chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PAIN IN FINGERS; FEVER; This spontaneous report received from a patient via other manufacturer (AbbVie) concerned a 58 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis, and other pre-existing medical conditions included: There was no reported medical history. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 58 years old. No concomitant medications were reported. The patient received non-company suspect drug: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis.  On an unspecified date in 2021, the patient experienced fever (covid vaccine issue low grade temperature) (dose number in series 1). On an unspecified date, the patient experienced pain in fingers (dose number in series 1). The patient received additional dose of non-company suspect vaccine: Moderna covid-19 vaccine (Elasomeran) (dose number in series 2) (form of admin unknown, intramuscular, batch number was not reported) dose was not reported, administered on 23-NOV-2021 for prophylactic vaccination.  On an unspecified date 2021, the patient experienced fever (covid vaccine issue low grade temperature) (dose number in series 2). On an unspecified date, the patient experienced pain in fingers (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab, and elasomeran was not reported. The patient was recovering from pain in fingers, and the outcome of fever was not reported. This report was non-serious.
05/25/2019 --Pt is here alone over concern of the above issue.  Her mother has been in contact with this office over the past week expressing concern of a vaccine reaction.  No known sick contacts.  She missed volunteering (school function) 5/22 - 5/24/2019.   Timeline:    5/9/19: Hep A, HPV, MMR vaccines given 5/20/19: triage - eye pain, frontal headache, nausea started 1 day prior 5/21/19: triage - Full body rash, low grade temps,   5/22/19: triage - Continued full body rash - itchy/dry, fatigue, body aches, mild sore throat   Rash described as erythematous macules ranging in size from circumference about size of pencil erasure (largest) to smaller, slightly raised with some confluent areas on the trunk, arms, legs, face Rash itchy --currently resolved   Arthralgias - involving shoulders, elbows, hips, ankles --no swelling.  Currently resolved   Myalgias - resolved   HA, eye pain --resolved   Fatigue, nausea -- resolved   Currently "feel 100% normal"
A 36 year old female patient developed an increased effort to breath after receiving a second dose of RabAvert, batch no. 334011. The patient received the first dose of RabAvert, 1 ml via intramuscular injection, for pre exposure prophylaxis on 06/11/04, and the second dose on 06/17/04. The patient was well until 06/21/04, when she experienced a sensation of "an increased effort to breath" which lasted less than a day and spontaneously remitted. However, the previous event was followed with symptoms of drooping face, drooling and inability to drink from a straw. No other generalized or focal symptoms mentioned. The patient was to see her physician soon. The reporter assessed the event as possible related to the drug. Follow up received 07/13/04: The events of facial paralysis and related neurological disorder and drooling started on 06/23/04, six days after receiving the second dose of RabAvert. The patient stated on 07/08/04 (three weeks after receiving the second dose) that facial paralysis continued but had improved with no treatment. The patient had not seen her primary physician.
Within 3-4 days of first shot on 3/11/2021 increased pain throughout body, increased agitation and greater confusion and ability to follow simple commands. With 24 hours of second shot on 4/1/2021 unbearable pain throughout body, pain for someone to touch, balance issues. By 4/15/2021 tremors in arms and legs, loss of balance, hallucinations\ Patient died on 4/19/2021
Patient under the age of 18 y.o had a flublok vaccine administered in error. No reported adverse event from patient.
Numb tongue within minutes of both injections. Ever since getting the first injection, I've been getting hives all over my body that require me to take Zyrtec daily. Soon after getting the second shot (my healthcare professional told me to still get the second shot), I also had swelling in my lips and face. I took Zyrtec in the morning and Benedryl at night for two weeks. I have darkened skin where the injection was and both times the injection area was bright red, hot, and painful to touch for more than a week.
