chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately eight days following the Moderna injection, my arm at the injection site was itchy, then became red and blotchy and warm to the touch. Over the next several days it?s spread to my elbow. After approximately four days the symptoms went away
Gardasil 9 : IM in L deltoid. Pt initially tolerated well. She went to stand after remaining seated for 1-2 minutes. While getting ready to leave, standing and talking, she started to feel faint. The color drained from her face, and she was helped to a chair by this RN, and her mother.  A Cool cloth was applied to her neck, and she was given some cool water to sip on. She did not have complete LOC but was diaphoretic and shaky. Once she was stable enough to move to the bed, She felt she wanted to lay down, her mother and I helped her to lay down on the exam table. Pulse remained stable, at 80 and she layed flat for approximately 5 minutes. She said she was feeling better and was helped a seated position. All symptoms resolved, color had returned to her face, and she felt ready to leave the office.
Nausea on 1/19.  Awoke on 1/20 with extreme muscle aches and fatigue, more nausea in evening, fatigue,.  Got up on 1/21 still slightly achy but headache all day.       Slept a great deal and took advil.
Local inflammation with large, hot induration measering 4cmx9cm. Received second dose elsewhere on 09/03/2021 (Lot FA7485 Exp. 10/1/2021) and reports a similar reaction with the second dose. Resolved without treatment. Developed shingles a week after second dose.
Arm red and hot to touch at the injection sight. Told the patient to ice his arm and take BENADRYL. If no improvement, I advised patient to seek medical attention.
This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 73-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. Concurrent medical conditions included myasthenia gravis. On 1st December 2021, the patient received the 1st dose of Menveo. On 1st December 2021, unknown after receiving Menveo, the patient experienced inappropriate age at vaccine administration. The patient was treated with eculizumab (Soliris). On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional details were provided as follows: This case was reported by the patient's wife. The reporter stated that the 73 year old patient received dose of Menveo, which led to inappropriate age at vaccine administration. The reporter stated that he needs a booster and it was scheduled for 26th January 2022, and asked was that the appropriate time frame or should it be 1st February 2022. The Menveo was a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. The Menveo was approved for use in persons aged 2 months through 55 years and a single booster dose of Menveo may be administered to individuals aged 15 through 55 years who were at continued risk for meningococcal disease if at least 4 years have elapsed since a prior dose of a meningococcal (serogroups A, C, Y, W-135) conjugate vaccine. The reporter stated that the patient was taking the drug Soliris and needs to get the vaccine as he was 1000 to 2000 times more likely to get meningitis. The follow-up would not possible as no contact details were available.
flu like symptoms; severe stomach pain; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 2AH5M, expiry date 18th May 2021) for prophylaxis.   On 28th March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms and stomach pain. On an unknown date, the outcome of the influenza-like symptoms and stomach pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms and stomach pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that, after vaccination with Shingrix, the patient experienced flu like symptoms and severe stomach pain.
body chills; This is a spontaneous report from a contactable consumer.  A 41-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration in the left arm on 09Feb2021 at 41-years-old at a single dose for COVID-19 immunization; administered in a nursing home (workplace).  The patient medical history was not reported.  There were no concomitant medications. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on 19Jan2021.  On 10Feb2021, the patient experienced body chills (non-serious); with no treatment received.  The clinical outcome of the event was not recovered.
Red, itching, swollen rash on left arm, that is spreading.  Pt instructed to take Benadryl.
6 x 8 cm swelling and redness, left upper deltoid, site of injections 2 d before.
Known allergies to Phenergan.  Pt c/o dizziness 10 minutes after receiving the Moderna vaccine. Says she had similar reaction after receiving Shingrix over a month ago.   No swelling, hives, shortness of breath, palpitations.   Pt reports only minimal coffee and water taken before the vaccine.   O: NAD, breathing free and easy. Skin without rash.   BP at 10:27 am 149/89 Oxygen at 99% HR 82 RR 20   At 10:35 am BP 132/74 99% O2 68 pulse 20 RR   Pt says she feels better after drinking water and resting. Says she is ready to leave and feels fine to drive home.   Pt is okay to have second COVID 19 vaccine as this was NOT an allergic reaction but vasovagal response.
