chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sky high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (sky high blood pressure) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Liver resection in 2018. Concurrent medical conditions included Cancer (Liver cancer). Concomitant products included LENVATINIB MESILATE (LENVIMA) for Cancer of liver, primary.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced HYPERTENSION (sky high blood pressure). The patient was treated with LOSARTAN (oral) in February 2021 for Hypertension, at an unspecified dose and frequency and AMLODIPINE (oral) in February 2021 for Hypertension, at an unspecified dose and frequency. At the time of the report, HYPERTENSION (sky high blood pressure) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt recv vax; wheezing & hives 4 days p/ vax;tx in ER;MD does not believe rxn related to vax;
Pfizer-BioNTech  COVID-19 Vaccine EUA  Fevers of 101.2 degrees F, on and off starting  from 10 hours after receiving vaccine lasting for 100 hours. Body aches, muscle weakness, severe muscle and joint pain in lumbar spine, SI joint and hips. Making it extremely difficult to move. Headaches. Loss of appetite. Swollen tonsils and lymph nodes- neck and inguinal. Swollen left arm around injecting site. Stiffness and pain in shoulder joint- unable to lift arm more than 40%. Extreme fatigue starting 5 hours after injection lasting 96 hours. Felt like a severe case of influenza.
Pt received a Pfizer booster for pediatrics that had expired 6 days prior. No adverse reaction noted. Pt is not immunocompromised.
fever/Her body is very hot (99.8F); This is a spontaneous report from a contactable consumer.   A female patient (mother of the reporter) of an unspecified age receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient woke up with fever on 19Dec2020 with outcome of unknown. Her body was very hot. The temperature was 99.8F.  Information about lot/batch number has been requested.
Patient reported to ED with complaints of weakness, shortness of breath, burning sensation throughout his body, and numbness in his arms and legs, progressively worsening since receiving his Pfizer COVID vaccination approximately 3 weeks prior.  Patient's CBC and other labs have all been normal last few days including his thyroid and other testing today we did the lumbar puncture which shows a normal glucose and normal protein.  Spinal fluid there was no detection of any bacterial fungal or bacterial components.  Case was discussed again with Neurology with a negative LP highly unlikely this is Guillain-Barre has no signs of any transverse myelitis or other myelopathy that we can see at this time with his symptomatology I do not think he needs to be admitted there would be no benefit in outpatient management is warranted he will be followed up in the neuro clinic and was given the referral if he has any problems or concerns before then he will return here.
24hrs post vax pt turned cold & clammy & pale for 5-6hrs;
lightheaded, nausea, feels like unable to get enough air. Observed for one hour lying down. Symptoms persisted. EMS called and transported to local ED.
During my first period after receiving the vaccine, I experienced markedly worse menstrual cramps than usual throughout the day. I took Midol extra strength to combat the pain. I couldn't sleep until approximately 2:30 am, and I woke up at 4:00am due to the pain. I noticed that my vagina itself was swollen on the inside and essentially numb - even as my abdomen was cramping painfully. After sitting in the bathroom for a while, I tried to stand. At that point, I briefly passed out and collapsed into the bathtub. This has never happened before in my life.
Hospitalized 12/3/2021; COVID-19 positive 12/3/2021; fully vaccinated  BRIEF OVERVIEW: Discharge Provider: DO Primary Care Provider: DO Admission Date: 12/3/2021 Discharge Date: Dec 5, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute hypoxemic respiratory failure (HCC) [J96.01] COVID-19 [U07.1]   HOSPITAL COURSE:   66-year-old female with PMH of hypertension, hypothyroidism, obesity, gastritis, depression anxiety, vitamin-D deficiency, who presented on 12/03/2021 with cough and shortness of breath since Sunday 11/28/21.  Found to COVID-19 positive.  Patient has been vaccinated x3.  Admitted for COVID-19 pneumonia.   Throughout admission, patient was requiring minimal oxygen requirement with only 2 liter nasal cannula.  Hemodynamically stable.  She was started on dexamethasone.  Not a candidate for remdesivir or monoclonal antibody.  She received Lovenox for DVT prophylaxis.  Low suspicion for PE.   She had some mild laboratory abnormalities, including mild hyponatremia 132. Home lisinopril-hydrochlorothiazide was held, replaced by lisinopril only during admission. Sodium normalized the following day.  She also had mild elevated ALT 42, which normalized the following day.  CRP on admission was 148, trended down to 49 on day of discharge.    Given patient's overall benign clinical course, she was discharged with instructions to follow-up with COVID-19 at home program.  Discharged home on 2 liters oxygen.
3 days post vaccination developed subjective fever, myalgia.  15 days after vaccination presented to ED with periorbital swelling, found to have nephrotic-range proteinuria.  This will be the first renal manifestation of her lupus.
been 3 year from the first Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years before the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was self reported by the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter reported that if it had been 3 year from the first Shingrix vaccine was there a need to start over. Follow up would not be possible, as contact details were not provided.
