chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lymph node tenderness under left armpit; Body aches; Fatigue; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 74-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the left arm on 25Feb2021 at 14:30 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included irregular heartbeat, occasional high blood pressure, low thyroid and recurring shingles. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included thyroid (MANUFACTURER UNKNOWN), valaciclovir hydrochloride (VALTREX), betablockers and vitamins (unspecified); all from unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and also received pethidine hydrochloride (DEMEROL) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Feb2021 at 14:30, 24 hours after injection, the patient experienced body aches, fatigue and headache and all subsided by the following morning. On 27Feb2021 at 14:30, 48 hours after injection, the patient experienced same symptoms reoccurred, along with lymph node tenderness under left armpit. Symptoms subsided by the following morning and did not recur. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, fatigue, headache and lymph nodes tenderness was resolved on 28Feb2021.  No follow-up attempts are possible. No further information is expected.
Patient's arm was really sore for a week (also and she said her arm felt numb at the site of injection) and she couldn't lift the arm for few days. She had to go to the ER where she was told the needle might have hit the blood vessel.
Got the shingles shot, got shingles/suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shingles shot, got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-Mar-2023 The case was received from the patient via interactive digital media. The patient got the shingles shot and got shingles for the second time. The patient stated from hospital in. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
felling of SOB with normal sat; dizziness; nausea; abd pian; elevated HR; headaches; body aches; sore throat; This is a spontaneous report from a contactable consumer. This 41-year-old female (Non pregnant) consumer (patient) reported that she received second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 VACCINE, solution for injection, LOT: EL3302 Expiry date: unknown), via an Intramuscular route of administration in right arm on 27Jan2021 at 13:00, at a single dose for covid 19 immunization. Patient historical vaccine included she received first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 VACCINE, solution for injection, LOT: EL0140, Expiry date: unknown), via an Intramuscular route of administration in right arm on 06Jan2021 at 12:00, at a single dose for covid 19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not tested for COVID-19 since the post vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications included Clonazepam, fiber, but vitamin D3 and medical history included that 'Botox' done on 20Jan21 for hemifacial spasms on right side of my face. Patient had no allergies. On 28Jan2021 05:00 after received the second dose the patient was feeling dizziness, nausea, abdominal pain, elevated HR, felling of SOB with normal sat, headaches and body aches, on 3rd day better but now with a sore throat, headaches and every some often heart rate going fast. Patient didn't take treatment for the events. The outcome of event was unknown.   Follow-up attempts are completed. No further information is expected.
Severe vaginal itching / itching was really bad; Not feeling good; Weakness; Sleepy / drowsy; Swelling at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VULVOVAGINAL PRURITUS (Severe vaginal itching / itching was really bad), MALAISE (Not feeling good), ASTHENIA (Weakness), SOMNOLENCE (Sleepy / drowsy) and VACCINATION SITE SWELLING (Swelling at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031BZ11A and 03UA21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, AMLODIPINE, ATORVASTATIN, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE), VITAMIN D NOS and RISPERIDONE (RISPERDAL) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced MALAISE (Not feeling good), ASTHENIA (Weakness), SOMNOLENCE (Sleepy / drowsy) and VACCINATION SITE SWELLING (Swelling at the injection site). On an unknown date, the patient experienced VULVOVAGINAL PRURITUS (Severe vaginal itching / itching was really bad). The patient was treated with CLOBETASOL PROPIONATE at a dose of 1 dosage form twice a day. On 13-Apr-2021, MALAISE (Not feeling good), ASTHENIA (Weakness), SOMNOLENCE (Sleepy / drowsy) and VACCINATION SITE SWELLING (Swelling at the injection site) had resolved. At the time of the report, VULVOVAGINAL PRURITUS (Severe vaginal itching / itching was really bad) had not resolved.            Treatment medication also included an unspecified cream.  The patient stated the itching was really bad the first two months and at the time of report it was a little better but it still itches.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 1808980 expiry: 18-SEP-2021) dose was not reported, 1 total, administered to right arm on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced symptoms of covid after receiving the Covid 19 vaccine(dose number in series: 1), suspected covid-19 infection and suspected clinical vaccination failure The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000212824.; Sender's Comments: V0: 20220133988,covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Information was received on 17APR2014 from an employee on behalf of five consumers.This is case 1 of 5. On 08MAR2014 a consumer (age / gender unspecified) received immunization with BIOTHRAX (lot FAV349) and Typhoid vaccines. Subsequently the individual experienced dizziness, hypertension, rapid pulse and hallucinations which resulted in hospitalization. The reporter requested that the product be tested for possible contamination. No further information provided. Further information has been requested.
