chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling sick; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (Intramuscular) UNK dosage form. On an unknown date, the patient experienced MALAISE (Feeling sick). At the time of the report, MALAISE (Feeling sick) outcome was unknown.            No treatment medication were reported.  Patient submitted via social media what happens if you get the vaccine while feeling sick.
Prior to receiving the vaccine I had mild sciatica. I was able to walk a mile before it bothered me. The pain was perhaps a 3 on a scale of 1 to 10. After receiving the vaccine it became so severe that I was unable to walk or stand for more than a couple minutes, the pain was a 7 on a scale of 1 to 10, and it therefore interfered with daily tasks such as cooking, cleaning, showering, shopping and so on.
After sitting in the observation area for 15 minutes she was ambulating to leave the clinic when suddenly noted feelings of air hunger and pressure on her chest.  Said she just "felt funny".  Was taken to triage room where her O2 levels, pulse, and BP were monitored.  O2 level 98-99%, Pulse 65-69 bpm, BP around 160/60.    After being allowed to remove her mask and have some water she stated she felt better. Was monitored for 15-20 more minutes during which time BP remained around 160/60.  Eventually stated that feeling of air hunger and chest pressure had resolved and she was allowed to leave the facility .  No other symptoms noted.  Felt fine the rest of the day.  No other symptoms noted the following day.
h/a began 4-5 hrs p/vax & lasted x 3 days;
Patient is 13 years old, Flublok is indicated for 18+ years old.  No adverse reaction as on 7pm 11/1/22.  Reporting the incident solely due to patient's age.
Myocarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 20Nov2021 as dose number unknown (booster), single (Lot number: EW0186) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "chest pain" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Janssen covid-19 vaccine (she got the J and J and had a good night's sleep and was fine), administration date: Mar2021, for COVID-19 immunisation. The following information was reported: MYOCARDITIS (life threatening) with onset 25Nov2021, outcome "recovered" (Jan2022). It was reported that the patient suffered from myocarditis 5 days after Pfizer booster vaccine. Had some chest pain. The event "myocarditis" required physician office visit. The patient underwent the following laboratory tests and procedures: Cardiac stress test: Unknown results; Chest X-ray: Unknown results; Echocardiogram: Unknown results; number of tests: Unknown results, notes: Went to the doctor, had a number of tests then went to the cardiologist and had a number of tests. Therapeutic measures were not taken as a result of myocarditis.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300036624 same reporter, product and patient, different event.;
Body aches, fever up to 102.1, loss of appetite, extreme sleepiness. Fever was the worst the day following the injection. Although it was over 100.5 for the three days following the shot.
Chest cold; Vicious cough; Couldn't sleep nights; Ribs so sore couldn't hardly stand to move; Flu; Ribs so sore; This is a spontaneous report contactable consumer reporting for herself from a Pfizer Sponsored Program Prevnar Adult.   A female patient of an unspecified age (age 65, units unknown) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration at single dose on an unspecified date 2 or 3 yrs befor this report for immunisation.   Medical history included influenza when a few times in the past she had the flu shot and every time got the worse case of flu. The patient's concomitant medications were not reported.   On an unspecified date after vaccination the patient experienced chest cold with, vicious cough, couldn't sleep nights, ribs so sore couldn't hardly stand to move, flu, ribs so sore. The outcome of all events was unknown. Course of events: She was never sick over winter, except when a few times in the past she had the flu shot and every time she got the worse case of flu. After PREVNAR 13 shot that winter she had awful chest cold with vicious cough that took several months to get rid of. She couldn't sleep nights from coughing, ribs were so sore and couldn't hardly stand to move. Then next winter she had a minor case again and this past winter nothing, no colds, flu, finally got all that shot out of her system with massive amount of immune building supplements.  Information on the lot/batch number has been requested.
