chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Weakness; Fast Heartbeat; Dizziness; believes she is experiencing a severe allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), HEART RATE INCREASED (Fast Heartbeat), DIZZINESS (Dizziness) and HYPERSENSITIVITY (believes she is experiencing a severe allergic reaction) 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 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced ASTHENIA (Weakness), HEART RATE INCREASED (Fast Heartbeat), DIZZINESS (Dizziness) and HYPERSENSITIVITY (believes she is experiencing a severe allergic reaction). At the time of the report, ASTHENIA (Weakness), HEART RATE INCREASED (Fast Heartbeat), DIZZINESS (Dizziness) and HYPERSENSITIVITY (believes she is experiencing a severe allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Pt reported having nausea, body aches and headache after most recent COVID vaccine.  on 10/17/23 pt developed severe pain to the left axilla. Very tender to the touch and somewhat warm. Per MD, most likely lymphadenopathy. Pt advised to continue OTC pain relievers and ice as needed and watch for signs of cellulitis/abscess.
Fever. Fatigue. Cough. Headache. Myalgias. Nausea. Injection site pain and shoulder soreness  For 2 days.  Started on zofran. Sumatriptan. Norflex. Motrjn
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Physician). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 21Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 29Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 02Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Aug2023) Negative; (29Aug2023) Positive. Therapeutic measures were taken as a result of Treatment of COVID-19 included Paxlovid from 22Aug2023 to 26Aug2023. The patient experienced negative COVID test on day 4 of Paxlovid and then had rebound COVID positive test.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Vaccine was stored in the freezer for 21 days, instead of 14 days. the vaccine was supposed to be removed from the freezer on 5/27 and placed in the fridge however it was not and was stored in the freezer and given to the patient.
AFTER RECEIVING VACCINE, PT STATED FEELING A LITTLE DIZZY AND MILD SHORTNESS OF BREATH (PT HAS MEDICATION FOR BREATHING). GAVE PT WATER AND HAD THEM SIT DOWN FOR 15 MINUTES. MONITORED PT CONSTANTLY. PT BREATHING WENT BACK TO NORMAL AND NO MORE DIZZINESS. PT HAD SOMEONE ELSE DRIVE THEM. TOLD PT THAT IF THEY STARTED HAVING BREATHING ISSUES AGAIN TO GO TO URGENT CARE OR CALL 911.
On 01/01/2023 I started to feel mild back pain. As time progressed I went to my health care provider on 02/14/2023 and had an MRI done for back issues. I was later diagnosed with Spinal stenosis. I had to have steroid and Lidocaine injections
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 13-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (strength, dose and frequency were not reported) lot # L008355, expiration date 11-SEP-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
approx 13mos p/vax pt exp hives on arms & chest. on 20jan99 pt exp blotches on upper body & legs, flushing, low grade fever & nausea. addl info requested
No adverse event reported, vaccine expired on 9/30/2022, vaccine administered 10/1/2022
Patient given vaccine. Patient stood up from table and walked around the room for a few seconds. Patient then sat down on the chair and within seconds patient had an episode of syncope. Patient began to shake, eyes rolled back. Within 20-30 seconds patient came out of it. Was then very light headed, dizzy, nauseous.
11/23 vaccination administered; 11/24 onset of sore throat. Ongoing symptoms next few days. 11/26 Friday night it got worse, took her to urgent care. No temp. Cough. Congestion. Symptoms lasted every day since. Rinse with salt water to help, gargle. Cough medicine, over the counter. She missed school 11/30/2021. Lingering but not worse.
Less than 24 hours after injection - pt. reported rash from neck to thigh area - completely cover - bright red - whelps - c/o itching and burning.
On 4/10/2021 i was vomiting, 4/11/2021 i had hives on my face
Patient inadvertently received high-dose Flu vaccine.  Patient is pregnant, unknown gestational age.  Patient reported no ill effect from vaccination.
Initial information received on 26-Jun-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves Adult female patient who experienced had severe allergic reaction to MENACTRA, while he/she received vaccines MENACTRA. The patient's past medical history, medical treatment, vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect MENACTRA (lot number, expiry date not reported) and her college was required MENINGOCOCCAL VACCINE B. On an unknown date, following the vaccination patient developed a non-serious severe allergic reaction to MENACTRA (and her college is requiring Men B). No lab data provided. Final diagnosis was had severe allergic reaction to MENACTRA. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for had severe allergic reaction to MENACTRA.
