chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse practitioner and refers to a 15 year old patient, of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided. On an unknown date, when the patient was 14 years old, the patient was vaccinated with the fist dose of GARDASIL 9 (strength, dose, frequency, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. Subsequently, 13 months after receiving the first dose,the patient was vaccinated with the second dose of GARDASIL 9 (strength, dose, frequency, route, anatomical location, lot # and expiration date were not provided), at the age of 15 years old (inappropriate schedule of product administration). No adverse effects were reported.
pain in left arm, patient has used topical analgesic in addition to her regular dose of tramadol and percocet that she uses for her general chronic pain
Headache, body aches, shortness of breath, headache, generalized weakness "shortly after" vaccination. The next morning she felt progressively worse, had elevated heart rate , and felt warm and flushed.  She was transported to ER by ambulance and noted to have a low grade fever. Was hydrated with 2L of LR, ketorolac, and acetaminophen with some relief.
8/26 15:20, patient received DTaP IM (LAT) #5, IPV 0.5cc SC (LL) #5 and MMR 0.5cc SC (RL). Patient tolerated well. 15:30 Mom returned to nurses station holding child; skin blotchy over face and trunk. Returned to exam room. Doctor notified; pulse box applied after reading of 97. Prednisone 30mg and Benadryl 12.5mg SQ LLT. Patient with slight cough; lungs clear per doctor. Patient discharged to home. At 16:30, no signs of distress.
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant information were reported. No treatment medication were reported.
patient stated that he had arm/shoulder pain that did not resolve and was later diagnosed with adhesive capsulitis
Information has been received from a physician concerning a female patient who was vaccinated with a first dose of varicella vaccine live. Subsequently, the patient developed a "mild rash" with about 20 lesions. Medical attention was sought and no treatment was required. No product quality complaint was involved. Additional information has been requested.
I had been having problem with my arm; it hurt but it had gone away; from my arm, elbow to my shoulder the whole joint you know, just pain, really bad pain; I am getting pins and needles in my fingers; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Sep2021 (Lot number: EW0191, Expiration Date: 31Dec2021) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Psoriasis " (ongoing), notes: Onset date: 20 Years ago. Concomitant medication(s) included: VITAMIN D (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 22Sep2021, outcome "not recovered", described as "I had been having problem with my arm; it hurt but it had gone away; from my arm, elbow to my shoulder the whole joint you know, just pain, really bad pain"; PARAESTHESIA (non-serious) with onset 22Sep2021, outcome "not recovered", described as "I am getting pins and needles in my fingers". The events "i had been having problem with my arm; it hurt but it had gone away; from my arm, elbow to my shoulder the whole joint you know, just pain, really bad pain" and "i am getting pins and needles in my fingers" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, paraesthesia.  Additional information: Patient took Motrin as treatment received. Patient was not diagnosed with any prior vaccination (4 weeks prior). The patient was provided with information to you reported adverse event(s) with the use of the product.  No follow-up attempts are possible. No further information is expected.
The adverse event that had occured is mistakenly giving the Moderna vaccine to the patient who at the time was under the age requirement to receive the vaccine.
A really bad dry cough that started 3 days after the injection and it has not gone away weeks later. I have to sleep sitting up in order to not cough and gag all night.; A really bad dry cough that started 3 days after the injection and it has not gone away weeks later. I have to sleep sitting up in order to not cough and gag all night.; This is a spontaneous report from a contactable consumer (the patient). A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot Number: unknown) via an unspecified route of administration, administered in the arm right on 26Apr2021 at 17:00 (at the age of 44-year-old) as dose 1, single for COVID-19 immunization. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 19:30, the patient experienced a really bad dry cough that started three days after the injection and it had not gone away weeks later. The patient had to sleep sitting up in order to not cough and gag all night. The patient had none of this before the vaccine. Therapeutic measures were taken as a result of the dry cough which included treatment with inhaler. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. The patient underwent COVID-19 test via nasal swab and the result was negative on 09May2021. The clinical outcome of the events bad dry cough that started three days after the injection and it had not gone away weeks later, had to sleep sitting up in order to not cough and gag all night was not recovered at the time of this report.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient said in 5-8 days after getting shot, he developed pain radiating down arm, in bicep and tricep and shoulder.
