chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning several patients who were vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot #s 657403/0715U and 657404/0592U). The nurse reported that several patients came back to the office complaining of fever and red "knot" at the injection site. The patients outcome was not reported. There was no product quality complaint involved. Additional information has been requested. Follow-up information received stated that this Caucasian 15 year old male patient with an allergy to cefixime (SUPRAX) received a second subcutaneous dose of varicella virus vaccine live (Oka/Merck) (lot # 657403/0715U) in the right arm on 22-JUN-2007. Concomitant vaccine administered on the same day included an intramuscular first dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (Lot # U2331AA) in the in the left arm. there was no illness at the time of vaccination. The patient developed a silver dollar sized knot, warm to touch with a swollen arm. No medical attention was sought. Subsequently, the patient recovered.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE PERICARDITIS, UNSPECIFIED MYOCARDITIS HYPOTENSION
pt recv vax APR96 & 10 to 12 days later pt exp rash on face, arms, neck swollen nodes behind ears, & sore throat;
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient reported being dizzy after the vaccine dose, sat down after vaccine, and then patient briefly lost consciousness for aprox 10-20 seconds. Ambulance was called, BP/BG/EKG taken, patient eventually agreed to be admitted, leaving with the paramedics. Patient had reported not eating anything this morning prior to the vaccine.
teeth sensitivity; pigmentation on skin brown spots; This spontaneous case was reported by a consumer and describes the occurrence of HYPERAESTHESIA TEETH (teeth sensitivity) and PIGMENTATION DISORDER (pigmentation on skin brown spots) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERAESTHESIA TEETH (teeth sensitivity) and PIGMENTATION DISORDER (pigmentation on skin brown spots). At the time of the report, HYPERAESTHESIA TEETH (teeth sensitivity) and PIGMENTATION DISORDER (pigmentation on skin brown spots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant history was not reported. The treatment history was not provided.
BODYACHES, SORE ARM, HEADACHE, SCRATCHY THROAT, FATIGUE
Patient was given the wrong vaccine . She has had two Pfizer 1/19/21 EL8982 2/9/21 EL9261 today she was given Moderna
Patient noted that he had itching at injection site. After looking at arm patient noted that area was red, warm to touch and hard. Patient stated itching seemed to be getting worse. Came to pharmacy on 11/27/2012 to seek treatment. At pharmacy, pharmacist inspected injection site. The area was warm to touch, noted induration and erythema about 4 inches in diameter. Pharmacy contacted manufactuer and physician. Physician told patient to put Benadryl cream on area and warm compress. Called patient around 3pm and patient said heat and warm compress seemed to be helping symptoms.
body aches; increased temp; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (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 (1st dose of covid-19 vaccine), administration date: 26Feb2021, for Covid-19 immunisation. The following information was reported: PAIN (non-serious) with onset 21Mar2021, outcome "unknown", described as "body aches"; BODY TEMPERATURE INCREASED (non-serious) with onset 21Mar2021, outcome "unknown", described as "increased temp"; FATIGUE (non-serious) with onset 21Mar2021, outcome "unknown", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: This is a report from a Pfizer-sponsored program and other program. Patient received Pfizer Covid-19 vaccine first dose on 26Feb2021 and 2nd dose was 20Mar2021 and after receiving the 2nd dose experienced side effects (body aches, increased temp & fatigue).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started experiencing shortness of breath on Tuesday evening-- on Wednesday afternoon she started to develop a rash on her face, neck , chest, and arms along with itching. Patient went to the ED at Hospital last night for SOB and was given a breathing treatment and steroids. Denies any changes to routine or soaps lotions or detergents.