chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8°C (10 mins); This spontaneous report with reference numbers 02197725 / 02197588 was received by partner on 05-JUL-2022 and forwarded on 06-JUL-2022 from a consumer.    The causal relationship between Vaxelis and the reported event "multiple doses of VAXELIS administered since temperature excursion" was assessed as not applicable due to the nature of the event.    Further information is expected.  FOLLOW-UP INFORMATION was received by a partner on 01-AUG-2022 and forwarded on 03-AUG-2022, from a HCP. The case is maintained as non-serious.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8°C (10 mins)" and Vaxelis remained not applicable.  For reference purposes this case is linked to MCM-003725, MCM-003726, MCM-003729, MCM-003734, MCM-003735, MCM-003737, MCM-003738, MCM-003739, MCM-003740, MCM-003741, MCM-003742, MCM-003743, MCM-003724, MCM-003747, MCM-003749, MCM-003751, MCM-003752, MCM-003753, MCM-003757, MCM-003759, MCM-003760, MCM-003761, MCM-003763, MCM-003766, MCM-003767, MCM-003769, MCM-003770, and MCM-003772, due to same reporter.  No further information is expected.
DROWSINESS; TIREDNESS; This spontaneous report received from a patient concerned a male of unspecified age. 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 20-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAY-2021, the subject experienced drowsiness. On 20-MAY-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from drowsiness, and tiredness on 20-MAY-2021. This report was non-serious. This case, from the same reporter is linked to 20210544414.
Clotting; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 10Mar2021 at a single dose for COVID-19 immunisation. Medical history included allergies and asthma. Concomitant medication included levocetirizine dihydrochloride (XYZAL) taken for allergies. The patient previously received first dose of BNT162B2 on 17Feb2021 for COVID-19 immunisation; and experienced thrombophlebitis and leg swelled up and got very sore, painful, and red (lot number: EL9266 at 04:00 PM). About 2 weeks after the first dose, patient's leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis. She received the second dose on 10Mar, and her leg got worse a few days later. She visited the emergency room and was sent to a specialist who put her on blood thinners for clotting. Patient stated that the only significant change or occurrence in her life was that she received the vaccine. The events resulted to a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Patient was not pregnant. Outcome of the event clotting was unknown, while not recovered for the other events.   Information on the lot/batch number has been requested.
On day 7 after receiving the vaccine, a fist sized welt emerged at the injection site. It's 7cm diameter, red and hot. I've been taking Benadryl for 2 days and it has diminished a little but is still there and red/hot.
sore arm; muscle soreness; general fatigue; This is a spontaneous report from a non-contactable consumer. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 22Mar2021 as single dose for COVID-19 immunization. Medical history included high blood pressure and cholesterol. Prior to vaccination, the patient did not diagnose with COVID-19. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He experienced sore arm and muscle soreness and general fatigue on 22Mar2021. Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a nurse, fro the Pregnancy Registry for GARDASIL, concerning a 25 year old female with no pertinent medical history who on 24-MAR-2009 was vaccinated with a first IM 0.5 ml dose of GARDASIL (Lot No. 661846/1312X) and a second IM 0.5 ml dose (658271/0058X) on 26-MAY-2009. There was no concomitant medication. It was reported that on 24-JUN-2009 the patient found out she was pregnant. On 25-JUN-2009 the patient had an ultrasound (results not provided). The nurse reported the fetus was underweight. Patient was having another ultrasound scheduled on 01-DEC-2009. The patient sought medical attention by an office visit. At the time of the report, the outcome of the fetus was unknown. The mother's experience has been captured in WAES# 0911USA04741. Additional information has been requested.
Approximately 2 hours after the injection, my arm went from feeling slightly sore to being extremely sore. The next morning I was feeling run down - temperature was 99.6. Temperature, shivering, and arm pain continued all day and overnight. Temperature reached 100.6 before finally returning to normal on second morning. Arm soreness still occurring as of second afternoon.
