chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ASTHMA" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Lyme Disease" (unspecified if ongoing); "Celiac Disease" (unspecified if ongoing); "Ehlers Danos Syndrome" (unspecified if ongoing); "Ptsd" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE, start date: 15Feb2023. Past drug history included: Naproxen, reaction(s): "Known allergies: Naproxen"; Gluten, reaction(s): "Known allergies: Gluten". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Antigen test was negative; positive, notes: antigen test positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid treatment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccine,  cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   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.
Patient complains that her arm is still very painful and numb a month after the shout (11/10/2013). She states that it is affecting her quality of life and that she cannot sleep on that arm and it is always bothering her.
This spontaneous report was received from a nurse refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 10-JUL-2018, the patient was vaccinated with an expired dose of VAQTA injection, (expiry date: 15-MAY-2018) intramuscularly (lot # and dosage details were not reported) for prophylaxis. No known adverse effects were reported. No product quality complaint (PQC) was involved.
Tingling of my tongue/ tingling in her lower lip and upper lip; upper lip on the left hand side and it's a little bit swollen; Numbing of my upper jaw and the numbing of my lower jaw and a numbing of left side my mouth; I have the numbing of my mouth again; I got 2 red marks on my right hand (dark red blotches); Rash on my chest; rash on my neck; Tingling of my tongue/ tingling in her lower lip and upper lip; This is a spontaneous report from a contactable consumer or other non hcp (patient). This is first case of the 2 cases.  A 68-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9266) via an unspecified route of administration on 24Feb2021 (at the age of 68-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. She is not allergic to food or nuts but is allergic to penicillin, cardiac valve disease from an unknown date and unknown if ongoing. Other Medical Conditions: Consumer stated I don't know what this is a problem Damaged Heart Valve. Concomitant medications included Metoprolol (METOPROLOL) 12.5mg taken as It was cut in half so 12.5 twice a day for an unspecified indication, start and stop date were not reported. The patient experienced numbing of my upper jaw and the numbing of my lower jaw and a numbing of left side my mouth, I have the numbing of my mouth again, I got 2 red marks on my right hand (dark red blotches), rash on my chest, rash on my neck, tingling of my tongue/ tingling in her lower lip and upper lip on 24Feb2021. The patient also experienced tingling in her lower lip and upper lip, upper lip on the left hand side and it's a little bit swollen on 25Feb2021 09:00. The clinical course as follows Consumer stated, "No I am a person who just got the vaccine yesterday and I had numbing of my upper jaw and the numbing of my lower jaw and a numbing of my mouth left side my mouth and I got 2 red marks on my right hand. I waited there for 30 minutes and since I did not have itchiness, just the tingling of my tongue, not itchiness, they allowed me to go. I had a rash on my chest but it was not an itchy rash and I had a rash on my neck. It was not an itchy rash either. So, they let me go and they said if I had a problem to call #. I got children's Benadryl (treatment) and it took it away. Well, I have the numbing of my mouth again today and this is my first shot. So, my question is, is this something not to worry about and my second question is can I get the second shot or not.Therapeutic measures were taken as result for all event except upper lip on the left hand side and it's a little bit swollen. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Patient had 1st monovalent Pfizer on 08/30/2022.  This nurse gave Pfizer Bivalent dose instead of 2nd monovalent Pfizer dose.  No s/s report as of this date/time.
Information has been received from a physician who found out from another treating physician who was also the father of the patient, concerning a 16 year old female patient who on an unknown date, was vaccinated with a dose of GARDASIL. Subsequently the patient developed a severe headache. Then the patient went to sleep that night and passed away. The autopsy was performed which revealed no cause of death. It is unknown if the patient sought medical attention. Severe headache was considered to be immediately life-threatening. Additional information has been requested.
Right upper arm, lateral aspect, swelling roundish, tender skin & subcutaneous tissue same reaction to left arm.
