chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy area on her hip and scratched it; had a small abrasion on her hip; had a small abrasion on her hip; This is a spontaneous report from a Pfizer-sponsored program  Support via contactable other hcp (retired nurse) (patient). An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 80-year-old), dose 1 via an unspecified route of administration on 25Feb2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. About a week ago, on an unspecified date, she had an itchy area on her hip and scratched it. It was a small abrasion and applied cream, but it never bled and had no discharge and it had a thin scab on it now. She used Voltaren ointment and used it in the area and her skin reacts to everything. She was not concerned that it was an allergic reaction to the vaccine, she was just concerned that she had this abrasion. She was wondering if for some reason she would be unable to get the second vaccine. She had read all the information that came with the vaccine and saw nothing about this. She had a call in to her doctor, too. Caller was asking if she would be to take the second dose. Creating an AE Form since the caller second dose was more than 21 days on and second dose on 25Mar2021. Therapeutic measures were taken as a result of had a small abrasion on her hip. The clinical outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Large rash 20cm right arm, fevers, chills, nausea, vomiting.
the left side of my face and neck broke out in a rash/hives; the left side of my face and neck broke out in a rash/hives; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient (Non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: Ew0170), dose 1 via an unspecified route of administration, administered in Arm Left on 19Apr2021 at 16:00 (at the age of 43-years-old) as DOSE 1, SINGLE for covid-19 immunisation at Doctor's office/urgent care. The patient medical history included crohns and pyoderma gangrenosum. Concomitant medications received within two weeks included adalimumab (HUMIRA). The patient previously took infliximab (REMICADE) and experienced drug allergy. No other vaccine was administered in four weeks. The patient did not have covid prior vaccination. The patient reported that the left side of my face and neck broke out in a rash/hives on 25Apr2021. Patient reported that, one week after I got my first vaccine show on 19Apr, and the day after I did my humira injection, the left side of my face and neck broke out in a rash/hives. It was milder the first shot and resolved in about of week. The patient underwent lab tests and procedures which included sars-cov-2 test that was negative on 07Jul2021. It was reported that, Patient tested for covid post vaccination with Nasal Swab on 07Jul2021 that was Negative. Therapeutic measures were taken as a result of the left side of my face and neck broke out in a rash. Event resulted in the Doctor or other healthcare professional office/clinic visit. Event received treatment with Cream for the rash. The Outcome of the events was resolving.
Unable to walk/he patient developed a serious cannot walk yet without walker.; This spontaneous report was received from a consumer, via Sanofi, and refers to a male patient who would be 76-years-old at the time of this report. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions, or allergies.  On an unknown date, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) as prophylactic vaccination (prophylaxis) (concentration, dose number, vaccination scheme frequency, route and anatomical site of administration, lot number and expiration date were not provided).  On an unspecified date, the patient was vaccinated with a dose of influenza vaccine inact split 3v (FLUZONE HIGH DOSE) suspension for injection in pre-filled syringe as prophylactic vaccination (concentration, dose number, vaccination scheme frequency, route and anatomical site of administration, lot number and expiration date were not provided).  On an unknown date, he was also vaccinated with a dose of influenza vaccine inact sag 3v (FLUVIRINE) as prophylactic vaccination (concentration, dose number, vaccination scheme frequency, route and anatomical site of administration, lot number and expiration date were not provided).  On an unspecified date, the patient experienced (reported as "developed") been unable to walk yet without a walker (Gait inability).   If any lab diagnostics or studies were performed this information was not provided. Additionally, it was not reported if the patient received a corrective treatment for the events.  The outcome of the event was unknown. The causal relationship between zoster vaccine live (ZOSTAVAX) and the event was not reported. Information regarding the other suspect vaccines also was not provided.  Gait inability was considered to be medically significant that leaded to disability by the reporter.
