chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rigors; Chest pain; pyrexia; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Rigors), CHEST PAIN (Chest pain) and PYREXIA (pyrexia) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM inhalation gas for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension.   On 22-Apr-2021, the patient started TREPROSTINIL SODIUM (unknown route) at an unspecified dose four times per day. On 29-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-2021, the patient experienced CHILLS (Rigors) (seriousness criterion hospitalization), CHEST PAIN (Chest pain) (seriousness criterion hospitalization) and PYREXIA (pyrexia) (seriousness criterion hospitalization). The patient was hospitalized from 30-May-2021 to 31-May-2021 due to CHEST PAIN, CHILLS and PYREXIA. At the time of the report, CHILLS (Rigors), CHEST PAIN (Chest pain) and PYREXIA (pyrexia) outcome was unknown.            Concomitant and treatment medications were not provided.  Based on current available information and the temporal association between produce use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between produce use and the start date of the events a causal relationship cannot be excluded.
Red rash started on right forearm over the next three days the rash spread to trunk, thighs, and groin starting as small red papules growing to macules with areas of violaceous hue seemed pruritic.
Swollen lymph nodes; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I feel a little tired; Did not sleep well; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer sponsored program.   A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 31Jul2021 at 09:30 am (Batch/Lot Number: EW0182) as dose 1, single for covid-19 immunization (at the age of 62-years-old). The patient medical and concomitant medications were not reported. It was reported that after receiving the first dose of vaccine on an unspecified date in 2021, the patient felt a little tired and did not sleep well. The patient further stated she was calling also because she wants to know if ever she will feel headache or something and fever, what does she need to take as a medication. She was scheduled for the second dose on 21Aug2021 at 9:30am. She further stated that she was feeling okay and she felt a little tired because she did not sleep well last night and it might be from that and she was not sure. The outcome of the event was unknown.
approx 20-30 minutes after injection: tingling lips & tongue, which then turned numb. Inability to take deep breath. Severe difficulty swallowing. Difficulty getting words out, then slurring of words/poor pronouncing of words. Foggy head. Poor balance.
Information has been received from a physician concerning an 8 year old male pt who in approx. October 2000, was vaccinated with hep b vaccine recombinant. In approximately October 2000, the pt developed hives. Subsequently, the pt recovered from hives. Additional info has been requested.
initial soreness at injection site (Left Shoulder) A couple days after the shot that soreness subsided but started experiencing tightness in left chest/heart area. Will experience the tightness for a period of time then it will go away. More prevalent with activity, and is accompanied with shortness of breath as well.
patient awoke to find upper arm from above injection site to elbow ecchymotic, with firm painful area at site of injection.  Patient did see personal physician 11/24/09.
My daughter had a lot of swelling and rash on her arm the day she got the shot in her left upper arm. The next day she woke up with a cough which I thought she may have caught a cold. Days go by and she has low-grade fevers and cough. By Wednesday, she has 103 fever and severe cough. I brought her to Urgent Care and they said her ears were red and gave an antibiotic. Saturday morning, she was still feeling ill. I brought her back and they preformed a chest x-ray where they found pneumonia in her left lung.
Localized reaction started one day after receiving injection. Redness, itching, pain at site of injection with red raised spots. Ten days later 18 cm x 20 cm red area, with central nodule: Apply cold compress, BENADRYL/TYLENOL.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 68-year-old female patient who received SHINGRIX (batch number 95LX9 ?, expiry date February 2019) for prophylaxis. On 1st August 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 3rd August 2018, 2 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced rash on her stomach. The batch number reported was not available as per sales data sheet, clarification was raised however no reply was received.
I had very tinder lymph nodes.  I had a very sore arm, fatigue, and leg muscle pain. These other symptoms lasted for about 3 days but the leg muscle pain are still ongoing.
Redness at injection site, about 1 and 1/2 inches in diameter.
Fever recorded after home Tylenol @>103. Seizure-like symptoms (whole body twitching, excessive blinking, screaming cry). Recurrence x5.
17 yr old patient received first dose; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 yr old patient received first dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 yr old patient received first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 yr old patient received first dose) outcome was unknown. Not Provided      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.
Numerous small scattered erythematous papules, many with vesicles - spread across entire body, pruritic, some coalescing on the hands, and large erythematous almost purple plaques on both heels.
The significant correction has been performed on 30 December 2016 to add narrative. Initial unsolicited report received from a pharmacist via other company (Pfizer) (Manufacturer Report Number: 2016558876) on 19 December 2016. This case involves three male patients under the age of 65 years they were vaccinated  with a dose of INFLUENZA VACCINE (FLU VACCINE) other company product and PNEUMOVAX 23 other company product (Merk) (batch number and expiratory date was reported as unknown for both vaccines) (dose, dose in series, route and site of administration was not reported for both vaccines) on an unspecified date. The patient's medical history and concomitant medications were unknown. On an unspecified date, following the vaccination, the patients experienced fatigue. Relevant laboratory data was not reported. Corrective treatment was unknown. The outcome of event was reported as unknown.  The reporter assessed the causal relationship with POLYSACCHARIDE and PNEUMOVAX 23 as related. List of documents held by sender: none.