Beginning in upper thighs around 4 days post vaccine - both legs. Becoming severe by 10 days post vaccine - moving to back of thighs and finally calf muscles over the next 6 weeks post vaccination.  Self treated with Advil up to 1800 mg per day and using ice on legs before bed.  Fever spike each night with night sweats sometimes up to 3x a night during this 6 week period. About 2 weeks post vaccine afternoon temperature spike  - went on for another 2 weeks.  Dry, unproductive couch began about 3 weeks post vaccine. Tested negative for Covid-19 4x during this period.  Tested negative for influenza and other known infectious diseases. By week 6 post vaccine, leg muscle pain subsided, night sweats continued for 1 more week, cough persisted but dissipated around week 7 post vaccine.
pt recv vax 26FEB96 pt exp a fever & then later that evening had a sz;pt has had intermittent sx since then;
10 hours after the vaccine was administered, I had a fever of 102. I had significant chills and fatigue along with a sore arm at the injection site.   Symptoms lasted 36 hours. from the onset.
Headache, muscle pains, and fever for 2-3 days, treated with aspirin.  A few days later, itchy rash and hives on chest and back, treated with antihistamines.
Patient stated that this was her first COVID vaccine and requested the Johnson and Johnson vaccine. Patient received a Johnson and Johnson vaccine on 9/23/2021.  After receiving Johnson and Johnson vaccine, it was noted in the system that patient had received a Pfizer vaccine on 08/24/2021. When patient was confronted about the Pfizer vaccine, she stated that " I felt the Pfizer vaccine did not work effectively for me, so I wanted to get the J&J."
Arthralgias ankles, knees, hips, hands, great toe and mild welling ankles.
On 1/8/21 (day of injection): Severe bodyaches, fatigue, headache, and mild lymph node tenderness that started 10 hours after the second vaccine dose (booster dose 21 days post initial vaccine administration. ) On 1/11/21: Mild bodyaches, fatigue, headache, and worsening lymph node renderness and visible swelling.
TINGLING ALL OVER THE BODY; CHILLS; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a female 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 and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the patient experienced tingling all over the body. On 08-APR-2021, the patient experienced headache. On 08-APR-2021, the patient experienced chills. On 08-APR-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 09-APR-2021, was recovering from headache, and fatigue, and had not recovered from tingling all over the body. This report was non-serious.
Fluctuate blood sugar, tossed/turned at night and awoke freezing. "Experienced something like a sitting seizure" "keep jerking", SOB/severe HA, "awful feeling on all my upper body".
Patient developed rash on his body on 05/23/2019 10 days after he received MMR.  his mother contacted the Doctor office. rash got better by its own.
SWELLING IN LOWER LEGS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported 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 25-OCT-2021, the patient experienced swelling in lower legs. Laboratory data (dates unspecified) included: Blood test (NR: not provided) No blood clots found. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from swelling in lower legs. This report was non-serious.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD lot # N010246, subcutaneously (strength and dose was not reported). Sterile diluent used for reconstitution was properly stored. No adverse effect was reported. The vaccines were stored between 6 degrees Fahrenheit (F) and 10 F for 54 minutes. There was no previous excursion reported. Data logger was involved.
approximately 6 months after last injection I noticed heart palpitations and more noticeable chronic fatigue, joint achneness, night sweats.  My doctor informed that the markers for Epstein Barr Syndrome were elevated.  My Doctor give me a prednisone pack and prescribed low dose naltrexone.    I had been informed in 2015 after rotator cuff surgery that several markers commonly associated with older adults who had developed Mono were elevated in my blood.  I was explained that these markers were part of the Epstein Barr virus and part of the Herpes family. My doctor explained that 75% of people have these markers similar to Mersa, Staph, lupus, etc.  but they remain at lower levels suppressed by a healthy immune system  My doctor had given me prednisone and low dose naltrexone longer term.  After a couple of years the markers remained down in the normal range and I stopped using low dose naltrexone.  The markers had been dormant since 2017 even after a complete right shoulder joint replacement.
approx 2yrs1mo p/vax pt exp mild breakthrough varicella w/10 lesions. no further info avail
pt passed out w/in 3-4 mins p/vax was administered; fell back against wall & onto floor-bumping head on edge of baseboard; skin clammy; bumps on occipitation of head;
second dose administered was not successful, there was leakage. Staff had to repeat the intradermal vaccine
Patient stated that she was feeling light headed and has a headache. Vitals taken BP 101/73 pulse 94. She remained seated in wheelchair and apple juice given. She stayed for 25 min.  She mentioned that she has high anxiety and she did not eat lunch. She was taken to her car in the wheelchair. Advised to call her primary health care provider if not feeling well and call 911 if an emergency.
