chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.
Vial initially stored in refrigerator on 04-Jun-2022 and administered on 26-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 26-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 26-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 26-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 26-Jul-2022).    Concomitant medication information was not provided.  Patient received half dose.  Vial was initially stored in the refrigerator on 04-Jun-2022.  Vaccine administered to patient after the 30 day by used involved 35 vials. Vial did not undergone any temperature excursions.  Treatment information was not provided.
Reporting adverse events after the 2nd dose noted above.  Developed cellulitis; deep cancer lesion (left leg), "extreme fatigue, no appetite, severe shaking, chills, nausea for 6 weeks +"; spike/advancing symptoms of osteoarthritis;
Fever 101.5  Body aches , muscle pain, joint pain Palpitations  Headache  Started about 12 hrs after dose (worst the first night) and continued for about 24-48 hrs  Improved after acetaminophen 500 mg followed by ibuprofen 200 mg 6 hours later
Lump formed in the neck under the left ear. No pain, a little sensitive to touch. Referred to an Otolaryngologists specialist.
developed Hives around 10 days after third injection.  Random  outbreaks mostly upper body
Right arm pain at injection site and headache started morning of 10/30/21. Fever and chills started night of 10/30/21. Lymphedema right axilla started night of 10/30/21.
gave me shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient thought that his/her 1st Shingles shot gave him/her shingles. The follow-up could not be possible as no contact details were available.
Patient states after receiving the vaccine whole body aches, injection site warmth, redness and tenderness and is still experiencing these symptoms today.
Allergic reaction; This spontaneous case was received on 05-Jan-2021 from other non-health professional (consumer) via Agency (reference number: NUS2020US193921) and concerned a female patient of unreported age.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with influenza virus vaccine monovalent (brand not specified; indication, dose, route of administration and anatomical location: not reported). The batch number was not reported.  On an unknown date, an unknown amount of time after receiving influenza virus vaccine monovalent, the patient experienced allergic reaction.  On an unknown date, the patient was hospitalized due to the event for seven days.  The outcome of the event of allergic reaction was not reported.  The reporter did not provide a causality assessment.  The event of allergic reaction was considered to be serious due hospitalization.  Company comment: A female patient experienced hypersensitivity an unknown amount of time after administration of influenza virus vaccine monovalent. The patient's medical history and concomitant medications were not reported. Causality is unassessable due to lack of reported information.; Sender's Comments: A female patient experienced hypersensitivity an unknown amount of time after administration of influenza virus vaccine monovalent. The patient's medical history and concomitant medications were not reported. Causality is unassessable due to lack of reported information.
Patient, was given his first dose of the Janssen J&J vaccine my  the staff pharmacist. He was then asked to wait for about 15 minutes just to make sure he was ok, and that he will be given his vaccine card. He then left the vaccine room and sat in the waiting area in front of the pharmacy. He then started to dose of on his chair, almost as if he was going to fall over. Pharmacist, then told me about it and I went out and spoke to patient. I held his shoulder and asked him if he was ok. He nodded, saying that he felt light headed. I then told Pharmacist to call 911. I kept talking to Patient, and asked him if he wanted some water - he said yes, I then gave him some water to drink. he darnk the water and said that he felt much better. The paramedics came, asked him if he wanted to go to the hospital, he refused their service saying that he was alright. I later gave him his vaccine and asked if he was feeling better and will be ok going home. He said he was feeling much better. I called Patient today (next day after the event) to check on him. He thanked me for the call and said that he was feeling much better. He explained to me that he had just felt hot right after receiving the vaccine, felt his vision narrowing and was  light- headed. I told him that I was glad he was feeling much better and that I would report the incident to VAERS.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: DURING SYNCOPE EPISODE, PATIENT STATED HE "COULDN'T SEE". VISION RETURNED AFTER LESS THAN 1 MINUTE. PATIENT WAS UNCONCIOUS FOR LESS THAN 30 SECONDS. AFTER LAYING DOWN FOR 1 MINUTE, I RETURNED PATIENT TO CHAIR AND MONITORED BLOOD PRESSURE. PATIENT WAS HYPOTENSIVE FOR 20 MINUTES. PATIENT BECAME HEMODYANMICALLY STABLE AFTER 20 MINUTES USING 4 SEPERATE READINGS 5 MINUTES APART EACH. PATIENT'S FATHER ACCOMPANIED PATIENT AND OPTED TO TAKE HIM HOME AFTER HE WAS STABLE.
patient was sick with sinus infection and Bronchitis; patient was sick with sinus infection and Bronchitis; Initial information received on 17-Dec-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case involves a patient was sick with sinus infection and bronchitis (sinusitis) and (bronchitis), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick with sinus infection and bronchitis (sinusitis) and (bronchitis) (Unknown latency) following the administration of INFLUENZA VACCINE.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The outcome was reported as unknown for all events.  There will be no information available on the batch number for this case.
