chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness, nausea, pale 5 min after vaccine (HPV) given. Made pt lay down, took blood pressure, gave drink and monitored x 30 min. PCP made aware.
Patient presented to the ED on 3/6/21. Patient presented to the ED on 3/9/21 and was subsequently hospitalized for 5 days. Prinicpal problem was syncope and collapse. He was diagnosed with elevated brain natriuretic peptide and pleural effusion. These visits are within 6 weeks of receiving COVID vaccination.
Dizziness, Tachypnea, Palpitations, HYPERtension, Tachycardia, lightheadedness, shaking Narrative:  Taken to hospital for further eval and treatment
3 episodes of vasovagal syncope this morning, clustered over approximately 1 hour, on the day following her second dose of Pfizer Covid-19 vaccine.
Subacute Thyroiditis Following COVID-19 Vaccination; This is a literature report.  A 42-year-old male patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE (UNKNOWN MANUFACTURER)), for COVID-19 immunisation. Case: A patient with no past medical history, presented to the Endocrinology clinic with anterior neck pain around his thyroid area that started 3 days after his 2nd Pfizer COVID-19 vaccine. He described the pain as severe enough to wake him up from sleep. No weight loss, palpitation, heat intolerance or tremors. No prior exposure to stable iodine or radiation treatment. He takes no medications. He denies tobacco or alcohol use. Initial thyroid labs showed a T3 2.8 (2.5 - 4.4 pg/mL), T4 1.4 (0.61 - 1.44 ng/dL), TSH 1.4 (0.45 - 5.33 uIU/mL), TPO antibodies positive, thyroglobulin Ab undetectable, sedimentation rate of 42 (<30 mm/Hr). Ultrasound of the neck showed 1.7-centimeter TIRADS 4 nodules in the left lobe, and 0.9 cm on the right. The patient was noticing a discomfort in the right side of the neck. He was also having swallowing difficulties, low-grade fever, body ache, night sweats and unintentional weight loss. Though he initially presented with thyroid labs that were within the normal reference range, by the time he repeated them one month later, he was hyperthyroid. He was started on prednisone 20 mg and NSAID. At 2 weeks follow-up, his pain and swallowing difficulty have significantly improved. Over time, the patient's thyroid labs normalized and the pain in the neck subsided, repeat neck US 5 months later showed decreased nodule size. Steroids was stopped.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of Subacute Thyroiditis cannot be fully excluded, considering the temporal relationship.  More immunological and biomolecular evidence would be needed to explore the plausible physiopathologic mechanism between the vaccination and the event occurrence.  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
Reported itching to hands, then spread to feet, arms, legs, numbness on tongue, mouth/throat felt hot and increase in Anxiety
pain in the joints; Severe headache; Chills; Fever of 39°C that did not drop down after taking several Tylenol; This spontaneous case was reported by an other health care professional and describes the occurrence of ARTHRALGIA (pain in the joints), HEADACHE (Severe headache), CHILLS (Chills) and PYREXIA (Fever of 39°C that did not drop down after taking several Tylenol) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No reported medical history was provided.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced ARTHRALGIA (pain in the joints), HEADACHE (Severe headache), CHILLS (Chills) and PYREXIA (Fever of 39°C that did not drop down after taking several Tylenol). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 2 dosage form. At the time of the report, ARTHRALGIA (pain in the joints), HEADACHE (Severe headache), CHILLS (Chills) and PYREXIA (Fever of 39°C that did not drop down after taking several Tylenol) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: (Positive) Test done after first dose of Moderna vaccination..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Translated Document received on 10-JUN-2021 and does not have any new information On 01-Jun-2021: Email
1/21/22 family reports pt has had SOB all day; recently diagnosed 1/13/22  positive for COVID at an urgent care; EMS called to home due to pt being found on the ground unresponsive; cardiac arrest; CPR x 30mins without success; pt died in the ED
Experienced malaise, dizziness, nausea, flushing 15 minutes after receiving dose 2. Patient reported no side effects on dose 1 received 2/5/2021. Additional 30 minutes of monitoring was performed, which the symptoms persisted. Patient instructed to call out from her shift and go home after.