16 days p/vax pt exp mild rash w/less than 50 lesions.
pt recvd vax & exp severe vomiting & nausea;sx persist;pt had not informed the PA a/inj of prev adverse experiences;
I tested positive for COVID on March 2, 2021 after having all of the symptoms.  I had a body rash, no taste or smell, muscle aches, diarrhea, cough, shortness of breath.
Swelling, redness, and heat at injection site, soreness, difficulty walking because of soreness.
Patient called  3/08/22 that her left arm (administered vaccine) has mild and has decreased range of motion since first COVID vaccine. First dose 11/6/2021, then second dose 12/4/2021  did not mention soreness or ROA upon administration. She called pharmacy over 3 months later on 3/8/22 to discuss her symptoms and instructed to apply compress and take ibuprofen/acetaminophen. She came in person 3/10/21 and instructed to continue applying compress and medication. If Aes continue, contact primary for further studies or physical therapy.
Brought from home to ER by ambulance due to seizure activity, convulsions. Found by father after hearing thud. Patient was on ground, disoriented, shaking, eyes rolled back into head. Epi pen enroute to hospital. Arrived ER at 2045. Answering questions and stable vital signs in ER. Given Benadryl 50mg IV and Solumedrol 125 mg IVP in ER.  6/27/08 Reviewed hospital medical records of 5/30-5/31/2008. FINAL DX: convulsions Records reveal patient experienced fall, disoriented, shaking, eyes rolled back into head.  Tx w/epi, steroids, antihistamine.  Admitted overnight for observation.  No further seizure activity noted.  Referred for outpatient neuro consult.  7/11/08 Reviewed neuro records of 6/2/2008. FINAL DX:convulsion, probably vaccine related Records reveal patient experienced seizure & seen in ER where injection sites were noted to by red & hot.  No treatment ordered & was to have repeat MRI in 6 mos.
Appetite pretty much zero; Lost 8-10 pounds in three weeks; skin senstivity; achey body; Super tired; Feet hurt; Abdomen tightness; Diarrhea / loose stool; Tingling sensation; Numbness; Felt like tired muscles all over the body; Joint pains; Swollen lymph node under armpit; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation), HYPOAESTHESIA (Numbness), MUSCULAR WEAKNESS (Felt like tired muscles all over the body), PAIN IN EXTREMITY (Feet hurt) and ABDOMINAL DISCOMFORT (Abdomen tightness) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.     On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node under armpit). On 27-Mar-2021, the patient experienced PARAESTHESIA (Tingling sensation), HYPOAESTHESIA (Numbness), MUSCULAR WEAKNESS (Felt like tired muscles all over the body), DIARRHOEA (Diarrhea / loose stool) and ARTHRALGIA (Joint pains). On 05-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (Abdomen tightness). On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (Feet hurt) and FATIGUE (Super tired). On 01-May-2021, the patient experienced SENSITIVE SKIN (skin senstivity) and MYALGIA (achey body). On an unknown date, the patient experienced DECREASED APPETITE (Appetite pretty much zero) and WEIGHT DECREASED (Lost 8-10 pounds in three weeks). On 08-Apr-2021, ARTHRALGIA (Joint pains) had resolved. At the time of the report, PARAESTHESIA (Tingling sensation), HYPOAESTHESIA (Numbness), MUSCULAR WEAKNESS (Felt like tired muscles all over the body), PAIN IN EXTREMITY (Feet hurt), DECREASED APPETITE (Appetite pretty much zero), WEIGHT DECREASED (Lost 8-10 pounds in three weeks), LYMPHADENOPATHY (Swollen lymph node under armpit) and FATIGUE (Super tired) was resolving and ABDOMINAL DISCOMFORT (Abdomen tightness) and DIARRHOEA (Diarrhea / loose stool) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment details was not provided. The patient reports that she felt fine for a week post vaccination except swollen lymph nodes and for two weeks the symptoms were bad then started to get better in third week but still had abdomen tightness and loose stool. She also felt sensation in her body kept changing.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Initial Addition Info Received on 27-Apr-2021 and it contains reporter address  AE start date, additional AE, medication taken and consumer saying that : I feel much better now and able to live a normal life but I'm not 100% back to baseline.
Patient experiencing headache, fatigue, cough for 1.5 weeks, with lingering body pain and upper respiratory burning. Symptoms (besides cough) for one month.
