chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 36-year-old male patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
administer the vaccine to patient under 18 years old patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administer the vaccine to patient under 18 years old patient) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0047A21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administer the vaccine to patient under 18 years old patient). On 16-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administer the vaccine to patient under 18 years old patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14-MAY-2021, contains no new information.
No additional AE reported; a dose of VAQTA expired on 6/4/2021 and was administered on 7/19/2021; This spontaneous report has been received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not provided.  On 19-JUL-2021, the patient was vaccinated with an expired dose of Hepatitis A vaccine, inactivated (VAQTA) 0.5 milliliter (mL), once, (route of administration, anatomical site of vaccination and vaccination scheme were not reported, lot number T008698 has been verified to be a valid lot number, expiration date reported and established as 04-JUN-2021) (expired product administered) as prophylaxis. It was reported that the vaccine had never had a temperature excursion. No additional adverse events (AEs) were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008698; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Rash on left arm that appeared about a week after the vaccine. It isn?t considerably itchy, or painful but has a mild outline below the vaccine site.
13AUG96 1AM went to hosp severe h/a, eye pain, fever/chills, rash on back & chest;
appendicitis; This is a spontaneous report from a non-contactable consumer. An adult male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced appendicitis on an unspecified date with outcome of unknown. The consumer reported her husband developed appendicitis 2 weeks following the Pfizer vaccine. It's listed as a major adverse event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PERIOD LASTING APPROXIMATELY TWO WEEKS AND NOT STOPPED; This spontaneous report received from a patient concerned a female of unspecified age. 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-JUN-2021, the subject experienced period lasting approximately two weeks and not stopped. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from period lasting approximately two weeks and not stopped. This report was non-serious.
At night I started having body aches and extreme fatigue. The body aches went away by mid morning the next day.  I experienced the extreme fatigue for about 2-3 days. I was exhausted. I also felt dizzy, almost like vertigo. I wanted to let you know I was  COVID positive on 12/30/2020
metallic taste; This is a spontaneous report from a contactable physician (patient). A 41-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced metallic taste on 19Dec2020. It was reported as "He got the Covid-19 vaccine 10 days ago (19Dec2020) and now he's experiencing altered taste specifically, metallic taste for 10 days now". Outcome of event was not recovered.    Information on the lot/batch number has been requested.
Bell's palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's palsy) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L2012 and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Shingles (Shingles virus). Concurrent medical conditions included Diabetes (Sugar).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in July 2021 due to BELL'S PALSY. At the time of the report, BELL'S PALSY (Bell's palsy) outcome was unknown.            Concomitant medication information was not provided.  The patient stated that he received steroids and antiviral medications and stated that they thought it came from the shingles virus.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pain - swelling - very sore, movement limited but getting better. Pt called MD - MD thought maybe it hit a nerve. Just monitor it.
Nausea, Malaise Narrative:  approx 1 hour after injection mild nausea and general malaise developed. nausea resolved in approx 4 hours malaise persisted, cervical and upper thoracic localized muscle pain began and persisted and fatigue worsened to impact daily activity. felt like "mono"; persisted 48 hours before gradually resolving. additionally injection site pain and warmth for about 48 hours (no erythema or edema) Ibuprofen 400mg was take one hour prior to injection ; repeated 4 hours later then 600mg q6hours x 48 hours
Patient seen for first time in July 2022 when she stated the should pain. She has been evaluated by our orthopedics service line for shoulder pain.  She has had 2 MRIs of her shoulders that demonstrate lack of tear.  She received a right shoulder steroid injection with success.  She now has mild pain in her right shoulder.  She does have a very sore indented place on her left shoulder that she was told is a bursitis.  She is unaware if the timing of this indentation in her left deltoid is near receiving a vaccine.  The location does appear to be in a similar place to postvaccine deltoid atrophy.  Will be seen by Neurology.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 20th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 21st August 2018, the patient experienced injection site erythema, feeling unwell, fever, injection site warmth and injection site swelling. SHINGRIX was continued with no change. On an unknown date, the outcome of the injection site erythema, feeling unwell, fever, injection site pain, injection site warmth and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, feeling unwell, fever, injection site pain, injection site warmth and injection site swelling to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient stated that on the same day that she received the injection, she experienced soreness at the injection site. On 21st August 2018, 1 day after vaccination, the patient experienced injection site erythema, feeling unwell, fever, injection site warmth and injection site swelling. The patient stated that the day before reporting, she noticed redness at the injection site that is raised and feels hot to the touch. The patient stated that she was not feeling well and she was running a slight fever. The patient stated that her not feeling well and the fever started afternoon on the prior day before the reporting date. The patient had not been to see her doctor, however, she had a nurse at the school check it out and also reported this to the pharmacy.
mom states when pt had first immun on 22SEP92 that evening had excessive sleepiness, limpness, & paleness; ran temp not higher than 103- mom cant remember temp; by mid morning of 23SEP92 mother stated pt was back to nl;
Patient called on the morning of 3/9/19. She said that left eye lid of her eye was drooping.
