chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9 days after the vaccination, the patient suddenly developed a high fever (104 at home, 107 at the hospital) and turned blue and unresponsive.  She had what was determined to be a febrile seizure.  Parents were unsure what was happening and began CPR.  Called 911.  Patient drowsy for a couple of days and has seemingly recovered completely.
No adverse reaction; received one shot of GARDASIL 9 on 7 / 2017 and then a second one year later on 11/2018"; This spontaneous report was received from a pharmacist regarding a 20-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date in July 2017 the patient was vaccinated with one shot of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot#M037770 and expiry date: 01-JUN-2019) via intramuscular route for prophylaxis. On an unspecified date in November 2018, patient was vaccinated with second one a year later (inappropriate schedule of product administration). The patient was looking to complete the three dose series. Pharmacist inquired if she should continue with the third dose or restart the series due to the lapse in time. It was not specified if the patient will be given the third dose to complete the series or if the patient should be revaccinated. At the time of report, no adverse reaction was reported (no adverse event). The outcome of inappropriate schedule of product administration and no adverse event was unknown.
This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Pt vaccinated with DTP c/o of pain in arm at site of injection about 12 hrs after injection. passed out, went limp & fell to floor. No evidence of seizure activity or fever. Was lethergic for several minutes.
LEFT DELTOID AREA HOT TO TOUCH, REDNESS AND INDURATION( LARGE AREA).
Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Severe, Systemic: Shakiness-Mild, Systemic: Vomiting-Medium
March 14 2:00 PM experiencing flu like symptoms and fatigue, took two BAYER Aspirin x 325mg. Normal appetite at dinner. By 7:30 PM to bed due to extreme chills that dissipated once in bed. Worked 5 hour day on March 15 took two aspirin. Injection site and large area very red and warm to touch. As of today, March 16 site is still red, warm and swollen.
SEVERE CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, Laboratory data included: Body temperature (NR: not provided) fever of 100.2, low grade fever 99.8. On an unspecified date, the subject experienced severe chills, and fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and severe chills was not reported. This report was non-serious.
Patient had delayed reaction after shot causing tongue swelling, swollen arm, fever, dizziness, and developed cellulitis.
Cried x 3 hrs w/fever 103, irritability last 2 days & fever last 2 days;
Patient was to recieve Pfizer Bivalent booster vaccine.  Pt was given Pfizer Monovalent booster vaccine.  No adverse signs/symptoms noted.  No treatment required.
Patient dob 9/10/1955 walked in for a covid vaccine on 6/26/21.  About 10 minutes after administering the 1st Moderna vaccine at 4:27pm the patient fainted on his chair. A man waiting in line for pickup noticed the patient and luckily supported the patient to prevent him from falling off the seat. We provided the patient with a cold compress, cold bottle of water, and some life saver candies as the wife stated he hadn't eaten anything since the morning. We instructed patient to lie down on the back with legs elevated, but the patient refused. Patient also refused calling for ambulance.  A member of management was also notified. The blood pressure was monitored at 100/70, 118/78, then 126/84 all taken approximately 10 minutes apart. Patient initially looked pale and felt clammy.  With his BP returning to normal, patient is looking more alert and color back. Patient authorized us to contact Dr. his PCP.  Patient was with his wife who will be driving him home. Patient stayed for at least 45 minutes before leaving pharmacy.
I test positive February 18, 2022 for COVID 19. I felt a little tried, had a headache. My symptoms was very, very, mild.
Information has been received from a registered nurse concerning a 20 year old female with asthma who on 18-Dec-2007 was vaccinated with her first dose of Gardasil (Lot #659652/1448U).  Concomitant therapy included hormonal contraceptives (unspecified).  About 15 minutes post vaccination the patient developed a cold sweat and nausea.  She was observed for about 20 minutes and was allowed to leave when the symptoms subsided.  No other information was available.  Additional information has been requested.