I did not have an adverse reaction to the vaccine but since having the vaccine, I have had two respiratory illnesses. The first was on 11/09/2022. I contacted with my doctor via telehealth and received an antibiotic. I began getting sick again on 12/13/2022. I saw my doctor on 12/19/2022 and was diagnosed with bronchitis. Previously, I tested positive for COVID-19 on 08/16/2022. Also, my doctor diagnosed me with long COVID-19 on 10/17/2022. As of today, I continue with headaches, insomnia, brain fog and extreme fatigue. First COVID-19 vaccine I had a terrible headache for a day and extreme sore arm.
Headache, brain fog from 1/1/2022 - 1/5/2022. Chest and abdominal pain (under left rib cage) 1/6/2022 (ongoing). Doctor visit performed EKG (was normal). Diagnosed with costochondritis. I am also making an appointment with my gastro doctor to checkout gastritis.
Red, swollen, welt-like rash at injection site measuring 3 inches in diameter. Hard, tender and warm to the touch.
2 days after the 1st vaccine, mild itchy rash on trunk, neck, chest, and back/the rash was worse/rash still spreading; she started feeling sick/did not feel well; This is a spontaneous report from a non-contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27May2021 at 11:30 (at 57 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included early Sjogren's and pre-diabetes, both from unknown date. Known allergies: sensitive to polysorbate 80 and had allergic reaction to tetanus booster. Concomitant medications included daily vitamin and fish oil (OMEGA 3) both from unspecified date. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient reported 2 days after the first vaccine mild itchy rash on trunk, neck, chest, and back on 29May2021 at 09:30. The patient took diphenhydramine (BENADRYL) and felt itchier. It was reported that when the diphenhydramine wore off, the patient felt ok until 5 hours later, when she started feeling sick and the rash was worse, so the patient took loratadine (CLARITIN). On 30May2021 (third day), the rash was still spreading, did not feel well. All events were reported as non-serious. The patient added that she normally had rash after a virus and she had early Sjogren's and pre-diabetes. Outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Within moments of the injection, patient lost consciousness. Left sitting with no support, she fell from table and started convulsions on the floor.
White blood count drop to 1.82 K/cmm, AST elevated to 170, ALT elevated to 194. Resolved after one week and back to normal values.
face feels very heavy/Nose and cheeks being squeezed tightly/hard to move muscles in face; tingling; feel pressure like being squeezed from outside in and inside out; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 24Mar2021 12:45 (at the age of 37-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS), and patient was a new mother (baby was almost 2 months old). Patient had no known allergies. No COVID prior vaccination, and no COVID tested post vaccination. Concomitant medication included daily vitamin. On 24Mar2021 13:00 (also reported as 30 min after vaccine), patient's face started to feel pressure like being squeezed from outside in and inside out. It got worse following hour. Patient had no issues breathing yet (2 hours post vaccine) but face felt very heavy. Sometimes patient had tingling, nose and cheeks being squeezed tightly, and it was hard to move muscles in face. Otherwise patient felt ok. No treatment received for events. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Began experiencing edema and arthalgia (severe) in bilateral lower legs and right arm. Injection given in left arm. Seen at Health Center 5/27/03 and placed on Celebrex. Now edema has subsided but still complains of right arm pain with sensation. HS is better, but not completely resolved.
Described numbness to left side of face, inside of mouth and leg and arm.  Arm and leg numbness quickly dissipated but left facial numbness continued.
This spontaneous report was received from a other health professional refers to a patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. On 19-NOV-2018, the patient was vaccinated with improperly stored PNEUMOVAX 23 (dose, strength, frequency, route, were not reported) from lot R018732, expiry date 27-FEB-2020, for prophylaxis. No adverse effects reported.
