chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via medical records refers to a 11 year old male patient with shellfish allergy. Prior vaccine administration on 05-SEP-2014 included FLUZONE, the fifth dose. (Patient denies medical history, past medical surgery, no smoke exposure, personal history: joint custody, living with: parents and sibling, diet: no shellfish, home smoke detector use: yes, housing: no guns in the home, pets: yes-one dog, and no travel outside of the country). On 22-SEP-2014 at 14:47, the patient was vaccinated with the second dose of GARDASIL, intramuscular, Lot # K008335 and expiration date on 23-JUN-2016, in the left arm. Other suspect therapy included the first dose of MENVEO, intramuscular, Lot # 14044, in the right arm, received on 22-SEP-2014. Concomitant therapies taken PRN included EPIPEN, SINGULAIR, albuterol sulfate (manufacturer unknown) and ORAPRED. It was received medical records from 22-SEP-2014. A routine child exam was performed. The patient's review of systems, interval History, nutrition, developmental assessment, key family checks, vital signs, and general examinations resulted normal. On that day, the second dose of GARDASIL and the first dose of MENVEO were administered. On 25-SEP-2014 the patient presented on physician's office complaining of right arm swelling beginning several hours after vaccination, extending to below the elbow. It was received medical records from 25-SEP-2014. Interim history: Patient got his vaccines on 22-SEP-2014, Monday. The first night it was hard the next day it was hard and then it was swollen over his elbow. The patient's review of systemic and vital signs were normal. On general examination, regarding extremities, it was reported: swelling from shoulder joint down to below the right elbow, circumferential, with redness to below the elbow on the right, normal range of motion and non-tender but hard throughout to palpation, no evidence of compartment syndrome. Assessment: Cellulitis -682.9 (Primary), aseptic post immunization with MENVEO. Treatment: Start Clindamycin HCl capsule, 300 mg, 1 capsule, orally, every 8 hours, 10 days, 30, refills: 0. Start MEDROL (pak) tablet, 4mg, as directed, orally, following package instructions, 7 days, 1, refills 0. Notes: it was recommended starting clindamycin today and considering steroid in the next 1-2 days if not improving or worsening. Script sent for mom to pick up as needed. If he was getting worse, they had instructions to follow up at the physician's office. At the time of the report, the patient's outcome was not provided. The relatedness between GARDASIL and adverse events was not provided. It was reported as Allergies: MENVEO (swelling of arm to below elbow: contraindication). All available medical records will be provided upon requested. Additional information has been requested.
Immediately after injection, my heart raced, I got a metallic taste in my mouth, and my fingers got cold and tingly. The next day, I developed chest pain, racing heart, shortness of breath, and insomnia. I continue to have chest pain. On 04/08/2021, without injury or anything that I did, my right middle finger swelled and turned purple and it's still purple. The ER doctor said it was a hematoma.
Paralyzed legs; Broke his nose; Experiencing insulin resistance/feels like his insulin is not working; Fall; Hypoglycemic; This spontaneous case was reported by a consumer and describes the occurrence of DIPLEGIA (Paralyzed legs), NASAL INJURY (Broke his nose), INSULIN RESISTANCE (Experiencing insulin resistance/feels like his insulin is not working), FALL (Fall) and HYPOGLYCAEMIA (Hypoglycemic) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044H21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus (type 1). Concomitant products included INSULIN ASPART (NOVOLOG) for Diabetes mellitus, LISINOPRIL, GABAPENTIN, CYCLOBENZAPRINE, ATORVASTATIN, OXYCODONE, OMEPRAZOLE and GLUCAGON (BAQSIMI) for an unknown indication.    On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIPLEGIA (Paralyzed legs) (seriousness criteria medically significant and life threatening), NASAL INJURY (Broke his nose) (seriousness criterion life threatening), INSULIN RESISTANCE (Experiencing insulin resistance/feels like his insulin is not working) (seriousness criteria medically significant and life threatening), FALL (Fall) (seriousness criterion life threatening) and HYPOGLYCAEMIA (Hypoglycemic) (seriousness criterion life threatening). At the time of the report, DIPLEGIA (Paralyzed legs), NASAL INJURY (Broke his nose), INSULIN RESISTANCE (Experiencing insulin resistance/feels like his insulin is not working), FALL (Fall) and HYPOGLYCAEMIA (Hypoglycemic) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 500 (High) High.         The treatment information was not provided.  The action taken with mRNA 1273 with the events was considered as not applicable.  Very limited information regarding these events has been provided at this time. However, medical history of Diabetes mellitus (type 1)may remain as confounding factor.Further information is required.; Sender's Comments: Very limited information regarding these events has been provided at this time. However, medical history of Diabetes mellitus (type 1)may remain as confounding factor.Further information is required.
