chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chronic Spontaneous Urticaria; This is a literature report.  A 35-year-old female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto disease" (unspecified if ongoing); "asthma" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing); "Ehlers-Danlos syndrome" (unspecified if ongoing). The patient had no previous COVID-19 infection diagnosed.  The patient's concomitant medications were not reported. The following information was reported: CHRONIC SPONTANEOUS URTICARIA (medically significant), 7 hrs after the suspect product(s) administration, outcome "recovering". Resolution reported as symptom control but no resolution. Therapeutic measures were taken as a result of chronic spontaneous urticaria, included Anti-H1, sCS.; Sender's Comments: Based on the known the information available the Causal relation between the event CHRONIC SPONTANEOUS URTICARIA  and suspect drug cannot be excluded completely The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : US-PFIZER INC-PV202300166685 Same article/ drug/patient/ different event;
Patient did not feel well after receiving vaccination.  Indicated that she developed a cough, shortness of breath and increased respirations and pulse.  She admitted to the hospital on 6/8/21 and was diagnosed with pneumonia.
BLOWS  THE NOSE; SORE THROAT; LIKE I HAVE A COLD; WATER GETS OUT FROM EYES; LEG FELT ICKY; LEG HURTS ALL THE TIME; DIARRHEA; COUGH WAS WITH SPUTUM AND  BLOOD COMES; HEADACHE; FEVER; CHILLS; This spontaneous report received from a patient concerned a 73 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included CHF, heart surgery, hospitalized for gall bladder issue, heart surgery for chronic AIFB, circulation problem, stomach issue, seasonal allergy, strawberry allergy, non-alcoholic, and non-smoker, and other pre-existing medical conditions included no drug abuse/illicit. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced headache. Laboratory data included: Headache (NR: not provided). On 09-APR-2021, treatment medications included: guaifenesin. On 12-APR-2021, the subject experienced cough was with sputum and blood comes. On 14-APR-2021, Laboratory data included: Headache (NR: not provided) SCALE 2. On an unspecified date, the subject experienced diarrhea, blows the nose, sore throat, like I have a cold, water gets out from eyes, leg felt icky, and leg hurts all the time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 09-APR-2021, and the outcome of diarrhea, headache, cough was with sputum and blood comes, blows the nose, sore throat, like i have a cold, water gets out from eyes, leg felt icky and leg hurts all the time was not reported. This report was non-serious.
Pt brought to ED after presenting with 1 week hx of cough, SOB and 2-3 day hx of nausea, decreased appetite, somnolence. Was found to be COVID positive (7/24) despite receiving Pfizer vaccines on 1/20 & 2/10. Was admitted for management of acute hypoxic respiratory failure secondary to COVID-19 PNA in which she received respiratory support via O2 and dexamethasone.  Was ultimately discharged w/home O2 therapy and follow-up on 7/28.
my arm is still hot; my arm is still swollen; my arm is still red; my arm is still hurts; This case was reported by a consumer via call center representative and described the occurrence of feeling hot in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th February 2020, the patient received Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced feeling hot, swelling arm, erythema of extremities and pain in arm. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the feeling hot, swelling arm, erythema of extremities and pain in arm were unknown.   It was unknown if the reporter considered the feeling hot, swelling arm, erythema of extremities and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and arm was still hot, red and swollen and hurts. The reporter asked how long would this last.
SOB, fever with chills, dyspnea, tachycardia,  PNA, cough
p/vax pt devel weakness in hands;had extensive eval in hosp;MRI revealed T2 hypersensitivity in cervical thoracic cord w/o cord expansion;1 white cell, 36 red cells, protein 23, glucose 61;felt to be transverse myelitis;positive EBV viral I
Nurse called to room by patient's mother.  Mom guided patient to floor and reported LOC. Patient awake, alert and oriented upon nurse arrival to room. Patient safely moved to examination table and asked to remain in supine position.  Nurse performed vitals every 5 minutes for 30 minutes until patient was assessed as stable by attending physician.
Pt started with fever and local reaction next day. Temp increased 105 on 3/5/16. Local swelling , erythema and pain at vaccination site -> ->. Pt seen in office then temp decreased 96 at nite and pt taken to ER. vs stable but due to increased erythema pt placed on BACTRIM po. Erythema and pain slowly resolved over approximately 7-10 days.
Client's mother in LHU for services today 10/4/07 - states daughter had reaction to Gardasil given on Monday, 8/27/07.  States Tuesday, she had fine rash all over body, went away by Wednesday afternoon.
On the 8th day after my 1st dose, the injection site swollen up about the size of a kiwi.; I had shallow breathing; felt like I smoked a joint/disoriented all day long.; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8732) via an unspecified route of administration in the left arm on 30Mar2021 at 13:00(at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had known allergy to penicillin(pcn). It was reported that the patient was healthy and did not have any health issues. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included modafinil (MANUFACTURER UNKNOWN) and quetiapine fumarate (SEROQUEL); both for an unknown indication from unknown date and unknown if ongoing. On 07Apr2021 at 04:00, On the 8th day after her first dose the patient reported that the injection site swollen up about the size of a kiwi, had shallow breathing and felt like she smoked a joint/disoriented all day long. she was completely fine until the 8th day. The 9th day the swelling subsided, but she had been slightly short of breath since then. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site swollen up about the size of a kiwi, shallow breathing and felt like she smoked a joint/disoriented all day long was recovered with sequelae on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
No adverse events reported by patient. Patient received beyond use date Pfizer vaccine. Pt aware and no unusual symptoms reported.
