chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pneumonia; abdominal cramps; This spontaneous case was reported by a patient and describes the occurrence of PNEUMONIA (pneumonia) in a 71-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 25-Oct-2023, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant) and ABDOMINAL PAIN (abdominal cramps). At the time of the report, PNEUMONIA (pneumonia) and ABDOMINAL PAIN (abdominal cramps) had not resolved.            No concomitant medications were reported. Patient experienced upper respiratory and also lower abdominal cramps. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported. Company Comment: This is a spontaneous case concerning a 71-year-old female patient with no reported medical history, who experienced the serious (due to medically significant) unexpected, event of Pneumonia, which occurred on the same day after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine (unknown COVID-19 vaccination schedule). The outcome of the event was reported as not recovered. It was reported that patient experienced upper respiratory and lower abdominal cramps. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.
Developed redness around injection site, left arm pain , pain discomfort around pacemaker radiating up to left side of neck starting on 11/8/22. Had a slight fever and headache the day after the vaccine that resolved with Tylenol. Was evaluated 11/15/22, rash had resolved but was still experiencing  tenderness noted in the left deltoid, trapezius, and sternocleidomastoid muscles. Was prescribed  Tylenol 1000 mg by mouth three times per day for 5 days.
Symptoms began about 10 hours after the shot. Had muscle aches all over, fatigue, and woke up with a fever of 100.2. Fever hovered just under 100 the rest of the day. The 24 hours from symptom onset felt almost identical to the first 24 hours I had Covid 3 months ago (likely Delta, based on timing). Significantly better the following 2 days, but still a little fatigued. The part I considered unusual was that I had very little side-effects on the first and second doses in May and June. The shot facility and staff were professional. I'm glad to have had the shot, but thought maybe my experience would be useful to add to your database.
sweating so bad; vertigo; Dizziness; Nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating so bad), VERTIGO (vertigo), DIZZINESS (Dizziness), NAUSEA (Nausea) and CHILLS (chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001821A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 CHILLS (chills). On 26-Mar-2021, the patient experienced NAUSEA (Nausea). On 27-Mar-2021, the patient experienced HYPERHIDROSIS (sweating so bad), VERTIGO (vertigo) and DIZZINESS (Dizziness). At the time of the report, HYPERHIDROSIS (sweating so bad), DIZZINESS (Dizziness), NAUSEA (Nausea) and CHILLS (chills) outcome was unknown and VERTIGO (vertigo) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient  had a bad vertigo that lasted for 4 days before it tapered off  It was reported that the patient is concerned about getting the 2nd dose  No concomitant medication reported   No treatment medication reported
Swollen upper and lower lip, swollen, red, warm, painful joints. Doctor prescribed medication- referral to an allergist.   Symptoms resolved after a few days.
stomach ache; Heartburn/ stomach burns like she drank hot sauce; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Aug2021 11:00 (Lot number: FA7485) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 06Aug2021, outcome "not recovered", described as "stomach ache"; DYSPEPSIA (non-serious) with onset 06Aug2021, outcome "not recovered", described as "Heartburn/ stomach burns like she drank hot sauce". Therapeutic measures were taken as a result of abdominal pain upper, dyspepsia.  Additional information: Patient stated that as treatment for events she was drinking a lot of water. She was scheduled for the second dose on 27Aug2021. The events did not require visit to Emergency Room or Physician Office. Patient did not had any prior Vaccinations (within 4 weeks), any event following prior vaccinations and family medical history relevant to the adverse event. Also no additional vaccines were administered on the same date as the suspect and no lab test were performed.  No follow-up attempts are possible. No further information is expected.
PAINFUL RAISED HARD KNOT STARTED TUESDAY 10/13/15 STOPPED SUNDAY 10/18/15.