This spontaneous report was received from a registered nurse referring to a 13 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 05-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
blood sugar was high (758 mg/dL); Ketoacidosis; A spontaneous report was received from consumer concerning a 73 Year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced High blood sugar(758mg/Dl) and Ketoacidosis.  The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. The report stated that the patient was physically and mentally healthy before vaccination.   On 4 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown)  via intramuscular route on her upper Arm for prophylaxis of COVID-19 infection.   On 11 Feb 2021, Patient experienced high blood sugar (758 mg/DL) and she was admitted to hospital because of her high blood sugar and ketoacidosis. The patient was hospitalized on 11 Feb 2021 and released on 20Feb 2021.  High blood sugar and Ketoacidosis were deemed as life threatening for seriousness criteria. Consent was received to save the caller information within our database and for safety to follow up.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events experienced High blood sugar (758mg/Dl) and Ketoacidosis  was considered recovered.; Reporter's Comments: Based on the 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.
Client presented to clinic c/o rash on upper chest- slight itching. Client stated on 6/01/11 that he noted a rash on his body after receiving first hep B shot on 7/2/2010, but did not inform nurse on 5/24/11 dut to family hx of psoriasis-he thought that the rash was due to psoriasis.
Patient initial triage: Pt reports a 2 hour history of SS chest pain. Pt states it feels as if there is a baseball under his sternum. Pt reports in the spring he had and esophageal rupture and that led to him having a-flutter. Pt had an ablation about 2 months ago. Pt's pain today increases with deep breathing. Pain 5-6/10.  Aspirin 324 mg Nitro SL 0.4mg  IV toradol 15 mg - decreased pain to 0-1/10
Syncope, Migraine, Blood Test, Urinalysis, CT scan, chest xray. IV. Discharge condition stable.
(L) arm lateral area 2 1/2 circular red, raised, warm to touch - c/o itching slight pain when touched. Seen by MD - private - 3/27/14 - Rx BENADRYL. F/U as needed.
Information has been received from a licensed practical nurse referring to multiple unspecified patients. The patient's medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # M036057, expiration date 18-MAY-2019) via intramuscular injection for prophylaxis. No adverse effect was reported. No product quality complaint (PQC) was involved. The vaccine was stored in temperature between 46 degrees Fahrenheit and 77 degrees Fahrenheit for 5 hours and 50 minutes. "Data logger" was involved and there was no previous temperature excursion. This is one of several reports from the some source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA009130: US-009507513-1703USA001072:
anaphylaxis (hives, shortness of breath, face nose and throat swelling, difficulty swallowing, rapid heart rate. ER visit: diphenhydramine, solu-medrol, famotidine, epinephrine, oxygen, IV fluids.
Case with red, swollen, warm, hard areas on both upper arms. Area on left arm larger than right arm. Case stated his right hand was tingling. Case to FNP this a.m. reporting some shortness of breath.
C/O arm numbness.  Color of both arms=, pink and warm to touch.  Able to move arm.  After 10 minutes complained of left wrist and fingers numb on L arm.  Able to move digits of fingers.  Left hand slightly cooler than right, and color the same.  Denies any other symptoms.  Bandaid at site of injection indicates given in deltoid.   After 20 minutes, symptoms did not improve and patient willing to go to hospital ER.
2.5 diameter circles below injection site; Hot to the touch; Puffy; Itchy; Swollen lymph node under arm; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (2.5 diameter circles below injection site), VACCINATION SITE WARMTH (Hot to the touch), SKIN SWELLING (Puffy), PRURITUS (Itchy) and LYMPHADENOPATHY (Swollen lymph node under arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Oill2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE REACTION (2.5 diameter circles below injection site), VACCINATION SITE WARMTH (Hot to the touch), SKIN SWELLING (Puffy), PRURITUS (Itchy), LYMPHADENOPATHY (Swollen lymph node under arm) and VACCINATION SITE ERYTHEMA (Redness). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) at an unspecified dose and frequency. On 29-Jan-2021, VACCINATION SITE REACTION (2.5 diameter circles below injection site), VACCINATION SITE WARMTH (Hot to the touch), SKIN SWELLING (Puffy), PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Redness) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph node under arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided.