Patient came in for a Pfizer COVID Bivalent booster. Received a primary dose in error.
RUNNING FEVER, OFF AND ON 102.9 SEVERE REDNESS AT SITE POSSIBLE NECROSIS AT INJECTION SITE INDURATION 11 1/2 CM X 11 1/2 CM HEADACHE
About a week after my 2nd dose, I started having heart palpatations (PVC's).  The palpatations were infrequent at first, but after about 2 weeks post-2nd dose, they started increasing significantly. I was having dozens an hour for several weeks, and then slowly they started to slow down.  A year later, I still have a few/ day.  I had an EKG and Echo about a month after my second shot (May 2021) and I wore a holter monitor for 2 weeks about 10 months later (Feb 2021). Visited 3 different cardiologists.  All tests came back normal.
This spontaneous report as received from other health professional refers to a 22 year old patient. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, lot no. unknown). No concomitant medication was reported. On an unknown date the patient was mistakenly administered a dose of ZOSTAVAX instead of a dose of (Oka/Merck) VARIVAX. No adverse effects were reported. The outcome of events was unknown. Additional information has been requested.
Extreme fatigue (not experienced before - ongoing), joint pain (both knees, right hip - ongoing), neck pain, dizziness (brief), headache (daily for one week).
Symptom of dizziness after receiving the 1st dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Symptom of dizziness after receiving the 1st dose of vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, ALOGLIPTIN, GLIPIZIDE, EMPAGLIFLOZIN (JARDIANCE), CITALOPRAM HYDROBROMIDE, LISINOPRIL, ROSUVASTATIN, CALCIUM, FISH OIL, PANTOPRAZOLE, HYDROCHLOROTHIAZIDE, METAXALONE (FLEXURA), LORATADINE (CLARITIN [LORATADINE]) and PREGABALIN (LYRICA) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced DIZZINESS (Symptom of dizziness after receiving the 1st dose of vaccine). At the time of the report, DIZZINESS (Symptom of dizziness after receiving the 1st dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-058297 (Patient Link).
CoughWheeze swollen lymph node, swollen and redness on right arm, fatigue Narrative:
Covid toes, red tender slightly swollen toes with mild purple discoloration at the tip of toes, developed 3 days after receiving the first vaccine dosage in the series.  I have tested negative for covid as of 1/10/21.  It was initially thought that I had a skin infection from clipping my nails too short and was prescribed doxyclycline. I saw an improvement within a few days on the antibiotic but them saw a reappearance of the covid toes presenting symptoms on 1/8/21. I have since been told by a physician that I likely have covid toes and not a bacterial infection. I was told to take baby asprin and that is helping to reduce the symptoms.   In the past few weeks I have had no symptoms of Covid besides the appearance of covid toes. I understand that covid toes are often a latent symptom and that the timing of the appearance of this symptom could be coincidental. I am mildly concerned that the first vaccine dosage could have caused a flair up of a potential previous covid infection or could have caused the red covid toes symptom itself.
21FEB97 pt states started to get a rash all over body;DPH prescribed;
This patient is a 16yo who was given the Moderna vaccine for 1st dose at a different clinic, when presented to this clinic brought in card, asked for Moderna and was given the 2nd dose as a Moderna which is and unauthorized age group 12-17
patient with intermittent blurry vision, no headaches. will refer to ophthalmology
Pt received GARDASIL #1 on 8/3/09. Pt returned to office 8/31/09 and was pregnant. Lmp 7/25/09
Patient presented with redness, hives, and coughing 30 minutes after receiving DTAP, IPU, and MMR.
Patient was given a varicella on 1-2-08. Patient came in on 1-18-08 with complaint of spot on arm. Patient diagnosed with local reaction due to Varicella vaccine.
Mother noted twitching of hands and feet. He seemed very tired and had a fever of 103.5.
Began having itchy eyes and scratchy throat -- no aches, rash, no difficulty with breathing.
pt completed 2 doses series at age 11, no longer needing 3rd dose. 3rd dose was inadvertently given at age 15.
some heat coming off the area of injection; I have a large red spot; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (some heat coming off the area of injection) and VACCINATION SITE ERYTHEMA (I have a large red spot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced VACCINATION SITE WARMTH (some heat coming off the area of injection) and VACCINATION SITE ERYTHEMA (I have a large red spot). At the time of the report, VACCINATION SITE WARMTH (some heat coming off the area of injection) and VACCINATION SITE ERYTHEMA (I have a large red spot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.   Reporter did not allow further contact
Burning feeling in the left arm, patchy feeling of numbness of the left arm, feeling lightheaded, nauseated, chills.