Received a test dose (skin testing). No reaction. Got lightheaded, saw stars, had facial pain/congestion about 1/2 hour after vaccine.  Took Claritin and Benadryl.  When arrived home, was fatigued with sinus pain.  Slept intermittently that evening: had h/a, head congestion, chills, diaphoresis, cough, chest congestion, intestinal cramps, and muscle-aches.  Took Tylenol and Mucinex, then Benadryl later that evening.  Ill for 3 days (submitted on this day) with sinus pain, headache, head and chest congestion, cough, fatigue, and muscle-aches.
"No previous allergic reactions, no medical hx  administration time 1315,  1325-patient reported that she noted slight rash on bilateral arms 1330 reported rash to clinic staff, denied other symptoms; moved closer to staff for closer monitoring; rash observed to be from upper arms to wrist 1335- patient went to restroom 1340- patient to obs area, rash spread to trunk/flank; patient reports feeling ""fuzzy"" 1345- 175/96 HR 68 98% continued report of fuzzy feeling, additional report of tongue ""thickness"" 1350- 170/82 63 100% report of difficulty swallowing, tongue thickness and continued rash to BUE, trunk and flank 1400 -med w/ benedry 50 mg PO 179/111 64 100%  1405- 178/103 69 100%- reported increased throat swelling, rapid response called 1410- 193/100 69 100%  transported to ED
2 hours after left deltoid injection, developed left lateral upper arm and left facial numbness/tingling along with left orbicularis muscular twitching/fasiculations.
lt shoulder swollen, warm-med started by 27JUN97 swelling down using arm;
BODY ACHE; This spontaneous report received from a consumer concerned a 59 year old male. 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: unknown, expiry: unknown) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAR-2021, the subject experienced body ache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache on 21-MAR-2021. This report was non-serious.
Patient received a dose of Pfizer COVID-19 Vaccine  Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial  was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL ,  0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.
This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients. On unknown dates the patients were  vaccinated with doses of VAQTA (lot #, expiration date and dose unspecified) that were exposed to 8.5 degree centigrade to 12 degree centigrade for 158.5 hours, which was an excursion that was not supported by in-house stability data. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
tingling in her fingers; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 26Aug2021 10:30 (Lot number: FC3182, Expiration Date: 31Oct2021) at the age of 60 years as dose 1, 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PARAESTHESIA (non-serious) with onset 26Aug2021, outcome "unknown", described as "tingling in her fingers".  Additional Information: It was reported that, after administering first dose to the patient, couple minutes later while the patient was waiting, there was tingling in her fingers. The caller did not  know if event was from the vaccine as the patient was leaning on her arm on a table and she was nervous prior to receiving the vaccine. History of all previous immunization with the Pfizer vaccine considered as suspect were none. Additional vaccines administered on same date of the Pfizer suspect were none. Adverse event did not result in emergency room visit or physician office visit. Prior vaccinations within 4 weeks and hence, adverse events following prior vaccinations were none. relevant laboratory tests were none. Family medical history relevant to adverse event was none. Vaccination Facility Type was Pharmacy. The reporter considered "tingling in her fingers" as unrelated.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse concerning a male with no prior drug reactions and with asthma who on 22-FEB-1998, was vaccinated with a 0.5 mL Varivax (Lot #626399/0654H). Concomitant therapy included FLONASE, ADVAIR, CLARITIN. Subsequently, after receiving Varivax, the patient developed chickenpox lesions. Unspecified medical attention was sought. As of 15-FEB-2007, the lesions were less than 30 and the patient was not recovered. The patient's chickenpox lesions persisted. Additional information has been requested. 02/11/2010 Follow up information indicated that on 15-FEB-2007 the patient developed chickenpox. The patient recoverd. There were no relevant diagnositic tests or laboratory data. It was noted that the patient's sibling developed chickenpox on 01-FEB-207 at 12 years of age (WAES # 071USA043411). No additional information is expected.
Roughly five minutes after the vaccines were administered, the patient fainted. He was still seated in his chair in which the vaccines were administered. A pharmacy tech called 911 as I was tending to the patient. The patient was pale and sweaty and lost consciousness but regained within a few seconds. Blood pressure was 118/72 and pulse was 60 when I checked his vitals (with a few minutes of regaining consciousness). Paramedics checked him out and agreed that it was syncope.