Started having hives at random times on my wrists and forearms.  One time each day Tue, Wed, Thur then Friday morning I woke up with my whole forearm on the arm I got the vaccine covered in hives.  After an hour the other arm started having hives then on my stomach.  After Benadryl it stopped. Sun morning at 5:00 am I woke up with hives covering from my elbow to my shoulder on the vaccinated arm. I took Benadryl immediately and it did not spread
I TOOK THE FLU SHOT AT ABOUT 10:00 AM ON NOVEMBER 10, 2003.  THAT AFTERNOON ABOUT 1:00 I STARTED TO HAVE SEVERE STOMACH CRAMPS WHICH CONTINUE ALL AFTERNOON AND NIGHT.  I DID NOT GO TO THE DOCTOR AT THIS TIME. ON WEDNESDAY MORNING THE 12TH MY FINGERS ON MY RIGHT HAND BEGAN TO TINGLING. THIS EVENTALLY CONSUMED MY WHOLE RIGHT HAND WITH THIS SENSATION AND THEN I START TO FILL IT IN THE RIGHT SIDE OF MY FACE.  AT THIS POINT I HAVE BEEN TO THE EMERGENCY ROOM, A CLINIC, FAMILY PHYSICAN AND A NEUROLOGIST.  I AM SCHEDULED TO HAVE A SPINAL TAP DONE ON MONDAY TO CHECK FOR MS AND I SUGGESTED ALSO TO CHECK FOR GBS.
COVID-19; VOMITING; BAD DYSGEUSIA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 05-APR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ibuprofen for drug used for unknown indication, and paracetamol for drug used for unknown indication.  On 28-JUL-2022, the patient experienced bad dysgeusia, and vomiting. On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad dysgeusia, and vomiting, and the outcome of covid-19 was not reported. This report was non-serious.
Started with metallic taste in my mouth when eating food, then progressed to any liquid tasting salty.  Two days after Metallic taste left side of face and moth went numb.  Diagnosis was Bells Palsy.
The baby receive the vaccines at 10:00 AM and by 3:00 PM became pale, shocky and was rushed to the ER. Pt was treated with IV Solumedrol.
Swollen and red area around vaccine administration, per patient yellow pus was coming out, none seen on day of visit 09/12/2016. Only redness observed.
Red and sore with infection Pneumovax 2.5 days achy, temp, sweating.
About 20 minutes after the injection, I had shooting pains up and down my arm for about an hour, along severe pain in the joints/bones of my right wrist. The pains in my arm subsided, however, the intense pain in my wrist and wrist bone still exist. I have tried Voltaren and applying heat, yet the pain returns. Whenever I move my wrist, use my hand with my thumb, type, carry items with my left hand the pain is very intense.
Has been in pain since he got the vaccine because he is used to taking Tylenol, and now he is not.; This is a spontaneous report from a non-contactable consumer (patient).  This male patient (age not provided) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 12Jan2021 at a single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. Past drug history included paracetamol (TYLENOL). He has been in pain since he got vaccine because he is used to taking paracetamol (TYLENOL), and now he is not (as reported). The outcome of the event was unknown.  No follow-up attempts are possible. No further information expected. Information about batch/lot number cannot be obtained.
edema at injection site Narrative: employee states that she is experienced a "rise" where the shot was administered which is dark in coloration and sore to the touch which has yet to resolve
Fatigue; small periodic headaches; This is a spontaneous report received from a contactable consumer (patient). A 32-years-old female patient received BNT162B2, dose 2 via an unspecified route of administration on 19Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Patient received second Covid-19 vaccination on 19Apr2021. The patient stated she got fatigue and small periodic headaches on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
PATIENT WAS GIVEN DILUTED DOSE/SALINE SOLUTION AT APPOINTMENT TIME. PT WAS GIVEN NEW APPOINTMENT 3/21 TO GET THEIR VACCINE AGAIN FOR CORRECT DOSE.
This spontaneous report was received from a physician refers to an approximately 15 month old male patient. On an unknown date, the patient was vaccinated with a dose of M-M-R II (lot #, expiry not reported). On an unknown date, the patient experienced rash that looked like german measles after receiving M-M-R II. The physician stated the patient developed the rash "20 days after" receiving M-M-R II. No medical attention was sought. After asking a few of the safety questions, the physician was not willing to answer any further questions. The outcome of rash was unknown. Additional information is not expected.
Patient received expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was reported that there had been some miscommunication as a coworker in the reporter's facility told that there were some other lot numbers whose expirations dates have been extended.  On 19-Apr-2022, the patient received the first booster dose.  No treatment information was provided.   This case was linked to MOD-2022-546523 (Patient Link).