Narrative: COVID infection following COVID vaccine series 03/05, Janssen , dose #1 12/22, Pfizer, dose #2 12/27 COVID swab, result: detected 12/27 pt cc: exposure: unknown
This spontaneous report was received from a pharmacist refers to a 50 year old female patient. No drug reactions or medical history was reported. On 22-FEB-2013, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (lot # reported as H021292, expiry: 20-FEB-2014, dose not reported) in the arm for shingles prophylaxis. No concomitant medications were reported. On 25-FEB-2013, the patient noted "her arm looked like it got hit by softball". There was no rash but her arm was purple at the injection site and the area around that was red, raised, and warm. No treatment was received. The patient sought medical attention (patient presented at the pharmacy). No laboratory diagnostics studies were performed. The outcome of her arm was purple at the injection site, area around that was red, raised and warm was reported as not recovered. Additional information has been requested.
PATIENT REFERRED PAIN , INFLAMMATION AND RASH ON THE ADMINITRATION SITE
This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 4-month-old female patient who received INFANRIX. Co-suspect products included INFANRIX. Concurrent medical conditions included milk protein allergy. Concomitant products included Polio vaccine and Polio vaccine. On an unknown date, the patient received the 1st dose of INFANRIX (intramuscular). On 23 November 2016, the patient received the 2nd dose of INFANRIX (intramuscular). On an unknown date, 8 hrs after receiving INFANRIX and not applicable after receiving INFANRIX, the patient experienced vomiting, diarrhea, vomiting and diarrhea. On an unknown date, the outcome of the vomiting, diarrhea, vomiting and diarrhea were recovered/resolved. The reporter considered the vomiting and diarrhea to be almost certainly related to INFANRIX. The reporter considered the vomiting and diarrhea to be almost certainly related to INFANRIX. Additional details were provided as follows: The age at vaccination was not reported for 1st dose. The patient received 1st dose of INFANRIX at the standard time, after receiving 1st dose of INFANRIX, the patient experienced vomiting and diarrhea. Eight hours after receiving dose of INFANRIX, the patient experienced vomiting and diarrhea. Both times the patient also received a polio vaccine. The reporter believed they were administered in the same leg. The reporter not reported any other vaccines when asked. The patient had a severe allergy to milk protein, and the reporter thought the presence of milk product in the vaccine might had caused the reaction.
Chills; upset stomach; fever; weak legs; This is a spontaneous report received from a contactable consumer (patient's parent). A 22-year-old male patient received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 13Apr2021 at 10:15 AM (Batch/Lot Number: Unknown) at the age of 22-year-old as single dose for COVID-19 immunization. Medical history included eczema and peanuts allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included Allergy. COVID prior vaccination was none. COVID tested post vaccination was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication was not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 23Mar2021 at 01:15 PM at the age of 22-year-old as single dose for COVID-19 immunization. On 14Apr2021, the patient experienced chills, upset stomach, fever and weak legs overnight only. Started late at night and went away when Advil was taken in the morning after. The patient became aware of this event on 14Apr2021 and reported it within 24 hours of learning of the event. The outcome of events was recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
8/21 Pt. mother called stating pt. C/O hard, red, warm, and pain (R) thigh. Told to ice, BENADRYL, TYLENOL/ibuprofen for pain. 8/22 Pt. mother called, pt. seen in ER night before, redness worse line drawn around redness, called today redness outside outline from night before. 8/22 Seen in office redness/swelling in (R) thigh worse. Dx cellulitis (R) lower limb given sulfamethoxazole 200 mg - trimethoprim 40 mg/mL. pt. to take 10 mL BID for 7 days. 8/23 seen in office, area of redness increase erythema 16 x 12 cm and induration 9 x 7 cm pt. ask to follow up w/provider next day. 8/24 Pt. into office for F/U visit no change to treatment. Continue BACTRIM, BENADRYL, and warm compresses. Pt. asymptomatic other than local reaction. Pt. father states area not as dark and not painful. Pt's. father told to follow up if any new persistent or worsening symptoms.
Pt discovered dead in bed with vomitus.  Autopsy reveal aspiration of formula.  Full autopsy report pending.  Pt was the product of a preterm 25 week gestation with a birth weight of 1lb 6oz.  Her neonatal course was prolonged and complicated by ligation of a patent ductus arteriosus, Broncopulmonary Dysplasia, Gastro-Esophageal Reflux Disorder, Retinopathy of Prematurity status post laser surgery, and a grade 4 intraventricular hemorrhage with severe developmental delay and cerebral palsy.  Neonatal hospitalization discharge date = 07/15/2002.  Her latest MRI showed a porencephalic cyst.  During her NICU course she also lost the tips of her left fingers 2,3,4 and 5 secondary to a PIC line complication.  Her developmental issues, constipation and poor weight gain were her most active problems.  Her weight gain had improved after starting supplemental Pediasure at 17 months of age.  She was seen in our office 11/24/03 for a weight check and incidentally found to have a upper respiratory tract infection and bilateral otitis media.  She was afebrile and nontoxic appearing with no wheezing or other adventitious chest sounds at that time.  For her otitis media she was prescribed Omnicef.  Because she looked well, she also received her second dose of influenza vaccine.  She had received her first dose of influenza vaccine on 10/23/2003 w/out incident or adverse reaction.