On R arm, at the site of DTaP vaccine, arm became red, warm, ruddy and swollen ( about 1.5 times the size of his other arm, this was measured) from elbow to top of shoulder. Patient also developed a fever of 102.4 the night of receiving the vaccine.
Patient received booster dose of Moderna vaccine in left arm at around 10:03 am on Friday, 11/19/21. A few minutes after vaccine administration patient complained of "weird metallic taste" in her mouth and was offered a bottle of water. After a few sips of water patient complained of a "tingling sensation" down left arm. Patients BP was checked and was 148/99. patient was then escorted upstairs to  see nurse practitioner. I am unsure what tests/laboratory results were completed. As patient was coming down the steps she said she "hurt all over and was nauseated". Patient was helped down the stairs were she said she felt lightheaded and was having trouble breathing. Nurse practitioner listened to patient and said she was starting to wheeze and needed epinephrine. Pharmacist (me) called emergency number and administered 0.3 mg of epinephrine via auto injector. Patient began to shake all over and said she was still struggling to breath. patient was given 25 mg of liquid benadryl. The nurse then brought a solu medrol shot and administered it to patient in hip. Ambulance arrived a few moments later and took patient to Hospital.
aches for a short period of time; Chills/ body chills; soreness in the arm from the needle; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (aches for a short period of time), CHILLS (Chills/ body chills) and VACCINATION SITE PAIN (soreness in the arm from the needle) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (aches for a short period of time), CHILLS (Chills/ body chills) and VACCINATION SITE PAIN (soreness in the arm from the needle). At the time of the report, MYALGIA (aches for a short period of time), CHILLS (Chills/ body chills) and VACCINATION SITE PAIN (soreness in the arm from the needle) 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.   Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-221084 (Patient Link).
PT RECEIVED A MILD CASE OF VARICELLA AFTER RECEIVING 2 DOSES OF VARIVAX VACCINE. THIS WAS BREAKTHROUGH ILLNESS. VARICELLA REPORT IN CDRSS CASE ID 463810
No adverse event; accidentally given a bivalent booster dose; first dose more than 35 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (accidentally given a bivalent booster dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose more than 35 days ago) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Nov-2022, the patient experienced INCORRECT DOSE ADMINISTERED (accidentally given a bivalent booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose more than 35 days ago). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (accidentally given a bivalent booster dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose more than 35 days ago) and NO ADVERSE EVENT (No adverse event) outcome was unknown.    For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INCORRECT DOSE ADMINISTERED (accidentally given a bivalent booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose more than 35 days ago).    Concomitant drugs were not reported. It was reported that patient received dose 1 of Moderna on 09-Feb-2022 and wanted to receive second dose but instead was administered bivalent booster dose. Treatment medications were not provided.
The patient briefly fainted.  The patient had to sit for about 1/2 and hour and did eat a granola bar.  I tested her blood pressure and it was normal.
Since receiving the shot, I?ve had pain in my upper arm. It has gotten significantly worse, now affecting my shoulder. MRI diagnosed it as tendinitis of the rotator cuff.
Infant had fever over 100 degrees Fahrenheit for over 7 days.  On day 4, fever was 101.4.  The night infant received vacination - the baby did not eat for 15 hours afterwards and was lethargic for 72 hours.
Information has been received from a physician concerning his current approximately 36 month old son who on an unspecified date was vaccinated with the first dose of MMR II (Lot # not provided). The physician reported that his son experienced toxic synovitis after a shot of MMR II. Also experienced pain in the hip and was unable to walk. Four or five days after "it took place" the patient recovered. The patient sought unspecified medical attention. No further information is available.
Initial misuse report received from health care professional on 03 June 2013. A dose of TENIVAC vaccine was administered to a patient instead of ADACEL. No adverse event was reported. List of documents held by sender: none.
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-AUG-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N000683 with expiry date: 06-JAN-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Only had a subtle headache day after first dose.   About 15 minutes after the second dose, I experienced a lot of brain fog and mild confusion. Sweats, fatigue, and fever began about 9 hours after injection. About 11 hours after injection, I experienced nausea, headache, chills, fever of 99.4. All of the symptoms stated lasted until I woke up the next morning.
pt devel rash noted all over by body rash;woke up 7AM 14AUG98 started to have noc mucoid stools;loose stool x3 w/cough;no fever;scattered erythema blanching, maculopapular rash;T99R;
Pt c/o fever, body aches (extremely bad), chills, runny nose, nasal congestion, headache, nausea, dry heaves.