post menopausal menstrual heavy period a week after the first dosage; Also reporting a headache and sore arm with the first one; Also reporting a headache and sore arm with the first one; This is a spontaneous report from a non-contactable consumer. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right, on 13Mar2021 03:30 (Batch/Lot Number: EN6206) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included vitamins nos taken for an unspecified indication, start and stop date were not reported.  On an unspecified date, the patient reported a post menopausal menstrual heavy period a week after the first dosage and second period two weeks after the second dose. It had been 11 months since her last period.  Also reporting a headache and sore arm with  the first dose. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
"Pt has a hx of allergy to Amoxicillin.  No other known PMH. 19mins post vaccination, pt c/o itchy throat w/ no difficulty breathing. Vitals: @17:25 BP 179/99, HR 79, RR 20 -- > @118/80, HR 68, RR 18. Pt stable and released from vaccination clinic."
45 minutes post vaxx- hit with the most intense wave of nausea, heart palpitations, sweats, chills, pain, numbness and tingling.  First 48 hours- I've never felt worse in my body, never felts stranger in my body, and I honestly can't describe half of the sensations I experienced as I've got no reference points for them. 3 weeks later-was still spiking 101 fevers almost daily, most consistent symptom has remained numbness and tingling of my upper left quadrant, 2x the whole right side of my body went numb, far higher pulse rate than normal, diarrhea, nausea, lack of appetite, easily fatigued. 3.5 weeks-with treatment nerve symptoms are lessoning, and feeling better over all although still incredibly fatigued, and have brain fog/fullness sensation.
10MAY96 gen malaise,t101-102,h/a;11MAY fever 101-102,h/a,chilling,gen malaise;13MAY 430PM t104.8&severe h/a;5:00PM adm to ER,spinal tap,foley catheter,blood tests to r/o meningitis;
Initial visit to Emergency Department (ED)on 05/12/2013 for swollen tongue and rash located on nipple line to neck. Prednisone given, released. Follow up on 05/13/2013 with wide based ataxic gait observed with macular papular rash on nipple line to neck. Normal Sinus Rythm and rate per EKG. Reflexes hyperific or unable to elicit. Transferred via ambulance to ED. Hyperkalemia per lab report, per hospital report SM is stable but hyperkalemia has not resolved. Remains hospitalized.
Awoke to severely sore and swollen glands and neck. At 11:30 AM became unable to speak without choking and gasping for air. By 01:00 PM had fever, chills, body aches. Conditions have continued to date, and are on-going.
PATIENT RECIEVED A 3RD DOSE OF SHINGRIX, WHEN ONLY 2 IS INDICATED.
Patient woke up on Friday April 30 at 4:00 am and noticed upper lip swelling. He is unsure if this is vaccine related or work related (landscaper works outside). He did not take any allergy medicine for the lip swelling, but according to patient it went away by 6:00 pm the same day.
Had a temperature of 104.9 (ax); lethargic; irritable starting 2 days after last DTaP given on 12/29/03. Symptoms lasted for 2-3 days.
Pregnancy; Initial Report Received on 30-Jan-2020  This report was received from the HEPLISAV-B Pregnancy Registry.   A medical assistant reported to PPD's Registry Staff that they had a female patient (age and race not reported) who was 11 weeks pregnant and had received HEPLISAV-B (hepatitis B vaccine).   No medical history or concomitant medications were reported.  Information regarding HEPLISAV-B administration was not reported.    On 25-Nov-2019, the PPD Registry Staff received a call from a medical assistant (MA) with vaccinating provider. The MA reported they have a patient who is currently 11 weeks pregnant and she has received the HEPLISAV-B vaccine.  The MA informed me that the patient is interested in enrolling and they heard about the study from a package insert, and that she will provide the toll-free number to the patient and ask that she call and enroll herself. The MA was agreeable to a return call in 2 weeks if the patient has not called to enroll in the Registry."  The PPD Registry Staff attempted multiple phone call follow-ups to the HCP office but were unsuccessful.    The PPD Registry Staff reported that no further follow-up would be conducted by the Registry and permission for company to follow-up with the HCP office was not obtained.  At the time of the report, no adverse events were reported.   The action taken with HEPLISAV-B was not reported.    Company comment: The company assessed the pregnancy as non-serious. The event of pregnancy is unlisted per HEPLISAV-B ; Sender's Comments: The company assessed the pregnancy as non-serious. The event of pregnancy is unlisted per HEPLISAV-B.
