chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives; Sore arm; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021. The most recent information was received on 07-Jul-2021 and was forwarded to Moderna on 07-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hay fever and Heartburn. Concomitant products included COLECALCIFEROL (VIT D [COLECALCIFEROL]) and CALCIUM for an unknown indication.    On 05-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 URTICARIA (hives) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Sore arm). At the time of the report, URTICARIA (hives) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.2 (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant concomitant medications included medication for heart burn. No treatment products information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded. Further information has been requested.   This case was linked to US-MODERNATX, INC.-MOD-2021-058213 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up document received on 07-JUL-2021 contains significant information and updated patient demographics and Type of Vaccination facility and Clinic name. Added events Hypertension and Hypothyroid.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded. Further information has been requested. US-MODERNATX, INC.-MOD-2021-058213:Case for second dose
significant swelling without pain; This is a spontaneous report from a non-contactable other-HCP. A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on an unspecified date in Jan2021 as dose 2, single for COVID-19 immunization and received lidocaine HCL strength 180 mg via an unspecified route of administration for an unknown indication. Patient medical history and concomitant medications were not reported. Patient was injected with Juvéderm VOLIFT Lidocaine in the lips a few months ago. Patient received the second Pfizer vaccine in Jan. 3 days after the vaccination, patient presented significant swelling without pain on an unspecified date in 2021. Treatment included hydrochloride 180 mg for one day without improvement, therefore the day after patient started steroids as Prednisone 20mg BID. The patient was getting better and continued with the medications. The outcome of the event was unknown.   No Follow-up attempts are needed. No further information is expected.
Severe, debilitating headache, now continuing on for over 24 hours after vaccination.  Patient not normally prone to headaches. Injection site sore.  Muscle underlying injection site stiff.
Patient received flu vaccine that was for ages 18yrs and up.  No adverse effects noted while patient was in office. No adverse events reported by parents as of reporting date.
Patient stated that approximately 1 month after he got the Janssen vaccine he had internal bleeding that started in his kidney.  He was taken off his Eliquis for about a week and ended up with a blood clot in his leg and in his lung.
Sweats, chills, nausea, dizziness, loss of balance, slurred speech.
Patient reports pain during injection.  Pain intensified the following Monday.  The pain felt like "being hit by a mac-truck".  Patient reports pain was in left arm, then spread to left trap and then to the right shoulder/arm area.  It stayed with severe intensity for 3 weeks, finally subsiding at 3.5 weeks after injection.
R ant chest at 10 red lesion w/ some blister.  Back 1 red, no blister.  Rash is very attenuated chickenpox like + pt has received 2 shots!  Varicella 9/27/95 and 3/12/07!
Slight swelling around injection site and small hard bump where needle went in. No fever. Mild discomfort.
she cound breath; both times was so sick; Initial information received on 11-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves female patient of an unknown age who experienced she cound breath (dyspnoea) and both times was so sick (illness), while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received (twice) a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious she cound breath (dyspnoea) and both times was so sick (illness), (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that mother had the flu shot twice and both times was so sick she cound breath after that never took one again and never was sick.  Details of laboratory data not reported.    It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
w/in 2 hrs, severe itching & swelling of eyes, runny nose; next morning, red eyes, stinging, burning, runny nose, achiness, neck nodes swollen, t98.2;
Chills, severe headache, muscle and joint pain ,loss of appetite. Stayed in bed for 48 hours.  Severe symptoms lasted for 48 hours. Symptoms became less severe after that. I continued to have aches and loss of appetite for 3-4 more days.
Tinnitus - The morning after I received my second dose I woke up to extremely loud ringing in my left ear. It has been continuous, and loud, since 4/14/21. I reported it to my primary care clinic by phone and have not heard anything from them since.
Itchiness on left lower arm. BPs 162/86 (pulse 80), 126/69 (pulse 84. O2 sat 100%.
Began with a temperature of 100 in the evening of vaccination date.  Then temp spiked the following day to 103.3 and returned to 100 degrees 48 hours following vaccine.