Swelling and redness and warmth around the site. Started at 8:30 pm.
Severe Muscle Aches, Fever, Weakness, Fatigue. I get kinda confused, lathargic, lack of breathing- lack of air in my lungs. Short of breath. Now I am like in a daze, and weak.
SEVERE PAIN AND STIFFNESS IN LEFT ARM TOO PAINFUL TO MOVE. HEADACHE, PAIN IN NECK & FATIGUE THAT LASTED FOR 4 DAYS. HAD TO TAKE PARACETAMOL REGULARLY TO RELIEVE PAIN. UPPER MUSCLE STILL VERY TENDER AFTER 1 WEEK.
Patient was vaccinated on 1/05/2021 and 1/26/2021 with Pfizer vaccine. He then  became symptomatic on 8/09 and tested positive for COVID-19 on 8/10
Shoulder pain, stiffness neck, difficulty breathing, chest pain. Client states resolved after (O2 therapy).
Before going to bed at 10:30p with really bad chills that made it feel like I was freezing and was sweating profusely. I woke up super nauseous at 4:00am and quickly vomited afterwards. From there on I slept for 10-30 minutes in between vomiting for 3 hours. Afterwards the chills and extreme nauseous feeling didn't leave until the 3rd day after the shot.
Fever, nausea 1 hour of getting shot.That evening chills; nausea 1 hour of getting shot; that evening chills; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8737) via an unspecified route of administration in the right arm on 14Apr2021 at 16:00(at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure was little high and penicillin allergy. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ) and amlodipine (MANUFACTURER UNKNOWN); both for unspecified indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Apr2021 at 17:15, the patient after one hour of shot, experienced fever, nausea and that evening chills. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event fever, nausea and chills was recovered on an unknown date in 2021, at the time of this report.  No follow-up attempts are needed. No further information is expected.
(L) deltoid with swelling and redness extended down arm to elbow. No pain associated with above symptoms.
1 wk p/vax t101-102-103; 2nd day devel rash all over body, tiny bumps, cries alot; tx w/APAP/Motrin
36 hours after first shot, she began having chest pains. 20 hours later the pains became worse (5 out of 10 on a pain scale) and worsened with exertion (7-8 out of 10). Stated that the pain correlated with heart rate.   After discharge from ER, bed rest and Ibuprofen every 6 hours until pain subsided - 6 days after onset.
heavy vaginal bleeding; headache; fatigue; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 51-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 04May2021 10:00 (Batch/Lot number and Expiry date was not reported) (at the age of 51-years-old) as DOSE 2, SINGLE for Covid-19 immunization. Medical history included: Uterine fibroids, migraines, lupus. There were no known allergies reported. Concomitant medications included: ethinylestradiol, norethisterone acetate (LOESTRIN), hydroxychloroquine, magnesium and fish oil. Start and stop dates and dosing regimen details were not reported. The patient previously received BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) for covid-19 immunization.The patient did not receive any other vaccine within 4 weeks of covid-19 vaccine administration. Prior to vaccination, the patient did not have covid and since vaccination the patient has not been tested for covid -19. On 06May2021, the patient experienced headache and fatigue. On 08May2021, the patient experienced heavy vaginal bleeding. It was reported that 2 days after vaccine, had severe headache & fatigue. On 08May2021, 4 days after, the patient had heavy vaginal bleeding. She reported that she did not have periods, as she takes birth control pills continuously to stop them. Therapeutic measures were taken as a result of heavy vaginal bleeding. The clinical outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Itching on arms then legs, buttocks, back. At 2:00am took 2 Benadryl tablets - at 2:00Pm took another Benadryl - to ease itching sensation.