Since my second dose, I have ensured exponential lower back and leg pain, tingling, cramping, migraines, and in June developed a gastrointestinal problem that has not subsided, along with bloating, feeling full quickly, and lower abdominal pain. I had PCOS and endometriosis, but in August of 2021, CT scan detected a 3 inch cyst on my left ovary, and the cyst had a cyst on it. The left ovary was 15 times its normal size, so both were removed in September. After surgery, my leg and back pain have not subsided, and since my booster administered on 2/7/22, I have endured near crippling pain, have had to miss work and/or work from bed.
PT reports swelling, erythema, hot to the touch, satellite welts, general malaise, lethargy, tenderness and reduced range of motion due to swelling and pain that had a gradual onset and sustained for three days. Self treatment included icing, rest and ibuprofen 400mg by mouth every 6 hours for three days and found relief.
Chest tightness upon inhalation, mouth dryness. Patient was treated at clinic.
Pt experienced a sore, scratchy throat, swelling and painful; watery eyes, swelling and red; and shortness of breath. No local reaction noted. Pt was treated with Zyrtec PO X 3 doses.
Severe deltoid pain and flashing lights, detached vitreous lens (step before detached retina)
12 hrs p/vax pt was having severe pain & swelling of left arm; inflammation inc in size from elbow to back of scapula, (red, & hot to touch); family MD treated w/DPh & PCN & APAP & ice packs;
My lymph nodes in neck became very painful at 7 am and got worse through the day. I had to leave work bc pain was so severe.  I had bad wheezing and a terrible cough. I now three days later still have swollen lymph nodes, low temp, and hot sweats.
Patient is reporting injection site discomfort, body aches and a tactile fever (unable to measure fever due to no thermometer).
Dizziness, lightheadedness, nausea, lower abdominal pain. Began in morning 11/5/08, symptoms subsided within 6 hours.
Rash from base of chin down her chest to below her breasts, nipples itch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 12Oct2021 (Batch/Lot number: unknown) as dose 3 (booster dose), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose-1), administration date: Jan2021, for COVID-19 immunization; Bnt162b2 (Dose-2), administration date: Jan2021, for Covid 19 immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "Rash from base of chin down her chest to below her breasts, nipples itch". Therapeutic measures were taken as a result of rash. Additional Information: Patient had the Covid vaccines in Jan2021, and she just got the COVID booster shot on 12Oct2021, several days later she broke out in a rash, just put lotion on it, rash starts at base of her chin, goes down past her breasts, her nipples itch, states she is putting hand lotion to get some relief.   Follow-up attempts completed. No further information is expected.
Child developed fever x 2, then generalized rash 2 to 4 days after MMR, Varicella and Comvax vaccines were given.
posterior cervical lymphadenopathy;occipital lymphadenopathy;rash;all sx 10 days p/vax;pt sent home for 5 days;
got the flu that put me down for a week; Initial information received on 23-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp. This case involves a patient with unknown demographics who had got the flu that put him down for a week while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. 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. On an unknown date the patient who got the flu that put him down for a week (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (got the flu that put me down for a week). At time of reporting, the outcome was Unknown for the event got the flu that put me down for a week.
