chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blood pressure was 150+/100+; I was still feeling a bit crappy overall from the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 18:15 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: OTC Zyrtec for allergies/mild asthma. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity, asthma. Past drug history included: Gantrisin for bladder infections, reaction(s): "allergy", notes: Known allergies: Gantrisin - and old school medicine for bladder infections. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, at 10:00:00, anatomical location: Left arm), administration date: 26Jan2021, for COVID-19 immunisation; bnt162b2 (DOSE 2, SINGLE, at 11:00:00, anatomical location: Left arm), administration date: 21Feb2021, for COVID-19 immunisation; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, at 14:00:00, anatomical location: Left arm), administration date: 25Sep2021, for COVID-19 immunisation; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, at14:00:00, anatomical location: right arm), administration date: 31Mar2022, for COVID-19 immunisation; bnt162b2 (DOSE 5 (BOOSTER), SINGLE, at14:00:00, anatomical location: Left arm), administration date: 14Sep2022, for COVID-19 immunisation. The following information was reported: FEELING ABNORMAL (non-serious) with onset 03Oct2023 at 15:30, outcome "recovering", described as "I was still feeling a bit crappy overall from the shot"; BLOOD PRESSURE INCREASED (medically significant) with onset 03Oct2023 at 15:30, outcome "recovering", described as "blood pressure was 150+/100+". The event "blood pressure was 150+/100+" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 126/86, notes: my blood pressure is usually never about 126/86; 150+/100+; elevated - 135/91. Therapeutic measures were not taken as a result of blood pressure increased, feeling abnormal. Clinical course: Patient did not received any other vaccine in four weeks. She couldn't be sure, but her blood pressure was usually never about 126/86. The next day while at PRIVACY, withheld follow-up, her blood pressure was 150+/100+. She was still feeling a bit crappy overall from the shot, so she asked if this might have been her bodies reaction to that. She had been monitoring it since, and it still seems a bit elevated - 135/91 or so. Like she said, couldn't be for sure, but its odd that it spiked so high the day after her shot. Her doctor wanted her to monitor her BP for a few weeks. Hopefully it would return to normal. Patient did not received any treatment, had not tested positive post or prior vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
pt recvd 5 doses of Engerix-B & was not seroconverted; most recent titer was drawn 27APR92 & was neg;
Headache, body aches (sore muscles, sensitive skin). It felt like it triggered a fibromyalgia outbreak which I haven't had in years. I've also been experiencing more fatigue and brain fog since then which is preventing me from looking for work.
No additional AE; VAQTA was administered after temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 30-AUG-2023, the patient was vaccinated with improperly stored dose (product storage error) of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 dose, lot # reported as: Y3ME2, expiration date reported as: 23-FEB-2025, administered for prophylaxis (exact dose, formulation, site and route of administration were not provided) by a healthcare provider. Temperature excursion details: 8.9 degree Celsius for 12 hours and 20 minutes (14-AUG-2023), 9.4 degree Celsius for 8 hours and 20 minutes (28-AUG-2023); no previous temperature excursions. There was no additional adverse event reported.   Lot number Y3ME2 is an invalid lot number for hepatitis a vaccine, inactivated (VAQTA).
Sweating; Severe Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating) and DIARRHOEA (Severe Diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweating) and DIARRHOEA (Severe Diarrhea). At the time of the report, HYPERHIDROSIS (Sweating) and DIARRHOEA (Severe Diarrhea) outcome was unknown.            No treatment or concomitant medications were reported.   Reporter did not allow further contact
Three bruises on her stomach/3 bruises on my stomach/bruise; Sore arm (injection site); This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Three bruises on her stomach/3 bruises on my stomach/bruise) and VACCINATION SITE PAIN (Sore arm (injection site)) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     Concurrent medical conditions included Gluten sensitivity, Food allergy (tomato based food allergy), Food allergy (beets allergy), Drug allergy (NSAIDS Allergy), Drug allergy (doxycycline allergy), Drug allergy (Percocet allergy) and Hypersensitivity (outdoor smell allergy).    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced VACCINATION SITE PAIN (Sore arm (injection site)). On 07-Aug-2021, the patient experienced CONTUSION (Three bruises on her stomach/3 bruises on my stomach/bruise). On 06-Aug-2021, VACCINATION SITE PAIN (Sore arm (injection site)) had resolved. At the time of the report, CONTUSION (Three bruises on her stomach/3 bruises on my stomach/bruise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: No new information was updated.
