chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Persistent twitch of eyelid right eye; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 28May2021 at 12:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications included unspecified multivitamins from an unknown date and for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 07May2021 at 12:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jun2021 at 09:00, the patient experienced persistent twitch of eyelid right eye. The patient did not receive any treatment for the reported event. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event persistent twitch of eyelid right eye was not resolved at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
On March 7, 2021 my daughter experienced extreme tiredness.  I called 911 and paramedics said it may be the effects of vaccine.  I was concerned because this symptom came on 2 weeks later.  On 3/6/21, I took her to urgent care because I didn't feel comfortable with her extreme tiredness.  I was told the same thing. On 2/23/2021, the day that she was supposed to get the second vaccine, she awoke at 12 midnight and was having a full blown psychotic episode.  She was make loud noises, hitting the wall, etc.  I then took her to the emergency room. My major concern was because my daughter has Down syndrome, a seizure disorder and had heart surgery at three months old (atrio ventricular canal defect).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 01Sep2022 as dose 5 (booster), single (Lot number: FN2908) at the age of 58 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Auto immune disease, undetermined" (unspecified if ongoing); "asthma" (unspecified if ongoing); "blood clotting disorder" (unspecified if ongoing); "chronic pain" (unspecified if ongoing); "known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was on treatment with Paxlovid from 12Sep2023 to 16Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300308115 Same patient, different drug and different event (Paxlovid case);
Second dose on more than 28 days; Pain and soreness at injection site; Received 1ml of Moderna Covid vaccine as 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of OVERDOSE (Received 1ml of Moderna Covid vaccine as 1st dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on more than 28 days) and INJECTION SITE PAIN (Pain and soreness at injection site) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (compazine  ), Drug allergy (vancomycin ) and Drug allergy (doxycycline).   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced OVERDOSE (Received 1ml of Moderna Covid vaccine as 1st dose) and INJECTION SITE PAIN (Pain and soreness at injection site). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on more than 28 days). The patient was treated with IBUPROFEN ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. On 26-Jan-2021, OVERDOSE (Received 1ml of Moderna Covid vaccine as 1st dose) had resolved. On 29-Jan-2021, INJECTION SITE PAIN (Pain and soreness at injection site) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on more than 28 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
On April 7, 2022 at 2:00AM I started having right sided pain. I went to the hospital and they said that I had a kidney stone. I was given fluids and medication to help with the pain. On April 9, 2022 I had similar pain and some nausea. I went back to the hospital and received some fluids and medicine again. I updated my doctor on what was going on and they said that I had some high elevation on my kidney test. I went to the ER and  more IV fluids was given. They did another CT Scan which showed the kidney stone still. They did the lithotripsy treatment on April 12, 2022.   I went back on April 19, 2022 and had the stent removed.
TINGLING 5 MINUTES AFTER LEAVING CLINIC VOMITED.  MOTHER AND CHILD CAME BACK TO CLINIC AFTER LEAVING.  SUGGESTED GOING TO ER.  CALL MOTHER IN EVENING STATED WENT TO ER DIAGNOSED AS ADVERSE REACTION TO SHOT.  TESTS DONE AT ER.
Two hours post vax, the pt's blood pressure increased to 130/90 and she experienced a migraine. The vaccinee reported that she had not eaten prior to the migraine. She was treated with Advil.
Problems with remembering now; Lethargy; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Problems with remembering now) and LETHARGY (Lethargy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Meningitis and Infection (Had an infection before 1st dose and took medicine.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MEMORY IMPAIRMENT (Problems with remembering now) and LETHARGY (Lethargy). At the time of the report, MEMORY IMPAIRMENT (Problems with remembering now) and LETHARGY (Lethargy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-072608, MOD-2021-226822 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072608:Same reporter (wife case) MOD-2021-226822:Dose 2 case
Extreme shoulder pain..ache like a toothache that radiates down arm.  Reported to Dr in April of 2016.  Still remains painful today 10/23/2016.