Headache, fever, chills, all over pain, sleeping.Temps ran 100.3  - 104.  Duration was approximately 24 hours
pt recvd vax; exp fever; on 24oct95 devel "moderate covering of pox";
Client described symptoms such as feeling nauseated, lightheaded with sore left arm approximately 1.5 hours after receiving influenza vaccine. No indication or symptoms of difficulty breathing. No fever present. BP 140/90. Provided wet cloth to apply to forehead and neck as well as water and food. Nurse instructed client to to remain seated with us for approximately 10 minutes to rule out any other type of reaction. Nurse encourage patient to eat and drink fluids. Patient has had food to eat and says is feeling better.
pt had a positive COVID test on 2/3/22; pt died at home; no medical records
This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered the second Moderna initial series too early. Instead of doing it at the 1 month or 28 days mark, they gave it at the 19th day mark.) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 015B22A and 015B22A) for COVID-19 prophylaxis.     The patient had no known drug allergies. The patient had no acute illnesses at the time of vaccination and up to one month before. The patient had no chronic conditions or long-standing health conditions at the time of vaccination. The patient did not receive any prescription, over the counter medications, dietary supplements, or herbal remedies at the time of vaccination or at the time of adverse event.  The patient's past medical history included COVID-19 (PCR) on 12-Aug-2020.    For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered the second Moderna initial series too early. Instead of doing it at the 1 month or 28 days mark, they gave it at the 19th day mark.).    No concomitant medications were reported.
Already reported minimal side effects first evening following second Moderna vaccine before realizing that it wasn't over, not by a long shot. The next day when I reported the initial side effects, I felt pretty good. That night I had a fever of 101, and so much pain all over that I could not walk or dress myself unaided. I am otherwise very healthy and fit. The nest morning again I felt pretty good, and that evening, I got intense pain in my chest and ended up in the ER with Pleurasy. The effects of that lasted two days. The day after that ended, I experiences a strange numbness in my left forearm and right thigh. The pain in my arm when away in a few hours. The pain in my leg got worse with each day. On the 5th day it was too painful to sit, walk or lie in bed. I ended up in the ER again. It was extreme nerve pain.  Just as that started to improve I got sharp pains in my ribcage and that continues today, more than 3 weeks after the second vaccine.  I know that these things are a result of the vaccine. My spouse who got the second shot on the same day has to this day been experiencing nerve related pain and/or discomfort.  Again we are otherwise quite healthy individuals. There is no way this is a coincidence, nor could it be rare. WHY IS THIS NOT BEING REPORTED IN THE NEWS?
12 hours after SECOND Pfizer covid:  Fever 104; chills, body aches, nausea, headache, severe body ache, for 48 hours, then fever subsided and diarrhea and cold-like symptoms set in.
The patient received Moderna COVID-19 Vaccine from a vial that was first punctured more than 12 hours ago, the vial was  stored post puncture at Room Temperature.; Received the second booster dose of the Moderna Covid 19 Vaccine from a vial that was first punctured more than 12 hours ago.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the second booster dose of the Moderna Covid 19 Vaccine from a vial that was first punctured more than 12 hours ago.) and PRODUCT STORAGE ERROR (The patient received Moderna COVID-19 Vaccine from a vial that was first punctured more than 12 hours ago, the vial was  stored post puncture at Room Temperature.) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006K21A, 076C21A, 037A21B and 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOVASTATIN, METOPROLOL, LEVOTHYROXINE and ATORVASTATIN for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022 at 2:40 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the second booster dose of the Moderna Covid 19 Vaccine from a vial that was first punctured more than 12 hours ago.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received Moderna COVID-19 Vaccine from a vial that was first punctured more than 12 hours ago, the vial was  stored post puncture at Room Temperature.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the second booster dose of the Moderna Covid 19 Vaccine from a vial that was first punctured more than 12 hours ago.) and PRODUCT STORAGE ERROR (The patient received Moderna COVID-19 Vaccine from a vial that was first punctured more than 12 hours ago, the vial was  stored post puncture at Room Temperature.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 18-Apr-2022, the vial was initially stored in the refrigerator. On 21-Apr-2022 at 9:20, the vial was first punctured. The vial was stored at Room Temperature post puncture. The vial did not undergo any temperature excursions. Healthcare professional had no further contact with patients for side effects. No treatment  medications were reported.   This case was linked to MOD-2022-548545 (Patient Link).
Patient with acute onset of R facial Bells Palsy 0n 10/10/2021.  Patient with numbness and R facial paralysis.  Loss of blink reflex.
Patient presented to pharmacy stating they needed their 1st dose of Covid vaccine.  Weeks after we gave the shot, we found out the patient had already received a J&J vaccine and 2 Pfizer vaccines at other facilities.
Flare of my rheumatoid arthritis Autoimmune flare Autoimmune reaction in my skin and joints  After taking many medications and months of treatment, as well as injectable TNF - I have recovered from this adverse event.
10/30/02 woke up at 6 AM with "thick tongue". By 12 noon 10/30/02, symptom of thick tongue was gone. Did not see MD or take any treatment. Had same symptoms previously after an insect bite, but never from flu shot.
