chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT INITIALLY APPEARED NERVOUS AND IMMEDIATELY AFTER THE VACCINATION. IT WAS APPARENT SHE WAS NOT FEELING WELL. PATIENT REPORTED BEING VERY NERVOUS, HANDS WERE SHAKY, AND SHE COMPLAINED OF THE LIGHTS BEING WEIRD. SHE APPEARED PALE AND CLAMY. AFTER A COUPLE MINUTES IT APPEARED THAT THE PATIENT'S SYMPTOMS WERE NOT RESOLVING. AFTER CHECKING HER PULSE, IT WAS ELEVATED, AND THE PATIENT'S FEET WERE THEN ELEVATED ABOVE HER HEART IN ANOTHER CHAIR AND MONITORED FOR SEVERAL MINUTES. WHEN SYMPTOMS BEGAN TO RESOLVE THE PATIENT SAT BACK UP SLOWY AND DRANK WATER AND WAS THEN MONITORED FOR A TOTAL OF 30 MINUTES BEGINNING AT THE TIME OF THE VACCINATION. BLOOD PRESSURE WAS 126/84 BEFORE LEAVING AND REPORTED RESOLUTION OF ALL SYMPTOMS. I CALLED TO CHECK ON HER AN HOUR AFTER SHE LEFT THE PHARMACY AND SHE REPORTED FEELING FINE AND SHE WAS JUST EXTREMELY NERVOUS AT THE TIME OF THE VACCINATION.
Pt. came in on 8/6/2017 complaining of rash on her face and forehead. Pt. went to dermatologist and he confirmed that she had episode of shingles. Pt. came back on 8/6/17 after receiving vaccine (ZOSTAVAX) on 8/2/17 complaining of rash on her upper face and forehead. The pharmacist on duty advised the patient to see MD for further evaluation. Pt. came back on 8/6/17 and stated that she was seen by her dermatologist and he did confirm that the rash was shingles and did say that it was most likely due to vaccine. Pt. was prescribed VALTREX and prednisone for treatment.
Information has been received from a registered nurse concerning a 69 year old female with anemia, colitis and Crohn's disease who on 13-Dec-2001 was vaccinated with a dose of hepatitis A virus vaccine inactivated. Concomitant therapy included cyanocobalamin (B12) injections. It was reported that the patient never returned for the booster dose. On 17-Dec-2003 a hepatitis A titer was taken and was negative. No prescription drug was required. A product quality complaint was involved. Unspecified medical attention was sought. No additional information is expected.
First of all, pt was given shots in both arms, yet the person who filled out the paper work took a short cut and said she only got her shots in the left arm. Pt got her shots and then went to school, when i picked her up at 2:15 pm on 4/12/16 from school she said she wasn't feeling well and felt warm. I took her home and took her temp, she was at 102. I did not treat the fever. At 4pm she told me there were snakes crawling on her stomach, she was having hallucinations and had a fever of 104.6; at this point I gave her ibuprofin for her size. Her fever would only drop to 101. She had fever for 3 days. On the night of 4/12/16 pt also was complaining of weak arms and legs and that they were hurting. To this very day she has severe leg pains. On June 12, 2016 pt was displaying symptoms to Type 1 Diabetes. She was extremely thirsty, urinating freqently, had a ketone smell on her breath and was losing weight. We tested her blood sugar and she was 436, she was diagnosed with Type 1 Diabetes later that week.
This spontaneous report as received from a healthcare student refers to 13 year old patient (unknown gender). On 30-JUL-2013 the patient was vaccinated with a first dose of VARIVAX (route, lot number and expiration date not reported). There was not concomitant medication reported. On 07-AUG-2013 the patient was vaccinated with a second dose of VARIVAX (route, lot number and expiration date not reported. No adverse symptoms reported. Additional information has been requested.
MAGNETIC INJECTION SITE; PANIC; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) .5 ml, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced panic. On an unspecified date, the subject experienced magnetic injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the panic and magnetic injection site was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be no pqc was identified within the reported complaint reported. complaint is approved for void. void:y based on the PQC evaluation/investigation performed.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
stomach cramps 13MAR - 16MAR93 no other sx; no rash no temp, no local rxn; taken to Er 15MAR;
Information was received from a field employee (MARRS# 1209USA005601) who reported that a nurse stated to her that a drop in blood pressure and fainted was first shot "has happened several times in this office" with GARDASIL. Additional information has been requested.