Breakthrough case admission after three vaccines Pfizer 3/21/21 Lot# EN6202;  Pfizer 4/13/21 Lot# ER8733;  Pfizer 10/29/21 Lot#FF2593
Woke up the next morning with fever 101.7, severe chills, general malaise. Moderate to severe swelling and pain at injection site, and golf ball sized swelling in axillary lymph node, same side as vaccine. Day two, fever still present, chills reduced, sub clavian lymph node grossly swollen, axillary swelling remains. Day three, swelling has progressed to left occipital nodes, neck extremely stiff. Day four,  neck stiffness and pain and swelling in all nodes persists, and left parietal nodes also now swollen.
Pain and swelling at injection site. Mild headache.  Rash around my midsection
Patient received flu shot (1st flu vaccination) in left deltoid intramuscularly on 01/10/2006.  Later that day, experienced swelling in bicep with tenderness.  Left axillary node tenderness/swelling.  Symptoms resolved, but does have occasional sharp pain and tenderness.
pt recvd vax 27AUG92 & devel a fever of 102 approx 14 hrs p/vax; 28AUG fever cont (rise & fall); there has been an outbreak of viruses in the area;
This spontaneous report as received from a pharmacist refers to a 67 year old female patient. On 16-SEP-2014 the patient was vaccinated with PNEUMOVAX23 (lot # K007773, expiry date: 01-MAY-2015, 0.5 ml intramuscular. Pertinent medical history and concomitant medications were unspecified by reporter. The reporter stated that the patient had developed bruising at the injection site that has spread to the "inside of the elbow" after receiving PNEUMOVAX23. The patient was also experienced injection site itches which were "real bad". The patient visited pharmacy on 18-SEP-2014 and informed pharmacist of the symptoms  and then "two hours later" went to an unspecified clinic and received a prescription of an unspecified antibiotic and was diagnosed with cellulitis on an unknown date in September 2014. The outcome of cellulitis was reported as not recovered/not resolved. The causality was unknown. No further information was provided. Additional information has been requested.
I got two vaccines on 11/2/19, a flu shot (Fluarix quadrivalent) and Shingrix (1st dose). Within 6 hrs was feeling some muscle aches and slight fever. Both worsened and persisted for an additional 24 hrs or so.
chronic bronchitis; COPD; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 18Sep2021 (Batch/Lot number: unknown) as dose 2, 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: 21Aug2021, for Covid-19 immunization. The following information was reported: BRONCHITIS CHRONIC (non-serious) with onset 2021, outcome "unknown", described as "chronic bronchitis"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious) with onset 2021, outcome "unknown", described as "COPD". Therapeutic measures were taken as a result of bronchitis chronic, chronic obstructive pulmonary disease.  Additional information: Patient asked about the 100 dollar card they could receive after getting the Pfizer covid-19 vaccine. While reading the isi (unspecified), the patient mentioned that she was on a blood thinner (unspecified), with COPD (chronic obstructive pulmonary disease) and chronic bronchitis.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Mother noticed pt. was limping this morning. Pt. showed mother the area on her left thigh. Mother stopped by the clinic with the pt. requesting someone asses the area where she received her vaccines yesterday. Mom states that pt. has a large red circle that is hot. Pt. received 2 injections yesterday, Kinrix and Proquad. The site of the Proquad injection is red and inflamed, warm to touch and measures 5 cm in diameter. No treatment given.
Rapid heartbeat; Fell really hot; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Rapid heartbeat) and FEELING HOT (Fell really hot) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (Rapid heartbeat) and FEELING HOT (Fell really hot). At the time of the report, TACHYCARDIA (Rapid heartbeat) and FEELING HOT (Fell really hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported No treatment information was provided.
The day after the shot, had "covid arm", as I had after first shot, but milder, redness/swelling, temp under 101...no problem.... then about a week later, left eye swelled shut, not conjunctivitis, it was my lid and my cheek. Is diminishing with time, no infection, it appears to be inflamation or allergic reaction.  Strange, ugly, but more curious than anything. No vision changes, still somewhat... swollen and red (orangey), but not like first couple days.
This spontaneous report was received from a licensed practical nurse referring to a 9 week old patient (gender unknown). The patient's pertinent medical history, current conditions and concomitant medications were not reported. On 17-OCT-2016, the patient was vaccinated with improperly stored dose of ROTATEQ lot # M006112 expiration date:16-NOV-2016, orally; (volume/dose reported as 2) for prophylaxis. The vaccine was exposed to temperature of 49 Fahrenheit for 30 minutes. No previous temperature excursion was reported. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA004378: US-009507513-1610USA004376: US-009507513-1610USA004377: US-009507513-1612USA006675: US-009507513-1610USA003097: US-009507513-1612USA006673: US-009507513-1612USA006676: US-009507513-1612USA006672.