I was ill for 3 days and could not get out of bed.  For the first 24 hours after my shot, I was extremely nauseous (I eventually vomited which helped).  I was running a temperature. I felt light headed when I tried to get out of bed.  For the next 24 hours, I ran a temperature, had an extreme headache, had an ear ache in my right ear and my right sinus hurt.  Again, I could not get out of bed.  After around 48 hours, the fever broke, but I still felt like I had an extreme migraine, my right sinus hurt and my right ear hurt.  Light hurt my eyes. I spent 72 hour sleeping.  I drank hot tea and ate a little soup during this time, but that was all.  I felt HORRID for three full days.  This was MUCH longer than I expected.  If you decide we need booster shots, I hope you figure out what was making me feel so horrible.  I can't imagine going through this for three days every time I get a booster.  Thank you for making the vaccine.  I do feel like it will protect me.
Heart was racing "pounding" in her chest, severe fatigue, body aches, very dry mouth feeling.
Patient received the COVID-19 vaccine.  Patient described feeling dizzy and light headed.  Patient placed on floor.  Syncopal event / vaso-vagal. No signs of anaphylaxis or allergy, but epipen 0.3mg was administered. anticubital IV line placed for access if needed.  Patient taken to ED for observation.  Returned to duties within 1 hour of the event.
Admission Date: 6/13/2023 Discharge Date: 6/17/2023   DETAILS OF HOSPITAL STAY:   Clinical Narrative: Patient is a 69 y.o. male patient who presented on 6/14/2023 with shortness of breath and exertional dyspnea that started on 6/13. He has hx of severe COPD/lives on 5L/uses Trilogy, GERD, hypertension, OSA, lung cancer s/p chemo/resection in close surveillance, diabetes mellitus. His wife has had a cold for a few weeks, and a few days ago, he started having cough, nasal drainage. He began having dyspnea that responded to his inhalers on the day prior to admission, but on 6/14, met with no improvement so came in. In the ED, he was quite distressed, given steroids multiple breathing treatments with little relief but finally improved when placed on Bipap. CXR without acute findings, however with mass in RUL similar to prior.    CT C/A/P obtained as his pulmonologist wanted one this month for surveillance of his NSCC, and to better elucidate cause of his acute on chronic respiratory failure. This showed stable changes in RUL, no evidence for metastatic disease in chest, abd or pelvis. There was some note of mild pancreatic fat stranding, though had no abdominal pain or nausea. He requires admission for further evaluation and management of Acute on chronic respiratory failure with hypoxia and hypercapnea.
Swelling and redness upper arm - pain 12/26/13. Swelling increased redness now extended below elbow traveling to wrist - pain ER visit #2 12-28-13.
Patient did not have any reaction. Patient was given wrong dose. Patient was given a water solution mixed with the medication. She did not recieve the refrigerated diluent that came with the vaccine vial.
pt had episode of vomiting, lethargy, & pallor; hypotonic/Hyporesponsive;
2"x3" (size of reaction) redness, hot on left leg. Benadryl po/Tylenol po.
The patient experienced swelling at the injection site, redness and hot to touch. The patient had a fever, swollen glands, body aches and chills. The patient was diagnosed with left nasal turbinitis, erythema, left submandibular adenitis, right submandibular adenitis, lung sounds (rales at bases); a nonproductive cough. Still treating.