Presented with c/o of lower extremities rash and bilat buttock, hip pain. Began over the weekend worsened yesterday. Rash this AM. No other S/S than red non blanching rash to lower extremities from sock line down below to knee.
I received the vaccine on 01/13/2021 and only had mild arm tenderness at the site for a couple of days with some mild to moderate fatigue and sleepiness. On the 10th day after the vaccine which would have been on 01/21/2021 my left arm which was the arm that I received the vaccine in was itching and red with hives and warm to the touch and these symptoms lasted until the evening of 01/24/2021 and then that night I developed a fever with severe stomach pain along with vomiting and diarrhea  and headache which lasted throughout the day of 01/25/2021. I was very fatigued and sleepy and then on 01/28/2021 I woke up with a blister to my forehead and then later that afternoon developed another one on my neck and then a few more later that night to the back of my neck on my c-spine. On 01/30/2021 my left ear was very sore to the back side of it and also the inside of my ear was itchy and painful as if I was developing a small pimple . This developed into itching to the inside of my ear and also redness and what looks like a rash and some eczema as this was looked at by  one of the RN's here at the clinic. I am still continuing to have fatigue and sleepiness which is not normal for me and I am still having bouts of diarrhea and stomach pain that is not my normal stomach pain. I also sent this to doctor as I wanted this to be documented in my medical record as I am due for my booster vaccine on 02/10/2021 and I am not feeling up to par to receive this at that time. Another concern is the fact that at times I do feel energetic but then all of a sudden I just feel weighed down like my arms and legs are too heavy to use. I have continued to exercise during this time but not for my full hour that I normally do every day. I am very concerned how I will react to the booster if this first one caused all of these reactions as on a normal day I only weigh 114 pounds and at my heaviest maybe 116 and I dropped down to 111 pounds this past week and I am aware that this is more than likely due to the vomiting and diarrhea and was dehydrated for a couple of days. I am going to wait for my booster until I can get more reassurance on this and am feeling more like myself .
itchy skin; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Jan2021 12:00 (Lot number: EL9263) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL1283, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 08Jan2021, when the patient was 75 years old, for COVID-19 Immunization. The following information was reported: PRURITUS (non-serious) with onset 01Feb2021 12:00, outcome "not recovered", described as "itchy skin". The event "itchy skin" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pruritus.  Additional information: No other vaccine was taken in four weeks. Doctor suggested allergy and for 6 month follow up scan. Treatment was given with Steroid ointment and OTC antihistamines. Patient was not tested COVID prior and post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
She felt fatigue for a few days, after both vaccines; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9264), via an unspecified route of administration in left arm (high up on shoulder) on 05Feb2021 at 12:07PM (at the age of 70 years) as first dose, single for COVID-19 immunization. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202), via an unspecified route of administration in left arm on 26Feb2021 at 13:44 (at the age of 70 years) as second dose, single for COVID-19 immunization. Family history included her sister had Psoriasis, and she also got a Spike Protein antibody test. Medical history included thyroid and psoriasis from Jan2020 and ongoing. The patient was taking thyroid pills and because of medication it (thyroid) was okay. She also had psoriasis but she did not take any medicine for it sometime she used a cream but she did not take any medicine for it. The patient previously took Otezla (start date: unspecified, stop date: 28Dec2020) for psoriasis. It was reported that she took it for a month in Dec2020. The patient's concomitant medications were not reported. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. It was reported that she never had pain with the first one, she couldn't even feel the first one. On 05Feb2021, the patient felt fatigue for a few days, after the vaccine. AE did not require emergency room or physician office. Patient stated that she had regular Covid antibody tests on an unspecified in the past and they were negative. She did not clarify if those other tests were before or after her vaccines. The outcome of event was recovered on an unspecified date in 2021.  Information on the lot/batch number has been requested.
COVID breakthrough; COVID breakthrough; migraine; This is a solicited report received from a contactable consumer (patient) based on the information received by Pfizer from. (Mfr. Control No. :21K-163-4064367-00).   A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), intramuscular on an unspecified date (at an unspecified age) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported), at citrate free for moderate to severe pediatric Crohn's. The patient medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient experienced COVID breakthrough on 2021, migraine on 2021. The patient underwent lab tests and procedures which included Covid-19: positive on 2021. The action taken in response to the events for adalimumab was unknown. The outcome of event COVID breakthrough was recovering, outcome of event migraine was recovered in 2021.  Causality for BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE): The reporter's causality for the event of migraines and COVID breakthrough with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was possible. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event of migraines and COVID breakthrough with HUMIRA (adalimumab) was no reasonable possibility.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be completely excluded.
