chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pins & needle feeling in my limbs especially my finger tips to the point I couldn't open a fruit snack; Extreme pain & pressure in my head, ears, & jaw; Extreme pain & pressure in my head, ears, & jaw; Extreme pain & pressure in my head, ears, & jaw; Extreme pain & pressure in my head, ears, & jaw; Blurry vision; muffled sounds; balance was off; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2022 09:30 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma, Arthritis; "Arthritis" (unspecified if ongoing), notes: Other medical history: Asthma, Arthritis. The patient had no known allergies. The patient's concomitant medications were not reported. Patient did not receive other vaccine in four weeks and not received other medications in two weeks. Covid prior vaccination and covid tested post vaccination was reported as no. The following information was reported: PARAESTHESIA (disability) with onset 15Jan2022 08:00, outcome "not recovered", described as "pins & needle feeling in my limbs especially my finger tips to the point I couldn't open a fruit snack"; PAIN (disability), HEAD DISCOMFORT (disability), EAR DISCOMFORT (disability), PAIN IN JAW (disability) all with onset 15Jan2022 08:00, outcome "not recovered" and all described as "Extreme pain & pressure in my head, ears, & jaw"; VISION BLURRED (disability) with onset 15Jan2022 08:00, outcome "not recovered", described as "Blurry vision"; HYPOACUSIS (disability) with onset 15Jan2022 08:00, outcome "not recovered", described as "muffled sounds"; BALANCE DISORDER (disability) with onset 15Jan2022 08:00, outcome "not recovered", described as "balance was off"; VOMITING (disability) with onset 15Jan2022 08:00, outcome "not recovered", described as "vomiting". Therapeutic measures were not taken as a result of paraesthesia, pain, head discomfort, ear discomfort, pain in jaw, vision blurred, hypoacusis, balance disorder, vomiting. It was reported that extreme pain & pressure in her head, ears, & jaw! It effected all of her senses! Blurry vision, muffled sounds, balance was off, pins & needle feeling in her limbs especially her finger tips to the point she couldn't open a fruit snack & vomiting.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On the following below listed dates multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB lot # L027733 expiry date of 13-SEP-2017. On 09-FEB-2016 and 13-FEB-2016 the RECOMBIVAX HB, was exposed to a lowest temperature of + 1.0 degree centigrade for 29 minutes and 30 minutes respectively. On 10-FEB-2016, 11-FEB-2016, 14-FEB-2016 and 16-FEB-2016, RECOMBIVAX HB, was exposed to a lowest temperature of + 1.2 degree centigrade for 25 minutes, 22 minutes, 24 minutes and 34 minutes respectively. On 12-FEB-2016, RECOMBIVAX HB, was exposed temperature of +1.3 degree centigrade for 21 minutes. On 15-FEB-2016, RECOMBIVAX HB, was exposed to a lowest temperature of +1.1 degree centigrade for 25 minutes. On 17-FEB-2016, RECOMBIVAX HB, was exposed temperature of +0.0 degree centigrade duration not reported. On 18-FEB-2016, RECOMBIVAX HB, was exposed to a lowest temperature of -1.0 degree centigrade for 12 hour 29 minutes. On 19-FEB-2016, RECOMBIVAX HB, was exposed to a lowest temperature of -1.1 degree centigrade 12 hours 1 minute. Also reported that the vaccine was administered on an unspecified date from 20-FEB-2016 to 29-FEB-2016. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB, lot # L033343 with an expiry date of 13-SEP-2017. Dosing details were not provided. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
EE starting with migraine about 5 minutes after receiving vaccine. That night had rash to trunk and back with the chills. Took benadryl that night. Next am, had swollen eyes and hands. Within 24 hours,those sx resolved- but then had 48 hours of sx similar to past covid infection.