very sleepy, nausea, diarrhea. went home from work early next day after shot was in bed by 4:00pm and slept till 6:30 next morning called in sick to work and took a nap from 9am to 1:30 pm
This spontaneous report as received from a nurse practitioner via a company representative refers to a 12 year old female patient. The patient's medical history included abdominal pain. Drug reactions or allergies were unspecified by the reporter. The patient was a think girl who was in the 9th percentile in weight and hadn't eaten anything all day on 14-JUL-2014, when the patient was vaccinated with a dose of GARDASIL injection as a routine vaccine (dose, lot number and route were not reported). The reporter believed it was the patient's first dose. Concomitantly the patient was administered three unspecified vaccines in addition to GARDASIL. On 14-JUL-2014, after the administration of GARDASIL, the patient fainted. The patient was given water and sat in the office for 15 minutes after recovering from fainting, but never lot consciousness. Her heart rate might have gone low, but went up again after those 15 minutes of sitting down. There were not lab diagnostics studies performed. The patient did not seek medical attention. The outcome of the events was reported as recovered on 14-JUL-2014. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Evening of severe vomiting - 12 hours Fever/chills - 12 hours Muscle and Joint Pain - 48 hours Extreme headache - evening of and has continued through present time, it won't go away; called pharmacist to report, was told don't worry about it unless it continues for 3 weeks; PLEASE CALL ME TO HELP ME
"Noticed on 9/23/15 that my feet were hurting (soreness). Gradually my lower legs felt tingling and numb. The next day both my arms and legs felt tingling and numb. Saw my primary care physician, she felt I had the symptoms of possible Guillain Barre. Referred to neurologist for F/u on 10/7/15."
Patient  infectious disease unspecified. Onsite EMS was called vitals  BP 150/100 BG 99 HR 88 99% O2.  Patient refused evaluation or care. Released against medical advise.
Soreness at the injection site; chills; low grade fever; This is a spontaneous report from a contactable other healthcare professional reporting for himself  A 59-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3247, via an unspecified route of administration on 20Jan2021 at 11:45 (at the age of 59 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included gastroesophageal reflux disease, and heart disease, both from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medication included Evolocumab (REPATHA) and omeprazole (OMEPRAZOLE DR). The patient did not receive any other vaccines within four weeks prior to the vaccination,  On 21Jan2021 at 01:00AM, the patient experienced soreness at the injection site, chills, and low grade fever. The patient did not receive treatment for the events. The clinical outcome of soreness at the injection site, chills, and low grade fever was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Patient presented to ED and code was called for evaluation 15 minutes after 1st dose of  pfizer vaccine. He presented with chills, dizziness, and anxiety. No treatment medications were given, just monitored.
up and down all night long; legs are cramping so bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (up and down all night long) and MUSCLE SPASMS (legs are cramping so bad) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced FEELING ABNORMAL (up and down all night long) and MUSCLE SPASMS (legs are cramping so bad). At the time of the report, FEELING ABNORMAL (up and down all night long) and MUSCLE SPASMS (legs are cramping so bad) outcome was unknown.            Concomitant medication included blood pressure medication. Treatment medications were not provided.  It was reported that patient had received second booster dose.  It was reported that patient had no side effects with other doses.
client states she had a fever of 106, currently has a fever of 102, currently taking IBU 600 mg every 5 hours, erythema, swelling, warmth, and tenderness noted
4 ROUND RING RASHES ON ABDOMEN. SIZE OF QUARTER (25 CENTS)IN A ROW FROM UNDER HEART FOLLOWING RIB CAGE TO LEFT. DOES NOT ITCH, YET!JUST THERE!
LITTLE BIT OF DIARRHEA; TOOK THE FIRST PILL THAT WAS LEFT OUT AT ROOM TEMPERATURE FOR 36 HOUR; LITTLE BIT FEVERISH; This case (PVX2019-2166) was received from a consumer on 26-Aug-2019. It described a male consumer who felt "little bit feverish" (PT: Pyrexia) and had "little bit of diarrhea" (PT: Diarrhoea), after the administration of Vivotif for an unknown indication. He also "took the first pill that was left out at room temperature for 36 hour" (PT: Product storage error).  Case report: The consumer left Vivotif doses at room temperature for 36 hour and took the first dose on 25-Aug-2019. Afterwards, he felt a little bit feverish on the same day. On 26-Aug-2019, he had a little bit of diarrhea in the morning. He stated it was not too bad. Also, he stated he felt off.  Action taken with Vivotif with respect to the events "little bit feverish" and "little bit of diarrhea" was unknown, while with respect to the event "took the first pill that was left out at room temperature for 36 hour" was not applicable.  The consumer had recovered from the events "little bit feverish" and "little bit of diarrhea" on 25-Aug-2019 & 26-Aug-2019, respectively. The clinical outcome of the event "took the first pill that was left out at room temperature for 36 hour" was unknown.  Company's Comment: In this case, it was reported that the consumer felt "little bit feverish" and had "little bit of diarrhea" after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. Also, fever and diarrhoea is labelled as per agency. The causality of the event "took the first pill that was left out at room temperature for 36 hour" was considered as not applicable. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer  felt "little bit feverish" and also had "little bit of diarrhea" after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events.Hence, the causality of the events with Vivotif is assessed as possible. Also, fever and diarrhoea is labelled as per agency. The causality of the event "took the first pill that was left out at room temperature for 36 hour" was considered as not applicable.