Mother of the minor refers that in the early morning of 2/7/2020, the minor presented rash on the entire body and was taken to the Emergency Room at Hospital
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Additional Details: Patient came to the pharmacy and received both flu and moderna vaccines. While patient was waiting after vaccination, she became unresponsive for less than a minute upon which I intervened. Patient said she was hung over from drinking alcohol. Epipen was not administered because she regained consciousness as sson as I got to the vaccination area and she refused epipen.
Very hard, hot, painful, red lump and area on skin that has increased in size over two days.  Fever of 101.5. Nausea, fatigue, chills, lethargy.
got influenza B; Initial information was received on 23-Jan-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a male patient (age not reported) who got influenza B, while he received INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date (2 years ago), the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious influenza B (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  According to patient's grandparent, he received only flu shots for the most prevalent type of flu that year. They did NOT inoculate for influenza B 2 years ago.   It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the event.  There will be no information on batch number for this case.
Localized erythema from deltoid to elbow on left lateral arm with localized tenderness.
Within a day of first dose I had a large red welt at injection site which was gone by day 5. At day 8 the red welt returned with raised borders and was itchy and was gone by day 12. At day 14 the red welt returned even bigger (8 cm x 9 cm) and more raised. By day 20 it was also gone. I notified my healthcare provider with no treatment other than topical steroid cream. After the second dose (in the opposite arm) I immediately began to notice a red welt and within 24 hours found that I had  a red welt that was 10 cm x 12 cm  covered with dozens of small blisters. Notified my HCP who advised cortisone cream, Zyrtec or Claritin, and cool compresses. Within a week they were gone but the red faded over several weeks.
15JAN97 10:50 c/o weakness & not feeling well;skin diaphoretic w/shallow color, pt trembling;BP 82/40, AP 65, R16;tx shock;pt placed w/legs inc, warmed w/a blanket;BP, pulse monitored;BP 104/66, AHR 88;12:15 T101.4, BP 102/58;
Left arm cellulitis, red, swelling, warm to touch, Rx with Abx, ice, NSAIDS. 5/27 - Sx resolved per phone conversation with pt. Redness and swelling decreased 24 hours after starting AB.
Chills; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Hypertension and Blood pressure. Concomitant products included INSULIN for Diabetes, CYANOCOBALAMIN (VITAMIN B-12) and IBUPROFEN (ADVIL 12 HOUR) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
FELT BAD; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (FELT BAD) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, Solution for injection in pre-filled pen and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced FEELING ABNORMAL (FELT BAD). At the time of the report, FEELING ABNORMAL (FELT BAD) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  The reporters causality for the events of FELT BAD was not provided.  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Administered without antigen; Administered without antigen; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 9DM72, expiry date 28th January 2023) and (batch number 3N3GH, expiry date 28th January 2023) for prophylaxis.   On 10th September 2021, the patient received the 2nd dose of Shingrix (intramuscular) 1 ml. On an unknown date, the dose was an unknown dose. On 10th September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient was administered 1 ml of adjuvant in the left deltoid. The medical assistant reported that, 2 vials of Shingrix adjuvant (batch number 3N3GH) were administered to the patient without active component (antigen), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter gave a consent to follow-up with health care professional office.
Information has been received from a physician concerning a 5 year old pt who on 06/08/1996 was vaccinated with a dose of varicella virus vaccine live. On 03/29/2000 the pt experienced a case of breakthrough varicella. There were less than 50 lesions. Unspecified medical attention was sought, but there was no tx and no hospitalization. The pt recovered. No product quality complaint was involved. This is one pt out of 40 reported. Thirty nine other  cases (WAES 0407USA01446 and 0409USA01855 through 0409USA01880 and 0409USA01880 and 0409USA01882 through 0409USA01893) experienced breakthrough varicella after vaccination with varicella virus vacciene live. Additional information is not expected.
