chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine brand=Pfizer / BioNTech/product=COVID-19 Treatment, brand=Paxlovid; Vaccine brand=Pfizer / BioNTech/product=COVID-19 Treatment, brand=Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "IBD" (unspecified if ongoing); "Autoimmune" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; STELARA; IRON. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "not recovered" and all described as "Vaccine brand=Pfizer / BioNTech/product=COVID-19 Treatment, brand=Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Positive; (May2022) Negative; (May2022) Negative; (May2022) Negative; (May2022) Negative; (May2022) Negative; (May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient took treatment for covid-19, brand= Paxlovid, treatment start date: 30Apr2022, treatment stop date: 05May2022, the patient took other medication/products within 2 weeks of starting covid-19 treatment, Previously patient took covid-19 vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Flu clinic started at 8:15 am. Patient received LAIV. At 11:00 am patient was in health room with redness and mild swelling around right eye, dime size erythema to both arms (4) and 1 on right neck with itching. Denies allergies.
pain; swelling; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain and swelling. On an unknown date, the outcome of the pain and swelling were unknown.   It was unknown if the reporter considered the pain and swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patients husband reported that she had pain and swelling similar to the 2nd shingrix shot. This case has been linked with US2019141361, reported by the same reporter and US2019141362 same patient and same reporter.
patient received varivax 08-22-2008, on 09-23-2008 patient hasd fever and multiple erythematous patches with vescular bases and diagnosed with chicken pox.
tested positive for Covid-19 today; tested positive for Covid-19 today; running a fever of 102 F; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset Apr2022, outcome "unknown", described as "running a fever of 102 F"; COVID-19 (medically significant) with onset 25Apr2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "tested positive for Covid-19 today". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) fever of 102 F, notes: fever of 102 F; SARS-CoV-2 test: (25Apr2022) positive, notes: tested positive for Covid-19 today. Therapeutic measures were taken as a result of covid-19, pyrexia. Clinical course: Reporter stated she received two primary series doses of the Pfizer BioNTech COVID-19 Vaccine and a booster dose. Reporter states she went on vacation with her family and when she got back her niece tested positive for COVID-19. Reporter states she, herself, also tested positive for COVID-19 on 25Apr2022. Reporter states her doctor prescribed her Paxlovid and she just started her treatment a few moments ago with her first dose. Reporter was running a fever of 102 F. Reporter asking if it was okay that she started her Paxlovid at night instead of in the morning. Reporter asking if Tylenol can be taken with Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
red itchy rash developed on 5/5/2021 from injection site to elbow
I had a mild case of COVID-19; I had a fever, body aches, and head congestion. The next morning, the symptoms slightly faded, but I developed a minor cough with no phlegm or anything. I took an at-home COVID-19 on 12/11/2022 which came back positive. I scheduled a virtual appointment with my doctor on 12/13/2022. She said since my symptoms were so mild, she didn't recommend any anti-viral prescriptions but said to take DayQuil or ibuprofen or any congestion medications to help speed my recovery.
My period has not been late or irregular for 8 years.  As of today, my period is now 7 days late.  A pregnancy test was negative.  I am not having any premenstrual symptoms that would indicate my period will start any time soon.
Received first Moderna vaccine on 1/20/2021, had large bruise, swelling and hives to left arm. Was seen at ER on 1/29/2021 and prescribed antibiotics, steroid and topical cream per client.
Chills; fever; Injection site pain; muscle aches; vomiting; nausea; This is a spontaneous report from a non-contactable consumer (patient).  A 24-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231, expiration date not reported), via an unspecified route of administration, on the left arm, on 15Jan2021 at 11:00, at a single dose for Covid-19 immunization.  Medical history included allergies to penicillin. The patient did not receive other vaccines in four weeks. The patient is not pregnant. Concomitant medications included metformin, omeprazole, melatonin, iron and ethinylestradiol, levonorgestrel (SRONYX).  The patient previously took first dose of bnt162b2 (lot number EH9899) on 28Dec2020 at 11:15 AM, on the left arm, at a single dose for Covid-19 immunization, cephalosporin and Imitrex and experienced allergies. On 16Jan2021 at 01:00, the patient experienced chills, injection site pain, fever, muscle aches, and nausea/vomiting. No treatment was given for the adverse events. The patient has no Covid prior to vaccination and not Covid tested post vaccination. The patient recovered from the events in Jan2021.   No follow-up attempts are possible. No further information is expected.