Accidently administered an undiluted dose of the Pfizer BioNTech Covid 19 vaccine; He has experienced is a sore arm; He also had some diarrhea; Accidently administered an undiluted dose of the Pfizer BioNTech Covid 19 vaccine; This is a spontaneous report from a contactable pharmacist. A 17-year-old male patient (age at vaccination 17-year) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 20May2021 as unknown, single dose for COVID-19 immunization. Medical history included autism and bowel issues from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date the patient experienced he has experienced is a sore arm and he also had some diarrhea. Pharmacist accidently administered an undiluted dose of the Pfizer BioNTech Covid 19 vaccine on 20May2021. Mother reports that all that he has experienced is a sore arm. He also had some diarrhea a few days later but he has a history of bowel issues. The clinical outcome of the events was unknown.   Information on the lot/batch number has been requested.  Amendment: This follow-up report is being submitted to amend the previously reported information which includes: Deleted the event "Vaccination site pain" since there was no indication the pain in injection site and removed the classification "At Risk".
Experiencing headache, nausea, body aches, fever approximately 10 hours after injection of J&J vaccine.
Redness, swelling, warmth, 24 hours after vaccines, talked to doctor on call, gave Benadryl for 24 hours, swelling and redness, worse, doctor on call phoned in antibiotics.
reconstituted with expired STERILE DILUENT; This spontaneous report was received from a study coordinator and refers to a patient of unknown age and gender, who was enrolled in an unspecified clinical study, which was not a Merck sponsored or Merck investigator initiated study. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 14-APR-2020, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023504, expiration date 16-APR-2020 (exact dose, frequency, route of administration were not reported) for prophylaxis, which was reconstituted with an expired dose of sterile diluent lot# N028746, expiration date 17-MAR-2020 (exact dose, frequency, route of administration were not reported).
A report has been received from a physician, concerning a male subject, who had been receiving nasal FLUMIST. No pertinent history, concomitant medications and concurrent diseases were reported. FLUMIST started on an unknown date. The patient (who was a physician) stated that for the last (3) years after his kids received FLUMIST, the patient developed flu-like symptoms for several days. At the time of reporting the outcome of the events was unknown. The event of flu-like symptoms was considered to be non-serious by the reporter. The event of after the patient's kids received FLUMIST, the patient developed flu like symptoms was considered to be non serious by company physician.
(L) arm swelling in site where DTaP was given, swelling started 2 days after. Redness, blistering, warm to the touch.
The next day, I had trimmer in my right hand.  It was mainly in my was in my thumb. I had serve headache, fever, fatigue, and body aches. Then I developed a running nose, chill and cough.  I went a got a Covid-19 test, negative result.   I had a really bad RA flair.  These lasted for about 2 weeks.  Then after the flair had ended.  I started getting the left sided facial numbness.  I went to my doctor about this.  They are unsure what is causing it.  I have 3 more trimmers and my facial numbness is still ongoing today.
Pt complained of numbness in tongue. Benadryl 25mg given. Very anxious and diaphoretic. Pt left with husband.
Arm pain, fingers/toes numbness, chills, fever,  headache. All symptoms lasted for around 24 hours with some lingering fatigue lasting for 48 hours.
>24 hours after 1st dose onset of a bulletin ous  rash over legs and trunk as well as lip swelling and tingling; no SOB, nausea, altered mental status or dizziness
12 hours after booster had body aches and fever which lasts about 24 hours then felt fine Approx 8 days after booster vaccine had severe chills and overall body aches - fever spiked to 102 on third day - led to acute prostatitis and GI  problems - urinary issues seem to be resolved with antibiotic and now FloMax - still in treatment for GI issues
2/4/21 @ 9pm- fatigue, swimmy head 2/4/22 @11pm- extreme body pain, severe head pressure, headache, on and off fever , cold sweats, low back pain. continued symptoms through night. interrupted sleep from pain. (2) tylenol 650mg used.  2/5/21 @12noon- symptoms continue barley able to walk. slept with symptoms on and off through day, no fever after 12noon but hot body flashes ensued.  (2) 500mg tylenol used.  2/5/21- @8pm body ache lessened  slightly, fatigue continued, head ache lessened , had some slight itching on thighs and arm pits felt prickly.  2/6/21-@ 8am body pain almost gone, no fever , hot flashes continue, rash  covering bilateral thighs few on stomach , under triceps, left pinky finger . fatigue continues, swimmy head.  @2pm Urgent care clinic- diagnosis of covid 19 vaccine allergic reaction meds prescribed: prednisone 50mg once a day for 6 days, claritin 10mg daily , benedryl 25mg every 6 hours .  @6pm rash itch decreased bumps. not as red.