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Customer states immunizer injected at angle, once injected, syringe was straigtened at 90 degrees, felt pain and muscle ache.  Husband and Mom witnessed and questioned immunizer if thats normal he said "no" according to customer.  Customer has tried numerous home remedies including tylenol and ibuprofen no relief.  Stated site is hard and painful like "muscle torn"
Patient was given Pfizer 0.3ml dose IM instead of Moderna 0.5ml IM.
pt recvd vax 10MAY88 following mid morning lie seizing in stroller, paramedics called; szs spells cont & became more apparent; required exam w/nerologist; no more pertussis prescribed; suspect DTP MAR95; pt is delayed speech, cog. motor; sz
Missed 2nd dose, 7 months after 1st; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received seven months before).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient missed 2nd shot now by 7 months after 1st dose and asked if it was going to be okay. The follow-up would not possible as no contact details were available.
administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccine temperature reported as temperature changes 40-41 F.  No concomitant medication was reported. No treatment medication was reported.
Pt developed varicella rash and was seen in the office on 3/15/02 and dx'd as varicella. He was treated with a 5 day course of Zovirax and anti-itch medicine.
Heart failure with reduced ejection fraction (15 to 20%) Atrial fibrillation with RVR at a ventricular rate of approximately 100 bpm.
Ringing in my ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in my ear) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LOSARTAN for Blood pressure high, VITAMIN B [VITAMIN B NOS], VITAMIN C [ASCORBIC ACID], VITAMIN D [VITAMIN D NOS] and CALCIUM for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced TINNITUS (Ringing in my ear). At the time of the report, TINNITUS (Ringing in my ear) had not resolved.             She went to the doctor and they don't know if it was correlated to the vaccination or not. It has been consistent. She has not taken any treatment medications for it.
she got a hive on her face in a different spot on the same side of her face; arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), in Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diverticulitis" (unspecified if ongoing); "Pulmonary Langerhans autoimmune" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing); "blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement; TRAZODONE taken for sleep deficit; SIMVASTATIN taken for blood cholesterol; OMEPRAZOLE taken for gastrooesophageal reflux disease; B12 1000 SR taken for supplementation therapy; PEPCID AC taken for gastrooesophageal reflux disease. Vaccination history included: BNT162b2 (Dose number 1), administration date: 30Jan2021, when the patient was 68-year-old, for COVID-19 Immunization, reaction(s): "Covid-19". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm soreness"; URTICARIA (non-serious) with onset 2021, outcome "unknown", described as "she got a hive on her face in a different spot on the same side of her face". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: No additional vaccines were administered on same date of the Pfizer suspect. Patient believes that her flu shot was not with in four weeks of suspect administration.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
MILD FATIGUE; This spontaneous report received from a patient via a company representative concerned a 60 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 11-MAR-2021, the subject experienced mild fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild fatigue was not reported. This report was non-serious.
A few hours after administration, patient noticed sudden onset of pruritic rash around eyes. It quickly spread down to her face, neck, anterior chest (sparing breasts), B arms. Spared back, sparing legs, sparing perineum/genitalia. Was given kenalog 40 mg IM and medrol dose pack, no relief.  presented to ER a few days later, they gave her famotidine and Epi-pen. Recheck today (6/15/22) and the rash has stopped spreading and skin is desquamating on her face. Arms, chest, abdominal wall still red and angry, but dry, no vesicles. Almost appears to be psoriatic in nature, no previous dx of psoriasis. Extremely pruritic. interfering with sleep and daily activity.
HCP calling to inquire on catch-up dosing with GARDASIL 9 for patient who received first two doses of GARDASIL in her 20s and now wishes to complete 3-dose vaccine schedule.; No additional AE; This spontaneous report was received from a physician and refers to a 43-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On unknown dates, the patient was vaccinated with the first and second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, 0.5ml / 0, 2, 6 month intervals, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) in her 20s.  Now the patient wished to complete 3-dose vaccine schedule (inappropriate schedule of product). No additional information provided, no additional adverse events reported.
Paralysis to central nervious system requiring intensive care for no motor skills arms, legs, eyes.. Tremors in hands/ARMS/Fingers. I had Guillian Bare Syndrome as a Result, of a swine flu vaccination. Today, I still experience tremors and tingling in my hands and arms I have long standing health condition of heart disease and asthma To be noted: The pharmacy refuse to administor a tetanus  or flu vaccination/inoculation to me I am requesting a  card/letter of exemption, no vaccination. In regard to receiving a Covid-19 inoculation.