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 02Apr2021 as dose 2, single (Lot number: ER8733), in left arm and on 05Oct2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 34 years, in left arm for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: had not experienced rebound (negative on rapid antigen and PCR tests); (06Sep2022) Positive, notes: I first tested positive on 06Sep when I had a fever (on an rapid antigen test and on a PCR test); (unspecified date) not positive, notes: tested myself every day after that with rapid antigen tests and was not positive for the coronavirus; (unspecified date) Negative, notes: had not experienced rebound (negative on rapid antigen and PCR tests); (unspecified date) Positive, notes: Product=COVID 19 Treatment; (Jul2022) Positive, notes: I had previously tested positive for with the coronavirus in late Jul, taken Paxlovid; (05Sep2022) Negative, notes: tested negative on at home rapid antigen test; (06Sep2022) Positive, notes: I first tested positive on 06Sep when I had a fever (on an rapid antigen test and on a PCR test); (11Sep2022) Negative, notes: I tested negative for the coronavirus on an at-home rapid antigen test on Day 6 on 11Sep2022; (15Sep2022) Positive, notes: back positive with a faint line on 15Sep; (16Sep2022) positive line showed up almost immediately. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Client presented to EMT c/o global mild itchiness. Observed for additional 15min post vaccination (total of 30min). VVS
On the third day I experienced lightheadedness/then extreme dizziness to the level that I could not get out of bed easily; I could not get out of bed easily; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 14:00 (Lot number: ER8736) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "mild heart disease" (unspecified if ongoing). Concomitant medication(s) included: NORVASTATIN. The following information was reported: DIZZINESS (non-serious) with onset 24May2021 08:00, outcome "recovering", described as "On the third day I experienced lightheadedness/then extreme dizziness to the level that I could not get out of bed easily"; BEDRIDDEN (non-serious) with onset 24May2021, outcome "recovering", described as "I could not get out of bed easily". Therapeutic measures were not taken as a result of dizziness, bedridden.  Additional information: No other vaccine in four weeks. No covid prior vaccination. Not Covid tested post vaccination. No known allergies.  Follow-up attempts are completed. No further information is expected.
No adverse event; A dose was given to a patient 26 hours after puncture on 29Dec2022; A dose was given to a patient 26 hours after puncture on 29Dec2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose was given to a patient 26 hours after puncture on 29Dec2022), PRODUCT STORAGE ERROR (A dose was given to a patient 26 hours after puncture on 29Dec2022) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose was given to a patient 26 hours after puncture on 29Dec2022) and PRODUCT STORAGE ERROR (A dose was given to a patient 26 hours after puncture on 29Dec2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose was given to a patient 26 hours after puncture on 29Dec2022), PRODUCT STORAGE ERROR (A dose was given to a patient 26 hours after puncture on 29Dec2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (A dose was given to a patient 26 hours after puncture on 29Dec2022) and PRODUCT STORAGE ERROR (A dose was given to a patient 26 hours after puncture on 29Dec2022).    No concomitant medication was reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. A dose was given to a patient 26 hours after puncture on 29Dec2022. It was his second booster. The patient did not report any issues or reactions after that. The lot number is AS7143C.  Vial size was 2.5 mL  The vial was initially stored in the refrigerator on 28Dec2022. The vial was first punctured was on 28Dec2022 at 3:30, almost 4 PM 7.  Date and time of administration of vaccine was 29Dec2022 at 6:10 PM.  The vial was stored in the fridge post puncture. No temperature excursions. Amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 30 seconds.  No treatment medication was reported.   Reporter did not allow further contact
Pt presented at Clinic on 3/9/14 because she has redness, swelling and warmth of her entire upper arm starting the day after her vaccination; the arm has also been very itchy also. She did research online and came in to request a VAERS form to be completed. Medical director notified. Treatment with oral antibiotics started for cellulitis on 3/9/14. She was instructed to follow up with her PCP.