Received vaccine on 01/12/05. On 01/17/05, developed low grade fever. Developed joint stiffness and pain by 01/18/05, was taken to the doctor and tylenol and motrin were ordered. on 01/28/05, feeling better.
MANUFACTURER EXPIRATION WAS FOR 9/30/2022. DOSE WAS ADMINISTERED 10/01/2022. "On Oct. 12, stores received an internal Urgent Removal Notice regarding Pfizer COVID-19 Vaccine- Pediatric 5-11 Years Tris-sucrose, Lot #FL2757 with manufacturer?s expiration date of Sept. 30.  Information has been received from the manufacturer indicating that stability data supports the use of this product through Oct. 19."
- At time of vaccine (8:30am) no soreness or reaction. - Approximately 6pm injection site became sore and mild body aches and chills noted. Temperature 99.1; 2 Tylenol taken. - 1/3/2021 Approximately 12am woke up with severe chills and body aches. Temperature 101.5; 2 Advil taken. - Approximately 8am decreased body aches/chills. Temperature down to 98.8; 2 Advil taken. -Approximately 4pm mile-moderate body aches and chills. Temperature 101.8; 2 Advil taken. - Approximately 5:15pm  Temperature 101.1 - Approximately 6:30pm Temperature 99.8; 1 Tylenol taken. - Approximately 7:30pm Temperature 98.6 - Approximately 8:30pm Temperature 97.8 - Approximately 10pm Temperature 96.6; 2 Advil taken. - 1/4/21 approximately 7:15am Temperature 96.6; no chills or body aches; injection sight remains slightly tender.
On 2/17/03 patient was vaccinated in her left arm with smallpox vaccine.  On 2/26/ she c/o Muscle pain, and on 2/28 she was seen in the ER. Appeared to have some confusion for 2-3mins, unsteady on her feet, lightheaded, dizziness accompanied by a basilar headache. Experienced right sided facial drooping in ER for about 15 mins. Later an infection control nurse observed facial drooping on right side of face, leg weakness, and difficulty walking. Temp was 98.4/ Pulse-109/ Resp-20 BP-146/96. Pt. states that she is better, but continues to have a headache as of 3/13/03. Has not worked since 2/28/03.3/5- Robust take- 1&1/2 cm.
Whole area on the arm is very itchy; Rash; Arm has been sore for the past couple of days; hives; it was very itchy at the injection site; allergic reaction; very red; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction), ERYTHEMA (very red), PRURITUS (Whole area on the arm is very itchy), URTICARIA (hives) and VACCINATION SITE PRURITUS (it was very itchy at the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced HYPERSENSITIVITY (allergic reaction), ERYTHEMA (very red), URTICARIA (hives) and VACCINATION SITE PRURITUS (it was very itchy at the injection site). On 28-Aug-2021, the patient experienced PRURITUS (Whole area on the arm is very itchy), RASH (Rash) and MYALGIA (Arm has been sore for the past couple of days). At the time of the report, HYPERSENSITIVITY (allergic reaction) had not resolved and ERYTHEMA (very red), PRURITUS (Whole area on the arm is very itchy), URTICARIA (hives), VACCINATION SITE PRURITUS (it was very itchy at the injection site), RASH (Rash) and MYALGIA (Arm has been sore for the past couple of days) 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.   No treatment medication information was provided. No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Aug-2021: Follow up report contains additional events were added. On 03-Sep-2021: Follow-up document received on 03-SEP-2021. It contains no new information.
Pt recv vax on 3/29/99; on 3/30/99 pt exp red/ warm right thigh
Swollen and sore Lymph Nodes under Left Armpit; Swollen and sore Lymph Nodes under Left Armpit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 12:15 (Lot number: EP6955) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies codine" (unspecified if ongoing), notes: Codine, Chocolate, Strawberries, Nuts; "Known allergies Chocolate" (unspecified if ongoing), notes: Codine, Chocolate, Strawberries, Nuts; "Known allergies Strawberries" (unspecified if ongoing), notes: Codine, Chocolate, Strawberries, Nuts; "Known allergies nuts" (unspecified if ongoing), notes: Codine, Chocolate, Strawberries, Nuts. Concomitant medication(s) included: RELPAX taken for migraine; UBRELVY taken for migraine. Vaccination history included: Bnt162b2 (Dose: 1, lot number: EL3247, administration time: 12:00 PM, vaccine location: Left arm), administration date: 02Mar2021, when the patient was 58 years old, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 25Mar2021, outcome "not recovered" and all described as "Swollen and sore Lymph Nodes under Left Armpit". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain.  Additional information: Patient reported that she was neither been diagnosed with COVID-19 prior to vaccination and nor been tested for COVID-19 since vaccination. List of any other medications the patient received within 2 weeks of vaccination was reported as Relpax or Ulbrevy as needed for migraine headaches. Patient also reported that she did not received any other vaccines within 4 weeks prior to the COVID vaccine. Seriousness criteria (Results in death/Life threatening/Caused or prolonged hospitalization/Disabling or Incapacitating/Congenital anomaly or birth defect) was reported as No.  No follow-up attempts are possible. No further information is expected.