Information has been received from a physician and the office manager concerning a 12 month old female patient who on 12-MAR-2009 was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of (PREVNAR) by mistake due to an office error. It is unknown if the patient sought medical attention. Follow up information was received from the physician which reported that the patient was vaccinated IM with PMEUMOVAX (lot # 661934/1441X). There was no illness at the time of vaccination. No reactions or adverse events were reported. The patient did not seek medical attention. This is one of several; reports from the same source. Additional information is not expected.
Swelling at injection site, redness, sore arm, and itchy. Started approximately 1-2hours after injection. Got worse as the day went on and through the night. Went to urgent care the day after injection and they said it was an allergic reaction. They prescribed prednisone. Swelling has gone down but still very itchy.
This case was reported by an wholesaler and described the occurrence of paralysis in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). In October 2012 the subject received a dose of FLULAVAL (unknown details). In November 2012, within a month after vaccination with FLULAVAL, the subject experienced paralysis and was placed on ventilation. The wholesaler stated that "the attending physician has remarked that he thinks the FLULAVAL dose was possible causative." At the time of reporting, the wholesaler did not have any specific details on the case but will attempt to gain that information. It was also reported to the wholesaler that the subject signed the waiver to receive the flu shot indicating that he was not allergic to eggs. The subject was hospitalised in the intensive care unit. At the time of reporting the outcome of the events were unspecified.
1 of 2 pts immunized from the same vial who had an adverse event;sxs unspecified;
Redness and edema to inijection site. Complaints of itching to skin at 6 pm 10/3/14. Small red raised areas to arm, shoulder, back and chest. Took BENADRYL 25 mg po.
11/30/21 Patient presents to hospital with c/o some diarrhea and vomiting, off and on, over the past 2 wks; cough and myalgias recently; went to an urgent care and had a positive COVID test on 11/26/2021; having dyspnea with exertion; admitted; O2 supplementation; Decadron, Lovenox, Vitamins C and D and zinc; found to have a left pneumothorax, chest tube placed; CRRT also initiated; pt deteriorated and pt was made a DNR and then transitioned to comfort care; he passed away in the hospital
# 8-10 for pain to injection site -> R deltoid radiating to R neck / R wrist / Fingers. Also with nausea/vomiting x's
Headache, quick onset within 5 minutes of vaccination..  Severity 4 on a scale of 10.
Patient was passing out for 1 minutes while he was waiting for 15 minutes after vaccination. Patient was sitting on a chair and didn't fall.  Paramedic came but patient refused paramedic service since he was feeling okay after 1 minutes. Patient was breathing normally.
nerve pain; burning; pricking pain; pricking sensations; This case was reported by a consumer via interactive digital media and described the occurrence of nerve pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nerve pain, burning sensation, pain and tingling sensation. On an unknown date, the outcome of the nerve pain, burning sensation, pain and tingling sensation were not recovered/not resolved.   It was unknown if the reporter considered the nerve pain, burning sensation, pain and tingling sensation to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received a dose of Shingrix in an unknown arm and was still dealing with nerve pain, burning, pricking pain/ sensations on his/her back same side as the shot in his/her arm. The follow-up could not be possible as no contact details were available.
