chrisvoncsefalvay/vaers-outcomes huggingface dataset:
big knot in throat, left of adams apple; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (big knot in throat, left of adams apple) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (big knot in throat, left of adams apple). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Feb-2021, OROPHARYNGEAL DISCOMFORT (big knot in throat, left of adams apple) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Patient went to the Doctor and the doctor could not figure it out. No Concomitant medications were reported. The patient had taken steroid.   This case was linked to MOD-2021-038759 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: On 03-May-2021, follow up document was attached in which the outcome of the events is recovered.
Oct. 18 Fri evening pain in right arm at the site to rival a hornet sting. 5 days latter pain, redness, swelling where shot was given in right arm, foggy feeling fatigue, headache, chills, itchy at sight, arm still hurts 13 days latter.
some soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (some soreness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ALPHA LIPOIC ACID, GABAPENTIN, GLIMEPIRIDE, METFORMIN, METOPROLOL, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), COENZYME Q10 [UBIDECARENONE], VITAMIN D [VITAMIN D NOS] and VITAMIN B12 NOS for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (some soreness). At the time of the report, VACCINATION SITE PAIN (some soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-030683 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received on 25-JUN-2021 does not contain any significant information
Vaccines administered on 2-17-09 - says "3 to 4" days after receiving vaccines, client experienced symptoms of fever (102-103), chills, nausea - client presents to Clinic today 2/25/09 for Hep B #2 accel. - says no fever today and symptoms subsiding - client taking accelerated booster series due to international trip schedule in early March 04.
This case was reported by a consumer and described the occurrence of left arm was swollen in a 83-year-old male patient who received FLUARIX QUADRIVALENT (batch number 7239G, expiry date June 2015). The patient's past medical history included blood clot in left leg (Patient takes warfarin because of the blood clot in his leg a few years ago). Concurrent medical conditions included no known drug allergy. Concomitant products included amlodipine, lisinopril, lovastatin, Pneumonia vaccine and warfarin. On 6th October 2014 13:00, the patient received FLUARIX QUADRIVALENT. On an unknown date, the dose was an unknown dose. On 7th October 2014, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced left arm was swollen, concentration difficulty, cannot drive, severe drive, severe allergic reaction, back pain, left arm pain, knee and leg pain, redness in arm, and difficultyto stand up. On an unknown date, the outcome of the left arm was swollen, concentration difficulty, cannot drive, severe allergic reaction, back pain, left arm pain, knee and leg pain and difficulty to stand up were not recovered/not resolved and the outcome of the redness in arm was recovering/resolving. It was unknown if the reporter considered the left arm was swollen, concentration difficulty, cannot drive, severe allergic reaction, back pain, left arm pain, knee and leg pain, redness in arm and difficulty to stand up to be related to FLUARIX QUADRIVALENT. Additional information: Patient reports that around 1:00pm Monday, October 6, 2014, he was administered a FLUARIX QUADRIVALENT vaccine and a pneumonia vaccine in his left arm. He reports that he was fine on Monday, but when he woke up on Tuesday October 6, 2014, he had symptoms of arm pain, redness, and swelling. He also had difficulty concentrating, and could not drive or get out of his chair. On Wednesday, October 8, 2014, the patient consulted with his pharmacist who advised if the reaction worsened that he should go to the ER. The patient went to his doctor on Thursday, October 8, 2014, and the doctor told him that he had a severe allergic reaction that was also neurological in nature to the FLUARIX QUADRIVALENT vaccine. The doctor told him that the reaction would not be from the pneumonia vaccine, and the he would not have gotten the reaction had he got the trivalent flu vaccine. The doctor told him that the reaction could persist for up to two weeks, and he told him to report the experience to the manufacturer. The patient has received flu vaccines yearly for the past 20 years, and he has never had symptoms before.
Pt received her vaccine.  She was waiting in the waiting area for the 15 minutes.  She approached the nurse and said she felt flushed and her tongue felt "heavy".  Patient was seated in a chair and ice packs were applied to nape and face.  Patient complained of pressure in her chest.  Emergency response was called.  Vital signs taken-HR 107; BP 144/78; Oxygen saturation 97% on Room Air.  Taken to Emergency Department by 2 nurses via wheelchair.
Onset of Pityriasis Rosea about 4 days after vaccination.  This is typically self-limited, unclear if this was related to the vaccination or coincidental.