Complained of tongue feeling thick and numbness right side of face 30 minutes after vaccine was given. No SOB, or distress. Alert and oriented. VS:@1122:P=72,R=24,B/P=125/80    @1133:P=88,R=18,B/P=132/80    @1148: P=78; RR=18; B/P=124/80    @1203: P=70; RR=19, B/P=102/60 Epi 1:1000 .75mg intramuscular to Left arm @11:25
1/29/21 4:26p received 2nd vaccine                      8:10p became extremely tired 1/30/21 awoke to low grade temp, pain, swelling, red injection site, headache; rest of the day tiredness, chills, muscle & joint pain, nausea. Taking Tylenol for pain 1/31/21 awoke to low grade temp, tiredness and enlarged right under arm lymph node, size of an egg, very sore, injection site remains red, tender to touch and swollen, taking Tylenol for pain As of 12:49p no temp
recvd vax 20MAR95 & devel inconsolable crying, fever 102 & tender red area in rt thigh that evening; seen 21MAR in ofc-8cm diameter red, warm area w/surrounding bruise on rt thigh; rt inj site rx w/Ibuprofen & heat
Seen at Medical Center ER on the evening of 9/23/15 with stomach pain, nausea and diarrhea. Eval from ER was normal. Was given a prescription for ZOFRAN and CULTURELLE. Recheck visit at PCP's office on 9-24-15 was normal.
Discoloration, edema of inject site; MD dx local cellulitis per parent's report;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 17-NOV-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K011562, expiry date: 08-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On the following below listed dates multiple unspecified patients were vaccinated with improperly stored ROTATEQ lot # L027719 expiry date of 28-APR-2017 and L035276 expiry date 09-JUN-2017. On 09-FEB-2016 and 13-FEB-2016 the ROTATEQ, was exposed to a lowest temperature of + 1.0 degree Centigrade for 29 minutes and 30 minutes respectively. On 10-FEB-2016, 11-FEB-2016, 14-FEB-2016 and 16-FEB-2016, ROTATEQ, was exposed to a lowest temperature of + 1.2 degree Centigrade for 25 minutes, 22 minutes, 24 minutes and 34 minutes respectively. On 12-FEB-2016, ROTATEQ, was exposed temperature of + 1.3 degree Centigrade for 21 minutes. On 15-FEB-2016, ROTATEQ, was exposed to a lowest temperature of + 1.1 degree Centigrade for 25 minutes. On 17-FEB-2016, ROTATEQ, was exposed temperature of + 0.0 degree Centigrade duration not reported. On 18-FEB-2016 ROTATEQ, was exposed to a lowest temperature of - 1.0 degree Centigrade for 12 hours 29 minutes. On 19-FEB-2016, ROTATEQ, was exposed to a lowest temperature of - 1.1 degree Centigrade for 12 hours 1 minute. Also reported that the vaccine was administered on an unspecified date from 20-FEB-2016 to 29-FEB-2016. On an unknown date the patients were vaccinated with improperly stored ROTATEQ, lot # L027719 with an expiry date of 09-JUN-2017, (incorrect product storage). Dosing details were not provided. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Moderna Covid-19 vaccine was administer to 17 year old patient which lies outside age group per CDC guidelines.
painful lump, that holds a magnet to the skin, at the injection site. swollen mass in the left armpit. Lymph node is swollen in the left armpit.
No adverse event; Administered Moderna vaccine for 6 months to 5 year to a patient  greater than 5 year old / dosage given was 0.5 mL; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Administered Moderna vaccine for 6 months to 5 year to a patient  greater than 5 year old / dosage given was 0.5 mL) and NO ADVERSE EVENT (No adverse event) in a 9-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Administered Moderna vaccine for 6 months to 5 year to a patient  greater than 5 year old / dosage given was 0.5 mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Administered Moderna vaccine for 6 months to 5 year to a patient  greater than 5 year old / dosage given was 0.5 mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Administered Moderna vaccine for 6 months to 5 year to a patient  greater than 5 year old / dosage given was 0.5 mL).    No concomitant medications were provided by the reporter.  It was reported that nurse administered the Moderna COVID-19 vaccine for 6 months to 5 year to a patient greater than 5 year old. The wrong product was administered but the correct dosage was given to patient (0.5 mL).  Patient had not reported any adverse reactions to the dose.  No treatment medications were provided by the reporter.
