full recovery within 72 hours.
This spontaneous report as received from a Licensed Practical Nurse refers to a 71 years old male patient. The patient was vaccinated intramuscularly on right deltoid with 0.5 ml expired PNEUMOVAX 23 (lot # 667269/113Z, expiration date 10-DEC-2011) on 20-JUL-2012. No adverse effects reported at the time of the report. It was unspecified whether the patient had sought medical attention. Additional information has been requested.
administered a dose of Shingrix one month too early.; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date).   On 25th October 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 25th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The medical assistant administered dose of Shingrix to a patient one month too earlier than the recommended interval, which led to shortening of vaccination schedule. Number for GSK Medical Information given for future reference and warm transfer provided.  The reporter did not consent to follow-up.
This spontaneous report as received from a pharmacy technician (also reported as "pharmacist") refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-FEB-2019, the patient was vaccinated with one expired dose of M-M-R II (rHA) injection, lot # R002930, expiration date 31-JAN-2019 (dose, route of administration and vaccination site were not reported) for prophylaxis. There was no adverse event reported. Product quality complaint was not involved.
Pt presented to the ED on 07/19/21 with complaints of nausea, vomiting, sore throat, and generalized weakness. Pt was found to be COVID positive that same day. Pt has been fully vaccinated.
Pt came in stating she received her pneumonia vaccine yesterday and stated that she was told by the pharmacist that the swelling would only last 24 hours (she stopped by the pharmacy today at 6:30pm and she received her vaccine around 5:45pm yesterday) however the swelling has lasted longer than 24 hours and she is feeling feverish. I examined her arm and there was slight erythema and swelling that went from the area of injection to close to her elbow. I asked her she had any pain and she said she her arm was really sore. I asked her if she had taken anything for the pain or if she had iced the area since the time she had received the immunization... She stated she had not... she said she took some tylenol 650mg as she regularly does. I asked her if there were any contraindications to taking ibuprofen and she stated she had no contraindications.. She stated that she received a pneumonia vaccine a few years ago and she had no reaction to that vaccine.. I determined that it was the prevnar she received in the past.
BODY ACHES; LOST APPETITE; SWEATS; HARD TIME SLEEPING; UP/DOWN ALL NIGHT; CHILLS; FEELING OK, JUST A LITTLE TIRED; ARM WAS BURNING AFTER INJECTION; LOW GRADE TEMPERATURE; NAUSEA; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 230 pounds, and height was 68 inches. The patient's past medical history included covid-19 positive, and concurrent conditions included diabetes mellitus, hypothyroidism, latex sensitivity, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021;14:00-15:00 on Right Arm. for prophylactic vaccination . No concomitant medications were reported. On 04-APR-2020, Laboratory data included: COVID-19 virus test positive (NR: not provided) POSITIVE. On 06-MAR-2021, the subject experienced body aches. On 06-MAR-2021, the subject experienced lost appetite. On 06-MAR-2021, the subject experienced sweats. On 06-MAR-2021, the subject experienced hard time sleeping. On 06-MAR-2021, the subject experienced up/down all night. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced feeling ok, just a little tired. On 06-MAR-2021, the subject experienced arm was burning after injection. On 06-MAR-2021, the subject experienced low grade temperature. On 06-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 98-99 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sweats, chills, low grade temperature, and nausea on 08-MAR-2021, lost appetite on 07-MAR-2021, feeling ok, just a little tired on 09-MAR-2021, and arm was burning after injection on 06-MAR-2021, and the outcome of hard time sleeping and up/down all night was not reported. This report was non-serious.
- Fever of 103 degrees - diarrhea - loss of appetite - severe stomach pain - weight loss - weak/pale - lasted over 7 days. Hospital stay was 3 days, treated with IV. and meds.  7/22/09 Hospital records received to 5/18/19 - 5/19/09 Assessment: Gastroenteritis, likely rotavirus. Patient presented with fever and diarrhea. Drinking has decreased. Pale.  ICD-9 Codes: "6589 Noninfectious gastroenteritis and colitis".
This case was reported by a male consumer aged between 60 and 69 years old regarding himself. Concurrent medical conditions included acid reflux, allergy to animals and allergy to citrus, dairy allergy, iodine allergy, osteoporosis (October 2010), peanut allergy, shellfish allergy and walnut allergy. On 24-SEP-2010 the patient was vaccinated with PCV (manufacturer unknown) (dose, route, lot# not reported). Other suspect therapies included ADVAIR multi dose powder inhaler for lung congestion and influenza virus vaccine (unspecified). It was reported that the physician or other health care professional has not verified this report. Concomitant medications included Metformin, Vitamin D (manufacturer unknown), Multivitamins (manufacturer unknown) and NEXIUM. It was reported that within months of vaccination with Influenza vaccine unspecified and PNEUMOVAX23, the patient reported that I got serum sickness when I received PCV (manufacturer unknown) and Flu shot that was given 24-SEP-2010. The patient states he still suffering and seeing doctor. On 15-NOV-2013 the patient started ADVAIR (inhaled) 500/50, prescribed to be taken 1 puff, twice daily for lung congestion secondary to serum sickness. He was concerned about taking a steroid medication so he reduced his dose to ADVAIR 250/50 on 24-NOV-2013 and would taken the medication on an as needed basis. He would take the product one puff at night before bedtime when he would feel a buildup in his chest of phlegm and he would start to cough. The ADVAIR product allowed him to sleep [not sleeping well] and he was pleased with the medication. In late December 2013, the patient experienced diabetes and borderline diabetes. The patient "was diagnosed with diabetes in late December 2013 but also stated that his doctor said he was right on the edge of having diabetes. Two weeks prior to this report (approximately 23 December 2013,), he received a blood test and his blood sugar numbers increased to 5.8 (units not provided) during treatment with ADVAIR diskus. At the time of reporting the outcome of the not sleeping well resolved. The outcome of diabetes, borderline diabetes and increased blood sugar were unresolved. The outcome of serum sickness, lung congestion and mucus increased in chest and coughs were unspecified. Additional information has been requested.