0.2 to 0.3 mL of Vaccine wasted out; Vaccine squirting out of patient's arm; Vaccine squirting out of patient's arm; Might been a 3rd dose given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 9T2L9, expiry date 28-MAY-2024) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose on  23 May 2022 ) and Shingrix (Received 2nd dose on 1 Nov 2022).   On 27-MAR-2023, the patient received the 3rd dose of Shingrix. On 27-MAR-2023, an unknown time after receiving Shingrix, the patient experienced accidental underdose (Verbatim: 0.2 to 0.3 mL of Vaccine wasted out), exposure via skin contact (Verbatim: Vaccine squirting out of patient's arm), inadvertent exposure to vaccine (Verbatim: Vaccine squirting out of patient's arm) and extra dose administered (Verbatim: Might been a 3rd dose given). The outcome of the accidental underdose, exposure via skin contact, inadvertent exposure to vaccine and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 27-MAR-2023 The pharmacist reported that they tried to administered Shingrix to a patient but during administration the needle was inside the patient's arm and some of the liquid squirted back.  The pharmacist stated 0.2 mL to 0.3 mL of the the Shingrix dose wasted out mentioned that the patient did not feel anything went inside.  The patient stated that first dose was on 01 November 2022 and this was an attempt for a second dose but pharmacist thought it might had been a third dose. But the patient stated that she did not got a first dose on 23 May 2022.  The pharmacist stated 0.2 mL to 0.3 mL of the the Shingrix dose wasted out, which led to underdose. During administration the needle was inside the patient's arm and some of the liquid squirted back, which led to exposure via skin contact and inadvertent exposure to vaccine. The pharmacist thought it might had been a third dose of Shingrix which led to extra dose administered. The reporter did not consent to follow up.
PT EXPERIENCE DIZZINESS  AND BLURRED VISIONAPPROXIMATELY 20 MINUTES POST IMMUNIZATION, TOOK PT BLOOD PRESSURE AND GLUCOSE READING. PT REMAINED AT PHARMACY FOR ABOUT 45 MINUTES UNDER OBSERVATION. HE FELT BETTER AND LEFT PHARMACY
Mother of infant called health dept on 04/03/2002 reporting periods of prolonged crying up to two hrs which began the next day.
He was in a line at clinic (ortho resident), got his shot, and then walked out. Within 30 seconds he felt dizzy and flushed. He leaned over thinking he was having a vasovagal event. He then started wheezing. He went back into the clinic said he could barely breathe. A code was called. A nurse had her child's epinephrine autoinjector and used it on him (they did not have epinephrine readily available). He improved and had no further symptoms.
Warm; Red (Erythema-like); This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (Warm) and VACCINATION SITE ERYTHEMA (Red (Erythema-like)) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm) and VACCINATION SITE ERYTHEMA (Red (Erythema-like)). At the time of the report, VACCINATION SITE WARMTH (Warm) and VACCINATION SITE ERYTHEMA (Red (Erythema-like)) 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 medications were not provided. Treatment information was not reported.
I BEGAN GETTING A PRICKLY ACHY, SLIGHTLY ITCHY RASH WITHIN A FEW HRS OF RECEIVING THE INFLUENZA VACCINE. THE RASH WAS DEVELOPED ON UPPER ABDOMEN, THEN FELT PRICKLY AND ACHY AROUND MY RIGHT SIDE TO BACK WHERE IT WAS LIGHT RED IN COLOR. THE RASH ON MY UPPER ABDOMEN IS MORE PRONOUNCED WITH LITTLE HIVES IN ONE AREA THAT HAVE SCABBED. I HAVE NOT NOTICED IT ELSEWHERE YET. I HAD A NURSE AND DR LOOK AT THE RASH AND THEY BELIEVED IT TO BE THE ONSET OF SHINGLES.
In June, 2009, I received a shingles vaccination. My arm swelled up enormously, and was red as if I have a boil from elbow to shoulder. I became sick and had some spots on my legs. I immediately started feeling exhausted and my body ached. One and a half years later, I still have fibromyalgia and chronic fatigue. I have not had one day without extreme fatigue and deep muscle aching in my legs. My life is entirely changed. I am extremely damaged and impaired as a result of this vaccination. I reported to my doctors and to Merck at the time of this reaction. I have lost my ability to work in my profession without many medications, but at this time, I am going to have to stop the minimal work that I do because of the fatigue and mental confusion and pain.