Losing vision in her right eye; The eye, sight issues or anything to do with the optic nerve; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Unknown), via an unspecified route of administration in Mar2021 for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), via an unspecified route of administration for COVID-19 immunization. Caller stated she had the second dose of the Pfizer covid 19 vaccine the end of March. Caller was wondering if there were any side effects linked to the vaccine that were related to the eye, sight issues or anything to do with the optic nerve. Caller stated she was losing vision in her right eye. Caller stated they were having trouble diagnosing the cause. she just got out of the hospital. she had no history of any eye issues or optic nerve issues. she was calling about the Covid Vaccine. she was just wondering if Pfizer has seen any side effects linked to the vaccine relating to the optic nerve, eye or sight issues. Caller states that she does not know if she needs to report it. She does not know if it was from the vaccine. She just knows that before she had no eye issues. States she had the second shot at the end of March. She was recently at the hospital because she was losing sight in her right eye. Caller states they were having a hard time diagnosing what was going on. States her CAT scan, MRI, and spinal tap didn't show anything. Says she was told her optic nerve was having trouble sending messages to her brain. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Screaming for hours approx 4 hrs post vaccination. Significant swelling at vax site, L leg.
Headache. 11:00 PM hives on neck, chest, arms. Took Benadryl.  Hives gone by midnight. Headache lasted all day, 9/24/2013.
Infected Abscess. Treated with Augmentin x R T po BID x 10 days. Culture sent to lab.
lymph nodes inflammation Pain at the side of the shot Throughout the rest of my body: Tiredness. Headache. Muscle pain. Chills. Fever.
pain in the arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm). At the time of the report, PAIN IN EXTREMITY (pain in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment information was provided.
5 days of fever at injection site. Arm hurts from elbow to shoulder.  100.6 temp on Friday and 99.8 on Sunday. Continued fatigue still on day 5.
Received vaccinations, to include second anthrax, in process of deployment.  Within 24 hours, the patient reports joint and surrounding tendon pain in the left knee.  Patient denies any trauma to the knee or leg.  The pain has continued and progressed to the point that he now limps.  The pain has migrated from the lateral aspect of the left kneecap to the ligaments and tendons surrounding the kneecap.  He was seen at the clinic 7 May 2004 and diagnosed with patellar tendonitis.  He was given a profile allowing tennis shoes instead of boots  and physical therapy was recommended.  The patient did not pursue physical therapy.  He now wears an ace bandage, applies Ben Gay and takes Motrin continually to control the pain.  He has not had a pain free interval since this began.
About 3 hrs after vaccination on 9/26/16, I was unable to move left shoulder, and arm. Throughout that night I experienced pain in arm and shoulder(moderate). I had to us (R) hand to undress. On 9/27/16 I call Dr office. Gradually improved thru week. Still experience occasional tenderness in upper (L) arm. Still have occasional tenderness in upper (L) arm 12/07/16.
This spontaneous report has been received from a Registered Nurse refers to a 13-year old patient of unknown gender. The patient's medical History, concurrent conditions and concomitant therapies were not reported. On 01-SEP-2017, the 13-year old patient received the improperly stored dose of GARDASIL 9 (lot # N000326, expiration date 14-OCT-2017; dosing details unknown) for prophylaxis. The temperature excursion occurred on an unknown date at a temperature of 35.4 Fahrenheit (F) for a time frame of 8 hours. The previous temperature excursion was at 34.9F for a time frame of 2 hours. The call was because of a data logger. No adverse effects were reported. Sender's Comments: US-009507513-1710USA004063.
patient ears and throat became itchy, patient began to cough and gasp for air.  EpiPen was administered a couple of minutes after and the paramedics were called , Patient was vomiting but started coughing less after EpiPen,  Paramedics arrived after about 10 minutes, Patients vital signs improved by the time they arrived. They took her to hospital emergency where she was given Benadryl and another EpiPen, She was released from hospital later in the afternoon  to go home and rest.
Typical side effects including fever, chills, headache, etc.   I also had a non typical response which included uncontrollable shaking of my hands and forearms. All of this subsided within a day or two.
muscle contractions, muscles were bothering him; right eye has been hurting him; muscle spasms; a fever of 100-101; has been feeling terrible; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (has been feeling terrible), MUSCLE CONTRACTIONS INVOLUNTARY (muscle contractions, muscles were bothering him), EYE PAIN (right eye has been hurting him), MUSCLE SPASMS (muscle spasms) and PYREXIA (a fever of 100-101) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced FEELING ABNORMAL (has been feeling terrible) and PYREXIA (a fever of 100-101). On 28-Jul-2021, the patient experienced MUSCLE CONTRACTIONS INVOLUNTARY (muscle contractions, muscles were bothering him), EYE PAIN (right eye has been hurting him) and MUSCLE SPASMS (muscle spasms). At the time of the report, FEELING ABNORMAL (has been feeling terrible), MUSCLE CONTRACTIONS INVOLUNTARY (muscle contractions, muscles were bothering him), EYE PAIN (right eye has been hurting him), MUSCLE SPASMS (muscle spasms) and PYREXIA (a fever of 100-101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-2021, Body temperature: 101-102 (Inconclusive) 101-102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Severe swelling, redness, hot to touch on (L) leg 5" x 6 3/4" on 05-16-2012. Patient rechecked on 5-17-12 8 1/2 x 6 3/4, less painful, decreased redness.