after the shot, pt said she felt very hot, her face was bright red and not very responsive. Checked her blood pressure, laid her down on the floor, elevated her legs and she felt better. Pt left with her mom
Baby broke out with hives after 5 minutes following vaccinations, resolved after 20 minutes. (hives, head to toe)
following the initial moderna dose, my chronic urticaria restarted after it had been quiescent for several years.  following each additional dose, the urticaria became worse.
pt recv vax;had fever of 103 x 72 hr despite antiseptics;had limpness & high pitched crying for 24 - 48 hr p/ vax;
patient received Boostrix subcutaneously; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix (subcutaneous). On an unknown date, unknown after receiving Boostrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient received Boostrix subcutaneously which led to intramuscular formulation administered by other route. No other information was available. The reporter did not consented to follow up.
PLEASE NOT THERE WERE NO ADVERSE EFFENTS RELATED TO THIS REPORT  A higher dose of the COVID-19 (Pfizer-BioNTech) was administered.  Inadvertently a higher dose of the vaccine (0.3ml) approver for ages 12-18 was administered.  Pt. should have received Pfizer 0.2ml.
Received Expired Dose of Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Sharp abdominal pain; Loose bowels; Pain; Nausea; Vomitting; Severe migraine; Dehydration; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (Severe migraine), DEHYDRATION (Dehydration), ABDOMINAL PAIN (Sharp abdominal pain), DIARRHOEA (Loose bowels) and PAIN (Pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical  history reported). Concomitant products included LORAZEPAM for an unknown indication.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced MIGRAINE (Severe migraine), DEHYDRATION (Dehydration), PAIN (Pain), NAUSEA (Nausea) and VOMITING (Vomitting). On 19-Feb-2021, the patient experienced ABDOMINAL PAIN (Sharp abdominal pain) and DIARRHOEA (Loose bowels). On 17-Feb-2021, MIGRAINE (Severe migraine), DEHYDRATION (Dehydration), PAIN (Pain), NAUSEA (Nausea) and VOMITING (Vomitting) had resolved. On 19-Feb-2021, ABDOMINAL PAIN (Sharp abdominal pain) and DIARRHOEA (Loose bowels) had resolved.            Concomitant product medications included  lorazepam and vitamin supplements.  She was treated with aluminum hydroxide, magnesium hydroxide, simethicone and discharged. Treatment provided was iv fluids, paracetmol, ondansetron; Sender's Comments: This case concerns a 58 Y/O F with nonserious unexpected events of migraine, abdominal pain, diarrhea, dehydration, pain and expected nausea, vomiting.  Event onset the same day as second dose mRNA-1273. Event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I received the first dose of the Covid 19 vaccine on September 30, 2021 . I began to break out in a rash on  my left arm on October 5, 2021. It eventually spread to covered my entire body after two days. It was very itching and swollen looking. I went  to an Urgent Care facility on Oct 11,2021  and had to receive Steroid injections(Celestone shot and Kenalog shot)to stop the itching and inflammation. I am currently still taking Prednisone tablets. I went to my primary care physician  on Oct 12 and he had never seen such a bad reaction to the vaccine. He referred me to the dermatologist in   I saw him on Oct 12 as well.  Dr.  had also not seen such a serious rash reaction to the Covid-19 vaccine in a patient. He gave me Triamcinolone Acetonide Cream and Prednisone tablets.  He also recommended that I not take the second vaccine shot due to this severe reaction.  I reported to the Pfizer Company that I had a bad reaction to this shot.  I am currently still have the rash on me but it is drying up finally.  This has been scary and miserable.
Redness, itching, and large hives (welts?) on anterior neck within 4 hours of receiving vaccine.
Patient experienced severe flu like symptoms including body aches chills and a fever of close to 104 for 3 days straight, starting about 6 hours after receiving the vaccination. This was 2nd dose in the series. She just now reported it to the pharmacist. She said she also experienced a severe headache. She called her PCP because she was concerned it was not normal, the doctor assured her it could happen with this vaccination the symptoms finally resolved after a full 72 hours.
