chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a nurse via other company (Pfizer) (manufacturer report number- 2017101323) on 20-MAR-2017. This case involves a male patient (unknown age) who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced fever. On an unspecified date, patient died (reported as dropped dead). The cause of death was not reported. Patient's lab data and corrective treatment were not reported. The events outcome was reported as fatal. It was unknown whether autopsy was performed or not. List of documents held by sender: none.; Sender's Comments: Patient was vaccinated with flu shot had fever and died. Case is poorly documented, latency post vaccination is not provided, detailed medical history, past vaccination history and concomitant medication are unknown. Results of laboratory analysis and autopsy report are not provided. Additional information is required to fully assess role of the vaccine in reported event.; Reported Cause(s) of Death: Fever.
This case was reported by a other health professional via call center representative and described the occurrence of hives in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced hives large all over her body. The reporter wanted to know was this considered as hypersensitivity. The reporter wanted to know should she not get the second dose. The patient was in the pharmacy now because she did not want to get the second dose.
Patient felt faint after receiving  his vaccine. EMS was called since the patient stated he felt like he was "blacking out". EMS arrived shortly afterwards and examined the patient. The Patient mother arrived shortly afterwards and took the patient home after EMS examined him.
Pain in injection site for few days. The second day I felt awful! Terrible headache. Flu-like for 2 days. Had no energy could barely function and spent most of the day on the sofa. I'd say that I felt "off" for about 5-7 days. But the worst sensation was a "numbness" on the L side of my face and my head hurt!! My skull (top of head mostly) hurt! It was scary. These more scary sensations lasted about 5 days. I'm afraid to get the second shot!
patient caught Covid in Apr2021 and was sick for 2 weeks; patient caught Covid in Apr2021 and was sick for 2 weeks; This is a spontaneous report received from a non-contactable physician reporting for himself via sales representative. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in late Dec2020 and second dose in Jan2021 both at single dose for COVID-19 immunization. Medical history included extremely over weight. Concomitant medications were not reported. The patient was a physician who works in a hospital as a psychiatrist. He recieved his first vaccine in late Dec2020 and had his second vaccine 3 weeks later in Jan2021. The patient caught Covid in Apr2021 and was sick for 2 weeks. He believed he caught Covid from a patient. The outcome of the event was unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Covid 19. The case will be reassessed once new information is available.
Week 1: was a migraine that lasted for 4 days. Nothing that took at the time was working. Usually Excedrin works for me but it didn't this time. There was no warning, it just came and did not go away for 4 days, week of 11/07/2021. Week 2: respiratory sinus problems, no allergy medication was working. I was completely congested. I am used to having congestion that goes away 1 or 2 days, never a full week. Going into week 3 and 4: Left shoulder, upper back, arm was all hurting. Lasted about 4 days. During week 2 to week 4 it was harder to breathe then usual and my bowels were not normal. There were streaks of blood on the toilet paper, the stool looked like fish tank algae. I went to do the doctor and she made sure I didn't have type of cancer or COVID.
Pt fainted after getting vaccinated and afterwords told us that he had not had food that morning due to being nervous.
Adult dose administered to pediatric patient; 13yo received adult dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 13-year-old female patient who received HAV (Havrix 1440 adult) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis.   On 29-MAR-2023, the patient received the 1st dose of Havrix 1440 adult. On 29-MAR-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: Adult dose administered to pediatric patient) and adult product administered to child (Verbatim: 13yo received adult dose). The outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 31-MAR-2023 The reporter was a medical assistant. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up. The pediatric patient was accidentally administered with Havrix 1440 adult vaccine, which led to accidental overdose and adult product administered to child. The case is linked with case US2023048545, reported by same reporter.; Sender's Comments:  US-GSK-US2023048545:Same report/other patient
my period is now very off  i have been extremely regular for decades but they have been off ever since the vaccination -it  can be as much as 18 days early and they are now "evening off" & happening every 3 weeks - this affects my moods and mental health (pmsing more often SUCKS ) as well as having limited eggs left and now they're going faster.