Dull chest/arm/neck pain with some shortness of breath, ekg was performed & normal, discussed possible affected lymph nodes, directed to ice area & take Tylenol for pain
It was reported in a published article that a male patient's mother received a booster dose of rubella virus vaccine live (second generation) the postpartum period in 1987. The patient had speech and language difficulties and was enrolled in a special education program. The author noted that vaccination can be frequently associated with early onset autism. It was also reported that in spite of its limitations, this study suggests that an autism/vaccine connection may exist. Upon internal review, speech difficulties was considered to be an important medical event (OMIC). It was unknown if medical attention was sought.
Hives; Dermatographia; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and MECHANICAL URTICARIA (Dermatographia) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Dec-2021, the patient experienced URTICARIA (Hives) and MECHANICAL URTICARIA (Dermatographia). At the time of the report, URTICARIA (Hives) and MECHANICAL URTICARIA (Dermatographia) had not resolved.            No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. It was reported that patient height was 6 feet 2 inches.
Allergic reaction that took the form of hives that started 18-24 hours after the shot. It was located on the left side of the neck (same side as the injection). It was small the first 2 days, then began to grow. The biggest it got was on Monday, August 23rd, where it was red, itchy, site and was hot to the touch, and breaking out. We went to Apex Pediatrics on Tuesday, August 24th. They said she could take Benadryl  if needed to sleep and was prescribes a topical steroid: Mometasone 0.1% Cream 15 GM - Apply topically to the affected area every day as needed for rash.
No additional adverse event; a patient was administered an expired VAQTA; This spontaneous report as received from a nurse refers to a 12-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On 04-MAY-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) injection, lot # S002507, expiration date 04-APR-2020 (dose and route of administration were not reported) for prophylaxis. No additional adverse effects were reported.
pt recv vax 19AUG97 & 1wk p/vax pt exp inc in transaminase & alk phosphatase;pt current condition is unk;
Pt has a large swollen lump on L arm. Area as per grandmother is red and swollen and the size of the bottom of a coffee mug.
Sore left arm from 2/16/2021 thru 02/18/2021.  Extreme fatigue and  tiredness from 02/17/2021 thru 02/18/2021
Fever; chills; sweating; aches; nausea; vomiting; fatigue; sore arm ((at site of injection); This is a spontaneous report from a contactable Consumer. This 28-Year-old non-pregnant female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 03Mar202 at 05:30 PM on left arm as dose 1, single for COVID-19 immunization. The medical history of the patient included allergy to dogs, cats, pollen allergy, fruit and vegetable allergy. The patient did not have covid prior vaccination and was tested for covid post vaccination. The patient's concomitant medications were not reported. It was mentioned that patient did not receive other vaccine in four weeks. On 04Mar2021 at 02:00 AM the patient received fever, chills, sweating, aches, nausea, vomiting, fatigue and sore arm (at site of injection). No treatment was received for events. The patient was recovering.  No follow-up attempt was possible. information about lot/batch number could not be obtained.
Took First dose of vaccine more than 42 days ago and is yet to get a second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Took First dose of vaccine more than 42 days ago and is yet to get a second dose) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CABERGOLINE for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Took First dose of vaccine more than 42 days ago and is yet to get a second dose). On 24-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Took First dose of vaccine more than 42 days ago and is yet to get a second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Neck pain prior to getting vaccinated and after the vaccination was administered the pain had worsened; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain prior to getting vaccinated and after the vaccination was administered the pain had worsened) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Neck pain prior to getting vaccinated and after the vaccination was administered the pain had worsened). At the time of the report, NECK PAIN (Neck pain prior to getting vaccinated and after the vaccination was administered the pain had worsened) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient inquired about contraindications of OTC pain medications and the vaccine. Treatment information was unknown.
Bruise at injection site; Second dose of BNT162b2 was received on 18th day after the first dose; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 06Apr2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not allergic to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 19Mar2021 at 09:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 20:30, the patient experienced a bruise at injection site. Even after 2 weeks of vaccination the bruise at injection site was ongoing. This patient did not experienced bruise at injection site with the first dose of vaccination. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event bruise at injection site was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
After 4-5 hours, soreness at injection site began. After 7 hours, body began feeling as though fight low fever and flu-like fatigue; patient then took 1-500 mg TYLENOL. Both symptoms above continued to worsen during following 12 hours and added headache; at hour 21, patient took second 500 mg TYLENOL. During day 2, patient slowly began recovering; by late day 2 (after second night's sleep) patient felt fully recovered.
Information has been received from a nurse practitioner concerning a patient who on approximately 24-AUG-2007 was vaccinated with a dose GARDASIL and fainted immediately thereafter. Subsequently, the patient recovered in the office and was monitored by the nursing staff. No other symptoms or treatment reported. Additional information has been requested.
