chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 16-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to a temperature excursion of 1.1 Celsius degrees for 208 hours with lowest temperature recorded of 34 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
9/22 5AM while nursing noticed body tremors x 45 secs- nursing stopped, mom tried to stop- no impact on movement, then continues nursing, then fell asleep. She was not herself the night of shots (9/21). Husband said same thing happened last time she got Dtap.
This spontaneous report as received from a licensed practical nurse, refers to a 46 year old female patient. The patient's concurrent conditions included hypothyroidism and pulmonary valve stenosis. On an unspecified dates in 2006, the patient received 3 dose series of RECOMBIVAX HB lot# 653363/1063R (also reported as '1063R), expiration date: 21-SEP-2008, dose and route were not reported. Concomitant therapies included ATENOLOL, WELLBUTRIN ADN levothyroxine sodium (manufacturer unknown). The nurse reported, that the patient showed no immunity on her Hepatitis B surface antibody (HBsAg) titer test on 28-APR-2015. HBsAg titer was 1.9 mIU/ml. The patient sought medical attention - she saw a doctor. No treatment was given for the event. A booster dose of RECOMBIVAX HB (lot# reported as K018796, expiration date: 24-OCT-2016) was given on 06-MAY-2015. The outcome of the event was reported as not recovered/not resolved. The relatedness between the event and RECOMBIVAX HB was not provided. Additional information has been requested.
Patient has first dose of Moderna vaccine on 3/10/2021 he got his second dose of Moderna today 4/1/2021 this was too soon (22 days after his first dose).
got the shot and then developed got gbs; paralyzed; Initial information received on 13-Sep-2023 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who got the shot and then developed got gbs and paralyzed after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer via unknown route in unknown administration site for prophylactic vaccination (strength, formulation, dose, batch number and expiry date: unknown). Information on the batch number was requested  On an unknown date the patient had got the shot and then developed got gbs (guillain-barre syndrome) and paralyzed (paralysis)(unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (guillain-barre syndrome and paralysis).  At time of reporting, the outcome was Unknown for the event guillain-barre syndrome and paralysis  Seriousness criteria: Medically significant for guillain-barre syndrome and paralysis; Sender's Comments: Sanofi Company Comment dated 19-Sep-2023: This case involves an unknown age and unknown gender patient who got the shot and then developed got gbs and paralyzed after receiving influenza vaccine. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
I noticed that in the way the blood came out on my mensural cycle very different. It was liquidly bright red and a lot of blood -- and I haven't experienced this in a decade. I feel like it reset the way my cycles have been in decades. And now I'm  I was diagnosed with Endometriosis when I was 25 and for years now I've been super regular without pain. But now I am getting intense pain to the point of feeling like I would fainting with periods after vaccination and this hasn't happened in years.  This started on my next cycle after my vaccination. I went to the Doctor May 27th to explain what was happened.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (lot # 670616/0617AA) on 29-JUL-2012 after its expiration date (26-JUL-2012). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Vaccinator attempted to vaccinate pt. Vanish Point needle retracted inappropriately and discharged majority of vaccine around needle and onto patients arm. Less than 1/2 of vaccine went into patients arm. Pt received a full dose in the opposite arm.
Evening of the 4th post-vaccine day I had highly unusual visual disturbances and radiating heat from my feet to neck.  BP 200/ 100+, extreme weakenss and feeling of heat radiating and then receding .   This occurred over and over again.  Called ED and spent the night in the hospital for a whole gamit of tests and ovservation.
Persistent fever x 5-7days, MMR on 01/17-01/24. Swelling at injection site for 5 days, Prevnar on 01/08-01/13.
Experienced swelling in the face; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 80 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, UNKNOWN MANUFACTURER), for COVID-19 immunization; Bnt162b2 (dose:3, UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: SWELLING FACE (hospitalization) with onset 13Apr2022, outcome "unknown", described as "Experienced swelling in the face".  Clinical information: Pharmacist stated, "They did well it was reported by the facility that they were taken to the hospital to get look at another word what treatment they might receive. That's what were reported to us that they were taken for the hospital to get test, yes that's what we were told.  Causality: Pharmacists stated, "In my medical opinion I think it's unlikely just because how long after the experiencing reactions and because the unsteady gaits which was reported is not necessary be I don't think actually report unsteady gaits haven't see in fact either all of the patients who did that have a history of falls and you know they are more elderly so unsteady gaits may not be related in my opinion, I say unlikely.; Sender's Comments: Based on the available information in the case, the causal association between the event swelling face and the suspect drug BNT162B2 cannot be excluded. 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.