Stevens Johnson Syndrome; rash was starting to peel; developed a rash all over her neck/ the rash has spread to face eyes, cheek; developed a rash all over her neck, "looks like its peeling and taut"; developed a rash all over her neck, "looks like its peeling and taut"; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age (Age: 48, Unit unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jan2021 at single dose for covid-19 immunization. Medical history included she had an allergic reaction to sulfa and developed Stevens Johnson syndrome from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced Stevens Johnson Syndrome, developed a rash all over her neck/ the rash has spread to face eyes, cheek; "looks like its peeling and taut"; and the rash was starting to peel, all in Jan2021. The patient received 1st dose of vaccine on 10Jan2021, developed a rash all over her neck, "looks like its peeling and taut". She had an allergic reaction to sulfa and developed Stevens Johnson syndrome, this looks similar to that (Experience of Stevens Johnson Syndrome). The patient was asking if she did take the steroid dose pack from her dermatologist for the skin rash will it prohibit her from taking the second dose of the vaccine. She called yesterday and reported a rash after receiving the first dose of the COVID-19 vaccine. She stated that she went to her Dermatologist this morning because the rash has spread to face eyes, cheek and the rash was starting to peel. She stated that the dermatologist wanted to know if it was safe to treat her with a prednisone dose pack after receiving the vaccine. Her rash was worsening so she went to her dermatologist for treatment. She was asking if she should get the second dose. The outcome of events for developed a rash all over her neck/ the rash has spread to face eyes, cheek was not resolved, for other events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of suspect Stevens Johnson Syndrome presented as skin reactions cannot be excluded, considering the plausible temporal relationship.  Severe allergic reaction is the known risk for the vaccine. The underlying predisposing condition of an allergic reaction to sulfa developed Stevens Johnson syndrome may put the patient at high risk of the similar occurrence. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Received vaccination at approximately 1:00 pm.  At approximately 8:00 pm, started feeling sick.  Went to bed.  Had a fever and chills all night.  Some dizziness.  Approximately 18 hours later, I still feel  tired and weak.  I can 100% assure you that I will never take a covid booster vaccination again.   This isn't worth the suffering and feeling sick.
Itching/hives bilateral axilla. Sensation of lump in throat/itching tingling in throat. EMS on site. Patient's Epi-pen used left thigh. EMS started IV in left AC gave fluids and gave 25 mg Benadryl IV. Vitals monitored. Symptoms improved shortly after medication administration. Med unit transported patient to hospital for further evaluation.
First COVID Vaccine given on 2/11/2021. Moderna. Lot: 031L20A. Body Site and Administration Route unknown
Redness at injection site, also itching and arm swollen, joint pain in the back also reported.
tested positive for COVID; tested positive for COVID; sore throat; runny nose; headache; Symptoms described as mild, "like a cold"; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 13-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 28Mar2022, outcome "recovering", described as "Symptoms described as mild, "like a cold""; HEADACHE (non-serious) with onset 28Mar2022, outcome "recovering"; RHINORRHOEA (non-serious) with onset 28Mar2022, outcome "recovering", described as "runny nose"; OROPHARYNGEAL PAIN (non-serious) with onset 28Mar2022, outcome "recovering", described as "sore throat"; DRUG INEFFECTIVE (medically significant) with onset 31Mar2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 31Mar2022, outcome "recovering" and all described as "tested positive for COVID". The events "tested positive for covid", "sore throat", "runny nose", "headache" and "symptoms described as mild, "like a cold"" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Mar2022) Positive, notes: Patient was rechecked for COVID on day 3 of symptoms and was positive; (unspecified date) Negative, notes: get another rapid COVID and strep tests, which were both negative; (28Mar2022) Negative, notes: had a rapid COVID test at school which was negative; (unspecified date) Negative, notes: get another rapid COVID and strep tests, which were both negative. It was unknown if therapeutic measures were taken as a result of suspected covid-19, oropharyngeal pain, rhinorrhoea, headache, nasopharyngitis.  Clinical course: Patient had not received any other vaccine within 4 weeks and not diagnosed covid-19 prior to vaccination. On 28Mar2022 had a sore throat and had a rapid COVID test at school which was negative. Pt father took him to urgent care after school to get another rapid COVID and strep tests, which were both negative. Doctor told the patient to take antihistamine as it was likely allergies. His symptoms of sore throat, runny nose, and some headache persisted. Patient was rechecked for COVID on day 3 of symptoms and was positive. His Symptoms described as mild, "like a cold". Patient had visited emergency room with respect to events. No one else in the family has tested positive for COVID nor has any symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax 15JAN96 & was tested using natural varicella test & registered a negative titer;no further details were provided;
I noted that I had a very patchy burning tongue 14MAR2023 I kept an eye on it and used warm gargles it was covering the main part of my tongue IO made an appointment to see my Doctor on 24MAR2023 I had been taking Zyrtec but it did not seem to effect it my Doctor noted all my vitals were fine and was unsure what it was but recommended that I go see a specialist or an ENT doctor.   28MAR2023 I saw Dr. my tongue was still red maybe not as wide some days worse than others, Dr thought maybe it was geographic tongue or an autoimmune disorder or stress. . It was suggested that I take a multivitamin and continue the warm water gargling a mouthwash could be ordered if so desired.  A two month follow up was suggested.  I began a regiment of B complex vitamins and just began taking a multivitamin.  I have seen my Dentist as well and my Dentist was not sure it was a geographic tongue. The redness and burning continues although somewhat less and my blood levels will be checked today.