Heart palpitation and neck pain 30 hours after vaccine  Oct 2021 Extreme Chest pain, trouble breathing, burning chest, pericarditis, heart palpitations, inflammation in the neck
9:25 tongue had slight reaction, funny taste 10:23Anaphylaxis, took homeopathic Antihistimine, and Benadryl 25mg , Throat & Tongue swelling, funny chemical taste more intense. Tired all day, and pain at injection site. Day #2 Body aches, tired  Day #3 Flu like symptoms  Day #4 Flu like symptoms and SOB Chemical Taste more intense  Day #5 Tongue Throat swelling all week, Benadryl all week. PM Start Prednisone  Day #6 Throat better on the L side.  Day #8 Tongue swollen & Chemical taste, throat  esp on R, PM go to ER. shakey. Day#8-Day#14 Dry cough, more SOB, same symptoms, continue Prednisone Day #15 Saw Pulmonologist, hot w/ head rush, productive cough for 2wks;  Day # 42 Not good, call for current status
Developed papular raise to back of arms within 1 hour of vaccine, a few hours later spread to inner thighs and later to left hand, one to R knee and 24 hours became more red and macular, warm to touch, no fevers, concerning for serum sickness, developing erythema multiforme
tiredness; weakness; headache; muscle pains; feeling unwell; stomachache; heavy breathing; This is a spontaneous report from a contactable consumer (patient).   A 29-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 19Feb2021 at 10:45 (Lot Number: EL9266) (at the age of 29-year-old) as single dose for COVID-19 immunisation.  Medical history included type 1 diabetes and penicillin allergy, both from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not tested positive for COVID-19. Concomitant medications included insulin and sertraline hydrochloride (ZOLOFT), both taken for an unspecified indication, start and stop date were not reported.  On 19Feb2021 at 11:30, the patient experienced tiredness, weakness, headache, muscle pains, feeling unwell, stomachache and heavy breathing. No therapeutic measures were taken as a result of the events. The patient outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
A report was received from a healthcare professional on 11/10/03 concerning a 1 year old male vaccinee who inadvertently received Fluvirin on 11/4/03. On 11/4/03, the vaccinee received a single dose of Fluvirin 0.5ml. At the time of reporting, the vaccinee did not exhibit any adverse effects. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Menstrual cycle changes. Dysmenorrhea and Cycle length prolonged by 2-3 days ever since the vaccination.
Client presented to the vaccination site on 11/04/2021. The client notified RN that he received 1st Sputnik COVID vaccine(Lot # I-980521) on 07/27/2021, and 2nd Sputnik dose(Lot # II-37-0721) on 09/15/2021. RN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the Janssen COVID vaccine. Per CDC guidance, approval to proceed with COVID vaccine Janssen was obtained from medical consult team via text message from (Privacy) RN, Vaccine Operations Lead . Client received COVID vaccine (Janssen, Lot# 1855194) on 11/04/2021. The client did not report any symptoms during the 30 minute observation period. RN educated client on possible adverse reactions and when to seek medical care. The client left the vaccination site at 12:55pm, walking with steady gait.
hives onset 24OCT94-31OCT94 & sore throat; dx URI-poss vax react; AMoxicillin;
81 Y female with PMHx of DM2, allergies, and asthma who presents with weakness, confusion, SOB and cough. Pt admitted for acute hypoxemic respiratory failure 2/2 COVID pneumonia  # Sepsis and acute hypoxemic respiratory failure both 2/2 COVID Pneumonia - Symptom onset on 8/2/21. COVID positive on 8/4/21. Low grad fever to 99.6 on 8/8/21. No clinical signs of bacterial pna. Will hold off on further abx. Patient received 2 doses of Pfizer vaccine in April and May 2021.  - Nasal Cannula at 3-4 Lpm. Goal SpO2 >92%. Consider ICU evaluation if requiring >40LPM and 60% FiO2 for SpO2 >/= 90% - Self-proning as tolerated for O2 req >3L - Decadron 6mg IV or PO qday for up to 10 days (8/8 - ) or until no longer hypoxic. - Remdesivir 200mg IV x1, followed by 100mg IV daily until clinical improvement or 5 days (8/9 - )  - Daily LFTs. Hold Remdesivir if ALT >10xULN or CrCl<30 - pepcid for GI prophylaxis while on steroids - trend inflammatory markers - Lovenox 40mg SQ daily and hold for Plt <25k, Fibrinogen <100, active bleeding - continue isolation in hospital per Regional/Local ID guidance.   # Normocytic Anemia: Hgb 10.8 on admission, 9.3 today (hgb was 12 back in 2016, no data since). Pt reports dark brown stool, not black or bloody. No blood in urine. Unclear cause of anemia at this time. - Iron labs - B12, folate - If hgb down trends will need to consider holding Lovenox.  Pt will be discharged in a day or 2 pending improvement in O2 requirements. So far pt has been in hospital 4 days and not yet discharged.
very sick for two days; This is a spontaneous report from a non-contactable consumer communicated to a Pfizer colleague. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the COVID vaccine and was very sick for two days. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt given Td 5/9; called 5/10 to report fever > 101, and headache overnight.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Between 09-NOV-2015 and 12-NOV-2015, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L014428 with expiration date on 12-MAR-2018, (dose and route were not provided). This is one of several reports received from the same reporter. Additional information has been requested.