01:10 PM-Patient consented to receive Bexsero vaccine. Mother present. 01:11 PM-Patient states, "I feel light headed like the last time." Began to slump down in seat. Moved patient into a safe position, legs elevated and Code Blue was called. 01:13 PM-Patient Alert and oriented X 3. Cool towel placed on forehead. Blood pressure 137/82, pulse 77. 01:15 PM-Alert and oriented. Sitting in upright position. Given juice and crackers. Tolerated well. No complaints voiced.  01:17 PM-Alert and oriented. Blood pressure 125/86, pulse 76. Able to stand without difficulty. Ambulated to lobby unassisted. Denies any dizziness or difficulty. Mother present. Instructed to notify MD if symptoms return.
On 3.23.16 provider order PCV 13 for one patient and Tdap for another. 5.19.16 patient called to confirm vaccine administered because her summary of benefits reflected Tdap not PCV 13. Discussed with staff and provider. Staff states they are adamant they administered correct vaccine, although inadvertently charted in wrong chart. Provider determined best to re-vaccinate. Patient who needs Tdap will return next available and patient who needs PCV 13 will return in one year. Reminder for both set in patients chart.
3 other people who came in with similar symptoms, after receiving COVID-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (3 other people who came in with similar symptoms, after receiving COVID-19 vaccine) 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 VACCINATION COMPLICATION (3 other people who came in with similar symptoms, after receiving COVID-19 vaccine). At the time of the report, VACCINATION COMPLICATION (3 other people who came in with similar symptoms, after receiving COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided No treatment medication information was provided
PT. RECIEVED BOOSTER SHOT ON 07/18/2022. VACCINE WASNT DILUTED BUT PT. RECIEVED CORRECT DOSAGE OF VACCINE. INFORMED GUARDIANS OF ERROR AND INFORMAED THEM OF THE IMFORMATION THAT I REIVED FROM THE CDC.
Felt very cold and in pain as vaccine was being injected, slight headache on right side above eye for 15 minutes after vaccine, headache on back of neck for half an hour then went away. On 2/1, scalp started hurting on the back of the head, felt like hair being pulled tight in a ponytail (still currently, but not as tight), feeling of tightness. Started noticing hair falling out more (a lot more than usual), started steroid shampoo on 2/9. Nothing has changed since patient has been on it. Chiropractor on 2/16, the neck muscles are inflamed, really tender per chiropractor. Symptoms are slightly better on top of skull but otherwise symptoms are the same.
About a month and a half after getting 2nd dose of Modera 3/30, I had covid arm, it came out of no where and about 3-4 days ago another bump has come up but it's not big as the first one.
Lip swelling, eyes itching, palm itching, throat, tongue, lips itchy. Took 2 doses of Benadryl 50mg each dose.
hardness and redness x 3 1/2 cm in diameter at site;  left arm numbness; describes as feels like I slept on it wrong and it fell asleep; redness developed  pencil eraser size 6 hours after injection.   Took po tylenol prior to bed; woke up in morning 2/10/22 with 2 cm diameter redness and numbness; continued to take tylenol; pm of 2/10/22 applied ice; 2/11/22 woke up with redness 3.5 cm diameter; warm to touch and hard; will continue tylenol and ice; if no improvement will see provider 2/14/22
grandma said that pt was laying on stomach & turned to back & became stiff & rigid w/head & feet extended; tongue was uncontrollable (wagging)-pupils were dilated;
flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu like symptoms".  Additional information: The patient had flu like symptoms for a couple days and she was fine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt was here for his 17yr physical exam today at 8:30am. When exam was completed, I administered the ordered vaccines:  Administered Influenza and Menactra in Left deltoid, then administered Trumenba in Right deltoid. Immediately after giving the Trumenba, pt leaned back against the wall and was grabbing his right arm. I asked if he felt ok, he said yes. I asked if he has eaten anything yet this morning and he replied no, so I gave him a juicebox. I advised pt and his mother the concern for possible passing out due to receiving vaccines early in the morning on an empty stomach. Mom assured me he was ok and I left the room.     Around 9:15am, I was alerted to patients status and went into the exam room. At that time, pt was sitting in a chair and was extremely pale. Immediately alerted provider and she came into the exam room. His eyes rolled back and seemed to have passed out, was unresponsive for about 5-10 seconds. Pt then opened his eyes and was responsive and vomited small amount onto the floor. He was weak and sweating.  Applied icepack to back of his neck, then was  given water and some pretzels. Continued to have pt sit and was monitored by RN, for about 10 more minutes. At that time, pt reprted he was feeling normal. Pt and mother felt they were comfortable to leave, they left the office around 9:31am. Advised mom to please notify office asap of any changes or symptoms today, also notify us if pt develops fever or chills tonight.
