chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient "developed a red rash, with eyelid and ear swelling"; patient "developed a red rash, with eyelid and ear swelling"; patient "developed a red rash, with eyelid and ear swelling"; This spontaneous report was received from a nurse regarding a 12-months-old male patient. The patient did not have medical history, drug reactions, allergies or concomitant medications.   On 27-JUN-2019, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # R030803, has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 22-APR-2020) (dose and route of administration were not provided); diluted in sterile diluent (STERILE DILUENT MRK INJ) (dose, lot # and expiration date was not reported) as prophylaxis.  On 29-JUN-2019, he developed a red rash on an unspecified location, with eyelid and ear swelling. On 01-JUL-2019, the patient recovered from the events after receiving diphenhydramine hydrochloride (BENADRYL). There were no diagnostics laboratories or studies performed.   The reported causality between Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), sterile diluent (STERILE DILUENT MRK INJ) and the events was not reported.
The night about 9 pm low grade fever. I woke up next day hives chest , later aches pain chills lasting to Tues 1/26 morning.
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On 12-MAY-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016, (dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. On an unspecified date, the vaccine experienced a temperature excursion of 32 F for 48 hours (lowest recorded temperature). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Vaccinations given morning of 8/19/21 visit as noted prior. Mother of child reported that hours after vaccinations patient began to have right sided mild facial weakness. At office visit 8/20/2021 patient was determined to have facial nerve paralysis (Bell's palsy).
patient describes a tingling feeling down her right arm that started after the vaccine was administered in the evening and has continued into following morning. Counseled patient that this is a documented reaction to the vaccine and should go away over the course of the next couple of days. Told patient to see the doctor if pain has not subsided in the next three days.
Received dose from expired vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported. The vial was initially stored in the refrigerator on 21-OCT-2021.
Very large rash, very inflammed. Skin looks dark and puffy, hot or warm to touch, very tender / painful to touch.
Pt had generalized rash involving shoulder and upper arm of injection arm. Rx'd OTC Caladryl lotion.
Loss of taste; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FR8727) via an unspecified route of administration in the left arm on 01Apr2021 at 12:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not take any other medications in two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 00:00, the patient experienced loss of taste. The patient did not receive any treatment for the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event loss of taste was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient presented with epigastric abdominal pain radiating into his back. He had elevations in his lipase over 100. CT scan showed evidence of acute pancreatitis in the pancreatic head and surrounding inflammation. He was admitted to the hospital and started on IV pain medication with Dilaudid given 0.5 every 2 hours. He also got some Carafate and GI cocktails. Discharged him on some hydrocodone to use as needed. ED to hospital admission within 6 weeks of receiving the COVID vaccine.
Ten hours post vax while relaxing in bed, the vaccinee experienced pounding heart, throbbing temples, dizziness, weakness, nausea. In addition her throat hurt and felt swollen. The episode lasted twenty minutes, after which things returned to normal. No treatment was given.
temperature of 100 (unknown units); Fatigue; Joint pain; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 30Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program.   A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot Number: EN0150), dose 2 via an unspecified route of administration on 05Apr2021 09:30 (at the age of 73-years-old) as dose 2, single and  on 15Mar2021 (Batch/Lot Number: EN6207) as dose 1, single for covid-19 immunization. Patient had no medical history and concomitant drugs. Prior to vaccination, the patient did not receive any other vaccines. The patient experienced temperature of 100 (unknown units), fatigue  and joint pain on 2021. The outcome of the event was unknown.
Patient experienced slight fever and tiredness after second vaccine shot.; Patient experienced slight fever and tiredness after second vaccine shot.; This is a spontaneous report from non-contactable Non-healthcare Professional. This Non-healthcare Professional reporting for a 74-year-old male patient. A 74-year-old male patient received second dose of bnt162b2 (Pfizer Covid-19 Vaccine, solution for injection, Lot number: Not available), via an unspecified route on 10Apr2021 (age at vaccination: 74-year-old), as a single dose for covid-19 immunization. Medical history included cancer prostate. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer Covid-19 Vaccine, solution for injection, Lot number: Not available) at the age of 74-year, as a single dose for covid-19 immunization. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 10Apr2021, patient experienced slight fever and tiredness after second vaccine shot. It was unknown if patient received any treatment for the events. The clinical outcome of the events was recovered in 2021.  No follow-up attempts possible. Information about Batch/ Lot number cannot be obtained.
No adverse event; My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Feb-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .).    No concomitant medication details was reported. No treatment medication details was reported.   This case contains information for the 4th patient out of 4 pediatric patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-712814, US-MODERNATX, INC.-MOD-2023-712821, US-MODERNATX, INC.-MOD-2023-712819 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712814:Patient 1 case US-MODERNATX, INC.-MOD-2023-712821:Patient 3 case US-MODERNATX, INC.-MOD-2023-712819:Patient 2 case
I had the usual sore arm, muscle aches, nausea, weakness for a couple of days that went away in 3 or 4 days. However, I also developed shooting nerve pains in various areas of my body that moved around and persisted for about 2 plus months. It was almost debilitating depending on where the nerve pain moved to.