BUD in refrigerator of 70 days was exceeded by 1 day. Expiration of product is 09/30/22 but 70 days under refrigeration was 08/12/2022. Vaccine was given 11:30am on 08/13/2022. No ADE from patient reported.
pt states her heart started beating out of control.  She was SOB and had some burning and pain in her chest.  Her heart rate was 235.  She went to the Hospital ER.  They did lab work (troponin levels were high), CT and EKG (abnormal results).  She was given O2 and was given a medication.  Her DX was Supraventricular Tachycardia.  She was released to go home w/ supervision.  She was told to FU w/ a Cardiologist.  She saw a doctor on 4/7/2021.  She had EKG and echo.  Both test were normal but pt was told she could have another episode.  She will FU in 6 months.
Case was vaccinated for Covid in June 2021, then hospitalized for Covid in January 2022. Hospitalized at:  Hospital.  * COVID Assessment & Plan Patient had diagnosis January 6 Progressing shortness of breath and mild hypoxia, chest x-ray findings consistent with viral pneumonia -Exacerbation of asthma as likely to contribute to her present symptoms ? Order Tessalon for cough, albuterol inhaler, and dexamethasone 6 mg daily -- titrate oxygen to 90-94% ? Given duration of illness remdesivir is not ordered.   Acute hypoxemic respiratory failure due to COVID-19 Assessment & Plan Pt admitted on 1/18: required 2 liters supplemental oxygen to maintain sat > 90.    Plan:  Titrate oxygen to 90-94%
Hives approx 3 days following local rxn which occured 24 hrs post vax;
Severe migraine, muscle aches, cough, fever, cold sweats and muscle fatigue.
Temperature 100 + for 3 days Achy, flu like symptoms for 3 days General lack of energy Stayed in bed 2 days Fine after that
Pt vaccinated with Typhoid/Fluzone developed swollen lt arm elbow to shoulder, hot to touch, not too painful. Pt did not apply ice packs as directed when vaccinated nor take ASA or Tylenol. This is the 2nd of this series.
4cm by 3.5 cm area on (L) upper arm.(+) indurated erythema non tender, slightly warm to the touch-itching-not painful -occurred 24 hours after shot.
A report was received from a health care professional on 10/20/2003, concerning an unknown number of children under 4 years of age who inadvertently received the Fluvirin vaccine on 10/15/2003. The reporter was uncertain how many children were vaccinated. At the time of th report no adverse events had occurred. There was insufficient information to determine the reporter's causality assessment. Update1, 11/25/2003: Follow up information received from a health care professional indicated that a 1 year old male vaccinee had been inadvertently administered a dose of Fluvirin instead of Fluzone between 10/06/2003 and 10/16/2003. No adverse event as reported at the time of report.
infanrix/ Patient was 85.; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 85-year-old male patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   The patient's past medical history included surgery (had stem cell surgery).   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The 85 years old patient received Infanrix, which led to inappropriate age at vaccine administration. The reporter did not consent to follow up.
Patient complained of arm pain after flu shot was given. She said pain went away after a few day the returned and worsened to the point that she could not lift her arm and requires help with dressing. She has visited MD 2 times.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 16-OCT-2012 18:01, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of the event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient states she had fever, and a large knot on her arm for a two days after the vaccine. Patient received the vaccine 12/18/18 and reported the symptoms 12/21 while picking up another medication. By 12/21 symptoms were begining to resolve. Did not seek treatment. State she did not have problems with the first shot.
patient started to feel hot and wheezing. wheezing appeared to worsen and he started reporting acid reflux. patient had his asthmatic inhaler and took it with no resolution of symptoms. patient was given a cold compress for his head and neck to help cool him down. EMS came in and checked his vitals. He was cleared after patients symptoms resolved.
Clts was living with father, recently moved back to mother's care.  HD called provider for IMMs record at which time there was 1 sheet received, with 1 Gardasil recorded. There was only the 1 recorded on MICR. This RN administered HPV on 4/12/2011 as 2nd dose.  There was a subsequent fax that came to the HD after clt's visit that 3 doses of HPV vacc. recorded.  The 4/12/2011 dose was then clts. 4th dose.