Heavy chest, nausea, dizziness, pt. believes she might have passed out. Feels out of it today.
Breakthrough covid case. Pt. presented to ED with cough, congestion, sob, sore throat. On dialysis, hx of asthma. Discharged home.
Narrative:  The patient received two dosed of Moderna COVID 19 Vaccine. The patient tested positive for COVID 19 on 30 Jan 2022. The patient presented to the ED with chest discomfort, cough, and chills and was admitted with covid pneumonia and community acquired pneumonia. The patient was treated with antibiotics, dexamethasone, and remdesivir. The patient was discharged in stable condition on 2 Feb 2022.
Chills - 2 hours Muscle Ache - 6 hours  Lethargic - 6 hours  Took Tylenol am/pm
Viral exanthema NOS on 2013-02-18, clinician comment: Likely Rubella symptoms following MMR.
This spontaneous report as received from a Nurse refers to a patient of unknown age. On 04-MAY-2014, the patient was vaccinated with VARIVAX (dose and frequency were not reported) which was improperly stored at temperature of 8C for 54 hours. No adverse effects reported. No further information provided. Additional information has been requested.
Patient complained about being dizzy after about 1 minute after receiving shot, said throat felt closed too. We administered an EPIPEN.
01/22/22 presents to ED for "right side paralysis, right hemineglect, facial droop and was aphasic ". PMHx of "asthma, HTN"
saliva was getting thicker; file (bad) tasting; burning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 22Sep2021 as dose 3 (booster), single (Lot number: EW0168) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, lot: ER8733, NDC: Unknown , expiration: Unknown), administration date: 27Mar2021, when the patient was 73-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, lot: EW0162, NDC: Unknown , expiration: Unknown), administration date: 17Apr2021, when the patient was 73-year-old, for Covid-19 immunization. The following information was reported: BURNING SENSATION (non-serious) with onset 01Mar2022, outcome "unknown", described as "burning"; DYSGEUSIA (non-serious) with onset 01Mar2022, outcome "unknown", described as "file (bad) tasting"; SALIVA ALTERED (non-serious) with onset 01Mar2022, outcome "unknown", described as "saliva was getting thicker". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of saliva altered. Additional information: On 1Mar2022, I started noticing saliva was getting thicker, file (bad) tasting, burning and stringy. I thought I had an abscess in my teeth so went to dentist since I was constantly sucking out from the gums. All x-rays show nothing wrong, no abscess. Dentist said to just to drink more water and take Xylo melt so saliva will thin out.
The mother of a 7 month old male reported that her son received his 3rd Prevnar in 1/01. The pt recently recovered from a "chronic dermatitis around his mouth" that resolved when he was switched to a latex-free bottle. He received his 1st and 2nd doses of Prevnar in 8/00 and 9/00, respectively. In 11/00, the pt (approx. 5 month of age) developed a bilateral ear infection and sinusitis and was prescribed Zithromax (azithromycin); see HQ7407020FEB2001 for this report. In 12/00, the symptoms were not resolving and the pt was prescribed Cefzil (cefprozil). In 1/01, the pt developed bronchiolitis and "a more sever" bilateral ear infection. He was prescribed steroids and Cefzil again.