Immediately my left arm became sore. The soreness never left. Movement of my left arm is still painful after all this time. Sleeping it wakes me up if I move it wrong. Got a steroid shot and was told the person giving the shot had adm. It wrong and now I am left with some syndrome. I need more shots but use Tylenol. It takes it but pain us always present. I am scared to go to the doctor of fear of getting covid so I suffer through it. Strength is limited now in left arm.
Patient requested P.F. flu shot since she was trying to get preg. She has had previous flu shots with no adverse effects. Approximately 25 min. after receiving shot developed cough. Effects worsened causing swollen, lips, mouth sores, N/V, difficulty breathing, hoarseness. Patient went to E.R. + received EPINEPHRIN + BENADRYL.
Information has been received from a female medical assistant who on 12-DEC-2006 was vaccinated with a 0.5 ml first dose of Gardasil. On 06-APR-2007 the patient was vaccinated with a 0.5 ml second dose of Gardasil. On 06-APR-2007 the patient developed swelling and a "bubble area" at the injection site. The arm became red and hard. There was no drainage noted. Unspecified medical attention was sought. Subsequently, the patient recovered from swelling and a "bubble area" at the injection site and a red and hard arm. The medical assistant did not experience any difficulties with the first injection. Additional information has been requested.
fatigue; shortness of breath with light activity; dizziness; heart premature atrial contractions; This is a spontaneous report received from a non-contactable consumer (patient) reported for herself. A 68-year-old non-pregnant female patient received bnt162b2 (formulation: Solution for injection. Lot number: EN5318), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 12:00 as single for covid-19 immunisation. Medical history included hypertension, high cholesterol, valve regurge and anxiety disorder. Known allergies to ibuprofen penicillin and sulfa. The patient received no other vaccine in four weeks. It was unknown if the patient was covid prior to vaccination and no covid tested post vaccination. Concomitant medications included atenolol, amlodipine besilate (NORVASC) and buspirone, all taken for an unspecified indication, start and stop date were not reported. On 06Feb2021 12:00, the patient experienced fatigue, shortness of breath with light activity, dizziness, heart premature atrial contractions. This has been going on now for 6 days. No treatment received for the events. Outcome of the events was reported as not resolved.
After giving the patient her vaccine, we realized we had drawn up her vaccine from a vial that was punctured approximately 16.5 hours prior.  Moderna vials are only good for 12 hours after being punctured.
Dizzy; This is a spontaneous report from a contactable consumer (patient).   A 68-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  via an unspecified route of administration, administered in Arm Left on 01Mar2021 06:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. No other vaccine was received in four weeks. The patient previously took erythromycin and experienced drug hypersensitivity. No covid prior vaccination. No covid tested post vaccination. The patient experienced dizzy on 01Mar2021 06:45. No treatment of the event. The outcome was recovered on 01Mar2021 07:45.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Missed period, about a month late. Received second dose about 5 days before expected period.  Pms symptoms the entire time. Confirmation not pregnant.
None with Shot 1  Shot 2 : Headache, fatigue, nausea, vomiting, diarrhea, nightmares, unclear thinking, instability on feet   2days recovery except for headache and fatigue remain Imodium  Zofran Sumatriptan  Fully recovered  except for headache and fatigue
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 51-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included multiple sclerosis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: The patient was vaccinated with the 1st dose of SHINGRIX in the left arm. The patient experienced injection site pain that lasted for a couple of days. This case was linked to case US2018146959, reported by the same reporter for the same patient.
Night of 2nd shot, woke up with 101.3 fever, shaking and achy joints. Racing heart- arm were recieved shot extremely painful.
Swelling and redness of the arm, the size of an orange; Swelling and redness of the arm, the size of an orange; Headaches; Tiredness; Feeling unwell; This is a spontaneous report from a contactable other health professional. A 59-year-old female patient (pregnant: No) received second dose of bnt162b2 (lot number: EL1283), intramuscularly in left arm on 12Jan2021 16:00 at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included sertraline hydrochloride (ZOLOFT), ibuprofen. The patient previous received first dose of bnt162b2 (lot number: EK5730) intramuscularly in left arm on 21Dec2020 11:30 AM for COVID-19 immunization. The patient experienced swelling and redness of the arm, the size of an orange, headaches, tiredness, feeling unwell on 13Jan2021 06:00. No treatment received. The outcome of events was resolving. The event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No covid prior vaccination. No covid tested post vaccination. Not known allergies. Facility type vaccine was hospital. No other vaccine in four weeks.
left eye swollen shut. tingling in limb from point of shot to fingers  hives Headache.
Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) and varicella virus vaccine live (Oka/Merck) (VARIVAX) both have the same ingredient of "varicella virus vaccine live", were administered on the same day; Fever of 103F; This spontaneous report was received from a medical assistant referring to currently 12-months-old female patient.  The patient's current condition, medical history, drug reactions, allergies and concomitant therapies were not provided.    On 07-DEC-2021 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), 1 dosage form (lot # T032144 and expiration date provided as 20-MAR-2022) and varicella virus vaccine live (oka/merck)(VARIVAX), 1 dosage form (lot # U015689 and expiration date provided as 18-MAY-2023) for prophylaxis on same day (Overdose). On same day HAVRIX and PREVNAR 13 were administered.  On 10-DEC-2021, the patient experienced a fever of 103F.   The outcome and causality assessment of pyrexia was not provided.
Patient ran a fever of 102 post immunization and developed diffuse morebilliform rash on day 6 post immunization.
24 hours after receiving H1N1 LAIV developed rash which began under eyes and spread behind ears and then to chest. Rash looks like sunburn with pinpoint bumps.
Upon post vaccination for second dose of monkeypox, patient had a vasovagal episode with syncope. Patient brought safely to floor with legs elevated and ice packs applied. Water offered. Vital signs taken and patient expressed resolution of symptoms 10 seconds post syncope. Patient vitals within normal limits. Patient contacted friend to accompany out of the facility. Patient left facility safely.
Patient reported palm-sized hives about an inch below the injection site. She's not sure whether it's from the injection itself or possibly poison ivy. She applied OTC hydrocortisone and the hives began to improve.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51-year-old male patient received BNT162b2 (COMIRNATY), as dose number unknown (booster), single (Lot number: FL3197, Expiration Date: 30Jun2022) for covid-19 immunization. The patient's relevant medical history included: "elevated blood pressure" (unspecified if ongoing), notes: elevated blood pressure. Concomitant medication(s) included: LISINOPRIL AND HYDROCHLORTIAZIDE taken for blood pressure increased. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer.), for COVID-19 Immunization; Covid-19 vaccine (Dose number unknown first Booster, unknown manufacturer.), for COVID-19 Immunization. The following information was reported: POOR QUALITY SLEEP (non-serious), outcome "recovering", described as "A very restless night of sleep was experienced"; VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "developed soreness at the injection site"; CHILLS (non-serious), outcome "recovering"; NAUSEA (non-serious), outcome "recovering", described as "very nauseous/bit of nausea"; VOMITING (non-serious), outcome "unknown", described as "became very nauseous, which led to vomiting"; PYREXIA (non-serious), outcome "recovering", described as "fever"; HEADACHE (non-serious), outcome "recovering", described as "a persistent headache". Additional information: Several hours after receiving the 2nd booster of Comirnaty, patient developed soreness at the injection site. 12 hours after the dose, patient experienced chills. 14 hours after dose, patient developed a fever and became very nauseous, which led to vomiting. A very restless night of sleep was experienced. He awoke to a bit of nausea and a persistent headache. Symptoms at the 25 hour point (post dose) are improving substantially. No follow-up attempts are possible. No further information is expected.
Per Dr. Recommendation due to child's fear of needles and need to catch up on immunization, Pediarix was given. MD and legal guardian informed of questionable validity after.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 26Sep2021 at 13:00 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 11May2022 at 13:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Dec2022) Negative, notes: Took Paxlovid for 5 days. Tested negative two days later; (Dec2022) Positive, notes: positive for Covid (again). Therapeutic measures were taken as a result of drug ineffective, covid-19.
Case was vaccinated and boosted x1 against Covid by October 2021 , but was then hospitalized for Covid in May 2022. Hospitalized at:  Hospital.  COVID Assessment & Plan Feels much better today. Triple-vaxxed, Covid + on admission screen. She has no respiratory symptoms but has had runny nose, generalized malaise and diarrhea / nausea / vomiting.  - Covid antigen test negative on 5/16. - Repeat Covid Ag test on 5/17 negative.      Nausea and vomiting Assessment & Plan N/V/D have resolved. Presented w/about a week of nausea and vomiting. Unclear cause. She's had diarrhea as well. This may be due to COVID. Suspect that the poor PO intake led to her hyponatremia.  - Supportive care.
Information has been received from a medical assistant concerning a 26 month old male patient who on 26-FEB-2007, was vaccinated intramuscularly in the left thigh with a 0.5 mL dose of Vaqta (lot # 652809/1008F). Two hours after vaccination, the patient's pupil became dilated and the patient developed cerebral ataxia. He came into the office on 27-FEB-2007 for his symptoms. The patient was not hospitalized for the events. An MRI and laboratory work were performed with normal results. The patient is currently recovering and is seeing a neurologist. There was no product quality complaint. Dilated pupils and cerebral ataxia were considered to be disabling by the reporter as "the patient could not walk". It was noted that the patient's inability to walk was a symptoms of the cerebral ataxia. Additional information is expected.
5pm - body aches and fever began 11pm - fever reached 39 degrees Celsius 4am - fever ended, body aches continued headache and some joint pain continued for another full day