June 20, 2021 - Anaplasmsis - treated with Doxycycline Hyclate 100 mg  July 12, 2021 - Lyme d. - treated with Doxycycline Hyclate 100 mg Late July 2021 - right axillary pain started with paresthesia in right forearm and hand.  Persists to present.   September 9, 2021 - sudden onset of pain and swelling in 3rd finger Right hand September 20, 2021 - pain on lateral border Left hand
Woke up on 1/31/22 with left eye red, painful. Was referred to a retina specialist and seen on 2/4/2022. There they took a number of pictures of my eye/retina/optic nerve and took a biopsy of my left eye. They were concered for Acutre Retina Necrosis, vision loss and retinal detachment. On 2/4/22 I was prescribed 2g Valacyclovoir daily and Durezol. Went back into doctors on 2/7/2022 and things had progressed much worse. My vision went from 20/20 to 20/200. I had necrosis of the left retina. I was sent to the Hospital for an emergency Intravitreal Foscarnet. Received biopsy results back that day and was positive for Varicella Zoster Virus (VZV+), also known as the shingles virus.\  I am a healthy 28 Year old female and my doctors believe the COVID booster shot, which I received one month prior, reactivated the dormant VZV virus which attacked my left retina. I went to the lab that day and over the course of the next week to rule out any other cause for this. All lab work came back negative, pointing to the Booster shot once again. I had to receive a second intravit foscarnet on 2/10/22. Treatment has been 6g of Valacyclovoir/day and 40g Prednisone/day. Doctor believes I will need to be on Valacyclovoir for life so the virus does not attack my right eye. Today I have lost all peripheral vision on the left side of my left eye where the necrosis is and will never get that back. I am suffering from black floaers, blurred vision and inflammation. My vision is 20/70 in that eye. I can send all lab work if needed.
Initial information received on 23-Jul-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case was also linked with 2018SA033791 and 2018SA036621 (same reporter). This case involves a 61 years old female patient who experienced pain in her wrist/sharp pain in her finger, pain all over her body in one degree or another, painful flares and heart rate sometimes goes to the 140-180, while she received vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included FLUZONE QUADRIVALENT with she took the flu vaccine for 17 years prior without complication. The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Rheumatoid arthritis in Jul-2017 whose diagnosis was made after her primary care doctor referred her to a rheumatologist. On an unspecified date in Oct 2017, the patient received a single dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported. On an unspecified date in Oct 2017, 24 hours post vaccination, she experienced a sharp pain in her finger. Since this initial sharp pain, she has experienced pain all over her body in one degree or another. On an unspecified date, the patient developed a pain in her wrist. It was reported that she had relief of the pain when she takes her methotrexate and prednisone as prescribed. Because the methotrexate and prednisone have undesirable side effects, she often times does not take either. This will inevitably lead to painful flares. It was also reported that her heart rate sometimes goes to the 140-180, which she believes is not because of the known side effect of prednisone, but rather caused by the flu vaccine. Final diagnosis was painful flares, pain all over her body in one degree or another, pain in her wrist/sharp pain in her finger and heart rate sometimes goes to the 140-180. The patient was treated with METHOTREXATE and PREDNISONE. The outcome of the events was not reported. The patient believes the events were related to the vaccination. List of documents held by sender: none.
A long term care facility patient was given three COVID-19 vaccines each 21 days apart. No adverse reaction reported but the patient should not have received a third vaccine.
The patient has a history of COPD on 2L O2. She was brought to the ED by EMS on 10/1/23 with confusion, generalized weakness, and cough. The patient tested positive for COVID via home test the day prior (9/30/23), and her family reports the patient has been increasingly fatigued and weak. A repeat COVID test done in the ED also resulted positive. Ultimately, the patient was admitted 10/1/23 - 10/12/23. Discharge diagnoses include acute on chronic hypoxic hypercapnic respiratory failure secondary to COVID pneumonia and COVID-19 pneumonia/infection improving on antibiotics, among other diagnoses. The patient did require ICU admission and was transferred out of the ICU on 10/4 in stable condition. During admission, the patient was on BiPAP however by discharged was weaned to her baseline 2L O2.   Of note, the patient has received three doses of the Pfizer monovalent COVID vaccine (2/1/2021; 2/22/2021; 12/7/2021). The Lot number, vaccine route, and vaccine site for the most recent vaccine given on 12/7/2021 is unknown.
Palmoplantar psoriasis flare up and arthritis pain, chronic chills and nausea
Extreme fatigue lasting approximately 8 weeks. Inability to wake up normally, or get out of bed. Sleeping, up to 12 or more hours per day.