Large injections site swelling/rash; nausea, loss of appetite; loose bowel movements; fatigue.
Pt recvd DTP/OPV/HIB #2 in the AM of 1OCT91 pt found dead in crib Tues AM; pt was fine when went to bed Mon night;
pt developed fever , body aches and eventually pancytopenia had neg eval for other causes  and resolved
Information has been received from a physician concerning a 24 week old male with no pertinent medical history who on 16-NOV-2007 and 18-JAN-2008 was vaccinated with his first and second doses of ROTATEQ (lot# 657671/0902U, 657635/0770U).  On 07-MAR-2008 the patient experienced illness with vomiting for 24 hours and was seen in the physician's office on 08-MAR-2008.  On 08-MAR-2008 the patient was diagnosed with intussusception characterized by vomiting, dehydration and abdominal pain and was hospitalized for one night for observation.  There was no diarrhea or blood in the stool reported.  The patient was treated with IV rehydration in the emergency room.  The intussusception was successfully reduced via air enema.  It was noted that on 18-MAR-2008 the patient received the third dose of ROTATEQ (lot# 659917/0017X).  Therapy with ROTATEQ was discontinued.  On 09-MAR-2008 the patient was discharged from the hospital and was recovered.  There was no product quality complaint.  Intussusception was also considered to be immediately life-threatening and an other important medical event by the physician.  Additional information has been requested. 4/28/08-records received for DOS 3/8-3/9/08-DC DX: Intussusception. Presented to ED with 1 1/2 day C/O vomiting, dehydration and fever 101. No currant jelly or bloody stools.
Gland under L Armpit tender to touch, chills and  body aches Narrative:   Other Relevant History:
Patient woke up with whole left arm swollen and tiny raised bumps around injection site. Swelling subsided to just around bicep around by end of day. Sunday morning patient woke with large blisters in a circle around injection site and upper arm still swollen and red.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a Pfizer-sponsored program from a contactable nurse reporting for herself. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the vaccine and 2 days later developed positive COVID-19 test and go bed. The patient wanted to know how many days she needs to wait until she receives the 2nd vaccine. The outcome of the event was unknown.   Information on lot number/batch number was requested.; Sender's Comments: The patient developed positive COVID-19 test two days after vaccination of BNT162B2.  No complete protection can be achieved to prevent from the targeted infection/disease due to the very short time lag. The company considers that the COVID-19 is more likely pre-existing condition prior to vaccine use, and unrelated to BNT162B2.
Information has been received from a physician, concerning a male patient who received VARIVAX (Merck) (Lot #557099/0453U) 0.5 mL SQ on 05-JUN-2007 and developed chicken pox and was seen in the office on 11-JUL-2008. At that time he had a mild case and about 15 lesions. On 14-JUL-2008 the patient's father called and reported that the patient has "chicken pox all over". The patient did seek medical attention on office visit There was no product quality complaint. Follow up information has been received from a physician, concerning a 25 months old male patient with no previous medical history reported or a history of adverse events following prior vaccinations, who on 05-JUN-2008 was vaccinated with his initial dose 0.5 mL VARIVAX (Merck) (Lot #657099/043U) SQ in the right arm, and his second dose of hepatitis B (Lot #655550/1416F) SQ in the left arm (MSD). Concomitant therapy included a third dose of PREVNAR (Lot #B08679F) IM in the left leg. On 11-JUL-2008, the patient developed classic chickenpox with no serious sequelae, he had over 50 lesions. There were no lab test performed. There was no illness at the time of vaccination. On 22-JUL-2008, the patient recovered. No further information is expected.
Systemic: Abdominal Pain-Mild, Additional Details: Similar to previous stomach issues she experienced during pregnancy.
Client given dose of adult hep A. Client was 2 - 3 mos pregnant at time dose given. Client has not reported an adverse reaction.
On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for covid) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test positive: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication reported. patient was administered with second dose.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up received updated outcome of the event.
No effects after 1st shot.  After second shot was sick for approximately 18 hours.  Then took  Acetaminophen and felt better in two hours. Patient feels tinitis got worse after vaccination.