Fever deery first 24 hours ag=fter vaccine. Resolved over next 24 hours (2 doses of Tylenol given).
THE PATIENT RETURNED TO THE PHARMACY REPORTING LIGHT HEADEDNESS, DIZZINESS, SWEATING. THE PATIENT WAS CONCERNED ABOUT LOW BLOOD GLUCOSE. AFTER TESTING HIS GLUCOSE LEVEL IT WAS DETERMINED HE WAS NOT HYPOGLYCEMIC AT 142 BLOOD GLUCOSE LEVEL.
Incorrect booster administration; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Incorrect booster administration) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Incorrect booster administration) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Incorrect booster administration) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Incorrect booster administration).    No concomitant medication were reported.  It was reported that there was a couple who were received their bivalent booster doses. One dose was drawn from the correct bivalent vial and the other was incorrectly drawn from the monovalent vial. The vaccines were drawn in the pharmacy and taken out to the patients to administer. Unfortunately, after video review they could not verify which patient received the correct dose  The lot for the bivalent vaccine was  reported as AS7162B.  No treatment medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-649416 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-649416:Same reporter
erythema & edema of lt deltoid 30hr p/vax;denies SOB, difficulty swelling;12x10cm erythematous lesion lt deltoid, +edema, + warm to touch;non tender, no SOB moving w/o difficulty;apply ice, DPH;
High fever x 2 days, body wide muscle pain and soreness (more severe at injection site), syncope 09/28
Case received on 30-OCT-2009, reference: NL-NVI-17641.09.006. Information has been received from a public health physician concerning an 11 year old patient with Lennox-Gastaut syndrome who on 01-OCT-2009 was vaccinated subcutaneously with a dose of MMR II (lot number not reported) (manufacturer probably "SPMSD") and intramuscularly with a dose of DT+IPV (manufacturer NVI). On 05-OCT-2009 at 16:00, 4 days after vaccination, the patient experienced epileptic fit/status epilepticus and fever in the evening. No details provided concerning hospitalization dates or duration. The patient outcome is not explicitly reported in the report, but is considered to be recovered. The primary reporter commented: According to the father, the neurologist had said that the status epilepticus was caused by the DT+IPV. To the opinion of the reporter ( a municipal public health physician) there was no causal relationship. Other business partner number included E200910744. No further information is available.
low energy; very cold; difficulty breathing; hard to sleep; no taste; itching ALL over body; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (low energy), NASOPHARYNGITIS (very cold), DYSPNOEA (difficulty breathing), INSOMNIA (hard to sleep) and AGEUSIA (no taste) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid cancer. Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced ASTHENIA (low energy), NASOPHARYNGITIS (very cold), DYSPNOEA (difficulty breathing), INSOMNIA (hard to sleep), AGEUSIA (no taste) and PRURITUS (itching ALL over body). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (low energy), NASOPHARYNGITIS (very cold), DYSPNOEA (difficulty breathing), INSOMNIA (hard to sleep), AGEUSIA (no taste) and PRURITUS (itching ALL over body) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
A non-serious spontaneous report of expired FLUMIST administered was received from a health professional concerning a seven-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 08-Jan-2012. On 11-Jan-2012, the patient inadvertently received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Pt received her second doses of Pediatrix, Hib, and Prevnar 13 too early, but she did not have any adverse effects/symptoms. Pt received her second doses only 15 days after the first doses.
-Arm soreness the first couple of days.  -Subsequently nothing till exactly two weeks post vaccination (vaccinated 3/13/21, onset of symptoms 3/27/21) characterized by lymphadenopathy of the supraclavicular lymph node. Slight soreness extends down the arm and underarm (no additional lymph node swelling). Soreness still lasting on day 3/29/21.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On 18-JUL-2012, the patient was vaccinated with the first dose of improperly stored VARIVAX lot # 671861/1907AA. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Generalized wipe spread hives, throat itching, tongue numb, generalized itching with long term dermatographias and intermittent itching. Required prednisone, hydroxyzine, epi pen, and Zyrtec still daily
MODERNA COVID-19 VACCINE EUA HOSPITAL CONTRACT EMPLOYEE (AGE 17) WAS SCHEDULED, AND SUBSEQUENTLY WAS ADMINISTERED THE MODERNA COVID-19 VACCINE. NO ADVERSE REACTION NOTED TO VACCINE, BUT ADMINISTRATION ERROR DUE TO AGE OF PATIENT.
PT REPORTS HE NOTICED RED PAINFUL SPOTS ON HIS ARMPITS, CHEST, ARMS, AND LEGS.  AT FIRST HE THOUGHT THEY WERE PIMPLES BUT HAD THEM CHECKED OUT BY HIS PHYSICIAN AND IT WAS DIAGNOSED AS SHINGLES.