Information has been received from a woman in a physician's office concerning a 23 month old female who on 1/20/99 was vaccinated with MMR. On 5/29/99, the pt was dx'd with measles following a physician's visit. Additional information has been requested.
Pt was administered H1N1 immunization at 09:40. She began to feel lightheaded and diaphoretic, states "I think I am going to pass out". Ammonia cap placed under nose to prevent pt from losing consciousness. At 09:45 pt lost consciousness. Attempted to arouse pt by calling her name and also activated EMS. BP checked 104/52, HR 41. O2 at 6 LPM started. O2 sat at 100% on O2. Pt head lowered without feet elevated. Returned consciousness at approx 1 min. EMS arrived, BP 116/67, HR 52. Pt feels nauseous when EMS assisted pt to stand up. HR 99. Pt. transported to hospital.
Per Dr, pt has 24 inch rash from thigh to ankle, 6 or more satellite lesions and was tender to touch.
Patient has a hx of cardiac pacemaker, mild cognitive impairment, aflutter on Eliquis, aortic valve disease s/p AVR, BPH/LUTS, urinary retention requiring foley catheter placement x approx. 1 year.. Patient was seen for routine home visit by Nurse Care Manager on May 8, 2023 at 1100. Patient was administered Moderna COVID-19 bivalent booster around approx. 1115, and was observed for remainder of Nursing visit until completed at 1200 w/o evidence of acute reaction/side effects, stable vital signs and examination. Patient had received COVID-19 Moderna vaccines in the community x 3 w/o documented or reported side effects. The Team was informed on May 10, 2023 that the patient was found deceased in his home on May 9, 2023 and was pronounced so by EMS at 1636. Due to timing of patient receiving vaccine and patient's time of death, it was discussed to enter a report for continuity of care.
His arm is blac and blue and fairely bruised; Lethargy; He began experiencing fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HAEMORRHAGE (His arm is blac and blue and fairely bruised), LETHARGY (Lethargy), PYREXIA (He began experiencing fever) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced INJECTION SITE HAEMORRHAGE (His arm is blac and blue and fairely bruised), LETHARGY (Lethargy), PYREXIA (He began experiencing fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, INJECTION SITE HAEMORRHAGE (His arm is blac and blue and fairely bruised), LETHARGY (Lethargy), PYREXIA (He began experiencing fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 101.5 f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
difficulty swallowing without water; tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (difficulty swallowing without water) and TINNITUS (tinnitus) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPHAGIA (difficulty swallowing without water) and TINNITUS (tinnitus). At the time of the report, DYSPHAGIA (difficulty swallowing without water) and TINNITUS (tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Pt noted a faint red rash around the injection site.  It was about 1/2" X 1&1/2" in the shape of a lenthwise oval.   It does not itch.
Violently vomiting, severe abdominal pain, headache, chills, abdominal cramping
Tingling and numbness around lips, front part of tongue and around mout; Tingling and numbness around lips, front part of tongue and around mout; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tingling and numbness around lips, front part of tongue and around mout) and HYPOAESTHESIA (Tingling and numbness around lips, front part of tongue and around mout) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA ORAL (Tingling and numbness around lips, front part of tongue and around mout) and HYPOAESTHESIA (Tingling and numbness around lips, front part of tongue and around mout). At the time of the report, PARAESTHESIA ORAL (Tingling and numbness around lips, front part of tongue and around mout) and HYPOAESTHESIA (Tingling and numbness around lips, front part of tongue and around mout) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Rash developed on back of neck; patchy hives. C/O itchiness, painful to touch. No resp. sx.
Migraine Headache, Nausea, Vomiting, Pain at injection cite the morning after the injection.
TESTED POSITIVE FOR COVID AFTER THE VACCINE; 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced tested positive for covid after the vaccine. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid after the vaccine was not reported. This report was non-serious.