Child was a 3 year old (DOB 01/09/2006) and received a 4 years old and above vaccine.
Patient stated loss of feeling in left traveling up arm to wrist and EMS was called.  BP- 150/100 and oxygen sat 97% and Pulse 86
Sunday 12/5/2021, when I woke up I felt something different on my right eye. Around noon time, I noticed my right eye brow was lower than the left one, but I could still blink and move the eye brow. When I woke up the next morning, on Monday, I noticed I could not completely close my right eye, my right eye brow was lower and my right lip was drooping down, and it was very obvious and I couldn't move it. So, I called my PCP and, due to difficulty with scheduling, they told me to go to the ER. I went to the ER immediately and they did CT scans and an MRI. At that time, they drew blood and did tests and they told me it wasn't a stroke but Bell's Palsy. They gave me antivirals and some other medicine: prednisone 20mg and valacyclovir 500mg. I took them as instructed and by 01/01/2022 I was pretty much recovered from the Bell's Palsy. Once that went away, then I noticed my upper lip was numb, then itchy and I put on lip balm. Then, the lips started to burn, swell and turn red. Then I developed an itch and rash on my face all over a 4-5 day period. So, it was painful and I went to the Clinic and they gave me prednisone 10mg for 14 days and an antiviral which helped. All of the symptoms were gone while taking the medicine and then once it was done the symptoms came back. Then, 02/02/2022 I went to urgent care and they gave me prednisone 10mg for 5 days. 02/07/2022 I went to my PCP facility and the PA gave me another round of prednisone 10mg for 5 days. They referred me to a dermatologist thinking it could be an allergy. i went to the dermatologist and they gave me doxycycline 100mg for 7 days and the symptoms got much better. She gave me hydrocortisone cream to put on the rashes 2x daily and I'm still continuing to use it. Sometimes I take the over the counter allergy medicine but not all the time.
shingles; This initial spontaneous report was received from a lawyer referring to a currently 56 year old patient of unknown gender regarding a case in litigation. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In or about 2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, route and lot # were not provided) at a physician's office for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the patient was treated by a healthcare provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX): shingles. At the time of the report, the patient's outcome was unknown.   The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Patient started feeling light headed and shaky/anxious about 10 minutes after vaccine administration. Patient sat in immunization booth for a total of 35 minutes and was given something to eat and drink, as he had nothing to eat yet for the day and only had caffeine and nicotine in his system.  Patient started to feel less shaky but was still light headed.  It was suggested we call the paramedics for evaluation and he refused, and then left the pharmacy 35 minutes after vaccine (against pharmacist advise).  The patient called approximately 2 hours later and said he was feeling better, no longer shaky or light headed and had a headache as the only symptom at the time.
2 weeks after vaccination developed itchy erythematous maculopapular Rash NOT uriticarial right side of neck, spread to L neck & L upper chest/axilla. In adequate response to oral antihistamine, Topical steroids. Pt now on systemic steroids
Information has been received from a registered nurse concerning a 4.5 year old female who on 29-Jun-2000. was vaccinated SC in the thigh with a 0. ml first dose of varicella virus vaccine live. The nurse reported on 15-Sep-2003 that the patient presented to the office "today" with a chickenpox rash. The reporter indicated that it was a "very mild case" of only about six lesions with three on the torso, one on the leg, one on the cheek, and one on the arm. The nurse also indicated that the school told the patient's mother that there was a chance some children could have been exposed to chickenpox because a classmate also was infected. It was noted that no treatment was necessary and the child seemed unaffected. A product quality complaint was not involved. Follow-up information was received from the registered nurse which indicated that the adverse event began on 15-Sep-2003. The patient was exposed to varicella at school and developed about six pox two weeks later. The patient was noted to be afebrile and in no acute distress. The patient subsequently recovered. No further information is expected.
Opened IPOL given to patient on 6/22/22 following a temperature excursion. Per DOH, patient needs to be revaccinated. Talked to mom over mom recommending revaccination.
0.25ml administered as a 1st dose of flu vaccine for the 2017-2018 flu season. 0.5ml is the recommended dose for this vaccine. No adverse reactions were noted. Parents have been notified to return to clinic for revaccination.