Injection site inflamed; right arm was red; spots four inches wide by two inches high on his arm at the injection site; tiredness; achiness; feel crappy; headache; fever; stuffy nose; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site inflammation, injection site rash, tiredness, pain, feeling bad, headache, fever and nasal stuffiness. On an unknown date, the outcome of the injection site erythema, injection site inflammation, injection site rash, tiredness, pain, feeling bad, headache, fever and nasal stuffiness were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site inflammation, injection site rash, tiredness, pain, feeling bad, headache, fever and nasal stuffiness to be related to Shingrix.  Additional details were provided as follows: The patient received the injection on his right arm just below the deltoid muscle. The patient received Shingrix and within 36 hours he started to feel crappy and his right arm was red and inflamed and he has spots four inches wide by two inches high on his arm at the injection site. He was tired, achy, has a headache, fever, and a stuffy nose. He claims that he has all the side effects listed on our website for Shingrix. He reported that he started to get a little better and all his symptoms are back. He claims that he received the injection on his right arm just below the deltoid muscle. The reporter consented to follow up.
INITIAL REACTIONS WERE NORMAL; SMALL FEVER, TIRED AND SORE ARM, LASTED 1 DAY. ABOUT 30 DAYS OR MORE POST SECOND SHOT I WENT INTO A-FIB. I HAD A CARDIAC ABLACION PERFORMED ON MAY 4. I WAS HOSPITALIZED FOR 3 NIGHTS IN JUNE WITH WHAT WE BELIEVE WAS PERICARDITIS.
Resting heart beat went from 65 to 40 BPM started to raise and then dropped back to 40BPM for two weeks. ECG measurements indicated AFIB. After approximately 6 weeks I was back to normal and getting SINUS RYTHMS.  I have  data to prove this. I visited a cardiologist during this time.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # L034367, exp. 18-SEP-2017, dose and route of administration was unknown). No concomitant therapy was unknown. The vaccine was exposed to an unspecified number of defrost cycles which went up to maximum of 14.7 F. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the two reports from the same reporter link. Additional information has been requested.
pt recvd vax; exp swelling at site of inject & induration of eight & a half by six cm; 23oct95 allergist placed pt on atbs for cellulitis;
while administering FLUZONE HD QIV, complications with either the needle or syringe led to some of the vaccine leaking out, and the patient did not receive the full dose of the vaccine/no AE; while administering FLUZONE HD QIV, complications with either the needle or syringe led to some of the vaccine leaking out/no AE; Initial information was received on 10-Nov-2021 regarding an unsolicited valid non-serious case received from a pharmacist via Medical Information - 00852341.  This case involves a 65 year-old male patient who did not receive the full dose of the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] because there was complications with either the needle or syringe led to some of the vaccine leaking out (Underdose) (Syringe leak).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On 08-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (pre-filled syringe; lot UJ766AA and expiry date not reported) via an intramuscular route at the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to vaccine under dose (latency was on same day).   It was also a case of syringe leak.  At the time of report, no adverse event reported.   Outcome of event was unknown.   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.
chills; headache; extreme nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache), NAUSEA (extreme nausea) and FATIGUE (fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced CHILLS (chills), HEADACHE (headache), NAUSEA (extreme nausea) and FATIGUE (fatigue). At the time of the report, CHILLS (chills), HEADACHE (headache), NAUSEA (extreme nausea) and FATIGUE (fatigue) had not resolved. Not Provided          No concomitant medications were reported.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Potentially excessive doses. The Registry identified that the record of this patient had received a first dose of vaccine at a different clinic 1 week prior to receiving a first dose of Pfizer at our clinic. The other clinic was doing a community outreach through the Institute and recording giving a vaccine to someone with the same name and date of birth. When I spoke with the patient, who is an employee at our university, she denied receiving a vaccine from anywhere else. The person who received their first dose of vaccine at the other clinic cancelled their second dose appointment. The patient maintained that she had only received one dose so we made the decision to provide her a second dose. It is possible this was a third dose and the patient was not forthcoming about this; it is also possible there was someone else with the same name and birthdate; another possibility is that someone was utilizing this patient's identity to receive the vaccine. We will attempt to follow up to make sure there is not someone else that needs a second dose.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, vaccine lot unknown, vaccine dose number unknown: True, vaccine lot unknown reason: misplaced/discarded, vaccine dose number unknown reason: unknown), on 05Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "heart disease" (unspecified if ongoing). known allergies: No. Concomitant medication(s) included in 2 weeks: GLIPIZIDE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Took paxlovid tested; (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti viral details: product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 12Aug2022, treatment stop date: 15Aug2022, indication: Treatment of COVID-19. Adverse event: took Paxlovid tested negative and have a rebound case. Adverse event start date: 20Aug2022. if patient recovered: not recovered.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The above is unknown, the patient received the Janssen (J&J) vaccine at a pharmacy. The patient has had a high fever, nausea and vertigo.  The patient had body aches lasting 3 days and described a chemical taste in mouth that occurred immediately after vaccination.  The patient still reports a HA, other symptoms have subsided.