Patient received first dose of Pfizer vaccine on 3/31/2021. She was admitted to the hospital on 4/7/2021. Per ICU provider note: Patient is a 67-year-old female with multiple comorbid conditions including but not limited to coronary artery disease, pulmonary hypertension, paroxysmal atrial fibrillation, asthma, diabetes mellitus, obstructive sleep apnea, and chronic hypoxemic respiratory failure who was brought to ER by EMS for cardiac arrhythmia. Patient was intubated for respiratory distress in the ER and admitted to ICU.  ASSESMENT AND PLAN Severe septic shock: Blood and urine cultures pending Tracheal aspirate pending Ceftriaxone switch back to cefepime, vancomycin added as well as doxycycline for atypical coverage Continue stress dose steroids Wean pressors for MAP greater than 65, currently requiring levo, vaso-, phenylephrine Procalcitonin was greater than 100 Echocardiogram pending  Acute on chronic hypoxemic respiratory failure: Underlying chronic O2 requirement, as well as COPD and OSA COVID-19 negative Lung protective ventilation as able Tracheal aspirate pending Not stable at present for prone positioning  Elevated troponin: Likely secondary to demand ischemia in the setting of tachycardia Heparin drip added with bolus, continue to trend troponin  Wide-complex tachycardia: Attempted synchronized cardioversion, w/o sustained benefit Continue amio, w/repeat bolus  Metabolic Acidosis: Increased minute ventilation to aide in metabolic acidosis compensation Sodium bicarb amp x2, will add gtt  Recent diarrhea: Flagyl added empirically, no diarrhea since admission, if present will consider C. difficile PCR  Hyperglycemia continue insulin sliding scale  Acute renal failure: Received IV fluid rehydration overnight of approximately 2.5 L, continue to trend  Electrolyte abnormalities: Calcium and magnesium replaced
TDAP vaccine (unknown which brand). Feeling very ill - nausea, headache, no appetite, weak, soreness, chills. No fever. x1 week
inflammed; hot; Raised; This case was reported by a pharmacist via sales rep and described the occurrence of inflammation in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several hours after receiving Shingrix, the patient experienced inflammation, feeling hot and swelling. On an unknown date, the outcome of the inflammation, feeling hot and swelling were unknown.   It was unknown if the reporter considered the inflammation, feeling hot and swelling to be related to Shingrix.  Additional details were provided as follows: Within 48 hours the 1st administration patient reported to reporter that she feels hot, raised, inflamed.  Referred to provider, provider decide that she could proceed with 2nd dose. The reporter agreed to follow up from GlaxoSmithKline.
This spontaneous report as received from a physician concerning a 3 month old male patient with no drug reactions/allergies and no pertinent medical history. On 27-FEB-2014 the patient was vaccinated with the first dose of ROTATEQ, oral (total dose was not reported). There was no concomitant medication. The physician reported that on 16-APR-2014, the patient developed intussusception and blood on his stools after receiving the first dose of either ROTATEQ or ROTARIX. The physician stated that she was not sure which product was administered to the patient and stated that she stocked both products in her office. The physician mentioned that the patient was sent to the emergency room from her office and was then hospitalized overnight  at a medical center. The patient was treated with IV fluids and air enema. On an unknown date, an x ray and an unspecified blood work were performed (no result were provided). At the time of the report, in 2014, the patient recovered from intussusception. The physician considered intussusception as life threatening. The causality between intussusception and ROTATEQ was not provided. Lot number A41FB396A is an invalid lot number for ROTATEQ. Additional information has been requested.
Felt a lot of headache and 38 degree C fever; Felt a lot of headache and 38 degree C fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Felt a lot of headache and 38 degree C fever) and HEADACHE (Felt a lot of headache and 38 degree C fever) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 042B21A and 046A217) for COVID-19 vaccination.     Patient never had COVID positive test or diagnosis.  The patient's past medical history included HbA1C increased (because of inactive insulin she was taking). Concurrent medical conditions included Type 1 diabetes mellitus (started 8 or 9 years ago), Hypothyroidism (Started 8 or 9 years ago), Allergic reaction to analgesics (Paracetamol) and Allergic reaction to analgesics (Acetaminophen). Concomitant products included LEVOTHYROXINE for Hypothyroidism, INSULIN GLULISINE (APIDRA SOLOSTAR) and INSULIN DEGLUDEC (TRESIBA) for Type 1 diabetes mellitus, VITAMIN D NOS and IRON for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PYREXIA (Felt a lot of headache and 38 degree C fever) and HEADACHE (Felt a lot of headache and 38 degree C fever). On 15-Apr-2021, PYREXIA (Felt a lot of headache and 38 degree C fever) and HEADACHE (Felt a lot of headache and 38 degree C fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Body temperature: 38 degree Celsius. On 01-Dec-2021, Body temperature: 38 degree Celsius.         .  On 01-Dec-2021, after receiving first booster dose, the patient felt a lot of headache and 38 degree Celsius fever. That lasted until the second day of 02-Dec-2021.  No treatment information was reported.   This case was linked to MOD-2022-675472, MOD-2022-679419 (Patient Link).   Reporter did not allow further contact