Mom reported to our office today on Mon 5/15/2023 that patient had experienced an allergic reaction 1 day after his initial HPV9 vaccine administered on 11/15/2022 at 4pm.  She did not call into our office to notify us of this initially. He developed lip swelling only. no angioedema or hives to other parts of his body.  He was scheduled for his #2 dose today and she mentioned it during his physical exam. We held off on administering his 2nd dose due to this new information.  Mom administered PO benadryl and reaction resolved. no UC or ED visit.  patient also did not develop anaphylaxis reaction.
erythema, pain, tenderness, swelling, warmth, or pruritus at the injection site
No adverse event to date.  Client received Janssen for the first dose. Client then received the monovalent Pfizer instead of the bivalent Pfizer for the second dose.
11/7/14 Pt reported sore arm at injection site with tolerable, periodic pain with movement. No redness, swelling, or inflammation. Pt was advised to use apap or ibu for pain if neccessary. 11/20 Pt states pain has stopped and has experienced no other complications.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 13-AUG-2014 (also reported as "this morning") the patient was inadvertent vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous that underwent a temperature excursion on 12-AUG-2014. The temperature excursion was supported. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected.
My appointment was set for 1:50pm. After 3 minutes: a quick spirt of dizziness but was sudden. After 5 minutes: chest pain and tightness on the left side of my chest that felt like it was coming from my heart. After 10 minutes: pain from deltoid and across pectoralis muscle groups. After 12 minutes: pain on the left side of my breast - a pressure/heaviness. After 20 minutes: migraine and dry mouth, told the nursing staff about my reactions. 2 hours after shot: nauseous, constant pressure on left breast, along with arm soreness. 2-3 hours after shot: fatigue, nauseous. 3-4 hours after shot: left calf pain, pain in calf is NOT an ongoing medical issue. Over night: still had dry mouth regardless of the amount of water I drank, upset stomach/diarrhea, chills, and fever. Next morning and 3 days after: dry mouth, fatigue, bloody noses (NOT typical), nauseous, soreness, breast tenderness, no appetite, fever, chills, and cloudiness. These symptoms are not common for my person.
At first, I noticed that I had a fever of 101.6, fatigue, high pulse rate 100 and a sore throat. I reached out to the PA at my Doctors office. I was prescribed Molnupiravir an antiviral medication. Additionally I was alternating Tylenol and Tylenol for fever and pain. Symptoms lasted 5 days.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (fever, didn't checked it but feels really hot ), DECREASED APPETITE (Lost the appetite), PAIN (Body aches), PYREXIA (fever, didn't checked it but feels really hot) and CHILLS (Chills) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported.). On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced FEELING HOT (fever, didn't checked it but feels really hot ), PYREXIA (fever, didn't checked it but feels really hot) and HEADACHE (headaches). On 02-Mar-2021, the patient experienced DECREASED APPETITE (Lost the appetite) and NAUSEA (Nausea). In March 2021, the patient experienced PAIN (Body aches) and CHILLS (Chills). At the time of the report, FEELING HOT (fever, didn't checked it but feels really hot ), PAIN (Body aches), PYREXIA (fever, didn't checked it but feels really hot), CHILLS (Chills) and HEADACHE (headaches) outcome was unknown and DECREASED APPETITE (Lost the appetite) and NAUSEA (Nausea) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was linked to MOD21-043005 (E2B Linked Report).; Sender's Comments:  MOD21-043005:same patient and reporter.
This case was reported by a nurse and described the occurrence of photophobia in a 45 year old female patient who received hepatitis B vaccine recombinant for prophylaxis. On 5/15/03, the patient received the 1st dose of Engerix B. Two to three hours post immunization, on 5/15/03, the patient experienced a headache. On 5/15/03, at an unspecified time post immunization, the patient also experienced photophobia. The photophobia resolved after 12 hours. The headache was relieved after treatment with paracetamol, but was not totally gone until 5/16/03. A healthcare professional was consulted regarding the events. The nurse considered the events to be not related to Engerix B. On 6/15/03, the patient received the second dose of Engerix B after pre-medication with paracetamol. No adverse event occurred.
Symptoms began w/HA at 1:45 pm, then some lightheadness, and chest pressure rated at 2-3 of 10.At 2:54 pm P-85, BP-138/81. EMS called, pt. declined transport.