I had normal injection site sensitivity after the initial 1st dose, and that cleared within 2 days.  Then on the 6th day post injection, my upper arm started feel hot and taught, hard to the touch and itched.  Not really pain in the muscle but more of a large red skin irritation has increased in symptoms all day.  I have read there is a slight chance of Cutaneous Hypersensitivity, and presume that's what's happening, but thought I should report it.  I have not seen a Dr. at this point.  Will try Benadryl or hydrocortisone cream in the morning if not improving.
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program.  A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced first symptoms of headache, vertigo, loss of smell and taste on 08Jan2021. The patient tested positive for covid-19 on 10Jan2021. The patient reported the Saturday before the Pfizer-BioNTech vaccine was administered, he tested negative for COVID-19 disease with a rapid test, but felt it was possible he had COVID-19 disease but it was so recent that the rapid test may have not been accurate. He reported being mostly recovered from his symptoms at this time with some tiny headache remaining. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Right deltoid pain since receiving the vaccine 3 weeks ago. We started treating her today with naproxen 500mg 1 tablet by mouth twice a day.
On 10-20-12 pt returned stating arm very sore. Told pt that is common. On 10-21-12 pt returned complaining of soreness and now her arm is swollen, red and warm to the touch. Told pt to see MD. She went to urgent care and was diagnosed with cellulitis and given antibiotic.
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. A contactable male consumer of unspecified age reported that he received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date in Jan2021 the patient tested positive for COVID. He was supposed to come back on 27Jan2021 and was asking if it was possible to delay the second vaccine. Event outcome was unknown. Information on the lot/batch number has been requested.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 25-AUG-2010, the patient was vaccinated with the first dose, on 14-JAN-2011 with the second dose and on 09-JUL-2014 with the third dose of GARDASIL (dose, route of administration and lot # were not reported). No adverse effects were reported. Additional information has been requested.
No symptoms after vaccine administration on 10/4.  Resident monitored as is normal practice, no symptoms noted on 10/5.  On 10/6 at approximately 11:50am, resident experienced a cerebral vascular accident and was transferred and admitted to the hospital.
Six days after getting the vaccine I started itching in my armpits and the next day I got a large rash around my injection site. This area is hard and itchy and is a bit swollen.
flu like symptoms; sick like a dog; sniffles; headache; feeling like having a fever; feeling like they were dying for a day; Initial and Additional information received on 23-Sep-2019 and 24-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacy other/non-hcp.  This case is linked to cases 2019SA267183 and 2019SA267182 (same reporter).  This case involves a 67 years old male patient who experienced flu like symptoms (influenza like illness), sick like a dog (malaise), sniffles (rhinorrhoea), headache (headache), fever (pyrexia) and feeling like they were dying for a day (unevaluable event), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The concomitant vaccination included prevnar.   On 06-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Lot: UJ232AA and expiry date: 10-Apr-2020) via intramuscular route in the left deltoid.  On 07-SEP-2019, 1 days post vaccination, the patient had flu like symptoms (influenza like illness), sick like a dog (malaise), sniffles (rhinorrhoea), headache (headache), fever (pyrexia) and feeling like they were dying for a day (unevaluable event) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Lab data was not reported.  Final diagnosis was influenza like illness, malaise, rhinorrhoea, headache, pyrexia and unevaluable event.   It was not reported if the patient received a corrective treatment and spent the whole day in bed.  The patient outcome was reported as unknown for all the events.  List of document held by sender:  none.
8:00- Left arm became numb up to upper deltoid. 12:00- progressed to left shoulder. 14:00- face numb. . Nose, mouth and lips numb. 15:00- Tongue tingling. 21:00- Eye lids, lips, and left side of face swelled. Fingers puffy.
Patient developed a rash 10 minutes after vaccine was administered. BENADRYL was prescribed. I called patients parents the following day. Per mom, rash subsidized, she was taking BENADRYL and MOTRIN, and drinking lot of water.