Heart attack (episodes); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "Heart attack (episodes)".  Clinical course: Sent this letter for information only. They live an Independent Living facility and had the Pfizer COVID-19 vaccine on schedule as recommended by the CDC. There have been five of them on one floor that have had heart issues after receiving the vaccine. Patient one had Heart attack (episodes), second had Procedure to get heart in Sync, third and fourth had Pacemaker, fifth patient had A-Fib that has worsened. They thought this might be information worth nothing.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
tested positive for covid; diarrhea; stomach upset; nausea; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid), DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (stomach upset) and NAUSEA (nausea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, CLONIDINE, DILTIAZEM, GABAPENTIN, LOSARTAN, QUETIAPINE, TRAMADOL, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HCTZ), INSULIN ASPART (NOVOLOG) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced COVID-19 (tested positive for covid), DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (stomach upset) and NAUSEA (nausea). The patient was treated with ONDANSETRON ongoing since an unknown date at an unspecified dose and frequency; DIAZEPAM at an unspecified dose and frequency; HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE [HYDRALAZINE HYDROCHLORIDE]) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; PANTOPRAZOLE ongoing since an unknown date at an unspecified dose and frequency; BAMLANIVIMAB at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ACRIVASTINE (BENADRYL [ACRIVASTINE]) at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for covid), DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (stomach upset) and NAUSEA (nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) tested positive for COVID-19.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       On 11Feb2021, the patient visited ER and received infusion of Bamlanivimab
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "known allergies Erythromycin", notes: known allergies Erythromycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 15Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Itching and erythema at injection site the evening of the vaccine administration. Spreading erythema two days after injection at the injection site with some swelling. Pt reports no pain, no fever or shortness of breath. Recommendation cetirizine 10mg daily as needed for itching, erythema and swelling. Observe site and call if symptoms worsen.
Information has been received from a nurse practitioner for the pregnancy registry for GARDASIL, concerning a female patient with a history of miscarriage who on 22-MAY-2008 was vaccinated with a dose of GARDASIL (lot # 660389/1968U) intramuscularly.  The nurse practitioner reported that on 05-JUN-2008, the patient had a miscarriage.  The last menstrual period and weeks gestation was not reported.  It is unknown if the patient sought medical attention.  A lot check has been initiated.  Upon internal review, miscarriage was considered an other important medical event.  Additional information has been requested.
Vaginal yeast infection; Soreness in my arm for a few days; This case was reported by a other health professional via interactive digital media and described the occurrence of vaginal yeast infection in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced vaginal yeast infection and pain in arm. On an unknown date, the outcome of the vaginal yeast infection was not recovered/not resolved and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the vaginal yeast infection and pain in arm to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The patient received Shingrix a week before the date of reporting. The patient had the soreness in her arm for a few days but it was gone away.  Now she was experiencing symptoms of vaginal yeast infection for a few days. The patient asked if there were any chance the Shingrix shot could have triggered this or was just a coincidence.
Following administration of both BEXSERO vaccines (0 and 6 months), patient developed fatigue and myalgias. He also developed redness at the injection site. Treatment was supportive.
Pt vaccinated with DTP developed a red, indurated area of 4 cm with Erythema. Treated with Ice pack.
I felt impaired  (similar to being intoxicated) about a half hour to an hour later.  I had trouble saying some words., like my brain and my mouth weren?t communicating effectively.  My heart was racing at times and I was  a little short of breath. All of this subsided a few to a couple hours later. I then just became extremely fatigued,  sometimes light headed, with a slight headache and back ache. My arm hurts a little, but not near as bad as shot one. I ended up taking two days off of work to sleep and recover.
vertigo; Blood pressure went up so high; Nausea; terrible brain fog; anxiety so bad couldn't leave the house; sick; caller topples over all the time; hasn't been able to work; tunnel vision; feeling like half dead; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0178; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in right arm on 08Jun2021 as single dose for COVID-19 immunisation. The patient's medical history included tachycardia (has had tachycardia for probably 20 years), she was tested for red measles when pregnant and had no antibodies and was not protected, as soon as delivered child had to get that vaccine. The patient's concomitant medications were not reported. The patient previously received measles vaccination for immunization and smallpox vaccine for immunization (The caller also states when she received the smallpox vaccine and it never left an indentation on the caller's arm.). Vaccine was not administered at military facility. The patient experienced tunnel vision on Jun2021, feeling like half dead on Jun2021, vertigo on 09Jun2021, topples over all the time on Jun2021, hasn't been able to work on Jun2021, blood pressure went up so high on 08Jun2021, nausea on 08Jun2021, terrible brain fog on 08Jun2021, anxiety so bad couldn't leave the house on 08Jun2021, sick on Jun2021. The events resulted in emergency room visit. The patient underwent lab tests and procedures which included blood pressure: 110/80 (blood pressure was taken prior to receiving the first dose Pfizer Covid Vaccine and it was 110/80) on 08Jun2021 and 146/80 (The caller was released from the emergency room when the blood pressure went down to 146/80 something) on Jun2021; EKG: heart attack and enzymes were tested and stuff (The caller was monitored, given an EKG and of course because of high blood pressure thought the caller may have a heart attack and enzymes were tested and stuff) on 08Jun2021. The outcome of the events tunnel vision, nausea and terrible brain fog was recovering, and the outcome of the other events was unknown.