Mother called to let a nurse know that 11 days after receiving varicella, pt had an allergic reaction. Client had also been on "OMNISEF" for an ear infection. Parent took the child to the ER because hands, ears and feet became swollen. MD unsure if it's related to vaccine or antibiotic.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 20-FEB-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
lethargy; Fever; chills; body aches; This is a spontaneous report from a non-contactable consumer. A 36-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on his left arm, via an unspecified route of administration on 27Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced Fever, chills, body aches, lethargy; all on 28Dec2020. No treatment was received for the events. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a registered nurse through a pregnancy registry concerning an otherwise healthy 38 year old white female patient with insulin dependent diabetes, who on 5/5/03 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included insulin lispro and prenatal vitamins for one year; also reported as from 4/03 until 1/04. The patient's last menstrual period was 4/30/03. It was noted the patient's beta human gonadoptropin chorionic level was 9998, and her HgbA1c was 7.1. Product quality complaint was not included. Follow up information indicated that the woman had no previous pregnancies. An ultrasound obtained on 1/26/03 indicated +FHA (normal). There as no local reaction at the vaccination site. There was no varicella symptoms post vaccination. There was no herpes zoster symptoms post vaccination. Additional follow up information received from a registered nurse on 2/27/04 indicated that the patient was referred to the office because of complications (type of complications was not specified). Additional follow up information received from a registered nurse on 3/2/04 indicated that it was unknown if there was a local reaction at the vaccination site, and it was unknown if the patient had varicella or herpes zoster symptoms post vaccination. The mother had no previous pregnancies, and no birth defects or stillbirth or miscarriage occurred in the previous pregnancy. The infant was born on 1/14/04, 37 weeks from the mother's LMP. The infant was a normal female weighing 6 pounds 6 ounces. Complications included a posterior cerebral bleed. During labor, the infant had CANx2 (cord around neck x2) and cephalohematoma. There were no infections or illnesses during pregnancy. During pregnancy, the mother used amoxicillin 250mg TID on 12/24/03 and metronidazole Q HS in 12/03. Upon internal review, posterior cerebral bleed was considered to be an other important medical event (OMIC). Unspecified medical attention was sought. No further information is expected.
chilled; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, UNKNOWN MANUFACTURER), for covid-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chilled". Therapeutic measures were taken as a result of chills.  Additional information: The patient spouse reported that her husband was chilled after his vaccine but she doesn't even know what Covid 19 vaccine he received. She covered him with a blanket and sat him on the heating pad. It was his second vaccine.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
kicked her butt; This case was reported by a pharmacist and described the occurrence of feeling unwell in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's pharmacy friend. The patient born about in 1966. The age at vaccination was not reported. The patient received Shingrix in year 2020. The reporter stated that the 2nd dose of Shingrix kicked the patient's butt. The reporter consented to follow up. No further information available but agreeable to contact by email. This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020246485:same reporter US-GLAXOSMITHKLINE-US2020246486:same reporter
Uncontrollable shaking, loss of balance, total body discomfort, inability to sleep or do daily tasks, total feeling of absolute sickness so severe that I thought I was going to die. This lasted for 2 days from April 17 thru April 19, 2021
fever 102.9 R given APAP & tub sponge bath; also limp for few minutes seen by MD who stated not due to shot but no infection;
Patient had a shoulder pain 8 hours after vaccination. Patient experienced tendonitis and bursitis. She is being treated according to her.
Hives in local area and down arm to finger tips and on neck and shoulder.  Itching.