No additional AE reported; improperly stored VARIVAX were administered to patients.; This spontaneous report was received from a registered nurse and referring to a 13 months 14 days old male patient. The patients' medical history and current conditions were not reported. Concomitant medications included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), Hepatitis A Vaccine, Inactivated (VAQTA) and pneumococcal vaccine conj 13v (PREVENAR 13).   On 02-MAR-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number W021740 with expiration date: 10-JUL-2024, administered subcutaneously on right thigh for prophylaxis (strength, and route of administration were not provided).   On 21-MAR-2023, it was found on the look back data logger monitoring that the defrost on the freezer has been getting too warm, out of range temp noted to be out of manufacturer storage recommendations. Temperature and time frame were unknown. There was previous temperature excursion (-9.8 degree celsius for 8 hours and 38 minutes) (product storage error). No complications, no reactions, no complaints. No adverse event.  The outcome of the event was reported as recovering.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2303USA007314:
Heart racing at rest/during sleep. Headaches, fatigue, weakness, severe dizziness. All are present and have been since a couple of days after the vaccine
Broke out in a sweat, like a hot flash per patient.  Lasted approximately 2 hours then developed general itching.  Woke up next morning with "goose bump" like lesions on chest, inner/upper arms and neck, face, jaw and nose."  Stated is now decreasing.  Instructed to notify her physician.
Expected swelling and tenderness at injection site. Expected flu like symptoms of fatigue, body aches, etc. NOT expected serious and all through the night "night terrors" - worst night of sleep I've ever had.
Stopped getting monthly menstrual cycle. It went from monthly to every other month and now every two and half months.
Upon awakening the morning after shot was administered, pt experience significant bilateral shoulder and knee joint pain. Pt cites she has never experience arthralgias in the past.
Patient's mom reported her having dizziness.  Patient later said she's having blurry vision and chest tightness.  Pharmacy staff called 911 and personnel from the fire department came, awaiting the ambulance. When patient's vitals were checked they were normal. Patient's mom said, patient has a history of anxiety and she had told patient not get the vaccine; so she thinks patient got anxious after having blurry vision. Patient later reports of feeling fine, paramedics arrived and patient and mom went with them. Patient said she had Hep A and Meningitis vaccine about 3 weeks ago and was ok.
Reactions after receiving Vaccine A (Anthrax Shot) in the middle of the desert.  nausea  diarrhea  double vision  dizziness  shortness of breath  Reactions after receiving Pyridostigmine Bromide Pills.  Severe Chest Pain and tightness of chest Trouble Breathing and shortness of breath Gastrointestinal upset, nausea, vomiting  Abdominal cramps and diarrhea  Increased salivation and tearing  Increased sweating  Muscle cramps  Muscle twitching  Muscle weakness  Migraine Headaches  Hallucinations Cough Blurry Vision Problems with swallowing food and water Problems with Balance  Botulinum Toxoid Vaccine received in arm.  Was still experienceing same signs associated with Anthrax vaccine.  Botulinum Toxoid Vaccine seemed to intensify these symptoms.  Received and took 1991 pink Malaria Pill/vaccine for several weeks.
SWOLLEN LYMPH NODES UNDER ARMS ; BACK HURTING ; CHEST / SINUS CONGESTION
06/15/2022, woke up to sore throat headaches a little cough. I took ALLEGRA because I thought it was allergies. Later that night before bed I took SINGULAIR because I didn't want it in my lungs. 06/16/2022, my children where all on a cruise came back around me and had symptoms as well. I decided that I needed to be checked out so I went thru a drive clinic and told the results on the next day. 06/17/2022, I received notification that my results were positive. I contacted my doctor via email. The doctor told me to take ALLEGRA and SINGULAIR and EXCEDRIN for headaches. 06/22/2022.
High fever (from 100/101 to maxing at 102.7) for four full days following vaccination (received vaccination on Thurs., fever persisted Fri.-Mon.) Flu-like vomitting and diarrhea for 3+ days Chills/body shakes and aches
nausea; vomiting; low grade temp 100; general tiredness; continuous stomach ache; This is a spontaneous report from a contactable consumer. A 13-year-old non-pregnant female patient received BNT162B2 (PFIZER COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via intramuscular route of administration, administered in arm left on 04Jun2021 17:30 (05:30 PM) (at the age of 13-year-old and non-pregnant at the time of vaccination) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient experienced about 36 hours after the injection patient had nausea, vomiting, low grade temp 100, general tiredness continuous stomach ache on 06Jun2021 05:00 AM. The patient underwent lab tests and procedures which included low grade temp was 100 on 06Jun2021. The patient received Pepto bismol tablets and Tylenol as a treatment medication for the events nausea, vomiting, low grade temp 100, general tiredness continuous stomach ache. Outcome of the events was recovered on an unspecified date in 2021.