Patient called the pharmacy stating she experienced redness and swelling at the injection site.  Patient stated that they tried icing the arm but the pain would not go away.   Patient went to the urgent care where they were prescribed keflex for possible cellulitis.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: vision blurry/pain behind eyes if moving head-Severe, Systemic: Visual Changes/Disturbances-Severe
Pt recvd 3 doses of Engerix-B & was a non-responder;
swollen area 6" high 3" wide on right arm in oval shape. started with small red dots progressing to large oval area lasting ten days. warm to the touch, tender  and very sore and swollen, poor mobility.
Patient developed boils in multiple areas  within 24 hours following both vaccines requiring antibiotic therapy  with nasopharyngeal swab positive for MRSA.  Received vaccines from admin facility.
Information has been received from the mother of a 17 year old female patient with acne and pertinent medical history and drug reactions/allergies reported as none who on 19-DEC-2006 was vaccinated with an initial dose of Gardasil, injection in the left upper arm. Concomitant therapy included sulfamethoxazole/trimethoprim. On 19-DEC-2006, the patient experienced two seizures after receiving the Gardasil vaccine. The patient's mother reported that the patient "blacked out" about one to two minutes after receiving the injection and was unconscious for about a minute before she experienced the first seizure. The patient had felt nauseous when she had regained consciousness. The patient's mother then reported that the patient "blacked out again" and had the second seizure which was more "severe". When the patient came out of it she started crying. The patient's mother reported that the physician kept them at the office for about three hours to watch her and she was given water. The patient was instructed to see a neurologist. Subsequently at the time of this report, the patient recovered from seizures. Seizures was considered to be an other important medical event (OMIC). Additional information has been requested.
Severe pain at any movement of leg shot was administered in for about 24 hrs. Not as responsive/alert as normal, almost as in a daze for about 12hrs. No BM for 6 days, then irregularity for 2 weeks.
patient not experiencing any symptoms; Patient recived second dose, however it was noted the dose had expired; patient was recommended by an unespecified dermatologist to receive GARDASIL 9 to help treat many warts on her feet; 32 year-old patient was recommended by an unespecified dermatologist to receive GARDASIL 9; This spontaneous report was received from a regional director, concerning an approximately 32-year-old female patient of unspecified race. Information regarding her medical history, drug reactions or allergies and concomitant medications was not reported.  In approximately September 2019, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (dose, frequency, lot number and expiration not reported), administered to treat many (unspecified) warts on her feet, recommended by an unspecified dermatologist (product use in unapproved indication and product administered to patient of inappropriate age). On 15-NOV-2019 (also reported as "today"), the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), injection (dose, frequency and indication not reported), lot number: R024264, expiration date: 29-OCT-2019, which was noted as an expired dose (expired product administered). The patient was not experiencing any symptoms (no adverse events) and no product quality complaint (PQC) was reported.
Patient complained of dizziness at 1041 am in recovery area, escorted to cot via wheel chair and assisted her to lay down. Pulse 72, gave water, no complaints of difficulty breathing. Pulse ox checked, 99%. Patient started nausea with some dry heaves, remained alert and oriented.  Began to complain of chest pressure and squeezing feeling in head. 911 was called  10:59  Bp 124/82, Hr 92, pulse ox 99. Assessed patient, says she is starting to feel better  Refusing to go to hospital. Advised patient not to drive and awaiting a ride from friend.EMT left at 11:30. Feeling better at 1145.
Patient's mom called to say that right at the injection site there is a lump that has gotten larger over time. The lump didn't show up till a few days after injection however the area is red, bumpy and itchy now.
Pt seen ER Dr this moring 5/21, Vaccine reaction, initial encounter, dysphagia and pain with swallowing, received Pfizer first covid vaccine yesterday, some pain in arm after vaccination, no initial issues noted, went to bed, woke up in night complaints of painful and difficulty swallowing water, no shortness or breathe or difficulty breathing, no rash, mom gave bendayl at home this morning, able to swallow food and water now, no issues with prior vaccines, pt does have seasonal allergies, pt. discharged home with mom, continue over the counter allergy med like claritin or zyrtec for next few days, follow up with PCP for recheck prior to decision about 2nd vaccine.
My son started to stutter slightly, which quickly escalated into a severe stutter with intervals of normalcy in-between.  He was so frustrated by the inability to express himself that each bout of severe stuttering was followed by very violent self-hitting. He, at times, was completely unable to talk.  These proceeded for hours until he went to sleep. It was less severe the next morning and then disappeared for roughly a day and a half.  The stutter came back and lasted for a few days - the hitting has become rare.  It has been losing frequency and seems to reoccur every few weeks for a few days.  I gave him charcoal for one week following the shot.  He received an EEG, results were normal.  No other treatment yet except for some vitamin supplementation to try and help.  We are in the process of scheduling a speech evaluation.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 69-year-old male patient received BNT162b2 (BNT162B2 NOS), in Dec2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.