Information has been received from a nurse referring to an unspecified number of unspecified patients of unknown gender and age. The patients' pertinent medical history and drug reactions/allergies were not provided. On unknown dates the patients were vaccinated with improperly stored VARIVAX (lot # L005301, expiration date 17-FEB-2017; lot # L010144, expiration date 24-MAR-2017; lot # L048462, expiration date 01-DEC-2017) (strength, dose and route were not provided). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, couple of weeks after receiving Flu vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Flu vaccine.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the heard a conversation in a pharmacy while waiting to receive flu shot where a patient stated they became sick a couple weeks after receiving a flu vaccine in the past. The reporter declined to provide further information for safety report. The reporter did not consent to follow up.
Severe nausea, malaise(lack of energy) 4am to 230 pm March 16 2021
About 6" long. About 8" around arm. Bright red, hard, painful bruising in the center. BENADRYL decreased on 9/23.
Patient presented to ER with complaints of weakness and headache, as well as feeling ill with cough and congestion for a few days prior. She was experiencing chest pain that was exacerbated by coughing. Patient was admitted to hospital with positive COVID 19 status and ongoing respiratory failure per ED provider note.
Fatigue; Fever; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 61 years as dose 1, single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. On an unspecified date patient experienced fatigue, fever, headache. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (16Dec2021): 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 completed. No further information is expected.
Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported.
RED SPOT WITHIN LEFT EYE; BLURRED VISION; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 20SA21A expiry: UNKNOWN) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. Concomitant medications included amlodipine, hydrocortisone, levothyroxine, paroxetine, and prednisone non-company. On 05-JUN-2021, the subject experienced red spot within left eye. On 05-JUN-2021, the subject experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the red spot within left eye and blurred vision was not reported. This report was non-serious.
Received the flu vaccine on 10/8/18 and developed left thigh pain after receiving the injection. Pt went to school the next day and after school his left leg was swollen from the knee up, pain worsens with ambulation.
On November 18th, I developed hives on my stomach which started moving around to my legs, thighs, low back, hands and feet
1st shot - no reaction, 2nd shot- redness, itching and pain on face and neck. After two months and taking  an antihistamines and seeing a dermatologist I was told to use Klisyri ointment  1 percent for rive days. Completed that an still have redness and pain on face.
Nightime heart palpitations, Hollow feeling in the diaphragm(difficulty to get deep breaths), blood pressure spike. Effects lasted about 2 weeks.
Pain in arm; In the center the skin is like wrinkled; The skin is hard; A red circle is hot; A red circle is hot; Rash like a penny size; Chills; Headaches; Tired; I felt sick; Sleepy; Small bruise like a penny; A lot of arm pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), SKIN WRINKLING (In the center the skin is like wrinkled), SKIN INDURATION (The skin is hard), ERYTHEMA (A red circle is hot) and FEELING HOT (A red circle is hot) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Tendon pain (Normally get tendon pain and bones) and Allergy (Sensitive to some unidentified substances.). Concomitant products included MULTIVITAMINS [VITAMINS NOS], DICLOFENAC, VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]) and COLECALCIFEROL (VITAMIN D3) for an unknown indication.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced ILLNESS (I felt sick), SOMNOLENCE (Sleepy), CONTUSION (Small bruise like a penny), PAIN IN EXTREMITY (A lot of arm pain), CHILLS (Chills), HEADACHE (Headaches) and FATIGUE (Tired). On 26-May-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), SKIN WRINKLING (In the center the skin is like wrinkled), SKIN INDURATION (The skin is hard), ERYTHEMA (A red circle is hot), FEELING HOT (A red circle is hot) and RASH (Rash like a penny size). The patient was treated with IBUPROFEN (oral) at a dose of 800 milligram twice a day. On 21-May-2021, ILLNESS (I felt sick), SOMNOLENCE (Sleepy), CONTUSION (Small bruise like a penny), PAIN IN EXTREMITY (A lot of arm pain), CHILLS (Chills), HEADACHE (Headaches) and FATIGUE (Tired) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in arm), SKIN WRINKLING (In the center the skin is like wrinkled), SKIN INDURATION (The skin is hard) and FEELING HOT (A red circle is hot) outcome was unknown, ERYTHEMA (A red circle is hot) had resolved and RASH (Rash like a penny size) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Products include One shot natural medicine capsules for weight loss.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Significant follow-up Event outcome updated