This spontaneous report as received from a healthcare business professional refers to a 14 year old female patient. The patient did not have concurrent conditions or medical history. The patient's historical drugs and concomitant therapies were not reported. On an unknown date, the patient was prescribed with PROQUAD, and on 12-OCT-2017, the patient was vaccinated with PROQUAD in the left arm, first dose, lot # N019253, expiration date 20-DEC-2018 (dose and route were not reported) for prophylaxis. It was reported that the patient never had vaccines before, and that she was recovered. No adverse events were reported.
losing air and having breathing problems; pain in his left leg near his knee; This is a spontaneous report from a contactable consumer. A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EW0198), dose 1 via an unspecified route of administration, administered in left arm on 26Jul2021 at 11:02 (at the age of 44-years-old) as DOSE 1,SINGLE for COVID-19 immunization. Vaccination facility type at pharmacy not at military facility. Medical history included (including any illness at time of vaccination) mental disorder (mental illness), asthma, Diabetes mellitus (Diabetic) and cardiac murmur (Heart murmur) from an unknown date and unknown if ongoing. Blood cholesterol increased (blood cholesterol) from 26Jul2021 to an unknown date. Hypersensitivity (Allergy) from an unknown date and unknown if ongoing. Family Medical History Relevant to AE(s): Mother asthma. Concomitant medication(s) included metformin (METFORMIN), aripiprazole (ABILIFY), benztropine [benzatropine] (BENZTROPINE [BENZATROPINE]) and atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported. It as mentioned that, Up until the 31st the patient was not taking medications every day. History of all previous immunization with the Pfizer vaccine considered as suspect and additional Vaccines Administered on Same Date of the Pfizer Suspect reported as none. No prior Vaccinations (within 4 weeks). No adverse events following prior vaccinations. On 26Jul2021, after vaccination patient did not report anything because patient thought it was part of the vaccine. When the caller was at CVS, when patient got the vaccine patient had pain, after a few seconds or a minute, in left leg near knee. Then the patient was drinking a lot of water and when patient got home, about 30-40 minutes to an hour after leaving CVS, patient started losing air and having breathing problems. The patient has asthma, a heart murmur, allergies, and a few other things. The patient was praying for breathing to get better and it did. After a while the patient started losing air again and drank more water. The patient drank over a gallon of water or a liter, patient could not remember, probably a liter. The second day patient did not have any problems. Today the patient was supposed to get the second dose and patient talked to the woman and she said, should report this to the CDC and talk to his doctor to see what they say about receiving the second dose. The patient was scared. Patient not visited to Emergency Room/Physician office. The outcome of the events were recovering.
Moderna COVID-19 Vaccine EUA -- bright red rash, swelling, and intense intense itching started on Sunday, 3/7.  Rash was from just below shoulder to about 7 inches down & almost 4 inches across.  The center area of the rash has faded and swelling is gone.  Still have outline of rash which has expanded about an inch lower that it was.  Still itches but not as much.  Using Benadryl for the itch and ice packs for the swelling.
Vaccinations given at 12:15 PM, at 9 M that day he started to experience chills with a fever, lethargic ness, sore arm and muscle fatigue. Wife called me about 3PM the following day reported that the symptoms have yet to resolve.
extreme joint pain; muscle pain; headache; nausea; chills; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 74 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 03Feb2021 (Batch/Lot Number: EL9262; Expiration Date: May2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing autoimmune thyroiditis Hashimoto's thyroiditis , ongoing osteoarthritis. Concomitant medication(s) included meloxicam (MELOXICAM) taken for osteoarthritis, start and stop date were not reported. The recipient discontinue Meloxicam 2-3 days before immunization.The patient experienced extreme joint pain, muscle pain, headache, nausea and chills on 04Feb2021 with outcome of recovered.  Follow-up attempts are completed. No further information is expected.