Joint pain in hands, knees and feet; Joint pain in hands, knees and feet; Whole Body Soreness/over all body soreness; Very Tired; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: FD8448) dose 1 via an unspecified route of administration in left arm on 19Aug2021 09:30 as dose 1, single dose for COVID-19 immunisation. Medical history included none. Concomitant medications not reported. The patient experienced joint pain in hands, knees and feet, whole body soreness/overall body soreness, very tired and on an unspecified date fatigue. On 09Sep2021, the patient underwent lab tests and procedures which included laboratory test: labs drawn at the doctor's office today. Treatment was not taken. Patient was taking a medical assistant class and due for clinicals in the Dr's office. Should patient wait until 2 vaccine doses to do clinicals or is one dose ok. The outcome of fatigue was recovering and outcome of other events was not recovered.  Information on the lot/batch number has been requested.
Swollen lymph nodes in her arm; This is a spontaneous report received from a contactable consumer or other non hcp. A 18-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller was calling for her daughter who is 18 years old. She has gotten the first dose of the Pfizer COVID-19 vaccine and after that, she developed swollen lymph nodes in her arm on unknown date. A week ago, she received the second dose of the vaccine and she had developed swollen lymph node near her throat. Caller wanted to know if this adverse event could be from the Pfizer COVID-19 vaccine. Caller said that her daughter hasn't noticed it until today and it may had occurred earlier than today. The outcome of the events was reported as unknown.  No follow-up attempts are possible, information about batch/ lot number cannot be obtained.
Injection site swelling (Injection site edema, injection site edema) (Edema inject site) - recovered/resolved Injection site redness (injection site reaction, injection site reaction)(inject site react) - recovered/resolved Injection site warmth (Injection site reaction, injection site reaction) (Inject site react)- recovered/resolved Administration by an unlicensed route (Medication error, medication error) (Med error) - recovered/resolved     A report was received from a health professional on 05 November 2003, concerning approximately 20 vaccines who experienced local swelling, warmth and redness at the injection site an unspecified length of time after inadvertently receiving Fluvirin subcutaneously between 03 November - 04 November 2003. Between 03 November - 04 November 2003, the vaccines experienced local swelling, warmth and redness at the injection site. No other information was available. There was insufficient information to determine the reporter's causality assessment. Update 1, 09 March 2004 Follow-up information received from a health care professional indicated that approximately 18-20 female vaccines received Fluviron on 05 November 2003 subcutaneously and within 1 hour of administration experienced local swelling and redness at injection site. The adverse reactions resolved approximately 12-24 hours later. No long term complications were reported. No follow-up pending, all information recevied.
fever  of 104; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever  of 104) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever  of 104). At the time of the report, PYREXIA (fever  of 104) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (abnormal) fever of 104.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided.  No treatment medication provided.
Cellulitis at injection site; swelling at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site cellulitis in a adolescent patient who received Men B NVS (Bexsero) for prophylaxis.   In November 2019, the patient received Bexsero. In November 2019, less than a week after receiving Bexsero, the patient experienced injection site cellulitis and injection site swelling. On an unknown date, the outcome of the injection site cellulitis and injection site swelling were unknown.   It was unknown if the reporter considered the injection site cellulitis and injection site swelling to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Bexsero in the last week from the date of reporting. The parent of the patient called back and stated that, the patient had injection site swelling. The patient went back in and diagnosed with cellulitis. The reporter was not sure, if the cellulitis and injection site swelling was related with Bexsero. This case has been linked with case US2019AMR210855, reported by same reporter.