cough; voice hoarseness; lack of smell; loss of taste; congestion/ cough and congestion is the wrost; headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), DYSPHONIA (voice hoarseness), ANOSMIA (lack of smell), AGEUSIA (loss of taste) and CONDITION AGGRAVATED (congestion/ cough and congestion is the wrost) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced COUGH (cough), DYSPHONIA (voice hoarseness), ANOSMIA (lack of smell), AGEUSIA (loss of taste), CONDITION AGGRAVATED (congestion/ cough and congestion is the wrost) and HEADACHE (headache). At the time of the report, COUGH (cough), DYSPHONIA (voice hoarseness), ANOSMIA (lack of smell), AGEUSIA (loss of taste), CONDITION AGGRAVATED (congestion/ cough and congestion is the wrost) and HEADACHE (headache) outcome was unknown. Not Provided          No concomitant information was provided.  No treatment information was provided.
Patient up to date on COVID vaccinations, last dose 09/23/21, who admitted the hospital with an upper GI bleed.  Incidental COVID finding (asymptomatic for respiratory issues during stay) during admission testing.  Provider discharge note below:  "75 YO male with h/oCABG, AV repair (2008), HTN, HLD, who was admitted 4/18 after presenting with UGIB. He was hemodynamically unstable and was treated initially in the CCU where intubation/pressors were required (4/19-4/21). EGD  4/19 showed erosive esophagitis and in the distal esophagus there was an ulcer with oozing vessel. This was treated with epinephrine injection and cauterization. Second look EGD 4/21 was done and showed no evidence of active bleeding.  He was extubated uneventfully following 2nd EGD. He was able to be restarted on his PTA antihypertensives and transferred to general floor 4/22.  diet was advanced to a soft diet which he tolerated well there was no evidence of any further bleeding.  Hemoglobin was stable greater than 7. Discharged home in good condition with plan as below.   UGIB - erosive esophagitis in distal esophagus, with ulcer and oozing vessel; s/p epinephrine injection and cauterization with hemostasis.   - Continue PPI BID x 8 weeks  - Carafate QID x4 weeks  - advanced to soft diet x1 week, then slowly introduce general foods  - Per GI recs: will need to maintain soft diet for at least 1 week, protonix 40mg BID x8 weeks, sucralfate 1g QID x4 weeks   Acute blood loss anemia due to upper GI bleed - stable over 7.  Monitor daily or as needed  - completed IV iron for 3 days.  Will discharge with daily iron  - during admission, required 6u prb, 1u FFP, 1u platelets   EKG, telemetry review - Telemetry is reading ""afib"" however on my personal review and formal EKG, rhythm is sinus with PAC.    Peripheral edema - due to aggressive fluid/blood repletion for hemorrhagic shock. Will continue HCTZ, encourage elevation. Can try compression stockings. Resolving traveler's diarrhea - resolved. Recently returned from over seas. More likely diarrhea was due to UGIB.  AKI - due to hypotension/hemorrhagic shock. - resolved.  HTN - PTA losartan, verapamil, HCTZ. Resumed COVID-19 - incidental positive. Asymptomatic. Patient fully vaccinated.  Today is 5th day of isolation.  Okay to be on public as long as he wears a mask starting tomorrow per CDC guidelines Hypothyroidism - continue Synthroid Hx Panic disorder - pta xanax prn"
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL8982) at the age of 66 years, in right arm, on 09Feb2021 as dose 2, single (Lot number: EN9581) at the age of 66 years, in right arm, on 26Sep2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 67 years, in right arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "mild asthma" (unspecified if ongoing), notes: Mild asthma. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jun2022) Positive; (16Jun2022) Negative; (17Jun2022) Negative; (04Jul2022) Positive, notes: Home test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient did not have known allergies. Tested positive for COVID on 07Jun2022. Started Paxloid on 09Jun2022. Finished her last dose on 13Jun2022. Tested negative for COVID on 16Jun2022 and negative again on 17Jun2022. She was experiencing COVID mild symptoms on 03Jul2022 and she tested positive for COVID on 04Jul2022 using a home test. She have an appointment for a PCR test on 05Jul2022 at 7:15 am. Patient had received Anti-viral medication Paxloid as COVID 19 treatment and the treatment was started on Jun2022 and stopped on 13Jun2022.