Mother of patient reports the night of 07/28/2003 patient had pain of left arm and on 07/29/2003 had redness and swelling of left upper arm, and was seen by a MD in the ER.  They gave him Benadryl and Tylenol and he will see his primary MD today.  Observed redness and swelling of left
I had instant pain in arm in spot of injection and entire arm even down into my wrists and hands. The burning sensation went away about 2 weeks later however 6 months later my entire upper arm and shoulder area still hurt. I had none of this pain before the shot!
Right arm was sore for four days , and has had a headache since 3/5. Sometimes the headaches were sever and it has been mild in between.
This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness Of Breath (SOB) after booster) and FATIGUE (Tired after booster) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 014M20A and 012M20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high (Blood Pressure is under control by taking Medication).Concomitant products included OMEPRAZOLE (AZORAN [OMEPRAZOLE]) for an unknown indication.On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced DYSPNOEA (Shortness Of Breath (SOB) after booster) and FATIGUE (Tired after booster). At the time of the report, DYSPNOEA (Shortness Of Breath (SOB) after booster) and FATIGUE (Tired after booster) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. Lab test included Cardiac Lab values ECG, cardiac test, cardiac enzymes. No treatment information was provided.
Pt c/o chest tightness on and off, alert and verbally responsive, no c/o pain no change LOC. no SOB. Pt. assisted to lie down on bed then symptoms of chest tightness relieved after resting.   !:19pm V/s  BP 132/89  102bpm, 19cpm, 99%RA 1:45pm V/S BP 122/71  90bpm, 19cpm, 99%RA  #21 stable, and went home
100.2 Fever; Body Aches; chills; Pain; Not feeling the greatest; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (100.2 Fever), PAIN (Body Aches), CHILLS (chills), PAIN (Pain) and FEELING ABNORMAL (Not feeling the greatest) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PYREXIA (100.2 Fever), PAIN (Body Aches), CHILLS (chills), PAIN (Pain) and FEELING ABNORMAL (Not feeling the greatest). At the time of the report, PYREXIA (100.2 Fever), PAIN (Body Aches), CHILLS (chills), PAIN (Pain) and FEELING ABNORMAL (Not feeling the greatest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Student/Patient stated her cheeks became flushed.  She returned to the clinic where she was evaluated by a nurse.  She denied any other symptoms at that time.  Her cheeks were visibly flushed.  Temperature was normal.  About 30 minutes later she stated she thought her throat felt a little tight.  She was given 25 mg of Benadry po.  Parent was contacted. She was observed for another 30 minutes - 45 minutes. Her cheeks returned to a normal color, she stated her throat was no longer tight.  Denied any further symptoms.  Upon follow-up with student a few days later, she stated she had no further complications.
PFIZER COVID VACCINE #3 GIVEN 12/9/21, LOT #FJ8751; 4/29/22 pt had a positive COVID test; 5/15/22 pt brought to ED via EMS with AMS; coughing; admitted to Hospital with a positive COVID test in ED; oncologist consulted; suffered acute GI bleed, likely aspiration into lungs; O2 sats immediately dropped to 74%; placed on NRB; pt non-responsive with congested breathing; wife decided to transition pt to GIP hospice services for comfort measures; pt passed away the following day
Large and hot to the touch, red, circular raised area at the injection site.  Measured 2 inches in diameter.  He noticed it at lunch but didn't tell mom until 5:00pm.  No fever.  Just the hot arm and sore to the touch. So far it has not gotten any worse or better.  Was told by the nursing hotline to take him in Monday if it has not improved or to the urgent care if it gets any worse.
Pt present to clinic with facial swelling, edema and tenderness. Pt states he started with symptoms 1 hour after flu injection. Treatment consisted of tapering doses of Prednisone.
The patient has epigastric pain, nausea, shakiness, chills, and weakness for about 6 hours (started 18 hours approximately after injection). The patient had some lower abdominal cramping, and slight diarrhea the second day after her shot.