Golf-ball size hematoma on forehead, severe pain and pressure headache on the top of the skull, severe exhaustion, right arm pain
Silver dollar sized swelling and redness around the injection site for 4 days; Silver dollar sized swelling and redness around the injection site for 4 days; Silver dollar sized swelling and redness around the injection site for 4 days. After 4 days the redness subsided but a knot remains under the skins surface with heat to the touch and itching; Silver dollar sized swelling and redness around the injection site for 4 days. After 4 days the redness subsided but a knot remains under the skins surface with heat to the touch and itching; Silver dollar sized swelling and redness around the injection site for 4 days. After 4 days the redness subsided but a knot remains under the skins surface with heat to the touch and itching; This is a spontaneous report from a contactable Other Health Professional (patient). A 32-years-old female patient received first dose bnt162b2 (BNT162B2, lot: EL3247), intramuscular on 14Jan2021 11:15 at SINGLE DOSE on Arm Left for covid-19 immunisation. The patient medical history was not reported. Pregnant: No. No other vaccine in four weeks. The patient's concomitant medications were none. The patient experienced Adverse event: Silver dollar sized swelling and redness around the injection site for 4 days. After 4 days the redness subsided but a knot remains under the skins surface with heat to the touch and itching since 18Jan2021. The event outcome of redness around the injection site was recovered on 22Jan2021, outcome of other events were not recovered. No treatment received.
Within 1 hour of administration had swelling of corresponding arm (left arm), subsequent redness: 1 day later fever, chills, swelling slightly improved.
This patient wanted to report that she began her period as expected on 5/11 but has had spotting to normal menstrual bleeding for 30 days since onset so far. She is wondering if it could be related to the vaccine
Mandibular tender to touch; Chest and neck area became swollen/ Face to her breast region feels swollen/Feels like the inside of her ears are swollen; Pain in my left armpit; Swollen Lymph nodes; Injection arm was sore; Injection arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection arm was sore), SWELLING (Chest and neck area became swollen/ Face to her breast region feels swollen/Feels like the inside of her ears are swollen), PAIN IN JAW (Mandibular tender to touch), AXILLARY PAIN (Pain in my left armpit) and MYALGIA (Injection arm was sore) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection arm was sore) and MYALGIA (Injection arm was sore). On 24-Mar-2021 at 2:20 AM, the patient experienced AXILLARY PAIN (Pain in my left armpit). 24-Mar-2021 at 2:20 AM, the patient experienced LYMPHADENOPATHY (Swollen Lymph nodes). On 04-Apr-2021, the patient experienced SWELLING (Chest and neck area became swollen/ Face to her breast region feels swollen/Feels like the inside of her ears are swollen). On an unknown date, the patient experienced PAIN IN JAW (Mandibular tender to touch). The patient was treated with IBUPROFEN for Axillary pain, at a dose of 1 UNK. At the time of the report, VACCINATION SITE PAIN (Injection arm was sore), SWELLING (Chest and neck area became swollen/ Face to her breast region feels swollen/Feels like the inside of her ears are swollen), PAIN IN JAW (Mandibular tender to touch), AXILLARY PAIN (Pain in my left armpit), MYALGIA (Injection arm was sore) and LYMPHADENOPATHY (Swollen Lymph nodes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient stated that she had an appointment with her doctor on 07-Apr-2021.The patient stated that she took her second vaccine on 23-Apr-2021 and experienced some adverse events.   This case was linked to MOD-2021-258052 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Updated dose 2 details and new events were added corresponding to dose 2. On 27-May-2021: Translation received on 05-Jul-2021 and does not contain any new information. On 30-Jul-2021: Translation received on 09-Aug-2021 as event outcome updated for all events.
Admitted to hospital -- almost lost leg -- almost died -- 16 hours of surgery to clear blood clotting in left leg.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/24/2023 PLEURAL EFFUSION R09.02 HYPOXIA 7/10/2023 PLEURAL EFFUSION
I did not have an adverse reaction to the vaccine. I tested for COVID-19 in 12/2022. I contacted my doctor and got a prescription for Paxlovid. It took over two weeks to get over the congestion. I tolerated the medication without any complications. As of today, I do not have any lingering COVID-19 symptoms.
Initial case report received from a consumer on 25 NOV 2009. A 57 year old female was vaccinated with i.m. FLUVIRIN (batch no. 8788201) on 18 OCT 2008. On the same day, she experienced arm pain after injection. No other symptoms were noted at the time. The caller then stated that the pain got progressively worse and she was diagnosed with chronic bursitis in the area. She also developed a thickening around the injection area. These events were reported as bursitis, pain and skin hypertrophy. The patient's outcome was not reported.