expired ACT-HIB was administered to a patient with no reported adverse event; Initial information received on 22-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves 19 months old female patient who was administered expired haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for Immunisation.  On 15-Sep-2023, the patient received a standard expired dose 4 of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection at a dose of 0.5 ml total (lot UJ798AB, expiry date- 11-SEP-2023) via intramuscular route in the right thigh for Immunization with no reported adverse event (expired product administered) (latency- same day).  Caller asks if the efficacy of ACT-HIB is diminished after 11Sep2023, of if it is still good for a certain amount of time after the expiration date?   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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.
Hives/redness on trunk and head. Difficulty hearing with slight difficulty breathing. Self-treated w/ Benadryl 50mg.
Generalized macular-papular eruption beginning 08/10/2003. Petechiae on face beginning 08/10/2003
This spontaneous report was received from a physician via a Company representative concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 21-DEC-2015, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336 (dose, route and the expiration date were not reported). The total cumulative hours out of range were 64 hours with 48 degrees C as the highest recorded temperature. On the other hand, the total cumulative hours out of range were 328 hours with 29 degrees C, 304 hours with 33 degrees C, 88 hours with 30 degrees C, 40 hours with 34 degrees C as the lowest recorded temperature. The storage type was a refrigerator. There was no concomitant medication provided nor no Product Quality Complaint(PQC) involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Initial information received on 07-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 21-years old female patient who received a partial dose of vaccine TYPHIM VI and was revaccinated with another dose. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Nov-2018, the patient received a dose (less than 0.5 mL) of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot N1K811M via intramuscular route in the left deltoid. On 29-Nov-2018, she revaccinated with a dose of the same vaccine (batch number: N1K901M, expiry date: 24-Oct-2019), via unknown route in unknown administration site. It was actual medication error case due to vaccine underdose and syringe leak. It was reported that the vaccine leaked out from leak out between the plastic hub and the syringe, not between the needle and the hub. It was not reported whether the patient had any 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 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. List of documents held by sender: none.
Experienced rash in both arms; This is a spontaneous report from a non-contactable consumer (patient) reporting for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, NDC number and Expiry date are not provided), via an unspecified route of administration, administered in arm on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Investigation assessment was not provided. On an unspecified date, the patient experienced rash in both arms. The clinical course was reported as follows: The reporter stated that she received her first Pfizer covid vaccine and experienced rash in both arms. Started in the injection arm below the site. The rash was on the arm the shot was in, but not where they put it, it was right below it. Now, it's moved to the other arm. She wanted to know about it. She was wondering if it was normal to have a rash after the first Pfizer Covid vaccine. The paperwork given where she got the shot didn't say anything about a rash. The case was reported as non-serious. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
"Patient c/o frontal headache with sinus pressure x 4 days. She has no tenderness with sinus palpation, denies any sinus drainage or congested. She received her second covid vaccine 4 days ago. She has no pain or swelling at injection site. She reports her headache started about 12 hours after her shot."
Severe headache, burning skin, odd pressure in head, dizziness, odd feeling overall, exhaustion, night sweats, difficulty sleeping, fever,, swollen lymph nodes all over, rash at injection site, swelling, loss of appetite, uneasy feeling, pain at back of head, burning muscles, vision disturbance. Unlike anything I have ever experienced. Tried ibuprofen, Tylenol, prednisone, Valium, clonazepam, nothing helped. I missed time from work and I?m still experiencing odd lingering  symptoms that are disrupting my life and require ongoing care. I am scared to say the least. I Don?t understand what happened to me or how to fix it and that scares me
Client presented to clinic for second dose of covid vaccine.  Site had Pfizer.  Client presented vaccine card and nurse looked at it and did not review it properly to see that client had Moderna as their first dose. Client was vaccinated with Pfizer for their second dose.  Client was aware.  Left clinic with no side affects.
30 minute monitoring required d/t reported anaphylaxis to Bee's. Tingling all over with itching sensation to the throat at 15 minute mark. No respiratory distress and PCP and pharmacy onsite gave Benadryl 25mg PO at 1145am. Tingling was slowly improving at 1200. Left with no further reaction/complaint at 1210pm.