Diarrhea and lethargic Wednesday night 10/9/13 then emesis after only 2 oz. of formula and lethargic Thursday 10/10/13. Was seen by Dr. 10:00a.m. was prescribed medication for emesis and Pedialyte.  Was not better within 2 hours so was addmited into the hospital.
grandma was holding pt approx 1030AM head went forward, eyes rolled around, pale & was limp; episode lasted 45 sec; apparent sz;
not feeling great; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "not feeling great".  The patient (a teacher) sent a group communication to parents stating that she would not be in class today because she received her 2nd dose of Pfizer vaccine and was "not feeling great this morning.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
He already had 5 doses of Pfizer COVID vaccines. He has Parkinsons; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 75-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer covid vaccine (Dose 1, single), for COVID-19 immunisation; Pfizer covid vaccine (Dose 2, single), for COVID-19 immunisation; Pfizer covid vaccine (Dose 3, single), for COVID-19 immunisation; Pfizer covid vaccine (Dose 4, single), for COVID-19 immunisation. The following information was reported: PARKINSON'S DISEASE (medically significant), outcome "unknown", described as "He already had 5 doses of Pfizer COVID vaccines. He has Parkinsons".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme arm/muscle pain from shoulder to wrist beginning a few hours after the injection.  Not typical injection site pain.  The extreme arm pain lasted at least 2 weeks resulting in a decrease in range of motion of the arm.  As of today (more than a month after injection given), pain and soreness still present limiting full arm mobility.  Ultrasound treatments recommended but did not result in improvement.
PAIN, ITCHING, REDNESS, SWELLING, MUSCLE SPASMS, NAUSEA, LIGHTHEADED w/WALKING, LOSS OF APPETITE.
Nurse put vaccine/syringe (vanish point) into the patients arm, when needle disappeared some of the vaccine dripped down the patients arm. Unable to determine how much of vaccine went into the arm. Patient educated that we could not give another vaccine bc that may give hime too much vaccine at one time. Patient very understanding and verbalized understanding. Patient will return for 2nd dose in May.
Encephalitis; This case was reported by a pharmacist via call center representative and described the occurrence of encephalitis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced encephalitis (serious criteria GSK medically significant). On an unknown date, the outcome of the encephalitis was unknown.   It was unknown if the reporter considered the encephalitis to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per the vaccine indication. The patient received 1st dose of Shingrix a week prior to date of reporting and experienced encephalitis symptoms. The reporter did not consent to follow up.
SEVERE FATIGUE, BODY ACHES, LOSS OF INEREST IN ANYTHING, EXTREME BACK PAIN, RESTLESS LEGS,
After about 3 days, patient had vomiting and diarrhea, body aches, sore throat. This progressed to severe joint pain, muscle pain resembling an arthritis flare. Weak hands, difficulty walking.  Large red, swollen area where shot was injected was still visible 10-14 days after shot. It did turn white in the middle.  Currently patient still doesn't have full range of motion in left shoulder.
Information has been received from a health professional concerning a 34 or 25 week old patient received a third dose of Rotateq. No adverse experience was related to that event. A product quality complaint was not reported. Further information was not available. Additional information has been requested.
PT STATED HAVING A SPIKE IN HER BLOOD SUGARS (>500) ROUGHLY 24 HOURS AFTER HER 2ND DOSE OF COVID VACCINE.  PT STATED IT WAS VERY UNUSUAL FOR HER BLOOD SUGARS TO SPIKE THAT HIGH AND HAS HAD NO RECENT HISTORY OF A BLOOD SUGAR THAT HIGH.