PATIENT HAD FEVER ON 6/30 EARLY AM AFTER RECEIVING VACCINE ON 6/26. PATIENT WAS TAKE TO MD AND DIAGNOSED WITH EAR INFECTION. PATIENT CONTINUED TO HAVE FEVERS. ON 7/3/04 PATIENT HAD GENERALIZED SEIZURE AND TAKEN TO LOCAL HOSPITAL.  PRELIMINARY SPINAL TAP DIAGNOSED HER WITH MENINGITIS.  PATIENT WAS STARTED ON CEFTRIAXONE AT THAT TIME.  ON 7/5/04 PATIENT HAD TONIC/CLONIC SEIZURE AND WAS TRANSFERRED TO HOSPITAL.  PATIENT WAS THEN DIAGNOSED WITH HERPES ENCEPHALITIS AND TREATED WITH ACYCLOVIR AND PUT ON DILANTIN. Information received from medical records received on 1/31/06 states patient experienced otitis media, fever, seizures, herpes meningitis, brain edema, brain hemorrhage, speech delay and hyperactivity. Patients left temporal lobe of the brain has been permently damaged. She is currently under the care of a speech therapist, develomental therapist, occupational therapist, and social worker.
Bell's Palsy: Symptoms were those of a cerebral stroke affecting the right side of my face - intermittent face, head and jaw pain, drooping right eyelid and eyebrow.  Had X-ray, cat scan, blood work in E.R. on April 4, 2021. E.R. physician settled on Bell's Palsy after eliminating other possible diagnoses. Prescribed Deltasone (prednisone) 10mg sequence for 7 days (180mg total) and Valacyclovir 500mg sequence for 7 days (21,000mg total). May have laso received medication for Lyme disease.  Within about 8 days the symptom were greatly diminished to the point of not needing any additional treatment. Mild headaches/jaw aches occurred infrequently for about three weeks that seemed to  be related to the Palsy.
Bruised arm at and above injection site.  Warm to the touch and felt bruised. Not horrible at all .. I just wanted to report it for your records. (I noticed it at around 9pm the day of the vaccination, and it is still bruised.) I'm sure it will go away with time.
A consumer report has been received. The report concerns an Adult, Female consumer, who had been receiving nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on Dec-2014. The patient experienced PAIN IN HANDS and SWELING ON HANDS. At the time of reporting, the event of PAIN IN HANDS and SWELLING ON HANDS was ongoing. The report was considered to be non-serious.
GAVE PT PFIZER VACCINE WHEN SHE WAS SUPPOSED TO RECEIVE SECOND DOSE OF MODERNA VACCINE, PT HAD NO SYMPTOMS OR REACTION WHEN IN PHARMACY SETTING
inadvertently administered an extra dose with no reported adverse event; Initial information received on 10-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 years old female patient who reported  inadvertently administered an extra dose  of vaccine meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 02-Aug-2022, the patient received a  dose of suspect meningococcal A-C-Y-W135 (T CONJ) solution for injection vaccine 0.5 ml total lot U7447AC strength not reported via unknown route in unknown administration site. On 06-Feb-2023 she also received a dose of the same vaccine  0.5 ml lot U7447AC via unknown route in unknown administration site for prophylactic vaccination.  On 06-FEB-2023 the patient developed a non-serious inadvertently administered an extra dose with no reported adverse event (accidental exposure to product).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event inadvertently administered an extra dose with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I woke up with no voice; runny nose; sore throat; nasal congestion / chest congestion; chest congestion.; chills; was really tired, but couldn't fall asleep; my arm was sore at injection site; I had body pain; fever/ fever of 100.4°F (my normal is 98.5°F); but couldn't fall asleep; I was feeling like I'm on a ride at when I stood up.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I was feeling like I'm on a ride at Disney when I stood up.), APHONIA (I woke up with no voice), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat) and NASAL CONGESTION (nasal congestion / chest congestion) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, the patient experienced FEELING ABNORMAL (I was feeling like I'm on a ride when I stood up.), INSOMNIA (but couldn't fall asleep), CHILLS (chills), FATIGUE (was really tired, but couldn't fall asleep), VACCINATION SITE PAIN (my arm was sore at injection site), MYALGIA (I had body pain) and PYREXIA (fever/ fever of 100.4°F (my normal is 98.5°F)). On 17-Jun-2021, the patient experienced APHONIA (I woke up with no voice), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (nasal congestion / chest congestion) and CHEST DISCOMFORT (chest congestion.). The patient was treated with PARACETAMOL (TYLENOL) on 18-Jun-2021 for Cold, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (I was feeling like I'm on a ride at Disney when I stood up.), APHONIA (I woke up with no voice), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (nasal congestion / chest congestion), INSOMNIA (but couldn't fall asleep), CHEST DISCOMFORT (chest congestion.), CHILLS (chills), FATIGUE (was really tired, but couldn't fall asleep), VACCINATION SITE PAIN (my arm was sore at injection site), MYALGIA (I had body pain) and PYREXIA (fever/ fever of 100.4°F (my normal is 98.5°F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 38 degree Celsius Patient normal is 98.5°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.