Breakthrough case - got COVID 1/15/2022 Had 103 degree F fever, congestion/cough in chest & nose, headache, sinus pain,
got sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Weakness; Headache; Fatigue; Muscle Pain; Joint Pain; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle Pain) and ARTHRALGIA (Joint Pain) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced ASTHENIA (Weakness), HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ASTHENIA (Weakness), HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
bleeding from her intestines; hemoglobin level was very low/blood being low; could not breath, it took her a whole minute to catch her breath; couldn't raise her hand over her head; had a severe headache and other symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003916 (Novavax).  A 62-year-old female patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 2, single (Lot number: EN6198) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: INTESTINAL HAEMORRHAGE (medically significant), outcome "unknown", described as "bleeding from her intestines"; HAEMOGLOBIN DECREASED (medically significant), outcome "unknown", described as "hemoglobin level was very low/blood being low"; DYSPNOEA (medically significant), outcome "unknown", described as "could not breath, it took her a whole minute to catch her breath"; JOINT RANGE OF MOTION DECREASED (medically significant), outcome "unknown", described as "couldn't raise her hand over her head"; HEADACHE (medically significant), outcome "unknown", described as "had a severe headache and other symptoms". The patient underwent the following laboratory tests and procedures: Haemoglobin: very low, notes: hemoglobin level was very low; SARS-CoV-2 test: Negative, notes: got tested 3 times, but it was negative; Negative, notes: got tested 3 times, but it was negative; Negative, notes: got tested 3 times, but it was negative. Therapeutic measures were taken as a result of intestinal haemorrhage, haemoglobin decreased, dyspnoea, joint range of motion decreased, headache.  Clinical course: It was reported that the patient stated treatment on 25Mar2021 with Pfizer-BioNTech COVID-19 Vaccine at second dose for an unspecified indication. It was reported that the patient could not breath, it took a whole minute to catch breath. Patient thought she had COVID and got tested 3 times, but it was negative. So, patient ran to the hospital, and they found out that patient hemoglobin level was very low. They gave patient two blood transfusions and then they said patient was bleeding from intestines. All the other symptoms that patient had were related to blood being low, patient couldn't raise hand over head, had a severe headache and other symptoms.  No follow-up attempts are possible. No further information is expected.
Approximately 10 mins after the administration of the first dose of the Moderna COVID vaccine, the patient fainted in the waiting room chair.  I rendered first aid by calling out to him to rouse him.  I provided him with water and apple slices as he complained of not having eaten for an extended period of time and being thirsty.  He stated that he had no history of seizures, but had terrible anxiety.  He also stated that he was still nervous about the vaccine even after administration. He sat in the pharmacy for almost an hour afterwards. In that time he finished off the apple slices and water bottle. He did not complain of any further symptoms and was able to leave the pharmacy under his own power.
patient felt like she was going to pass out and realized it was her blood pressure. pt recorded bp of 76/63 with hr of 140bpm the symptoms quickly resolved after a few minutes and hr decreased to 80bpm after she remained lying down flat. Pt continued to have POTS through out the day and was managed by lying down
Loss of taste on 6/10/07 and 6/11/07. Left side of lips numb and part of left cheek which started 6/10/07 in the morning. Tiredness since vaccinations on 6/8/07.
aches /pains; side effects; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches /pains), IMMUNISATION REACTION (side effects) and PYREXIA (Fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1), Pfizer (Additional Dose: additional dose of Pfizer was pretty rough, had a fever, aches and pains for about 5 days), Pfizer (Additional Dose: additional dose of Pfizer was pretty rough, had a fever, aches and pains for about 5 days) and Pfizer (Dose 2). Past adverse reactions to the above products included Ache with Pfizer; Fever with Pfizer; and No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Relapsing-remitting multiple sclerosis (living with RRMS for 25 years now), MS (been NEDA since 2015), Immunosuppression, Coronary artery disease, Polycystic kidney and Anxiety.    In January 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced PAIN (aches /pains), IMMUNISATION REACTION (side effects) and PYREXIA (Fever). In 2022, PAIN (aches /pains), IMMUNISATION REACTION (side effects) and PYREXIA (Fever) had resolved.            The patient got the first 2 Pfizer and an additional dose of Pfizer and boosted in Jan with the Moderna vaccine. The last additional dose of Pfizer was pretty rough, had a fever, aches and pains for about 5 days. No relapse. The Moderna booster was much milder than the additional dose and side effects lasted about 3 days. No relapse and had to be off DMT for a month to get the shots. Now saying this, the patient had been NEDA since 2015, but always live with the anxiety that MS could reactivate at any time.   No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
have elevated TSH levels in the more recent labs, they all have gotten the Pfizer covid vaccine also/TSH level is markedly increased; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID: (004756).  A female patient received BNT162b2 (BNT162B2), as unk, single (Batch/Lot number: unknown) for covid-19 immunisation; levothyroxine sodium (SYNTHROID), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD THYROID STIMULATING HORMONE INCREASED (hospitalization), outcome "unknown", described as "have elevated TSH levels in the more recent labs, they all have gotten the Pfizer covid vaccine also/TSH level is markedly increased". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: 57, notes: Increased. The action taken for levothyroxine sodium was unknown. Clinical course: Caller wanted to know about reports of elevated TSH levels after covid vaccine. How long it takes to resolve, is there any inflammation going on. She had seen this with herself and with other members of her family, her Sister, daughter and brother- in-law, they all took Synthroid and had elevated TSH levels in the more recent labs, they all had gotten the Pfizer covid vaccine also. She stated other people were also experiencing it post covid injection they were having thyroid problems. Members were not having any symptoms but their TSH level were very elevated, her was 57 and she was in the hospital due to it. Her doctors were also not aware of this side effect. Her brother- in law stated that this could be reaction from covid vaccine /reagents as he did the research internationally. Their doctor thought that they were not taking Synthroid. The TSH level is markedly increased when taking Synthroid and after receiving the Covid vaccine: TSH 57. Caller stated she would like to report a concern and obtain some information regarding the Pfizer Covid vaccine, adult. Caller stated she was a nurse practitioner. Caller stated that she had noticed with herself, and some of her family members, that the TSH level was markedly increased when taking Synthroid and after receiving the Covid vaccine. Caller did not provide any specific identifiers for her family members. Caller stated she had read information about the Covid vaccine, and it could cause autoimmune difficulties, including thyroid problems  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event TSH increase and the suspect drug BNT162b2.