9-24-09 L arm swollen and red with fever. BENADRYL 150 by mouth given. Applied ice pack to arm. 09-26-09 arm swelling is gone.
Developed redness, warmth and pain shortly after the injection was administered and worsened over 2 days. Treated for cellulitis in ED with antibiotics
After I received the vaccine, I had a little of a sore arm and some fatigue. In July I traveled to see my daughter. I was having a massive fatigue toward the end of the trip. I felt lightheaded and weak. The next few hours it did not go away. I felt extremely lightheaded. I woke up the next morning and drove home 7 hours. I was in bed for 2 days after I got home. On the third day I called to see the doctor. I felt like I was going to pass out and sweaty and weak. That day I had an appointment and he check my blood pressure, did an EKG. He advised I see a cardiologist due to finding an irregular heartbeat. I just saw a cardiologist which I believe it has resolved itself by now. He did an echocardiogram.  The results were good. I have never had heart problems before the vaccine. I am unsure if it is related to the vaccine.
I experienced flu-like symptoms after taking my 3rd dose. I was extremely tired, achy, and felt really bad for 24 hours. When I contracted COVID-19, I felt like I had a bad cold. I had a snotty nose and a stuffy head.
Heart beating quickly for 1 hour followed by itching hives on scalp, face, arm, stomach and legs. Took Benadryl 11/09/10 and 11/10/10. At present time still slightly itchy. Also stomach ache and frequent bowel movements during evening of 1109/10.
Pt recvd DT/OPV nurse noted lt arm red & swollen around inject site immediately p/placing needle in muscle & injecting; 5cm x 4cm wheel & flare noted 10min p/inject given; Lasted 72 hrs
This is a spontaneous report from a non-contactable consumer (patient) received from a Pfizer sponsored program Patient Testimonial Recruitment. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on 13Dec2017 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient reported that it made her really sore, very sore arm for a day and a half on an unspecified date. The patient experienced pain and swelling at the injection site on an unspecified date (patient thought it was a little swollen because it was painful), much more than when got the flu shot. It was reported that it was really uncomfortable to lay on that side. The next day (14Dec2017) the fatigue and headache lasted until 4pm. Patient had hardly had any joint pain. The patient hadn't lost appetite, no redness. The patient had a pretty good headache the day after and general fatigue, and had swelling in her left lymph node on an unspecified date which she thought meaning she was fighting something. The patient stated she was better, had a little bit of a headache on the top of head. The patient was feeling a little soreness around her shoulders on an unspecified date, but that may be from stress. The outcome of event headache was recovering, outcome of the other events was unknown. No follow up attempts are possible. No further information is expected.
severe body aches, nausea, chills.  The symptoms began 7/31/2019  between 1400 and 1500 and are still ongoing as of 8/1/2019 0731.
Fatigue; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (Fatigue) and NAUSEA (Nausea) in a female patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the parent received the product for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the parent received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved.            Reporter did not allow further contact
Shortly after receiving vaccination patient fainted while sitting on bench.  Paramedics were called and patient was transported to hospital for evaluation.