1) Few minutes after vaccine given, patient walked to sink to drink of water, became pale, dizzy, nausea. 2) Escorted to lie down on exam table, then head jerked to right. Some drooling then about 12 sec t/c jerking of extremities. 3) Awoke alert but weak, dizzy, with nausea.
PATIENT WAS GIVEN IMMUNIZATION AND SAID SHE FELT LIGHT HEADED, BUT STATED IT COULD HAVE BEEN BECAUSE SHE HAD NOT EATEN. SHE WAS GIVEN A BANANA AND A WATER AND STILL DID NOT IMPROVE. AT THAT TIME SHE MOVED SEATS AND SAID WALKING AROUND HELPED A BIT. WE TOOK BP WHICH WAS SLIGHTLY ELEVATED, PT TOOK BP MEDICATION WHICH SHE HAD NOT YET TAKEN TODAY. SHE STAYED WITH US FOR 45 MINUTES BEING MONITORED, AND A FAMILY MEMBER CAME TO PICK HER UP.
Facial swelling, Rash to lower body, itching, headache, chest pain. All side effects have resolved at this time. Took Benadryl and extra Lasix.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 79-year-old female patient who received SHINGRIX for prophylaxis. On 8th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 8th March 2019, less than a day after receiving SHINGRIX, the patient experienced fever, headache, shooting pain, chills, weakness, fatigue and pain in extremity. On an unknown date, the outcome of the fever, headache, shooting pain and chills were recovered/resolved and the outcome of the weakness, fatigue and pain in extremity were not recovered/not resolved. The reporter considered the fever, headache, shooting pain, chills, weakness, fatigue and pain in extremity to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for herself. The patient received a dose of SHINGRIX in the left deltoid. The patient stated that starting the evening of vaccination, she had fever, headache, shooting pain and aching in her legs, chills, weakness, fatigue and a sore arm for that night and all next day. In March 2019, all the events had resolved except the weakness, fatigue. At the time of this report, the patient's arm was still sore. The patient provided the consent for follow up and stated that she had an appointment to see her doctor.
Left deltoid has a 3 inch erythematous painful to touch extremely warm area. Place on KEFLEX 500mg bid x 10 days.
This was my 2nd shot.  First was given 3/16/21.  No issues with first shot.  After 2nd shot - Large canker sore under tongue day after injection.  Diarrhea on 4/6 and 4/7.  Friday 4/9/21 blood pressure spiked to 180/128.  Eventually came down to 150/101.  This was determined at a doctors office where I was to have a minor surgical procedure.  Had to cancel due to BP so high.   4/7 through today 4/13/21 have felt anxious, difficulty sleeping and weird dreams when I do, hot flashes and itching at night , lethargic, loss of appetite, dizzy,  anxiety, general feeling of being unwell.  I thought it was important to report these side effects as they are not the usual ones listed for this vaccine.  I have heard other people having similar side affects as me.
Information has been received from a registered nurse concerning an approximately 13 month old male with no past medical history and no known drug allergies who on 6/21/02 was vaccinated with a dose of MMR II (640792/1381L). There was no concomitant medication. Subsequently, the pt developed a rash on trunk, face, legs, arms. The pt was treated with Tylenol and Motrin. The pt sought unspecified medical attention. Additional info has been requested. It was also reported that two other approximately 13 month old patients (WAES0207USA00624 and 0208USA02719) had similar symptoms following vaccination.
The end of my tongue swells to about double in size. Not on the back of my throat.  All along the edge of the tongue are welts, swollen up white rings that look like blisters or sores, as many as 10-12. The skin is not broken. These welts and tongue have a throbbing burning last lasts 3- 4 hours. It is painful. And terrifying. The tongue is sore and painful for many days following.  Fever and ache about a week after first dose. Fever and ache for 3 weeks after 2nd shot.
Very strong stinging / tingling /itchy feeling of face, neck, chest, arms and a feeling of fever.