After receiving mandatory flu vaccine in right deltoid, worsening  stiffness and pain beginning about 2 weeks after administration progressing into adhesive capsulitis / chronic inflammation of entire shoulder girdle causing severe pain lasting many months post injection.  This reaction is identical to that of the Left shoulder adhesive capsulitis which occurred after influenza vaccination 2012!!
He began to have some severe pain in his ears to the point of 8/10.  He went to the hospital, saw a doctor and they gave him some medication Amox/clav that he took.  He did not help the pain.  After 2 days he went back to the ER on 3/7/21, they gave him another antibiotic called Ofloxacin ear drops.   He found out that he had a hole in his ear drum.  He has never had an issue like this before, and he was fine when he got the vaccine and feels it's related to that.  He has had no problems other than the regular side effects which only lasted for 1 day and then went away.  Yesterday, 3/8/21 the problem shifted to the other ear.  He is beginning to feel pain on his left ear as well now.  He has terrible hearing loss due to this issue.
Pt developed vesicular rash and burning pain at exam site about 1 week after vaccine. This then spread down arm.
7/6/11 received ADACEL Tdap (L) arm 60 mm hot, red, tender over injection site. Rx KEFLEX 500 mg q 12 hrs x 7 days.
AFTER VACCNATION, PATIENT BECAME EXTREMELY LIGHTHEADED AND DIZZY. HE DESCRIBED THE SENSATION AS "A RUSH ALL OVER HIS BODY". PATIENT WAS AFRAID HE MAY PASS OUT.
have covid; have covid; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration  date were not reported), via an unspecified route of administration in Feb2021 at dose 1 single and via an unspecified route of administration in Mar2021 at dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had covid (medically significant) in sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive in Sep2021. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
12/17/2021 I had a started with flu-like symptoms and later progressed to just a headache but with a double ear ache. This started about 10 days after the booster shot. By 12/24 I decided to go to urgent care and was given a COVID-19 PCR test (negative) but doctor considering the symptoms, situation, and timing, decided that I needed to quarantine anyway. Antibiotics and Antibiotic drops for ears was prescribed along with steroids. Was advised if gets worse come back. As of today my ears are still giving me trouble but only intermittent and with less pain. Was given a different ear drop for duration after I went to see doctor again for it. Been on the new drops for 10 days.
4/3/19 Body aches, shaking, fever, redness and swelling at injection site. Temp 98.8 at office visit. 4/7/19 Rash (pitryriasis Rosea). Pt told to alternate TYLENOL and ADVIL for fever, body aches.
Approximately 4-6 weeks after last vaccination, began to have constant salty taste in my mouth which continues to this day.  It's more pronounced when I eat anything containing lemon juice.; This is a spontaneous report from a non-contactable consumer, the patient. A non-pregnant female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on an unknown date in Apr2021 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included calcium (MANUFACTURER UNKNOWN) and melatonin (MANUFACTURER UNKNOWN) and OTC sleep aid (MANUFACTURER UNKNOWN), all medications taken for an unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG207) via an unspecified route of administration in the left arm on an unknown date in Mar2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in May2021, approximately 4-6 weeks after last vaccination the patient experienced to have constant salty taste in the mouth which continued to the date of this report. It was more pronounced when the patient ate anything containing lemon juice. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event salty taste in the mouth was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected
24 hours after vaccination began with warmth and redness to left upper arm. Antibiotics/Benadryl prescribed
This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter.  Sender's Comments: US-009507513-1804USA005153.
Five minutes after vaccine, I started having trouble breathing. Thought it was anxiety attack but I didn't feel anxious. I felt light headed and I don't get that with my panic attacks; At 15 minutes, my heart was beating really fast. They checked my vitals - pulse and BP was elevated. Pulse is over 130 and normally when I have an anxiety attack it doesn't go above 110. Went to the  ER . The breathing felt better after thirty min after being in ER and Blood pressure 1-2 hours later went down. No treatment. After about two weeks I saw my primary care doctor for check up.