The evening after the first shot, I had intense leg cramps all night, that kept me awake.; This is a spontaneous report from a contactable 56-year-old female consumer.  A 56-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL6198, Expiration date: unknown), via unspecified route, administered in left arm on 09Mar2021 04:00 PM as DOSE 1, SINGLE for COVID-19 immunization. Patient took the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6208, Expiration date: unknown) via unspecified route, administered in left arm on 26Mar2021 04:00 PM as DOSE 2, SINGLE. The patient medical history includes Osteoarthritis, Atrial fibrillation, Enlarged Thyroid, Goiters, and Sulphonamide allergy. Past drug events include CEFZIL induced Drug hypersensitivity and MACROBID induced Drug hypersensitivity. Concomitant medications include bisoprolol fumarate, hydrochlorothiazide (BISPROLOL), Vitamin D, cyanocobalamin (B-12), acetylsalicylic acid (ASPIRIN). Patient was not tested positive prior and post vaccination. No other vaccines were taken in four weeks. On 09Mar2021, 10:00 PM in the evening after the first dose of vaccination, the patient experienced intense leg cramps all night, that kept the patient awake. Adverse event resulted in Doctor or other healthcare professional office/clinic visit and doctor suggested an x-ray, ice and exercise. Lab data includes X-Ray on an unspecified date with normal results. The outcome of the events was not recovered.  No follow-up attempts possible. No further information expected
I have diabetes; This is a spontaneous report from a non-contactable consumer (patient). A 71-year-old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 18Feb2021 (Batch/Lot number was not reported) as dose 2, single for Covid-19 immunisation. The patient received the first dose of bnt162b2 (BNT162B2 reported as COVID VACCINE) on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient mentioned that he heard that Pfizer was doing clinical trials for booster shots of the Covid vaccine which was done in a state. The patient mentioned that I stay in the state of (withheld) and I'm willing to travel". The patient mentioned that "I'm 71 years old and I have diabetes (unknown date)". The patient received second dose of the Pfizer vaccine on 18Feb2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax 27JUL93 w/rash, t99; pt devel quarter size red & raised wheals on face, arms, neck & trunk; no wheezing or SOB; rt arm red & swollen @ inject site w/rest of arm from shoulder to wrist whealed up;
Weakness, nausea, extreme fatigue. Patient reported that most symptoms subsided by 12/09/2013 evening.
Pt reported 6 days /p immun. that inject site was painful & red, exam showed induration - redness 8cm X 6cm at inject site
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1-0A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
He had a fever the night he received the shots and was vomiting the next morning, he also had a little headache, That afternoon he felt fine and has had no other problems.
First I had the same coffee I drink the last 4 years, and it was bad, then I was cold. I put a blanket over me and went to bed. The next day the coffee tasted normal and I was warmed up as usual.
Strong Metallic Taste in the mouth right after vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSGEUSIA (Strong Metallic Taste in the mouth right after vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Strong Metallic Taste in the mouth right after vaccination). At the time of the report, DYSGEUSIA (Strong Metallic Taste in the mouth right after vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
1 minute after administration Pt had fainting episode with profuse sweating and decreased BP decreased pulse, paleness, resolved over next 10 minutes, gradually.
Pt did not respond to a series of Engerix-B; 9ARP92 booster series of vax is scheduled to begin;
fever; left arm has a pocket from swelling; redness from mid forearm to shoulder; malaise; sore arm; dizziness; body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of   in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
rashes behind her knees/rashes besides her knees 1st dose; This spontaneous case was reported by a non-health professional and describes the occurrence of RASH (rashes behind her knees/rashes besides her knees 1st dose) 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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rashes behind her knees/rashes besides her knees 1st dose). At the time of the report, RASH (rashes behind her knees/rashes besides her knees 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-407587 (Patient Link).