Pt awoke at 11:30 pm wheezing and coughing. His mother administered routine nebulizer tx twice. Sx fully resolved.
pt screamed & parent went in to check pt & pt was limp & wouldn't respond to parent or wake up;pt taken to ER;
Temperature for 4 straight days and continuing. Highest at 105.3 and currently at 102. Fever continues to spike and dip but never below 101. Body aches in back and legs. Headaches. Lethargic.
Gas; Bloating; Loose stools; Pain stomach; Vaccination site warmth; Vaccination site swelling; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE PAIN (Vaccination site pain), FLATULENCE (Gas) and ABDOMINAL DISTENSION (Bloating) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Panuveitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced FLATULENCE (Gas), ABDOMINAL DISTENSION (Bloating), DIARRHOEA (Loose stools) and ABDOMINAL PAIN UPPER (Pain stomach). At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain) had resolved and FLATULENCE (Gas), ABDOMINAL DISTENSION (Bloating), DIARRHOEA (Loose stools) and ABDOMINAL PAIN UPPER (Pain stomach) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information were provided.
Right hand significantly colder than left.; Severe pain in right shoulder blade along bottom curve.; Right arm felt like it weighed a ton; Sore throat; Sore neck; Sore back; Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 22Apr2021 at 08:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder, anxiety. The patient previously received hydrocodone bitartrate/paracetamol (VICODIN) on an unspecified date for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lamotrigine (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN); for unknown indications, from an unknown date and unknown if on going. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Apr2021 at 10:30, the patient experienced right hand significantly colder than left, felt like it had been in ice bucket, not painful but very noticeable to the touch. The condition had improved but not resolved. The patient also experienced severe pain in right shoulder blade along bottom curve, which was not improved. The patient's right arm felt like it weighed a ton on 1st day, which was resolved. The patient's joint pain both knees, right hip, right shoulder, both elbows, right wrist was not improved, sore throat, neck and back was not improved, exhaustion was resolved. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events right arm felt like it weighed a ton and exhaustion was recovered on an unknown date in Apr2021. The clinical outcome of the events right hand significantly colder than left was recovering; whereas severe pain in right shoulder blade, joint pain both knees, right hip, right shoulder, both elbows, right wrist and sore throat, neck and back was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Vomiting; Leg pain (limping); Tiredness; Fussiness.
Varicella vaccine 0.5 cc S/C RUA given Oct 1st and got locally wheel and flare with redness measuring 7.5cm x 4.5cm. Local temp increased.
Massive headaches, overall muscle aches, weakness in left arm, minor nausea, loss of appetite. Disruption to INR.
Chest tightness, closing of throat, rapid heartbeat, rash on chest, coughing
ITCHING UNDER BREAST; SUNBURN LOOKING RASH UNDER BREAST; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-JUN-2021, the subject experienced itching under breast. On 14-JUN-2021, the subject experienced sunburn looking rash under breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sunburn looking rash under breast, and itching under breast. This report was non-serious.
Mother reports quarter-sized hard, red area on back of right arm that is hot to the touch.  Child is not complaining about site and is acting normally.  Mother declined to see PCP.
productive cough with mucus; nasal congestion; dry cough; This is a spontaneous report from a contactable other health care professional. A 44-year-old male patient received bnt162b2 (BNT162B2 BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date in Jul2021 as dose 1, single for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications was reported as none.On an unspecified date in 2021, the patient had a productive cough, last week from the day of report, symptoms of obstructive cough and nasal congestion and described it as mucus from his nose and throat from the cough and a dry cough as well. He did not have fever or fatigue or other symptoms besides productive cough and mucus. He did not have any experience when it comes to the vaccine and it did not come from the vaccine. The patient was due to get his second dose of the pfizer COVID-19 vaccine at 3 weeks, the next day from the day of report and the dates for will be 4 weeks tomorrow since first dose. He was supposed to take the vaccine last Friday from the day of report, but he did not as he was out of town and is looking to get this week. She just wanted to know if he could take the second dose. The clinical outcome of events was unknown.  Information about lot/batch number has been requested.