Information has been received for the Merck Pregnancy Registry for Gardasil from a 20 year old female with no pertinent medical history or drug reactions/allergies who in August 2007, was vaccinated with a first dose of Gardasil (lot# unknown) 0.5 mL injection. There was no concomitant medication. On an unspecified date, the beginning of September 2007, the patient became pregnant. Seven weeks into the pregnancy the development of the baby had stopped and the baby was pronounced dead. The patient can not miscarriage until 12 weeks into the pregnancy which she had an appointment not do so the week of 12-NOV-2007 but the day of the week was unknown. The patient was supposed to receive her second dose of Gardasil on 09-OCT-2007, around the same time 06-OCT-2007 "4 weeks ago" the baby was pronounced dead, which makes her think Gardasil and the baby's death is a coincidence. No further information was provided. The patient's last menstrual period was unknown but the patient is 11 weeks pregnant. Upon internal review intra-uterine death and fetal disorder was considered to be an other medical event (OME) Additional information has been requested.
t102 x 2 days, airway problem thick coating from nose, coughing spasms;hard time eating, drinking, breathing;
Diarrhea, stomach cramping, body aches,  flank/rib pain, leg pain, nausea, headaches, chills, shivering, severe brain fog, loss of period, fatigue.  Diarrhea, loss of period, brain fog, some pains, headaches persist
Was made worse by coughing; Head rushes; Sunday I was just really tried w/ headache/ I thenproceeded to have a headache for a full 2 weeks. Headache ranged from a 2-6 on pain scale; Fever of 100.4/ Fever remained b/w 101-102 for the next 12 hrs; Body aches; Fatigue.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 46-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: WAG 03657) via an unspecified route of administration in the right arm on 30Apr2021 at 14:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), sulfamethoxazole, trimethoprim (BACTRIM), gliclazide (CLARITIN) and fluticasone propionate (FLONASE); all from an unknown date for unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: WAG 03657), via an unspecified route of administration in the right arm on 02Apr2021 at 16:30 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01May2021 at 07:00, following 2nd shot the next morning, the patient woke up with fever of 100.4 and body aches. Fever remained between 101-102 for the next 12 hours with body aches and fatigue. The patient took 2 naproxen (ALEVE) at 8pm which resolved fever and body aches within a couple of hours. On 02May2021, Sunday the patient was just really tried with headache. She then proceeded to had a headache for a full 2 weeks. Her headache ranged from a 2-6 on pain scale and was made worse while coughing or bending over. She had head rushes for the first week when ever going from sit to stand. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of fever and body aches which included treatment with 2 naproxen (ALEVE) at 8pm on 01May2021. No therapeutic measures were taken as a result of remaining events. The clinical outcome of fever of 100.4/ fever remained between 101-102 and body aches were recovered on 01May2021. The clinical outcome of coughing, fatigue, headache and head rushes were recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Redness; firmness and warmth noted left deltoid; approximately 5cm. in diameter.
I had low-grade fever, chills, and a mild cough.  I was serve fatigue.  I had a really bad headache.  These symptoms lasted for about 5 or 6 day.  The fatigue is still ongoing. I went to a testing site for a COVID-19 test, positive result.
Fluzone vaccine given 10-21-05. Presented in office 12-13-05 with c/o extremity pain 5 times days. Labs ordered. Presented back in office 12-7-05 with Arthralgia and back pain and sent to ER. 12-21-05 admitted to hospital (Guillain Barre Syndrome). Per telephone follow up with reporter vaccine provider, the patient also received fluzone on 10/21/2005. Vaccine sites were not recorded for any vaccine. The patient later presented in the office on 12/3/05 (not 12/13/05) C/O extremity pain X 5 days. The AE onset date therefore was 11/28/05 (not 12/26/05). He was hospitalized from 12/21/05-12/26/05. Only fever was reported after previous fluzone immunizations in 2002 & 2003. 1/26/06 Review of 3-page d/c summary confirms GBS as final diagnosis. Additional symptoms include profuse diarrhea for 2 weeks just prior to admission, poor appetite, and weakness.  1/26/06  Review of 14-page medical record confirms GBS per neurology consult. Additional symptoms include poor appetite, fatigue, and weakness.
Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was received to date  and noted the vaccine expired 1 day prior.  Notified Vaccine program Administrators.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministerd.  An email was sent from Pfizer with the following info to verify that there is 2 additional days for expire time but the vaccine over all expire date has not had any extension time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is received the staff have to determine the expire date and then COVID vaccines are constantly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured  to the vaccine receipent (patient) and all staff have met and will place visible expire labels on each box upon recieving and monitor expire dates daily to prevent further occurances.
I initially only had a mild response with a sore arm, mild headache and slight nausea. About 36 hours later I woke in the middle of the night with severe chest and back pain, the same that I get when I have a eosinophilic esophagitis reaction to a food allergy, however I am certain that I did not consume any of the foods I am allergic to. This lasted for a couple of hours I then took a 5 mg prednisone (as prescribed by my allergy doctor) which eventually helped. I then had flu like symptoms (fever, chills, general malaise) for about an hour. I was then able to go back to sleep and woke feeling okay and those symptoms have not returned.
This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In approximately August 2016 (reported as "on or after 04-AUG-2016"), the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX injection, subcutaneously (exact dose, lot # and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines were stored in refrigerator for 24 hours upon arrival, before being moved to freezer at that correct storage temperature. Additional information has been requested.
This spontaneous report was received from a pharmacist and refers to a 64 year old female patient. The patient did not have any concurrent conditions, pertinent medical history or drug reactions or allergies. On 02-AUG-2016, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously on an unspecified arm (lot number and expiry date were not reported). Concomitant therapies included LIPITOR, ONGLYZA and losartan potassium (+) hydrochlorothiazide (manufacturer unknown). On 04-AUG-2016, the patient developed redness and warmth in a circular area around the injection site. The patient sought medical attention with the reporting pharmacist and unspecified treatment was given for the events. No laboratory diagnostic studies were performed. No product quality complain (PQC) was involved. At the reporting time, the outcome of injection site erythema and injection site warmth was reported as not recovered. The reporter did not provided a causality assessment between the events and the ZOSTAVAX. Additional information has been requested.
Information has been received from a LPN and a physician concerning a 5 year old white female student with no known drug allergies and no past medical  history who on 08/16/99 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (Lot # 631065/0445J).  Concomitant vaccination on the same day included a first dose SC in the right arm of MMRII (Lot # 630119/1983H). There was no other concomitant medication. On 07/14/03, the pt was vaccinated with a second dose of MMRII. On 10/01/03 (also reported as 09/30/03), the pt developed a rash included approximately 10 lesions on the left side of her face, neck and ear. The pt had a maximum temperature of 99.3. Pain was quantified as 7 out of 10. Other systemic symptoms included a stiff neck. Medical attention was sought. The physician diagnosed herpes zoster. The diagnosis was not confirmed by lab tests. There was no history of chickenpox and no recent exposure to chickenpox or herpes zoster. A rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. A direct fluorescent antibody was not done, a specimen was not collected for PCR and a photo was not taken. No treatment was given to the pt. Subsequently, the pt recovered. A product quality complaint was not involved. Additional information is not expected.
Sweating, chills, fever, nausea, Tachycardia, lightheaded
Redness to area/itchy area and pt claims vaccine gave her sinus infection. Pt came in 12/18 and ARNP/Pharmacist, looked at area and it was a little red and itchy. Pt advised to ice, BENADRYL and to call PCP if gets worse. Pt was suppose to call pharmacy with update and we were not able to reach her until today, 1/4/16. Pt stated she forgot to call pharmacy and that she did visit PCP who gave her antibiotic for sinus infection and just in case area was infected (which she said was not). Pt states she no longer has rash/itchiness or sinus infection and that she is well.