COVID-19 virus detected  Exposure to viral disease  Cough  Nasal congestion
The vaccine was administered on 2/1/2021 and the vaccine expired 1/28/2021.  The client reported injection site soreness for 1 day after receiving the vaccine.  The client denied any adverse effects.
Itching, bloody nose, palpitations, headaches  for the week following, one severe, nausea
Moderna vaccine was administered to the patient after the manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered to the patient after the manufacturer date of expiry) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084j21a, 047b21a and 046a21a) for COVID-19 vaccination.     The patient had no allergies to medications, food and other products.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered to the patient after the manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered to the patient after the manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 11-Apr-2022.  It was reported that one vial of the Moderna vaccine was administered to two patients on 09-May-2022 after the manufacturer date of expiry of 05-May-2022.  The vial had not undergone any temperature excursions.  On 20-Oct-2021, the patient received first booster dose of Moderna COVID-19 Vaccine.  On 09-May-2022, the patient received second booster dose of Moderna COVID-19 Vaccine.  The patient received Merck pneumonia vaccine on 09-May-2022 at a dose of 0.5 ml.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-561896 (Patient Link).
Information has been received from a 65 year old female with high blood pressure and allergic to sulfa who 0n 11-MAR-2009 was vaccinated with a dose of ZOSTAVAX vaccine (Merck). Concomitant therapy included lisinopril (manufacture unknown) and NIASPAN. On 20-MAR-2009, 9 days after receiving ZOSTAVAX vaccine (Merck), the patient developed the shingles on her left breast and then it moved to the thoracic area of her upper back. She reported that she saw her physician on a week later and was diagnosed with shingles. Her shingles was improving that the rashes were not as red and not as itchy. Follow up information was received from representative who stated that the patient was fine now. No additional information was provided. Follow up information was received via medical records from the patient's physician which reported the 65 year old patient also had allergic rhinitis due to pollen, essential hypertension, hypercholesterolaemia, asthma NOS and history of osteopenia, hyperlipidaemia, stress urinary incontinence, urge urinary incontinence, depression, seasonal allergy, granuloma annulase extensive rx with puva Ferrell-Blickenstaff-Burr, laryngospasm since at least 1970's triggered by sweets sometimes, father also had them. She underwent breast reduction, liposuction (neck lift), sinus operation, hysterectomy/BSO due to HPV. The patient had a colonoscopy in November 2003 which was negative. Her density in January 2009 was Hip-1.2, Spine-1.5 that indicated osteopenia. The patient quit smoking in 1960, prior 1/2 ppd 1 yr, ,1 ppv and has 4 drinks/week or so. She was subcutaneously vaccinated with the first dose of ZOSTAVAX vaccine (Merck) (lot #663893/0128Y) into the right deltoid in a pharmacy on 11-MAR2009. Her family history included father (deceased) diabetes mellitus type 2 and hypertension, mother (alive) with hepatitis, unclear etiology, hypertension, and chronic pain, and one brother with diabetes mellitus type 2. Concomitant therapy also, included vitamin D (unspecified), METROGEL, COMBIVENT, omega-3 marine triglycerides, melatonin (+) pyridoxine, "ZICAM", nystatin (+) triamcinolone acetonide topical, aspirin, green tea extract, vitamins (unspecified), ALLEGRA, FLONASE along with lisinopril (manufacturer unknown) and NIASPAN. On 19-MAR-2009, 8 days after getting ZOSTAVAX vaccine (Merck) (previously reported as 9 days after vaccination), the patient had rash consistent with zoster injection breakout on her left chest and back. She was not ill when she got the vaccination and her lesions were better but still there. She was feeling better at time of reporting. The patient declined further testing. Additional information is not expected.
Patient received his 2nd dose on Thursday 7/1/2021. He had flu-like symptoms the next two days (fatigue, fever, headache, myalgias). On Sunday morning (7/4/21), the patient woke from sleep with sharp, stabbing left sided chest pain that did not relent. He was taken to the hospital where he was found to have sequential troponins of 6.6 and 8.12. He was started on fluids and underwent EKG and Echo which were unremarkable. He also had repeat labs. Serial troponins downtrended on 7/5/2021.
It started off with a headache and it was a bad headache on the right side of your head like with COVID. Along with that came nausea and diarrhea. I was very weak and then I started a fever. With the fever came severe chills and muscles jerks and body aches. About 2 weeks later, I noticed my period coming and going. They didn't last as long; they were just all over the place. I've had histories of this before, but they were decent up until that point. The treatment I got, I had a virtual appointment with Dr. and I was to take PHENERGAN for the nausea and TYLENOL for headache and body aches. So, they don't know if it was the 2nd vaccine or COVID, but they don't know if my periods totally stopped in December due to the vaccine or due to COVID itself. I am supposed to be going to a COVID clinic (long hauler). I still experience COVID symptoms such as night sweats to this day. Fatigue, exhaustion, headaches associated with COVID. Persistent migraines. Body aches. I don't have a fever anymore, but I get flushed. I don't really have chills anymore but I have noticed that I cannot tolerate cold at all. I did see Dr. (gynecologist).