had his third booster shot on 20Aug2021; had his third booster shot on 20Aug2021; got shingles; had a slight pain in the chest/ pain was on the patient's left chest and back; rash; pain was on the patient's left chest and back; This is a spontaneous report from a contactable consumer. A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0186), via an unspecified route of administration, administered in Arm Left on 20Aug2021 11:00 (At the age of 75 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation at Pharmacy. Medical history included Kidney transplant (patient got his kidney transplant 11 years ago). Concomitant medications included tacrolimus (TACROLIMUS) and mycophenolate mofetil hydrochloride (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]), both taken for an unspecified indication, start and stop date were not reported, high blood pressure medication, and cholesterol medication. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9266), via an unspecified route of administration, on 23Feb2021 (At the age of 74 years) as DOSE 1, SINGLE for covid-19 immunization and also received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration, on 16Mar2021 (At the age of 75 years) as DOSE 2, SINGLE for covid-19 immunization. Patient did not took other vaccination within 4 week of COVID vaccine. The patient had his third booster shot on 20aug2021 on 20aug2021, got shingles, had a slight pain in the chest/ pain was on the patient's left chest and back, rash, pain was on the patient's left chest and back on 2021. Event reported as, the patient had a slight pain in the chest area which is where the shingles started. The patient thought it was a back ache which began three days before the rash bloomed. The pain was on the patient's left chest and back. On 20Aug2021 the patient got the shot and he got the shingles medication on 26Aug2021. The patient clarified and confirmed that he had 3 doses total of the Pfizer covid vaccine. This event happened after the third dose. The patient said Aspercream helped a lot on the shingles. Adverse event resulted in physician office visit. Therapeutic measures were taken as a result of got shingles. At the time of reporting the outcome of the event shingles was recovering and for rest of the other events the outcome was unknown.  Follow-up attempts are completed. No further information is expected.
Ache: bones, joints, arrhythmia (AF), dry mouth, nausea, headaches, pain: lower back, bones and joints, right shoulder, hips and leg.
Moderna #1 given at 0815 and by 0835 was complaining of tingling and heavy eyelids, mouth felt "funny", no swelling, no SOB, sick to stomach, no N/V, later c/o itchy eyelids but never observed scratching.  Sent to the ER after an hour of monitoring and symptoms did not worsen but they also did not subside.
Information has been received from a current 56 year old male patient with a history of shingles (two cases) who at the age of 55 on 05-JUN-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not reported). The patient reported that on 04-JUN-2010 experienced a case of shingles. The patient called back and reported that he went to a dermatologist who verified that he had poison ivy and no shingles. At the time of the report, the patient had not recovered. Additional information has been requested.
I noticed two or three weeks after the first vaccine that my hips started hurting and occasional back pain and after the 3rd dose it seemed to come on a little stronger. There was typical soreness in my arm at injection sight. I didn't seek treatment until recently, March 2022. I just recently got my 4th vaccine on the 14th of April 2022.
DTAP, HIB, IPV and Prevnar were given on3/30/01 with > 3 hours screaming inconsolable.
Flushed face, "felt like I had a glass of wine."  Felt dazed.
pt recv vax 29AUG95 & 1SEP95 pt was seen in MD ofc w/t102 & bilat knots of swelling @ inj site which were 2-3cm in size;the pt was treated w/APAP & monitored;
I would compare my reaction to the vaccine to having malaria. I had two full days of fevers, extreme chills and body aches, hallucinations, vomiting, nausea, headaches/head pressure. It has been a week since my vaccine today and I am still experiencing some nausea and shortness of breath.
less than 24 hours later arm was red, sore, no fever, by Tuesday evening redness got brighter and swollen above elbow, bottom outer area where shot was.
fever, cough ,brain fog, chills, fatigue, headache, muscle aches, runny nose, sore throat