soreness of the arm for 48 hours; A spontaneous report was received from a healthcare professional concerning a female consumer who received Moderna's COVID-19 vaccine and developed soreness of the arm for 48 hours.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.     On 29 Dec 2020, after the patient received the vaccine, she developed soreness of the arm. She states the soreness has lasted for 48 hours. Treatment for the events included ibuprofen.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the event, soreness of the arm for 48 hours was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
However, her mother currently has Covid-19; However, her mother currently has Covid-19; This is a spontaneous report from a non-contactable consumer. An 82-year-old female patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection) on an unknown date as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Consumer said her 82-year-old mother already received the 1st dose of the Pfizer-BioNTech Covid-19 vaccine and was scheduled to receive the 2nd dose on Thursday. However, her mother currently had Covid-19 and wanted to know if she should receive the 2nd dose beyond the 3-week recommended interval. She also wanted to know how long her mother should isolate herself. And how she could schedule a new appointment for her mother's 2nd dose. No PQC was present. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This case was reported by a consumer via call center representative and described the occurrence of weakness in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included breast cancer and mastectomy bilateral (both conditions experienced 2 years before reporting date). On 12th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 13th June 2018, 1 days after receiving SHINGRIX, the patient experienced weakness, nausea, influenza and tremor. On 14th June 2018, the outcome of the weakness, nausea, influenza and tremor were recovered/resolved. The reporter considered the weakness to be related to SHINGRIX. It was unknown if the reporter considered the nausea, influenza and tremor to be related to SHINGRIX. Additional information was reported as follows: The patient received the vaccine on the right arm. The patient reported that she felt weak, shaky and nauseated. She said it felt like she had the flu. The reporter gave permission to contact his physician and provided contact details for the same.
Temperature 99, rash appeared on face and trunk approximately 45 minutes after vaccination. Flat, pink to red, macular on face, trunk and arms. Mucous membranes intact. Observe for any changes; child happy and playful.
n/a.  Pt asymptomatic.  Pt notified, facility notified
This spontaneous report as received from a nurse refers to 4 patients of unknown age. No concomitants were reported. On 19-MAY-2014, the patients were vaccinated with VAQTA INJ, lot K000943, expiration date 26-SEP-2016 (dose, frequency, route of administration and indication were not provided) that was exposed to 8.8C for 10 days. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. On 02-JUN-2014 at phone call was placed to reporter. The receptionist stated they do not have any one by that name employed at this facility. No further information is available at this time. This report is linked to 1405USA013915 and 1405USA013916, 1406USA004906, 1406USA004908, 1406USA004909, 1406USA004913, 1406USA004914, 1406USA004915, 1406USA004863, 1406USA004874, 1406USA004881, 1406USA004891, 1406USA004896, 1406USA004897, 1406USA004900, 1406USA004901, 1406USA004814, 1406USA004830, 1406USA004831, 1406USA004832, 1406USA004835, 1406USA004837, 1405USA013338 by the same reporter link. Additional information is not expected.
3-4 mm red papules: some with central vesicle. Less than 50 over body including scalp.
1st dose followed by 2nd only1 month later; This case was reported by a consumer via sales rep and described the occurrence of drug dose administration interval too short in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comment: Reporter stated that 50 plus patients were given a dose of Shingrix followed by a second dose only 1 month later. Additional supportive information: Patients received second dose of Shingrix earlier then recommended interval, which led to shortening of vaccination schedule.
Red circle aroung injection site that increased in redness, tenderness and diameter of circle until patient presented to pharmacy on 10/15/15- where red circle around injection site was approx. 2 inch diameter around injcetion site. Patient states only took Tylenol. Pt was advised to take 50mg diphenhydramine and contact a doctor to ensure there wasn't an infection.  Patient stated they contacted doctors office and was told to take diphenhydramine as directed by pharmacist and if rash did not improve by 10/19/15 to see Dr. in person. Pt stated on 10/19/15 that all signs and symptoms where nearly gone.
I started out with a headache that lasted for 4 days. I was overly tired I had no energy. By Saturday I was feeling fine. I never did run a fever, I didn't lose sense of smell or taste. I just didn't feel up to par.
Patient was brought to the ED via EMS for altered mental status.  According to EMS, patient was found hypoxic, 84% on 4 L supplemental oxygen via nasal cannula.  Patient unable to provide history.  No family at bedside.  Per ED provider, discussion with son yielded a do not resuscitate code status and a possible history of lung cancer, although this is not documented in medical history/chart. - ED workup significant for HR 71, RR 20, borderline blood pressure 91/61, normal WBC, elevated troponin 36, positive COVID-19 swab - Oxygen saturation 84% on 4 L.  97% on 10 L.  - Chest x-ray below Moderna 3/10/21, 4/12/21, 2/8/22.  Pt left hopsital AMA 2/20/22; had been on home hospice