This is a spontaneous report from a contactable nurse (other health care professional (HCP)) via medical information team. A 41-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced some numbness/burning sensation in his right foot on the same side where he got the vaccine on an unspecified date. It happened dozens of time and lasts for 10-15 seconds. It's a warm burning sensation and occurred 10 days of post vaccination. It was reported to the nurse that the patient should not get the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) if he had a severe allergic reaction after a previous dose of the vaccine or to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by the company. It was advised to use the clinical judgement as the company cannot provide individual recommendation. The outcome of these events was unknown at the reporting time.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Hives or red swollen itchy rash developed on torso and genitals. First appeared one week after shot and is still present today, 8 days after it appeared. Doctor prescribed hydroxyzine and it seems to be helping after taking it for 2 days. But the hives/rash is still present. Very itchy.  Makes me very worried about getting a second dose and would rather not do it
Upon date of injection 11/3 had no adverse effects at injection site, but same day within 3 hrs had severe Cramping in Right Trapezius.   Had no adverse effects other than malaise & general overall Muscular & Joint aches for next 3 -5 days with constant cramping still within Right Trapezius. Between the 5th -10th day started having increased muscular cramping with contractures throughout the body primarily Left Buttocks & Right Calf as well as increased severe Joint Pain with swelling in fingers, feet, both knees (right worse), Elbows, and Shoulders.  Progressively getting worse prompting a MD visit on 11/ 18 and a follow up  12/14 with another scheduled for 1/6.
Muscle fatigue; loss of smell; dry mouth; felt wobbly; chills; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCLE FATIGUE (Muscle fatigue), ANOSMIA (loss of smell), DRY MOUTH (dry mouth), FEELING ABNORMAL (felt wobbly) and CHILLS (chills) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Muscle damage. Concomitant products included MELOXICAM for Muscle damage.    In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE FATIGUE (Muscle fatigue), ANOSMIA (loss of smell), DRY MOUTH (dry mouth), FEELING ABNORMAL (felt wobbly) and CHILLS (chills). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, MUSCLE FATIGUE (Muscle fatigue), ANOSMIA (loss of smell), DRY MOUTH (dry mouth), FEELING ABNORMAL (felt wobbly) and CHILLS (chills) outcome was unknown. Not Provided      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.
This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a female patient who received ENGERIX B. Co-suspect products included ENGERIX B, ENGERIX B and ENGERIX B. On an unknown date, the patient received the 1st dose of ENGERIX B, the 2nd dose of ENGERIX B, the 3rd dose of ENGERIX B and the 4th dose of ENGERIX B. On an unknown date, unknown after receiving ENGERIX B, ENGERIX B and ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B, ENGERIX B, ENGERIX B and ENGERIX B. Additional details were reported as follows: The age at vaccination was not reported. The patient had received 4 doses of ENGERIX-B, and still did not have an adequate response. The healthcare professional (HCP) had limited data about the patient. The HCP had no data on lot number or expiry date of the vaccine.
soreness at injection site (left arm); This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number L7SY9, expiry date 4th July 2021) for prophylaxis.   On 4th March 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient received the first of the Shingrix in their left arm and had a injection site sore for a couple of days and then resolved. The batch number reported for Shingrix(L7SYN) did not exist and was updated to L7SY9, as per sales database. The reporter was unable to provide any additional information. This case has been linked with case US2019125917, reported by the same reporter.
Did make his lungs bleed a little bit; lethargic; Severe panic anxiety and panic attacks; Severe panic anxiety and panic attacks; This spontaneous case was reported by a consumer and describes the occurrence of LUNG DISORDER (Did make his lungs bleed a little bit), LETHARGY (lethargic), ANXIETY (Severe panic anxiety and panic attacks) and PANIC ATTACK (Severe panic anxiety and panic attacks) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 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 LUNG DISORDER (Did make his lungs bleed a little bit), LETHARGY (lethargic), ANXIETY (Severe panic anxiety and panic attacks) and PANIC ATTACK (Severe panic anxiety and panic attacks). At the time of the report, LUNG DISORDER (Did make his lungs bleed a little bit), LETHARGY (lethargic), ANXIETY (Severe panic anxiety and panic attacks) and PANIC ATTACK (Severe panic anxiety and panic attacks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided. Patient has been not taking high blood pressure pills anymore.