Two days after injection I began having a severe headache lasting 7 days as I write this. I was evaluated at an ER and released but the headache has been constant with minimal response to treatment.
Small rash on left thigh noted 12/20/2011. Similar rash noted 12/30/11 on left wrist. As of 01/06/12, both still present.
Had shot at 1pm 9/7/19 at midnight I had a severe headache, fever, chills, body aches, nausea and then diarrhea two days later very weak and still have a slight headache and body ache
vial was used to vaccinate 9 patients and the 10th dose was not used to vaccinate a patient because it was not a complete dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT PACKAGING QUANTITY ISSUE (vial was used to vaccinate 9 patients and the 10th dose was not used to vaccinate a patient because it was not a complete dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) 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 09-Mar-2021, the patient experienced PRODUCT PACKAGING QUANTITY ISSUE (vial was used to vaccinate 9 patients and the 10th dose was not used to vaccinate a patient because it was not a complete dose). On 09-Mar-2021, PRODUCT PACKAGING QUANTITY ISSUE (vial was used to vaccinate 9 patients and the 10th dose was not used to vaccinate a patient because it was not a complete dose) had resolved.        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.   No concomitant medication was provided by the reporter.  No treatment medication was reported.  The nurse reported that she drew only 9 doses out of a vial and the 10th dose was only 0.2ml instead of 0.5ml. She received the shipment on 18Feb2021 and has already dispense 80 of the 100 vials. Only this one vial has had this problem so far. She just called to report it.
Erythema multiform and urticaria pruritus. Diphenhydramine 50 mg once.
Presented via EMS w/ n/v, weakness, syncopal episode at home. PCR Covid +, pneumonia. Tx / Remdesivir, solumedrol, O2. Next day dx of LLE DVT, refractory hypoxemia, bilat pulm. Embolism. Thrombolytics initiated resulting in intracranial hemorrhage.
Nausea and vomiting for 4 days Diarrhea for 2 day stopped with Imodium A-D
I hesitate to call this an adverse event.  However,  I contacted CDC and was told I should still submit to VAERS.    I've had the skin condition Vitiligo since I was 11.  I've never undergone any treatment for it, as I was able to camouflage it with makeup.  About 4-5 days after my second vaccination, I noticed there appeared to be a few spots of  repigmentation on my forehead.   To be clear, I have never had repigmentation in this area.  On the following morning, I noticed a few more spots appeared to be darker in the same area.  Now, several weeks later, I have a significant level of repigmentation which matches the unaffected skin around the patches of Vitiligo.  Of course, I have no way to be certain the vaccine and this event are related, but I can say with confidence the latter is unprecedented in the 31 years since I was diagnosed.
He got his vaccine, everything that generally comes with it, brain fog, fatigue, soreness, all the general side effect.  Within the week of the vaccine his blood pressure dropped where he was taking two medicines for it, this happened after the 2nd vaccine and then happened again.  It is now 100/60 which is how it typically runs now and there is not much he can do to get it up.  This happened last year after the 2nd vaccine, and did not come up until the week of September 15th, almost 6 months after the vaccine.  He has a feeling that this is going to be the same way around this time.  He is on a transplant list trying to get a kidney transplant and he keeps getting cancelled due to his BP being so low.    He has spoken with his nephrologist who thinks that it is a good BP and wants to keep it low.
Patient needed to have DTaP/IPV for school. School refused to allow patient to continue school without appropriate vaccine. Discussed issue with both the school nurse, parent and patient. Patient understood the need for the vaccine for school and agreed to having vaccine.
My issues initially started about an hour after the vaccine.  I became very subdued, no appetite and "foggy" for a lack of better words.  I attributed this to what others stated were "typical reactions" and did not make a fuss over it.   The following day I was VERY tired and stayed in bed and then about half way thru day 3, I became alert and resumed normal activity.  At day 13 I began to have upper thigh pain in my left leg and began to feel winded as I was would walk up steps and do housework which had not happened previously ever..  On 4/14/21 I requested an appointment with my primary care doctor, however he was booked for 2 weeks and I was referred to an associated PA  where I received a virtual consult.  He told me that I was "over the age" of the women that were having reactions ,even though I had requested a Doppler.  He only ran bloodwork, and in fact never even called me back on the bloodwork, and just posted it in the online profile.  My ankles are VERY swollen and have bluish pitting and my feet do have considerable pain.  I do have right side abdominal pain everyday since the 13th of April.  I now need to find a doctor that will run diagnostics and respect my concerns