toes became reddened, swollen, and achy; substance similar to earwax started seeping out of the skin of the big toes; Pain in extremity; both of big toes turned Purple; Sore Arm; This spontaneous case was reported by a physician and describes the occurrence of BLUE TOE SYNDROME (both of big toes turned Purple), SKIN DISCHARGE (substance similar to earwax started seeping out of the skin of the big toes), PAIN IN EXTREMITY (Sore Arm), ABSCESS LIMB (toes became reddened, swollen, and achy) and PAIN IN EXTREMITY (Pain in extremity) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation in 2000, Hypertension in 2000, Obesity in 1990, Prostate cancer in 2017 and Barrett's esophagus in 2015. Concomitant products included APIXABAN for Atrial fibrillation, OMEPRAZOLE for Barrett's esophagus, ROSUVASTATIN for Cholesterol, DILTIAZEM HCL and METOPROLOL TARTRATE for Hypertension.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 12-Mar-2021, the patient experienced BLUE TOE SYNDROME (both of big toes turned Purple) and PAIN IN EXTREMITY (Pain in extremity). On 13-Mar-2021, the patient experienced SKIN DISCHARGE (substance similar to earwax started seeping out of the skin of the big toes). On an unknown date, the patient experienced ABSCESS LIMB (toes became reddened, swollen, and achy). On 29-Apr-2021, SKIN DISCHARGE (substance similar to earwax started seeping out of the skin of the big toes) had resolved. On 30-Apr-2021, PAIN IN EXTREMITY (Pain in extremity) had resolved. At the time of the report, BLUE TOE SYNDROME (both of big toes turned Purple), PAIN IN EXTREMITY (Sore Arm) and ABSCESS LIMB (toes became reddened, swollen, and achy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.   This case was linked.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Patient demographics,  other relevant history, concomitant medications were added and event details and outcome was updated.; Sender's Comments:  Cross link;Wife case
Patient may have received two Influenza (Fluad) vaccines for this current flu season.  The first was received on 8/14/2021 and the second on 10/21/2021.
The patient suffered a rash and a rash on the scalp, painful and itching blisters on the back of the neck and was later diagnosed with Herpes Zoster.; This spontaneous report was received from a lawyer and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant medications were not reported.  In or around 19-MAR-2018, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for prevention of shingles.         On 22-MAR-2018 (reported as "4 days after vaccination"), the patient experienced a rash and a rash on the scalp, painful and itching blisters on the back of the neck and was later diagnosed with herpes zoster.  The outcome of herpes zoster was not recovered.     As a result of the vaccination, the patient had severe and permanent personal injuries, for that reason, the event was considered as a disabling event.   The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Information has been received from a physician concerning an 8 year old male with no known drug allergies, hay fever and urethral stenosis, who on 27-SEP-1999 was vaccinated SC in the right arm with a first dose of Varivax (lot # 630414/0302J). On 18-NOV-2006 the patient experienced a frontal headache and dizziness. On 19-NOV-2006 the patient presented to the emergency department with a fever and rash which started on his legs. The rash spread to his face, back, chest and all extremities. The patient's palms and oral mucosa were spared. The rash was reported to be reddened area 1 1/2 to 2 1/2 cm in diameter with blister like centers, the patient also complained of itching. The rash was also reported to be spotty and palpable. The patient also had a cough and muscle/joint pain. The patient was discharged in stable condition with a diagnosis of chickenpox. It was reported that on an unspecified date the patient's 6 year old sister had rash and pneumonia. Information received on 20-DEC-2006 contained the following adverse experience: concussion at the age of 2. No additional information was provided. Additional information has been requested.
Information was received from a lawyer regarding a case in litigation concerning a female, age and medical history not provided. The patient was inoculated with ZOSTAVAX by her physician on 03-AUG-2012 for routine adult health maintenance and for the intended purpose of the prevention of shingles. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus ZOSTAVAX was intended to prevent. On or about 16-JUL-2016 the patient was treated at an urgent care for a blistering vesicular outbreak, which was diagnosed as herpes zoster/shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for the long term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient suffered and continue to suffer significant medical expenses, and pain and suffering and other damages. Outcome of herpes zoster/shingles was unknown. Additional information has been requested.