This spontaneous report was received from a certified medical assistant and refers to a 53 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 26-JAN-2016, the patient was vaccinated with the third dose of RECOMBIVAX HB, lot number L029631, expiration date 14-AUG-2017, (dose, anatomical location and route were not reported) that experienced temperature excursion. There was no concomitant medication reported. No adverse event was reported. This is one of several reports from the same source. Additional information has been requested.
multiple patients were vaccinated with improperly stored VARIVAX; No adverse effect; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 28-NOV-2018, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R017642 and expiry date 20-JUN-2020) for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
After 1st Pfizer shot I experienced the worst headache of my life 4-6 hours after the shot with localized pulsation in my right temporal region prior to the headache.   The headache persisted through the night and I could not sleep and did not decrease with over the counter medication, my pain was rated 9/10 to 10/10 in the same area the pulsation happened.  This headache continued for 4-6 hours at a severe level than for another 6-8 hours at a moderate to severe level.  I ended up checking in at the Emergency department that I worked at after my shift and got labs and CT scan, this was after my symptoms resolved.    I thought that I might have had a head bleed and wish I would have gotten my CT earlier when experiencing the symptoms.    I was not provided a vaccine disclosure sheet or any information on what to do if experience severe symptoms or what symptoms to expect.  I am upset that I was not provided guidance about what to expect and how to manage post vaccine symptoms, I would have gone into ED sooner with this information and feel I may have missed possible diagnosis due to lack of disclosure and guidance.
Parents report the patient had diarrhea for a full week following vaccination.  No fever, apparent abdominal pain, or vomiting reported.
At approximately 6pm day of receipt, a strong headache came on. Shortly after I experienced chills and had a fever of 99.1. By 6:30pm, I was down for the count with the cold sweats, diarrhea, headache and vertigo like symptoms (dizzy when standing or moving). Tylenol was taken for fever and water and Gatorade is all that was drank for the remainder of the night. When awaking around 8am the next morning,  fever was gone as well as chills. headache and dizziness remained. Around 1pm, toast and oatmeal was eaten and started feeling more normal again. by 5pm was fine, just tired and sore still.
LOCALIZED ZOSTER RASH ON ONE FINGER, ABOUT 1 MONTH AFTER ZOSTAVAX (RIGHT FINGER)
Four hours after receiving the PPSV23 in her right deltoid and 2016 annual influenza shot in the left deltoid patient began having pain from neck on right side to below the elbow on the right side and pain has not subsided. She has difficulty with moving the arm without pain.
Two days after receiving my shot, I received my period almost two weeks early. It then proceeded to last 12 days for me, which is double what I normally experience. It also was extremely heavy for all 12 days, which is abnormal. I experienced extreme nausea and fatigue. Now 1 month after receiving the vaccine, I am no longer getting a period. I missed a month. Both experiences are incredibly abnormal as I have had a standard period for years. This is incredibly DISTURBING AND UPSETTING.
Symptoms began morning after injection; pt reported mild HA, body aches, nausea, and runny nose for 1-2 days following vaccination.
Sinus infection; This is a spontaneous report from a contactable consumer. This male consumer (patient) reported for himself. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: 05Mar2021) via an unspecified route of administration, on 12Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. on 02Mar2021, the patient experienced sinus. It was reported that patient got the Pfizer shot on 12 of February (clarified as 12Feb2021), the first one and due for the second one on Friday but have found out yesterday that he has a sinus infection, and he has given him antibiotics and prednisone (treatment). Patient was wondering if he can still get the shot on Friday. Patient got his 1st shot and due to get his 2nd dose on Friday 05Mar, was consulting if he is able to get his 2nd dose and mentioned he found out he has sinus infection and was prescribed antibiotics and steroids. (Cefdinir & Prednisone). Patient will start taking the medications today (03Mar2021), 2nd dose is scheduled more than 21 days from the 1st dose. Therapeutic measures were taken as a result of sinus infection with Cefdinir and Prednisone. The clinical outcome of the event was unknown.  No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained
Severe Right Arm Pain Diagnosed as Nerve Damage due to Injection  Sharp Pain Limb Weakness Burning Sensation  Throbbing Aching Muscle Stiffness