UNABLE TO WALK; LOSS OF TASTE; LOSS OF SMELL; WEAKNESS GENERALIZED; FATIGUE; HEADACHE; FEVER; This spontaneous report received from a patient via a company representative 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination.  The Company is unable to perform follow-up to request batch/lot numbers .No concomitant medications were reported. On an unspecified date, the subject experienced unable to walk, loss of taste, loss of smell, weakness generalized, fatigue, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and the outcome of fatigue, headache, weakness generalized, loss of taste, loss of smell and unable to walk was not reported. This report was non-serious.
EE received influenza vaccine at 1012. At approximately 10:30 she notified staff that she was experiencing numbness in the right arm. Describes as numbness and tingling down the entire arm into her hand. Saw PCP. In consultation with Infectious Disease was diagnosed with atypical Guillain Barre syndrome. No specific treatment recommended at this time.
Mother states that after 4 and 6 months immunizations patient developed fever and pharyngeal inflammation/ulercations.  Along with hand and foot and body rash.  Today 94days s/p 12 month immunizations) patient has fever to 104 and pharyngeal redness with small ulcerations.  No skin findings at this time.
Red, raised quarter sized rash in upper part of left arm. Right thigh also presents with red, raised rash. Complaint of urticaria at both sites. Both sites now presenting as less red and raised.
4/26/2021 i started experiencing symptoms of erectile dysfunction, when i stand up it is harder to get an erection, when i lie down with my legs/upper body lifted it is easier to get an erection, but still so much more harder and not as long lasting / strong / doesn't throb with my heart beat as it used to, i was able to get an erection on 4/26/2021 , and today 4/27/2021 i have not yet had one, despite trying to stimulate and what usually would work for me to get an erection has not worked yet.
Pt.'s Caretaker states that after receiving the 2nd dose of Moderna 05/02/2021, started experiencing symptoms 09/12/2021 of Positive Covid + 09/20/2021, 09/12/2021  Acute Ascemic Temperal Lobe Stroke, 09/22/2021 home-care.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 3:03 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 16-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patients were given doses from vials that were stored in an ultracold freezer which was colder than should had been. Vaccine was stored in an ultra cold freezer at minus 82 degrees Fahrenheit. Storage condition at the time of the excursion was frozen storage and excursion duration was 1 month. Date when vials moved from freezer to refrigerator was 19 NOV 2021 and Moderna Covid 19 vials went from the super cold freezer to the refrigerator. No vaccine state changes were noticed and vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. There was no concomitant and treatment list was provided by the reporter.   This case was linked to MOD-2021-402935 (Patient Link).
Arm tenderness; Arm redness; Arm is hard; Chills; Arm soreness; Body aches; Felt rotten; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Arm tenderness), ERYTHEMA (Arm redness), PAIN IN EXTREMITY (Arm soreness), PAIN (Body aches) and FEELING ABNORMAL (Felt rotten) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), PAIN (Body aches), FEELING ABNORMAL (Felt rotten) and CHILLS (Chills). On 14-Mar-2021, the patient experienced TENDERNESS (Arm tenderness), ERYTHEMA (Arm redness) and INDURATION (Arm is hard). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-Mar-2021, PAIN IN EXTREMITY (Arm soreness), PAIN (Body aches), FEELING ABNORMAL (Felt rotten) and CHILLS (Chills) had resolved. At the time of the report, TENDERNESS (Arm tenderness), ERYTHEMA (Arm redness) and INDURATION (Arm is hard) outcome was unknown. Unknown          Concomitant medications reported included steroids oral 5mg qd chronically.   Treatment for the events included paracetamol and cold compress. Action taken with mRNA-123 is not applicable.
Vaccine expired on 08 Nov 2021, moved to refrigerator on 11 Nov 2021, Administered on 12 Nov 2021; Dose administered after expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 08 Nov 2021, moved to refrigerator on 11 Nov 2021, Administered on 12 Nov 2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 08 Nov 2021, moved to refrigerator on 11 Nov 2021, Administered on 12 Nov 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 08 Nov 2021, moved to refrigerator on 11 Nov 2021, Administered on 12 Nov 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Date moved to refrigeration 11 Nov 2021. No treatment information was reported.   This case was linked to MOD-2022-570637, MOD-2022-570643 (Patient Link).
Patient developed ascending sensory loss and lower extremity weakness beginning about 11-5-10. Received INFLUENZA vaccine 10-27-10 during inpatient stay for lumbar decompression related to spinal stenosis.