Patient describes development of metallic  taste and headache after vaccine administration . No other symptoms reported . No dizziness , sob, difficulty ambulating / standing noted . Patient sent home with ER precautions  and told to follow-up with PCM.
T1D; This is a spontaneous report from a contactable consumer. A 15-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 12Jul2021 10:00 (Batch/Lot Number: EW0178) at the age of 15 years old as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. The patient has no known allergies. There were no concomitant medications (other medications in two weeks none). Historical vaccine included bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE) received by the patient on 21Jun2021 10:00 (Batch/Lot Number: EW0167) administered in left arm as dose 1, single (at the age of 15 years old) for COVID-19 immunization. No other vaccine received in four weeks. The patient experienced T1D (Type 1 Diabetes Mellitus) on 16Aug2021 12:00. The patient was hospitalized for T1D for 3 days. Therapeutic measures were taken as a result of T1D which included insulin. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient has no history of COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination. Outcome of the event was recovered/resolved with sequelae (recovered with lasting effects).
shoulder and injection site pain of both shoulders; shoulder and injection site pain of both shoulders/ left shoulder he has pain 10-20% of the time/ "feels like I was hit with brick"; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (shoulder and injection site pain of both shoulders) and ARTHRALGIA (shoulder and injection site pain of both shoulders/ left shoulder he has pain 10-20% of the time/ "feels like I was hit with brick") in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (shoulder and injection site pain of both shoulders) and ARTHRALGIA (shoulder and injection site pain of both shoulders/ left shoulder he has pain 10-20% of the time/ "feels like I was hit with brick"). At the time of the report, VACCINATION SITE PAIN (shoulder and injection site pain of both shoulders) and ARTHRALGIA (shoulder and injection site pain of both shoulders/ left shoulder he has pain 10-20% of the time/ "feels like I was hit with brick") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment medication include Advil, Tylenol. Ice and heat alternation.   This case was linked to MOD-2021-314550 (Patient Link).
Injection site pain; dose administered after beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (dose administered after beyond use date) and VACCINATION SITE PAIN (Injection site pain) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 025C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (sulfa), Allergy to homeopathic drugs (fish oil), Hyperlipidemia since 14-Nov-2017, Chronic lymphocytic leukemia since 30-Apr-2018, Type 2 diabetes mellitus since 08-Feb-2017, Chronic candidiasis since 25-Jan-2017, GERD, Arrhythmia, Heart failure and Candidiasis. Concomitant products included AMIODARONE from 28-May-2021 to an unknown date for Arrhythmia, FLUCONAZOLE from 25-May-2021 to an unknown date for Candidiasis, PANTOPRAZOLE from 31-Mar-2021 to an unknown date and SUCRALFATE from 22-Mar-2021 to an unknown date for GERD, METOPROLOL SUCCINATE from 28-May-2021 to an unknown date for Heart failure.   On 26-May-2021 at 11:52 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced OFF LABEL USE (dose administered after beyond use date). On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site pain). On 26-May-2021, OFF LABEL USE (dose administered after beyond use date) had resolved. At the time of the report, VACCINATION SITE PAIN (Injection site pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jul-2021: No new information received. On 06-Jul-2021: Updated information included dose 1 time and dose 2 details, patient's race, ethnic group, medical history and concomitant medications.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy was not provided. On 24-JUL-2017, the patient was vaccinated with a dose of GARDASIL 9 (dosing details were not provided) for prophylaxis (extra dose administered and inappropriate schedule of drug administration). Reporter mentioned that the patient already received 3 doses of GARDASIL on 24-JUL-2008, 10-OCT-2008 and 31-MAR-2009, respectively. No adverse symptoms were reported. Additional information is not expected as the reporter did not wish further contact.
Bad headache and pressure in back of neck, along with extreme soreness at injection site and numbness/tingling to fingers on same side.