Felt horrible; Reaction to COVID booster was worse than having COVID; Had side effects in hands; Partial Humira dose injection; COVID-19; Anxiety; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt horrible), IMMUNISATION REACTION (Reaction to COVID booster was worse than having COVID), MUSCULOSKELETAL DISORDER (Had side effects in hands), ANXIETY (Anxiety) and BACK PAIN (Back pain) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult Crohn's disease).   On 20-Nov-2020, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. In April 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 01-Jan-2022, the patient experienced COVID-19 (COVID-19). On 27-Feb-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Partial Humira dose injection). In 2022, the patient experienced ANXIETY (Anxiety) and BACK PAIN (Back pain). On an unknown date, the patient experienced FEELING ABNORMAL (Felt horrible), IMMUNISATION REACTION (Reaction to COVID booster was worse than having COVID) and MUSCULOSKELETAL DISORDER (Had side effects in hands). In February 2022, COVID-19 (COVID-19) had resolved. In 2022, ANXIETY (Anxiety) and BACK PAIN (Back pain) had resolved. At the time of the report, FEELING ABNORMAL (Felt horrible), IMMUNISATION REACTION (Reaction to COVID booster was worse than having COVID), MUSCULOSKELETAL DISORDER (Had side effects in hands) and INCORRECT DOSE ADMINISTERED (Partial Humira dose injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2021, SARS-CoV-2 test: (Positive) Positive. On 12-Jan-2022, Tuberculin test: Unknown.         No concomitant medication was reported. No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of had side effects in hands, felt horrible, partial Humira dose injection, anxiety, COVID-19 and back pain was not provided. The reporter's causality for the event of reaction to COVID booster was worse than having COVID with Humira (adalimumab) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
JOINT ACHE; TIREDNESS; SORENESS ON THE INJECTION SITE; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no pertinent medical history and no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. Concomitant medications included influenza vaccine for prophylactic vaccination.  On 14-MAR-2021, the subject experienced joint ache. On 14-MAR-2021, the subject experienced tiredness. On 14-MAR-2021, the subject experienced soreness on the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint ache, tiredness, and soreness on the injection site on MAR-2021. This report was non-serious.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium
Eryth macular papular rash at right anterior thigh at injection site by second upper and lower extremities with varicella form rash about 8 to lesions total x4d. Denied ill contact with known chcken pox. Also with ulcers at post pharynx and eryth macules at palms and soles. Consistent with hard foot mouth. Had tactile fever, emeris x 3, presumably sx of Hard Foot Mouth. Unclear if visicles at skin related to hard foot mouth. Seen yesterday 10/01/2001.
10 HOURS AFTER I GOT THE BOOSTER  SHOT, i WAS VERY ILL,  A LOT SICKER THAN I WAS WHEN I HAD COVID. I EVEN TOOK A COVID TEST. THE FIRST 3 DAYS I HAD A FEVER 102 ,CHILLS. AFTER THAT I HAD DIARRHEA, FOR 2 DAYS. THEN FOR THE NEXT 7 DAYS I HAD THE WORST COLD EVER,  THEN FOR 5 WEEEKS , I HAD A SERVERE  COUGH, A BARK OF A COUGH, ON AND ON. TO THIS DAY I GET FITS A COUGHING.
Information has been received from the husband of a female consumer (age not reported) who on 31-OCT-2006 was vaccinated with a dose of Pneumovax 23 and a dose of Zostavax (MSD) concomitantly in separate arms.  There has been no reaction at the Zostavax site (MSD).  On 01-NOV-2006, the husband of the patient reported that the Pneumovax 23 site became red, hot and swollen the morning after the injection.  Over the course of the day, the patient developed a warm "bump" that extended from shoulder to elbow, associated with shoulder and neck pain.  The patient's primary care physician evaluated the patient for a possible infection.  The physician thought that the reaction was a large hive and an antibiotic was prescribed.  The outcome of the event was not reported. No further information is available.
Extreme headaches- migraines -diarrhea   Extreme headaches continual 5 days after inoculation- OTC pain killers not effective.  headaches increased there after 3-4 days a week migraines increased to weekly and bi weekly occurrence 6 weeks after