Pt developed induration, erythema and warmth about the size of a 50 cent piece.
Patient had an episode of syncope and became unresponsive  within  a few minutes patient was able to communicate . Assessment done vital signs taken , 1rst BP 192/102 ,Sat 100 % @RA,HR  99, Resp 20   ,2nd set of Vital BP 114/91 ,HR 89, Sat 100 % RA RESP 20. 911  called patient assessed by the paramedic and refused to go to the hospital stating "I'm doing great I feel better".
Patient went to hospital because Heart doctor thought the pain in his arm might be his heart but they have decided that the needle might have hit the auxiliary nerve.
patient was feeling short of breath starting the night of and for 2 days after. He was having  chest tightness which led him to going to the hospital, they ran several tests and stated he had inflammation around his lung consistent with side effects from the vaccine.
This spontaneous report as received from a 50 year old male patient refers to himself. The patient's medical history was not reported. On 24-MAR-2017, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous (lot # and dose were not reported) for prophylaxis. Concomitant therapies included LIPITOR. On 27-MAR-2017, the patient experienced diarrhoea and chills. He took "PEPTO BISMOL tablets" for 2 days as treatment and recovered on 29-MAR-2017. The patient did not seek medical attention. He considered diarrhoea and chills to be related to ZOSTAVAX. Additional information has been requested.
Noticable swelling and erythma, edema, Induration around site of injection. Pt's left arm. Tricep area
Patient is a very pleasant 58-year-old female who comes in with complaint of pain" all her joints."  She states symptoms began about 3 days after she had her first Covid vaccine.  She complains of a slight sore throat which she describes as "more irritated and sore."  She has no fevers no chills no sweating.  She states that she feels that her right ear is "harder to get a Q-tip in" than the left but denies any ear pain. Review of Systems  Constitutional: Negative for activity change, appetite change, chills and fever.
Pt. arrived for first Pfizer vaccine, pt. alerted staff to anaphylaxis risk to bees and trees but stated she has never had an adverse reaction to vaccinations. Pt. has not used her epi pen in 10 years. Approx 10 minutes into observation pt. complains of lip tingling, swollen lips and states "half of face is swollen". EMS contacted and vital signs stable except for elevated blood pressure.  Pt. given 25mg Benadryl and water. Second dose of Benadryl 25mg given at 1733. Pt. educated to seek medical attention if reaction increases. Cleared by EMS, pt. exited facility in stable condition with partner.
husband got the vax and then got Shingles/ suspected vaccination failure; now has them, shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's husband. The age at vaccination was not reported. The patient got the Shingles shot to not get Shingles, and now had them. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available. This case was linked with US2022AMR010989, reported by the same reporter.
With booster on 11/01/21 had booster and after 1 hour lip swelling and hand/tingling. Went to health department and given an epipen and felt better. Arm pain at injection site and radiates up to the neck and gets worse, has decreased/limited range of motion and stiffness. Prescribed ibuprofen 800 mg and cyclobenzaprine for ongoing muscle spasm/inflammation following vacaine.
approx 3 hrs p/inject pt was in playpen lips white & temp inc acting as though gasping for breath brought back to office t103.2 & pale; MD advised no further pertussis;
Child cranky, flailing arms & legs - tantrums NOT eating well Frequent staring episodes. Referred to Neurology
Patient is 12 and received the pediatric dose of 0.2 instead of the 0.3
Moderna arm- rash, redness and itching near site of injection, Fatigue and bodyache, Swollen and painful lymph nodes in armpit
Redness, swelling, warmth, pain, and itching noted at injection site starting a little more than a week after injection. Lasted 10 days. Pain bad enough to wake me from sleep. Called my doctor, had televisit. She recommended antihistamine and ibuprofen. It resolved in another week or so. My doc counseled me that this reaction was not a reason not to get my next dose.