This spontaneous report as received from a Nurse refers to multiple unspecified patients. On unknown dates the patients were vaccinated with improperly stored M-M-R II (lot number, expiration date, dose and route unknown) for prophylaxis. No adverse effects reported. The vaccine was exposed to 47 Fahrenheit (F) to 77 F (47.5F) for 888 hours. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010403: US-009507513-1708USA010402: US-009507513-1708USA010320: US-009507513-1708USA010401:
pt recv vax; aching all over, joints sore, rash - blanches to pressure; sores in mouth
Patient had worsening of symptoms of muscle ache, back pain, tingling of fingers and toes, lethary on 12/25/09.  According to patient's mother, the patient had been weak and achy for several weeks preceding 12/25/09.  Patient was unable to be interviewed for more precise history.
Fever, muscle aches, HA, diarrhea, lightheadedness, fainted and disoriented.
Mother reports on 3/15/23 @ 1112 is not with pt at present, kept her home from school today, pt began c/o pain/numbess to right arm  and inj site yesterday- numbness has resolved, now c/o of being dizzy, fatigued, "doesn't feel right", mother reports inj site looks like a red bug bite DENIES: streaking, swelling, drainage, inj site feeling hot, fever, swelling to lips/nose/mouth/tongue, drooling, chest pain, shortness of breath, difficulty breathing, itching, numbness, tingling, turning blue.   Per Dr. 3/15/2023 @ 4:30ASSESSMENT & PLAN   1. Vaccine reaction, initial encounter  To continue using ibuprofen for pain.  Cool compresses to reduce the swelling. Return to clinic if symptoms persist  M.D.
Patient's daughter reports that the patient developed "chicken pox" within 3 days of receiving the vaccine. She also stated that the patient later developed viral meningitis as a directed result of the vaccine.
01/27/2021 I felt dizzy, I had a headache, around the afternoon around 4, I felt short of breath, tightness in chest, maybe around 6pm I started feeling my heart racing and I could feel abnormal heart rate, my pulse 180, my watch does an EKG and I did one and it said irregular heart rate possible Afib, seek medical care, went to ER.  Saw cardiologist for an echo and it was okay. By the 28th of Jan I was fully recovered
25 year old / pediatric dose of Havrix; 25 year old / pediatric dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 25-year-old female patient who received HAV (Havrix pediatric) (batch number Y4FL4, expiry date 28th January 2022) for prophylaxis.   On 7th December 2020, the patient received the 1st dose of Havrix pediatric .5 ml. On 7th December 2020, unknown after receiving Havrix pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were reported as follows: The nurse practitioner reported that the patient was administered Havrix pediatric dose, which led to unerdose and adult use of a child product. No symptoms reported. The reporter consented to follow up. The reported batch number Y4SL4 for Havrix pediatric did not exist and was updated to Y4FL4 as per the sales database.   Follow up information was provided by nurse on 29th March 2021: The patient demographic details were updated. The VAERS details were updated. The reporter stated that no adverse effects were seen and the wrong vaccination given was discovered during billing process. Then the patient received correct dose of Havrix adult.
About 45 mins post vax, pt became nauseated, vomiting, chilling perspiring, anxious and pale. Symptoms continued with no decrease or increase. Adrenaline was given, anxiety decreased, nausea and vomiting, chilling decreased. Color and strength returned. Pt had not eaten breakfast. Recommended she consult her private health care provider. Family member called.
Began w/elevated temp on Friday evening @ 101 then temp to 104; pt given APAP Q 4 hrs;
Erythema and edema at injection site 8 hours after administration. Fever of 103 degrees F. Hydrocortisone 1% cream bid prn.
Swollen and painful deltoid muscle (expected). On next morning redness developed - biceps muscle to elbow. Nurse noticed it and thought it was cellulitis. Went to hospital Urgent Care Center. Received intramuscular antibiotic and RX for cephalexin 500 mg for 10 days.
cried for 4 1/2hr p/vax, up during noc crying, fussy in AM day p/shot;