Rheumatoid arthritis flare up of lower back pain and left hip pain; Early stage osteoarthritis; Severe fatigue; Rheumatoid arthritis flare up of lower back pain and left hip pain; Rheumatoid arthritis flare up of lower back pain and left hip pain; Sore arm; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4250457-00 (AbbVie), US-PFIZER INC-202200230136 (Pfizer).  A 52 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 02Dec2021 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single, intramuscular, administration date 20Feb2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 20Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (ongoing) (Lot number: 1154505) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", OSTEOARTHRITIS (non-serious), outcome "not recovered" and all described as "Early stage osteoarthritis"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown", described as "Severe fatigue"; ARTHRALGIA (non-serious), BACK PAIN (non-serious), outcome "unknown" and all described as "Rheumatoid arthritis flare up of lower back pain and left hip pain". The action taken for upadacitinib was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event(s) of early stage osteoarthritis and sore arm after receiving covid-19 pfizer brand with rinvoq (upadacitinib) was no reasonable possibility. The reporter's causality for the event(s) of rheumatoid arthritis flare up of lower back pain and left hip pain with rinvoq (upadacitinib) was a reasonable possibility.  The reporter's causality for the event vaccination site pain with Vaccination site pain with pfizer biontech covid-19 vaccine (tozinameran) was a reasonable possibility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.Suspect Adverse Reaction.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
pt recv shot w/o incident @ 8PM;devel cough immed;woke up 4AM, dizzy, nauseated & feeling of diarrhea;did not have diarrhea or vomiting;ER visit h/a in ER;devel rash on chest 30OCT;
she was diagnosed with covid on the 3rd of this month; she was diagnosed with covid on the 3rd of this month; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5, as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: INFLUENZA VACCINE taken for immunisation as dose number unknown, single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Sep2023, outcome "not recovered" and all described as "she was diagnosed with covid on the 3rd of this month". Clinical course: Patient was diagnosed with covid on the 3rd of this month (03Sep2023). She said she tested positive again on Tuesday (12Sep2023) and still had symptoms. She wanted to know if she still can receive the new Pfizer covid 19 vaccine. She stated that she had never had a negative reaction to any previous covid 19 vaccines. She was a 73-year-old person and also had received the flu shot. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Sep2023) Positive; (12Sep2023) Positive.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient complained of shortness of breath, chest discomfort, dry heaves, cough, chills, lightheadedness, muscle aches. Doctor is prescribing zofran and is monitoring additional symptoms.
Pt had both flu shot (left arm), pneumonia shot (right arm) on 9/30 3:30pm, started around 8pm, pt got dizzy with a lots of pain, & red & swollen around right arm injection site and below area on right upper arm, & unable to sleep, and have headache took ADVIL for pain on 10/1/10 around 9 am and getting better. Came to pharmacy to report around 2:30 pm. Called pt on 10/5/10, the day after he came to Rx, per pt he was c/o just itch but pain & swelling went away
Numbness and tingling in bilateral thumb, index, and third fingers, associated with chest tightness. Onset 3-7 days after H1N1 vaccine. Symptoms still present and may be resolving. Has not impaired work.
Sudden onset at 6:15pm of severe chills and ear ringing. Later that evening chills started to slightly subside with onset of fever (101.9) and diaphoresis. Chills and sweating continued throughout the evening with temperature drop to 99.7 in the morning at 6:45am. Onset of headache at 7am that persisted 8hours despite use of aspirin/acetaminophen (Excedrin).