This spontaneous report was received from a nurse and refers to unspecified patients of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 21-DEC-2015, the patients were vaccinated with improperly stored doses of VAQTA lot # L018499, expiration date 25-FEB-2017 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 11Mar2021 as dose 2, single (Lot number: EN6208), in left arm and on 24Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 24 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ovarian cysts" (unspecified if ongoing), notes: Other medical history: ovarian cysts; "Known allergies: raisins" (unspecified if ongoing); "Known allergies: Sulfa antibiotics" (unspecified if ongoing), notes: Known allergies: Sulfa antibiotics; "Birth Control" (unspecified if ongoing). Concomitant medication(s) and other medications in 2 weeks included: ESCITALOPRAM; VITAMIN D NOS; APRI taken for contraception; ALLEGRA. Past drug history included: Omnicef, reaction(s): "Known allergies: omnicef", notes: Known allergies: omnicef. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: COVID-19: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. COVID-19 Treatment with Paxlovid, started on 26Jun2022.  No follow-up attempts are possible. No further information is expected.
Case number PHEH2015US022675 is an initial spontaneous report received from a pharmacist on 28 Oct 2015. This report refers to a 52 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) multi dose vial (MDV) on 28 Oct 2015. It was reported that the vaccine administered was pre-drawn into a syringe from multi dose vial for 10 days and held at proper temperature. No adverse events were reported following the maladministration.
shakiness, dizziness, vomiting, muscle weakness, vertigo, difficulty walking, difficulty raising the left foot, muscle aches, fast heartbeat
Patient was received by the nurses in the observation area at 10:58. Pt reports feeling dizzy and anxious. The vital signs were taken  by the nurse. Pt provided with water and asked to stay longer in the observation until she reports not feeling dizzy anymore. At 11.30 am the pt reports generalized itching with increased anxiety. She showed redness and increased itching on her body. Ice packs were applied.  VS were taken and patient was administered 0.5ml/25mg Benadryl IM to right deltoid. Patient reported feeling better and decrease in itching at 12.01 pm. Patient was monitored and released at 12.17 pm. Reported no more itching and dizziness.  3 rd vital signs obtained.
Severe fatigue the day after receiving vaccine Severe nausea, severe stomach pain,  moderate diarrhea, mild vomiting exactly 36 hours post-dose, lasted approximately 36 hours. Diarrhea and vomiting dissipated after 12 hours, stomach pain continued for approx 36 hours
5/21/04 pt has mild case of chickenpox. No fever. 8-12 lesions on torso. Pt. feels well.
Pt reported feeling anxious prior to getting the vaccination. She reported that after the vaccination she continued to feel anxious, dizzy, and lightheadedness. She reported feeling well after 30 minutes. Patient felt better, left site.
Pt had DTaP, INFLUENZA, pneumococcal, polio vaccine on 8/9/12. 36 hrs later pt broke out in itchy rash starting on chest, spreading to face, arms, back.
Developed a severe migraine about 7 days after receiving shot. Migraine has persisted despite multiple treatment attempts. Patient has thrown up and lost 10 pounds due to the severity of migraine and has only been able to work about 3 days since she received  her vaccine. Patient medicated with advil so much that she ended up with a stomach ulcer. Provider has tried toradol, nurtec, dicyclomine and patient is currently on emgality 120mg, zofran 8mg and omeprazole 40mg.
1st dose Aug2019, 2nd Aug2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2019).   In August 2022, the patient received the 2nd dose of Shingrix. In August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 18-OCT-2022 Reporter's Comments: The pharmacist reported that the patient received second dose of Shingrix in August 2022. The reporter reported that two patients were relatives (reporter´s parents) who received Shingrix the same month. The reporter consented to follow up. Additional Supportive Information: The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. This case was one of the 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022149871:Same reporter
shrill high pitched "terror" scream off & on for 3 days; very miserable; needed held 3 hrs; family MD ordered ped DT;
pain in back, knees, elbows, behind eyes. improved over the next 9 days but not completely resolved.
area on my arm where I had the injection hurts sometimes/My husband gets the same feeling sometimes where he got his vaccine; This is a spontaneous report received from a contactable reporter (consumer).  A male 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "area on my arm where I had the injection hurts sometimes/My husband gets the same feeling sometimes where he got his vaccine".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100950817 same reporter/drug/event, different patient