Subsequent to receiving first and second doses of varicella virus vaccine live, the 1st dose was given on 1/5/99 and the 2nd dose given on 3/2/99, the pt's laboratory evaluation revealed negative varicella IgG antibody.
hurt more at onset; SOB, muscle aches, HA lasting 1 1/2 days; swelling and redness at site lasting 3days
FEELS DRAINED; FEELS SLEEPY; HARDER TO BREATHE; LOSING TRACK OF THOUGHT/COGNATIVE THOUGHT IS OFF; TEETH ACHE; LOSS OF APPETITE; LIGHTHEADED; MASSIVE RINGING THE EARS; DRY MOUTH; LEFT HAND FEELS TINGLY; LEFT HAND FEELS NUMB; CHILLS; FEELS EXHAUSTED; LEFT ARM IS SORE AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 52 year old of unspecified sex. 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 and batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 10:15 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced feels sleepy. On 08-MAY-2021, the subject experienced harder to breathe. On 08-MAY-2021, the subject experienced losing track of thought/cognative thought is off. On 08-MAY-2021, the subject experienced teeth ache. On 08-MAY-2021, the subject experienced loss of appetite. On 08-MAY-2021, the subject experienced lightheaded. On 08-MAY-2021, the subject experienced massive ringing the ears. On 08-MAY-2021, the subject experienced dry mouth. On 08-MAY-2021, the subject experienced left hand feels tingly. On 08-MAY-2021, the subject experienced left hand feels numb. On 08-MAY-2021, the subject experienced chills. On 08-MAY-2021, the subject experienced feels exhausted. On 08-MAY-2021, the subject experienced left arm is sore at the injection site. On 08-MAY-2021 20:00, the subject experienced feels drained. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from teeth ache, and massive ringing the ears, and had not recovered from feels drained, chills, feels sleepy, harder to breathe, losing track of thought/cognative thought is off, loss of appetite, lightheaded, dry mouth, left hand feels tingly, left arm is sore at the injection site, feels exhausted, and left hand feels numb. This report was non-serious.
Hives slowly started showing and the allergic reaction peaked around 6:00 PM with hives all over back, shoulders and neck and swollen, puffy, itchy eyes.
rash around the injection site. patient has taken benadryl and using topical cream. rash is still present
arm hurt; fever of 104.4 F; chills; migraine; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), PYREXIA (fever of 104.4 F), CHILLS (chills), MIGRAINE (migraine) and ARTHRALGIA (joint pain) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt), PYREXIA (fever of 104.4 F), CHILLS (chills), MIGRAINE (migraine) and ARTHRALGIA (joint pain). On 12-Mar-2021, PAIN IN EXTREMITY (arm hurt), PYREXIA (fever of 104.4 F), CHILLS (chills), MIGRAINE (migraine) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       She took Tylenol for her symptoms. She spoke to her HCP to see if she should get the second dose. Her HCP advised her to call to see what the recommendation is.
Information has been received from a case in litigation via a case report concerning a 63 year old female with pre-diagnosis and pre-vaccination medical problems who in 1990 was vaccinated with RECOMBIVAX HB vaccine (manufacturer unknown). Subsequently, "a few days later the patient experienced optic neuritis. A special master said the patient had "deteriorating vision in her right eye and was treated with steroids. In 1994, she had a brain MRI and multiple sclerosis was diagnosed for the first time." A Vaccine Court Special master has ordered compensation for a woman who alleged that the RECOMBIVAX HB (manufacturer unknown) caused or aggravated MS, saying the respondent could not demonstrate no other challenge to the patient's immune system at the time of vaccination. "If petitioner had a pre-vaccination onset of MS, rather than chemotherapy-induced polyneuropathy, then RECOMBIVAX HB vaccine significantly aggravated it." A Special Master said "if the patient did not have a pre-vaccination onset of MS but experienced the onset of her MS with her optic neuritis post-vaccination, then the vaccine caused it." It was noted that this case was complicated by a variety of pre-diagnosis and pre-vaccination medical problems that the patient had. Upon internal review, multiple sclerosis was considered to be an other important medical event. No further information is available.